Interferon alpha-2B and ribavirin in combination for patients with chronichepatitis C who failed to respond to, or relapsed after, interferon alpha therapy: A randomized trial

PURPOSE: To assess the efficacy of interferon alpha-2b and ribavirin in com bination in the treatment of patients with chronic hepatitis C who had eith er failed to respond to therapy with interferon alpha (nonresponders), or w ho had relapsed after interferon therapy (relapsers). SUBJECTS AND METHODS: Four hundred patients with chronic hepatitis C (200 n onresponders and 200 relapsers) were randomly assigned in equal numbers to receive either subcutaneous administration of recombinant interferon alpha- 2b (3 million units three times per week) and ribavirin (1,000 to 1,200 mg/ daily orally) or interferon alpha-2b alone (6 million units three times per week). Both ribavirin and interferon alpha-2b were given for 24 weeks. The patients were then followed for an additional 24 weeks. RESULTS: At the end of the treatment period, normalization of serum alanine aminotransferase levels and absence of hepatitis C virus RNA were seen in 21% of nonresponders and in 39% of relapsers who were heated with interfero n alpha-2b and ribavirin, compared with 5% of nonresponders (P = 0.001) and 9% of relapsers heated with interferon alpha-2b alone (P<0.001). At the en d of follow-up, 14% of nonresponders and 30% of relapsers treated with the combination therapy had a sustained response, compared with 1% of nonrespon ders (P = 0.001) and 5% of relapsers treated with interferon alpha alone (P <0.001). CONCLUSIONS: A 24-week course of treatment with interferon alpha-2b and rib avirin offers a chance of sustained response, whereas retreatment with inte rferon alpha-2b, alone does not give satisfactory results. The role of long -term therapy in inducing prolonged remission remains to be explored, (C) 1 999 by Excerpta Medica, Inc.