HEPATITIS C ANTIVIRAL LONG-TERM TREATMENT TO PREVENT CIRRHOSIS (HALT-C) TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hepatitis C is one of the most common causes of chronic liver disease in the United States. Approximately 3-4 million Americans have chronic hepatitis C infection. Of these, 8,000-10,000 are estimated to die from cirrhosis or liver cancer each year. Currently, the only approved treatment for chronic hepatitis C is interferon alone or in combination with ribavirin. Although combination therapy is associated with a higher response rate, less than 50% hepatitis C patients will have a sustained response. Recent studies found that some patients who fail to respond (clear the hepatitis C virus) during treatment with interferon or combination therapy have improvement in liver disease demonstrated by decreased inflammation on repeat liver biopsies. There have also been reports indicating that interferon treatment may decrease the risks of developing liver cancer in patients with cirrhosis due to hepatitis C. The purpose of this study is to determine if long-term interferon treatment will prevent progression of fibrosis (scarring) and development of liver cirrhosis, liver failure and liver cancer in hepatitis C patients who failed to respond to previous therapy. This is a multi-center clinical trial sponsored by the National Institutes of Health (NIH). The University of Michigan is 1 of 9 centers selected to participate in this trial. Approximately 1000 patients (120 from the University of Michigan) with hepatitis C and stage 3 or more fibrosis on liver biopsy, who failed to respond to previous interferon therapy will be enrolled in this trial. All patients will be re-treated with a combination of pegylated interferon and ribavirin for 24 weeks. Pegylated interferon is a long-acting preparation of interferon, which has been shown in preliminary clinical trials to be more effective in inducing a response than standard preparations of interferon. The purpose of the re-treatment is to provide patients with the best treatment currently available. Patients who fail to clear the virus will then be randomized to continue treatment with pegylated interferon alone or no treatment for another 3.5 years. Both groups of patients will be closely monitored and liver biopsies will be repeated at the end of years 2 and 4 to determine if long-term pegylated interferon is safe and effective in preventing progression of liver fibrosis, cirrhosis, liver failure and liver cancer.