Background: A recommendation was made by the ACT-HBV Asia-Pacific Steering Committee regarding the withdrawal of lamivudine in chronic hepatitis B patients after achieving effective maintained virological suppression. The outcome of patients following this therapeutic guideline has not been clearly investigated.
Objective: In this study, we examined the outcome of patients adherent to the lamivudine withdrawal guideline.
Study design: Seventy-one chronic hepatitis B patients achieving seroconversion of hepatitis B e antigen (HBeAg) as well as effective maintained virological suppression during lamivudine therapy were included. Lamivudine was withdrawn provided that undetectable HBV-DNA had been documented on two separate occasions at least 6 months apart. The patients were followed for a median period of 15 months (range, 6-72 months). The effect of pre-therapeutic clinical and virological factors on time to relapse was analyzed.
Results: Of the 71 patients, 19 (27%) relapsed, of whom 5 showed reappearance of HBeAg and 14 had HBeAg-negative hepatitis. Cox proportional hazard model showed pre-therapeutic HBV-DNA level was the only predictor for time-to-relapse (hazard ratio=1.023, 95% confidence interval=1.004-1.043, P=0.020). Categorical analysis showed that 15/34 (44.1%) and 4/37 (10.8%) patients with pretreatment HBV-DNA levels >10(8) and <or=10(8)copies/mL, respectively, relapsed during follow-ups. The accumulative relapse rates were significantly different between the two groups of patients (Kaplan-Meier method, P=0.003).
Conclusions: In patients with pretreatment HBV-DNA levels <or=10(8)copies/mL, lamivudine could be withdrawn after achieving effective maintained virological suppression. Relapse of HBeAg-negative hepatitis remained a major problem.