Hepatitis C
Conditions
Keywords
7977, GS-7977, PSI-7977, Sofosbuvir (SOF), Pegylated Interferon (Peg-IFN), Ribavirin (RBV)
Brief summary
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Interventions
DRUGSOF
400 mg tablet administered orally once daily
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)
DRUGPeg-IFN
180 µg administered via subcutaneous injection once weekly
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: * Male or female, age greater than or equal to 18 years. * Confirmed chronic HCV infection. * Subjects will have cirrhosis status assessment; liver biopsy may be required. * Genotype 2 subjects must have cirrhosis of the liver to be eligible. * Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event * Infection with HCV genotype 2 or 3 as determined at Screening * Body mass index (BMI) greater than or equal to 18 kg/m\^2 * Screening laboratory values within predefined thresholds. * Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC. * Subject must be of generally good health as determined by the Investigator. Key
Exclusion criteria
* Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase * Pregnant or nursing female or male with pregnant female partner * History of any other clinically significant chronic liver disease. * HIV or chronic hepatitis B virus (HBV) infection. * Malignancy with the exception of certain resolved skin cancers. * Chronic use of systemically administered immunosuppressive agents. * Clinically-relevant drug or alcohol abuse. * History of solid organ transplantation. * Current or prior history of clinical hepatic decompensation. * History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. * Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients. Note: Other protocol defined Inclusion/
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 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA at Weeks 1, 2, 4, 8, and 12 | Weeks 1, 2, 4, 8, and 12 | — |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Baseline; Weeks 1, 2, 4, 8, and 12 | — |
| 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 Experiencing Viral Relapse | Up to Posttreatment Week 24 | Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. |
| Percentage of Participants Experiencing On-Treatment Virologic Failure | Up to 24 weeks | On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) |
| Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | — |
Countries
Australia, Canada, New Zealand, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Europe, North America, Australia, and New Zealand. The first participant was screened on 24 September 2013. The last study visit occurred on 07 July 2016.
Pre-assignment details
776 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| SOF+RBV 16 Weeks SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks | 196 |
| SOF+RBV 24 Weeks SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks | 199 |
| SOF+RBV+Peg-IFN 12 Weeks SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks | 197 |
| Total | 592 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomized Period | Adverse Event | 1 | 1 | 0 |
| Randomized Period | Death | 0 | 0 | 2 |
| Randomized Period | Lost to Follow-up | 2 | 4 | 4 |
| Randomized Period | Protocol Violation | 0 | 1 | 0 |
| Randomized Period | Randomized but Never Treated | 4 | 2 | 3 |
| Randomized Period | Withdrew Consent | 3 | 3 | 2 |
| Retreatment Substudy | Lack of Efficacy | 1 | 0 | 0 |
| Retreatment Substudy | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | SOF+RBV 24 Weeks | SOF+RBV 16 Weeks | Total | SOF+RBV+Peg-IFN 12 Weeks |
|---|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 9.8 | 51 years STANDARD_DEVIATION 9.7 | 50 years STANDARD_DEVIATION 9.9 | 50 years STANDARD_DEVIATION 10.2 |
| HCV Genotype Genotype 2 | 17 participants | 15 participants | 48 participants | 16 participants |
| HCV Genotype Genotype 3 | 182 participants | 181 participants | 544 participants | 181 participants |
| HCV RNA | 6.2 log10 IU/mL STANDARD_DEVIATION 0.71 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.68 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.69 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.69 |
| HCV RNA Category < 6 log10 IU/mL | 72 participants | 60 participants | 192 participants | 60 participants |
| HCV RNA Category ≥ 6 log10 IU/mL | 127 participants | 136 participants | 400 participants | 137 participants |
| IL28b Status CC | 73 participants | 75 participants | 226 participants | 78 participants |
| IL28b Status CT | 95 participants | 94 participants | 287 participants | 98 participants |
| IL28b Status TT | 31 participants | 27 participants | 79 participants | 21 participants |
| Race/Ethnicity, Customized American Indian/ Alaska Native/ First Nations | 0 participants | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 26 participants | 29 participants | 80 participants | 25 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 2 participants | 6 participants | 2 participants |
| Race/Ethnicity, Customized Hawaiian or Pacific Islander | 1 participants | 0 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 participants | 5 participants | 12 participants | 2 participants |
| Race/Ethnicity, Customized Not Disclosed | 6 participants | 1 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 188 participants | 188 participants | 567 participants | 191 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized White | 168 participants | 162 participants | 495 participants | 165 participants |
| Region of Enrollment Australia | 39 participants | 45 participants | 128 participants | 44 participants |
| Region of Enrollment Canada | 33 participants | 21 participants | 83 participants | 29 participants |
| Region of Enrollment New Zealand | 12 participants | 15 participants | 40 participants | 13 participants |
| Region of Enrollment United Kingdom | 82 participants | 86 participants | 248 participants | 80 participants |
| Region of Enrollment United States | 33 participants | 29 participants | 93 participants | 31 participants |
| Sex: Female, Male Female | 70 Participants | 62 Participants | 197 Participants | 65 Participants |
| Sex: Female, Male Male | 129 Participants | 134 Participants | 395 Participants | 132 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 | 0 / 196 | 0 / 199 | 0 / 197 | 0 / 30 |
| other Total, other adverse events | 173 / 196 | 176 / 199 | 192 / 197 | 29 / 30 |
| serious Total, serious adverse events | 8 / 196 | 10 / 199 | 12 / 197 | 1 / 30 |
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: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 16 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1.5 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1.5 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1.5 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 with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 16 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 71.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 85.4 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 92.9 percentage of participants |
Secondary
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline; Weeks 1, 2, 4, 8, and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF+RBV 16 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | -5.16 log10 IU/mL | Standard Deviation 0.684 |
| SOF+RBV 16 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | -4.86 log10 IU/mL | Standard Deviation 0.661 |
| SOF+RBV 16 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | -4.18 log10 IU/mL | Standard Deviation 0.559 |
| SOF+RBV 16 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | -5.11 log10 IU/mL | Standard Deviation 0.671 |
| SOF+RBV 16 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | -5.15 log10 IU/mL | Standard Deviation 0.686 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | -5.02 log10 IU/mL | Standard Deviation 0.735 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | -5.05 log10 IU/mL | Standard Deviation 0.788 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | -5.08 log10 IU/mL | Standard Deviation 0.708 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | -4.78 log10 IU/mL | Standard Deviation 0.714 |
| SOF+RBV 24 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | -4.15 log10 IU/mL | Standard Deviation 0.664 |
| SOF+RBV+Peg-IFN 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | -5.12 log10 IU/mL | Standard Deviation 0.691 |
| SOF+RBV+Peg-IFN 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | -5.12 log10 IU/mL | Standard Deviation 0.691 |
| SOF+RBV+Peg-IFN 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | -4.46 log10 IU/mL | Standard Deviation 0.556 |
| SOF+RBV+Peg-IFN 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | -4.96 log10 IU/mL | Standard Deviation 0.661 |
| SOF+RBV+Peg-IFN 12 Weeks | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | -5.12 log10 IU/mL | Standard Deviation 0.699 |
Secondary
HCV RNA at Weeks 1, 2, 4, 8, and 12
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOF+RBV 16 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0.021 |
| SOF+RBV 16 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | 1.19 log10 IU/mL | Standard Deviation 0.156 |
| SOF+RBV 16 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | 2.13 log10 IU/mL | Standard Deviation 0.658 |
| SOF+RBV 16 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | 1.44 log10 IU/mL | Standard Deviation 0.436 |
| SOF+RBV 16 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF+RBV 24 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | 1.21 log10 IU/mL | Standard Deviation 0.287 |
| SOF+RBV 24 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | 2.08 log10 IU/mL | Standard Deviation 0.749 |
| SOF+RBV 24 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | 1.45 log10 IU/mL | Standard Deviation 0.487 |
| SOF+RBV 24 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0.1 |
| SOF+RBV 24 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | 1.17 log10 IU/mL | Standard Deviation 0.318 |
| SOF+RBV+Peg-IFN 12 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF+RBV+Peg-IFN 12 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| SOF+RBV+Peg-IFN 12 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 1 | 1.81 log10 IU/mL | Standard Deviation 0.576 |
| SOF+RBV+Peg-IFN 12 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 4 | 1.16 log10 IU/mL | Standard Deviation 0.085 |
| SOF+RBV+Peg-IFN 12 Weeks | HCV RNA at Weeks 1, 2, 4, 8, and 12 | Week 2 | 1.32 log10 IU/mL | Standard Deviation 0.342 |
Secondary
Percentage of Participants Experiencing On-Treatment Virologic Failure
On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Time frame: Up to 24 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 16 Weeks | Percentage of Participants Experiencing On-Treatment Virologic Failure | 0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants Experiencing On-Treatment Virologic Failure | 1.5 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants Experiencing On-Treatment Virologic Failure | 0 percentage of participants |
Secondary
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Time frame: Up to Posttreatment Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOF+RBV 16 Weeks | Percentage of Participants Experiencing Viral Relapse | 26.7 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants Experiencing Viral Relapse | 12.3 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants Experiencing Viral Relapse | 4.6 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Time frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 1 | 14.8 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 2 | 53.3 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 4 | 86.6 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 8 | 99.5 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 12 | 100.0 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 16 | 99.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 24 | 100.0 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 4 | 91.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 8 | 99.5 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 20 | 99.5 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 12 | 98.5 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 1 | 20.1 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 2 | 53.5 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 16 | 99.5 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 4 | 97.4 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 12 | 100.0 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 2 | 67.0 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 8 | 99.5 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 | Week 1 | 25.9 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+RBV 16 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 73.0 percentage of participants |
| SOF+RBV 16 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 71.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 85.9 percentage of participants |
| SOF+RBV 24 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 84.4 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 | 95.9 percentage of participants |
| SOF+RBV+Peg-IFN 12 Weeks | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR24 | 93.4 percentage of participants |