Kang Minhee, Price Jennifer C, Peters Marion G, Lewin Sharon R, Sulkowski Mark
Center for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T.H. Chan School of Public Health, United States.
Division of Gastroenterology, University of California San Francisco School of Medicine, United States.
J Virus Erad. 2023 Aug 24;9(3):100344. doi: 10.1016/j.jve.2023.100344. eCollection 2023 Sep.
With growing interest and efforts to achieve a hepatitis B (HBV) cure, HBV therapeutics have increasingly entered the clinical testing phase. In designing an early phase clinical trial aimed at HBV cure, the heterogeneity in participants and the choice of a biomarker endpoint that signals a cure requires careful consideration. We describe the key elements to consider during the development of HBV clinical trials aimed at a functional cure, and how we have addressed them in the design of a phase II AIDS Clinical Trials Group (ACTG) study, A5394 (NCT05551273). The trial we present is for persons with both HIV and HBV, a unique population that has much to gain from an HBV cure. Our decisions on the design elements are specific to the study agent and the targeted population, but our deliberations may be informative in the emerging field of early phase HBV trials aimed at cure.
随着人们对治愈乙型肝炎（HBV）的兴趣日益浓厚并付出更多努力，HBV治疗药物已越来越多地进入临床试验阶段。在设计旨在治愈HBV的早期临床试验时，参与者的异质性以及表明治愈的生物标志物终点的选择需要仔细考虑。我们描述了在开展旨在实现功能性治愈的HBV临床试验过程中需要考虑的关键因素，以及我们在艾滋病临床试验小组（ACTG）的一项II期研究A5394（NCT05551273）的设计中是如何解决这些问题的。我们介绍的这项试验针对的是同时感染HIV和HBV的人群，这是一个独特的群体，有望从HBV治愈中获得诸多益处。我们在设计要素上的决策是针对研究药物和目标人群的，但我们的思考可能会为新兴的旨在治愈HBV的早期试验领域提供参考。
