A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus

The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).

Inclusion Criteria:

• Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
• Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
• HCV RNA > 100,000 IU/mL at screening.
• Genotype 1.
• A diagnosis of chronic HCV infection for at least 6 months.

Exclusion Criteria:

• Evidence of acute or chronic infection with HIV or HBV.
• Exposure within the previous three months to an investigational anti-HCV agent.
• Evidence of severe or decompensated liver disease.
• Subjects with liver disease unrelated to HCV infection.