AASLD 2013:回顾性研究评估恩替的疗效韩国现实生活中的临床结

StephenW

TITLE: Retrospective Observational study to evaluate the efficacy of Entecavir in patients with chronic hepatitis B virus infection in Korea ; Real-Life Clinical Outcomes

AUTHORS (FIRST NAME, LAST NAME): Chung-Hwa Park1, 2, Jin Mo Yang1, 2, Hee Yeon Kim1, 2, Do Seon Song1, 2, Myeong Jun Song1, 2, Jung Hyun Kwon1, 2, Chan Ran You1, 2, Jeong Won Jang1, 2, U Im Chang1, 2, Se Hyun Cho1, 2, JinMo Yang1, 2, Nam Ik Han1, 2, Young Sok Lee1, 2, Si Hyun Bae1, 2, Jong Young Choi1, 2, Seung Kew Yoon1, 2
Institutional Author(s):
INSTITUTIONS (ALL): 1. Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of.
2. The Catholic University Liver Research Center (CULRC), The Catholic University of Korea, Seoul, Korea, Republic of.
ABSTRACT BODY: Background:
Entecavir has demonstrated superior histologic, virologic, and biochemical benefits for chronic hepatitis B worldwide. Still, its long-term clinical outcome is not well established in Korean clinical area, and also in subjects who stopped the treatment .

Methods:
This is a multicenter, retrospective cohort observational study to evaluate the efficacy of Entecavir long-term treatment in CHB patients at hospitals affiliated to the Catholic University of Korea through analysis of the electronic medical record data from January 1, 2006 to December 31, 2012.

Results:
Among 2,440 patients who were prescribed with entecavir 0.5mg qd, 1,337 patients were treatment naïve. Excluding 533 patients with concomitant conditions, 578 patients were on-treatment and 226 patients stopped the treatment during the study period.
At 6mo, year 1, 2, 3, 4 and 5, cumulative incidences of complete virologic response (HBV-DNA <300 copies/mL) was 379, 530, 573, 577, 579 and 579, respectively. HBsAg loss rate was 9.86%, and among 440 HBeAg-positive patients, HBeAg loss rate and HBeAg loss with HBeAb positivity rate were 20.00% and 17.43%, respectively, at year 1.
During the study period, 226 patients stopped entecavir, and at year 1 after cessation, cumulative virologic relapse (HBV-DNA>10^4 copies/mL) and biochemical relapse rate (ALT>40U/L) were 22.57% and 20.35%, respectively with mean days of 191.06±67.0 and 188.39±90.15.
Prognostic factor for earlier CVR was HBV-DNA<10^7cpm at the initiation of entecavir treatment (p<0.005). Among those who stopped the medication, prognostic factor for virological relapse was HBV-DNA ≥10^7cpm at the initiation of entecavir treatment(p=0.022).

Conclusions:
Long term use of entecavir may achieve CVR in most patients, and patients with higher viral load should be considered for indefinite duration of treatment regardless of age, sex, biochemical markers or HBeAg status.

StephenW

背景：
恩替卡韦已经表现出卓越的组织学，病毒学，生化全球慢性乙型肝炎的好处。尽管如此，其长期的临床结果没有很好地建立了在韩国的临床面积，谁也停止了治疗。

方法：
这是一项多中心，回顾性队列观察研究，以评估通过分析电子病历数据从2006年1月1日至12月31日，韩国天主教大学附属医院的恩替卡韦长期治疗的慢性乙型肝炎患者的疗效。

结果：
其中2,440名患者与恩替卡韦0.5mg的QD规定， 1,337例患者初次接受治疗的患者。伴随的条件不包括533名患者，578例患者对治疗和226名患者在研究期间停止治疗。
在6MO ，今年1 ， 2， 3 ， 4， 5 ，完整的病毒学应答（ HBV-DNA < 300拷贝/ ml）的累计发生率分别为379 ， 530， 573 ， 577 ， 579和579 。 HBsAg消失率为9.86％ ，其中440例HBeAg阳性患者， HBeAg转阴率和HBeAg转阴， HBeAb的阳性率分别为20.00％和17.43％ ，分别在第1年。
在研究期间，有226名患者停止了恩替卡韦，在停药后1年，累计病毒学复发（ HBV-DNA > 10 ^ 4拷贝/ ml） ，生化复发率（ ALT > 40U / L），分别为22.57％和20.35 ％ ，分别平均为191.06 ± 67.0和188.39 ± 90.15天。
较早CVR的预后因素是HBV-DNA < 10 ^ 7cpm在开始恩替卡韦治疗（ P < 0.005 ） 。在那些人停止用药，预后因素病毒学复发是HBV-DNA ≥ 10 ^ 7cpm在开始恩替卡韦治疗（P = 0.022 ） 。

结论：
长期使用恩替卡韦可以达到CVR在大多数患者中，病毒载量较高的患者应考虑无限期治疗，不论年龄，性别，生化标记或HBeAg状态。