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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Guidance for Design and Endpoints of Clinical Trials in Chronic Hepatitis B—Report From the 2019 EASL-AASLD HBV Treatment Endpoints Conference
Hepatology, Volume 71, No. 3, Year 2020
Notification
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Description
Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic hepatitis B virus (HBV) treatment endpoints to guide clinical trials aiming to “cure” HBV. Agreement among the conference participants was reached on some key points. “Functional” but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV “functional cure”, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. © 2020 by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver.
Authors & Co-Authors
Cornberg, Markus
Germany, Hannover
Hannover Medical School
Lok, Anna Suk Fong
United States, Ann Arbor
University of Michigan, Ann Arbor
Terrault, Norah A.
United States, Los Angeles
University of Southern California
Zoulim, Fabien
France, Lyon
Chu de Lyon
France, Lyon
Université de Lyon
Berg, Thomas
Unknown Affiliation
Brunetto, M. R.
Unknown Affiliation
Butí, María Asunción
Unknown Affiliation
Chan, Henry Lik Yuen
Unknown Affiliation
Chang, Kyongmi
Unknown Affiliation
Dandri, Maura
Unknown Affiliation
Dusheiko, Geoffrey M.
Unknown Affiliation
Feld, Jordan J.
Unknown Affiliation
Ferrari, Carlo C.
Unknown Affiliation
Janssen, Harry L.A.
Unknown Affiliation
Kennedy, Patrick T.F.
Unknown Affiliation
Lampertico, Pietro
Unknown Affiliation
Locarnini, Stephen A.
Unknown Affiliation
Maini, Mala K.
Unknown Affiliation
Papatheodoridis, George V.
Unknown Affiliation
Wedemeyer, Heiner H.
Unknown Affiliation
Afdhal, Nezam H.
Unknown Affiliation
Beumont-Mauviel, Maria
Unknown Affiliation
Cloherty, Gavin A.
Unknown Affiliation
Donaldson, Eric F.
Unknown Affiliation
Gaggar, Anuj
Unknown Affiliation
Miller, Veronica
Unknown Affiliation
Picchio, Gastón Rafael
Unknown Affiliation
Revill, Peter A.
Unknown Affiliation
Wang, Su
Unknown Affiliation
Statistics
Citations: 50
Authors: 29
Affiliations: 5
Identifiers
Doi:
10.1002/hep.31030
ISSN:
02709139
Research Areas
Genetics And Genomics
Health System And Policy
Infectious Diseases