INTRON A + RIBAVIRIN IN PATIENTS WITH HEPATITIS C NOT TREATED WITH INTERFERON

Johns Hopkins University, Baltimore MD

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Abstract

This is a multicenter, randomized, parallel group study comparing two treatment strategies in interferon-naive patients with compensated chronic hepatitis C (HCV infection defined by positive second or third generation antibody test and positive HCV RNA). Eight hundred (800) patients will be enrolled at participating centers in the Hepatitis Resource Network (HRN). Patients will be randomized to one of two treatment groups (A and B). Group A will receive Intron A 3 MU TIW + ribavirin 1000-1200 mg/day for 12 weeks. Subjects with a response to therapy as defined by Week 12 RCV RNA concentrations that are undetectable reduced more than 1.0 log from baseline will continue Intron A 3MU TIW + ribavirin 1000-1200mg/day for an additional 36 weeks. Subjects with no response to therapy as defined by Week 12 IICV RNA concentrations that have not become undetectable or fallen more than 1.0 log below baseline will discontinue the treatment protocol. Group B will receive Intron A 3MU daily + ribavirin 1000-1200mg/day for 12 weeks. Subjects with a response to therapy as defined for Group A will continue Intron A 3MU daily + ribavirin 1000-1200mg/day for an additional 36 weeks. Subjects with no response to therapy as defined for Group A will discontinue the treatment protocol.