A One-Year Trial of Lamivudine for Chronic Hepatitis B

doi:10.1056/NEJM199807093390201

Volume 339:61-68		July 9, 1998		Number 2

A One-Year Trial of Lamivudine for Chronic Hepatitis B

Ching-Lung Lai, M.D., Rong-Nan Chien, M.D., Nancy W.Y. Leung, M.D., Ting-Tsung Chang, M.D., Richard Guan, M.D., Dar-In Tai, M.D., Keng-Yeen Ng, M.D., Pui-Chee Wu, M.D., Julie C. Dent, Ph.D., Judy Barber, M.Sc., Sally L. Stephenson, Ph.D., D. Fraser Gray, Ph.D., for The Asia Hepatitis Lamivudine Study Group

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ABSTRACT

Background and Methods In preliminary trials, lamivudine, anoral nucleoside analogue, has shown promise for the treatmentof chronic hepatitis B. We conducted a one-year, double-blindtrial of lamivudine in 358 Chinese patients with chronic hepatitisB. The patients were randomly assigned to receive 25 mg of lamivudine(142 patients), 100 mg of lamivudine (143), or placebo (73)orally once daily. The patients underwent liver biopsies beforeentering the study and after completing the assigned treatmentregimen. The primary end point was a reduction of at least twopoints in the Knodell necroinflammatory score.

Results Hepatic necroinflammatory activity improved by two pointsor more in 56 percent of the patients receiving 100 mg of lamivudine,49 percent of those receiving 25 mg of lamivudine, and 25 percentof those receiving placebo (P<0.001 and P=0.001, respectively,for the comparisons of lamivudine treatment with placebo). Necroinflammatoryactivity worsened in 7 percent of the patients receiving 100mg of lamivudine, 8 percent of those receiving 25 mg, and 26percent of those receiving placebo. The 100-mg dose of lamivudinewas associated with a reduced progression of fibrosis (P=0.01for the comparison with placebo) and with the highest rate ofhepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg,development of antibody to HBeAg, and undetectable HBV DNA)(16 percent), the greatest suppression of HBV DNA (98 percentreduction at week 52 as compared with the base-line value),and the highest rate of sustained normalization of alanine aminotransferaselevels (72 percent). Ninety-six percent of the patients completedthe study. The incidence of adverse events was similar in allgroups, and there were few serious events.

Conclusions In a one-year study, lamivudine was associated withsubstantial histologic improvement in many patients with chronichepatitis B. A daily dose of 100 mg was more effective thana daily dose of 25 mg.

Source Information

From the Departments of Medicine (C.-L.L.) and Pathology (P.-C.W.), Queen Mary Hospital, Hong Kong, China; the Liver Unit, Chang Gung Memorial Hospital, Taipei, Taiwan (R.-N.C.); the Department of Medicine, Prince of Wales Hospital, Hong Kong, China (N.W.Y.L.); the Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan (T.-T.C.); the Department of Medicine, National University Hospital, Singapore (R.G.); the Liver Unit, Chang Gung Memorial Hospital, Kaohsiung Hsein, Taiwan (D.-I.T.); the Department of Gastroenterology, Singapore General Hospital, Singapore (K.-Y.N.); the Medical Affairs Department, Glaxo Wellcome China, Hong Kong (J.C.D.); and the Departments of European Clinical Statistics (J.B.) and Infectious Diseases and Rheumatology (S.L.S., D.F.G.), Glaxo Wellcome Research and Development, Greenford, United Kingdom.

Address reprint requests to Dr. Lai at the Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong, China.

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