Long-term Follow-up of HALT-C Sustained Virological Responders

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a
multicenter clinical trial conducted to assess the effects of long-term antiviral drug
therapy on the progression of liver disease in patients who have advanced chronic hepatitis C
and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral
infection affecting the liver that may lead to permanent liver damage and cirrhosis
(replacement of healthy liver cells by scar tissue). If left untreated, a proportion of
patients with chronic hepatitis C will be at risk for complications of liver disease. The
drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient
s system in order to prevent or mitigate these potential complications. The purpose of this
research is to determine if patients with chronic hepatitis C who experienced clearance of
hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial
have developed any complications of their liver disease.

This study will include 180 subjects who participated in the initial phase of the HALT-C
trial and experienced an SVR. The participants will visit the National Institutes of Health
for an in-person study visit.

During the visit, patients will have blood drawn for lab tests to monitor the progress of
their liver disease, and may be asked to undergo an ultrasound examination of the liver to
detect any abnormalities that may be attributed to liver cancer. Patients will also answer
questions about their medical history particularly any outcomes or events related to their
hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of
information to allow researchers to obtain medical records from other clinics or physicians
where they have received treatment.