Combination therapy with ribavirin and alpha interferon for the treatment of chronic hepatitis C refractory to interferon

Background: Up to 80% of hepatitis C patients are refractory to treatment w ith interferon-alpha. These patients are not likely to benefit from higher dosages or longer duration of interferon alone. The addition of ribavirin h as been shown to improve the response rate in patients resistant to a previ ous course of interferon-alpha alone. Aim: To evaluate whether a sustained hepatitis C virus (HCV) RNA response c ould be obtained with combination therapy of interferon-alpha and ribavirin in patients who did not respond to or relapsed after a standard interferon -alpha treatment. Methods: A total of 73 patients, 59 non-responders and 14 relapsers after i nterferon-alpha alone, were treated with a combination of ribavirin (1000-1 200 mg/day) and interferon-alpha (3 MU three times a week) for 24 weeks. Al anine aminotransferase levels and HCV RNA were checked for 24 weeks after c ompletion of therapy. Results: At the end of the combination therapy, 36 patients (49%) showed al anine aminotransferase normalization and in 20 patients (27%), HCV RNA was undetectable in serum. At the end of the 24 weeks follow-up period, only 12 patients (16%) had a sustained response with serum negativity of HCV RNA. This response was significantly higher in relapsers than in non-responders: five (36%) vs. seven (12%) patients (P=0.03), respectively. Adverse effect s were restricted to flu-like symptoms and moderate haemolytic anaemia. Conclusions: Combination of interferon-alpha and ribavirin is quite limited , both in scope and efficacy, in HCV patients who had a non-response to mon otherapy with interferon. Better results may be expected in relapsers, but larger studies are necessary.