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

Gastroenterology. 2000 Jul;119(1):172-80. doi: 10.1053/gast.2000.8559.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

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