Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavir... | NCT02010255 | Trialant
NCT02010255
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Nov 19, 2018Actual
Enrollment
334Actual
Phase
Phase 2
Conditions
Chronic HCV Infection
Interventions
LDV/SOF
RBV
Countries
Australia
Austria
Belgium
Canada
France
Germany
Italy
Netherlands
New Zealand
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02010255
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-337-0124
Secondary IDs
ID
Type
Description
Link
2013-002802-30
EudraCT Number
Brief Title
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants 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
May 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
Jan 2014
Primary Completion Date
May 2015Actual
Completion Date
Aug 2015Actual
First Submitted Date
Dec 9, 2013
First Submission Date that Met QC Criteria
Dec 9, 2013
First Posted Date
Dec 12, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
May 11, 2016
Results First Submitted that Met QC Criteria
May 11, 2016
Results First Posted Date
Jun 20, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 19, 2018
Last Update Posted Date
Nov 19, 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
334Actual
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 and/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, kidney, or corneal.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Shampa De-Oertel, PhD
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Royal Prince Alfred Hospital, University of Sydney
Camperdown
New South Wales
2050
Australia
Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre
Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. 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 Europe, Canada, Australia, and New Zealand. The first participant was screened on 14 January 2014. The last study visit occurred on 27 August 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.
Posttreatment 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 Levels and Change From Baseline at Week 1
Baseline; Week 1
HCV RNA Levels and Change From Baseline at Week 2
Baseline; Week 2
HCV RNA Levels and Change From Baseline at Week 4
Baseline; Week 4
HCV RNA Levels and Change From Baseline at Week 6
Baseline; Week 6
HCV RNA Levels and Change From Baseline at Week 8
Baseline; Week 8
HCV RNA Levels 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
Heidelberg
Victoria
3084
Australia
Medizinische Universitaet Innsbruck
Innsbruck
A-6020
Austria
Medizinische Universitat Wien
Vienna
1090
Austria
UCL St-Luc Brussels
Brussels
1200
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
Division of Gastroenterology, University of Alberta, Edmonton
Edmonton
Alberta
T6G 2C2
Canada
University of British Columbia and Vancouver General Hospital
Vancouver
British Columbia
V5Z 3P1
Canada
London Health Sciences Centre-University Hospital
London
Ontario
N6A 5A5
Canada
University Health Network // Toronto General Hospital
Toronto
Ontario
M5G 2C4
Canada
Hopital St. Luc
Montreal
Quebec
H1T 2M4
Canada
McGill University Health Centre \\ Royal Victoria Hospital
Montreal
Quebec
H3A 1A1
Canada
Hospital Beaujon
Clichy
92118
France
Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,
Créteil
94010
France
Hopital Saint-Eloi
Montpellier
34295
France
Hopital Paul Brousse
Villejuif
94804
France
Universitätsklinikum RWTH Aachen
Aachen
52074
Germany
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie
Essen
45122
Germany
University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I
Frankfurt
60590
Germany
Medical School of Hannover
Hanover
30625
Germany
IRCCS Cà Grande Ospedale Maggiore Policlinico
Milan
20122
Italy
Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino
Torino
10126
Italy
Leids Universitair Medisch Centrum
Leiden
2333 ZA
Netherlands
Erasmus MC in Rotterdam
Rotterdam
3015 CE
Netherlands
Auckland City Hospital
Auckland
1023
New Zealand
Hospital General Universitari Vall d' Hebron
Barcelona
8035
Spain
Hospital Clinic i Provincial
Barcelona
8036
Spain
Puerta de Hierro, Madrid
Madrid
28220
Spain
Hospital Universitario y Politecnico La Fe de Valencia
Valencia
46009
Spain
University of Berne
Bern
3010
Switzerland
University Hospital Zurich
Zurich
CH-8091
Switzerland
University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2TH
United Kingdom
Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh
Edinburgh
EH3 9YW
United Kingdom
Kings College Hospital, Institute of Liver Studies
London
SE5 9RS
United Kingdom
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 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
FG00028 subjects
FG00128 subjects
FG00225 subjects
FG00326 subjects
FG00452 subjects
FG00549 subjects
FG00634 subjects
FG00733 subjects
FG00822 subjects
FG00923 subjects
FG0103 subjects
FG0115 subjects
FG0123 subjects
FG0133 subjects
COMPLETED
FG00022 subjects
FG00126 subjects
FG00218 subjects
FG00320 subjects
FG00448 subjects
FG00549 subjects
FG00633 subjects
FG00732 subjects
FG00821 subjects
FG00923 subjects
FG0101 subjects
FG0114 subjects
FG0123 subjects
FG0132 subjects
NOT COMPLETED
FG0006 subjects
FG0012 subjects
FG0027 subjects
FG0036 subjects
FG0044 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0034 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
Lack of Efficacy
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrew Consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Randomized but Not Treated
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 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
BG00028
BG00128
BG00225
BG00326
BG00452
BG00549
BG00634
BG00733
BG00822
BG00923
BG0103
BG0115
BG0123
BG0132
BG014333
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
BG00055± 9.9
BG00156± 8.6
BG00258± 8.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0016
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0001
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
New Zealand
Title
Measurements
BG0001
BG0010
BG002
Hepatitis C Virus (HCV) RNA
Mean
Standard Deviation
log 10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.0± 0.49
BG0015.9± 0.56
BG002
HCV RNA Category
Number
participants
Title
Denominators
Categories
< 800,000 IU/mL
Title
Measurements
BG00011
BG00114
BG002
HCV Genotype
Number
participants
Title
Denominators
Categories
Genotype 1a
Title
Measurements
BG00013
BG00112
BG002
IL28b Status
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0006
BG0019
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 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
OG00026
OG00125
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG00084.6
OG00196.0
OG00281.0
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 and 1 participant in Cohort B 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
Posttreatment 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
Full Analysis Set
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).
OG003
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 Levels 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 Levels 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 Levels 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 Levels 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 Levels 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 Levels 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).
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.
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 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 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.
OG001
Cohort A: Baseline CPT Class B (24 wk)
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.
OG002
Cohort A: Baseline CPT Class C (12 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).
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.
3
28
25
28
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).
6
28
25
28
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).
13
25
23
25
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).
10
26
23
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.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis.
9
52
49
52
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.
5
49
48
49
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
34
27
34
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).
7
33
30
33
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
22
20
22
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).
6
23
20
23
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
3
3
3
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).
2
5
5
5
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 FCH
2
3
3
3
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
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0022 affected25 at risk
EG0030 affected26 at risk
EG0040 affected52 at risk
EG0050 affected49 at risk
EG0060 affected34 at risk
EG0073 affected33 at risk
EG0080 affected22 at risk
EG0092 affected23 at risk
EG0100 affected3 at risk
EG0110 affected5 at risk
EG0120 affected3 at risk
EG0130 affected2 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Cardiac septal hypertrophy
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Left ventricle outflow tract obstruction
Congenital, familial and genetic disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Gastric varices haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Haemorrhagic erosive gastritis
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Localised intraabdominal fluid collection
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Oesophagitis haemorrhagic
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Chills
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Device dislocation
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Malaise
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Liver transplant rejection
Immune system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Empyema
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Endocarditis staphylococcal
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Haemophilus infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Peritoneal tuberculosis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Respiratory tract infection bacterial
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Osteochondritis
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 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
EG0001 affected28 at risk
EG0013 affected28 at risk
EG0025 affected25 at risk
EG0038 affected26 at risk
EG00421 affected52 at risk
EG00527 affected49 at risk
EG00610 affected34 at risk
EG00715 affected33 at risk
EG0086 affected22 at risk
EG00912 affected23 at risk
EG0101 affected3 at risk
EG0111 affected5 at risk
EG0122 affected3 at risk
EG0131 affected2 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected28 at risk
EG0020 affected25 at risk
EG003
Eyelid cyst
Eye disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Ocular icterus
Eye disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pterygium
Eye disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Vision blurred
Eye disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0013 affected28 at risk
EG0023 affected25 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected28 at risk
EG0023 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected28 at risk
EG0021 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0023 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0005 affected28 at risk
EG0016 affected28 at risk
EG0023 affected25 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected28 at risk
EG0020 affected25 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected28 at risk
EG0021 affected25 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0006 affected28 at risk
EG0014 affected28 at risk
EG0024 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected28 at risk
EG0026 affected25 at risk
EG003
Asthenia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected28 at risk
EG0023 affected25 at risk
EG003
Chest pain
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Fatigue
General disorders
MedDRA (17.1)
Systematic Assessment
EG00010 affected28 at risk
EG0019 affected28 at risk
EG0025 affected25 at risk
EG003
Feeling abnormal
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Gait disturbance
General disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Influenza like illness
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Oedema
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Oedema peripheral
General disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected28 at risk
EG0021 affected25 at risk
EG003
Peripheral swelling
General disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected28 at risk
EG0024 affected25 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected28 at risk
EG0021 affected25 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected28 at risk
EG0020 affected25 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Puncture site infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0023 affected25 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected28 at risk
EG0020 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Blood pressure increased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Blood sodium decreased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0024 affected25 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0022 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected28 at risk
EG0021 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected28 at risk
EG0022 affected25 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0015 affected28 at risk
EG0025 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Benign pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0004 affected28 at risk
EG0013 affected28 at risk
EG0021 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0008 affected28 at risk
EG0017 affected28 at risk
EG0027 affected25 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0022 affected25 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected28 at risk
EG0023 affected25 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Tremor
Nervous system disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Depression
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0014 affected28 at risk
EG0024 affected25 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0014 affected28 at risk
EG0024 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0023 affected25 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0022 affected25 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (17.1)
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected28 at risk
EG0021 affected25 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0005 affected28 at risk
EG0018 affected28 at risk
EG0023 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0014 affected28 at risk
EG0022 affected25 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected28 at risk
EG0020 affected25 at risk
EG003
Flushing
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 at risk
EG003
Haematoma
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hot flush
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0021 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA (17.1)
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected28 at risk
EG0020 affected25 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
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 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
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
1 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
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
54
± 10.7
BG00458± 7.9
BG00559± 6.9
BG00657± 7.2
BG00762± 7.5
BG00858± 8.0
BG00960± 10.2
BG01062± 4.6
BG01162± 9.2
BG01258± 2.6
BG01356± 2.8
BG01458± 8.4
10
BG0036
BG00411
BG00510
BG0066
BG0077
BG0087
BG0098
BG0101
BG0110
BG0121
BG0131
BG01482
Male
BG00023
BG00119
BG00215
BG00320
BG00441
BG00539
BG00628
BG00726
BG00815
BG00915
BG0102
BG0115
BG0122
BG0131
BG014251
3
BG0038
BG0044
BG0058
BG0065
BG0077
BG0083
BG0094
BG0101
BG0112
BG0120
BG0130
BG01457
Not Hispanic or Latino
BG00022
BG00122
BG00222
BG00318
BG00448
BG00541
BG00629
BG00726
BG00819
BG00919
BG0102
BG0113
BG0123
BG0132
BG014276
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
1
BG0031
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0130
BG0145
White
Title
Measurements
BG00025
BG00128
BG00223
BG00325
BG00450
BG00547
BG00633
BG00730
BG00821
BG00921
BG0103
BG0115
BG0122
BG0131
BG014314
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0073
BG0080
BG0091
BG0100
BG0110
BG0121
BG0131
BG0147
Native Hawaiian or Pacific Islander
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0142
Other
Title
Measurements
BG0001
BG0010
BG0021
BG0030
BG0041
BG0051
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0145
1
BG0033
BG0042
BG0050
BG0062
BG0072
BG0082
BG0091
BG0100
BG0110
BG0122
BG0130
BG01416
Canada
Title
Measurements
BG0006
BG0015
BG0024
BG0031
BG0048
BG0056
BG0064
BG0075
BG0084
BG0095
BG0100
BG0110
BG0120
BG0131
BG01449
Austria
Title
Measurements
BG0002
BG0012
BG0021
BG0030
BG0048
BG0052
BG0062
BG0073
BG0081
BG0092
BG0100
BG0110
BG0120
BG0130
BG01423
Netherlands
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0043
BG0054
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0148
Belgium
Title
Measurements
BG0001
BG0012
BG0023
BG0030
BG0043
BG0053
BG0061
BG0071
BG0080
BG0092
BG0100
BG0110
BG0120
BG0130
BG01416
Italy
Title
Measurements
BG0002
BG0011
BG0022
BG0031
BG0042
BG0052
BG0063
BG0071
BG0083
BG0093
BG0101
BG0112
BG0120
BG0130
BG01423
United Kingdom
Title
Measurements
BG0005
BG0013
BG0020
BG0031
BG0048
BG0059
BG0064
BG0075
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG01436
Australia
Title
Measurements
BG0001
BG0011
BG0027
BG0034
BG0040
BG0052
BG0063
BG0073
BG0082
BG0092
BG0100
BG0111
BG0120
BG0131
BG01427
France
Title
Measurements
BG0001
BG0011
BG0021
BG0034
BG0044
BG0055
BG0066
BG0073
BG0083
BG0093
BG0100
BG0110
BG0121
BG0130
BG01432
Switzerland
Title
Measurements
BG0001
BG0014
BG0021
BG0032
BG0044
BG0053
BG0064
BG0072
BG0082
BG0090
BG0100
BG0110
BG0120
BG0130
BG01423
Germany
Title
Measurements
BG0002
BG0014
BG0023
BG0033
BG0046
BG0055
BG0060
BG0073
BG0081
BG0091
BG0100
BG0110
BG0120
BG0130
BG01428
Spain
Title
Measurements
BG0006
BG0015
BG0022
BG0037
BG0044
BG0058
BG0065
BG0075
BG0083
BG0094
BG0101
BG0112
BG0120
BG0130
BG01452
5.6
± 0.58
BG0035.7± 0.44
BG0046.4± 0.72
BG0056.5± 0.44
BG0066.3± 0.58
BG0076.5± 0.55
BG0086.1± 0.78
BG0096.2± 0.85
BG0106.0± 0.49
BG0116.5± 0.50
BG0127.3± 0.72
BG0136.0± 0.41
BG0146.2± 0.66
16
BG00317
BG00412
BG0055
BG0069
BG0075
BG0085
BG0099
BG0102
BG0110
BG0120
BG0131
BG014106
≥ 800,000 IU/mL
Title
Measurements
BG00017
BG00114
BG0029
BG0039
BG00440
BG00544
BG00625
BG00728
BG00817
BG00914
BG0101
BG0115
BG0123
BG0131
BG014227
13
BG00312
BG00427
BG00529
BG00614
BG00713
BG00811
BG00913
BG0101
BG0111
BG0122
BG0132
BG014163
Genotype 1b
Title
Measurements
BG00012
BG00113
BG00211
BG00311
BG00418
BG00515
BG00616
BG00715
BG0089
BG0097
BG0101
BG0114
BG0121
BG0130
BG014133
Genotype 4
Title
Measurements
BG0003
BG0013
BG0021
BG0033
BG0047
BG0055
BG0064
BG0075
BG0082
BG0093
BG0101
BG0110
BG0120
BG0130
BG01437
7
BG0034
BG0049
BG00510
BG0063
BG0077
BG0083
BG0095
BG0100
BG0113
BG0120
BG0131
BG01467
CT
Title
Measurements
BG00018
BG00110
BG00210
BG00315
BG00431
BG00525
BG00623
BG00721
BG00812
BG00911
BG0102
BG0112
BG0123
BG0131
BG014184
TT
Title
Measurements
BG0004
BG0019
BG0028
BG0037
BG00412
BG00514
BG0068
BG0075
BG0087
BG0097
BG0101
BG0110
BG0120
BG0130
BG01482
25
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
76.0
OG00494.2
OG005100.0
OG00697.1
OG00797.0
OG00895.5
OG009100.0
OG01033.3
OG01180.0
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 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
OG00028
OG00128
OG00225
OG00326
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Discontinued LDV/SOF
Title
Measurements
OG0003.6
OG0013.6
OG0020.0
OG0037.7
OG0041.9
OG0050.0
OG0060.0
OG0073.0
OG0080.0
OG0090.0
OG0100.0
OG01120.0
OG0120.0
OG0130.0
Discontinued Any Study Drug
Title
Measurements
OG0003.6
OG0017.1
OG00216.0
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 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
OG00026
OG00126
OG00223
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00096.2
OG001100.0
OG00291.3
OG00380.0
OG00498.1
OG005100.0
OG006100.0
OG00797.0
OG00895.5
OG009100.0
OG010100.0
OG01180.0
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 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
OG00026
OG00126
OG00222
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00088.5
OG001100.0
OG00290.9
OG00380.0
OG00494.2
OG005100.0
OG00697.1
OG00797.0
OG00895.5
OG009100.0
OG010100.0
OG01180.0
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 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
OG00026
OG00126
OG00222
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00084.6
OG00196.2
OG00281.8
OG00380.0
OG00494.2
OG005100.0
OG00697.1
OG00797.0
OG00895.5
OG009100.0
OG01033.3
OG01180.0
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 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
OG00025
OG00125
OG00220
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00922
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00084.0
OG00196.0
OG00280.0
OG00376.0
OG00494.2
OG005100.0
OG00697.1
OG00797.0
OG00895.5
OG009100.0
OG01033.3
OG01180.0
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 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
OG00026
OG00125
OG00221
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00015.4
OG0014.0
OG0029.5
OG0034.0
OG0041.9
OG0050.0
OG0060.0
OG0070.0
OG0080.0
OG0090.0
OG01033.3
OG0110.0
OG0120.0
OG0130.0
10
Title
Denominators
Categories
Title
Measurements
OG000100.0
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 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
OG00026
OG00127
OG00225
OG00326
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG0003.8
OG0013.7
OG00212.0
OG0033.8
OG0049.6
OG0056.1
OG0065.9
OG0073.0
OG0080.0
OG0098.7
OG0100.0
OG0110.0
OG0120.0
OG0130.0
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 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
OG00026
OG00127
OG00225
OG00326
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00026.9
OG00137.0
OG00240.0
OG00338.5
OG00448.1
OG00544.9
OG00626.5
OG00721.2
OG00831.8
OG00930.4
OG0100.0
OG0110.0
OG01233.3
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 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
OG00026
OG00127
OG00225
OG00326
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG00076.9
OG00181.5
OG00280.0
OG00384.6
OG00484.6
OG00591.8
OG00667.6
OG00781.8
OG00872.7
OG00982.6
OG010100
OG01125
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 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
OG00026
OG00127
OG00224
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG00291.7
OG003100.0
OG00498.1
OG005100.0
OG006100.0
OG00797.0
OG008100.0
OG009100.0
OG010100.0
OG011100.0
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 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
OG00026
OG00127
OG00224
OG00325
OG00452
OG00549
OG00634
OG00732
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG00396.0
OG004100.0
OG005100.0
OG006100.0
OG00796.9
OG008100.0
OG009100.0
OG010100.0
OG011100.0
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 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
OG00026
OG00127
OG00224
OG00324
OG00451
OG00549
OG00634
OG00732
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG004100.0
OG005100.0
OG006100.0
OG007100.0
OG00895.5
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
OG00026
OG00122
OG00249
OG00332
OG00423
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
OG00121
OG00249
OG00332
OG00423
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
OG00025
OG00121
OG00249
OG00332
OG00423
OG0054
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 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
OG00026
OG00127
OG00224
OG00325
OG00452
OG00549
OG00634
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.44± 0.665
OG0012.47± 0.696
OG0022.32± 0.868
OG0032.50± 0.645
OG0042.38± 0.716
OG0052.38± 0.653
OG0062.64± 0.784
OG0072.81± 0.729
OG0082.63± 0.780
OG0092.75± 0.888
OG0102.97± 0.229
OG0113.73± 0.434
OG0122.91± 0.825
OG0132.28± 0.620
Change at Week 1
Title
Measurements
OG000-3.60± 0.535
OG001-3.39± 0.634
OG002-3.28± 0.735
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 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
OG00026
OG00127
OG00225
OG00326
OG00452
OG00548
OG00633
OG00733
OG00822
OG00923
OG0103
OG0115
OG0123
OG0132
Title
Denominators
Categories
Week 2
Title
Measurements
OG0001.76± 0.668
OG0011.70± 0.579
OG0021.71± 0.625
OG0031.72± 0.573
OG0041.62± 0.604
OG0051.49± 0.477
OG0061.92± 0.839
OG0071.97± 0.607
OG0081.86± 0.607
OG0092.00± 0.718
OG0102.08± 0.378
OG0112.81± 0.709
OG0121.85± 0.731
OG0131.65± 0.122
Change at Week 2
Title
Measurements
OG000-4.29± 0.534
OG001-4.17± 0.538
OG002-3.92± 0.610
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 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
OG00026
OG00127
OG00224
OG00325
OG00452
OG00549
OG00634
OG00732
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Week 4
Title
Measurements
OG0001.26± 0.257
OG0011.20± 0.148
OG0021.23± 0.205
OG0031.18± 0.147
OG0041.23± 0.247
OG0051.18± 0.129
OG0061.29± 0.301
OG0071.21± 0.154
OG0081.25± 0.199
OG0091.32± 0.408
OG0101.15± 0.000
OG0111.56± 0.585
OG0121.15± 0.000
OG0131.15± 0.000
Change at Week 4
Title
Measurements
OG000-4.78± 0.430
OG001-4.66± 0.518
OG002-4.45± 0.521
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 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
OG00026
OG00127
OG00223
OG00325
OG00451
OG00549
OG00634
OG00732
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Week 6
Title
Measurements
OG0001.15± 0.000
OG0011.15± 0.000
OG0021.17± 0.102
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 6
Title
Measurements
OG000-4.90± 0.487
OG001-4.72± 0.535
OG002-4.51± 0.527
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 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
OG00026
OG00127
OG00224
OG00324
OG00452
OG00549
OG00634
OG00731
OG00822
OG00923
OG0103
OG0114
OG0123
OG0132
Title
Denominators
Categories
Week 8
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 8
Title
Measurements
OG000-4.90± 0.487
OG001-4.72± 0.535
OG002-4.53± 0.534
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 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
OG00026
OG00127
OG00224
OG00324
OG00451
OG00549
OG00634
OG00732
OG00821
OG00923
OG0103
OG0114
OG0123
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
OG000-4.90± 0.487
OG001-4.72± 0.535
OG002-4.53± 0.534
OG003
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 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
OG00024
OG00122
OG00221
OG00320
OG00432
OG00532
OG00621
OG00723
OG0082
OG0094
Title
Denominators
Categories
Decrease
Title
Measurements
OG00070.8
OG00177.3
OG00281.0
OG00370.0
OG00428.1
OG00562.5
OG00666.7
OG00765.2
OG00850.0
OG00975.0
No Change
Title
Measurements
OG00012.5
OG0019.1
OG00214.3
OG003
Increase
Title
Measurements
OG00016.7
OG00113.6
OG0024.8
OG003
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.