机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China[2]Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou, China[3]Department of Infectious Diseases,Huashan Hospital, Fudan University, Shanghai, China[4]Department of Infectious Diseases, The Second Xiangya Hospital ofCentral South University, Changsha, China[5]Department of Infectious Diseases, The First Affiliated Hospital of Harbin MedicalUniversity, Harbin, China[6]International Medical Department, Beijing YouAn Hospital, Capital Medical University, Beijing, China[7]Department of Infectious Diseases, The First Affiliated Hospital of Guangxi Medical University, Nanning, China[8]Department ofInfectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China[9]Department of InfectiousDiseases, Shengjing Hospital of China Medical University, Shenyang, China中国医科大学附属盛京医院[10]Department of Infectious Diseases, TangduHospital, Fourth Military Medical University, Xi’an, China[11]Department of Infectious Diseases, General Hospital of NingxiaMedical University, Yinchuan, China[12]Department of Infectious Diseases, Shenzhen Third People’s Hospital, Shenzhen, China深圳市康宁医院深圳医学信息中心[13]Department of Infectious Diseases, Xiangya Hospital Central South University, Changsha, China[14]Liver Disease Department,The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, China[15]Liver Disease Department, GuangdongHospital of Traditional Chinese Medicine, Guangzhou, China[16]Center of Infectious Diseases, West China Hospital, SichuanUniversity, Chengdu, China四川大学华西医院[17]Liver Disease Department, The Sixth People’s Hospital of Hangzhou, Zhejiang, China[18]LiverDisease Department, Beijing Ditan Hospital, Capital Medical University, Beijing, China[19]Department of Infectious Diseases,Guangdong General Hospital, Guangzhou, China广东省人民医院[20]Center of Liver Diseases, The First Affiliated Hospital of Fujian MedicalUniversity, Fuzhou, China[21]International Center for Liver Disease Treatment, 302 Hospital of PLA, Beijing, China[22]Departmentof Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China[23]Department ofInfectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China中山大学附属第三医院[24]Hepatology Unit, GuangzhouEighth People’s Hospital, Guangzhou, China[25]Hepatology Unit, Ruian People’s Hospital, Zhejiang, China
Background and Aims: 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 <1500 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. Conclusions: 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.
基金：
National Science and Technology Major Project of China [2008ZX10002-006, 2012ZX10002007001, 2017ZX10202203-007, 2017ZX10202203-008]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China [81171561, 30972584]; Shanghai Roche Pharmaceuticals Ltd.; F Hoffmann-La RocheHoffmann-La Roche
第一作者机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China[*1]Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
推荐引用方式(GB/T 7714)：
Peng Hu,Jia Shang,Wenhong Zhang,et al.HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study[J].JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY.2018,6(1):25-34.doi:10.14218/JCTH.2017.00072.
APA：
Peng Hu,Jia Shang,Wenhong Zhang,Guozhong Gong,Yongguo Li...&Hong Ren.(2018).HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study.JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY,6,(1)
MLA：
Peng Hu,et al."HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study".JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY 6..1(2018):25-34
