Clinical

Peginterferon monotherapy best for HBeAg-negative chronic hepatitis B

Last Updated: 2004-09-16 14:48:47 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Compared with lamivudine therapy, treatment with peginterferon alfa-2a produces higher response rates in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B, a late-phase form of the disease with a poor prognosis. Combining the two drugs offers no benefits over peginterferon monotherapy.

The study was funded by drug company Roche, which markets peginterferon alfa-2a under the trade name Pegasys.

As reported in The New England Journal of Medicine for September 16th, Dr. Patrick Marcellin, from Hopital Beaujon in Clichy, France, and colleagues assessed the response rates of 537 patients who were randomized to receive lamivudine, peginterferon alfa-2a, or both agents for 48 weeks. The subjects were followed for an additional 24 weeks after treatment cessation.

The authors found that both peginterferon-containing regimens were significantly better than lamivudine monotherapy at normalizing ALT levels and reducing hepatitis B virus (HBV) DNA levels.

The peginterferon regimens were also tied to higher rates of sustained HBV suppression-about 20% for each regimen vs. 7% for lamivudine monotherapy (p < 0.001). Moreover, 12 patients in the peginterferon groups experienced loss of hepatitis B surface antigen (HBsAg) compared with no patients in the lamivudine monotherapy group.

Adverse effects were more frequent with the peginterferon regimens than with lamivudine monotherapy, but were generally mild and included pyrexia, fatigue, myalgia, and headache.

"Our data demonstrate the possibility of achieving HBsAg loss or seroconversion in patients with HBeAg-negative chronic hepatitis B with the use of peginterferon alfa-2a and therefore support the use of this agent as a first-line therapy for HbeAg-negative chronic hepatitis B," the authors conclude.

N Engl J Med 2004;351:1206-1217.