Trial Information

Long-Term Follow-Up of HALT-C Sustained Virologic Responders

Subjects who have achieved a sustained virologic response during their participation in the
multicentered HALT-C clinical trial for treatment of chronic hepatitis C are being invited
to return for a single clinic visit to assess whether any decompensation events (e.g.
ascites, varicela hemorrhage, hepatic encephalopathy) or hepatocellular cancer has occurred.
Subjects able and willing to return to the NIH will undergo standard clinical examinations,
questionnaires and an ultrasound examination of the liver, to assess the status of their
hepatitis C. Data will be pooled from all of the 10 clinical centers, analyzed and compared
to an age and gender matched control group of nonresponder subjects who participated in the
HALT-C Trial. A data coordinating center (New England Research Institutes) will conduct the
data analysis. This will be a descriptive natural history study.