Chronic HCV Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.
Interventions
DRUGSofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
DRUGRBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUGPEG
Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
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
Key Inclusion Criteria: * Willing and able to provide written informed consent * HCV RNA ≥ 10\^4 IU/mL at screening * HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse * HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy Key
Exclusion criteria
* Current or prior history of any clinically-significant illness (other than HCV) * Pregnant or nursing female or male with pregnant female partner * Chronic liver disease of a non-HCV etiology * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 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 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 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 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. |
| Percentage of Participants With On-Treatment Virologic Failure | Up to 24 weeks | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment. |
| Percentage of Participants With Viral Relapse | Up to Posttreatment Week 24 | Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. |
| Change From Baseline in HCV RNA (log10 IU/mL) | Up to 24 weeks | — |
Countries
China, Hong Kong, South Korea, Taiwan, Vietnam
Participant flow
Recruitment details
Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.
Pre-assignment details
815 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 155 |
| SOF+RBV 12 Weeks (GT1 and GT6) Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 10 |
| SOF+RBV 16 Weeks (GT1 and GT6) Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks | 11 |
| SOF+RBV 24 Weeks (GT1 and GT6) Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks | 104 |
| SOF+RBV 12 Weeks (GT2) Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 280 |
| SOF+RBV 24 Weeks (GT3) Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks | 126 |
| Total | 686 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Enrolled but Never Treated | 1 | 0 | 0 | 0 |
| Overall Study | Investigator's Discretion | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 7 | 6 | 0 | 12 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Withdrew Consent | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | SOF+RBV 16 Weeks (GT1 and GT6) | SOF+RBV 12 Weeks (GT1 and GT6) | Total | SOF+RBV 24 Weeks (GT3) | SOF+RBV 12 Weeks (GT2) | SOF+RBV 24 Weeks (GT1 and GT6) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 12.8 | 43 years STANDARD_DEVIATION 17.6 | 43 years STANDARD_DEVIATION 17.2 | 47 years STANDARD_DEVIATION 13.3 | 40 years STANDARD_DEVIATION 8.1 | 53 years STANDARD_DEVIATION 12.3 | 49 years STANDARD_DEVIATION 13.3 |
| HCV Genotype Genotype 1 | 108 Participants | 7 Participants | 7 Participants | 203 Participants | 0 Participants | 0 Participants | 81 Participants |
| HCV Genotype Genotype 2 | 0 Participants | 0 Participants | 0 Participants | 280 Participants | 0 Participants | 280 Participants | 0 Participants |
| HCV Genotype Genotype 3 | 0 Participants | 0 Participants | 0 Participants | 126 Participants | 126 Participants | 0 Participants | 0 Participants |
| HCV Genotype Genotype 6 | 47 Participants | 4 Participants | 3 Participants | 77 Participants | 0 Participants | 0 Participants | 23 Participants |
| HCV RNA | 6.5 log10 IU/mL STANDARD_DEVIATION 0.74 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.88 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.49 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.84 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.71 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.96 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.71 |
| HCV RNA Category < 800,000 IU/mL | 21 Participants | 6 Participants | 2 Participants | 170 Participants | 32 Participants | 87 Participants | 22 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 134 Participants | 5 Participants | 8 Participants | 516 Participants | 94 Participants | 193 Participants | 82 Participants |
| IL28b Status CC | 114 Participants | 11 Participants | 8 Participants | 546 Participants | 102 Participants | 237 Participants | 74 Participants |
| IL28b Status CT | 40 Participants | 0 Participants | 2 Participants | 136 Participants | 23 Participants | 42 Participants | 29 Participants |
| IL28b Status TT | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 155 Participants | 11 Participants | 10 Participants | 686 Participants | 126 Participants | 280 Participants | 104 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Disclosed | 4 Participants | 0 Participants | 0 Participants | 10 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 151 Participants | 11 Participants | 10 Participants | 676 Participants | 126 Participants | 280 Participants | 98 Participants |
| Region of Enrollment China | 130 participants | 0 participants | 0 participants | 389 participants | 126 participants | 64 participants | 69 participants |
| Region of Enrollment Hong Kong | 0 participants | 11 participants | 10 participants | 31 participants | 0 participants | 0 participants | 10 participants |
| Region of Enrollment South Korea | 0 participants | 0 participants | 0 participants | 129 participants | 0 participants | 129 participants | 0 participants |
| Region of Enrollment Taiwan | 0 participants | 0 participants | 0 participants | 87 participants | 0 participants | 87 participants | 0 participants |
| Region of Enrollment Vietnam | 25 participants | 0 participants | 0 participants | 50 participants | 0 participants | 0 participants | 25 participants |
| Sex: Female, Male Female | 67 Participants | 2 Participants | 5 Participants | 351 Participants | 56 Participants | 160 Participants | 61 Participants |
| Sex: Female, Male Male | 88 Participants | 9 Participants | 5 Participants | 335 Participants | 70 Participants | 120 Participants | 43 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 | 145 / 155 | 215 / 290 | 5 / 11 | 177 / 230 |
| serious Total, serious adverse events | 5 / 155 | 7 / 290 | 0 / 11 | 4 / 230 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1 Participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1 Participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 Participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 2 Participants |
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 95.5 percentage of participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100 percentage of participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100 percentage of participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 94.2 percentage of participants |
| SOF+RBV 12 Weeks (GT2) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 96.8 percentage of participants |
| SOF+RBV 24 Weeks (GT3) | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 95.2 percentage of participants |
Secondary
Change From Baseline in HCV RNA (log10 IU/mL)
Time frame: Up to 24 weeks
Population: Participants in the Full Analysis Set with available data were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -5.12 log10 IU/mL | Standard Deviation 0.738 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -5.11 log10 IU/mL | Standard Deviation 0.734 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.81 log10 IU/mL | Standard Deviation 0.653 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -5.12 log10 IU/mL | Standard Deviation 0.738 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -5.12 log10 IU/mL | Standard Deviation 0.738 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -5.12 log10 IU/mL | Standard Deviation 0.738 |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -5.12 log10 IU/mL | Standard Deviation 0.739 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.59 log10 IU/mL | Standard Deviation 0.359 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 12 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -4.89 log10 IU/mL | Standard Deviation 0.488 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 16 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.36 log10 IU/mL | Standard Deviation 0.56 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -4.79 log10 IU/mL | Standard Deviation 0.858 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 16 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -4.82 log10 IU/mL | Standard Deviation 0.88 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 16 | -5.12 log10 IU/mL | Standard Deviation 0.708 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.61 log10 IU/mL | Standard Deviation 0.607 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -5.12 log10 IU/mL | Standard Deviation 0.708 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -5.12 log10 IU/mL | Standard Deviation 0.71 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -5.04 log10 IU/mL | Standard Deviation 0.682 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 20 | -5.14 log10 IU/mL | Standard Deviation 0.701 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -5.12 log10 IU/mL | Standard Deviation 0.71 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -5.12 log10 IU/mL | Standard Deviation 0.708 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 24 | -5.14 log10 IU/mL | Standard Deviation 0.701 |
| SOF+RBV 24 Weeks (GT1 and GT6) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -5.12 log10 IU/mL | Standard Deviation 0.708 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -4.83 log10 IU/mL | Standard Deviation 0.966 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -4.78 log10 IU/mL | Standard Deviation 1.008 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -4.81 log10 IU/mL | Standard Deviation 1.025 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -4.80 log10 IU/mL | Standard Deviation 1.038 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -4.83 log10 IU/mL | Standard Deviation 0.966 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -4.83 log10 IU/mL | Standard Deviation 0.966 |
| SOF+RBV 12 Weeks (GT2) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.46 log10 IU/mL | Standard Deviation 0.815 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 8 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 1 | -4.52 log10 IU/mL | Standard Deviation 0.695 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 12 | -4.84 log10 IU/mL | Standard Deviation 0.779 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 20 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 6 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 4 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 16 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 2 | -4.86 log10 IU/mL | Standard Deviation 0.706 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 24 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
| SOF+RBV 24 Weeks (GT3) | Change From Baseline in HCV RNA (log10 IU/mL) | Change at Week 10 | -4.87 log10 IU/mL | Standard Deviation 0.713 |
Secondary
Percentage of Participants With On-Treatment Virologic Failure
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment.
Time frame: Up to 24 weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants With On-Treatment Virologic Failure | 0 Participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants With On-Treatment Virologic Failure | 0 Participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants With On-Treatment Virologic Failure | 0 Participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants With On-Treatment Virologic Failure | 0 Participants |
| SOF+RBV 12 Weeks (GT2) | Percentage of Participants With On-Treatment Virologic Failure | 1 Participants |
| SOF+RBV 24 Weeks (GT3) | Percentage of Participants With On-Treatment Virologic Failure | 0 Participants |
Secondary
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are 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) |
|---|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 96.8 percentage of participants |
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 95.5 percentage of participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100 percentage of participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 100 percentage of participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 100 percentage of participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 90.9 percentage of participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 94.2 percentage of participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 94.2 percentage of participants |
| SOF+RBV 12 Weeks (GT2) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 97.5 percentage of participants |
| SOF+RBV 12 Weeks (GT2) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 96.8 percentage of participants |
| SOF+RBV 24 Weeks (GT3) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 97.6 percentage of participants |
| SOF+RBV 24 Weeks (GT3) | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 95.2 percentage of participants |
Secondary
Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Time frame: Up to Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOF+PEG+RBV 12 Weeks (GT 1 and GT6) | Percentage of Participants With Viral Relapse | 7 Participants |
| SOF+RBV 12 Weeks (GT1 and GT6) | Percentage of Participants With Viral Relapse | 0 Participants |
| SOF+RBV 16 Weeks (GT1 and GT6) | Percentage of Participants With Viral Relapse | 0 Participants |
| SOF+RBV 24 Weeks (GT1 and GT6) | Percentage of Participants With Viral Relapse | 6 Participants |
| SOF+RBV 12 Weeks (GT2) | Percentage of Participants With Viral Relapse | 6 Participants |
| SOF+RBV 24 Weeks (GT3) | Percentage of Participants With Viral Relapse | 6 Participants |