The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial

The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) is a randomized clinical trial of long-term use of peginterferon alfa-2a in patients with chronic hepatitis C. The study investigated whether long-term antiviral therapy could prevent progressive liver disease—including cirrhosis, liver failure, hepatocellular carcinoma, and death—in chronic hepatitis C patients. Patients with chronic hepatitis C and advanced fibrosis who failed to respond to prior treatment with peginterferon and ribavirin were enrolled in the study. The participants, who were stratified according to stage of fibrosis, were randomly assigned to receive either peginterferon or no therapy for 3.5 years. The primary outcome measure was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points. Results showed that the level of serum aminotransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly with treatment, but there was no significant difference between the groups in the rate of disease progression.

Some of the patients with hepatitis C-related advanced liver disease developed hepatocellular carcinoma (HCC), and there is an existing matched set of samples from these patients and controls. Please see the <a href="https://repository.niddk.nih.gov/studies/halt-c/HCC_Documents/">HCC Documents</a> link to download the documents detailing the description of this set of samples and guidelines for its use in validating serum biomarkers. Investigators interested in using this set should make sure to refer to it specifically in their requests.