Study Summary

This study will test whether long-term antiviral therapy with interferon can prevent liver disease from progressing in patients with chronic hepatitis C infection.

NOTE: The follow-up phase of the HALT-C trial is still underway. However no new patients are being enrolled into the study.

Patient Population for the Trial:

Adult (18 years or older)
Nonresponder to prior antiviral therapy (either monotherapy or combination treatment)
Advanced fibrosis or cirrhosis on liver biopsy

Study Protocol:

All patients receive 6 months of pegylated interferon alfa-2a plus ribavirin.
Responders who clear virus on treatment receive an additional 6 months of therapy.
Nonresponders are randomized to either no treatment or maintenance low-dose pegylated interferon alfa-2a for up to 4 years.

Clinical Effectiveness is Defined as Prevention of:

Liver failure
Transplant
Death
Liver cancer

Other Investigations:

Effect of iron
Effect of diet
Quantitative assessment of liver function
Studies of the virus
Studies of the immune system
Quality of life
Serum fibrosis markers
Tissue and blood repository

From: Living with Hepatitis C: A Survivor’s Guide. Everson GT, Weinberg H. Hatherleigh Press, Inc. Copyright 2001.

For additional information on the HALT-C Trial, go to: www.haltctrial.org/