The Impact of Peginterferon Alfa-2a Maintenance Therapy On Portal Hypertension in Patients With Chronic Hepatitis C Virus Infection and Advanced Fibrosis and Cirrhosis Enrolled in the Halt-C Trial

Investigators:

Primary Investigator: Mitchell L Shiffman

Co-investigator: Gregory Everson

Hypotheses/Aims

1. Peginterferon alfa-2a maintenance therapy (90 µ/week) will reduce portal pressure in patients with advanced fibrosis or cirrhosis.
2. Peginterferon alfa-2a maintenance therapy (90 µ/week) will reduce the incidence of complications in patients with advanced fibrosis or cirrhosis.

Objectives:

The study will be divided into two phases with the following objectives.

Phase 1:

Phase 1 of this study will assess portal pressure at the completion of the HALT-C trial. The study objectives for this phase 1 are as follows:

1. To determine if patients who received peginterferon alfa-2a maintenance therapy (90 µ/week) during the HALT-C trial have a significantly lower portal pressure than patients randomized to the control (no-treatment) group.
2. To determine if patients who developed complications of cirrhosis (variceal bleeding, ascites and hepatic encephalopathy) during the HALT-C trial had a higher portal pressure at the end of this trail than patients who did not develop complications of cirrhosis.

Phase 2:

Phase 2 will consist of a randomized trial of peginterferon alfa-2a maintenance therapy versus no treatment for patients who were in the control arm of the HALT-C trial and did not receive peginterferon alfa-2a maintenance therapy. The study objectives for phase 2 are as follows:

1. To determine if 6 months of treatment with peginterferon alfa-2a maintenance therapy (90 µ/week) will reduce portal pressure.