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

Overview

Journal J Virus Erad

Date 2023 Sep 25

PMID 37744732

Authors

Minhee Kang

Jennifer C Price

Marion G Peters

Sharon R Lewin

Mark Sulkowski

Affiliations

Soon will be listed here.

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.

Citing Articles

Evaluating the Efficacy of Repurposed Antiretrovirals in Hepatitis B Virus Treatment: A Narrative Review of the Pros and Cons.

Ugbaja S, Omerigwe S, Ndlovu S, Ngcobo M, Gqaleni N Int J Mol Sci. 2025; 26(3).

PMID: 39940695 PMC: 11817041. DOI: 10.3390/ijms26030925.

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