Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Official Title
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Mar 2016
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
Sep 2013
Primary Completion Date
Jan 2015Actual
Completion Date
Mar 2015Actual
First Submitted Date
Sep 5, 2013
First Submission Date that Met QC Criteria
Sep 5, 2013
First Posted Date
Sep 10, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 16, 2016
Results First Submitted that Met QC Criteria
Mar 16, 2016
Results First Posted Date
Apr 15, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 4, 2015
Certification/Extension First Submitted that Passed QC Review
Nov 4, 2015
Certification/Extension First Posted Date
Dec 1, 2015Estimated
Last Update Submitted Date
Oct 19, 2018
Last Update Posted Date
Nov 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic HCV Infection
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
339Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Drug: LDV/SOF
Drug: RBV
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Drug: LDV/SOF
Drug: RBV
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Drug: LDV/SOF
Drug: RBV
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LDV/SOF
Drug
LDV/SOF FDC tablet administered orally once daily
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.
Posttreatment Week 2
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able to provide written informed consent
Chronic genotype 1 or 4 HCV infection
Normal ECG
Negative serum pregnancy test for female subjects
Male subjects and female subjects of childbearing potential must agree to use contraception
Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits
Exclusion Criteria:
Serious or active medical or psychiatric illness
HIV or hepatitis B viral (HBV) infection
Stomach disorder that could interfere with the absorption of the study drug
Treated with an anti-HCV medication in the last 30 days
Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
History of clinically significant medical condition associated with other chronic liver disease
Active spontaneous bacterial peritonitis at screening
Females who are breastfeeding
Infection requiring systemic antibiotics
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Active or history (last 6 months) of drug or alcohol abuse
History of organ transplant other than liver or kidney
Welzel TM, Reddy KR, Flamm SL, Denning J, Lin M, Hyland R, Pang PS, McHutchison JG, Charlton M, Everson GT, Zeuzem S, Afdhal N. On-treatment HCV RNA in patients with varying degrees of fibrosis and cirrhosis in the SOLAR-1 trial. Antivir Ther. 2016;21(6):541-546. doi: 10.3851/IMP3037. Epub 2016 Feb 18.
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts was based on severity of liver impairment at screening (or presence of disease for FCH groups);
Randomization was 1:1 within groups to 12 or 24 weeks of treatment.
Recruitment Details
Participants were enrolled at study sites in the United States. The first participant was screened on 06 September 2013. The last study visit occurred on 25 March 2015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
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
No data available
No data is available for this block.
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
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
Experimental
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 7 (12 wk): FCH
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
Drug: LDV/SOF
Drug: RBV
Cohort B, Group 7 (24 wk): FCH
Experimental
LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Drug: LDV/SOF
Drug: RBV
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
Cohort B, Group 7 (12 wk): FCH
Cohort B, Group 7 (24 wk): FCH
Harvoni®
GS-5885/GS-7977
RBV
Drug
RBV tablets administered orally in a divided daily dose
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
Cohort B, Group 7 (12 wk): FCH
Cohort B, Group 7 (24 wk): FCH
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Posttreatment Week 4
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.
Posttreatment Week 8
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Posttreatment Week 24
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 24
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.
Posttransplant Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 1
Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 6
Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
Week 24
HCV RNA and Change From Baseline at Week 1
Baseline; Week 1
HCV RNA and Change From Baseline at Week 2
Baseline; Week 2
HCV RNA and Change From Baseline at Week 4
Baseline; Week 4
HCV RNA and Change From Baseline at Week 6
Baseline; Week 6
HCV RNA and Change From Baseline at Week 8
Baseline; Week 8
HCV RNA and Change From Baseline at Week 12
Baseline; Week 12
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Baseline to Posttreatment Week 4
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Baseline to Posttreatment Week 4
San Diego
California
92103
United States
San Francisco
California
94143
United States
Aurora
Colorado
80045
United States
Washington D.C.
District of Columbia
20007
United States
Jacksonville
Florida
32224
United States
Miami
Florida
33136
United States
Chicago
Illinois
60611
United States
Indianapolis
Indiana
46202
United States
Kansas City
Kansas
66160
United States
Lutherville
Maryland
21093
United States
Boston
Massachusetts
02215
United States
Ann Arbor
Michigan
48109
United States
Detroit
Michigan
48202
United States
Minneapolis
Minnesota
55455
United States
Rochester
Minnesota
55905
United States
St Louis
Missouri
63110
United States
New York
New York
10016
United States
New York
New York
10032
United States
Chapel Hill
North Carolina
27599
United States
Durham
North Carolina
27710
United States
Cleveland
Ohio
44195
United States
Portland
Oregon
97239
United States
Philadelphia
Pennsylvania
19104
United States
Pittsburgh
Pennsylvania
15213
United States
Dallas
Texas
75246
United States
Murray
Utah
84107
United States
Richmond
Virginia
23219
United States
Seattle
Washington
98101
United States
Seattle
Washington
98104
United States
Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
FG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
FG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
FG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
FG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis
FG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
FG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
FG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
FG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
FG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
FG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
FG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
FG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
FG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
FG00030 subjects
FG00129 subjects
FG00223 subjects
FG00326 subjects
FG00455 subjects
FG00556 subjects
FG00626 subjects
FG00725 subjects
FG00826 subjects
FG00926 subjects
FG0106 subjects
FG0114 subjects
FG0124 subjects
FG0133 subjects
COMPLETED
FG00026 subjects
FG00126 subjects
FG00218 subjects
FG00324 subjects
FG00455 subjects
FG00555 subjects
FG00624 subjects
FG00724 subjects
FG00822 subjects
FG00923 subjects
FG0103 subjects
FG0113 subjects
FG0124 subjects
FG0132 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0084 subjects
FG0093 subjects
FG0103 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
Type
Comment
Reasons
Randomized but Not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Investigator's Discretion
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
BG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
BG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
BG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
BG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
BG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
BG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
BG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
BG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
BG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
BG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
BG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
BG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
BG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00129
BG00223
BG00326
BG00455
BG00556
BG00626
BG00725
BG00826
BG00926
BG0105
BG0114
BG0124
BG0132
BG014337
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057± 9.1
BG00158± 6.5
BG00257± 6.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0013
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0001
BG0013
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00030
BG00129
BG002
Hepatitis C Virus (HCV) RNA
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0005.9± 0.68
BG0015.8± 0.82
BG002
HCV RNA Category
Number
participants
Title
Denominators
Categories
< 800 IU/mL
Title
Measurements
BG00014
BG00111
BG002
HCV Genotype
Number
participants
Title
Denominators
Categories
Genotype 1a
Title
Measurements
BG00019
BG00122
BG002
IL28b Status
The CC, CT, and TT alleles are different forms of the IL28b gene.
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0004
BG0015
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
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.
Posted
Number
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00222
OG003
Title
Denominators
Categories
Title
Measurements
OG00086.7
OG00188.9
OG00286.4
OG003
Primary
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Safety Analysis Set: participants who were randomized and received at least one dose of study drug
Posted
Number
percentage of participants
Up to 24 weeks
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.
Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.
Posted
Number
percentage of participants
Posttreatment Week 2
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.
Posted
Number
percentage of participants
Posttreatment Week 4
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.
Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.
Posted
Number
percentage of participants
Posttreatment Week 8
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.
Posted
Number
percentage of participants
Posttreatment Week 24
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA \
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Secondary
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.
Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.
Posted
Number
percentage of participants
Posttransplant Week 12
ID
Title
Description
OG000
All LDV/SOF+RBV
All participants in the analysis are presented in a single group, regardless of randomization group assignment.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 1
Full Analysis Set
Posted
Number
percentage of participants
Week 1
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG003
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 2
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 2
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 4
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 6
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 6
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 8
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 12
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 16
Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG002
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 20
Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Posted
Number
percentage of participants
Week 20
ID
Title
Description
OG000
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG002
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 24
Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG002
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Secondary
HCV RNA and Change From Baseline at Week 1
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 1
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
HCV RNA and Change From Baseline at Week 2
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 2
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
HCV RNA and Change From Baseline at Week 4
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 4
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
HCV RNA and Change From Baseline at Week 6
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 6
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
HCV RNA and Change From Baseline at Week 8
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 8
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
HCV RNA and Change From Baseline at Week 12
Participants in the Full Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline; Week 12
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Secondary
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
Posted
Number
percentage of participants
Baseline to Posttreatment Week 4
ID
Title
Description
OG000
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Secondary
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
Posted
Number
percentage of participants
Baseline to Posttreatment Week 4
ID
Title
Description
OG000
Cohort A: Baseline CPT Class A (24 wk)
Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG001
Cohort A: Baseline CPT Class B (12 wk)
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG002
Cohort A: Baseline CPT Class B (24 wk)
Time Frame
Up to 24 weeks on treatment plus 30 days
Description
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
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 A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
3
30
26
30
EG001
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
10
29
28
29
EG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
6
23
22
23
EG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
11
26
26
26
EG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
6
55
54
55
EG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
12
56
54
56
EG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
3
26
25
26
EG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
4
25
23
25
EG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
5
26
23
26
EG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
11
26
26
26
EG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
1
5
5
5
EG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
3
4
4
4
EG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
1
4
4
4
EG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
1
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG0030 affected26 at risk
EG0041 affected55 at risk
EG0051 affected56 at risk
EG0061 affected26 at risk
EG0071 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Splenic vein thrombosis
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Sinus arrhythmia
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Gastric varices haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0014 affected29 at risk
EG0020 affected23 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Oesophageal oedema
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Asthenia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Chest pain
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Generalised oedema
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Multi-organ failure
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pyrexia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hepatic artery thrombosis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cellulitis of male external genital organ
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Clostridium difficile sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Fungal peritonitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Localised infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Septic shock
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Complications of transplanted liver
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Graft loss
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Post transplant lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0003 affected30 at risk
EG0010 affected29 at risk
EG0022 affected23 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Hepatic hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hypotension
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Shock
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0003 affected30 at risk
EG0017 affected29 at risk
EG0024 affected23 at risk
EG00311 affected26 at risk
EG00424 affected55 at risk
EG00518 affected56 at risk
EG0068 affected26 at risk
EG0078 affected25 at risk
EG0087 affected26 at risk
EG00910 affected26 at risk
EG0104 affected5 at risk
EG0112 affected4 at risk
EG0120 affected4 at risk
EG0131 affected2 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Vision blurred
Eye disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0013 affected29 at risk
EG0020 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected29 at risk
EG0022 affected23 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0005 affected30 at risk
EG0017 affected29 at risk
EG0028 affected23 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0012 affected29 at risk
EG0022 affected23 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0008 affected30 at risk
EG00111 affected29 at risk
EG0029 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0013 affected29 at risk
EG0021 affected23 at risk
EG003
Asthenia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Chest pain
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Chills
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Fatigue
General disorders
MedDRA (17.1)
Systematic Assessment
EG00017 affected30 at risk
EG00115 affected29 at risk
EG00213 affected23 at risk
EG003
Generalised oedema
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Influenza like illness
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Localised oedema
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Malaise
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Oedema peripheral
General disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0014 affected29 at risk
EG0020 affected23 at risk
EG003
Pain
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Pseudocyst
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pyrexia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected29 at risk
EG0022 affected23 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0022 affected23 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0013 affected29 at risk
EG0022 affected23 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Peritoneal tuberculosis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected29 at risk
EG0022 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0022 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Lipase increased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Weight increased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0022 affected23 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0004 affected30 at risk
EG0016 affected29 at risk
EG0023 affected23 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Headache
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG00011 affected30 at risk
EG00112 affected29 at risk
EG0027 affected23 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0014 affected29 at risk
EG0021 affected23 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Tremor
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0022 affected23 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0023 affected23 at risk
EG003
Depression
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0013 affected29 at risk
EG0020 affected23 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0009 affected30 at risk
EG0017 affected29 at risk
EG0024 affected23 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0004 affected30 at risk
EG0013 affected29 at risk
EG0022 affected23 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0020 affected23 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0004 affected30 at risk
EG0016 affected29 at risk
EG0024 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0014 affected29 at risk
EG0023 affected23 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0003 affected30 at risk
EG0012 affected29 at risk
EG0020 affected23 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0021 affected23 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0011 affected29 at risk
EG0021 affected23 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0012 affected29 at risk
EG0021 affected23 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0013 affected29 at risk
EG0020 affected23 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected30 at risk
EG0014 affected29 at risk
EG0026 affected23 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0011 affected29 at risk
EG0022 affected23 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected30 at risk
EG0014 affected29 at risk
EG0021 affected23 at risk
EG003
Hypotension
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected30 at risk
EG0010 affected29 at risk
EG0020 affected23 at risk
EG003
There were no limitations affecting the analysis or results.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosures
Gilead Sciences
ClinicalTrialDisclosures@gilead.com
ID
Term
C000595958
ledipasvir, sofosbuvir drug combination
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
FG0093 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
59
± 4.6
BG00459± 6.6
BG00558± 6.4
BG00661± 6.2
BG00761± 10.4
BG00859± 5.8
BG00961± 6.6
BG01060± 3.8
BG01161± 1.7
BG01262± 3.2
BG01358± 8.5
BG01459± 6.9
9
BG0038
BG00410
BG00510
BG0067
BG0073
BG0084
BG0093
BG0100
BG0110
BG0120
BG0130
BG01473
Male
BG00022
BG00118
BG00214
BG00318
BG00445
BG00546
BG00619
BG00722
BG00822
BG00923
BG0105
BG0114
BG0124
BG0132
BG014264
2
BG0034
BG0044
BG0056
BG0062
BG0072
BG0085
BG0093
BG0103
BG0110
BG0120
BG0130
BG01438
Not Hispanic or Latino
BG00026
BG00126
BG00221
BG00322
BG00451
BG00550
BG00624
BG00723
BG00821
BG00923
BG0102
BG0114
BG0124
BG0132
BG014299
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
2
BG0031
BG0044
BG0054
BG0063
BG0074
BG0085
BG0092
BG0101
BG0110
BG0120
BG0130
BG01430
White
Title
Measurements
BG00029
BG00126
BG00221
BG00324
BG00450
BG00549
BG00621
BG00720
BG00821
BG00924
BG0104
BG0114
BG0124
BG0132
BG014299
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
American Indian/Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0143
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0052
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0144
23
BG00326
BG00455
BG00556
BG00626
BG00725
BG00826
BG00926
BG0105
BG0114
BG0124
BG0132
BG014337
5.6
± 0.62
BG0035.8± 0.71
BG0046.5± 0.62
BG0056.4± 0.93
BG0066.2± 0.77
BG0076.7± 0.34
BG0086.3± 0.55
BG0096.2± 0.67
BG0106.4± 0.42
BG0116.3± 0.37
BG0126.5± 1.24
BG0137.1± 0.90
BG0146.2± 0.77
14
BG00315
BG00410
BG00510
BG0067
BG0070
BG0086
BG0099
BG0101
BG0110
BG0121
BG0130
BG01498
≥ 800 IU/mL
Title
Measurements
BG00016
BG00118
BG0029
BG00311
BG00445
BG00546
BG00619
BG00725
BG00820
BG00917
BG0104
BG0114
BG0123
BG0132
BG014239
15
BG00318
BG00440
BG00540
BG00617
BG00717
BG00820
BG00918
BG0104
BG0113
BG0123
BG0132
BG014238
Genotype 1b
Title
Measurements
BG00010
BG0017
BG0026
BG0038
BG00414
BG00516
BG0069
BG0078
BG0086
BG0097
BG0101
BG0111
BG0121
BG0130
BG01494
Genotype 4
Title
Measurements
BG0001
BG0010
BG0022
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0145
6
BG0037
BG00411
BG00510
BG0067
BG0071
BG0083
BG0095
BG0102
BG0111
BG0120
BG0130
BG01462
CT
Title
Measurements
BG00020
BG00118
BG00213
BG00315
BG00433
BG00527
BG00611
BG00719
BG00814
BG00916
BG0102
BG0112
BG0122
BG0131
BG014193
TT
Title
Measurements
BG0006
BG0016
BG0024
BG0034
BG00411
BG00519
BG0068
BG0075
BG0089
BG0095
BG0101
BG0111
BG0122
BG0131
BG01482
23
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
87.0
OG00496.4
OG00598.2
OG00696.2
OG00796.0
OG00884.6
OG00988.5
OG01060.0
OG01175.0
OG012100.0
OG013100.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00326
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Discontinued LDV/SOF
Title
Measurements
OG0000.0
OG0016.9
OG0024.3
OG0037.7
OG0040.0
OG0053.6
OG0063.8
OG0070.0
OG0087.7
OG00911.5
OG0100.0
OG0110.0
OG0120.0
OG0130.0
Discontinued Any Study Drug
Title
Measurements
OG0000.0
OG00113.8
OG00213.0
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00222
OG00324
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00096.7
OG00192.6
OG00295.5
OG00395.8
OG004100.0
OG00598.2
OG00696.2
OG007100.0
OG00888.5
OG00992.3
OG010100.0
OG01175.0
OG012100.0
OG013100.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00222
OG00323
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00090.0
OG00188.9
OG00290.9
OG00395.7
OG00496.4
OG00598.2
OG00696.2
OG007100.0
OG00888.5
OG00992.3
OG010100.0
OG01175.0
OG012100.0
OG013100.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00222
OG00323
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00086.7
OG00188.9
OG00286.4
OG00395.7
OG00496.4
OG00598.2
OG00696.2
OG007100.0
OG00888.5
OG00988.5
OG01060.0
OG01175.0
OG012100.0
OG013100.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00221
OG00323
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00086.7
OG00188.9
OG00285.7
OG00387.0
OG00496.4
OG00598.2
OG00696.2
OG00796.0
OG00884.6
OG00988.5
OG01060.0
OG01175.0
OG012100.0
OG013100.0
OG002
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00222
OG00323
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00010.0
OG0013.7
OG0024.5
OG0038.7
OG0043.6
OG0050.0
OG0060.0
OG0070.0
OG0083.8
OG0090.0
OG01040.0
OG01125.0
OG0123.6
OG0130.0
7
Title
Denominators
Categories
Title
Measurements
OG00085.7
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00326
OG00455
OG00556
OG00626
OG00725
OG00826
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG0006.7
OG0016.9
OG00213.0
OG0033.8
OG00416.4
OG00512.5
OG00615.4
OG0074.0
OG0083.8
OG0097.7
OG0100.0
OG0110.0
OG01225.0
OG0130.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00326
OG00455
OG00555
OG00626
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00036.7
OG00141.4
OG00239.1
OG00338.5
OG00449.1
OG00541.8
OG00634.6
OG00728.0
OG0088.0
OG00942.3
OG01040.0
OG01125.0
OG01250.0
OG0130.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00326
OG00455
OG00555
OG00626
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG00083.3
OG00182.8
OG002100.0
OG00384.6
OG00487.3
OG00590.9
OG00688.5
OG00780.0
OG00872.0
OG00988.5
OG010100.0
OG011100.0
OG012100.0
OG01350.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00222
OG00326
OG00455
OG00555
OG00625
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG00396.2
OG00496.4
OG005100.0
OG006100.0
OG007100.0
OG008100.0
OG009100.0
OG010100.0
OG011100.0
OG012100.0
OG01350.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00222
OG00325
OG00455
OG00555
OG00625
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG00196.6
OG002100.0
OG00392.0
OG004100.0
OG005100.0
OG006100.0
OG007100.0
OG00896.0
OG00996.2
OG010100.0
OG011100.0
OG012100.0
OG01350.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00221
OG00324
OG00455
OG00554
OG00625
OG00725
OG00823
OG00925
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG00696.0
OG007100.0
OG008100.0
OG009100.0
OG010100.0
OG011100.0
OG012100.0
OG013100.0
OG003
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG004
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG005
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG006
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00027
OG00122
OG00254
OG00325
OG00422
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
OG003
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG004
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG005
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG006
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00027
OG00122
OG00254
OG00325
OG00422
OG0054
OG0062
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
OG003
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG004
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG005
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG006
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00026
OG00122
OG00251
OG00325
OG00422
OG0053
OG0062
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00324
OG00455
OG00555
OG00625
OG00724
OG00825
OG00926
OG0104
OG0114
OG0124
OG0132
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.26± 0.695
OG0012.49± 0.830
OG0022.11± 0.643
OG0032.46± 0.968
OG0042.33± 0.983
OG0052.42± 0.730
OG0062.40± 0.890
OG0072.86± 0.792
OG0082.84± 0.678
OG0092.56± 0.774
OG0102.76± 0.571
OG0112.75± 1.065
OG0122.28± 1.149
OG0134.30± 1.424
Change at Week 1
Title
Measurements
OG000-3.59± 0.476
OG001-3.34± 0.658
OG002-3.47± 0.579
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00324
OG00454
OG00552
OG00625
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0131
Title
Denominators
Categories
Week 2
Title
Measurements
OG0001.60± 0.484
OG0011.67± 0.574
OG0021.49± 0.404
OG0031.82± 0.748
OG0041.64± 0.751
OG0051.59± 0.516
OG0061.73± 0.631
OG0071.91± 0.641
OG0082.03± 0.585
OG0091.76± 0.628
OG0101.80± 0.645
OG0112.00± 0.746
OG0121.66± 0.637
OG0131.61± NA1 participant analyzed: SD not calculable
Change at Week 2
Title
Measurements
OG000-4.25± 0.575
OG001-4.16± 0.748
OG002-4.09± 0.604
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00223
OG00325
OG00455
OG00555
OG00626
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Week 4
Title
Measurements
OG0001.20± 0.117
OG0011.21± 0.153
OG0021.15± 0.000
OG0031.23± 0.265
OG0041.24± 0.271
OG0051.16± 0.065
OG0061.18± 0.120
OG0071.23± 0.212
OG0081.24± 0.184
OG0091.18± 0.150
OG0101.15± 0.000
OG0111.15± 0.000
OG0121.15± 0.000
OG0131.67± 0.738
Change at Week 4
Title
Measurements
OG000-4.65± 0.668
OG001-4.63± 0.789
OG002-4.44± 0.618
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00129
OG00222
OG00326
OG00454
OG00555
OG00625
OG00725
OG00825
OG00926
OG0105
OG0114
OG0124
OG0131
Title
Denominators
Categories
Week 6
Title
Measurements
OG0001.15± 0.000
OG0011.15± 0.000
OG0021.15± 0.000
OG0031.15± 0.042
OG0041.15± 0.004
OG0051.15± 0.000
OG0061.15± 0.000
OG0071.15± 0.000
OG0081.15± 0.000
OG0091.15± 0.000
OG0101.15± 0.000
OG0111.15± 0.000
OG0121.15± 0.000
OG0131.15± NA1 participant analyzed: SD not calculable
Change at Week 6
Title
Measurements
OG000-4.70± 0.676
OG001-4.69± 0.822
OG002-4.47± 0.616
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00128
OG00222
OG00324
OG00455
OG00555
OG00625
OG00725
OG00824
OG00925
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Week 8
Title
Measurements
OG0001.15± 0.000
OG0011.15± 0.000
OG0021.15± 0.000
OG0031.16± 0.081
OG0041.15± 0.000
OG0051.15± 0.000
OG0061.15± 0.000
OG0071.15± 0.000
OG0081.15± 0.000
OG0091.15± 0.000
OG0101.15± 0.000
OG0111.15± 0.000
OG0121.15± 0.000
OG0131.22± 0.110
Change at Week 8
Title
Measurements
OG000-4.70± 0.676
OG001-4.67± 0.834
OG002-4.47± 0.616
OG003
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
OG005
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
OG006
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG007
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG008
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG009
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG010
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG011
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG012
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
OG013
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
Units
Counts
Participants
OG00030
OG00127
OG00221
OG00324
OG00455
OG00554
OG00624
OG00725
OG00823
OG00925
OG0105
OG0114
OG0124
OG0132
Title
Denominators
Categories
Week 12
Title
Measurements
OG0001.15± 0.000
OG0011.15± 0.000
OG0021.15± 0.000
OG0031.15± 0.000
OG0041.15± 0.000
OG0051.15± 0.000
OG0061.15± 0.000
OG0071.15± 0.000
OG0081.15± 0.000
OG0091.15± 0.000
OG0101.15± 0.000
OG0111.15± 0.000
OG0121.15± 0.000
OG0131.15± 0.000
Change at Week 12
Title
Measurements
OG000-4.70± 0.676
OG001-4.70± 0.842
OG002-4.44± 0.614
OG003
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG003
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
OG004
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
OG005
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
OG006
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
OG007
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
OG008
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
OG009
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Units
Counts
Participants
OG00028
OG00125
OG00221
OG00320
OG00423
OG00525
OG00621
OG00720
OG0085
OG0093
Title
Denominators
Categories
Decrease
Title
Measurements
OG00060.7
OG00168.0
OG00261.9
OG00380.0
OG00430.4
OG00552.0
OG00666.7
OG00770.0
OG00840.0
OG00966.7
No Change
Title
Measurements
OG00017.9
OG00120.0
OG0029.5
OG003
Increase
Title
Measurements
OG00021.4
OG00112.0
OG00228.6
OG003
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG003
Cohort A: Baseline CPT Class C (12 wk)
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG004
Cohort A: Baseline CPT Class C (24 wk)
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG005
Cohort B: Baseline CPT Class A (12 wk)
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG006
Cohort B: Baseline CPT Class A (24 wk)
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG007
Cohort B: Baseline CPT Class B (12 wk)
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG008
Cohort B: Baseline CPT Class B (24 wk)
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG009
Cohort B: Baseline CPT Class C (12 wk)
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
OG010
Cohort B: Baseline CPT Class C (24 wk)
Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
Units
Counts
Participants
OG0001
OG00130
OG00226
OG00319
OG00418
OG00522
OG00623
OG00723
OG00822
OG0094
OG0103
Title
Denominators
Categories
Decrease
Title
Measurements
OG0000.0
OG00163.3
OG00250.0
OG00389.5
OG00472.2
OG00518.2
OG00647.8
OG00756.5
OG00859.1
OG00950.0
OG010100.0
No Change
Title
Measurements
OG0000.0
OG00123.3
OG00238.5
OG003
Increase
Title
Measurements
OG000100.0
OG00113.3
OG00211.5
OG003
0 affected
26 at risk
EG0041 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0071 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0121 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0071 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0071 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0051 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0052 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0061 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0111 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0051 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
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EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0092 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0061 affected26 at risk
EG0070 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0041 affected55 at risk
EG0050 affected56 at risk
EG0061 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
1 affected
26 at risk
EG0040 affected55 at risk
EG0051 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0111 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0051 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0041 affected55 at risk
EG0052 affected56 at risk
EG0060 affected26 at risk
EG0071 affected25 at risk
EG0080 affected26 at risk
EG0093 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
0 affected
26 at risk
EG0040 affected55 at risk
EG0053 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0041 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0041 affected55 at risk
EG0056 affected56 at risk
EG0061 affected26 at risk
EG0074 affected25 at risk
EG0082 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0121 affected4 at risk
EG0131 affected2 at risk
1 affected
26 at risk
EG0043 affected55 at risk
EG0052 affected56 at risk
EG0061 affected26 at risk
EG0071 affected25 at risk
EG0080 affected26 at risk
EG0092 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
2 affected
26 at risk
EG0047 affected55 at risk
EG00510 affected56 at risk
EG0062 affected26 at risk
EG0073 affected25 at risk
EG0081 affected26 at risk
EG0090 affected26 at risk
EG0100 affected5 at risk
EG0110 affected4 at risk
EG0121 affected4 at risk
EG0131 affected2 at risk
2 affected
26 at risk
EG0040 affected55 at risk
EG0050 affected56 at risk
EG0060 affected26 at risk
EG0070 affected25 at risk
EG0080 affected26 at risk
EG0091 affected26 at risk
EG0100 affected5 at risk
EG0111 affected4 at risk
EG0120 affected4 at risk
EG0130 affected2 at risk
34.6
OG00410.9
OG00517.9
OG00615.4
OG0078.0
OG00823.1
OG00934.6
OG01040.0
OG01125.0
OG01225.0
OG0130.0
-3.32
± 0.669
OG004-4.14± 0.721
OG005-3.98± 0.682
OG006-3.80± 0.712
OG007-3.86± 0.759
OG008-3.41± 0.409
OG009-3.68± 0.506
OG010-3.75± 0.584
OG011-3.52± 1.028
OG012-4.22± 0.864
OG013-2.76± 0.526
-3.98
± 0.581
OG004-4.83± 0.720
OG005-4.79± 0.845
OG006-4.48± 0.668
OG007-4.84± 0.636
OG008-4.22± 0.489
OG009-4.47± 0.503
OG010-4.56± 0.765
OG011-4.26± 0.825
OG012-4.85± 1.090
OG013-4.81± NA1 participant analyzed: standard deviation (SD) not calculable
-4.56
± 0.655
OG004-5.23± 0.629
OG005-5.24± 0.929
OG006-5.01± 0.736
OG007-5.52± 0.376
OG008-5.01± 0.537
OG009-5.05± 0.662
OG010-5.21± 0.422
OG011-5.12± 0.368
OG012-5.36± 1.237
OG013-5.39± 0.159
-4.61
± 0.695
OG004-5.32± 0.618
OG005-5.25± 0.936
OG006-5.05± 0.788
OG007-5.60± 0.345
OG008-5.10± 0.559
OG009-5.09± 0.669
OG010-5.21± 0.422
OG011-5.12± 0.368
OG012-5.36± 1.237
OG013-5.28± NA1 participant analyzed: SD not calculable