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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 |
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