聚乙二醇干扰素α-2a治疗的中国HBeAg阴性慢性乙型肝炎患者的

StephenW

J Clin Transl Hepatol. 2019 Sep 28;7(3):249-257. doi: 10.14218/JCTH.2019.00016. Epub 2019 Aug 20.
A Potential Functional Cure in Chinese HBeAg-negative Chronic Hepatitis B Patients Treated with Peg-interferon Alpha-2a.
Chen X1, Mao Q2, Xie Y3, Dou X4, Xie Q5, Sheng J6, Gao Z7, Zhou X8, Liu Y9, Zheng H10, Zhang S11, Li S12, Zhu F13, Xu Y14, Zhang M15, Hu Y16, Chen X17, Huang Y18, Ren H19, Jia J20.
Author information

1
    International Medicine Ward, Beijing YouAn Hospital, Capital Medical University, Beijing, China.
2
    Department of Infectious Diseases, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, Fujian, China.
3
    Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
4
    Department of Infectious Diseases, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
5
    Department of Infectious Diseases, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
6
    Department of Infectious Diseases, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China.
7
    Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
8
    Department of Gastroenterology, Liuzhou Traditional Chinese Medical Hospital, Liuzhou, Guangxi, China.
9
    Department of Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong, China.
10
    Department of Infectious Diseases, The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China.
11
    Department of Infectious Diseases, Hepatology Hospital of Jilin Province, Changchun, Jilin, China.
12
    Department of Infectious Diseases, Zhoushan Hospital of Zhejiang Province, Zhoushan, Zhejiang, China.
13
    Department of Infectious Diseases, General Hospital of Dagang Oilfield, Tianjin, China.
14
    Department of Infectious Diseases, The 211 Hospital of People's Liberation Army, Harbin, Heilongjiang, China.
15
    Department of Integrated Traditional and Western Medicine on Liver Diseases, The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, China.
16
    Department of Liver Disease, Ningbo No. 2 Hospital of Zhejiang Province, Ningbo, Zhejiang, China.
17
    Department of Infectious Diseases, Guangdong General Hospital, Guangzhou, Guangdong, China.
18
    Department of Medical Science, Shanghai Roche Pharmaceuticals Ltd., Shanghai, China.
19
    Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
20
    Department of Liver Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

Abstract

Background and Aims: Data are limited on the use of pegylated-interferon alpha-2a (peg-IFNα) in Chinese patients with chronic hepatitis B virus (HBV) infection (CHB). We evaluated the effectiveness and safety of peg-IFNα in Chinese patients with hepatitis B envelope antigen-negative CHB in routine clinical practice. Methods: In this prospective, multicenter, observational, non-interventional cohort study, patients were assessed for up to 1 year after peg-IFNα treatment cessation. Treating physicians established the dosing and treatment duration according to Chinese clinical practice. Effectiveness of peg-IFNα treatment was measured by the percentage of: patients with HBV DNA <2000 IU/mL and loss of hepatitis B surface antigen (commonly known as HBsAg); HBV DNA level at end of treatment (EOT), and 6 months and 1 year posttreatment; and time course change in quantitative HBV DNA and HBsAg. Results: At EOT, 6 months posttreatment, and 1 year posttreatment, the percentage of patients with HBV DNA <2000 IU/mL was 90.0%, 81.8%, and 82.2%, and that of patients with HBsAg loss was 6.5%, 9.4%, and 9.5%, respectively. The HBV DNA level decreased from 5.61 log IU/mL at baseline to 2.48 log IU/mL at EOT and 2.67 log IU/mL at 1 year posttreatment. The HBsAg level decreased from 3.08 log IU/mL at baseline to 2.24 log IU/mL at EOT and 2.10 log IU/mL at 1 year posttreatment. The incidence of adverse events was 52.0%. Conclusions: Peg-IFNα has the potential to provide functional cure (HBsAg loss) for CHB and is well tolerated in hepatitis B envelope antigen-negative CHB patients in routine clinical practice in China. Clinical Trial Registration: ClinicalTrials.gov (NCT01730508).

© 2019 Authors.
KEYWORDS:

Chronic hepatitis B; Interferon alpha; Observational study; Prospective studies

PMID:
    31608217
PMCID:
    PMC6783682
DOI:
    10.14218/JCTH.2019.00016

StephenW

J临床翻译肝素。 2019年9月28日; 7（3）：249-257。 doi：10.14218 / JCTH.2019.00016。 Epub 2019八月20。
聚乙二醇干扰素α-2a治疗的中国HBeAg阴性慢性乙型肝炎患者的潜在功能性治疗。
陈X1，毛Q2，谢Y3，窦X4，谢Q5，盛J6，高Z7，周X8，刘Y9，郑H10，张S11，李S12，朱F13，徐Y14，张M15，胡Y16，陈X17 ，黄Y18，任H19，贾J20。
作者信息

1个
    首都医科大学附属北京佑安医院国际病区，中国北京
2
    厦门市中医院传染病科，福建厦门
3
    首都医科大学附属北京地坛医院肝病科，北京
4
    中国医科大学附属盛京医院传染病科，辽宁沉阳。
5
    上海交通大学医学院附属瑞金医院传染病科，上海
6
    浙江大学附属第一医院感染科，浙江杭州
7
    中山大学附属第三医院感染科，广东广州
8
    柳州市中医院消化内科，广西柳州。
9
    深圳市第三人民医院传染病科，广东深圳。
10
    石家庄市第五医院传染病科，河北石家庄。
11
    吉林省肝病医院传染病科，吉林长春
12
    浙江省舟山市医院传染病科，浙江舟山。
13
    天津市大港油田总医院传染病科。
14
    解放军第二十一医院传染病科，黑龙江哈尔滨
15
    沉阳市第六人民医院肝病中西医结合科，辽宁沉阳。
16
    浙江省宁波市第二医院肝病科，浙江宁波。
17
    广东省广州市总医院传染病科。
18岁
    上海罗氏制药有限公司医学部，上海。
19
    重庆医科大学附属第二医院感染科，重庆。
20
    首都医科大学附属北京友谊医院肝病科，北京

抽象

背景与目的：在中国慢性乙型肝炎病毒（HBV）感染患者中使用聚乙二醇干扰素α-2a（peg-IFNα）的数据有限。在常规临床实践中，我们评估了peg-IFNα在中国乙型肝炎包膜抗原阴性CHB患者中的有效性和安全性。方法：在这项前瞻性，多中心，观察性，非干预性队列研究中，对peg-IFNα治疗停止后长达1年的患者进行了评估。治疗医生根据中国临床实践确定给药和治疗时间。通过以下百分比衡量peg-IFNα治疗的有效性：HBV DNA <2000 IU / mL且乙肝表面抗原（通常称为HBsAg）丢失的患者；治疗结束（EOT）以及治疗后6个月和1年的HBV DNA水平； HBV DNA和HBsAg定量的时间变化。结果：在EOT时，治疗后6个月和治疗后1年，HBV DNA <2000 IU / mL的患者比例分别为90.0％，81.8％和82.2％，HBsAg丢失的患者比例分别为6.5％，9.4％和9.5％。 HBV DNA水平从基线时的5.61 log IU / mL降至治疗后1年时的EOT的2.48 log IU / mL和2.67 log IU / mL。 HBsAg水平从基线时的3.08 log IU / mL降至治疗后1年的EOT的2.24 log IU / mL和治疗后1年的2.10 log IU / mL。不良事件发生率为52.0％。结论：在中国的常规临床实践中，Peg-IFNα可能为CHB提供功能性治疗（HBsAg丧失），并且在乙型肝炎包膜抗原阴性的CHB患者中具有良好的耐受性。临床试验注册：ClinicalTrials.gov（NCT01730508）。

©2019作者。
关键字：

慢性乙型肝炎；干扰素观察研究；前瞻性研究

PMID：
    31608217
PMCID：
    PMC6783682
DOI：
    10.14218 / JCTH.2019.00016