Hepatitis C
Conditions
Keywords
Hepatitis, Genotype 1, Genotype 3, Treatment experienced
Brief summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
Interventions
DRUGSOF
400 mg tablet administered orally once daily
DRUGVEL
Tablet administered orally once daily
DRUGRBV
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)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) ≥ 18 kg/m\^2 * HCV RNA ≥ 10000 IU/mL at screening * Prior treatment failure to a regimen including interferon with or without RBV * HCV genotype 1 or 3 * Chronic HCV infection * Cirrhosis determination * Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion criteria
* Current or prior history of clinically significant illness other than HCV * Screening ECG with clinically significant abnormalities * Prior exposure to HCV specific direct acting antiviral agent * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of non-HCV etiology * Hepatitis B * Active drug abuse * Use of any prohibited concomitant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping 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 SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | Posttreatment Weeks 4 and 24 | SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively. |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 24 | Virologic failure was defined as: * 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
Australia, New Zealand, Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Australia, New Zealand, and the United States. The first participant was screened on 17 June 2013. The last study visit occurred on 22 August 2014.
Pre-assignment details
416 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic) | 26 |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic) | 28 |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic) | 27 |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic) | 26 |
| SOF+VEL 25 mg (GT3 Cirrhotic) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic) | 26 |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic) | 25 |
| SOF+VEL 100 mg (GT3 Cirrhotic) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic) | 26 |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic) | 26 |
| SOF+VEL 25 mg (GT1) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1) | 27 |
| SOF+VEL 25 mg + RBV (GT1) SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1) | 29 |
| SOF+VEL 100 mg (GT1) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | 27 |
| SOF+VEL 100 mg + RBV (GT1) SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1) | 28 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 4 | 1 | 0 | 0 | 7 | 3 | 1 | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Randomized but Never Treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrew Consent | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | SOF+VEL 25 mg (GT3 Non-Cirrhotic) | SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | SOF+VEL 100 mg (GT3 Non-Cirrhotic) | SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | SOF+VEL 25 mg (GT3 Cirrhotic) | SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | SOF+VEL 100 mg (GT3 Cirrhotic) | SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | SOF+VEL 25 mg (GT1) | SOF+VEL 25 mg + RBV (GT1) | SOF+VEL 100 mg (GT1) | SOF+VEL 100 mg + RBV (GT1) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 11.8 | 51 years STANDARD_DEVIATION 10.4 | 55 years STANDARD_DEVIATION 6.9 | 56 years STANDARD_DEVIATION 6.4 | 57 years STANDARD_DEVIATION 7 | 56 years STANDARD_DEVIATION 5.6 | 56 years STANDARD_DEVIATION 5.7 | 54 years STANDARD_DEVIATION 4.7 | 55 years STANDARD_DEVIATION 8.1 | 57 years STANDARD_DEVIATION 5.8 | 57 years STANDARD_DEVIATION 6.4 | 56 years STANDARD_DEVIATION 6 | 55 years STANDARD_DEVIATION 7.4 |
| Cirrhosis Status Absent | 25 participants | 27 participants | 27 participants | 24 participants | 0 participants | 0 participants | 0 participants | 0 participants | 17 participants | 19 participants | 18 participants | 18 participants | 175 participants |
| Cirrhosis Status Missing | 1 participants | 1 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants | 0 participants | 8 participants |
| Cirrhosis Status Present | 0 participants | 0 participants | 0 participants | 0 participants | 26 participants | 25 participants | 26 participants | 26 participants | 8 participants | 10 participants | 7 participants | 10 participants | 138 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants | 3 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 26 Participants | 26 Participants | 24 Participants | 25 Participants | 24 Participants | 24 Participants | 26 Participants | 25 Participants | 28 Participants | 23 Participants | 25 Participants | 301 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HCV Genotype Genotype 1a | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 19 participants | 22 participants | 21 participants | 22 participants | 84 participants |
| HCV Genotype Genotype 1b | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 7 participants | 7 participants | 6 participants | 6 participants | 26 participants |
| HCV Genotype Genotype 1 (no confirmed subtype) | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| HCV Genotype Genotype 3 | 26 participants | 28 participants | 27 participants | 26 participants | 26 participants | 25 participants | 26 participants | 26 participants | 0 participants | 0 participants | 0 participants | 0 participants | 210 participants |
| HCV RNA | 6.7 log10 IU/mL STANDARD_DEVIATION 0.76 | 6.6 log10 IU/mL STANDARD_DEVIATION 0.7 | 6.6 log10 IU/mL STANDARD_DEVIATION 0.59 | 6.7 log10 IU/mL STANDARD_DEVIATION 0.53 | 6.6 log10 IU/mL STANDARD_DEVIATION 0.46 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.68 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.76 | 6.7 log10 IU/mL STANDARD_DEVIATION 0.51 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.59 | 6.8 log10 IU/mL STANDARD_DEVIATION 0.37 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.53 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.43 | 6.6 log10 IU/mL STANDARD_DEVIATION 0.6 |
| HCV RNA Category < 800,000 IU/mL | 5 participants | 6 participants | 2 participants | 2 participants | 3 participants | 7 participants | 7 participants | 2 participants | 6 participants | 0 participants | 3 participants | 3 participants | 46 participants |
| HCV RNA Category ≥ 800,000 IU/mL | 21 participants | 22 participants | 25 participants | 24 participants | 23 participants | 18 participants | 19 participants | 24 participants | 21 participants | 29 participants | 24 participants | 25 participants | 275 participants |
| IL28b Status CC | 8 participants | 10 participants | 8 participants | 11 participants | 12 participants | 5 participants | 12 participants | 13 participants | 0 participants | 1 participants | 2 participants | 3 participants | 85 participants |
| IL28b Status CT | 16 participants | 14 participants | 13 participants | 12 participants | 11 participants | 14 participants | 11 participants | 10 participants | 19 participants | 21 participants | 17 participants | 19 participants | 177 participants |
| IL28b Status TT | 2 participants | 4 participants | 6 participants | 3 participants | 3 participants | 6 participants | 3 participants | 3 participants | 8 participants | 7 participants | 8 participants | 6 participants | 59 participants |
| Prior HCV Treatment Non-responder | 7 participants | 10 participants | 7 participants | 5 participants | 6 participants | 9 participants | 10 participants | 3 participants | 6 participants | 13 participants | 7 participants | 8 participants | 91 participants |
| Prior HCV Treatment Relapse / Breakthrough | 19 participants | 18 participants | 20 participants | 21 participants | 20 participants | 16 participants | 16 participants | 23 participants | 21 participants | 16 participants | 20 participants | 20 participants | 230 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 1 participants | 0 participants | 1 participants | 2 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 7 participants | 2 participants | 4 participants | 4 participants | 19 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 25 participants | 26 participants | 25 participants | 24 participants | 25 participants | 23 participants | 25 participants | 24 participants | 20 participants | 27 participants | 23 participants | 21 participants | 288 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 9 Participants | 9 Participants | 5 Participants | 10 Participants | 6 Participants | 6 Participants | 12 Participants | 7 Participants | 12 Participants | 10 Participants | 100 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 18 Participants | 17 Participants | 21 Participants | 15 Participants | 20 Participants | 20 Participants | 15 Participants | 22 Participants | 15 Participants | 18 Participants | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 79 | 61 / 82 | 54 / 80 | 62 / 80 |
| serious Total, serious adverse events | 1 / 79 | 0 / 82 | 4 / 80 | 3 / 80 |
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) |
|---|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1.2 percentage of participants |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 84.6 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.4 percentage of participants |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| SOF+VEL 25 mg (GT3 Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 57.7 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 84.0 percentage of participants |
| SOF+VEL 100 mg (GT3 Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 88.5 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.2 percentage of participants |
| SOF+VEL 25 mg (GT1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| SOF+VEL 25 mg + RBV (GT1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.6 percentage of participants |
| SOF+VEL 100 mg (GT1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.4 percentage of participants |
Secondary
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time frame: Posttreatment Weeks 4 and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 84.6 percentage of participants |
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 88.5 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.4 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 96.4 percentage of participants |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| SOF+VEL 25 mg (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 61.5 percentage of participants |
| SOF+VEL 25 mg (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 57.7 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 84.0 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 84.0 percentage of participants |
| SOF+VEL 100 mg (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 88.5 percentage of participants |
| SOF+VEL 100 mg (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 92.3 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.2 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 96.2 percentage of participants |
| SOF+VEL 25 mg (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| SOF+VEL 25 mg (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| SOF+VEL 25 mg + RBV (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.6 percentage of participants |
| SOF+VEL 25 mg + RBV (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 96.6 percentage of participants |
| SOF+VEL 100 mg (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100.0 percentage of participants |
| SOF+VEL 100 mg (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100.0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 96.4 percentage of participants |
| SOF+VEL 100 mg + RBV (GT1) | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.4 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ 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) |
|---|---|---|
| SOF+VEL 25 mg (GT3 Non-Cirrhotic) | Percentage of Participants With Virologic Failure | 15.4 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With Virologic Failure | 3.6 percentage of participants |
| SOF+VEL 100 mg (GT3 Non-Cirrhotic) | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| SOF+VEL 25 mg (GT3 Cirrhotic) | Percentage of Participants With Virologic Failure | 42.3 percentage of participants |
| SOF+VEL 25 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With Virologic Failure | 12.0 percentage of participants |
| SOF+VEL 100 mg (GT3 Cirrhotic) | Percentage of Participants With Virologic Failure | 11.5 percentage of participants |
| SOF+VEL 100 mg + RBV (GT3 Cirrhotic) | Percentage of Participants With Virologic Failure | 3.8 percentage of participants |
| SOF+VEL 25 mg (GT1) | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| SOF+VEL 25 mg + RBV (GT1) | Percentage of Participants With Virologic Failure | 3.4 percentage of participants |
| SOF+VEL 100 mg (GT1) | Percentage of Participants With Virologic Failure | 0 percentage of participants |
| SOF+VEL 100 mg + RBV (GT1) | Percentage of Participants With Virologic Failure | 3.6 percentage of participants |