Guest guest Posted July 11, 2000 Report Share Posted July 11, 2000 Published online 10 July 2000 GASTROENTEROLOGY 2000;119:172-180 Effects of Extended Lamivudine Therapy in Asian Patients With Chronic Hepatitis B YUN-FAN LIAW,* NANCY W. Y. LEUNG, TING-TSUNG CHANG,§ RICHARD GUAN, DAR-IN TAI,* KENG-YEEN NG,¶ RONG-NAN CHIEN,* JULIE DENT,# LISE ROMAN,# SALLY EDMUNDSON,# and CHING-LUNG LAI for the ASIA HEPATITIS LAMIVUDINE STUDY GROUP** *Liver Research Unit, Chang Gung Memorial Hospital and University, Taipei, Taiwan; Department of Medicine, Prince of Wales Hospital, Hong Kong; §Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; Department of Medicine, National University Hospital, Singapore; ¶Department of Gastroenterology, Singapore General Hospital, Singapore; #Glaxo Wellcome Research and Development, Greenford, England; and **Department of Medicine, Queen Hospital, Hong Kong Background & Aims: One-year lamivudine therapy significantly suppressed hepatitis B virus (HBV) replication, improved hepatic necroinflammatory activity, and prevented progression of fibrosis. However, the effects of prolonged therapy are unknown. Methods: A total of 334 Asian patients with chronic hepatitis B from a previously reported 1-year study were randomized to receive either lamivudine (100 or 25 mg) or placebo for another year. The effects of treatment on serum HBV-DNA suppression, alanine transaminase (ALT) normalization, and hepatitis B e antigen (HBeAg) seroconversion were measured. The presence of YMDD variant HBV and its effect were also determined. Results: A significantly greater proportion of patients achieved sustained HBV-DNA suppression and ALT normalization with 100 mg lamivudine daily for 2 years compared with lamivudine for 1 year followed by placebo for the second year (P < 0.001). Daily lamivudine therapy for 2 years was safe and resulted in incremental HBeAg seroconversion from 17% at week 52 to 27% at week 104. HBeAg seroconversion during continued lamivudine therapy increased linearly with increasing pretherapy ALT levels (P < 0.001). Despite the emergence of YMDD mutant in 38% of the patients, they continued to clear serum HBeAg and maintain lower median serum HBV-DNA and ALT levels than baseline values. In contrast, ALT levels increased 8-12 weeks after switching from lamivudine to placebo, but returned to normal once lamivudine treatment was resumed. Conclusions: Treatment with lamivudine for 2 years is both well tolerated and efficacious in patients with chronic hepatitis B. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 11, 2000 Report Share Posted July 11, 2000 Published online 10 July 2000 GASTROENTEROLOGY 2000;119:172-180 Effects of Extended Lamivudine Therapy in Asian Patients With Chronic Hepatitis B YUN-FAN LIAW,* NANCY W. Y. LEUNG, TING-TSUNG CHANG,§ RICHARD GUAN, DAR-IN TAI,* KENG-YEEN NG,¶ RONG-NAN CHIEN,* JULIE DENT,# LISE ROMAN,# SALLY EDMUNDSON,# and CHING-LUNG LAI for the ASIA HEPATITIS LAMIVUDINE STUDY GROUP** *Liver Research Unit, Chang Gung Memorial Hospital and University, Taipei, Taiwan; Department of Medicine, Prince of Wales Hospital, Hong Kong; §Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan; Department of Medicine, National University Hospital, Singapore; ¶Department of Gastroenterology, Singapore General Hospital, Singapore; #Glaxo Wellcome Research and Development, Greenford, England; and **Department of Medicine, Queen Hospital, Hong Kong Background & Aims: One-year lamivudine therapy significantly suppressed hepatitis B virus (HBV) replication, improved hepatic necroinflammatory activity, and prevented progression of fibrosis. However, the effects of prolonged therapy are unknown. Methods: A total of 334 Asian patients with chronic hepatitis B from a previously reported 1-year study were randomized to receive either lamivudine (100 or 25 mg) or placebo for another year. The effects of treatment on serum HBV-DNA suppression, alanine transaminase (ALT) normalization, and hepatitis B e antigen (HBeAg) seroconversion were measured. The presence of YMDD variant HBV and its effect were also determined. Results: A significantly greater proportion of patients achieved sustained HBV-DNA suppression and ALT normalization with 100 mg lamivudine daily for 2 years compared with lamivudine for 1 year followed by placebo for the second year (P < 0.001). Daily lamivudine therapy for 2 years was safe and resulted in incremental HBeAg seroconversion from 17% at week 52 to 27% at week 104. HBeAg seroconversion during continued lamivudine therapy increased linearly with increasing pretherapy ALT levels (P < 0.001). Despite the emergence of YMDD mutant in 38% of the patients, they continued to clear serum HBeAg and maintain lower median serum HBV-DNA and ALT levels than baseline values. In contrast, ALT levels increased 8-12 weeks after switching from lamivudine to placebo, but returned to normal once lamivudine treatment was resumed. Conclusions: Treatment with lamivudine for 2 years is both well tolerated and efficacious in patients with chronic hepatitis B. Quote Link to comment Share on other sites More sharing options...
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