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