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Article: Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV/HDV treatment endpoints conference
Title | Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV/HDV treatment endpoints conference |
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Authors | |
Issue Date | 21-Jun-2023 |
Publisher | Elsevier |
Citation | Journal of Hepatology, 2023 How to Cite? |
Abstract | Representatives from academia, industry, regulatory agencies, and patient advocacy groups convened under AASLD and EASL in June 2022 with the primary goal of achieving consensus on chronic hepatitis B virus (HBV) and hepatitis delta virus (HDV) (HDV) treatment endpoints to guide clinical trials aiming to "cure" HBV and HDV. Conference participants reached agreement on some key points. The preferred primary endpoint for phase II/III trials evaluating finite treatments for chronic hepatitis B (CHB) is "functional" cure, defined as sustained HBsAg loss and HBV DNA less than lower limit of quantification (LLOQ) 24 weeks off-treatment. An alternate endpoint would be "partial cure" defined as sustained HBsAg level <100 IU/mL and HBV DNA |
Persistent Identifier | http://hdl.handle.net/10722/331684 |
ISSN | 2023 Impact Factor: 26.8 2023 SCImago Journal Rankings: 9.857 |
DC Field | Value | Language |
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dc.contributor.author | Ghany, MG | - |
dc.contributor.author | Buti, M | - |
dc.contributor.author | Lampertico, P | - |
dc.contributor.author | Lee, HM | - |
dc.contributor.author | Yuen, Richard Man Fung | - |
dc.contributor.author | 2022 AASLD-EASL HBV-HDV Treatment Endpoints Conference Faculty | - |
dc.date.accessioned | 2023-09-21T06:57:59Z | - |
dc.date.available | 2023-09-21T06:57:59Z | - |
dc.date.issued | 2023-06-21 | - |
dc.identifier.citation | Journal of Hepatology, 2023 | - |
dc.identifier.issn | 0168-8278 | - |
dc.identifier.uri | http://hdl.handle.net/10722/331684 | - |
dc.description.abstract | <p>Representatives from academia, industry, regulatory agencies, and patient advocacy groups convened under AASLD and EASL in June 2022 with the primary goal of achieving consensus on chronic hepatitis B virus (HBV) and hepatitis delta virus (HDV) (HDV) treatment endpoints to guide clinical trials aiming to "cure" HBV and HDV. Conference participants reached agreement on some key points. The preferred primary endpoint for phase II/III trials evaluating finite treatments for chronic hepatitis B (CHB) is "functional" cure, defined as sustained HBsAg loss and HBV DNA less than lower limit of quantification (LLOQ) 24 weeks off-treatment. An alternate endpoint would be "partial cure" defined as sustained HBsAg level <100 IU/mL and HBV DNA </p> | - |
dc.language | eng | - |
dc.publisher | Elsevier | - |
dc.relation.ispartof | Journal of Hepatology | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.title | Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV/HDV treatment endpoints conference | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jhep.2023.06.002 | - |
dc.identifier.issnl | 0168-8278 | - |