结合HBV RNA和乙型肝炎核心相关抗原：安全停止HBeAg阳性慢性

StephenW

J Infect Dis. 2020 Mar 25. pii: jiaa136. doi: 10.1093/infdis/jiaa136. [Epub ahead of print]
Combining HBV RNA and hepatitis B core-related antigen: guidance for safely stopping nucleos(t)ide analogues in HBeAg-positive chronic hepatitis B patients.
Fan R1, Peng J1, Xie Q2, Tan D3, Xu M4, Niu J5, Wang H6, Ren H7, Chen X8, Wang M9, Sheng J10, Tang H11, Bai X12, Wu Y1, Zhou B1, Sun J1, Hou J1; Chronic Hepatitis B Study Consortium.
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
    Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3
    Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China.
4
    8th People's Hospital, Guangzhou, China.
5
    Hepatology Unit, No. 1 Hospital affiliated to Jilin University, Changchun, China.
6
    Hepatology Unit, Peking University People's Hospital, Beijing, China.
7
    Department of Infectious Diseases, The second Affiliated Hospital，Chongqing Medical University, Chongqing, China.
8
    Beijing Youan Hospital, Beijing, China.
9
    Department of Infectious Diseases, 81st PLA Hospital, Nanjing, China.
10
    Department of Infectious Diseases, Zhejiang University 1st Affiliated Hospital, Hangzhou, China.
11
    Department of Infectious Diseases, West China Hospital, Chengdu, China.
12
    Department of Infectious Diseases, Tangdu Hospital, Xi'an, China.

Abstract
BACKGROUND:

Safe nucleos(t)ide analogue discontinuation in chronic hepatitis B (CHB) is an unmet need. We aimed to investigate whether combining HBV RNA and hepatitis B core-related antigen (HBcrAg) could perform satisfactorily in predicting off-treatment outcomes.
METHODS:

The evaluation cohort included 127 HBeAg-positive patients from a multi-centre prospective trial who stopped telbivudine-based therapy after achieving HBeAg seroconversion and HBV DNA<50 IU/mL for >48 weeks. As validation, 59 patients treated with entecavir or tenofovir before discontinuation were analysed.
RESULTS:

At the end of treatment (EOT), HBV RNA and HBcrAg were significant independent predictors of the clinical relapse risk. In the evaluation cohort, no clinical relapse occurred among patients with negative HBV RNA and HBcrAg <4 log10 U/mL at EOT (low-risk group), whereas 46.8% patients with positive HBV RNA and HBcrAg ≥4 log10 U/mL (high-risk group) experienced clinical relapse during 4-year post-treatment follow-up (P <0.001); the corresponding incidences in the validation cohort were 0% and 69.4% (P <0.001), respectively. More patients in the low-risk group achieved HBsAg loss than the other patients after treatment cessation (16.1% vs. 1.3%, P =0.002).
CONCLUSION:

Combining HBV RNA and HBcrAg performed satisfactorily in predicting clinical relapse and HBsAg loss after treatment cessation in HBeAg-positive CHB patients.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].
KEYWORDS:

HBsAg loss; biomarker; clinical relapse; discontinuation

PMID:
    32211776
DOI:
    10.1093/infdis/jiaa136

StephenW

感染杂志2020年3月25日。pii：jiaa136。 doi：10.1093 / infdis / jiaa136。 [Epub提前发行]
结合HBV RNA和乙型肝炎核心相关抗原：安全停止HBeAg阳性慢性乙型肝炎患者的核苷酸类似物的指南。
范R1，彭J1，谢Q2，谭D3，徐M4，牛J5，王H6，任H7，陈X8，王M9，盛J10，唐H11，白X12，吴Y1，周B1，孙J1，侯J1 ;慢性乙型肝炎研究联盟。
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
    上海交通大学医学院附属瑞金医院传染病科，上海
3
    中南大学湘雅医院传染病科，长沙
4
    广州市第八人民医院
5
    吉林大学附属第一医院肝病科，长春
6
    北京大学人民医院肝病科，北京。
7
    重庆医科大学附属第二医院感染科
8
    中国北京北京市佑安医院。
9
    南京市第八十一医院传染病科
10
    浙江大学第一附属医院传染病科，杭州。
11
    中国成都市华西医院感染科。
12
    西安市塘都医院传染病科。

抽象
背景：

慢性乙型肝炎（CHB）中安全的核苷酸（t）ide类似物停用尚待满足。我们旨在研究结合HBV RNA和乙型肝炎核心相关抗原（HBcrAg）是否可以令人满意地预测非治疗结果。
方法：

该评估队列包括来自一项多中心前瞻性试验的127名HBeAg阳性患者，这些患者在达到HBeAg血清转化和HBV DNA <50 IU / mL> 48周后停止了基于替比夫定的治疗。作为确认，分析了停药前用恩替卡韦或替诺福韦治疗的59例患者。
结果：

在治疗结束（EOT）时，HBV RNA和HBcrAg是临床复发风险的重要独立预测因子。在评估队列中，EOT时HBV RNA阴性且HBcrAg <4 log10 U / mL的患者（低危组）未发生临床复发，而HBV RNA阳性且HBcrAg≥4log10 U / mL的患者中有46.8％（高危） -高风险组）在治疗后4年的随访期间经历了临床复发（P <0.001）；验证队列中的相应发生率分别为0％和69.4％（P <0.001）。低风险组中HBsAg丢失的患者比停止治疗后的其他患者多（16.1％比1.3％，P = 0.002）。
结论：

HBV RNA和HBcrAg的结合在预测HBeAg阳性CHB患者停止治疗后的临床复发和HBsAg丢失方面令人满意。

©2020作者。牛津大学出版社，美国传染病学会出版。版权所有。有关权限，请发送电子邮件至：[email protected]。
关键字：

HBsAg丢失；生物标志物临床复发；停产

PMID：
    32211776
DOI：
    10.1093 / infdis / jiaa136