TY - JOUR
T1 - Chronic Hepatitis B Finite Treatment
T2 - Similar and Different Concerns With New Drug Classes
AU - HBV Forum Stopping Finite Therapy Working Group
AU - Peters, Marion G.
AU - Yuen, Man Fung
AU - Terrault, Norah
AU - Fry, John
AU - Lampertico, Pietro
AU - Gane, Ed
AU - Hwang, Carey
AU - Stamm, Luisa M.
AU - Leus, Mitchell
AU - Maini, Mala K.
AU - Mendez, Patricia
AU - Lonjon-Domanec, Isabelle
AU - Berg, Thomas
AU - Wang, Su
AU - Mishra, Poonam
AU - Donaldson, Eric
AU - Buchholz, Stephanie
AU - Miller, Veronica
AU - Lenz, Oliver
N1 - Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2024/4/15
Y1 - 2024/4/15
N2 - 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.
AB - 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.
KW - HBV biomarkers
KW - chronic hepatitis B
KW - functional cure
KW - new combination therapy
KW - stopping finite therapy
UR - http://www.scopus.com/inward/record.url?scp=85190526869&partnerID=8YFLogxK
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U2 - 10.1093/cid/ciad506
DO - 10.1093/cid/ciad506
M3 - Review article
C2 - 37633256
AN - SCOPUS:85190526869
SN - 1058-4838
VL - 78
SP - 983
EP - 990
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 4
ER -