Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases
 sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated
 interferon) in patients who failed to respond to prior interferon treatment. All patients who
 enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin.
 Patients who respond to this 6 month treatment will continue to be treated for an additional
 6 months.

 Patients who do not respond to this treatment will be eligible for the long-term maintenance
 phase of this study where patients will be randomly selected to be treated with Peginterferon
 alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will
 be followed closely with quarterly study visits.

 The combination of peginterferon plus ribavirin has recently been approved by the FDA for
 treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated
 for at least 6 months with peginterferon and ribavirin outside of this study may be eligible
 to directly enter the randomized portion of the HALT-C Trial.

 The HALT-C study is designed to determine if continuing interferon long-term over several
 years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer
 and reduce the need for liver transplantation.
Inclusion Criteria:

 -  Age at entry at least 18 years.

 -  Positive for Hepatitis C.

 -  Previous treatment with any interferon or interferon and ribavirin for at least 3
 months.

 -  Documented non-response to treatment with interferon.

 -  A liver biopsy demonstrating significant liver scarring.

 Exclusion Criteria:

 -  No other liver disease.

 -  No unstable major medical diseases or conditions.

 -  No major complications of cirrhosis.

 -  No recent abuse of alcohol or illicit drugs.