Reuters Health Information (2005-06-30): Peginterferon more effective than lamivudine for chronic hepatitis B Clinical
Peginterferon more effective than lamivudine for chronic hepatitis B
Last Updated: 2005-06-30 16:10:20 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with hepatitis
B e antigen (HBeAg)-positive chronic hepatitis B, treatment with
peginterferon alfa-2a or peginterferon alfa-2a plus lamivudine is
superior to lamivudine monotherapy in reducing viral load and inducing
seroconversion of HBeAg and hepatitis B surface antigen (HBsAg),
investigators report.
The findings, which appear in The New England Journal of Medicine
for June 30, are based on a multicenter study of patients who were
randomized to receive peginterferon alfa-2a (180 microgram/week) plus
placebo (n = 271), peginterferon alfa-2a plus lamivudine (100 mg daily,
n = 271) or lamivudine plus placebo (n = 272) for 48 weeks, followed by
24 weeks of treatment-free follow-up.
Lead author Dr. George K. K. Lau, from the University of Hong Kong,
and his associates report that, after 48 weeks, 52% treated with
peginterferon alfa-2a monotherapy achieved hepatitis B DNA suppression
to < 100,000 copies/mL, as did 86% of those receiving dual therapy
and 62% of those taking lamivudine.
After 72 weeks, corresponding rates of viral load suppression were
32, 34%, and 22%. Both peginterferon alfa-2a groups were significantly
more effective at reducing levels of virus than lamivudine (p = 0.01
and 0.003, respectively).
At 72 weeks, 41%, 39% and 28% of patients, respectively, had
normalized levels of alanine aminotransferase. Corresponding rates of
HBeAg seroconversion were 32%, 27% and 19%. HBsAg seroconversion
occurred in 16 of those on peginterferon alfa-2a and in none of those
on lamivudine monotherapy, the authors note.
Serious adverse events occurred in 4% of the peginterferon alfa-2a
group, 2% of the lamivudine group and 6% of the dual therapy group. Two
patients receiving lamivudine monotherapy had hepatic decompensation,
leading to liver transplantation in one and death in the other.
"The ability to achieve HBeAg and HBsAg seroconversion after a
defined period of peginterferon alfa-2a therapy supports the use of
peginterferon alfa-2a as a first-line therapy for patients with
HBeAg-positive chronic hepatitis B," Dr. Lau's team concludes.
In a related editorial, Dr. Anna Suk-Fong Lok, from the University
of Michigan Medical Center in Ann Arbor, points out that "treatment is
recommended for patients with high HBV DNA levels, but it is unclear
whether patients with low hepatitis B DNA levels will derive the same
benefits."
"Given the propensity for hepatitis B virus to persist," she adds,
"patients should be closely monitored when treatment is stopped, to
avoid fatal flares."
N Engl J Med 2005;352:2682-2695,2743-2746.
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