Hepatitis C Virus
Conditions
Brief summary
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
Interventions
BIOLOGICALPeginterferon Lambda-1a
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
BIOLOGICALPeginterferon Alfa-2a
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
DRUGRibavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
DRUGTelaprevir
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects * Naives to prior anti-HCV therapy \[Interferon (IFN) and direct antiviral agent (DAA) based\] * Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA \> 25IU/mL after discontinuation of treatment). Capped at 20% * HCV RNA ≥ 100,000 IU/mL * Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10% * Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg) * Men or women, 18-70 years of age
Exclusion criteria
* Chronic liver disease due to causes other than chronic HCV * Current or past evidence of decompensation * Conditions that preclude the use of Alfa/RBV/TVR per respective labels * Diagnosed or suspected hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Assessed at Week 4 and Week 12, week 12 reported | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL). |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL). |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Day 1 of treatment up to Week 48 | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | After Day 1 of treatment up to Week 48 | Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3. |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | Week 4 and Week 12 | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL). |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \ 10 IU/mL). |
| Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | Follow-up Week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \ 10 IU/mL). |
| Percentage of Participants With Rash | After Day 1 of treatment up to Week 48 | All skin reactions involving rash or rash-like events that occurred on treatment were reported. |
| Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | After Day 1 of treatment up to Week 48 | Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. |
| Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | Follow up week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. |
| Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL). |
Countries
Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Poland, Russia, Spain, Switzerland, United Kingdom, United States
Participant flow
Pre-assignment details
Out of 881 participants who were enrolled, 648 were randomized and only 644 were treated. 27 participants were treated in Part A and 617 participants were treated in Part B of the study.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) Participants with genotype (GT) -1 chronic Hepatitis C virus infection received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 27 |
| Part B: Peginterferon Lambda-1a + RBV + TVR Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon Lambda-1a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 411 |
| Part B: Peginterferon Alfa-2a + RBV + TVR Participants who were either treatment naive or who were relapsers to previous Peginterferon alfa- 2a/ribavirin treatment received Peginterferon alfa-2a 180 mcg subcutaneously, once weekly for 24 or 48 weeks depending on the extended rapid virologic response (eRVR); Ribavirin 1000 or 1200 mg (based on weight) tablets, orally daily in 2 divided doses for 24 or 48 weeks depending on the eRVR response; Telaprevir 750 mg tablets, orally three times a day for 12 weeks. Participants were followed-up for 48 weeks after treatment period. | 206 |
| Total | 644 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up Period | Death | 0 | 1 | 0 |
| Follow-up Period | Lost to Follow-up | 2 | 10 | 12 |
| Follow-up Period | No longer required per protocol | 1 | 3 | 2 |
| Follow-up Period | Not reported | 0 | 10 | 4 |
| Follow-up Period | Other reasons | 2 | 8 | 8 |
| Follow-up Period | Withdrawal by Subject | 0 | 3 | 2 |
| Treatment Period | Adverse Event | 2 | 33 | 17 |
| Treatment Period | Lack of Efficacy | 5 | 14 | 6 |
| Treatment Period | Lost to Follow-up | 1 | 5 | 1 |
| Treatment Period | No longer meet study criteria | 0 | 1 | 0 |
| Treatment Period | Other reasons | 0 | 4 | 1 |
| Treatment Period | Poor/non-compliance | 0 | 2 | 0 |
| Treatment Period | Withdrawal by Subject | 3 | 13 | 10 |
Baseline characteristics
| Characteristic | Total | Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Part B: Peginterferon Lambda-1a + RBV + TVR | Part B: Peginterferon Alfa-2a + RBV + TVR |
|---|---|---|---|---|
| Age, Customized 21 - <65 years | 616 Participants | 27 Participants | 392 Participants | 197 Participants |
| Age, Customized <21 years | 7 Participants | 0 Participants | 5 Participants | 2 Participants |
| Age, Customized >=65 years | 21 Participants | 0 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 241 Participants | 9 Participants | 152 Participants | 80 Participants |
| Sex: Female, Male Male | 403 Participants | 18 Participants | 259 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 1 / 411 | 1 / 206 |
| other Total, other adverse events | 26 / 27 | 369 / 411 | 197 / 206 |
| serious Total, serious adverse events | 6 / 27 | 43 / 411 | 20 / 206 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.
Time frame: Day 1 of treatment up to Week 48
Population: Safety analysis included all treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | AEs | 26 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | SAEs | 6 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Drug related AEs | 12 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Discontinuation due to AEs | 2 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Death | 0 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Dose reductions - Lambda | 3 Participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Dose reductions - RBV | 7 Participants |
Primary
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Assessed at Week 4 and Week 12, week 12 reported
Population: The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | 51.9 Percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Follow-up Week 12
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | 76.2 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | 82 Percentage of participants |
p-value: 0.0855Mantel Haenszel
Secondary
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Week 4 and Week 12
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | 64 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | 70.9 Percentage of participants |
Secondary
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Time frame: After Day 1 of treatment up to Week 48
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Flu-Like Symptoms | 14.4 Percentage of participants |
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Musculoskeletal symptoms | 21.4 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Flu-Like Symptoms | 36.4 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | Musculoskeletal symptoms | 30.6 Percentage of participants |
Secondary
Percentage of Participants With Rash
All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Time frame: After Day 1 of treatment up to Week 48
Population: The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Rash | 63 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Rash | 36.3 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Rash | 38.3 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Follow-up Week 12
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | 48.1 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Follow-up Week 24
Population: Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | 83 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | 87 Percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3.
Time frame: After Day 1 of treatment up to Week 48
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | 11.7 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | 55.8 Percentage of participants |
Secondary
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
Time frame: Follow up week 24
Population: Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | 40.7 Percentage of participants |
Secondary
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \ 10 IU/mL).
Time frame: Follow-up Week 12
Population: The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treatment-naive treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Peginterferon Lambda-1a + RBV + TVR (Open Label) | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | 73.6 Percentage of participants |
| Part B: Peginterferon Alfa-2a + RBV + TVR | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | 81.9 Percentage of participants |