The current FDA approved treatment for chronic hepatitis C is interferon alpha-2b at a dose of 3 million units (MU) three times a week. This regimen results in a 50% response rate, however, following cessation of the treatment more than half of the responders relapse. Overall, only about 20% of all patients treated with interferon alpha-2b have a significant sustained response. The remaining 80% can be considered to have failed treatment with interferon. At the present time, no additional drugs are available to treat such patients. Ribavirin, an anit-viral agent approved for the treatment of respiratory syncytial virus infections in aerosolized form, is of limited benefit in the treatment of chronic hepatitis C when used orally. Ribavirin alone has not been approved by the FDA for the treatment of this disease. Pilot studies have suggested, however, that a combination of ribavirin and interferon alpha may be superior to interferon alpha alone in the treatment of chronic hepatitis C. The present study is designed to determine if ribavirin plus interferon alpha-2b will be beneficial in the treatment of patients with chronic hepatitis C who have failed treatment with interferon. One hundred and ten subjects at Columbia-Presbyterian and other participating centers will be treated with interferon alpha-2b at a dose of 3 MU three times a week. Half of the patients will be randomly assigned to receive ribavirin (1000mg/day for patients who weigh less than 75 kg and 1200 mg/day for those who weigh more than 75kg) and the other half placebo (inactive compound). After 24 weeks, blood tests for liver inflammation and circulating hepatitis C virus will be performed to determine if there are differences in the two groups. Treatment will be continued for an additional 24 weeks except that patients initially receiving placebo will be switched to ribavirin. At the end of therapy and 24 weeks after stopping the medications, blood tests will again be performed to determine if there is a difference in the amounts of liver inflammation or circulating hepatits C virus in patients who received ribavirin for 24 or 48 weeks.
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