Hepatitis C Virus Infection
Conditions
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.
Interventions
DRUGVOX
100 mg tablet(s) administered orally once daily with food
DRUGSOF/VEL
400/100 mg FDC tablet administered orally once daily with food
DRUGRBV
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)
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 12 Weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | Posttreatment Weeks 4 and 24 | SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | 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 | Up to Posttreatment Week 24 | * 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. |
Countries
New Zealand, Puerto Rico, United States
Participant flow
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 36 |
| 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 | 33 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic 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 | 31 |
| 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 | 31 |
| 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 | 32 |
| 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 | 8 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 10 | 0 | 2 | 6 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 9.8 | 53 years STANDARD_DEVIATION 11.5 | 51 years STANDARD_DEVIATION 14.3 | 58 years STANDARD_DEVIATION 7.2 | 59 years STANDARD_DEVIATION 6.7 | 57 years STANDARD_DEVIATION 7.8 | 59 years STANDARD_DEVIATION 6.5 | 5.7 years STANDARD_DEVIATION 5.9 |
| HCV RNA | 6.2 log10 IU/mL STANDARD_DEVIATION 0.6 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.51 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.55 | 6.0 log10 IU/mL STANDARD_DEVIATION 0.59 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.47 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.77 | 6.0 log10 IU/mL STANDARD_DEVIATION 0.61 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.38 |
| HCV RNA Category < 800,000 IU/mL | 58 Participants | 6 Participants | 10 Participants | 14 Participants | 6 Participants | 6 Participants | 16 Participants | 0 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 147 Participants | 28 Participants | 26 Participants | 19 Participants | 25 Participants | 25 Participants | 16 Participants | 8 Participants |
| IL28b Status CC | 51 Participants | 12 Participants | 9 Participants | 7 Participants | 12 Participants | 4 Participants | 4 Participants | 3 Participants |
| IL28b Status CT | 110 Participants | 15 Participants | 21 Participants | 19 Participants | 12 Participants | 19 Participants | 21 Participants | 3 Participants |
| IL28b Status Missing | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| IL28b Status TT | 40 Participants | 7 Participants | 4 Participants | 7 Participants | 6 Participants | 7 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants | 3 Participants | 4 Participants | 7 Participants | 5 Participants | 4 Participants | 6 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 42 Participants | 3 Participants | 5 Participants | 8 Participants | 7 Participants | 4 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 163 Participants | 31 Participants | 31 Participants | 25 Participants | 24 Participants | 27 Participants | 22 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 175 Participants | 31 Participants | 32 Participants | 25 Participants | 26 Participants | 27 Participants | 26 Participants | 8 Participants |
| Region of Enrollment New Zealand | 7 Participants | 2 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 198 Participants | 32 Participants | 36 Participants | 28 Participants | 31 Participants | 31 Participants | 32 Participants | 8 Participants |
| Sex: Female, Male Female | 71 Participants | 11 Participants | 15 Participants | 14 Participants | 12 Participants | 8 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 134 Participants | 23 Participants | 21 Participants | 19 Participants | 19 Participants | 23 Participants | 26 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 | 0 / 33 | 0 / 31 | 0 / 31 | 0 / 32 | 0 / 8 |
| other Total, other adverse events | 21 / 34 | 20 / 36 | 18 / 33 | 24 / 31 | 15 / 31 | 16 / 32 | 6 / 8 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 | 2 / 33 | 0 / 31 | 0 / 31 | 0 / 32 | 0 / 8 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 Weeks
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 6.5 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
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.
Time frame: Posttreatment Week 12
Population: Full Analysis Set (FAS): participants who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 70.6 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 93.9 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 80.6 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
Secondary
HCV RNA Change From Baseline
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Population: Participants in the Full Analysis Set with available data were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -5.00 log10 IU/mL | Standard Deviation 0.504 |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.64 log10 IU/mL | Standard Deviation 0.556 |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -5.07 log10 IU/mL | Standard Deviation 0.514 |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -5.07 log10 IU/mL | Standard Deviation 0.514 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 8 | -5.08 log10 IU/mL | Standard Deviation 0.549 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -5.06 log10 IU/mL | Standard Deviation 0.534 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -5.08 log10 IU/mL | Standard Deviation 0.549 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.60 log10 IU/mL | Standard Deviation 0.595 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -4.98 log10 IU/mL | Standard Deviation 0.519 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -4.57 log10 IU/mL | Standard Deviation 0.662 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.15 log10 IU/mL | Standard Deviation 0.733 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 8 | -4.85 log10 IU/mL | Standard Deviation 0.591 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -4.84 log10 IU/mL | Standard Deviation 0.586 |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -4.81 log10 IU/mL | Standard Deviation 0.576 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -5.16 log10 IU/mL | Standard Deviation 0.48 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -4.85 log10 IU/mL | Standard Deviation 0.583 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.31 log10 IU/mL | Standard Deviation 0.658 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 8 | -5.16 log10 IU/mL | Standard Deviation 0.48 |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -5.17 log10 IU/mL | Standard Deviation 0.481 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -5.24 log10 IU/mL | Standard Deviation 0.767 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 12 | -5.24 log10 IU/mL | Standard Deviation 0.767 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.40 log10 IU/mL | Standard Deviation 0.577 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -5.22 log10 IU/mL | Standard Deviation 0.755 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 10 | -5.24 log10 IU/mL | Standard Deviation 0.767 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -4.97 log10 IU/mL | Standard Deviation 0.711 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | HCV RNA Change From Baseline | Change at Week 8 | -5.24 log10 IU/mL | Standard Deviation 0.767 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 2 | -4.66 log10 IU/mL | Standard Deviation 0.52 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 6 | -4.84 log10 IU/mL | Standard Deviation 0.611 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 1 | -4.19 log10 IU/mL | Standard Deviation 0.504 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 4 | -4.84 log10 IU/mL | Standard Deviation 0.601 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 8 | -4.84 log10 IU/mL | Standard Deviation 0.611 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 10 | -4.84 log10 IU/mL | Standard Deviation 0.611 |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | HCV RNA Change From Baseline | Change at Week 12 | -4.84 log10 IU/mL | Standard Deviation 0.611 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 8 | -5.35 log10 IU/mL | Standard Deviation 0.385 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 1 | -4.71 log10 IU/mL | Standard Deviation 0.486 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 12 | -5.35 log10 IU/mL | Standard Deviation 0.385 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 10 | -5.35 log10 IU/mL | Standard Deviation 0.385 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 4 | -5.35 log10 IU/mL | Standard Deviation 0.385 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 2 | -5.27 log10 IU/mL | Standard Deviation 0.45 |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | HCV RNA Change From Baseline | Change at Week 6 | -5.35 log10 IU/mL | Standard Deviation 0.385 |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Population: Participants in the Full Analysis Set with available data were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 23.5 percentage of participants |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 100.0 percentage of participants |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 79.4 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 94.4 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 75.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 38.9 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 90.9 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 63.6 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 97.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 33.3 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 16.1 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 54.8 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 96.8 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 12 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 22.6 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 10 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 58.1 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 93.5 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 96.9 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 28.1 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 12 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 10 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 62.5 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 12 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 12.5 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 75.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 6 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 10 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 100.0 percentage of participants |
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.
Time frame: Posttreatment Weeks 4 and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 88.2 percentage of participants |
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 70.6 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 93.9 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 93.9 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 87.1 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 80.6 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
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.
Time frame: Up to Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Virologic Failure | 29.4 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Virologic Failure | 6.1 percentage of participants |
| VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | Percentage of Participants With Virologic Failure | 19.4 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Percentage of Participants With Virologic Failure | 0 percentage of participants |