Reuters Health Information (2004-09-16): Peginterferon monotherapy best for HBeAg-negative chronic hepatitis B
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
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.