CLINICAL TRIAL: 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. The purpose of this study is to conduct a randomized, controlled trial to determine if long-term interferon therapy can reasonably reduce the risk of histologic progression to cirrhosis, decompensated liver disease and/or hepatocellular carcinoma in patients with chronic hepatitis C and advanced fibrosis or cirrhosis who failed to respond to previous interferon therapy. Specific aims: 1) To determine if 4 years of interferon therapy will prevent progression of advanced fibrosis to cirrhosis in patients with chronic hepatitis C who failed previous interferon treatment; 2) to determine if 4 years of interferon therapy, in patients with cirrhosis secondary to chronic hepatitis C who failed previous interferon treatment, will a) reduce the risk of developing hepatic decompensation; b) reduce the need for hepatic transplantation; c) reduce the risk of developing hepatoceullar carcinoma; and 3) To determine if 4 years of interferon therapy will improve the quality of life in patients with advanced fibrosis or cirrhosis secondary to chronic hepatitis C who failed previous interferon treatment. Approximately 1200 patients (at all centers) who meet the inclusion/exclusion criteria will be entered into a Lead-in Phase. They will be treated with a combination of Peginterferon alfa-2a and ribavirin for a period of 24 weeks. Patients who have no detectable Hepatitis C Virus (HCV)Ribonucleic Acid (RNA) at week 20 will continue on combination therapy until week 48. Patients who do not clear virus will be randomized 50:50 at week 24 to receive either Peginterferon alfa-2a alone or no further therapy for the next three and a half years. Both randomized groups will be monitored quarterly during these 42 months and biopsies will be obtained at 24 and 48 months after the start of the Lead-in Phase. An estimated 800 patients will be evaluable at the conclusion of the trial.