Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
Department of Infectious Disease, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
BMJ Open. 2021 Oct 25;11(10):e049104. doi: 10.1136/bmjopen-2021-049104.
Combination antiviral therapy of nucleos(t)ide analogue (NA) and pegylated interferon alpha (peg-IFN alpha) decrease hepatitis B virus (HBV) surface antigen (HBsAg) levels to achieve functional cure and improve long-term prognosis in chronic hepatitis B patients. However, for hepatitis B-related liver fibrosis, studies on combination of these two medicines are limited. This study was designed to compare the efficacy between peg-IFN alpha combined with tenofovir (TDF) and TDF monotherapy for the clearance of HBsAg in NA-experienced patients with HBV-related liver fibrosis.
This study was designed to be a prospective, multicentre, open, randomised controlled study. A total of 272 patients with HBV-related liver fibrosis will be randomised into the combination therapy group or the monotherapy group at a 1:1 ratio. Participants in the combination group will receive subcutaneous injections of peg-IFN alpha 180 µg per week for 48 weeks combined with oral TDF 300 mg daily. Participants in the monotherapy group will receive 300 mg oral TDF daily alone. All participants will undergo long-term treatment with TDF and will be followed up at the outpatient department for 144 weeks after randomisation. Clinical symptoms, laboratory tests and examination indicators will be collected at each follow-up time point, and adverse events will be recorded. The primary endpoint is serological clearance rate of HBsAg at 48 weeks.
The ethics committee of the Third Affiliated Hospital at Sun Yat-sen University approved this study (Approval Number: (2020)02-183-01). The results of the study will be presented at relevant meetings and published in an appropriate journal after the completion of the trial and the analysis of the data.
NCT04640129.
核苷（酸）类似物（NA）和聚乙二醇干扰素α（peg-IFNα）联合抗病毒治疗可降低乙型肝炎病毒（HBV）表面抗原（HBsAg）水平，从而实现慢性乙型肝炎患者的功能性治愈并改善长期预后。然而，对于乙型肝炎相关肝纤维化，这两种药物联合使用的研究有限。本研究旨在比较聚乙二醇干扰素α联合替诺福韦（TDF）与 TDF 单药治疗用于清除 NA 治疗后 HBV 相关肝纤维化患者 HBsAg 的疗效。
本研究设计为前瞻性、多中心、开放、随机对照研究。共 272 例 HBV 相关肝纤维化患者将按 1:1 比例随机分为联合治疗组或单药治疗组。联合治疗组患者每周接受皮下注射聚乙二醇干扰素α 180μg，共 48 周，同时每日口服 TDF 300mg；单药治疗组患者每日单独口服 TDF 300mg。所有患者均接受 TDF 长期治疗，并在随机分组后 144 周在门诊进行随访。每次随访时收集临床症状、实验室检查和检查指标，并记录不良事件。主要终点为 48 周时 HBsAg 的血清学清除率。
中山大学附属第三医院伦理委员会批准了这项研究（批准号：（2020）02-183-01）。研究完成并对数据进行分析后，将在相关会议上介绍研究结果，并在适当的期刊上发表。
NCT04640129。
