在恩替卡韦治疗的慢性乙型肝炎患者中开发和验证乙型肝炎e

StephenW

J Med Virol. 2019 Nov 14. doi: 10.1002/jmv.25628. [Epub ahead of print]
Development and validation of a model for hepatitis B e Antigen seroconversion in entecavir-treated chronic hepatitis B patients.
Shen S1, Lai-Hung Wong G2,3,4, Kuang Z1, van Campenhout MJH5, Fan R1, Wai-Sun Wong V2,3,4, Yip TC2,3, Chi H5, Liang X1, Hu X1, Lin W1, Wu Y1, Liu X1, Boonstra A5, Hou J1, Sun J1, Lik-Yuen Chan H2,3,4.
Author information

1
    State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
2
    Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
3
    Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.
4
    State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China.
5
    Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.

Abstract
BACKGROUND:

Achieving hepatitis B e antigen (HBeAg) seroconversion is a satisfactory endpoint during antiviral treatment for chronic hepatitis B (CHB).
AIM:

This study aimed to develop and validate a novel scoring system to predict HBeAg seroconversion during entecavir (ETV) treatment.
METHOD:

526 HBeAg positive CHB patients treated with ETV for at least 1 year were randomly assigned to the training and validation cohorts. Baseline parameters including HBV DNA, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and alanine aminotransferase (ALT) level were quantified. Patients who achieved HBeAg seroconversion were compared with those without HBeAg seroconversion. A prediction model was established to predict HBeAg seroconversion during ETV treatment.
RESULTS:

After a median follow up of 2.67 years, 93 (36.0%) and 87 (32.5%) patients in the training and validation cohorts developed HBeAg seroconversion. A prediction score composed of age, HBsAg and HBcAb quantification was derived. Areas under receiver operating characteristic (ROC) curves at 5 years of this prediction score were 0.70 and 0.72 in the training and validation cohorts. By using the dual cut-off values of 0.28 and 0.58, the model was endowed with high sensitivity and specificity to exclude or identify patients developing HBeAg seroconversion (90.3% sensitivity and 90.2% specificity in the training cohort as well as 92.8% sensitivity and 84.4% specificity in the validation cohort, respectively).
CONCLUSION:

A novel prediction score that uses baseline clinical variables was developed and validated. The score accurately estimates the probabilities of developing HBeAg seroconversion at 5 years entecavir therapy in CHB patients. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.
KEYWORDS:

entecavir; hepatitis B; hepatitis B core antibody; hepatitis B envelope antigen seroconversion; hepatitis B virus

PMID:
    31724212
DOI:
    10.1002/jmv.25628

StephenW

J Med Virol。 2019年11月14日.doi：10.1002 / jmv.25628。 [Epub提前发布]
在恩替卡韦治疗的慢性乙型肝炎患者中开发和验证乙型肝炎e抗原血清转换模型。
沉S1，黄丽红G2,3,4，匡Z1，范坎彭豪特MJH5，范R1，黄伟新V2,3,4，叶TC2,3，池H5，梁X1，胡X1，林W1， Wu Y1，Liu X1，Boonstra A5，Hou J1，Sun J1，Lik-Yuen Chan H2,3,4。
作者信息

1个
    南方医科大学附属南方医院传染病科，器官衰竭研究国家重点实验室，广东省病毒性肝炎研究重点实验室，广州。
2
    中国香港特别行政区香港中文大学消化系统疾病研究所。
3
    香港中文大学，香港特别行政区医学与治疗学系。
4
    香港中文大学，消化病国家重点实验室，香港特别行政区。
5
    荷兰鹿特丹伊拉斯姆斯MC大学医学中心胃肠病学和肝病学系。

抽象
背景：

在对慢性乙型肝炎（CHB）进行抗病毒治疗期间，实现乙型肝炎e抗原（HBeAg）血清转化是一个令人满意的终点。
目标：

这项研究旨在开发和验证新型评分系统，以预测恩替卡韦（ETV）治疗期间的HBeAg血清转化。
方法：

526名接受ETV治疗至少1年的HBeAg阳性CHB患者被随机分配到训练和验证队列中。定量基线参数，包括HBV DNA，乙型肝炎表面抗原（HBsAg），乙型肝炎核心抗体（HBcAb）和丙氨酸转氨酶（ALT）水平。将实现HBeAg血清转化的患者与未进行HBeAg血清转化的患者进行比较。建立了预测模型以预测ETV治疗期间的HBeAg血清转化。
结果：

经过2.67年的中位随访后，训练和验证队列中的93名患者（36.0％）和87名患者（32.5％）发生了HBeAg血清转化。得出了由年龄，HBsAg和HBcAb定量组成的预测评分。在训练和验证队列中，在此预测得分的5年时，接收器工作特征（ROC）曲线下的面积分别为0.70和0.72。通过使用0.28和0.58的双重截止值，该模型具有很高的敏感性和特异性，可以排除或鉴定正在发生HBeAg血清转化的患者（在训练队列中敏感性为90.3％，特异性为90.2％，敏感性为92.8％和84.4）。验证队列中的特异性百分比）。
结论：

开发并验证了使用基线临床变量的新型预测评分。该分数准确地估计了恩替卡韦治疗5年后CHB患者发生HBeAg血清转化的可能性。本文受版权保护。版权所有。

本文受版权保护。版权所有。
关键字：

恩替卡韦乙型肝炎；乙肝核心抗体；乙型肝炎包膜抗原血清转化；乙肝病毒

PMID：
    31724212
DOI：
    10.1002 / jmv.25628