To determine if the treatment of patients with chronic hepatitis C with a combination of interferon and ribavirin after they have failed to respond to treatment with interferon alone is effective. Interferon-a-2b (Intron-A) is the only current medication with proven effective results in treating hepatitis C (HCV). But, only 35% of patients achieve normalization of serum levels. Over the years, several attempts have been made to find the best way to increase response to medications. These include a higher dose of interferon along with other therapies. Unfortunately, no combination has been found to improve the response over that which is achieved by interferon alone. Recently, the anti-viral agent ribavirin has been used to treat HCV. It's results suggested that it reacted as an immune modulatory agent instead of an anti-viral agent. Some preliminary studies have suggested that the combination of interferon and ribavirin could increase response rates in patients with HCV.
The aims of this study are a) to determine if the addition of ribavirin to Intron-A is more effective than increasing the dose of Intron-A alone, and b) to determine if continuing ribavirin alone is more effective at achieving long term remission than continuing Intron-A alone. A total of 270 patients will be enrolled into the protocol. They must have a history of HCV for at least six months and must have been treated with Intron-A, but failed to respond. There will be three groups of therapies and patients will be randomly selected for each group. The treatment will be given for three months. If patients respond to their treatment, it will be continued for three more months. If patients fail to respond well, treatment will be altered and continued for three months. If there's no positive response after six months, the treatment will be discontinued. Depending upon the response, treatment may continue for 12 to 21 months. At the end of the study, a repeat liver biopsy will be performed to determine the benefits of the therapy.
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