Retreatment of non-responder or relapser chronic hepatitis C patients with interferon plus ribavirin vs interferon alone.

BACKGROUND AND AIM: Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20-30% of patients. This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to, or relapsed after, a standard Interferon-alfa treatment. PATIENTS AND METHODS: A total of 88 patients, 49 non-responders and 39 relapsers to previous Interferon-alfa therapy, were randomized to receive either natural Interferon-alfa (6 MU t.i.w.) plus ribavirin (1000 mg/daily) or natural Interferon-alfa alone (6 MU t.i.w.) for 6 months. All were followed for 12 months after stopping therapy. Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR (Amplicor, Roche) at end of therapy and the end of follow-up. RESULTS: After treatment, a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin: 4/28 (14%) vs 1/21 (5%) non-responder patients and 9/19 (47%) vs 5/20 (25%) in the relapsers group. At the end of follow-up, a sustained response was found only in the combination treatment group: 4% and 32% in non-responder and relapser patients, respectively. CONCLUSIONS: Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous standard IFN treatment whereas it is less effective in non-responder patients.