INTRON A VS INTRON A + RIBAVIRIN IN RELAPSED HEPATITIS C

$27,361M01FY2000RRNIH

Scripps Research Institute, La Jolla CA

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Abstract

This study addresses the efficacy and safety of interferon alpha-2b compared to interferon alpha-2b and ribavirin in hepatitis C patients who had previously responded to interferon but relapsed after therapy was stopped. The biochemical and virological response to treatment are measured at two time points: at the end of treatment and six months posttreatment sustained response. Secondary endpoints include improvement in liver biopsy at posttreatment, time to response and time to relapse. Based on these markers, this randomized clinical trial preliminary data suggests the treatment with combined therapy brings improvement in sustained responses of 50-60% compared to 26-30% of interferon alpha 2b alone. Future studies will focus on the need to provide optimal treatment during the initial course of therapy based on the finding that retreatment of initial responders who relapse is associated with a lower end of treatment response than previously reported.

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