Περίληψη:
Representatives from academia, industry, regulatory agencies, and
patient groups convened in March 2019 with the primary goal of
developing agreement on chronic 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-naive 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. (C)
2019 European Association for the Study of the Liver and American
Association for the Study of Liver Diseases. Published by Elsevier B.V.
All rights reserved.
Συγγραφείς:
Cornberg, Markus
Lok, Anna Suk-Fong
Terrault, Norah A. and
Zoulim, Fabien
Berg, Thomas
Brunetto, Maurizia R.
Buchholz,
Stephanie
Buti, Maria
Chan, Henry L. Y.
Chang, Kyong-Mi and
Dandri, Maura
Dusheiko, Geoffrey
Feld, Jordan J.
Ferrari,
Carlo
Ghany, Marc
Janssen, Harry L. A.
Kennedy, Patrick and
Lampertico, Pietro
Liang, Jake
Locarnini, Stephen
Maini,
Mala K.
Mishra, Poonam
Papatheodoridis, George
Petersen,
Joerg
Schlottmann, Silke
Wang, Su
Wedemeyer, Heiner
EASL
AASLD HBV Treatment
