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Comparison of Pegylated Interferon Alfa-2b (Peg-Intron) and Lamivudine
with Lamivudine Alone for the Treatment of Hepatitis B
Conventional
interferon alfa and lamivudine (Epivir-HBV)
monotherapy are not the optimal treatment for hepatitis
B virus (HBV) infection. The objective of the current randomized,
controlled, open-label study was to evaluate the efficacy and safety
of pegylated
interferon alfa-2b (Peg-Intron) and lamivudine combination therapy
for chronic hepatitis B.
The
study participants were 100 treatment-naive patients with hepatitis B e antigen (HBeAg) positive
chronic hepatitis B and moderately elevated alanine
aminotransferase levels who were treated in the outpatient
clinic in a referral center.
The primary end point was sustained
virologic response (HBeAg
seroconversion and HBV
DNA level < 500,000 copies/mL) at 24 weeks after cessation
of treatment.
A staggered regimen of combination
therapy with pegylated interferon alfa-2b (1.5 microgram/kg of body
weight per week; maximum, 100 microgram) given for 32 weeks plus
lamivudine (100 mg daily) given for 52 weeks versus lamivudine (100
mg daily) monotherapy given for 52 weeks.
Of the 100 participants, 96% completed
treatment and 80% completed post-treatment follow-up.
Results
The rate of sustained
virologic response (SVR) was 36% for the combination
treatment group and 14% for the lamivudine monotherapy group (absolute
difference, 22 percentage points).
End-of-treatment outcomes showed that,
compared with monotherapy, patients receiving combination therapy
more often had virologic response; had more substantial reductions
of HBV DNA (3.91 log10 copies/mL vs. 2.83 log10 copies/mL); and
less often had lamivudine-resistant
mutants (21% vs. 40%).
The percentages of patients with normalization
of alanine aminotransferase (ALT) levels and histologic improvement
did not differ.
Adverse
effects,
such as transient influenza-like
symptoms, alopecia, and local erythematous reactions,
were more common with combination therapy.
Study Limitations
The authors note some limitations
of the study, specifically that it lacked a double-blind design
and was conducted at a single institution. In addition, because
of the staggered pegylated interferon/lamivudine regimen, patients
assigned to combination therapy received treatment for 8 weeks longer
than those assigned to monotherapy.
Conclusions
In conclusion, the authors write,
“In patients with HBeAg-positive chronic hepatitis B, staggered
combination treatment with pegylated interferon alfa-2b (Peg-Intron)
and lamivudine may lead to a higher rate of virologic response than
lamivudine monotherapy. We now need head-to-head comparisons to see whether this combination treatment
leads to similar or higher rates of sustained response compared
with either pegylated interferon alone or conventional interferon
with or without lamivudine.”
Chinese
University of Hong Kong and Alice Ho Miu Ling Nethersole Hospital,
Hong Kong, China.
02/25/05
Reference
H Lik-Yuen Chan and others. A Randomized,
Controlled Trial of Combination Therapy for Chronic Hepatitis B:
Comparing Pegylated Interferon-2b and Lamivudine with Lamivudine
Alone. Annals
of Internal Medicine 142(4):
240-250. February 15, 2005.
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