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- Title
Chronic Hepatitis B Finite Treatment: Similar and Different Concerns With New Drug Classes.
- Authors
Peters, Marion G; Yuen, Man-Fung; Terrault, Norah; Fry, John; Lampertico, Pietro; Gane, Ed; Hwang, Carey; Stamm, Luisa M; Leus, Mitchell; Maini, Mala K; Mendez, Patricia; Lonjon-Domanec, Isabelle; Berg, Thomas; Wang, Su; Mishra, Poonam; Donaldson, Eric; Buchholz, Stephanie; Miller, Veronica; Lenz, Oliver
- 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.
- Subjects
COMBINATION drug therapy; PATIENT selection; CHRONIC hepatitis B; DNA; TREATMENT effectiveness; ANTIGENS; ANTIVIRAL agents; MACHINE learning; DISEASE relapse; NUCLEOSIDE reverse transcriptase inhibitors; BIOMARKERS; PATIENT aftercare
- Publication
Clinical Infectious Diseases, 2024, Vol 78, Issue 4, p983
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciad506