Efficacy and Safety of Sofosbuvir Containing Regimens for... | NCT01826981 | Trialant
NCT01826981
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Nov 16, 2018Actual
Enrollment
359Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C
Interventions
LDV/SOF
SOF
RBV
Peg-IFN
GS-9669
VEL
Countries
New Zealand
Protocol Section
Identification Module
NCT ID
NCT01826981
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-337-0122
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Official Title
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Sep 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
Apr 2013
Primary Completion Date
Mar 2015Actual
Completion Date
May 2015Actual
First Submitted Date
Apr 1, 2013
First Submission Date that Met QC Criteria
Apr 4, 2013
First Posted Date
Apr 9, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 28, 2016
Results First Submitted that Met QC Criteria
Jul 28, 2016
Results First Posted Date
Sep 16, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 22, 2016
Certification/Extension First Submitted that Passed QC Review
Jan 22, 2016
Certification/Extension First Posted Date
Feb 15, 2016Estimated
Last Update Submitted Date
Oct 19, 2018
Last Update Posted Date
Nov 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
Drug: LDV/SOF
Drug: RBV
Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
Experimental
SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Up to 24 weeks plus 30 days
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 1 and 2
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 4, 6, and 8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Chronic genotype 1, 2, 3, or 6 HCV infection
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
Pregnant or nursing female or male with pregnant female partner
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.
Participants were enrolled at a total of 2 study sites in New Zealand. The first participant was screened on 3 April 2016. The last study visit occurred on 25 May 2015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
FG001
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Drug: LDV/SOF
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
Experimental
LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Drug: LDV/SOF
Drug: RBV
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
Experimental
LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Drug: LDV/SOF
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
Experimental
LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
Drug: LDV/SOF
Drug: RBV
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
Experimental
LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 10
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 12
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Weeks 16, 20, and 24
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
Posttreatment Weeks 2, 4, 8, and 24
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
Posttreatment Weeks 16 and 20
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Up to Posttreatment Week 24
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Up to Posttreatment Week 24
Christchurch
New Zealand
Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
FG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
FG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
FG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
FG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
FG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
FG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
FG00019 subjects
FG00110 subjects
FG00225 subjects
FG00326 subjects
FG00425 subjects
FG00526 subjects
FG00625 subjects
FG00751 subjects
FG00820 subjects
FG00927 subjects
FG01024 subjects
FG01127 subjects
FG01226 subjects
FG01320 subjects
FG0148 subjects
COMPLETED
FG00019 subjects
FG0019 subjects
FG00225 subjects
FG00326 subjects
FG00418 subjects
FG00525 subjects
FG00624 subjects
FG00740 subjects
FG00813 subjects
FG00926 subjects
FG01022 subjects
FG01125 subjects
FG01225 subjects
FG01315 subjects
FG0148 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0047 subjects
FG0051 subjects
FG0061 subjects
FG00711 subjects
FG0087 subjects
FG0091 subjects
FG0102 subjects
FG0112 subjects
FG0121 subjects
FG0135 subjects
FG0140 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0050 subjects
FG0060 subjects
FG0078 subjects
FG0087 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0133 subjects
FG0140 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Upper G-I Haemorrhage
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Enrolled/Randomized but Not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety analysis set: Participants who were randomized and received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
BG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
BG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
BG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
BG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
BG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
BG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
BG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00110
BG00225
BG00326
BG00425
BG00526
BG00625
BG00750
BG00820
BG00927
BG01024
BG01127
BG01226
BG01320
BG0148
BG015358
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± 6.1
BG00149± 12.5
BG00256± 5.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0012
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00018
BG0019
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Not Hispanic or Latino
Title
Measurements
BG00019
BG00110
BG002
HCV Genotype
Number
participants
Title
Denominators
Categories
1b with possible mixed infection with Genotype 4
Title
Measurements
BG0000
BG0010
BG002
Cirrhosis Status
Number
participants
Title
Denominators
Categories
No
Title
Measurements
BG00018
BG0019
BG002
IL28b Status
CC, CT, and TT alleles are different forms of the IL28b gene.
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0004
BG0013
BG002
HCV RNA
Median
Standard Deviation
log 10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.3± 0.51
BG0016.5± 0.63
BG002
HCV RNA Category
Number
IU/mL
Title
Denominators
Categories
< 800,000
Title
Measurements
BG0003
BG0011
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 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
Posted
Number
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Units
Counts
Participants
OG00019
OG00110
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000100
OG00190
OG002100
OG003
Primary
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Safety Analysis Set
Posted
Number
Percentage of participants
Up to 24 weeks plus 30 days
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG003
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Weeks 1 and 2
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Weeks 4, 6, and 8
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 10
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Full Analysis Set
Posted
Number
percentage of participants
Weeks 16, 20, and 24
ID
Title
Description
OG000
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Units
Counts
Participants
OG00020
Secondary
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Posttreatment Weeks 2, 4, 8, and 24
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Secondary
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Units
Counts
Participants
OG0008
Secondary
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Full Analysis Set
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
OG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Time Frame
Up to 24 Weeks plus 30 days
Description
Safety Analysis Set
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
0
19
17
19
EG001
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
0
26
24
26
EG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
4
25
24
25
EG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
0
26
23
26
EG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
1
25
21
25
EG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
1
50
43
50
EG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
2
20
19
20
EG009
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
0
26
21
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG0030 affected26 at risk
EG0040 affected25 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected50 at risk
EG0080 affected20 at risk
EG0090 affected20 at risk
EG0100 affected8 at risk
EG0110 affected27 at risk
EG0120 affected24 at risk
EG0130 affected27 at risk
EG0140 affected26 at risk
Pericardial effusion
Cardiac disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Choroidal effusion
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lens dislocation
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Seizure
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Agitation
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG0030 affected26 at risk
EG0040 affected25 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected50 at risk
EG0080 affected20 at risk
EG0090 affected20 at risk
EG0100 affected8 at risk
EG0110 affected27 at risk
EG0121 affected24 at risk
EG0130 affected27 at risk
EG0140 affected26 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0003 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Eye irritation
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Eye pruritus
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Eyelid thickening
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Eyelids pruritus
Eye disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected10 at risk
EG0020 affected25 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0004 affected19 at risk
EG0013 affected10 at risk
EG0027 affected25 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 at risk
EG0021 affected25 at risk
EG003
Catheter site bruise
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Chest discomfort
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Chills
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected10 at risk
EG0020 affected25 at risk
EG003
Fatigue
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0006 affected19 at risk
EG0013 affected10 at risk
EG0025 affected25 at risk
EG003
Temperature intolerance
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Tenderness
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Ulcer
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Vessel puncture site phlebitis
General disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected10 at risk
EG0020 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Oral herpes
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected10 at risk
EG0023 affected25 at risk
EG003
Pertussis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0004 affected19 at risk
EG0011 affected10 at risk
EG0028 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Viral infection
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0024 affected25 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chest crushing
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal injury
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Weight decreased
Investigations
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected10 at risk
EG0020 affected25 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0002 affected19 at risk
EG0013 affected10 at risk
EG0020 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0022 affected25 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected10 at risk
EG0022 affected25 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Amnesia
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0005 affected19 at risk
EG0012 affected10 at risk
EG00210 affected25 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lethargy
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 at risk
EG0024 affected25 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Somnolence
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 18.0.
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0007 affected19 at risk
EG0012 affected10 at risk
EG0027 affected25 at risk
EG003
Irritability
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Tearfulness
Psychiatric disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0003 affected19 at risk
EG0012 affected10 at risk
EG0023 affected25 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0023 affected25 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 at risk
EG0025 affected25 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 at risk
EG0021 affected25 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0022 affected25 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0023 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0004 affected19 at risk
EG0012 affected10 at risk
EG0020 affected25 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected10 at risk
EG0020 affected25 at risk
EG003
Skin discomfort
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected10 at risk
EG0021 affected25 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 18.0.
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected10 at risk
EG0020 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 18.0.
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected10 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
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
OG009
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
OG009
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Units
Counts
Participants
OG00019
OG00110
OG00225
OG00326
OG00424
OG00526
OG00625
OG00750
OG00820
OG00927
OG01023
OG01126
OG01226
OG01320
OG0148
Title
Denominators
Categories
SVR2
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003100.0
OG00472.0
OG005100.0
OG006100.0
OG00790.0
OG00895.0
OG009100.0
OG01087.5
OG01196.3
OG012100.0
OG01395.0
OG014100.0
SVR4
Title
Measurements
OG000100.0
OG001100.0
OG00284.0
OG003
SVR8
Title
Measurements
OG000100.0
OG00190.0
OG002100.0
OG003
SVR24
Title
Measurements
OG000100.0
OG00190.0
OG002100.0
OG003
Title
Denominators
Categories
SVR16
Title
Measurements
OG000100
SVR20
Title
Measurements
OG000100
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
OG004
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
OG005
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
OG006
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
OG007
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
OG008
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
OG013
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study