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, 揑n 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.?/span>
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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发表于 2005-2-27 02:15
