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Randomized Controlled Trial

. 2018 Oct 20;26(10):756-764.

doi: 10.3760/cma.j.issn.1007-3418.2018.10.005.

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

[Article in Chinese]

P Hu¹, J Shang², W H Zhang³, G Z Gong⁴, Y G Li⁵, X Y Chen⁶, J N Jiang⁷, Q Xie⁸, X G Dou⁹, Y T Sun¹⁰, Y F Li¹¹, Y X Liu¹², G Z Liu¹³, D W Ma¹⁴, X L Chi¹⁵, H Tang¹⁶, X O Li¹⁷, Y Xie¹⁸, X P Chen¹⁹, J J Jiang²⁰, P Zha²¹, J L Hou²², Z L Gao²³, H M Fan²⁴, J G Ding²⁵, D Z Zhang¹, H Ren¹

Affiliations

Affiliations

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.

PMID: 30481882
DOI: 10.3760/cma.j.issn.1007-3418.2018.10.005

Randomized Controlled Trial

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

[Article in Chinese]

P Hu et al. Zhonghua Gan Zang Bing Za Zhi. 2018.

. 2018 Oct 20;26(10):756-764.

doi: 10.3760/cma.j.issn.1007-3418.2018.10.005.

Authors

P Hu¹, J Shang², W H Zhang³, G Z Gong⁴, Y G Li⁵, X Y Chen⁶, J N Jiang⁷, Q Xie⁸, X G Dou⁹, Y T Sun¹⁰, Y F Li¹¹, Y X Liu¹², G Z Liu¹³, D W Ma¹⁴, X L Chi¹⁵, H Tang¹⁶, X O Li¹⁷, Y Xie¹⁸, X P Chen¹⁹, J J Jiang²⁰, P Zha²¹, J L Hou²², Z L Gao²³, H M Fan²⁴, J G Ding²⁵, D Z Zhang¹, H Ren¹

Affiliations

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.

PMID: 30481882
DOI: 10.3760/cma.j.issn.1007-3418.2018.10.005

Abstract
in English, Chinese

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.

目的： 慢性乙型肝炎患者用核苷（酸）类似物（NAs）治疗很少能实现HBsAg消失，但通过序贯聚乙二醇干扰素（Peg-IFN）α-2a治疗可能改善。对接受NAs治疗出现部分应答的慢性乙型肝炎患者进行了48周和96周的Peg-IFNα-2a治疗，评估其HBsAg清除的情况。 方法： 将接受阿德福韦、拉米夫定或恩替卡韦治疗并出现HBeAg消失且HBV DNA < 200 IU/ml的既往HBeAg阳性患者，按1∶1的比例随机分配到2个治疗组，分别接受48周（n = 153）或96周（n = 150）的Peg-IFNα-2a治疗。研究主要终点为治疗结束时的HBsAg清除率。 结果： 在第48周和第96周治疗结束时，NAs治疗序贯Peg-IFNα-2a治疗的患者分别有14.4%（22/153）和20.7%（31/150）获得HBsAg清除。不论既往NAs治疗种类或基线是否获得HBeAg血清学转换，其清除率比较，差异无统计学意义（P > 0.05）。在第48周和第96周治疗结束时HBsAg清除的患者中，分别有77.8%（14/18）和71.4%（20/28）的患者在治疗结束后48周仍维持HBsAg清除。基线HBsAg < 1 500 IU/ml和第24周HBsAg < 200 IU/ml，与治疗第48周和第96周的高HBsAg清除率相关（分别为51.4%和58.7%）。将治疗从48周延长至96周能使更多的患者（48.3%，14/29）获得HBsAg清除。 结论： 长期接受NAs治疗但难以实现治疗目标的患者通过Peg-IFNα-2a序贯治疗可获得较高的HBsAg清除率。将疗程从48周延长到96周可以提高部分患者的HBsAg清除率，尽管两组间差异无统计学意义。基线及治疗期间的HBsAg水平可能可以预测Peg-IFNα-2a治疗的HBsAg清除。.

Keywords: Antiviral therapy; Hepatitis B, chronic; Nucleos(t)ide analog; Pegylated interferon.

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