OPTIMUM PATIENT POPULATION AND DOSING REGIMEN FOR TREAMENT OF HEPATITIS C

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An attempt to determine the effect of factors of the body's immune system on the natural development of Chronic Hepatitis C and its response to interferon therapy. It is recognized that Hepatitis C virus (HCV) is the most common cause of chronic hepatitis. Nearly 40% of all cases of chronic hepatitis are secondary to chronic HCV. Up to 77% of people with HCV will eventually develop cirrhosis (scarring) of the liver. This becomes the single most common indication for liver transplantation and is also recognized as a major cause of liver cancer throughout the western world. The disease of HCV progresses differently in people. Some patients will develop cirrhosis within 15 years, whereas some develop it within a 20 - 50 year period, or not at all. Possible theories to explain this variable rate of progression are viral factors and the way the immune system works in each patient. At the present time, it is not known how the immune system recognizes and responds to HCV. This is a pilot study which will attempt to identify the immune factors which may be important in the progression of chronic HCV to cirrhosis and in modulating response to interferon therapy. Subjects of this study must have documented chronic hepatitis C. A liver biopsy must be done to determine how much inflammation and/or scar tissue is present in the liver prior to taking the medication. Several blood tests will be done to check the liver and other organs, and a test for Hepatitis C will be done. If the chronic hepatitis virus is present within the liver, the subject will be a candidate for the interferon therapy. The medication will then be administered by injection for six months. The results may be complete response which will bring normal enzyme tests at the end of the therapy, no response, or relapse response which shows an initial response but elevated enzymes after discontinuation of therapy. To determine if the liver of the subject has responded to the interferon, the subject will undergo three more biopsies.