Chronic Hepatitis B Finite Treatment: Similar and Different Concerns With New Drug Classes

Author:

Peters Marion G1ORCID,Yuen Man-Fung2,Terrault Norah3,Fry John4,Lampertico Pietro56,Gane Ed7,Hwang Carey8,Stamm Luisa M9,Leus Mitchell10,Maini Mala K11,Mendez Patricia12,Lonjon-Domanec Isabelle13,Berg Thomas14,Wang Su15,Mishra Poonam16,Donaldson Eric16,Buchholz Stephanie17,Miller Veronica10,Lenz Oliver18

Affiliation:

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

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

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

4. Aligos Therapeutics, Clinical Development Consultant , San Francisco, California , USA

5. Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico , Milan , Italy

6. Department of Pathophysiology and Transplantation, CRC “A. M. and A. Migliavacca” Center for Liver Disease, University of Milan , Milan , Italy

7. Department of Medicine, University of Auckland , Auckland , New Zealand

8. Vir Biotechnology,   San Francisco, California , USA

9. Assembly Biosciences,   South San Francisco, California , USA

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

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

12. Gilead Sciences,   Warren, New Jersey , USA

13. Janssen Pharmaceutica , Issy les Moulineaux , France

14. Department of Medicine, Leipzig University Medical Center , Leipzig , Germany

15. Cooperman Barnabas Medical Center, RWJBarnabas-Rutgers Medical Group , Livingston, New Jersey , USA

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

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

18. Janssen Pharmaceutica , Beerse , Belgium

Abstract

Abstract Chronic hepatitis B, a major cause of liver disease and cancer, affects >250 million people worldwide. Currently there is no cure, only suppressive therapies. Efforts to develop finite curative hepatitis B virus (HBV) therapies are underway, consisting of combinations of multiple novel agents with or without nucleos(t)ide reverse-transcriptase inhibitors. The HBV Forum convened a webinar in July 2021, along with 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 Viewpoints article outlines areas of consensus within our multistakeholder group for stopping finite therapies in chronic hepatitis B investigational studies, including trial design, patient selection, outcomes, biomarkers, predefined stopping criteria, predefined retreatment criteria, duration of investigational therapies, and follow-up after stopping therapy. Future research of unmet needs are discussed.

Funder

Abbott

Gilead Sciences

GlaxoSmithKline

Roche

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Reference40 articles.

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4. Probability of HBsAg loss after nucleo(s)tide analogue withdrawal depends on HBV genotype and viral antigen levels;Sonneveld;J Hepatol,2022

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