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

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

Inclusion criteria

• Males and females, ≥ 18 years of age
• HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b 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
• Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
• Albumin < 3.5 g/dL (35 g/L)
• Alpha Fetoprotein (AFP) > 100 ng/mL (>82.6 IU/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)
• 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