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Effects of Extended Lamivudine Therapy in Asian Patients With Chronic Hepatitis B

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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.

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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.

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