J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.
HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study.Hu P1, Shang J2, Zhang W3, Gong G4, Li Y5, Chen X6, Jiang J7, Xie Q8, Dou X9, Sun Y10, Li Y11, Liu Y12, Liu G13, Mao D14, Chi X15, Tang H16, Li X17, Xie Y18, Chen X19, Jiang J20, Zhao P21, Hou J22, Gao Z23, Fan H24, Ding J25, Zhang D1, Ren H1. Author information 1Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.2Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, China.3Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.4Department of Infectious Diseases, The Second Xiangya Hospital of Central South University, Changsha, China.5Department of Infectious Diseases, The First Affiliated Hospital of Harbin Medical University, Harbin, China.6International Medical Department, Beijing YouAn Hospital, Capital Medical University, Beijing, China.7Department of Infectious Diseases, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.8Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.9Department of Infectious Diseases, Shengjing Hospital of China Medical University, Shenyang, China.10Department of Infectious Diseases, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.11Department of Infectious Diseases, General Hospital of Ningxia Medical University, Yinchuan, China.12Department of Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, China.13Department of Infectious Diseases, Xiangya Hospital Central South University, Changsha, China.14Liver Disease Department, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, China.15Liver Disease Department, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, China.16Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.17Liver Disease Department, The Sixth People's Hospital of Hangzhou, Zhejiang, China.18Liver Disease Department, Beijing Ditan Hospital, Capital Medical University, Beijing, China.19Department of Infectious Diseases, Guangdong General Hospital, Guangzhou, China.20Center of Liver Diseases, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.21International Center for Liver Disease Treatment, 302 Hospital of PLA, Beijing, China.22Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China.23Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.24Hepatology Unit, Guangzhou Eighth People's Hospital, Guangzhou, China.25Hepatology Unit, Ruian People's Hospital, Zhejiang, China.
AbstractBackground 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.