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Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1

Authors :
Douglas Cunningham
D. Ward
Mamta K. Jain
Faiza Ajana
Magda Opsomer
Anita Rachlis
Sharon Walmsley
Frank A. Post
Anders Blaxhult
Amanda Clarke
M. J. Galindo
Marcel Stoeckle
P.-M. Girardy
Karam Mounzer
David Shamblaw
U. F. Bredeek
L. Bhatti
J. J. Eron
Andrew Ustianowski
Mar Gutierrez
John Jezorwski
Javier O Morales-Ramirez
Antonio Rivero
M.A. Johnson
Gatell Jm
Erika Van Landuyt
Stéphane De Wit
A. Wilkin
Laurent Cotte
Cheryl McDonald
D. Murphy
Cynthia Brinson
Romana Petrovic
Olayemi Osiyemi
J. de Vente
I. Poizot-Martin
Juan Berenguer
Robin Dretler
J. Bailey
B. Rashbaum
Moti Ramgopal
A. Scribner
Yazdan Yazdanpanah
Eric Florence
A. Piekarska
Brian Gazzard
Chloe Orkin
W. Halota
Gary Richmond
Jacques Reynes
C. Ricart
C. Lucasti
Ignacio Pérez-Valero
Jason Brunetta
S. Shafran
Daniel Podzamczer
Franco Antonio Felizarta
Claudia Martorell
F. Post
Peter Ruane
Edwin DeJesus
J. Portilla Sogorb
C. Orkin
K. Tashima
Federico Pulido
Bernard Vandercam
F. Pulido
José L. Casado
Christine Katlama
Kimberley Brown
J Gasiorowski
A. Witor
Joseph J. Eron
Brian Conway
Andri Rauch
Jose R. Arribas
Michel Moutschen
H. Olivet
A. Scarsella
Leo Flamholc
A. Horban
D. Cunningham
Ronald Nahass
Félix Gutiérrez
G. Huhn
W.K. Henry
A. Thalme
S De Wit
Jan Fehr
Debbie Hagins
José Antonio Iribarren
J.-M. Molina
S. Henn
F Raffi
Juan A. Pineda
Marina B. Klein
Eugenia Negredo
Hernando Knobel
J. Slim
P. Benson
L. Waters
E. Teicher
Linos Vandekerckhove
Craig A. Dietz
Magnus Gisslén
Joel E. Gallant
J. Gathe
P. Shalit
D. Prelutsky
G. Voskuhl
D. Rey
E. Van Wijngaerden
Anthony Mills
Erkki Lathouwers
Carl J. Fichtenbaum
I. Brar
Gordon Crofoot
Veerle Hufkens
I. Santos Gil
University of North Carolina [Chapel Hill] (UNC)
University of North Carolina System (UNC)
Queen Mary University of London (QMUL)
Pueblo Family Physicians
Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM)
King's College Hospital (KCH)
Université libre de Bruxelles (ULB)
Janssen Pharmaceutica [Beerse]
Janssen Research & Development
Institute of Tropical Medicine [Antwerp] (ITM)
Department of Infectious and Parasitic Diseases (University Liege)
Université de Liège
Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven)
Living Hope Foundation
Ghent University Hospital
Cliniques Universitaires Saint-Luc [Bruxelles]
Maple Leaf Clinic
Vancouver Infectious Diseases Centre
McGill University = Université McGill [Montréal, Canada]
University of Toronto
Sunnybrook Health Sciences Centre
University of Alberta
University Health Network
Services des maladies infectieuses [Tourcoing]
Centre Hospitalier de Tourcoing
Hôpital de la Croix-Rousse [CHU - HCL]
Hospices Civils de Lyon (HCL)
Sorbonne Université (SU)
CHU Pitié-Salpêtrière [AP-HP]
Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Service de maladies infectieuses et tropicales [Saint-Louis]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP)
Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD)
Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Centre hospitalier universitaire de Nantes (CHU Nantes)
CHU Strasbourg
Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
Service de Maladies Infectieuses et Tropicales [CHU Bicêtre]
AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
University of Wrocław [Poland] (UWr)
Faculty of Medicine [Bydgoszcz, Poland]
Nicolaus Copernicus University [Toruń]
Medical University of Warsaw - Poland
Medical University of Łódź (MUL)
Regional Hospital [Chorzow, Poland]
La Paz Hospital, IdiPAZ
Hospital General Universitario 'Gregorio Marañón' [Madrid]
Hospital Universitario Ramón y Cajal [Madrid]
Universidad de Alcalá - University of Alcalá (UAH)
Infectious Diseases Service, AIDS Research Group, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain.
Hospital Universitario de Elche
Hospital Universitario de Valencia
Hospital de la Santa Creu i Sant Pau
Donostia Hospital Universitario San Sebastian
IMIM-Hospital del Mar
Generalitat de Catalunya
LLuita contra la Sida Fdn-HIV Unit, Germans Trias i Pujol University Hospital- Universitat Autònoma de Barcelona
Hospital Universitario de Valme
Hospital Universitari de Bellvitge
Universitat de València (UV)
Hospital Universitario Reina Sofía
Hospital La Princesa, Madrid
Karolinska Institutet, Södersjukhuset
Skane University Hospital [Malmo]
Lund University [Lund]
University of Gothenburg (GU)
Karolinska University Hospital [Stockholm]
University hospital of Zurich [Zurich]
Bern University Hospital [Berne] (Inselspital)
University Hospital Basel [Basel]
Royal Sussex County Hospital
Chelsea and Westminster Hospital
North Manchester General Hospital
University College of London [London] (UCL)
Johns Hopkins University School of Medicine [Baltimore]
Be Well
AIDS healthcare foundation [California]
Henry Ford Hospital
Metropolis Medical
Central Texas Clinical Research
The Crofoot Research Center
Orlando Immunology Center
Kansas City Free Health Clinic
University of Cincinnati (UC)
University of Minnesota System
University of Texas Southwestern Medical Center
South Jersey Infectious Disease
Infectious Disease
Tarrant County Infectious Disease Associates
Southern California Men’s Medical Group
Clinical Research Puerto Rico Inc
Philadelphia FIGHT
ID care
Community Research Initiative of New England
Triple O Research Institute PA
Washington University School of Medicine in St. Louis
Washington University in Saint Louis (WUSTL)
Midway Immunology Center
Capital Medical Associates
Broward General Medical Center
Ruane Clinical Research Group
Pacific Oaks Medical Group
DCOL Center for Clinical Research
Peter Shalit MD and Associates
La Playa Medical Group
Seton Hall University
Warren Alpert Medical School of Brown University
AIDS Arms, Inc
Dupont Circle Physicians Group
Wake Forest School of Medicine [Winston-Salem]
Wake Forest Baptist Medical Center
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité)
Hospital Universitario Donostia [San Sebastian, Spain] (HUD)
Universitat Autònoma de Barcelona (UAB)
Hospital Universitario de La Princesa
HAL AMU, Administrateur
UCL - SSS/IREC/SLUC - Pôle St.-Luc
UCL - (SLuc) Service de médecine interne générale
Source :
Antiviral Research, Antiviral Research, Elsevier Masson, 2019, 170, pp.104543. ⟨10.1016/j.antiviral.2019.104543⟩, ANTIVIRAL RESEARCH, Antiviral Research, 2019, 170, pp.104543. ⟨10.1016/j.antiviral.2019.104543⟩, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, Dipòsit Digital de la UB, Universidad de Barcelona, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, Antiviral research, Vol. 170, p. 104543 [1-11] (2019)
Publication Year :
2019
Publisher :
Elsevier, 2019.

Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL

Details

Language :
English
ISSN :
01663542
Database :
OpenAIRE
Journal :
Antiviral Research, Antiviral Research, Elsevier Masson, 2019, 170, pp.104543. ⟨10.1016/j.antiviral.2019.104543⟩, ANTIVIRAL RESEARCH, Antiviral Research, 2019, 170, pp.104543. ⟨10.1016/j.antiviral.2019.104543⟩, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, Dipòsit Digital de la UB, Universidad de Barcelona, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, Antiviral research, Vol. 170, p. 104543 [1-11] (2019)
Accession number :
edsair.doi.dedup.....017eb51bc97390ae19e12fb2aea5fdc8
Full Text :
https://doi.org/10.1016/j.antiviral.2019.104543⟩