Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group.

Abstract

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.

• Authors: Y F Liaw, N W Leung, T T Chang, R Guan, D I Tai, K Y Ng, R N Chien, J Dent, L Roman, S Edmundson, C L Lai
• Journal: Gastroenterology (Gastroenterology) Vol. 119 Issue 1 Pg. 172-80 (Jul 2000) ISSN: 0016-5085 [Print] United States
• PMID: 10889166 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• DNA, Viral
• Hepatitis B e Antigens
• Reverse Transcriptase Inhibitors
• Lamivudine
• Alanine Transaminase

Topics

• Adult
• Alanine Transaminase (blood)
• Asian People
• DNA, Viral (antagonists & inhibitors, blood)
• Drug Administration Schedule
• Ethnicity
• Female
• Hepatitis B e Antigens (analysis, genetics)
• Hepatitis B virus (genetics)
• Hepatitis C, Chronic (blood, drug therapy, virology)
• Humans
• Lamivudine (administration & dosage, adverse effects, therapeutic use)
• Male
• Mutation
• Reference Values
• Reverse Transcriptase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Serologic Tests