Pre-Study Serial Histology as a Predictor of Response to Continuous Therapy During the HALT-C Trial

Investigators:

Principal Investigator: Mitchell Shiffman

Hypotheses/Aims

In virologic non-responders to prior therapy:

1. Patients will be divided into cohort A (minimal decrease in inflammatory activity) and cohort B (decreased inflammatory activity) based on prior treatment responses as assessed by: 1) serum AST/ALT (SGOT/SGPT) during treatment and 2) liver biopsy within 6 months of stopping treatment.
2. Determine the individual rate of histologic progression from serial biopsies in the above two cohorts.
3. Correlate inflammatory treatment response with the rate of fibrosis from serial pre-study liver biopsies.
4. Identify a group of patients with rapid progression in histologic fibrosis despite therapy.
5. Determine whether these cohorts defined on pre-study response to interferon predicts the rate of progression in fibrosis, inflammatory improvement and outcome during continuous therapy.