Chen Xinyue, Mao Qianguo, Xie Yao, Dou Xiaoguang, Xie Qing, Sheng Jifang, Gao Zhiliang, Zhou Xiaoling, Liu Yingxia, Zheng Huanwei, Zhang Shuqin, Li Shibo, Zhu Fusheng, Xu Yuqin, Zhang Mingxiang, Hu Yaoren, Chen Xiaoping, Huang Yan, Ren Hong, Jia Jidong
International Medicine Ward, Beijing YouAn Hospital, Capital Medical University, Beijing, China.
Department of Infectious Diseases, Xiamen Hospital of Traditional Chinese Medicine, Xiamen, Fujian, China.
J Clin Transl Hepatol. 2019 Sep 28;7(3):249-257. doi: 10.14218/JCTH.2019.00016. Epub 2019 Aug 20.
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. 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. 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%. 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. ClinicalTrials.gov (NCT01730508).
在中国慢性乙型肝炎病毒（HBV）感染（CHB）患者中，聚乙二醇化干扰素α-2a（peg-IFNα）使用的数据有限。我们评估了peg-IFNα在中国乙肝e抗原阴性CHB患者常规临床实践中的有效性和安全性。在这项前瞻性、多中心、观察性、非干预性队列研究中，患者在停止peg-IFNα治疗后接受长达1年的评估。治疗医生根据中国临床实践确定给药剂量和治疗持续时间。peg-IFNα治疗的有效性通过以下百分比衡量：HBV DNA<2000 IU/mL且乙肝表面抗原丢失（俗称HBsAg）的患者；治疗结束时（EOT）、治疗后6个月和1年时的HBV DNA水平；以及定量HBV DNA和HBsAg的时间进程变化。在EOT、治疗后6个月和治疗后1年时，HBV DNA<2000 IU/mL的患者百分比分别为90.0%、81.8%和82.2%，HBsAg丢失的患者百分比分别为6.5%、9.4%和9.5%。HBV DNA水平从基线时的5.61 log IU/mL降至EOT时的2.48 log IU/mL和治疗后1年时的2.67 log IU/mL。HBsAg水平从基线时的3.08 log IU/mL降至EOT时的2.24 log IU/mL和治疗后1年时的2.10 log IU/mL。不良事件发生率为52.0%。Peg-IFNα有可能为CHB提供功能性治愈（HBsAg丢失），并且在中国常规临床实践中，乙肝e抗原阴性CHB患者对其耐受性良好。ClinicalTrials.gov（NCT01730508）。
