PILOT-STUDY OF COMBINATION THERAPY WITH RIBAVIRIN PLUS INTERFERON-ALFA FOR INTERFERON ALFA-RESISTANT CHRONIC HEPATITIS-C

Background/Aims: In chronic hepatitis C, interferon alfa (IFN-α) therapy fails to achieve a sustained response in approximately 75% of patients. Similarly, ribavirin induces only a transient response. The aim of this study was to evaluate whether ribavirin and IFN-α in combination could be effective in IFN-α-resistant chronic hepatitis C. Methods: Twenty patients with chronic hepatitis C resistant to a previous course of IFN-α were randomly assigned to receive either ribavirin combined with IFN-α or IFN-α alone for 6 months. Results: Serum alanine aminotransferase levels decreased significantly during therapy in both treatment groups, but after therapy, the levels remained significantly decreased only in the combination therapy group. Nine months after treatment, sustained normalization of aminotransferase levels, associated with sustained loss of serum hepatitis C virus RNA, was observed in 40% of the patients in the combination therapy group but in none of the patients treated with IFN-α alone (P < 0.05). The sustained response was accompanied by reduced hepatic necroinflammatory activity on biopsy. Conclusions: These findings suggest that ribavirin plus IFN-α combination therapy is able to induce a sustained biochemical and virological response in a significant proportion of patients with IFN-α-resistant chronic hepatitis C. © 1994.