Application of EASL 2017 criteria for switching hepatitis B patients from tenofovir disoproxil to entecavir or tenofovir alafenamide.


Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
10 2020
Historique:
received: 08 04 2020
revised: 02 06 2020
accepted: 22 06 2020
pubmed: 25 7 2020
medline: 5 8 2021
entrez: 25 7 2020
Statut: ppublish

Résumé

To overcome safety limitations of tenofovir-disoproxil, EASL guidelines proposed switching chronic hepatitis B patients older than 60 years or with bone or renal disease to tenofovir-alafenamide or entecavir. To estimate the number of patients who would benefit from a treatment switch in a real-life setting. Consecutive hepatitis B patients receiving tenofovir-disoproxil before 31 December 2017 were enrolled in a cross-sectional study in two European hospitals. Clinical and virological data were recorded; renal function was assessed by estimated glomerular filtrate rate, serum phosphate and creatinine, proteinuria, and albuminuria; bone involvement by spine and femur DEXA scan. In total, 565 patients included: 62 (18-91) years, 75% males, 92% Caucasian, 92% HBeAg-negative, 40% cirrhotic. Fifty-five percent of patients fulfilled age criterion (>60 years). Older patients had higher rates of cirrhosis (51% vs 26%, p<0.001), cardiovascular disease, and renal impairment. Thirty-six percent of patients met renal criteria, more commonly NA-experienced individuals (35% vs 21%, p=0.001); 17% had bone disease. Overall, 66% of patients had at least one criterion (71% if NA-experienced), 8% all three criteria, 28% age and renal criteria. Approximately two-thirds of patients receiving long-term tenofovir-disoproxil are candidates for an entecavir or tenofovir-alafenamide switch according to EASL recommendations.

Sections du résumé

BACKGROUND
To overcome safety limitations of tenofovir-disoproxil, EASL guidelines proposed switching chronic hepatitis B patients older than 60 years or with bone or renal disease to tenofovir-alafenamide or entecavir.
AIMS
To estimate the number of patients who would benefit from a treatment switch in a real-life setting.
METHODS
Consecutive hepatitis B patients receiving tenofovir-disoproxil before 31 December 2017 were enrolled in a cross-sectional study in two European hospitals. Clinical and virological data were recorded; renal function was assessed by estimated glomerular filtrate rate, serum phosphate and creatinine, proteinuria, and albuminuria; bone involvement by spine and femur DEXA scan.
RESULTS
In total, 565 patients included: 62 (18-91) years, 75% males, 92% Caucasian, 92% HBeAg-negative, 40% cirrhotic. Fifty-five percent of patients fulfilled age criterion (>60 years). Older patients had higher rates of cirrhosis (51% vs 26%, p<0.001), cardiovascular disease, and renal impairment. Thirty-six percent of patients met renal criteria, more commonly NA-experienced individuals (35% vs 21%, p=0.001); 17% had bone disease. Overall, 66% of patients had at least one criterion (71% if NA-experienced), 8% all three criteria, 28% age and renal criteria.
CONCLUSIONS
Approximately two-thirds of patients receiving long-term tenofovir-disoproxil are candidates for an entecavir or tenofovir-alafenamide switch according to EASL recommendations.

Identifiants

pubmed: 32703729
pii: S1590-8658(20)30322-4
doi: 10.1016/j.dld.2020.06.037
pii:
doi:

Substances chimiques

Antiviral Agents 0
entecavir 5968Y6H45M
Guanine 5Z93L87A1R
Tenofovir 99YXE507IL

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1164-1169

Informations de copyright

Copyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest M. Buti and R. Esteban report grant support and/or consultancy and lecture fees from AbbVie, Gilead Sciences, Bristol-Myers Squibb, Janssen and MSD. M. Riveiro-Barciela reports lecture fees from Gilead Sciences. P.Lampertico is an Advisory Board/Speaker Bureau for BMS, Roche, Gilead Sciences, GSK, Abbvie, MSD, Arrowhead, Alnylam, Janssen, Spring Bank, Myr-pharma, Eiger. A. Loglio is a Speaker Bureau for Gilead Sciences, Myr-pharma.

Auteurs

Luisa Roade (L)

Liver Unit, Department of Internal Medicine, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Alessandro Loglio (A)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.

Marta Borghi (M)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.

Mar Riveiro-Barciela (M)

Liver Unit, Department of Internal Medicine, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Roberta Soffredini (R)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.

Floriana Facchetti (F)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.

Dhanai di Paolo (D)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.

David Tabernero (D)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Liver Pathology Unit/Virology Unit, Biochemistry and Microbiology Departments, Hospital Universitario Vall d'Hebron, Barcelona, Spain.

Giovanna Lunghi (G)

Virology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.

Rafael Esteban (R)

Liver Unit, Department of Internal Medicine, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Maria Buti (M)

Liver Unit, Department of Internal Medicine, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: mbuti@vhebron.net.

Pietro Lampertico (P)

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Milan, Italy; University of Milan, Milan, Italy.

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