Maintenance Therapy With Peginterferon Alfa-2b Does Not Prevent Hepatocellular Carcinoma in Cirrhotic Patients With Chronic Hepatitis C

Gastroenterology
Volume 140, Issue 7 , Pages 1990-1999, June 2011.

Jordi Bruix, Thierry Poynard, Massimo Colombo, Eugene Schiff, Kelly Burak, Elizabeth J.L. Heathcote, Thomas Berg, Jorge–Luis Poo, Carlos Brandao Mello, Rainer Guenther, Claus Niederau, Ruben Terg, Pierre Bedossa, Navdeep Boparai, Louis H. Griffel, Margaret Burroughs, Clifford A. Brass, Janice K. Albrecht, EPIC3 Study Group

Received 1 October 2010; accepted 4 March 2011. published online 18 March 2011.

Abstract

Background & Aims

Several studies have reported that low doses of interferon can delay the development of hepatocellular carcinoma (HCC) and progression of chronic hepatitis C. We investigated the incidence of clinical events among participants of the Evaluation of PegIntron in Control of Hepatitis C Cirrhosis (EPIC)3 program.

Methods
Data were analyzed from an open-label randomized study of patients with chronic hepatitis C who had failed to respond to interferon alfa plus ribavirin. All patients had compensated cirrhosis with no evidence of HCC. Patients received peginterferon alfa-2b (0.5 μg/kg/week; n = 311) or no treatment (controls, n = 315) for a maximum period of 5 years or until 98 patients had a clinical event (hepatic decompensation, HCC, death, or liver transplantation). The primary measure of efficacy was time until the first clinical event.

Results
There was no significant difference in time to first clinical event among patients who received peginterferon alfa-2b compared with controls (hazard ratio [HR], 1.452; 95% confidence interval [CI]: 0.880–2.396). There was no decrease in the development of HCC with therapy. The time to disease progression (clinical events or new or enlarged varices) was significantly longer for patients who received peginterferon alfa-2b compared with controls (HR, 1.564; 95% CI: 1.130–2.166). In a prospectively defined subanalysis of patients with baseline portal hypertension, peginterferon alfa-2b significantly increased the time to first clinical event compared with controls (P = .016). There were no new safety observations.

Conclusions
Maintenance therapy with peginterferon alfa-2b is not warranted in all patients and does not prevent HCC. However, there is a potential clinical benefit of long-term suppressive therapy in patients with preexisting portal hypertension.

Keywords: Liver Cancer, Evaluation of PegIntron in Control of Hepatitis C Cirrhosis Program, EPIC3 Program, Clinical Trial

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