HBsAg loss with Pegylated-interferon alfa-2a in hepatitis B patients with partial response to nucleos(t)-ide analog: new switch study

Peng HU; Jia Shang; Wenhong Zhang; Guozhong Gong; Yongguo LI; Xinyue Chen; Jianning Jiang; Qing Xie; Xiaoguang Dou; Yongtao Sun; Yufang LI; Yingxia Liu; Guozhen Liu; Dewen MA; Xiaoling Chi; Hong Tang; Xiaoou LI; Yao Xie; Xiaoping Chen; Jiaji Jiang; Ping Zha; Jinlin Hou; Zhiliang Gao; Huimin Fan; Jiguang Ding; Dazhi Zhang; Hong Ren

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HBsAg loss with Pegylated-interferon alfa-2a in hepatitis B patients with partial response to nucleos(t)-ide analog: new switch study

VernacularTitle: 核苷（酸）类似物治疗部分应答的乙型肝炎患者通过聚乙二醇干扰素α-2a治疗获得HBsAg消失：New Switch研究
Author: Peng HU ¹ ; Jia SHANG ² ; Wenhong ZHANG ³ ; Guozhong GONG ⁴ ; Yongguo LI ⁵ ; Xinyue CHEN ⁶ ; Jianning JIANG ⁷ ; Qing XIE ⁸ ; Xiaoguang DOU ⁹ ; Yongtao SUN ¹⁰ ; Yufang LI ¹¹ ; Yingxia LIU ¹² ; Guozhen LIU ¹³ ; Dewen MA ¹⁴ ; Xiaoling CHI ¹⁵ ; Hong TANG ¹⁶ ; Xiaoou LI ¹⁷ ; Yao XIE ¹⁸ ; Xiaoping CHEN ¹⁹ ; Jiaji JIANG ²⁰ ; Ping ZHA ²¹ ; Jinlin HOU ²² ; Zhiliang GAO ²³ ; Huimin FAN ²⁴ ; Jiguang DING ²⁵ ; Dazhi ZHANG ¹ ; Hong REN ¹
Author Information

1. Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
2. Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou 450003, China
3. Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China
4. Department of Infectious Diseases, the Second Xiangya Hospital of Central South University, Changsha 410011, China
5. Department of Infectious Diseases, the First Affiliated Hospital of Harbin Medical University, Harbin 150001, China
6. International Medical Department, Beijing YouAn Hospital, Capital Medical University, Beijing 100069, China
7. Department of Infectious Diseases, the First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China
8. Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
9. Department of Infectious Diseases, Shengjing Hospital of China Medical University, Shenyang 110004, China
10. Department of Infectious Diseases, Tangdu Hospital, Fourth Military Medical University, Xi’an 710032, China
11. Department of Infectious Diseases, General Hospital of Ningxia Medical University, Yinchuan 750004, China
12. Department of Infectious Diseases, Shenzhen Third People’s Hospital, Shenzhen 518035, China
13. Department of Infectious Diseases, Xiangya Hospital Central South University, Changsha 410008, China
14. Liver Disease Department, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530023, China
15. Liver Disease Department, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510120, China
16. Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu 610041, China
17. Liver Disease Department, The Sixth People’s Hospital of Hangzhou, Hangzhou 310007, China
18. Liver Disease Department, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
19. Department of Infectious Diseases, Guangdong General Hospital, Guangzhou 510010, China
20. Center of Liver Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, China
21. International Center for Liver Disease Treatment, 302 Hospital of PLA, Beijing 100039, China
22. Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
23. Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510630, China
24. Hepatology Unit, Guangzhou Eighth People’s Hospital, Guangzhou 510060, China
25. Hepatology Unit, Ruian People’s Hospital, Ruian 325200, China
Publication Type:Journal Article
Keywords: Hepatitis B, chronic; Pegylated interferon; Antiviral therapy; Nucleos(t)ide analog
From: Chinese Journal of Hepatology 2018;26(10):756-764
CountryChina
Language:Chinese
Abstract: Objective:Hepatitis B surface antigen (HBsAg) loss is seldom achieved with nucleos(t)ide analog (NA) therapy in chronic hepatitis B patients but may be enhanced by switching to finite pegylated-interferon (Peg-IFN) alfa-2a. We assessed HBsAg loss with 48- and 96-week Peg-IFN alfa-2a in chronic hepatitis B patients with partial response to a previous NA.
Methods:Hepatitis B e antigen (HBeAg)-positive patients who achieved HBeAg loss and hepatitis B virus DNA < 200 IU/mL with previous adefovir, lamivudine or entecavir treatment were randomized 1:1 to receive Peg-IFN alfa-2a for 48 (n = 153) or 96 weeks (n = 150). The primary endpoint of this study was HBsAg loss at end of treatment. The ClinicalTrials.gov identifier is NCT01464281.
Results:At the end of 48 and 96 weeks' treatment, 14.4% (22/153) and 20.7% (31/150) of patients, respectively, who switched from NA to Peg-IFN alfa-2a cleared HBsAg. Rates were similar irrespective of prior NA or baseline HBeAg seroconversion. Among those who cleared HBsAg by the end of 48 and 96 weeks' treatment, 77.8% (14/18) and 71.4% (20/28), respectively, sustained HBsAg loss for a further 48 weeks. Baseline HBsAg < 1 500 IU/mL and week 24 HBsAg < 200 IU/mL were associated with the highest rates of HBsAg loss at the end of both 48- and 96-week treatment (51.4% and 58.7%, respectively). Importantly, extending treatment from 48 to 96 weeks enabled 48.3% (14/29) more patients to achieve HBsAg loss.
Conclusion:Patients on long-term NA who are unlikely to meet therapeutic goals can achieve high rates of HBsAg loss by switching to Peg-IFN alfa-2a. HBsAg loss rates may be improved for some patients by extending treatment from 48 to 96 weeks, although the differences in our study cohort were not statistically significant. Baseline and on-treatment HBsAg may predict HBsAg loss with Peg-IFN alfa-2a.