1. A Randomized, Controlled Trial of Combination Therapy for Chronic Hepatitis B: Comparing Pegylated Interferon-α2b and Lamivudine with Lamivudine Alone
- Author
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Vincent Wai-Sun Wong, Choong-Tsek Liew, Nancy Leung, Henry Lik-Yuen Chan, John Siu-Lun Tam, Joseph J.Y. Sung, Lawrence Cheung-Tsui Hung, Alex Yui Hui, Christopher Wai-Kei Lam, Y. T. Lee, Francis K.I. Chan, and Angel Mei-Ling Chim
- Subjects
Adult ,Hepatitis B virus ,medicine.medical_specialty ,Adolescent ,Combination therapy ,Interferon alpha-2 ,Antiviral Agents ,Gastroenterology ,Drug Administration Schedule ,Polyethylene Glycols ,law.invention ,Hepatitis B, Chronic ,Randomized controlled trial ,Pegylated interferon ,law ,Internal medicine ,Internal Medicine ,Humans ,Medicine ,Hepatitis B e Antigens ,Aged ,Reverse-transcriptase inhibitor ,business.industry ,Interferon-alpha ,Hepatitis A ,Lamivudine ,Alanine Transaminase ,General Medicine ,Middle Aged ,Viral Load ,Hepatitis B ,medicine.disease ,Virology ,Recombinant Proteins ,Hepatocellular carcinoma ,DNA, Viral ,Drug Therapy, Combination ,business ,medicine.drug - Abstract
Conventional interferon and lamivudine monotherapy are unsatisfactory in treating hepatitis B virus (HBV) infection.To evaluate the efficacy and safety of pegylated interferon-alpha2b and lamivudine combination therapy for chronic hepatitis B.Randomized, controlled, open-label trial.Outpatient clinic in a referral center.100 treatment-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B and moderately elevated alanine aminotransferase levels.The primary end point was sustained virologic response (HBeAg seroconversion and HBV DNA level500,000 copies/mL) at 24 weeks after cessation of treatment.A staggered regimen of combination therapy with pegylated interferon-alpha2b (1.5 microg/kg of body weight per week; maximum, 100 microg) 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.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.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.In patients with HBeAg-positive chronic hepatitis B, staggered combination treatment with pegylated interferon-alpha2b and lamivudine may lead to a higher rate of virologic response than lamivudine monotherapy.
- Published
- 2005
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