Four years of lamivudine treatment in Chinese patients with chronic hepatitis B
Article first published online: 11 JUN 2004
Journal of Gastroenterology and Hepatology
Volume 19, Issue 11, pages 1276–1282, November 2004
How to Cite
CHANG, T.-T., LAI, C.-L., CHIEN, R.-N., GUAN, R., LIM, S.-G., LEE, C.-M., NG, K.-Y., NICHOLLS, G. J., DENT, J. C. and LEUNG, N. W. (2004), Four years of lamivudine treatment in Chinese patients with chronic hepatitis B. Journal of Gastroenterology and Hepatology, 19: 1276–1282. doi: 10.1111/j.1440-1746.2004.03428.x
- Issue published online: 8 OCT 2004
- Article first published online: 11 JUN 2004
- Accepted for publication 6 November 2003.
- chronic hepatitis B;
Background and Aims: This study assessed the efficacy and safety of up to 4 years of lamivudine treatment and the clinical relevance of the emergence of YMDD-variant hepatitis B virus (HBV).
Methods: Fifty-eight Chinese adult patients with chronic hepatitis B (CHB) were randomized to lamivudine 100 mg/day for up to 5 years and were monitored for YMDD-variant HBV, hepatitis B e antigen (HBeAg) seroconversion (loss of HBeAg and detectable antibody to HBeAg) and serum alanine aminotransferase (ALT) concentrations. Four-year data are reported here.
Results: The rate of HBeAg seroconversion increased with extended therapy and also with higher baseline ALT concentrations. YMDD-variant HBV was detected in 67% (39/58) of patients at some point during treatment. After 4 years, a total of 47% (27/58) of patients achieved HBeAg seroconversion. Thirty-three per cent (13/39) of patients with YMDD-variant HBV achieved HBeAg seroconversion; this increased to 57% (8/14) in patients with moderately elevated (>2–5 × upper limit of normal) pre-treatment ALT concentrations. The proportion of patients that achieved normal serum ALT increased from 29% (17/58) at baseline to 69% (31/45) following 4 years of treatment. That included 68% (23/34) of patients with YMDD-variant HBV and 73% (8/11) of those without the variant. All patients receiving lamivudine had reduced serum concentrations of HBV-DNA compared with baseline, despite the emergence of YMDD-variant HBV in 39 patients. Lamivudine was generally well tolerated; there was little change in the number or type of drug-related adverse events in the fourth year of the study.
Conclusions: Despite the emergence of YMDD-variant HBV, Chinese patients showed increased HBeAg seroconversion and improvement in ALT levels with an increased duration of treatment with lamivudine.