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New
Perspectives in the Treatment of HBeAg-positive and HBeAg-negative
Chronic Hepatitis B
Available
treatments for hepatitis B e antigen (HBeAg)-negative
chronic hepatitis B are associated with poor sustained responses.
As a result, nucleoside and nucleotide analogues are typically continued
indefinitely, a strategy associated with the risk of resistance
and unknown long-term safety implications.
We
compared the efficacy and safety of peginterferon alfa-2a (Pegasys)
180 microgram once weekly plus placebo, peginterferon alfa-2a plus
lamivudine (100 mg daily), and lamivudine alone in 177, 179, and
181 patients with HBeAg-negative chronic hepatitis B, respectively.
Patients were treated for 48 weeks and followed for an additional
24 weeks.
Results
·
After
24 weeks of follow-up, the percentage of patients with normalization
of alanine aminotransferase (ALT) levels or hepatitis
B virus (HBV) DNA levels below 20,000 copies per milliliter
was significantly higher with peginterferon alfa-2a monotherapy
(59 percent and 43 percent, respectively) and peginterferon alfa-2a
plus lamivudine (60 percent and 44 percent) than with lamivudine
monotherapy (44 percent, P=0.004 and P=0.003, respectively; and
29 percent, P=0.007 and P=0.003, respectively).
·
Rates
of sustained suppression of HBV DNA to below 400 copies per milliliter
were 19 percent with peginterferon
alfa-2a monotherapy, 20 percent with combination therapy,
and 7 percent with lamivudine alone (P<0.001 for both comparisons
with lamivudine alone).
·
Loss
of hepatitis B surface antigen occurred in 12 patients in the peginterferon
groups, as compared with 0 patients in the group given lamivudine
alone.
·
Adverse
events, including pyrexia, fatigue, myalgia, and headache, were
less frequent with lamivudine monotherapy than with peginterferon
alfa-2a monotherapy or combination therapy.
Conclusions
Patients with
HBeAg-negative chronic hepatitis B had significantly higher rates
of response, sustained for 24 weeks after the cessation of therapy,
with peginterferon alfa-2a than with lamivudine. The addition of
lamivudine to peginterferon alfa-2a did not improve post-therapy
response rates.
06/01/05
Reference
T Berg. New perspectives in the treatment of HBeAg-positive
and HBeAg-negative chronic hepatitis B. Hepatology 41(6):
1402-1406. June 2005.
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