Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients

A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4

The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects

Inclusion Criteria:

• Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
• HCV RNA viral load ≥ 10,000 IU/mL
• Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
• Patients with compensated cirrhosis are permitted

Exclusion Criteria:

• Infected with HCV other than GT 1 or 4

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy

• Evidence of a medical condition contributing to chronic liver disease other than HCV

• History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)

• Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

• Laboratory values:

  1. Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
  2. Platelets < 90 x 1000000000 cells/L
  3. Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
  4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)