TREATMENT OF CHRONIC HEPATITIS C W/ COMBINATION OF INTERFERON PLUS

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To determine if the treatment of patients with chronic hepatitis C, after they have relapsed, with a combination of interferon and ribavirin, is more effective than treatment with interferon alone. Interferon-a-2b (Intron-A) is the only current medication with proven effective results in patients with hepatitis C (HCV). HCV is the most common cause for chronic viral hepatitis in the United States, plaguing nearly four million people. These patients are at risk for development of progressive liver damage and cirrhosis over a 15-30 year span. Because of the limitations of interferon, it was agreed upon that additional medications are needed and that the ribaviron, an anti-viral agent, may be very beneficial in preventing relapse in patients who initially responded to interferon therapy. Previous studies showed that 33-50% of patients treated with interferons achieved response to therapy. When patients were treated with a combination of interferon and ribavirin, relapse following discontinuation of therapy decreased from 80-90% to 40-60%. Despite the improvement in long term sustained response, following treatment with the two medications, there are many unanswered questions. The aims of this study are a) to determine if patients who relapse following a previous course of interferon therapy can achieve long term sustained response following treatment with the combination of interferon and ribavirin, and b) to determine if patients who achieve response relating to the viral infection during re-treatment with interferon and ribavirin will have an increased rate of long term sustained response when ribavirin is continued alone for an additional six months. There will be 150 patients enrolled into this study. They must meet specific criteria concerning length and dosage of therapy and other factors related to HCV. All patients will be treated with interferon-a-2b at the identical dose as when they achieved response in the past. All patients will be treated with ribavirin. All patients who achieve response after six months of the combination therapy will then be randomized to enter one of two groups, one to continue both medications, and the other to continue only ribavirin for six more months. Follow up will take place for 24 months or until relapse.