Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve patients with chronic hepatitis B: a randomized double-blind trial in China.

Abstract

BACKGROUND/AIMS Chronic hepatitis B has a high prevalence (>8%) in China. We compared the safety and efficacy of entecavir with that of lamivudine for the treatment of patients with chronic hepatitis B in China. METHODS A total of 519 nucleoside-naive Chinese patients with chronic hepatitis B were randomized (1:1) and treated with entecavir 0.5 mg/d or lamivudine 100 mg/d. The primary endpoint was serum HBV DNA <0.7 MEq/ml by bDNA assay and alanine aminotransferase <1.25 x upper limit of normal (ULN) at week 48. Patients with missing week 48 measurements were considered non-responders. RESULTS About 90% (231/258) of entecavir-treated versus 67% (174/261) of lamivudine-treated patients achieved the primary endpoint (P < 0.0001). The mean reduction from baseline in HBV DNA was greater with entecavir than lamivudine (5.90 vs. 4.33 log(10) copies/ml, P < 0.0001). Greater proportions of entecavir-treated patients achieved undetectable HBV DNA (<300 copies/ml) by polymerase chain reaction assay (76% vs. 43%, P < 0.0001) and alanine aminotransferase normalization (</=1 x ULN, 90% vs. 78%, P = 0.0003). Entecavir and lamivudine achieved comparable rates of HBeAg seroconversion (15% and 18%, respectively). Safety was comparable between the two treatments. CONCLUSIONS For nucleoside-naïve Chinese patients with chronic hepatitis B, entecavir achieves superior virological and biochemical benefit over lamivudine, with a comparable safety profile.

DOI: 10.1007/s12072-007-9043-0

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@article{Yao2007EfficacyAS, title={Efficacy and safety of entecavir compared to lamivudine in nucleoside-na{\"{i}ve patients with chronic hepatitis B: a randomized double-blind trial in China.}, author={Guang Yao and Chengwei Chen and Weilun Lu and Hong Ren and Deming Tan and Yuming Wang and Daozheng Xu and Zhengrong Jiang and Jessica Liu and Dong Jie Xu and Laurie A. Macdonald}, journal={Hepatology international}, year={2007}, volume={1 3}, pages={365-72} }