A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.

All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Inclusion Criteria:

• Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
• elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
• liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

• Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
• leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
• thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
• anemia (less than 12 g hemoglobin per deciliter )
• hepatitis B co-infection
• decompensated liver disease
• organ transplant
• creatinine clearance less than 50 milliliters per minute
• poorly controlled psychiatric disease
• poorly controlled diabetes
• malignant neoplastic disease
• severe cardiac or chronic pulmonary disease
• immunologically mediated disease
• retinopathy.