Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpa... | NCT02378935 | Trialant
NCT02378935
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Mar 6, 2020Actual
Enrollment
205Actual
Phase
Phase 2
Conditions
Hepatitis C Virus Infection
Interventions
VOX
SOF/VEL
RBV
Countries
United States
New Zealand
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT02378935
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-367-1168
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Official Title
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2017
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
Feb 17, 2015Actual
Primary Completion Date
Feb 1, 2016Actual
Completion Date
Apr 12, 2016Actual
First Submitted Date
Feb 27, 2015
First Submission Date that Met QC Criteria
Feb 27, 2015
First Posted Date
Mar 4, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 16, 2017
Results First Submitted that Met QC Criteria
Nov 6, 2017
Results First Posted Date
Dec 8, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 23, 2016
Certification/Extension First Submitted that Passed QC Review
May 23, 2016
Certification/Extension First Posted Date
Jun 6, 2016Estimated
Last Update Submitted Date
Feb 18, 2020
Last Update Posted Date
Mar 6, 2020Actual
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
Yes
Is FDA Regulated Device
No
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 primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C Virus 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
205Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
VOX+SOF/VEL 6 wk, TN, without cirrhosis
Experimental
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 8 wk, TN, without cirrhosis
Experimental
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 6 wk, TN, with cirrhosis
Experimental
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 8 wk, TN, with cirrhosis
Experimental
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
Experimental
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
Drug: VOX
Drug: SOF/VEL
Drug: RBV
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VOX
Drug
100 mg tablet(s) administered orally once daily with food
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Individuals with chronic HCV infection
HCV RNA ≥10^4 IU/mL at screening
HCV genotype 1
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
Pregnant or nursing female
Current or prior history of hepatic decompensation
Hepatocellular carcinoma (HCC) or other clinically significant malignancy
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):893-901.e1. doi: 10.1053/j.gastro.2016.07.039. Epub 2016 Jul 30.
255 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.
Recruitment Details
Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 17 February 2015. The last study visit occurred on 12 April 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
FG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
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
Not provided
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
Non-Randomized
Intervention Model
Sequential 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
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
Experimental
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
Experimental
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
Experimental
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 12 wk (GS-US-338-1121)
Experimental
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
Drug: VOX
Drug: SOF/VEL
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
GS-9857
SOF/VEL
Drug
400/100 mg FDC tablet administered orally once daily with food
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
GS-7977/GS-5816
Epclusa®
RBV
Drug
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)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
On-treatment virologic failure:
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)
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
Palo Alto
California
United States
Huntington Memorial Hospital Liver Center
Pasadena
California
United States
Medical Associates Research Group, Inc.
San Diego
California
United States
University of Colorado
Denver
Colorado
United States
Borland-Groover Clinic
Jacksonville
Florida
United States
University of Miami
Miami
Florida
United States
Orlando Immunology center
Orlando
Florida
United States
South Florida Center of Gastroenterology, P.A.
Wellington
Florida
United States
Center for Hep C/Atlanta Medical Center
Atlanta
Georgia
United States
Gastrointestinal Specialists of Georgia, PC
Marietta
Georgia
United States
University of Chicago
Chicago
Illinois
United States
Indiana University
Indianapolis
Indiana
United States
Indianapolis Gastroenterology & Hepatology, Inc.
Indianapolis
Indiana
United States
Beth Isreal Deconess Medical Center
Boston
Massachusetts
United States
Massachusetts General Hospital
Boston
Massachusetts
United States
Henry Ford Hospital and Health System
Detroit
Michigan
United States
ID Care
Hillsborough
New Jersey
United States
Southwest Care Center
Santa Fe
New Mexico
United States
North Shore/Long Island Jewish PRIME
Manhasset
New York
United States
Mount Sinai Beth Israel
New York
New York
United States
Cumberland Research Associates, LLC
Fayetteville
North Carolina
United States
Digestive Health Specialists, PA
Winston-Salem
North Carolina
United States
University of Pennsylvania Health Systems
Philadelphia
Pennsylvania
United States
UPMC Center for Liver Diseases
Pittsburgh
Pennsylvania
United States
Medical University of South Carolina
Charleston
South Carolina
United States
Gastro One
Germantown
Tennessee
United States
Nashville Gastrointestinal Specialists, Inc.
Nashville
Tennessee
United States
Texas Liver Institute
San Antonio
Texas
United States
Liver Institute of Virginia
Richmond
Virginia
United States
Swedish Medical Center
Seattle
Washington
United States
Auckland Clinical Studies
Auckland
New Zealand
Christchurch Clinical Studies Trust
Christchurch
New Zealand
Fundacion de Investigacion de Diego
San Juan
Puerto Rico
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis
FG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
FG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis
FG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
FG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
FG00034 subjects
FG00136 subjects
FG00233 subjects
FG00331 subjects
FG00431 subjects
FG00532 subjects
FG0068 subjects
COMPLETED
FG00024 subjects
FG00136 subjects
FG00230 subjects
FG00325 subjects
FG00431 subjects
FG00532 subjects
FG0068 subjects
NOT COMPLETED
FG00010 subjects
FG0010 subjects
FG0023 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00010 subjects
FG0010 subjects
FG0022 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Safety Analysis Set: participants who received at least 1 dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
BG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
BG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
BG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
BG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
BG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00136
BG00233
BG00331
BG00431
BG00532
BG0068
BG007205
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
BG00053± 11.5
BG00151± 14.3
BG00258± 7.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00115
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0003
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0003
BG0015
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00032
BG00136
BG002
IL28b Status
The CC, CT, and TT alleles are different forms of the IL28b gene.
Count of Participants
Participants
Title
Denominators
Categories
CC
Title
Measurements
BG00012
BG0019
BG002
HCV RNA
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.2± 0.51
BG0016.2± 0.55
BG002
HCV RNA Category
Count of Participants
Participants
Title
Denominators
Categories
< 800,000 IU/mL
Title
Measurements
BG0006
BG00110
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 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Full Analysis Set (FAS): participants who received at least 1 dose of study drug
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
OG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
OG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
Units
Counts
Participants
OG00034
OG00136
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00070.6(52.5 to 84.9)
OG001100.0(90.3 to 100.0)
OG00293.9(79.8 to 99.3)
OG003
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Safety Analysis Set
Posted
Number
percentage of participants
Up to 12 Weeks
ID
Title
Description
OG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
OG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
OG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
Secondary
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Full Analysis Set
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Weeks 4 and 24
ID
Title
Description
OG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
OG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
OG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
Secondary
HCV RNA Change From Baseline
Participants in the Full Analysis Set with available data were analyzed
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
ID
Title
Description
OG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
OG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
OG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
Secondary
Percentage of Participants With Virologic Failure
On-treatment virologic failure:
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)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Full Analysis Set
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
OG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
OG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
Time Frame
Up to 12 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
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
0
34
0
34
21
34
EG001
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
0
36
0
36
20
36
EG002
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
0
31
0
31
24
31
EG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
0
31
0
31
15
31
EG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
0
32
0
32
16
32
EG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
0
8
0
8
6
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial flutter
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0021 affected33 at risk
EG0030 affected31 at risk
EG0040 affected31 at risk
EG0050 affected32 at risk
EG0060 affected8 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0021 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG0037 affected31 at risk
EG0040 affected31 at risk
EG0050 affected32 at risk
EG0060 affected8 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0012 affected36 at risk
EG0022 affected33 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0014 affected36 at risk
EG0023 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected34 at risk
EG0016 affected36 at risk
EG0022 affected33 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected34 at risk
EG0010 affected36 at risk
EG0021 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG00110 affected36 at risk
EG0027 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0011 affected36 at risk
EG0022 affected33 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected34 at risk
EG0017 affected36 at risk
EG0021 affected33 at risk
EG003
Malaise
General disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0022 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0012 affected36 at risk
EG0020 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected34 at risk
EG0013 affected36 at risk
EG0021 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected34 at risk
EG0011 affected36 at risk
EG0020 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0022 affected33 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0022 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0012 affected36 at risk
EG0021 affected33 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected34 at risk
EG0017 affected36 at risk
EG0027 affected33 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0012 affected36 at risk
EG0020 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected34 at risk
EG0010 affected36 at risk
EG0021 affected33 at risk
EG003
Depression
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected34 at risk
EG0011 affected36 at risk
EG0020 affected33 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected34 at risk
EG0013 affected36 at risk
EG0020 affected33 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected34 at risk
EG0010 affected36 at risk
EG0020 affected33 at risk
EG003
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
D006526
Hepatitis C
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D006505
Hepatitis
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000619503
voxilaprevir
C000611331
sofosbuvir-velpatasvir drug combination
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
59
± 6.7
BG00457± 7.8
BG00559± 6.5
BG0065.7± 5.9
BG00756± 9.8
14
BG00312
BG0048
BG0056
BG0065
BG00771
Male
BG00023
BG00121
BG00219
BG00319
BG00423
BG00526
BG0063
BG007134
7
BG0035
BG0044
BG0056
BG0060
BG00729
White
Title
Measurements
BG00031
BG00132
BG00225
BG00326
BG00427
BG00526
BG0068
BG007175
Native Hawaiian or Pacific Islander
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0071
8
BG0037
BG0044
BG00510
BG0065
BG00742
Not Hispanic or Latino
Title
Measurements
BG00031
BG00131
BG00225
BG00324
BG00427
BG00522
BG0063
BG007163
28
BG00331
BG00431
BG00532
BG0068
BG007198
New Zealand
Title
Measurements
BG0002
BG0010
BG0025
BG0030
BG0040
BG0050
BG0060
BG0077
7
BG00312
BG0044
BG0054
BG0063
BG00751
CT
Title
Measurements
BG00015
BG00121
BG00219
BG00312
BG00419
BG00521
BG0063
BG007110
TT
Title
Measurements
BG0007
BG0014
BG0027
BG0036
BG0047
BG0057
BG0062
BG00740
Missing
Title
Measurements
BG0000
BG0012
BG0020
BG0031
BG0041
BG0050
BG0060
BG0074
6.0
± 0.59
BG0036.3± 0.47
BG0046.4± 0.77
BG0056.0± 0.61
BG0066.5± 0.38
BG0076.2± 0.60
14
BG0036
BG0046
BG00516
BG0060
BG00758
≥ 800,000 IU/mL
Title
Measurements
BG00028
BG00126
BG00219
BG00325
BG00425
BG00516
BG0068
BG007147
31
OG00431
OG00532
OG0068
80.6
(62.5 to 92.5)
OG004100(88.8 to 100.0)
OG005100.0(89.1 to 100.0)
OG006100.0(63.1 to 100.0)
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
Units
Counts
Participants
OG00034
OG00136
OG00233
OG00331
OG00431
OG00532
OG0068
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0036.5
OG0040
OG0050
OG0060
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
Units
Counts
Participants
OG00034
OG00136
OG00233
OG00331
OG00431
OG00532
OG0068
Title
Denominators
Categories
SVR4
Title
Measurements
OG00088.2(72.5 to 96.7)
OG001100.0(90.3 to 100.0)
OG00293.9(79.8 to 99.3)
OG00387.1(70.2 to 96.4)
OG004100.0(88.8 to 100.0)
OG005100.0(89.1 to 100.0)
OG006100.0(63.1 to 100.0)
SVR24
Title
Measurements
OG00070.6(52.5 to 84.9)
OG001100.0(90.3 to 100.0)
OG00293.9(79.8 to 99.3)
OG003
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
Units
Counts
Participants
OG00034
OG00136
OG00233
OG00331
OG00431
OG00532
OG0068
Title
Denominators
Categories
Week 1
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00331
ParticipantsOG00431
ParticipantsOG00532
ParticipantsOG0068
Title
Measurements
OG00023.5(10.7 to 41.2)
OG00138.9(23.1 to 56.5)
OG00233.3(18.0 to 51.8)
OG003
Week 2
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00331
Week 4
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00331
Week 6
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Week 8
ParticipantsOG0000
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00331
Week 10
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
OG004
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
OG005
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
OG006
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121