Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

• On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment [ Time Frame: Through the end of treatment (maximum up to 24 weeks) plus 7 days ] [ Designated as safety issue: Yes ]
• Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene [ Time Frame: At post-treatment Week 12 ] [ Designated as safety issue: No ]
• Proportion of subjects with HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24 ] [ Designated as safety issue: No ]
• Proportion of subjects with HCV RNA < LOQ [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24) ] [ Designated as safety issue: No ]
• Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]

The purpose of this study is to assess 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.

• ASV = Asunaprevir (BMS-650032)
• DCV = Daclatasvir (BMS-790052)
• Peg = Peg-interferon Alfa-2a (PegIFN)
• Rib = Ribavirin (RBV)

• Drug: Asunaprevir
  Capsule, Oral, 100 mg, Twice daily, 24 weeks
  Other Name: BMS-650032
• Drug: Daclatasvir
  Tablet, Oral, 60 mg, Once daily, 24 weeks
  Other Name: BMS-790052
• Drug: Peg-interferon Alfa-2a
  Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks
  Other Name: Pegasys®
• Drug: Ribavirin
  Tablet, Oral, 1000 mg/1200 mg (depending on subject weight), Twice daily, 24 weeks
  Other Name: Copegus®

Inclusion Criteria:

• Males and females, ≥ 18 years of age
• HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a and ribavirin (P/R), classified as previous null and partial responders based on previous therapy
• HCV RNA ≥ 10,000 IU/mL
• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
• Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

• Prior treatment of HCV with HCV direct acting antiviral (DAA)
• Evidence of a medical condition contributing to chronic liver disease other than HCV
• Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
• Diagnosed or suspected hepatocellular carcinoma or other malignancies
• Uncontrolled diabetes or hypertension
• Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
• Confirmed Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
• Confirmed Albumin < 3.5 g/dL (35 g/L)
• Alpha Fetoprotein (AFP) > 100 ng/mL or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
• Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
• Confirmed Platelets < 90 x 1000,000,000 cells/L
• Hemoglobin < 12 g/dL for females or < 13 g/dL for males
• Any criteria that would exclude the subject from receiving P/R