Hepatitis C Virus Infection
Conditions
Brief summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Detailed description
* Intervention Model: * Parallel: for all patients entering the trial * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study * Peginterferon alfa-2a * Ribavirin * Daclatasvir * Asunaprevir
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_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: * Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial * Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted) * HCV RNA viral load detectable Key
Exclusion criteria
* Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event * Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325 * Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening * Evidence of medical condition associated with chronic liver disease other than HCV infection * Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) | Week 12 (Follow-up period) | SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | Week 12 (Follow-up period) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. |
| Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | Week 4 | RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4. |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | Week 4 and 12 | eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12. |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Week 12 | cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12. |
| Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | Week 24 (Follow-up) | SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. |
| Percentage of Participants With End of the Treatment Response (EOTR) | End of the study (Week 24) | EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment. |
Countries
Argentina, Australia, Austria, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, New Zealand, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 92 centers in 20 countries.
Pre-assignment details
A total of 276 participants were enrolled, 228 were randomized and 227 received treatment. Participants were not treated because they no longer met study criteria (n=41), withdrew their consent (n=4), showed poor/non-compliance (n=1) or were lost to follow-up (n=2). One participant was randomized by mistake but received no treatment.
Participants by arm
| Arm | Count |
|---|---|
| Daclatasvir + Asunaprevir Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks | 99 |
| Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks | 122 |
| Daclatasvir + pegIFN-2a+ Ribavirin Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks | 6 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 0 |
| Overall Study | Lack of Efficacy | 8 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | No longer meets study criteria | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Daclatasvir + Asunaprevir | Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin | Daclatasvir + pegIFN-2a+ Ribavirin |
|---|---|---|---|---|
| Age, Customized 65 years and older | 27 Participants | 19 Participants | 8 Participants | 0 Participants |
| Age, Customized Younger than 65 years | 200 Participants | 80 Participants | 114 Participants | 6 Participants |
| Sex: Female, Male Female | 134 Participants | 48 Participants | 84 Participants | 2 Participants |
| Sex: Female, Male Male | 93 Participants | 51 Participants | 38 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 58 / 99 | 118 / 122 | 6 / 6 |
| serious Total, serious adverse events | 4 / 99 | 3 / 122 | 0 / 6 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.
Time frame: Week 12 (Follow-up period)
Population: Participants with genotype 1 HCV who received at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) | 94.6 Percentage of participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time frame: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 4 Participants |
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 2 Participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 2 Participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 1 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 2 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 1 Participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 2 Participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
| DCV + pegIFN-2a+ RBV | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | AEs leading to discontinuation of therapy | 0 Participants |
| DCV + pegIFN-2a+ RBV | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | Death | 0 Participants |
| DCV + pegIFN-2a+ RBV | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study | SAEs | 0 Participants |
Secondary
Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Time frame: Week 12 (Follow-up period)
Population: The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 85.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 90.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 40.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 100.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 90.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 76.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 84.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) | 50.0 Percentage of participants |
Secondary
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.
Time frame: Week 12
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 87.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 95.8 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 90.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 100.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 90.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 92.3 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 76.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants With Complete Early Virologic Response (cEVR) | 83.3 Percentage of participants |
Secondary
Percentage of Participants With End of the Treatment Response (EOTR)
EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.
Time frame: End of the study (Week 24)
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With End of the Treatment Response (EOTR) | 85.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants With End of the Treatment Response (EOTR) | 97.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants With End of the Treatment Response (EOTR) | 90.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants With End of the Treatment Response (EOTR) | 100.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants With End of the Treatment Response (EOTR) | 90.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants With End of the Treatment Response (EOTR) | 92.3 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants With End of the Treatment Response (EOTR) | 84.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants With End of the Treatment Response (EOTR) | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants With End of the Treatment Response (EOTR) | 83.3 Percentage of participants |
Secondary
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.
Time frame: Week 4 and 12
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 67.7 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 87.5 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 70.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 83.3 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 81.8 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 76.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 64.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 83.3 Percentage of participants |
Secondary
Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.
Time frame: Week 4
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 72.7 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 91.7 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 70.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 83.3 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 90.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 76.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 76.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 | 83.3 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Time frame: Week 24 (Follow-up)
Population: The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 84.8 Percentage of participants |
| DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 95.8 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 40.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 100.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 90.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 76.9 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (Treatment Naive) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 84.0 Percentage of participants |
| DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers) | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 88.9 Percentage of participants |
| DCV + pegIFN-2a+ RBV | Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) | 50.0 Percentage of participants |