Interferon-alpha plus ribavirin in chronic hepatitis C resistant to previous interferon-alpha course: results of a randomized multicenter trial

Background/Aims: Interferon-alpha plus ribavirin seem to be more efficaciou s than interferon monotherapy in chronic hepatitis C, In a multicenter rand omized trial, me evaluated the efficacy of this association for interferon- alpha resistant chronic hepatitis C, Methods: Fifty patients who were non-responders to recombinant or lymphobla stoid interferon-alpha were randomized to receive either ribavirin (800 mg/ day) plus leucocytic interferon-alpha (3 mega units thrice weekly) or the s ame dose of interferon-alpha alone, for 6 months. Effects of therapy were e valuated by serum aminotransferase and hepatitis C virus RNA levels and con trol liver biopsies. Results: At the end of treatment, aminotransferase levels become normal in 9/26 patients receiving combination therapy (35% [confidence interval, 16% to 53%]) and in 2/24 receiving interferon-a alone (8% [confidence interval, -3% to 19%]) (p=0,03), Aminotransferase normalization was never associated with hepatitis C virus RNA clearance, All patients with normal aminotransf erase relapsed after discontinuation of therapy, At the end of treatment, m ean hepatitis C virus RNA levels significantly decreased only in the group receiving combination therapy, but returned to pretreatment values 6 months thereafter. No histological improvement was observed in either group, Conclusions: There is no indication for treatment with interferon-alpha at the dose of 3 mega units thrice weekly plus 800 mg/day of ribavirin for 6 m onths in chronic hepatitis C resistant to interferon-alpha.