Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C

A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects

The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.

Inclusion Criteria:

• Chronic hepatitis C, Genotype 1
• HCV RNA ≥100,000 IU/mL at screening
• Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
• Naïve to prior anti-HCV therapy

Exclusion Criteria:

• Infected with HCV other than Genotype 1
• Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Use of hematologic growth factors within 90 days prior to study randomization
• Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria