An exploration into the treatment of Chronic Hepatitis C (HCV) with a combination of interferon and ribaviron to achieve long-term sustained response or a cure for HCV. HCV, a chronic viral infection which causes inflammation within the liver, is the single most common cause of chronic viral hepatitis in the United States. Nearly four million people have HCV. The majority of these people are at risk of developing progressive liver damage and cirrhosis over a span of 15-30 years from the time of exposure. Interferons are the only medications currently available with proven results for treatment of HCV. However, there are limitations to the therapy and additional medications are needed. Ribaviron may be a very beneficial agent for preventing relapse in patients who initially responded to interferon therapy.
The specific aim of this study is to determine if the combination of interferon and ribaviron will increase both end-of-treatment response and sustained response. A total of 200 patients, male or female, will be enrolled into this study. They must have a documented history of HCV of at least six months and must have had no previous therapy with either interferon or ribaviron. Patients will recieve a blood test to ensure that the HCV is present and will randomly be treated with either ribaviron plus interferon or a high daily dose of induction interferon followed by the addition of ribaviron. If the HCV has been eradicated from the blood after three months of treatment in either group, the patient will continue to be treated with interferon plus ribaviron for an additional nine months. If HCV has not been eradicated from the blood after three months, the participation in the study will be complete and the medications will be discontinued. Interferon will be injected under the skin and ribaviron will be taken orally. Routine blood tests will be given to monitor response to treatment.
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