Design and analysis considerations for early phase clinical trials in hepatitis B (HBV) cure research: the ACTG A5394 study in persons with both HIV and HBV

IF 3.5 4区医学 Q2 IMMUNOLOGY Journal of Virus Eradication Pub Date : 2023-09-01 DOI:10.1016/j.jve.2023.100344

Minhee Kang , Jennifer C. Price , Marion G. Peters , Sharon R. Lewin , Mark Sulkowski

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Abstract

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.

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乙型肝炎（HBV）治疗研究早期临床试验的设计和分析考虑因素：ACTG A5394在HIV和HBV感染者中的研究。

随着人们对乙型肝炎（HBV）治疗的兴趣和努力的增加，HBV治疗方法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，参与者的异质性和标志治愈的生物标志物终点的选择需要仔细考虑。我们描述了在开发旨在功能性治愈的HBV临床试验过程中需要考虑的关键因素，以及我们如何在设计II期艾滋病临床试验组（ACTG）研究A5394（NCT05551273）时解决这些问题。我们目前的试验是针对同时感染艾滋病毒和乙肝病毒的人，这是一个独特的人群，从乙肝病毒的治疗中可以获得很多好处。我们对设计元素的决定是针对研究试剂和目标人群的，但我们的讨论可能对旨在治愈的早期HBV试验这一新兴领域有参考价值。

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来源期刊

Journal of Virus Eradication Medicine-Public Health, Environmental and Occupational Health

CiteScore

6.10

自引率

1.80%

发文量

审稿时长

39 weeks

期刊介绍： The Journal of Virus Eradication aims to provide a specialist, open-access forum to publish work in the rapidly developing field of virus eradication. The Journal covers all human viruses, in the context of new therapeutic strategies, as well as societal eradication of viral infections with preventive interventions. The Journal is aimed at the international community involved in the prevention and management of viral infections. It provides an academic forum for the publication of original research into viral reservoirs, viral persistence and virus eradication and ultimately development of cures. The Journal not only publishes original research, but provides an opportunity for opinions, reviews, case studies and comments on the published literature. It focusses on evidence-based medicine as the major thrust in the successful management of viral infections.The Journal encompasses virological, immunological, epidemiological, modelling, pharmacological, pre-clinical and in vitro, as well as clinical, data including but not limited to drugs, immunotherapy and gene therapy. It is an important source of information on the development of vaccine programs and preventative measures aimed at virus eradication.