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