Liver, Pancreas, and Biliary TractEffects of extended lamivudine therapy in Asian patients with chronic hepatitis B☆,☆☆,★
Section snippets
Study design
A total of 358 Chinese patients with chronic HBV infection were recruited into the first year of the study between July 1994 and July 1995 from 7 centers in Taiwan, Singapore, and Hong Kong, as reported previously.10 In the first year of the trial, patients were randomized to receive either 25 or 100 mg lamivudine daily or placebo. To ensure blinding of the first year data and continuity of the study, patients were randomized again before the first year randomization codes were broken. Patients
Study population
Of the 358 patients enrolled in the first year of the study, 24 patients withdrew and/or declined to participate in the second year of the study after rerandomization. The intent-to-treat population for the follow-up study, therefore, consisted of 334 Chinese patients with chronic hepatitis B (Figure 1).
Discussion
This study is a 1-year follow-up study from a previous 1-year study that showed that lamivudine therapy induced suppression of HBV replication for up to 1 year, and was significantly associated with normalization of ALT levels, HBeAg seroconversion, reduction in liver necroinflammatory activity, and reduced progression of hepatic fibrosis.10 The current follow-up study shows that 100 mg lamivudine once daily for 2 years continues to suppress viral replication in association with ALT level
Acknowledgements
The authors thank Lynn Condreay, Ph.D., for the evaluation of genotypic resistance to lamivudine, and the study monitors Maggie Yang, Hilary Lau, See-Wah Loke, Stephen-Loucian Lowe, and Carmen Sephton.
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Address requests for reprints to: Yun-Fan Liaw, M.D., Liver Research Unit, Chang Gung Memorial Hospital, 199, Tung Hwa North Road, Taipei, Taiwan 105. e-mail: [email protected]; fax: (886) 3-328-2824.
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Supported by Glaxo Wellcome Research and Development, England.
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In addition to the authors, the members of the Asia Hepatitis Lamivudine Study Group were: Clinical Group: Y. T. Lee, Steve W. C. Tsang, Henry L. Y. Chan, Sara Cheung, and Yolanda Yan, Department of Medicine, Prince of Wales Hospital, Hong Kong; W. M. Wong and M. F. Yuen, Department of Medicine, Queen Mary Hospital, Hong Kong; Lim Seng Gee, Yeoh Khay Guan, and Dede Selamat Sutedja, Department of Medicine, National University Hospital, Singapore; Chuah Khoon Beng and Ng Han Seong, Department of Gastroenterology, Singapore General Hospital, Singapore; Chuan-Mo Lee, Liver Unit, Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Mei-Feng Ke, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; and Mark Atkins and Fraser Gray, Glaxo Wellcome.