Peters, Marion G;
Yuen, Man-Fung;
Terrault, Norah;
Fry, John;
Lampertico, Pietro;
Gane, Ed;
Hwang, Carey;
... Lenz, Oliver; + view all
(2023)
Chronic Hepatitis B Finite Treatment: similar and different concerns with new drug classes.
Clinical Infectious Diseases
, Article ciad506. 10.1093/cid/ciad506.
(In press).
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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.
| Type: | Article |
|---|---|
| Title: | Chronic Hepatitis B Finite Treatment: similar and different concerns with new drug classes |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/cid/ciad506 |
| Publisher version: | https://doi.org/10.1093/cid/ciad506 |
| Language: | English |
| Additional information: | © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/). |
| Keywords: | Chronic hepatitis B, Functional cure, HBV biomarkers, New combination therapy, Stopping finite therapy |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10177202 |
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