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Background and Aim: Severe acute hepatitis B is a rapid deterioration of liver function, which carries a high mortality rate. The aim of this study is to evaluate the efficacy of lamivudine in patients with severe acute hepatitis B.Methods: In this study, 80 patients with severe acute hepatitis B were randomly divided into lamivudine and the control group. For the two groups, we compared HBsAg, HBeAg seroconversion rates, serum HBV DNA-negative rate, biochemical indicators, the incidence of liver failure, and mortality. The influential factors on the mortality were studied by Cox proportional hazards model.Results: The improvement in serum TBiL, INR, and HBV DNA levels of the lamivudine group was significantly greater than that of the control group. The mortality of lamivudine group (7.5%, 3/40) was significantly lower than that of the control group (25.0%, 10/40) (p = 0.034). The incidence of liver failure (8.7%, 2/23) of patients receiving lamivudine within a week was significantly lower than that (35.3%, 6/17) of those who received it after a week (p = 0.038). In multivariate Cox proportional hazards analyses, age (p = 0.043), ratio of total to direct bilirubin (p = 0.009), treatment method (p = 0.006), and the decline of HBV DNA load during therapy (p = 0.017) were independent predictors of mortality. The HBsAg seroconversion rates (62.5%, 25/40) and HBeAg seroconversion rates (63.6%, 21/33) of the lamivudine group were significantly lower than those (85.0%, 34/40), (87.5%, 28/32) of the control group (p = 0.022, 0.026).Conclusions: Early treatment with lamivudine leads to a greater decrease in HBV DNA level, better clinical improvement and mortality improvement in patients with severe acute hepatitis B, but with a lower seroconversion rate. A rapid decline of HBV DNA load is a good predictor for the treatment outcome. [ABSTRACT FROM AUTHOR]