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. 2007 Sep;1(3):373-81.
doi: 10.1007/s12072-007-9016-3. Epub 2007 Oct 4.

Entecavir for the treatment of lamivudine-refractory chronic hepatitis B patients in China

Guangbi Yao  1 , Xiaqiu Zhou, Daozheng Xu, Baoen Wang, Hong Ren, Jessica Liu, Dong Xu, Laurie Macdonald
Affiliations

Entecavir for the treatment of lamivudine-refractory chronic hepatitis B patients in China

Guangbi Yao et al. Hepatol Int. 2007 Sep.

Abstract

Purpose: This randomized, double-blind, placebo-controlled study was undertaken to evaluate the efficacy and safety of entecavir in Chinese patients with lamivudine-refractory chronic hepatitis B.

Methods: One hundred forty-five lamivudine-refractory patients with chronic hepatitis B were randomized to double-blind treatment with oral entecavir 1 mg (n = 116) or placebo (n = 29) daily for 12 weeks, followed by 36 weeks of open-label entecavir treatment. The primary efficacy endpoint was the mean change from baseline in serum hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) assay at week 12.

Results: At week 12, the mean change from baseline in serum HBV DNA by PCR assay was -4.30 log(10) copies/ml for patients on entecavir compared to -0.15 log(10 )copies/ml for patients on placebo (P < .0001). Among patients with baseline serum alanine aminotransferase (ALT) >1 x upper limit of normal (ULN), a higher proportion of entecavir than placebo patients (68% vs. 6%, respectively) achieved ALT normalization by week 12 (P < .0001). After 48 weeks of entecavir treatment, the mean change in HBV DNA by PCR assay was -5.08 log(10) copies/ml, and 85% of patients with baseline ALT >1 x ULN had achieved ALT normalization. The safety profile of entecavir was similar to that of placebo during the first 12 weeks of blinded dosing. Entecavir was also well tolerated during 36 weeks of open-label treatment.

Conclusions: Lamivudine-refractory chronic hepatitis B patients treated with entecavir demonstrated marked HBV DNA reduction and normalization of ALT in most cases. Entecavir treatment for 48 weeks was well tolerated.

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Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Mean change from baseline in HBV DNA by PCR assay through 12 weeks of blinded treatment with entecavir 1 mg/d (●) or placebo (■). Error bars represent the standard error of the mean
Fig. 3
Fig. 3
Mean change from baseline in HBV DNA by PCR assay on entecavir through 48 weeks. Circles represent patients initially randomized to entecavir and squares represent patients initially randomized to placebo. Error bars represent the standard error of the mean
Fig. 4
Fig. 4
Mean change from baseline in HBV DNA by PCR assay at weeks 12 and 48 for patients with and without YMDD mutations at baseline
See this image and copyright information in PMC

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