High rate of long-term virological response after a 1-year course of interferon plus ribavirin in chronic hepatitis C relapsers. Results of a 191 patients randomized trial

We investigated the long-term efficacy of a 12-month course of interferon (IFN)+ribavirin in chronic hepatitis C relapsers. We randomized 191 relapsers with a 2:1 ratio to receive 3 million units three times a week of interferon alpha (IFN alpha)-2b+ribavirin (1-1.2 g/day) (group A=127 patients) or IFN alpha-2b (group B=60 patients) of same dosage and duration for 1 year. General and hepatitis C data of group A and B patients were similar. The main goal of the study was to determine the rate of sustained virological response evaluated 1 year after treatment. Results: Virological sustained response (SR) was 61% and 12% for groups A and B, respectively (P <0.001). A significant histological improvement was observed in both treatment groups. The Metavir activity score became significantly lower in the IFN+ribavirin group than in the IFN group (P <0/0001). The Metavir fibrosis scores remained unchanged. Also, at the end of the treatment, the virological response was 69% (88/127) for group A and 33% (20/60) for group B (P <0.001). Conclusion: One-year retreatment of relapsers with the combination of IFN+ribavirin led to 61% of virological SR and to a significant improvement of histological activity. Therefore, the therapeutic schedule presented here can be considered of particular interest for the retreatment of relapsers.