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The Efficacy of Combination Therapy with Lamivudine and Immunization
in Patients with Chronic Hepatitis B
Both
the hepatitis B virus (HBV) and the immune response of the hosts
to HBV play important roles in the pathogenesis of chronic
hepatitis B (CHB). Lamivudine
(Epivir-HBV) is a
potent antiviral agent with minimal immune modulator capacity. Moreover,
lamivudine causes severe side effects like breakthrough of HBV DNA
and breakthrough hepatitis in patients with CHB.
On
the other hand, vaccine
therapy, a recently-developed immune therapy, exhibits
potent immune modulatory potentials and almost no side effects,
but possesses little antiviral capacity in patients with CHB.
The
aim of this clinical trial is to evaluate the efficacy of a combination therapy of lamivudine and vaccine in patients with CHB.
Seventy-two
patients with CHB (hepatitis B e antigen (HBeAg)-positive,
40; antibody to HBeAg (anti-HBe)-positive,
32). All patients received lamivudine at a dose of 100mg daily for
12 months.
Fifteen
patients (HBeAg(+), 9; anti-HBe(+), 6) receiving oral lamivudine
were also given a vaccine containing 20mug of hepatitis
B surface antigen (HBsAg), intradermally, once every
2 weeks for 12 times (combination therapy).
Results
Twelve
months after the start of therapy, serum HBV DNA became negative
in 9 of 9 (100%) HBeAg (+) CHB patients receiving combination therapy
and in 15 of 31 (48%) HBeAg(+) CHB patients receiving lamivudine
monotherapy (P
< 0.05).
The
rate of seroconversion
from HBeAg to anti-HBe was also significantly higher
in patients receiving combination therapy (56% versus lamivudine
monotherapy, 16%, P < 0.05).
Of
the 57 patients receiving lamivudine monotherapy, breakthrough of
HBV DNA was found in 10 and breakthrough hepatitis was found in
4; however, these were not seen in any patient receiving combination
therapy.
Conclusions
Combination
therapy represents a better therapeutic regimen with few complications
in patients with CHB, according to the authors.
Third
Department of Internal Medicine, Ehime University School of Medicine,
Shigenobu-Cho, Ehime 791 0295, Japan.
01/21/05
Reference
N Horiike and others. In vivo immunization by vaccine therapy following
virus suppression by lamivudine: a novel approach for treating patients
with chronic hepatitis B. Journal Clinical Virology
32(2): 156-161. February 2005.
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