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15 February 2005 | Volume 142 Issue 4 | Pages 240-250
Background: Conventional interferon and lamivudine monotherapy are unsatisfactory in treating hepatitis B virus (HBV) infection.
Objective: To evaluate the efficacy and safety of pegylatedinterferon-
Design: Randomized, controlled, open-label trial.
Setting: Outpatient clinic in a referral center.
Participants: 100 treatment-naive patients with hepatitis B e antigen (HBeAg)–positive chronic hepatitis B and moderately elevated alanine aminotransferase levels.
Measurement: 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.
Intervention: A staggered regimen of combination therapy with pegylated interferon-
Results: The rate of sustained virologic response was 36% for the combination treatment group and 14% for the lamivudine monotherapy group (absolute difference, 22 percentage points [95% CI, 6 to 38 percentage points]). End-of-treatment outcomes showed that, compared with monotherapy, patients receiving combination therapy more often had virologic response (60% vs. 28% [absolute difference, 32 percentage points (CI, 14 to 50 percentage points)]); 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 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.
Limitations: This study lacked a double-blind design and was conducted at 1 institution. 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 patients with HBeAg-positive chronic hepatitis B, staggered combination treatment with pegylated interferon-
Editors' Notes
Context
Contribution
Cautions
–The Editors
Author and Article Information
From the Chinese University of Hong Kong and Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China.
Grant Support: Schering-Plough Corp. supplied pegylated interferon-
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Joseph J.-Y. Sung, MD, PhD, Department of Medicine and Therapeutics, 9/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China; e-mail, joesung{at}cuhk.edu.hk.
Current Authors Addresses: Drs. H.L.-Y. Chan, F.K.-L. Chan, Lee, and Sung; Mr. Hui; Mr. Wong; Ms. Chim; and Mr. Hung: Departments of Medicine and Therapeutics, 9/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China.
Dr. Leung: Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, Hong Kong SAR, Hong Kong.
Dr. Liew: Department of Anatomical and Cellular Pathology, 1/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China.
Dr. Tam: Department of Microbiology, 1/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China.
Dr. Lam: Department of Chemical Pathology, 1/F Prince of Wales Hospital, 30–32 Ngan Shing Street, Shatin, Hong Kong SAR, China.
Author Contributions: Conception and design: H.L.-Y. Chan, J.J.-Y. Sung.
Analysis and interpretation of the data: H.L.-Y. Chan, J.J.-Y. Sung.
Drafting of the article: H.L.-Y. Chan.
Critical revision of the article for important intellectual content: H.L.-Y. Chan, J.J.-Y. Sung.
Final approval of the article: H.L.-Y. Chan, J.J.-Y. Sung.
Provision of study materials or patients: H.L.-Y. Chan, N.W.-Y. Leung, A.Y. Hui, V.W.-S. Wong, F.K.-L. Chan, L.C.-T. Hung, Y.-T. Lee.
Statistical expertise: H.L.-Y. Chan.
Obtaining of funding: C.-T. Liew, J.J.-Y. Sung.
Administrative, technical, or logistic support: A.M.-L. Chim, J.S.-L. Tam, C.W.-K. Lam, J.J.-Y. Sung.
Collection and assembly of data: A.M.-L. Chim. ARTICLE
A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon-
2b and Lamivudine with Lamivudine Alone
2b and lamivudine combination therapy for chronic hepatitis B. 2b (1.5 µg/kg of body weight per week; maximum, 100 µg) 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. 2b and lamivudine may lead to a higher rate of virologic response than lamivudine monotherapy.
2b for 32 weeks plus lamivudine for 52 weeks or lamivudine monotherapy. Patients receiving combination therapy more often had virologic responses and less often developed lamivudine-resistant mutants than those receiving monotherapy. Transient influenza-like symptoms, alopecia, and local erythematous reactions were more common with combination therapy.
2b, and GlaxoSmithKline supplied lamivudine.
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