Combination therapy with interferon-alpha 2b and ribavirin for the treatment of relapse patients and non-responders with chronic HCV infection

Background: Treatment of patients with chronic hepatitis C after failure of an interferon monotherapy remains controversial. While relapse patients ha ve a sustained response after a combination therapy with interferon-alpha 2 b 3 x 3 MU/week plus ribavirin 1,000/1,200 mg daily for 24 weeks in up to 4 9 %, the standard therapy for initial nonresponders remains to be determine d. Methods: We therefore conducted a large multicenter trial to compare effica cy and safety of a combined interferon/ribavirin therapy in 327 non-respond ers and 181 relapse patients with chronic HCV infection outside of highly s pecialized institutions. Results: After 6 months therapy with interferon-alpha -2b 3 MU thrice a wee k plus ribavirin 1,000/1,200 mg daily for 24 weeks 31% of relapse patients and 11% of initial nonresponders achieved a sustained response according to an intent to treat analysis. Conclusions: These data could not confirm the high rate of sustained respon ders in relapse patients. In addition we were only able to induce a sustain ed response in every tenth non-responder. These results might reflect the r ealistic sustained response rates in a non-biased European population of HC V-infected patients.