Clinical

Adding ribavirin to peginterferon no help for HBeAg-negative HBV

Last Updated: 2010-05-25 14:59:21 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In patients with chronic hepatitis B virus (HBV) infection who are e antigen (HBeAg)-negative, peginterferon alpha-2a plus ribavirin is no better than peginterferon monotherapy for achieving an off-treatment sustained response, new research shows.

But monotherapy wasn't particularly effective in that regard, either, the investigators found; it resulted in only a limited sustained response.

Senior author Dr. Harry L.A. Janssen of University Medical Center Rotterdam, The Netherlands, and colleagues note that HBeAg-negative chronic hepatitis B, the late phase of chronic infection, is increasingly prevalent around the world and is the most common type in Europe.

Not only do HBeAg-negative patients have a generally poor long-term prognosis, but they're at a high risk of relapse when antiviral therapy stops, according to the researchers.

Their randomized, double-blind, controlled trial, conducted at 25 centers across Europe, compared peginterferon monotherapy (180 mcg/week) given to 69 patients, with peginterferon plus ribavirin (either 1,000 or 1,200 mg daily, depending on body weight) given to 64 patients.

After 48 weeks of treatment and 24 weeks of follow-up, 14 (20%) in the monotherapy group and 10 (16%) in the combined therapy group had sustained virologic and biochemical responses, according to a report published online May 11 in the American Journal of Gastroenterology.

Virologic response was defined as HBV DNA < 10,000 copies/mL; biochemical response meant normalization of alanine aminotransferase levels.

The combination therapy was relatively well tolerated. Fatigue was the most commonly reported side effect. Unexpectedly, neutropenia developed twice as often with combination therapy as with monotherapy.

The study was supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland, which also supplied the peginterferon (Pegasys) and ribavirin (Copegus) used in the study.

http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2010186a.html

Am J Gastroenterol 2010.