A Study to Evaluate the Safety, Pharmacokinetics and Effi... | NCT02569710 | Trialant
NCT02569710
Sponsor
Alios Biopharma Inc.
Status
Completed
Last Update Posted
Jul 16, 2019Actual
Enrollment
161Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C
Interventions
AL-335
Odalasvir (ODV)
Simeprevir (SMV)
Countries
Mauritius
Moldova
New Zealand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02569710
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AL-335-604
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
Official Title
A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis
Acronym
Not provided
Organization
Alios Biopharma Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 31, 2015Actual
Primary Completion Date
May 11, 2018Actual
Completion Date
May 11, 2018Actual
First Submitted Date
Oct 1, 2015
First Submission Date that Met QC Criteria
Oct 5, 2015
First Posted Date
Oct 7, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 9, 2019
Results First Submitted that Met QC Criteria
Jun 24, 2019
Results First Posted Date
Jul 16, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 24, 2019
Last Update Posted Date
Jul 16, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alios Biopharma Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis C
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
161Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV
Experimental
Treatment-naïve non-cirrhotic Hepatitis C virus (HCV)-infected participants will receive AL-335 and Odalasvir (ODV) with Simeprevir (SMV) for 8 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohort 1b (Without Cirrhosis) : AL-335+ODV
Experimental
Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV for 8 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV
Experimental
Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV for 6 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohort 4 (Without Cirrhosis) : AL-335+ODV
Experimental
Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV up to 8 or 12 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV
Experimental
Treatment-naïve non-cirrhotic HCV-infected participants will receive AL-335 and ODV with SMV up to 8 or 12 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AL-335
Drug
AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).
Cohort 1b (Without Cirrhosis) : AL-335+ODV
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Up to 43 weeks
Body Weight at End of Treatment
Body weight (measured using a calibrated scale) at end of treatment was reported.
End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Body Mass Index (BMI) at End of Treatment
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.
Up to 43 weeks
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (<) Lower limit of quantification (LLOQ) (<15 international unit per milliliter [IU/mL]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant has provided written consent
In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned
Male or female, 18-70 years of age
Body mass index (BMI) 18-35 kilogram per meter square (kg/m^2), inclusive
A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening
Female participants must either:
not be of childbearing potential defined as: i. Postmenopausal for at least 12 months (that is [i.e.], 2 years of amenorrhea without an alternative medical cause) and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (per reference laboratory), OR ii. Surgically sterile (example [e.g.], underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant, OR
be of childbearing potential AND
not heterosexually active (e.g., abstinent or homosexual) from screening until 6 months after study drug administration (or longer, if dictated by local regulations), OR
if heterosexually active
have a vasectomized partner (confirmed sterile per verbal account of the participant), OR
using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration (or longer, if dictated by local regulations). Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An intrauterine device (IUD), being either hormonal (i.e., Intra-Uterine System [IUS*]) or non-hormonal, is considered highly effective and reliable; therefore participants using an IUD/IUS are not required to use additional contraceptive methods (no double-barrier method is required). Other non-oral hormone-based contraception methods (e.g., injectable, implants, transdermal system, vaginal ring) may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore participants should use a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).
An IUS does not rely on systemic plasma concentrations and is therefore not expected to be impacted by a potential drug-drug interaction (DDI)
Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction
A post-menopausal female who is receiving hormone replacement therapy and is willing to discontinue hormone therapy 30 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation.
Male participants must either:
be surgically sterile (had a vasectomy), or otherwise incapable of fathering a child, OR
not be heterosexually active (e.g., abstinent or homosexual) from enrollment (Day 1) in the study until at least 6 months after study drug administration, OR
if heterosexually active:
have a partner who is postmenopausal (2 years amenorrhea), surgically sterile (e.g., has had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant OR
be practicing an acceptable method of birth control from enrollment in the study (Day 1) and agree to continue to use the same method of contraception throughout the study and for at least 6 months after study drug administration (or longer, if dictated by local regulations). An acceptable method of birth control for male participants is a double-barrier method (e.g., male condom+either diaphragm or cervical cap with or without spermicide).
Note: Male participants with a female partner who uses hormonal contraceptives (oral, injectable, implants) or a hormonal (IUS) or non-hormonal IUD and male participants who are vasectomized or otherwise incapable of fathering a child are not required to use additional contraceptive methods.
Note 1: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
Note 2: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
NOTE: Contraceptive use by men and women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria
Participants must agree to refrain from sperm/egg donation from start of dosing through 6 months after the completion of study drug administration
Genotype (GT) 1a or 1b or GT2 or 3 chronic hepatitis C (CHC), depending on cohort, with positive Hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA) at screening including documentation of CHC infection for at least 6 months. Genotype testing must occur at a screening visit. NOTE: GT1 patients are eligible for inclusion even if they cannot be successfully subtyped unless a specific subtype is required for a cohort
Screening HCV RNA viral load greater than or equal to (>=) 50,000 International Units per milliliter (IU/mL), except for participants with compensated cirrhosis (Child Pugh Class A) who may have HCV RNA viral load >=10^4 IU/mL
No prior treatment for CHC (defined as no prior exposure to any approved or investigational drug including direct-acting antivirals, and interferon-based treatments)
Fibroscan, collected within 6 months of baseline visit, with liver stiffness score less than or equal to (<=) 12.5 kilo Pascal (kPa) to be eligible (except for participants with cirrhosis, see below).
participants with compensated cirrhosis must meet the Child-Pugh Class A definition (see Appendix G) and at least one of the following criteria: i. Liver biopsy result indicating the presence of cirrhosis (e.g., Metavir F4; Ishak >5) or ii. Fibroscan evaluation with a liver stiffness score >12.5 kPa
Participant is otherwise in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECG)
Willing to avoid prolonged sun exposure and use of tanning devices while taking Simeprevir (SMV) and through 4 weeks of follow up. Participant should also be advised to use a broad-spectrum sunscreen and lip balm of at least sun protection factor >30 to help protect against potential sunburn
Exclusion Criteria:
Pregnant, planning on becoming pregnant (during treatment and up to 6 months after the end of treatment [EOT]), or breast-feeding female participant, or male participant whose female partner is pregnant or planning on becoming pregnant (during treatment and up to 6 months after the EOT)
Other than CHC with or without compensated cirrhosis, clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator and/or Sponsor's Medical Monitor
History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant ECG abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening
Screening echocardiogram ejection fraction <55 percentage (%) or any other echocardiographic finding suggestive of clinically relevant cardiomyopathy
Creatinine clearance of <60 mL/min (Cockcroft-Gault)
Positive test for Hepatitis A virus immunoglobulin (HAV) Immunoglobulin M (IgM), Hepatitis B surface antigen (HBsAg), or Human Immunodeficiency Virus (HIV) Ab
Abnormal screening laboratory results that are considered clinically significant by the investigator
History of clinical hepatic decompensation, e.g., variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within last year)
Any condition that, in the opinion of the investigator, would compromise the study's objectives or the well-being of the participant or prevent the participant from meeting the study requirements
Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to study medication
Clinically significant abnormal screening ECG findings (e.g., PR >200 msec, QRS interval >120 millisecond (msec) or corrected QT interval (QTc) >450 msec for male participants and >470 msec for female participants), based on an average of triplicate ECGs. Any evidence of heart block or bundle branch block is also exclusionary
History or family history of abnormal ECG intervals, for example prolonged QT syndrome (torsade de pointes) or sudden cardiac death
The participant has a positive prestudy drug screen, including methadone unless the drug is prescribed by the participant's physician. The list of drugs that should be screened for includes amphetamines, barbiturates, cocaine, opiates, phencyclidine (PCP), and benzodiazepines
Laboratory abnormalities including:
Hematocrit <0.34
White blood cell counts <3,500/millimeter (mm)^3 (<1,000/mm^3 for participants with compensated cirrhosis)
Absolute neutrophil count <1,000/mm^3 (<750/mm^3 for participants with compensated cirrhosis)
Platelets <=120,000/mm^3 (platelets ≤90,000/mm^3 for participants with compensated cirrhosis)
Glycosylated hemoglobin (HbA1C) >55 mmol/mol
Prothrombin time >=1.5 * upper limit of normal (ULN)
Albumin <=32 gram per liter (g/L), bilirubin >=1.5 milligram per deciliter (mg/dL) at screening (participants with documented Gilbert's disease allowed)
Serum ALT concentration >=5* ULN
CK >1.5* ULN A single repeat laboratory evaluation under appropriate conditions (e.g., fasted, no antecedent exercise) is allowed for eligibility determination
Any condition possibly affecting drug absorption (e.g., gastrectomy or other significant gastrointestinal tract surgery, such as gastroenterostomy, small bowel resection, or active enterostomy)
Clinically significant blood loss or elective blood donation of significant volume (i.e., >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of first dose of study drug
Evidence of clinically relevant active infection that would interfere with study conduct or its interpretation
History of regular alcohol intake >10 standard drinks per week of alcohol for females and >15 standard drinks per week for males (one unit is defined as 10 g alcohol) within 3 months of the screening visit
The use of prohibited medications, including prescription, over the counter (OTC) medications, herbal medications, inducers or inhibitors of Cytochrome P450 (CYP450) enzymes or drug transporters (including P-gp) within 14 days prior to the first dose of study medication is excluded, unless previously approved by the Sponsor's Medical Monitor. NOTE: Chronic medication use is permitted so long as they are medically necessary, deemed acceptable by the Principal Investigator and Medical Monitor, and not Prohibited Medications (see Section 5.12)
Hypersensitivity to the active substances (including sulfa allergy) or to any of the excipients of AL-335, Odalasvir (ODV) or SMV
Evidence on recent (within 6 months) liver ultrasound of hepatic mass or lesion concerning for malignancy (participants with cirrhosis only)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Alios Biopharma Inc. Clinical Trial
Alios Biopharma Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
CAP Research Ltd
Phoenix
Mauritius
Republican Clinical Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
No participants were recruited for Cohorts 10 and 12, hence no data is reported here for these two cohorts.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
FG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 3, 2017
May 9, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV
Experimental
Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 8 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
Experimental
Treatment naïve or treatment experienced HCV-infected participants with compensated cirrhosis will receive AL-335 and ODV with SMV for 12 weeks.
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohorts 12 to 15: AL-335+ODV With/without SMV
Experimental
Based on safety, pharmacokinetic (PK), and viral load data, the treatment duration (4 to 12 weeks) and dose levels (AL-335: 400-1,200 milligram [mg], ODV: 25-50 mg with/without SMV: 75-150 mg) may be changed for ongoing and future cohorts (up to 15) after obtaining agreement from the Sponsor and the Principal Investigator.
Drug: AL-335
Drug: Odalasvir (ODV)
Drug: Simeprevir (SMV)
Cohort 4 (Without Cirrhosis) : AL-335+ODV
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV
Cohorts 12 to 15: AL-335+ODV With/without SMV
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
Odalasvir (ODV)
Drug
ODV capsules will be administered in a dose range of 25 to 50 mg.
Cohort 1b (Without Cirrhosis) : AL-335+ODV
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV
Cohort 4 (Without Cirrhosis) : AL-335+ODV
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV
Cohorts 12 to 15: AL-335+ODV With/without SMV
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
ACH-3102
Simeprevir (SMV)
Drug
SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
Cohort 3 (Without Cirrhosis) : AL-335+ODV+SMV
Cohort 5 (Without Cirrhosis) : AL-335+ODV + SMV
Cohorts 1 and 2 (Without Cirrhosis) : AL-335+ODV+SMV
Cohorts 12 to 15: AL-335+ODV With/without SMV
Cohorts 6, 7, 8 and 12 (With Cirrhosis) : AL-335+ODV+SMV
Cohorts 9, 10 and 11 (With Cirrhosis) : AL-335+ODV+SMV
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Baseline up to End of treatment (up to 43 weeks)
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Up to 43 weeks
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Up to 43 weeks
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.
Up to 43 weeks
At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Simeprevir
Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Simeprevir
Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Simeprevir
Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Simeprevir
Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Simeprevir
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) of Simeprevir
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Simeprevir
Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmin of Odalasvir
Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Cmax of Odalasvir
Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Ctrough of Odalasvir
Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tmax of Odalasvir
Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-last) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
AUC (0-24) for Odalasvir
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Tlast of Odalasvir
Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
Percentage of Participants With Virologic Relapse During the Follow-up Period
Viral relapse is defined as participants SVR12, with HCV RNA <LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow up.
Follow up period (Up to Week 12 after end of treatment)
Percentage of Participants With On-treatment Failure
On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA >= LLOQ at the actual end of study drug treatment.
Up to 12 weeks
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.
Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Percentage of Participants Who Achieved HCV RNA <LLOQ
Percentage of participants who achieved HCV RNA \
Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.
Up to Week 24 (follow up visit)
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Up to Week 24 (Follow up visit)
Chisinau
Moldova
Auckland Clinical Studies
Auckland
1150
New Zealand
Christchurch Clinical Studies Trust
Christchurch
8011
New Zealand
Waikato Hospital
Hamilton
New Zealand
P3 Research Ltd - Hawkes Bay
Havelock North
New Zealand
P3 Research Ltd - Wellington
Wellington
New Zealand
Wellington Hospital
Wellington
New Zealand
King's College Hospital
Brixton
United Kingdom
NHS Greater Glasgow and Clyde Glasgow Royal Infirmary
Glasgow
United Kingdom
Pennine Acute Hospitals Trust
Oldham
United Kingdom
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
FG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
FG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
FG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
FG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
FG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
FG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
FG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
FG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
FG00020 subjects
FG00125 subjects
FG00220 subjects
FG00320 subjects
FG0048 subjects
FG0055 subjects
FG00614 subjects
FG00730 subjects
FG00815 subjects
FG0094 subjects
COMPLETED
FG00019 subjects
FG00125 subjects
FG00220 subjects
FG00320 subjects
FG0047 subjects
FG0054 subjects
FG00612 subjects
FG00730 subjects
FG00814 subjects
FG0094 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Virologic failure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
BG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
BG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
BG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
BG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
BG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
BG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
BG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
BG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
BG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00125
BG00220
BG00320
BG0048
BG0055
BG00614
BG00730
BG00815
BG0094
BG010161
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00056(30 to 61)
BG00155(29 to 64)
BG00256(36 to 62)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0018
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00020
BG00117
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United Kingdom
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00017
OG00119
OG00214
OG003
Primary
Body Weight at End of Treatment
Body weight (measured using a calibrated scale) at end of treatment was reported.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Posted
Mean
Standard Deviation
Kilograms (kg)
End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Primary
Body Mass Index (BMI) at End of Treatment
BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Posted
Mean
Standard Deviation
Kilograms per square meter (Kg/m^2)
End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Primary
Percentage of Participants With Worst Post-Baseline Values of Vital Signs
Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Primary
Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction
Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Baseline up to End of treatment (up to 43 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters
Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters
Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)
Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Primary
Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)
Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Primary
Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters
Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 43 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment
Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (<) Lower limit of quantification (LLOQ) (<15 international unit per milliliter [IU/mL]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
95% Confidence Interval
Percentage of participants
At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/ml)
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/mL
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Secondary
Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis. Here, 'n' signifies the number of participants analyzed for specified analyte.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Secondary
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
nanogram*hours per milliliters (ng*h/mL)
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Secondary
Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)
Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Secondary
Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)
Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227
Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Cmin of Simeprevir
Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Cmax of Simeprevir
Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Ctrough of Simeprevir
Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Tmax of Simeprevir
Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
AUC (0-last) of Simeprevir
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng*h/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
AUC (0-24) of Simeprevir
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Clast of Simeprevir
Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Tlast of Simeprevir
Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir
Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG002
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
Secondary
Cmin of Odalasvir
Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Cmax of Odalasvir
Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Ctrough of Odalasvir
Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Tmax of Odalasvir
Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
AUC (0-last) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng*h/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
AUC (0-24) for Odalasvir
AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Clast of Odalasvir
Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Tlast of Odalasvir
Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Median
Full Range
Hours
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir
Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).
PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.
Posted
Mean
Standard Deviation
ng/ml
Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)
ID
Title
Description
OG000
Cohort 1
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 + Cohort 3 + Cohort 5
Secondary
Percentage of Participants With Virologic Relapse During the Follow-up Period
Viral relapse is defined as participants SVR12, with HCV RNA <LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow up.
Safety set included all participants enrolled into study who had received at least 1 dose of any study drug, whether prematurely withdrawn from study or not.
Posted
Number
Percentage of participants
Follow up period (Up to Week 12 after end of treatment)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Secondary
Percentage of Participants With On-treatment Failure
On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA >= LLOQ at the actual end of study drug treatment.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Up to 12 weeks
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Secondary
Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable
Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Secondary
Percentage of Participants Who Achieved HCV RNA <LLOQ
Percentage of participants who achieved HCV RNA \
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of participants
Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Secondary
Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA
Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Data was not collected and analyzed for this outcome measure as per the change in planned analysis.
Posted
Up to Week 24 (follow up visit)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
Secondary
Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Participants who had virologic failure were included in this outcome measure.
Posted
Count of Participants
Participants
Up to Week 24 (Follow up visit)
ID
Title
Description
OG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
OG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
OG002
Time Frame
Up to 43 weeks
Description
Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 (8 Weeks Genotype [GT1])
Cohort 1 (Participants without Cirrhosis) received single dose of AL-335 400 milligrams (mg) tablets once daily (QD), odalasvir (ODV) 50 mg tablet and simeprevir 100 mg tablet QD for 8 weeks.
0
20
1
20
17
20
EG001
Cohort 1b + Cohort 4 (8 Weeks GT1)
Cohort 1b (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets every other day (QOD) for 8 weeks; Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 8 weeks.
0
25
2
25
20
25
EG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
0
20
0
20
14
20
EG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
0
20
0
20
14
20
EG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
0
8
0
8
7
8
EG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
0
5
0
5
4
5
EG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
0
14
0
14
13
14
EG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
0
30
1
30
18
30
EG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
0
15
2
15
10
15
EG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
0
4
1
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrioventricular Block Second Degree
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG0030 affected20 at risk
EG004
Pain
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Transitional Cell Carcinoma Urethra
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG0030 affected20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Atrioventricular Block First Degree
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Porphyria Non-Acute
Congenital, familial and genetic disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Ear Discomfort
Ear and labyrinth disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Ear Pruritus
Ear and labyrinth disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dry Eye
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Erythema of Eyelid
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Eye Irritation
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0022 affected20 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0003 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0012 affected25 at risk
EG0021 affected20 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Loose Tooth
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0002 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Noninfective Sialoadenitis
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Salivary Gland Calculus
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Chest Discomfort
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Chest Pain
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0006 affected20 at risk
EG0014 affected25 at risk
EG0022 affected20 at risk
EG003
Feeling Abnormal
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Pain
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Peripheral Swelling
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Swelling
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Vessel Puncture Site Bruise
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Vessel Puncture Site Haematoma
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Vessel Puncture Site Phlebitis
General disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Angular Cheilitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Conjunctivitis Viral
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Furuncle
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Respiratory Tract Infection Viral
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Skin Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0006 affected20 at risk
EG0013 affected25 at risk
EG0021 affected20 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Viral Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Wound Infection
Infections and infestations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Chest Injury
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0002 affected20 at risk
EG0012 affected25 at risk
EG0021 affected20 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Eye Contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Lip Injury
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Blood Creatine Phosphokinase Increase
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Electrocardiogram Pr Prolongation
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Lipase Increased
Investigations
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Appetite Disorder
Metabolism and nutrition disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Increased Appetite
Metabolism and nutrition disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0022 affected20 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Joint Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Muscle Tightness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Burning Sensation
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0008 affected20 at risk
EG0015 affected25 at risk
EG0022 affected20 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Memory Impairment
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Migraine
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0021 affected20 at risk
EG003
Sensory Disturbance
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Tension Headache
Nervous system disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Abnormal Dreams
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0002 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dysphoria
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Flat Affect
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0011 affected25 at risk
EG0023 affected20 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Libido Decreased
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Panic Attack
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Vaginal Discharge
Reproductive system and breast disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0012 affected25 at risk
EG0021 affected20 at risk
EG003
Dry Throat
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0002 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dermal Cyst
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hand Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Mechanical Urticaria
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected25 at risk
EG0020 affected20 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0001 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0021 affected20 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 19.1
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected25 at risk
EG0020 affected20 at risk
EG003
Limitations of the study included the open-label design, limited sample size, and the lack of a comparator group.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00019
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Title
Measurements
OG00076.02± 15.13
OG00184.58± 15.09
OG00280.19± 17.79
OG00374.07± 12.78
OG00473.09± 8.62
OG00581.30± 13.82
OG00681.83± 13.67
OG00780.15± 17.92
OG00886.02± 15.56
OG00969.90± 11.55
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00019
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Title
Measurements
OG00025.89± 4.63
OG00128.43± 4.26
OG00226.45± 5.53
OG00325.46± 3.53
OG00425.60± 3.21
OG00525.60± 2.82
OG00626.17± 4.20
OG00727.69± 5.28
OG00827.98± 4.37
OG00923.64± 4.50
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
sBP: Abnormally low
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0073.3
OG0080
OG0090
sBP: Grade 1 or mild
Title
Measurements
OG00020.0
OG00132.0
OG00235.0
OG003
sBP: Grade 2 or moderate
Title
Measurements
OG00010.0
OG0018.0
OG0020
OG003
sBP: Grade 3 or severe
Title
Measurements
OG0000
OG0014.0
OG0025.0
OG003
dBP: Abnormally low
Title
Measurements
OG0000
OG0014.0
OG0020
OG003
dBP: Grade 1 or mild
Title
Measurements
OG0005.0
OG00120.0
OG00235.0
OG003
dBP: Grade 2 or moderate
Title
Measurements
OG0005.0
OG00112.0
OG0020
OG003
dBP: Grade 3 or severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Heart Rate: Abnormally low
Title
Measurements
OG00035.0
OG00132.0
OG00235.0
OG003
Heart Rate: Abnormally high
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Decline of > 10%
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
Decline of >5-<=10%
Title
Measurements
OG0000.0
OG0014.0
OG00210.0
OG003
Decline of >0-<=5%
Title
Measurements
OG00065.0
OG00148.0
OG00260.0
OG003
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Hemoglobin: Grade 1
Title
Measurements
OG0005.0
OG0010.0
OG0020.0
OG0035.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
Hemoglobin: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Hemoglobin: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Hemoglobin: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Hemoglobin: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Lymphocytes: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Lymphocytes: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Lymphocytes: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Lymphocytes: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Lymphocytes: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Neutrophils: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Neutrophils: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Neutrophils: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Neutrophils: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Neutrophils: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Leukocytes: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Leukocytes: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Leukocytes: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Leukocytes: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Leukocytes: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Platelets: Grade 1
Title
Measurements
OG0005.0
OG0010.0
OG0025.0
OG003
Platelets: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Platelets: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Platelets: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Platelets: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Calcium: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0063.3
OG00713.3
OG0080.0
OG0090.0
Calcium: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Calcium: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Calcium: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Calcium: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Phosphate: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Phosphate: Grade 2
Title
Measurements
OG00010.0
OG00120.0
OG00225.0
OG003
Phosphate: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Phosphate: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Phosphate: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Potassium: Grade 1
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG003
Potassium: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Potassium: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Potassium: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Potassium: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Sodium: Grade 1
Title
Measurements
OG0000.0
OG0018.0
OG0025.0
OG003
Sodium: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Sodium: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Sodium: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Sodium: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bicarbonate: Grade 1
Title
Measurements
OG0000.0
OG00116.0
OG00215.0
OG003
Bicarbonate: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bicarbonate: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bicarbonate: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bicarbonate: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alanine aminotransferase: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alanine aminotransferase: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alanine aminotransferase: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alanine aminotransferase: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alanine aminotransferase: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alkaline phosphatase: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alkaline phosphatase: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alkaline phosphatase: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alkaline phosphatase: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Alkaline phosphatase: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Aspartate aminotransferase: Grade: 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Aspartate aminotransferase: Grade: 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Aspartate aminotransferase: Grade: 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Aspartate aminotransferase: Grade: 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Aspartate aminotransferase: Grade: 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bilirubin: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG00210.0
OG003
Bilirubin: Grade 2
Title
Measurements
OG0005.0
OG0010.0
OG0020.0
OG003
Bilirubin: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bilirubin: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Bilirubin: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Direct bilirubin: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Direct bilirubin: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Direct bilirubin: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Direct bilirubin: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Direct bilirubin: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Glucose: Grade 1
Title
Measurements
OG00015.0
OG0014.0
OG00210.0
OG003
Glucose: Grade 2
Title
Measurements
OG0000.0
OG0014.0
OG0025.0
OG003
Glucose: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Glucose: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Glucose: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Cholesterol: Grade 1
Title
Measurements
OG00020.0
OG00124.0
OG00230.0
OG003
Cholesterol: Grade 2
Title
Measurements
OG00015.0
OG0018.0
OG0025.0
OG003
Cholesterol: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0025.0
OG003
Cholesterol: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Cholesterol: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0025.0
OG003
Triglycerides: Grade 1
Title
Measurements
OG0005.0
OG00116.0
OG00210.0
OG003
Triglycerides: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Triglycerides: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Triglycerides: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Triglycerides: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Urate: Grade 1
Title
Measurements
OG0005.0
OG00112.0
OG0025.0
OG003
Urate: Grade 2
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG003
Urate: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Urate: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Urate: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Triacylglycerol lipase: Grade 1
Title
Measurements
OG0005.0
OG00112.0
OG0025.0
OG003
Triacylglycerol lipase: Grade 2
Title
Measurements
OG00015.0
OG0014.0
OG00210.0
OG003
Triacylglycerol lipase: Grade 3
Title
Measurements
OG0005.0
OG0018.0
OG0020.0
OG003
Triacylglycerol lipase: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0025.0
OG003
Triacylglycerol lipase: Grade 3+4
Title
Measurements
OG0005.0
OG0018.0
OG0025.0
OG003
Creatinine: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine clearance: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine clearance: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine clearance: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine clearance: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatinine clearance: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Albumin: Grade 1
Title
Measurements
OG0005.0
OG0014.0
OG0020.0
OG003
Albumin: Grade 2
Title
Measurements
OG0000.0
OG0018.0
OG0020.0
OG003
Albumin: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Albumin: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Albumin: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatine kinase: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatine kinase: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatine kinase: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatine kinase: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Creatine kinase: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Prothrombin INR: Grade 1
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
Prothrombin INR: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Prothrombin INR: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Prothrombin INR: Grade 4
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG003
Prothrombin INR: Grade 3+4
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG003
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Protein: Grade 1
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG0030.0
OG0040.0
OG0050.0
OG0067.1
OG0073.3
OG00826.7
OG00950.0
Protein: Grade 2
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Protein: Grade 3
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Protein: Grade 4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Protein: Grade 3+4
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
QTcF: Abnormal
Title
Measurements
OG0005.0
OG0010.0
OG0025.0
OG0030.0
OG0040.0
OG0050.0
OG0067.1
OG0073.3
OG0080.0
OG0090.0
QTcB: Abnormal
Title
Measurements
OG0005.0
OG0018.0
OG00210.0
OG003
Heart rate: Abnormal low
Title
Measurements
OG00025.0
OG00116.0
OG00210.0
OG003
Heart rate: Abnormal high
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
QRS: Abnormal high
Title
Measurements
OG0000.0
OG0014.0
OG0020.0
OG003
PR: Abnormally low (PR<120 ms)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
PR: Abnormally high (200 ms<PR<= 240 ms)
Title
Measurements
OG0005.0
OG0018.0
OG00215.0
OG003
PR: Abnormal high (240 ms<PR<=300 ms)
Title
Measurements
OG00010.0
OG0010.0
OG0020.0
OG003
OG002
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
4 weeks after end of treatment
Title
Measurements
OG000100(83.2 to 100)
OG00196.0(79.6 to 99.9)
OG002100(83.2 to 100)
OG003100(83.2 to 100)
OG00487.5(47.3 to 99.7)
OG0050(NA to NA)NA indicates that upper and lower limit of confidence interval (CI) was not estimable as no participant achieved SVR in this group.
OG00671.4(41.9 to 91.6)
OG007100(88.4 to 100)
OG00893.3(68.1 to 99.8)
OG009100(39.8 to 100)
12 weeks after end of treatment
Title
Measurements
OG000100(83.2 to 100)
OG00184.0(63.9 to 95.5)
OG002100(83.2 to 100)
OG003
24 weeks after end of treatment
Title
Measurements
OG000100(83.2 to 100)
OG00184.0(63.9 to 95.5)
OG002100(83.2 to 100)
OG003
OG002
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0000.0± 0.0
OG0010.0± 0.0
OG0020.0± 0.0
OG0030.0± 0.0
OG0040.0± 0.0
ALS-022399
Title
Measurements
OG0000.000± 0.000
OG0010.000± 0.000
OG0020.308± 1.233
OG003
ALS-022227
Title
Measurements
OG00035.73± 13.61
OG00135.80± 11.15
OG00257.25± 31.63
OG003
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG000414.79± 317.93
OG001547.36± 226.06
OG002563.04± 423.53
OG003529.17± 265.17
OG004677.59± 554.83
ALS-022399
Title
Measurements
OG000103.57± 52.25
OG001148.89± 48.77
OG002174.89± 87.05
OG003
ALS-022227
Title
Measurements
OG000364.4± 129.1
OG001392.6± 144.2
OG002658.0± 275.1
OG003
OG002
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ALS-022399
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0032
ALS-022227
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00216
ParticipantsOG0036
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants without Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis): received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0002.000(0.50 to 4.00)
OG0012.000(1.00 to 4.00)
OG0021.500(1.00 to 4.00)
OG0031.000(1.00 to 2.00)
OG0042.000(0.50 to 4.00)
ALS-022399
Title
Measurements
OG0003.0(1.00 to 6.00)
OG0013.000(2.00 to 4.00)
OG0023.000(1.00 to 4.00)
OG003
ALS-022227
Title
Measurements
OG0004.000(2.00 to 4.60)
OG0014.000(3.00 to 6.00)
OG0023.500(2.00 to 6.00)
OG003
OG002
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0001049.3± 890.0
OG0011185.8± 502.8
OG0021526.3± 1328.9
OG0031178.5± 594.0
OG0041774.8± 1348.5
ALS-022399
Title
Measurements
OG000469.3± 224.0
OG001660.7± 211.5
OG002945.2± 551.1
OG003
ALS-022227
Title
Measurements
OG0002920.0± 1029.1
OG0013238.2± 972.8
OG0025258.1± 1969.4
OG003
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0001058.0± 886.9
OG0011197.2± 507.7
OG0021532.7± 1329.5
OG0031187.3± 600.9
OG0041792.2± 1350.9
ALS-022399
Title
Measurements
OG000500.5± 230.8
OG001718.0± 240.7
OG0021009.7± 599.4
OG003
ALS-022227
Title
Measurements
OG0002897.0± 1081.8
OG0013238.2± 972.8
OG0025258.1± 1969.4
OG003
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0005.931± 4.752
OG0017.077± 4.676
OG0024.983± 3.339
OG0035.698± 5.620
OG0045.811± 8.622
ALS-022399
Title
Measurements
OG0005.995± 1.649
OG00110.335± 5.558
OG00214.591± 10.741
OG003
ALS-022227
Title
Measurements
OG00038.28± 12.20
OG00147.26± 10.68
OG00267.08± 40.66
OG003
OG002
Cohort 2 + Cohort 3 + Cohort 5
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
AL-335
Title
Measurements
OG0006.000(6.00 to 9.00)
OG0016.000(6.00 to 9.00)
OG0026.000(4.00 to 24.10)
OG0036.025(6.0 to 9.00)
OG0048.670(5.98 to 12.00)
ALS-022399
Title
Measurements
OG00012.000(9.00 to 12.00)
OG00112.000(12.00 to 12.00)
OG00212.000(9.00 to 24.10)
OG003
ALS-022227
Title
Measurements
OG00024.00(24.0 to 24.1)
OG00124.00(23.7 to 24.1)
OG00224.00(24.0 to 24.1)
OG003
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000121.49± 42.81
OG001135.20± 41.16
OG002218.88± 81.80
OG003217.17± 83.26
OG004227.37± 78.46
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG000379.75± 247.02
OG001452.65± 641.99
OG002517.00± 416.45
OG003561.19± 424.71
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG0001927.7± 1205.3
OG0011537.6± 1325.2
OG0021769.3± 881.6
OG0031925.1± 1034.0
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG000475.42± 317.63
OG001570.64± 816.36
OG002669.00± 442.50
OG003636.88± 455.94
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG0006.000(4.00 to 12.00)
OG0016.000(4.00 to 9.00)
OG0026.000(4.00 to 6.05)
OG0036.000(3.00 to 8.50)
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG00025018.2± 15248.7
OG00123061.3± 24724.4
OG00225266.7± 15523.4
OG00327070.7± 15895.7
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG00025018.2± 15248.7
OG00123061.3± 24724.4
OG00225266.7± 15523.4
OG00327070.7± 15895.7
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG000402.55± 244.20
OG001481.76± 644.76
OG002538.67± 456.21
OG003602.60± 453.12
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG00024.00(24.0 to 24.1)
OG00124.00(24.0 to 24.1)
OG00224.00(24.0 to 24.2)
OG00323.90(23.5 to 24.0)
OG003
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00116
OG0026
OG00327
Title
Denominators
Categories
Title
Measurements
OG0001042.8± 634.3
OG001960.5± 1030.7
OG0021053.8± 647.8
OG0031134.6± 666.6
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000322.45± 139.21
OG00197.21± 58.62
OG002107.90± 49.46
OG003102.73± 47.08
OG004131.31± 62.31
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000634.27± 257.29
OG001363.36± 184.48
OG002322.46± 167.29
OG003232.85± 187.53
OG004298.67± 133.99
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000335.18± 146.14
OG001100.98± 61.90
OG002112.44± 51.53
OG003119.82± 58.87
OG004141.56± 64.81
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG0006.000(4.00 to 12.00)
OG0016.000(4.00 to 12.00)
OG0026.000(3.00 to 9.00)
OG0034.500(0.00 to 9.00)
OG0046.000(3.98 to 9.00)
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG00011805.5± 4902.6
OG0018635.5± 4656.7
OG0028648.1± 4161.1
OG0037050.0± 4001.4
OG0048422.2± 3617.8
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG00011805.5± 4902.6
OG0015530.0± 2930.3
OG0025393.8± 2695.4
OG0034048.3± 2727.8
OG0044924.1± 2122.9
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000384.09± 172.29
OG001162.65± 87.39
OG002163.54± 78.10
OG003131.92± 74.01
OG004152.47± 66.50
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG00024.00(24.0 to 24.1)
OG00147.60(47.5 to 47.7)
OG00247.50(47.4 to 47.9)
OG00347.80(47.4 to 48.0)
OG00447.50(47.5 to 47.9)
Cohort 2+3+5 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD.
OG003
Cohort 6
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 8 weeks.
OG004
Cohort 7 + Cohort 8 + Cohort 9 + Cohort 11
Cohort 7+8+9+11 (Participants with Cirrhosis): Participants received single dose of AL-335 800 mg QD, ODV 25 mg QD and SMV 75 mg QD.
Units
Counts
Participants
OG00011
OG00111
OG00216
OG0036
OG00427
Title
Denominators
Categories
Title
Measurements
OG000491.55± 203.85
OG001181.60± 97.99
OG002181.58± 87.25
OG003147.40± 83.86
OG004176.86± 75.91
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Title
Measurements
OG0000
OG00116.0
OG0020
OG0030
OG0040
OG005100.0
OG00614.3
OG0073.3
OG0080
OG0090
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00412.5
OG0050
OG0067.1
OG0070
OG0080
OG0090
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Day 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Day 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 1
Title
Measurements
OG0005.0
OG00120.0
OG0020
OG003
Week 2
Title
Measurements
OG00035.0
OG00144.0
OG00245.0
OG003
Week 3
Title
Measurements
OG00070.0
OG00176.0
OG00275.0
OG003
Week 4
Title
Measurements
OG00080.0
OG00192.0
OG00290.0
OG003
Week 5
Title
Measurements
OG000100
OG00196.0
OG002100
OG003
Week 6
Title
Measurements
OG00090.0
OG001100
OG00285.0
OG003
Week 7
Title
Measurements
OG00090.0
OG00196.0
OG00295.0
OG003
Week 8
Title
Measurements
OG00095.0
OG001100
OG002100
OG003
Week 9
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 10
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 11
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 12
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
End of treatment
Title
Measurements
OG00095.0
OG001100
OG002100
OG003
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG00020
OG00125
OG00220
OG00320
OG0048
OG0055
OG00614
OG00730
OG00815
OG0094
Title
Denominators
Categories
Day 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Day 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 1
Title
Measurements
OG0000
OG0018.0
OG0020
OG003
Week 2
Title
Measurements
OG00020.0
OG00120.0
OG00215.0
OG003
Week 3
Title
Measurements
OG00040.0
OG00140.0
OG00245.0
OG003
Week 4
Title
Measurements
OG00055.0
OG00152.0
OG00260.0
OG003
Week 5
Title
Measurements
OG00075.0
OG00196.0
OG00285.0
OG003
Week 6
Title
Measurements
OG00080.0
OG00188.0
OG00285.0
OG003
Week 7
Title
Measurements
OG00080.0
OG00192.0
OG00295.0
OG003
Week 8
Title
Measurements
OG00085.0
OG00196.0
OG002100
OG003
Week 9
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 10
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 11
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG003
Week 12
Title
Measurements
OG000NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG001NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG002NANA indicates that the data was not estimable for the specified timepoint.
OG003
End of treatment
Title
Measurements
OG00085.0
OG00196.0
OG002100
OG003
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks.
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Cohort 2 (8 Weeks GT1)
Cohort 2 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG003
Cohort 3 (6 Weeks GT1)
Cohort 3 (Participants without Cirrhosis) received single dose of AL-335 800 mg QD, ODV 50 mg QOD and SMV 75 mg QD for 6 weeks
OG004
Cohort 4 (12 Weeks GT1)
Cohort 4 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD and ODV 50 mg tablets QOD for 12 weeks.
OG005
Cohort 5a (8 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks.
OG006
Cohort 5b (12 Weeks GT3)
Cohort 5 (Participants without Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 12 weeks.
OG007
Cohort 6,7,8 (8 Weeks GT1 F4)
Cohort 6 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 50 mg tablets QOD and SMV 75 mg tablets QD for 8 weeks; Cohort 7 and Cohort 8 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 8 weeks.
OG008
Cohort 9 (12 Weeks GT1 F4)
Cohort 9 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
OG009
Cohort 11 (12 Weeks GT2 F4)
Cohort 11 (Participants with Cirrhosis) received single dose of AL-335 800 mg tablets QD, ODV 25 mg tablets QD and SMV 75 mg tablets QD for 12 weeks.
Units
Counts
Participants
OG0000
OG0014
OG0020
OG0030
OG0041
OG0055
OG0063
OG0071
OG0080
OG0090
Title
Denominators
Categories
Title
Measurements
OG0014
OG0041
OG0050
OG0062
OG0071
0 affected
8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0073 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0042 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0073 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0081 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
3 affected
20 at risk
EG0042 affected8 at risk
EG0050 affected5 at risk
EG0066 affected14 at risk
EG0073 affected30 at risk
EG0081 affected15 at risk
EG0092 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0072 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0092 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0043 affected8 at risk
EG0052 affected5 at risk
EG0064 affected14 at risk
EG0073 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0072 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
3 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0074 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
2 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0061 affected14 at risk
EG0072 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0072 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
1 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0063 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0051 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
3 affected
20 at risk
EG0044 affected8 at risk
EG0052 affected5 at risk
EG0063 affected14 at risk
EG0072 affected30 at risk
EG0082 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0042 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0072 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
2 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0072 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0042 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0051 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
0 affected
20 at risk
EG0041 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0061 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
1 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0071 affected30 at risk
EG0080 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0081 affected15 at risk
EG0090 affected4 at risk
0 affected
20 at risk
EG0040 affected8 at risk
EG0050 affected5 at risk
EG0060 affected14 at risk
EG0070 affected30 at risk
EG0080 affected15 at risk
EG0091 affected4 at risk
25.0
OG00437.5
OG00560.0
OG00657.1
OG00726.7
OG00846.7
OG00925.0
5.0
OG00437.5
OG0050
OG0067.1
OG00720.0
OG00813.3
OG00950.0
0
OG0040
OG0050
OG0060
OG0073.3
OG00813.3
OG0090
0
OG00412.5
OG0050
OG0060
OG0070
OG0080
OG0090
20.0
OG0040
OG00560.0
OG00621.4
OG00710.0
OG00826.7
OG0090
0
OG0040
OG0050
OG00614.3
OG00713.3
OG0086.7
OG00925.0
0
OG00425.0
OG0050
OG0067.1
OG0073.3
OG0086.7
OG0090
30.0
OG00450.0
OG00520.0
OG00621.4
OG00713.3
OG00813.3
OG0090
0
OG00412.5
OG0050
OG0060
OG0070
OG0080
OG0090
10.0
OG00412.5
OG0050.0
OG00621.4
OG0073.3
OG0086.7
OG0090.0
50.0
OG00450.0
OG00520.0
OG00664.3
OG00780.0
OG00846.7
OG00950.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0067.1
OG00710.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG00710.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
5.0
OG0040.0
OG0050.0
OG0067.1
OG0076.7
OG00813.3
OG00925.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG00716.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
15.0
OG00412.5
OG0050.0
OG00614.3
OG00713.3
OG0086.7
OG0090.0
0.0
OG0040.0
OG0050.0
OG00621.4
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG00621.4
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG00412.5
OG00520.0
OG0060.0
OG0073.3
OG00820.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
5.0
OG00412.5
OG00520.0
OG0067.1
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG00925.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0086.7
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0086.7
OG0090.0
10.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG00925.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0086.7
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0086.7
OG0090.0
5.0
OG00425.0
OG0050.0
OG00635.7
OG00710.0
OG00813.3
OG0090.0
0.0
OG00412.5
OG0050.0
OG00614.3
OG00713.3
OG00813.3
OG00925.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
35.0
OG00412.5
OG0050.0
OG00642.9
OG0073.3
OG00820.0
OG00950.0
5.0
OG00437.5
OG0050.0
OG0060.0
OG0076.7
OG0086.7
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
15.0
OG00450.0
OG00520.0
OG00628.6
OG00716.7
OG00833.3
OG00925.0
0.0
OG0040.0
OG0050.0
OG00614.3
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG00412.5
OG0050.0
OG00628.6
OG00710.0
OG00826.7
OG0090.0
5.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG00412.5
OG00520.0
OG0067.1
OG00713.3
OG0080.0
OG0090.0
0.0
OG00412.5
OG0050.0
OG0067.1
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
5.0
OG0040.0
OG0050.0
OG0067.1
OG0070.0
OG0080.0
OG0090.0
0.0
OG00412.5
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG00412.5
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG00820.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG00425.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0067.1
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0086.7
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG00813.3
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG00925.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0073.3
OG0080.0
OG00925.0
0.0
OG0040.0
OG0050.0
OG00628.6
OG0073.3
OG0086.7
OG0090.0
15.0
OG00425.0
OG00520.0
OG00614.3
OG00713.3
OG0080.0
OG00925.0
0.0
OG00412.5
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
0.0
OG0040.0
OG0050.0
OG0067.1
OG0073.3
OG0080.0
OG0090.0
10.0
OG0040.0
OG0050.0
OG0060.0
OG0076.7
OG00813.3
OG0090.0
0.0
OG0040.0
OG0050.0
OG0067.1
OG0070.0
OG0080.0
OG0090.0
100
(83.2 to 100)
OG00487.5(47.3 to 99.7)
OG0050(NA to NA)NA indicates that upper and lower limit of CI was not estimable as no participant achieved SVR in this group.
OG00671.4(41.9 to 91.6)
OG00796.7(82.8 to 99.9)
OG00893.3(68.1 to 99.8)
OG009100(39.8 to 100)
100
(83.2 to 100)
OG00487.5(47.3 to 99.7)
OG0050(NA to NA)NA indicates that upper and lower limit of CI was not estimable as no participant achieved SVR in this group.
OG00671.4(41.9 to 91.6)
OG00796.7(82.3 to 99.9)
OG00893.3(68.1 to 99.8)
OG009100(39.8 to 100)
0.000
± 0.000
OG0040.280± 0.814
68.30
± 38.33
OG00464.96± 28.63
158.80
± 55.97
OG004186.28± 113.18
643.2
± 318.4
OG004619.7± 224.1
Participants
OG004
8
Title
Measurements
OG0024.640± 4.018
OG0034.570± 2.899
OG0044.400± 2.560
Participants
OG004
27
Title
Measurements
OG00042.74± 19.26
OG00136.77± 10.42
OG00261.82± 35.47
OG00386.20± 56.31
OG00473.85± 35.15
2.000
(1.00 to 4.00)
OG0043.000(2.00 to 6.00)
3.500
(2.00 to 6.00)
OG0044.000(2.00 to 6.00)
844.2
± 287.9
OG004933.3± 544.3
5218.3
± 2011.9
OG0045425.2± 1878.2
932.7
± 330.1
OG0041044.7± 561.1
4806.0
± 1945.4
OG0045425.2± 1878.2
14.793
± 8.738
OG00417.520± 10.972
69.18
± 38.01
OG00472.14± 29.23
12.000
(12.00 to 12.00)
OG00412.000(8.50 to 24.00)
24.00
(24.0 to 24.2)
OG00423.90(23.5 to 24.0)
5.0
OG0040
OG0050
OG0060
OG0070
OG0086.7
OG0090
30.0
OG00412.5
OG00520.0
OG00635.7
OG00716.7
OG00813.3
OG00925.0
70.0
OG00425.0
OG00540.0
OG00664.3
OG00750.0
OG00866.7
OG00975.0
80.0
OG00462.5
OG00560.0
OG00685.7
OG00773.3
OG00886.7
OG009100
85.0
OG00487.5
OG00560.0
OG00692.9
OG00780.0
OG00886.7
OG009100
90.0
OG004100
OG00580.0
OG00692.9
OG00790.0
OG008100
OG009100
90.0
OG004100
OG005100
OG00692.9
OG00796.7
OG008100
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG004100
OG00580.0
OG00685.7
OG007100
OG008100
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005100
OG00685.7
OG007100
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00886.7
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00685.7
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00893.3
OG009100
90.0
OG00487.5
OG005100
OG00685.7
OG007100
OG00893.3
OG009100
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
10.0
OG0040
OG0050
OG00614.3
OG00716.7
OG00813.3
OG00925.0
40.0
OG0040
OG00520.0
OG00642.9
OG00750.0
OG00866.7
OG00975.0
65.0
OG00437.5
OG00560.0
OG00650.0
OG00773.3
OG00886.7
OG009100
80.0
OG00462.5
OG00540.0
OG00678.6
OG00780.0
OG00886.7
OG009100
85.0
OG00475.0
OG00580.0
OG00685.7
OG00790.0
OG008100
OG009100
80.0
OG00487.5
OG00580.0
OG00692.9
OG00796.7
OG008100
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG00580.0
OG00685.7
OG007100
OG008100
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005100
OG00685.7
OG007100
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00893.3
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00692.9
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00886.7
OG009100
NA
NA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 6.
OG00487.5
OG005NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.
OG00678.6
OG007NANA indicates that data was not collected at this timepoint since participants in this arm ended treatment at week 8.