基线定量乙肝核心抗体滴度独强烈预测整个聚乙二醇干扰素

StephenW

Gut doi:10.1136/gutjnl-2014-308546

    Hepatology

    Original article

Baseline quantitative hepatitis B core antibody titre alone strongly predicts HBeAg seroconversion across chronic hepatitis B patients treated with peginterferon or nucleos(t)ide analogues
Open Access

    Rong Fan1,
    Jian Sun1,
    Quan Yuan2,
    Qing Xie3,
    Xuefan Bai4,
    Qin Ning5,
    Jun Cheng6,
    Yanyan Yu7,
    Junqi Niu8,
    Guangfeng Shi9,
    Hao Wang10,
    Deming Tan11,
    Mobin Wan12,
    Shijun Chen13,
    Min Xu14,
    Xinyue Chen15,
    Hong Tang16,
    Jifang Sheng17,
    Fengmin Lu18,
    Jidong Jia19,
    Hui Zhuang18,
    Ningshao Xia2,
    Jinlin Hou1,20,
    Chronic Hepatitis B Study Consortium

- Author Affiliations

    1State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China
    2State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, China
    3Department of Infectious Diseases, Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China
    4Department of Infectious Diseases, Tangdu Hospital, Xi'an, China
    5Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
    6Beijing Ditan Hospital, Capital Medical University, Beijing, China
    7Department of Infectious Diseases, First Hospital of Peking University, Beijing, China
    8Department of Hepatology, First Hospital, Jilin University, Changchun, China
    9Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China
    10Hepatology Unit, Peking University People's Hospital, Beijing, China
    11Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China
    12Department of Infectious Diseases, Changhai Hospital, Shanghai, China
    13Ji'nan Infectious Diseases Hospital, Ji'nan, China
    148th People's Hospital, Guangzhou, China
    15Beijing Youan Hospital, Capital Medical University, Beijing, China
    16Department of Infectious Diseases, West China Hospital, Chengdu, China
    17Department of Infectious Diseases, Zhejiang University 1st Affiliated Hospital, Hangzhou, China
    18Department of Microbiology, Health science Center, Peking University, Beijing, China
    19Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China
    20Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, Hangzhou, China

    Correspondence to Professor Jinlin Hou, Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China; [email protected] and Professor Ningshao Xia, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, 361105, China; [email protected]

    Received 8 October 2014
    Revised 5 December 2014
    Accepted 23 December 2014
    Published Online First 13 January 2015

Abstract

Objective The investigation regarding the clinical significance of quantitative hepatitis B core antibody (anti-HBc) during chronic hepatitis B (CHB) treatment is limited. The aim of this study was to determine the performance of anti-HBc as a predictor for hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive CHB patients treated with peginterferon (Peg-IFN) or nucleos(t)ide analogues (NUCs), respectively.

Design This was a retrospective cohort study consisting of 231 and 560 patients enrolled in two phase IV, multicentre, randomised, controlled trials treated with Peg-IFN or NUC-based therapy for up to 2 years, respectively. Quantitative anti-HBc evaluation was conducted for all the available samples in the two trials by using a newly developed double-sandwich anti-HBc immunoassay.

Results At the end of trials, 99 (42.9%) and 137 (24.5%) patients achieved HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. We defined 4.4 log10 IU/mL, with a maximum sum of sensitivity and specificity, as the optimal cut-off value of baseline anti-HBc level to predict HBeAg seroconversion for both Peg-IFN and NUC. Patients with baseline anti-HBc ≥4.4 log10 IU/mL and baseline HBV DNA <9 log10 copies/mL had 65.8% (50/76) and 37.1% (52/140) rates of HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. In pooled analysis, other than treatment strategy, the baseline anti-HBc level was the best independent predictor for HBeAg seroconversion (OR 2.178; 95% CI 1.577 to 3.009; p<0.001).

Conclusions Baseline anti-HBc titre is a useful predictor of Peg-IFN and NUC therapy efficacy in HBeAg-positive CHB patients, which could be used for optimising the antiviral therapy of CHB.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

StephenW

肠道DOI：10.1136/ gutjnl-2014-308546

    肝病

    原创文章

基线定量乙肝核心抗体滴度独强烈预测整个聚乙二醇干扰素或核苷（酸）类似物治疗慢性乙型肝炎患者HBeAg血清转换
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    荣风扇1，
    建SUN1，
    泉Yuan2，
    清Xie3，
    金学范Bai4，
    秦Ning5，
    君Cheng6，
    岩岩Yu7，
    军棋Niu8，
    广丰Shi9，
    郝Wang10，
    戴明Tan11，
    莫宾Wan12，
    使君Chen13，
    分Xu14，
    新月Chen15，
    香港Tang16，
    Jifang Sheng17，
    丰民Lu18，
    冀东Jia19，
    惠Zhuang18，
    宁绍Xia2，
    吉林Hou1,20，
    慢性乙型肝炎研究联盟

- 作者所属机构

    器官功能衰竭研究国家重点实验室，病毒性肝炎研究的广东省重点实验室，感染科和肝病单位，南方医院，南方医科大学，广州，中国
    分子疫苗学和分子诊断，诊断研究所和疫苗开发中的传染病，公共卫生学院，厦门大学，厦门，中国国家重点实验室
    3Department传染病，瑞金医院，交通大学医学院，上海，中国的
    4Department传染病，唐都医院，西安，中国
    5Department传染病，同济医院，同济医学院，华中科技大学，武汉，中国研究所
    6Beijing地坛医院，首都医科大学，北京，中国
    7Department传染病，北京大学第一医院，北京，中国
    肝病，第一医院，吉林大学，长春，中国的8Department
    9Department传染病，华山医院，上海复旦大学，中国
    10Hepatology单位，北京大学人民医院，北京，中国
    11Department传染病，湘雅医院，中南大学，长沙，中国
    12Department传染病，长海医院，上海，中国
    13Ji'nan传染病医院，济南，中国
    148人民医院，广州，中国
    15Beijing佑安医院，首都医科大学，北京，中国
    16Department传染病，中国西部医院，成都，中国
    17Department传染病，浙江大学附属第一医院，杭州，中国
    微生物学，健康科学中心，北京大学，北京，中国的18Department
    19Liver研究中心，北京友谊医院，首都医科大学，北京，中国
    20Collaborative创新中心的诊断和传染病防治，浙江大学，杭州，中国

    对应到吉林侯教授，肝病单位，南方医院，南方医科大学，广州，510515，中国; [email protected]和宁绍夏教授，诊断研究所和疫苗开发中的传染病，公共卫生，厦门大学，厦门361105，中国; [email protected]

    收到的2014年10月8日
    修订后的2014年12月5日
    接受2014年12月23日
    网上公布的第一2015年1月13日

抽象

客观定量方面乙肝核心抗体（抗-HBc）慢性乙型肝炎在临床意义调查（CHB）治疗是有限的。这项研究的目的是确定抗-HBc表现为乙肝e抗原（HBeAg）血清转换的HBeAg阳性与聚乙二醇干扰素（PEG-IFN）或核苷（酸）类似物治疗慢性乙型肝炎患者的预测（NUCs）分别。

设计这是一项回顾性队列研究，包括231和560例患者两个第四阶段，多中心，随机，对照用PEG-IFN或处理过的试验NUC为基础的治疗长达2年，分别。在两个试验所有可用的样品使用了新开发的双夹心抗-HBc免疫定量抗-HBc进行评价。

结果在试验结束时，99（42.9％）和137（24.5％）患者在聚乙二醇干扰素和NUC同伙，分别达到HBeAg血清转换。我们定义4.4 log10的国际单位/毫升，具有敏感性和特异性的最大总和，作为基线抗-HBc水平的最佳截止值来预测血清转换为聚乙二醇干扰素和NUC。患者基线抗-HBc≥4.4日志10 IU/ mL和基线HBV DNA<9 log10拷贝/ mL的有65.8％（50/76）和37.1％（一百四十○分之五十二）HBeAg血清转换在聚乙二醇干扰素和NUC同伙率分别。在汇总分析，比治疗策略等，基线抗-HBc水平是最好的独立预测HBeAg血清学转换（OR2.178;95％CI1.577到3.009，P <0.001）。

结论基线抗-HBc滴度是PEG-IFN和NUC治疗功效的HBeAg阳性CHB患者一个有用的预测，其可用于优化CHB的抗病毒治疗。

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阳光醉人

谁给大伙总结一下啊，谢谢了。