A randomized, double-blind controlled trial of interferon alpha-2b and ribavirin vs. interferon alpha-2b and amantadine for treatment of chronic hepatitis C non-responder to interferon monotherapy

Background/Aims: Interferon-based regimens (alone or with ribavairin) are s tandard therapies for chronic hepatitis C. The aim of this study was to com pare a 24-week regimen of interferon alpha-2b + ribavirin (LFN + RIBA) to i nterferon alpha-2b + amantadine (IFN + AMANT) in non-responders to previous interferon monotherapy. Methods: In a multi-center, double-blind clinical trial, 118 patients (non- responders to previous interferon mono-therapy) were equally randomized int o the two arms: interferon alpha-2b (3 MU thrice weekly) and ribavirin (800 mg daily) vs. interferon alpha-2b (3 MU thrice weekly) and amantadine (200 mg daily). Results: After 24 weeks of therapy, HCV RNA became undetectable in 34.8% (9 5% CI: 23.7-49.2) of IFN + RIBA and 19.6% (95% CI: 10.6-34.7) of IFN + AMAN T (P = 0.10). This response was sustained in 3.9% (95% CI: 1.0-14.9) of IFN + RIBA and 0% of IFN + AMANT (P = 0.16). Ten patients from IFN + AMANT (17 %) and 12 patients (20%) from IFN + RIBA were discontinued before completio n of therapy. Of these, 7% in IPN + AMANT and 12% in IFN + RIBA were discon tinued due to adverse effects. Conclusions: Re-treatment of interferon non-responders with a 24-week cours e of IFN + AMANT was not associated with any sustained viral eradication. A lthough IFN + RIBA in this group was associated with a reasonable end of tr eatment response, relapses were common and sustained responses were low. (C) 2001 European Association for the Study of the Liver. published by Else vier Science B.V. All rights reserved.