Author information

¹Department of Medicine, Northwestern University, Chicago, IL, USA.

²Department of Medicine, School of Clinical Medicine & State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong, China.

³Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

⁴Clinical Development Consultant, San Francisco, CA, USA.

⁵Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; and CRC "A. M. and A. Migliavacca" Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.

⁶University of Auckland, Auckland, New Zealand.

⁷Vir Biotechnology, Inc., San Francisco, CA, USA.

⁸Assembly Biosciences, Inc., South San Francisco, CA, USA.

⁹Forum for Collaborative Research, University of California, Berkeley School of Public Health, Washington DC Campus, Washington, DC, USA.

¹⁰Institute of Immunity and Transplantation, University College London, London, United Kingdom.

¹¹Gilead Sciences, Inc., Warren, NJ, USA.

¹²Janssen Pharmaceutica, Issy les Moulineaux, France.

¹³Leipzig University Medical Center, Leipzig, Germany.

¹⁴Cooperman Barnabas Medical Center, RWJBarnabas-Rutgers Medical Group, Livingston, NJ, USA.

¹⁵Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

¹⁶Department 32 Infectiology, Dermatology and Allergology, Federal Institute for Drugs and Medical Devices, Germany.

¹⁷Janssen Pharmaceutica, Beerse, Belgium.

Abstract

Chronic hepatitis B, a major cause of liver disease and cancer, affects over 250 million people worldwide. Currently there is no cure, only suppressive therapies. Efforts to develop finite curative HBV therapies are underway, consisting of combinations of multiple novel agents +/- nucleos(t)ide reverse transcriptase inhibitors. The HBV Forum convened a webinar in July 2021, and subsequent working group discussions to address how and when to stop finite therapy for demonstration of sustained off-treatment efficacy and safety responses. Participants included leading experts in academia, clinical practice, pharmaceutical companies, patient representatives and regulatory agencies. This Viewpoint outlines areas of consensus within our multi-stakeholder group for stopping finite therapies in chronic Hepatitis B investigational studies, including trial design, patient selection, outcomes, biomarkers, pre-defined stopping criteria, pre-defined retreatment criteria, duration of investigational therapies, and follow up after stopping therapy. Future research of unmet needs are discussed.