The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Name: Asunaprevir (ASV)
Type: DrugArm 1: Null or Partial Responder to P/R (ASV + DCV) Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Name: Daclatasvir (DCV)
Type: DrugArm 1: Null or Partial Responder to P/R (ASV + DCV) Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV) Arm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Name: Pegylated-interferon alfa 2a (PegIFN)
Type: DrugArm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Name: Ribavirin (RBV)
Type: DrugArm 3: Treatment naive (ASV + DCV) Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Description: eRVR = Extended rapid virologic response, EOT = End of treatment
Measure: Proportion of genotype 1b subjects with HCV RNA undetectable Time: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohortAllocation: Randomized
Parallel Assignment
There is one SNP
Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort.