在6个月恩替卡韦治疗HBV-DNA水平预测HBeAg阳性患HBeAg消失

StephenW

ORIGINAL ARTICLE
HBV-DNA level at 6 months of entecavir treatment predicts HBeAg loss in HBeAg-positive chronic hepatitis B patients
Cheng-Yuan Penga,b, Tsung-Cheng Hsiehc, Tsai-Yuan Hsieh d, Kuo-Chih Tsenge,f, Chih-Lin Ling, Tung-Hung Suh, Tai-Chung Tsengf,i, Hans Hsienhong Linf,i, Chia-Chi Wangf,i,**, Jia-Horng Kaoh,*

a School of Medicine, China Medical University, Taichung, Taiwan
b Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
c Institute of Medical Science, Tzu Chi University, Hualien, Taiwan
d Department of Gastroenterology, Tri-Service General Hospital, Taipei, Taiwan
e Department of Hepatology, Buddhist Tzu Chi General Hospital, Da-Lin Branch, Hualien, Taiwan
f School of Medicine, Tzu Chi University, Hualien, Taiwan
g Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan
h Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
i Department of Hepatology, Buddhist Tzu Chi General Hospital, Taipei Branch, New Taipei City, Taiwan
Received 1 June 2013; received in revised form 29 October 2013; accepted 31 October 2013
KEYWORDS chronic hepatitis B; complete virological response; entecavir; hepatitis B e antigen; HBeAg loss

Background/Purpose: To evaluate whether on-treatment HBV-DNA level could predict the treatment response to entecavir in hepatitis B e antigen (HBe)-positive chronic hepatitis B (CHB) patients.

Methods: A total of 68 treatment-naı ¨ve HBeAg-positive patients (75% male, mean age at 46.6 - 11.9 years) receiving at least 2 years of entecavir therapy were enrolled. The primary therapeutic endpoint was HBeAg loss. On-treatment complete virological response was defined as serum HBV-DNA < 63 IU/mL.

Results: The median baseline alanine aminotransferase (ALT) and HBV-DNA levels were 199.5 (27e1622) U/L and 7.7 (3.8e13.2) log10IU/mL, respectively. The median treatment duration was 31.7 (24.3e69.6) months. The rate of HBeAg loss at 2 years was 30.9%. By univariate anal- ysis, on-treatment complete virological response at Month 6 was associated with HBeAg loss at 2 years (p Z 0.019). After adjustment for age, gender, cirrhosis, baseline ALT, and HBV-DNA levels, this factor remained significant in multivariate analysis (odds ratio: 4.35; 95% confi- dence interval: 1.24e15.24, p Z 0.021). Conclusion: On-treatment complete virological response at Month 6 is a favorable factor pre- dictive of HBeAg loss at 2 years of entecavir therapy. Therefore, measurement of serum HBV- DNA level at 6 months of entecavir therapy is optimal to predict HBeAg loss at 2 years of ther- apy in HBeAg-positive CHB patients. Copyright ª 2013, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved.

StephenW

在6个月恩替卡韦治疗HBV-DNA水平预测HBeAg阳性慢性乙型肝炎患者HBeAg消失
彭成元A，B，崇锦城C，蔡媛谢D，郭智Tsenge，F，易芝玲岭，洪徐，大涌井F，I，汉斯Hsienhong林楼我，嘉驰往F，I，**，嘉宏高H，*

医药，中国医药大学，台中，台湾的学校
胃肠肝胆内科部，中国医药大学附设医院，台中，台湾的B组
医学科学，慈济大学，花莲，台Ç研究所
消化内科研发部，三军总医院，台北，台湾
肝病台湾电系，佛教慈济综合医院大林分公司，花莲，
医药，慈济大学，花莲，台f的学校
消化内科，台北市立联合医院仁爱分行，台北，台湾克系
临床医学与肝炎研究中心，医学和医院，台北，台湾的国立台湾大学为h研究所
我的肝病台系，佛教慈济综合医院台北分行，新北市，
收到2013年6月1日，在经修订的形式2013年10月29日收到;接受2013年10月31日
关键词慢性乙型肝炎;完整的病毒学应答，恩替卡韦，乙肝e抗原，HBeAg消失

背景/目的：探讨治疗HBV-DNA水平能否预测B型肝炎e抗原（HBe抗体）阳性慢性乙型肝炎（CHB）患者的治疗反应来恩替卡韦。

方法：共68治疗鼐¨已经HBeAg阳性患者（75％为男性，平均年龄在46.6  -  11.9岁）接受至少2年恩替卡韦治疗的患者。主要疗效终点是HBeAg消失。对治疗完全病毒学应答的定义为血清HBV-DNA <63 IU /毫升。

结果：中位基线丙氨酸转氨酶（ALT）和HBV-DNA水平分别为199.5（27e1622）U / L和7.7（3.8e13.2）log10IU/mL，分别。平均治疗时间为31.7（24.3e69.6）个月。 HBeAg消失2年率为30.9％。单因素分析显示，在第6个月的治疗完全病毒学应答的HBeAg损失相关在2年（对Ž0.019）。在调整了年龄，性别，肝硬化，基线ALT和HBV-DNA水平之后，这一因素仍多因素分析（优势比：4.35; 95％置信区间：1.24e15.24，第Ž0.021）显著。结论：在治疗第6个月完整的病毒学应答是一个有利的因素在2年恩替卡韦治疗前dictive HBeAg消失。因此，血清HBV-DNA水平在6个月恩替卡韦治疗的测量是最佳的预测HBeAg消失在HBeAg阳性CHB患者2年热敏APY的。版权所有ª2013年，爱思唯尔台湾有限责任公司与台湾医学会。保留所有权利。