AASLD2014:耐用性核苷（酸）类似物治疗慢性乙型肝炎：APASL指

StephenW

1914
Durability of Nucleos(t)ide Analogues Treatment in Patients with Chronic Hepatitis B: The Role of APASL Guideline
Yi-Hsiang Huang1,2, I-Cheng Lee1,2, Cheuk-Kay Sun3, Chien-Wei Su1, Yuan-Jen Wang4, Han-Chieh Lin1;
1Division of Gastroenterol-ogy, Taipei Veterans General Hospital, Taipei, Taiwan; 2Institue of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan; 3Division of Gastroenterology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; 4Healthcare Center, Taipei Veterans General Hospital, Taipei, Taiwan
Background & Aims Whether new generation nucleos(t)ide analogues (NUCs) had better durability in suppressing hepatitis B virus (HBV) was unclear. The aim of this study was to assess the virological and clinical relapse rates and their predictors after NUCs treatment in chronic hepatitis B (CHB) patients.

Methods: From February 2012, consecutive 90 CHB patients (28 HBeAg-positive and 62 HBeAg-negative) from two medical centers in Taiwan receiving NUCs therapy (78% underwent entecavir treatment) were enrolled. All patients were monitored every 3 months with serum qHBsAg, HBV DNA and ALT after end of the treatment (EOT). Virological relapse (VR) was defined as an HBV DNA >2,000 IU/mL while clinical relapse (CR) was defined as HBVDNA >2,000 IU/mL plus ALT elevation >2× ULN. Results The 90 patients had received a median 156 weeks of NUCs treatments before EOT. Seventy patients (77.8%) achieved the recommended APASL treatment endpoint, including 15 (53.6%) HBeAg-positive and 55 (88.7%) HBeAg-negative patients. During the median follow-up period of 36.6 weeks (range 3 to 102 weeks), VR and CR developed in 71.1% and 37.8% of patients, respectively. In HBeAg-positive patients, the median time to VR and CR were 24.1 and 66.4 weeks, respectively. There was no significant predictor of VR, while achieving APASL treatment endpoint was the only predictor of CR (HR = 0.127, p = 0.014). In the 15 HBeAg-positive patients who achieved APASL treatment endpoint, 8 (53.3%) and 3 (20%) patients still developed VR and CR, respectively. In HBeAg-negative patients, the median time to VR and CR were 31.9 and 74.7 weeks, respectively. Neither achieving APASL treatment endpoint nor low qHBsAg level at EOT were not associated with VR and CR. In the 16 HBeAg-negative patients with HBsAg <200 IU/mL at EOT, 11 (68.8%) and 3 (18.8%) patients still developed VR and CR, respectively.


Conclusions The risk of VR is high after cessation of NUCs treatment even achieving APASL treatment endpoint in both HBeAg-positive and –negative CHB patients. Low HBsAg level at EOT could not confer relapse-free status. HBV viral load should be closely monitored for all patients after cessation of NUCs.


Disclosures:
The following people have nothing to disclose: Yi-Hsiang Huang, I-Cheng Lee, Cheuk-Kay Sun, Chien-Wei Su, Yuan-Jen Wang, Han-Chieh Lin

StephenW

1914
耐用性核苷（酸）类似物治疗慢性乙型肝炎：APASL指南的作用
奕翔Huang1,2，我诚Lee1,2，焯凯Sun3，简伟SU1，元仁Wang4，汉洁琳;
1区Gastroenterol，术中，台北荣民总医院，台北，台湾; 2Institue临床医学院，国立阳明大学，台北，台湾; 3Division消化内科，新光吴火狮纪念医院，台北，台湾; 4Healthcare中心，台北荣民总医院，台北，台湾

背景与目的无论是新一代的核苷（酸）类似物（NUCs）具有更好的耐用性抑制乙肝病毒（HBV）不清楚。本研究的目的是评估的病毒学和临床复发率和NUCs治疗慢性乙型肝炎（CHB）患者后，他们的预测。方法自2012年2月，连续90例慢性乙型肝炎患者（28例HBeAg阳性和62例HBeAg阴性）接收NUCs疗法在台湾两个医疗中心（78％接受恩替卡韦治疗）的患者。所有患者进行了监测，每3个月，血清qHBsAg，HBV DNA和ALT的治疗（EOT）的结束之后。病毒学复发（VR）被定义为HBV DNA>2000国际单位/毫升，而临床复发（CR）定义为HBVDNA>2000 IU / mL的加ALT升高>2×ULN。结果90例患者EOT之前收到的中位数156周的NUCs治疗。 70例（77.8％）获得推荐的APASL治疗终点，其中15（53.6％），HBeAg阳性55例（88.7％），HBeAg阴性患者。在中位随访时间为36.6周（范围3〜102周），VR和CR发展71.1％的患者为37.8％，分别。在HBeAg阳性患者的中位时间为VR和CR分别为24.166.4周。有VR无显著的预测，同时实现APASL治疗终点是CR（HR=0.127，P =0.014）的唯一指标。在谁取得APASL治疗终点，8（53.3％）和3（20％）患者仍开发VR和CR分别为15例HBeAg阳性患者。在HBeAg阴性患者的中位时间为VR和CR分别为31.974.7周。无论是实现APASL治疗终点也不低qHBsAg水平EOT均与VR和CR有关。在16例HBeAg阴性患者的HBsAg<200 IU/ mL的在EOT，11（68.8％）和3（18.8％）患者仍VR开发和CR分别。结论VR的风险是停止NUCs治疗甚至达到APASL治疗终点在HBeAg阳性和阴性CHB患者后高。较低的HBsAg水平EOT不能赋予无复发情况。 HBV病毒载量应为停止NUCs后所有患者进行密切监测。

披露：

下面的人都没有透露：易祥黄，我诚李焯凯孙，建卫诉，元仁旺，韩佶霖