Abstract

Treatment of patients with chronic hepatitis C after failure of an interferon monotherapy remains controversial. While relapse patients have a sustained response after a combination therapy with interferon-alpha 2b 3 x 3 MU/week plus ribavirin 1,000/1,200 mg daily for 24 weeks in up to 49%, the standard therapy for initial non-responders remains to be determined. We therefore conducted a large multicenter trial to compare efficacy and safety of a combined interferon/ribavirin therapy in 327 non-responders and 181 relapse patients with chronic HCV infection outside of highly specialized institutions. After 6 months therapy with interferon-alpha-2b 3 MU thrice a week plus ribavirin 1,000/1,200 mg daily for 24 weeks 31% of relapse patients and 11% of initial non-responders achieved a sustained response according to an intent to treat analysis. These data could not confirm the high rate of sustained responders in relapse patients. In addition we were only able to induce a sustained response in every tenth non-responder. These results might reflect the realistic sustained response rates in a non-biased European population of HCV-infected patients.

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