Chronic Hepatitis B Finite Treatment: Similar and Different Concerns With New Drug Classes.
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| 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.
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| Authors | Marion G Peters, Man-Fung Yuen, Norah Terrault, John Fry, Pietro Lampertico, Ed Gane, Carey Hwang, Luisa M Stamm, Mitchell Leus, Mala K Maini, Patricia Mendez, Isabelle Lonjon-Domanec, Thomas Berg, Su Wang, Poonam Mishra, Eric Donaldson, Stephanie Buchholz, Veronica Miller, Oliver Lenz |
| Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 78 Issue 4 Pg. 983-990 (Apr 10 2024) ISSN: 1537-6591 [Electronic] United States |
| PMID | 37633256 (Publication Type: Journal Article) |
| Copyright | © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. |
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