PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Inclusion Criteria:

• Age at entry 18-65
• Positive for Hepatitis C
• Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
• Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

• Any cause for the liver disease other than chronic hepatitis C
• History or presence of complications of cirrhosis
• Alcohol or illicit drug use or methadone treatment within the past 2 years
• Treatment for chronic hepatitis C within the previous 6 months
• Diseases or conditions that could interfere with the subject's participation in and completion of the study