Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials

Efficacy; Chronic infection; Hepatitis B virus

Detalles Bibliográficos
Autores: Marcellin, Patrick, Buti Ferret, Maria, Lim, Young-Suk, Chan, Henry Lik Yuen, Agarwal, Kosh, BRUNETTO, MAURIZIA ROSSANA
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/12356
Acceso en línea:https://hdl.handle.net/11351/12356
http://hdl.handle.net/11351/12356
Access Level:acceso abierto
Palabra clave:Avaluació de resultats (Assistència sanitària)
Hepatitis B - Tractament
Medicaments antivírics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
Other subheadings::Other subheadings::/therapeutic use
DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic
Other subheadings::Other subheadings::Other subheadings::/drug therapy
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Otros calificadores::Otros calificadores::/uso terapéutico
ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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oai_identifier_str oai:recercat.cat:11351/12356
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
title Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
spellingShingle Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
Marcellin, Patrick
Avaluació de resultats (Assistència sanitària)
Hepatitis B - Tractament
Medicaments antivírics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
Other subheadings::Other subheadings::/therapeutic use
DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic
Other subheadings::Other subheadings::Other subheadings::/drug therapy
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Otros calificadores::Otros calificadores::/uso terapéutico
ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
title_short Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
title_full Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
title_fullStr Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
title_full_unstemmed Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
title_sort Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
dc.creator.none.fl_str_mv Marcellin, Patrick
Buti Ferret, Maria
Lim, Young-Suk
Chan, Henry Lik Yuen
Agarwal, Kosh
BRUNETTO, MAURIZIA ROSSANA
author Marcellin, Patrick
author_facet Marcellin, Patrick
Buti Ferret, Maria
Lim, Young-Suk
Chan, Henry Lik Yuen
Agarwal, Kosh
BRUNETTO, MAURIZIA ROSSANA
author_role author
author2 Buti Ferret, Maria
Lim, Young-Suk
Chan, Henry Lik Yuen
Agarwal, Kosh
BRUNETTO, MAURIZIA ROSSANA
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Buti M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBEREHD del Instituto Carlos III, Madrid, Spain. [Lim YS] Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. [Lik Yuen Chan H] Faculty of Medicine, The Chinese University of Hong Kong, HMA Office, Tai Wai, Shatin, Hong Kong. [Agarwal K] Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK. [Marcellin P] Hepatology Department, Hôpital Beaujon, APHP, INSERM, University of Paris, Clichy, France. [Brunetto MR] Department of Clinical and Experimental Medicine, University of Pisa and Hepatology Unit, Pisa University Hospital, Pisa, Italy
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Avaluació de resultats (Assistència sanitària)
Hepatitis B - Tractament
Medicaments antivírics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
Other subheadings::Other subheadings::/therapeutic use
DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic
Other subheadings::Other subheadings::Other subheadings::/drug therapy
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Otros calificadores::Otros calificadores::/uso terapéutico
ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
topic Avaluació de resultats (Assistència sanitària)
Hepatitis B - Tractament
Medicaments antivírics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
Other subheadings::Other subheadings::/therapeutic use
DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic
Other subheadings::Other subheadings::Other subheadings::/drug therapy
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Otros calificadores::Otros calificadores::/uso terapéutico
ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
description Efficacy; Chronic infection; Hepatitis B virus
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/12356
http://hdl.handle.net/11351/12356
url https://hdl.handle.net/11351/12356
http://hdl.handle.net/11351/12356
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Alimentary Pharmacology & Therapeutics;60(11-12)
https://doi.org/10.1111/apt.18278
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trialsMarcellin, PatrickButi Ferret, MariaLim, Young-SukChan, Henry Lik YuenAgarwal, KoshBRUNETTO, MAURIZIA ROSSANAAvaluació de resultats (Assistència sanitària)Hepatitis B - TractamentMedicaments antivírics - Ús terapèuticANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment OutcomeCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral AgentsOther subheadings::Other subheadings::/therapeutic useDISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, ChronicOther subheadings::Other subheadings::Other subheadings::/drug therapyTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamientoCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricosOtros calificadores::Otros calificadores::/uso terapéuticoENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónicaOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaEfficacy; Chronic infection; Hepatitis B virusEficacia; Infección crónica; Virus de la hepatitis BEficàcia; Infecció crònica; Virus de l'hepatitis BBackground In two phase 3 studies, tenofovir alafenamide (TAF) showed non-inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB). Aims Here, we report the studies' final 8-year results. Methods CHB patients (hepatitis B e antigen [HBeAg]-negative and HBeAg-positive) were randomised (2:1) to double-blind TAF 25 mg/day or TDF 300 mg/day for up to 3 years, followed by open-label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase/reverse transcriptase and by phenotyping. Results Among 1298 patients randomised to double-blind TAF (n = 866) or double-blind TDF (n = 432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y → TAF6y) or year 3 (TDF3y → TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y → TAF6y and TDF3y → TAF5y groups, 69%, 66% and 73% (missing-equals-failure analysis) and 95%, 94% and 97% (missing-equals-excluded) of patients, respectively, achieved HBV DNA <29 IU/mL. Estimated glomerular filtration rate (Cockcroft-Gault method; eGFRCG) and hip/spine bone mineral density (BMD) remained stable in patients receiving double-blind/OL TAF, with only small declines at year 8. Decreases in eGFRCG and hip/spine BMD observed during double-blind TDF improved after switching to OL TAF. No patients developed resistance to TAF. Conclusion Long-term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance. ClinicalTrials.gov numbers NCT01940341 and NCT01940471.These studies were funded by Gilead Sciences, Inc.WileyInstitut Català de la Salut[Buti M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBEREHD del Instituto Carlos III, Madrid, Spain. [Lim YS] Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. [Lik Yuen Chan H] Faculty of Medicine, The Chinese University of Hong Kong, HMA Office, Tai Wai, Shatin, Hong Kong. [Agarwal K] Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK. [Marcellin P] Hepatology Department, Hôpital Beaujon, APHP, INSERM, University of Paris, Clichy, France. [Brunetto MR] Department of Clinical and Experimental Medicine, University of Pisa and Hepatology Unit, Pisa University Hospital, Pisa, ItalyVall d'Hebron Barcelona Hospital Campus202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/12356http://hdl.handle.net/11351/12356Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésAlimentary Pharmacology & Therapeutics;60(11-12)https://doi.org/10.1111/apt.18278Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/123562026-05-29T05:05:01Z
score 15.812429

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