Author information

¹Center for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T.H. Chan School of Public Health, United States.

²Division of Gastroenterology, University of California San Francisco School of Medicine, United States.

³Department of Medicine, Feinberg School of Medicine, Northwestern University, United States.

⁴Department of Infectious Diseases, The University of Melbourne, Australia.

⁵Victorian Infectious Diseases Service, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Australia.

⁶Department of Infectious Diseases, Alfred Health and Monash University, Australia.

⁷Division of Infectious Diseases, Johns Hopkins University School of Medicine, United States.

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.