Effects of Interferon on Portal Hypertension Ancillary Study

Investigators:

Principal Investigator: Arun J. Sanyal

Hypotheses/Aims

The specific hypothesis to be tested in the portal hypertension ancillary study is:
Long-term interferon therapy in patients with hepatitis C-related cirrhosis inhibits the development and progression of portal hypertension and the development of gastro-esophageal varices.

This hypothesis will be tested by the following specific aims:

1. To perform a prospective, randomized controlled trial to compare the efficacy of long-term interferon therapy to no treatment for the prevention of development of gastro-esophageal varices in cirrhotic patients without varices who enter the HALT-C Trial. All patients with cirrhosis and no varices at the time of randomization will be studied. Varices will be assessed by endoscopy at randomization and year 04 (M48). Development of portal gastropathy is a secondary endpoint.
2. To perform a prospective, randomized controlled study of the effects of long-term interferon therapy to no treatment on the hepatic venous pressure gradient (HVPG) and hepatic hemodynamics in cirrhotic patients with either small or no varices who enter the HALT-C Trial.