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AIM: To evaluate the efficacy and safety of entecavir(ETV) in hepatitis Be antigen (HBeAg)-positive chronic hepatitis B (CHB) patients who had not received a nucleoside analogue and who had failed in lamivudine (LVD) therapy.METHODS: Sixty-one patients were divided into three groups. Forty-two patients who had not received a nucleoside analogue were randomized into two groups:group A (n = 21) received LVD 100 mg/d and group B(n = 21) received ETV 0.5 mg/d. The remaing 19patients treated with LVD (n = 19), who switched to ETV 1.0 mg/d served as group C. All patients were treated for 48 wk. HBV DNA levels were measured with polimerasechain-reaction (PCR) analysis. Liver function tests, HBV serology and safety assessments were also conducted.RESULTS: Significantly more patients in group B (52.1% and 71.4%) had undetectable HBV DNA levels than in groups A (35.8% and 38%; P ＜ 0.0001) and C (10.6%and 21.1%, P ＜ 0.0001) at wk 24 and 48, respectively.At wk 48, ALT levels were normalized in more patients in group B (85.7%) than in groups A (76.2%) and C (74%).CONCLUSION: ETV had a significantly higher response rate than LVD in patients with HBeAg-positive CHB who had not previously received a nucleoside analogue; ETV can effectively inhibit the replication of HBV DNA and normalize the levels of ALT in refractory CHB patients treated with LVD; and ETV is safe in clinical application.