Factors influencing outcome of lamivudine in anti-HBe-positive chronic hepatitis B

Abstract

Background/aims: Lamivudine has been shown to benefit patients with anti-HBe/HBV-DNA-positive chronic hepatitis B. The aim of the study was to evaluate factors influencing outcome of lamivudine therapy during two years of post-treatment follow-up in a prospective clinical trial.

Methodology: Thirty-one consecutive patients, submitted to liver biopsy, were treated with lamivudine at 100mg/daily for twelve months and followed-up for twenty-four months. The patients were never treated before with interferon or stopped at least six months before starting lamivudine. ALT was measured monthly and HBV-DNA every three months.

Results: At the end of therapy 25 (81%) patients had both biochemical and virological response; 2 (6%) patients showed persistent viremia and 4 (13%) patients developed viral resistance during treatment. Twenty-three (92%) out of 25 responders relapsed during the follow-up; over 50% of all cases relapsed within 6 months. The relapse is related to higher HBV-DNA baseline levels. At relapse, 4/23 (17%) patients had symptomatic acute hepatitis.

Conclusions: Lamivudine is associated with the risk of developing viral mutants and, after therapy discontinuation, to high rate of relapse. In relapsing patients severe acute recurrence of hepatitis B may occur. Decisions about lamivudine monotherapy should take into account the limited long-term efficacy, effects of relapse, costs and predictive factors for response.