1. 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
- Author
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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, and UCL - (SLuc) Service de médecine interne générale
- Subjects
Male ,DOLUTEGRAVIR ,Sustained Virologic Response ,HIV Infections ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine and Health Sciences ,Emtricitabine ,030212 general & internal medicine ,Pharmacology & Pharmacy ,Darunavir ,0303 health sciences ,Alanine ,Drug Substitution ,Cobicistat ,Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination ,Lamivudine ,Antiretrovirals ,Middle Aged ,Viral Load ,OPEN-LABEL ,3. Good health ,WEIGHT-GAIN ,Drug Combinations ,Treatment Outcome ,Dolutegravir ,NON-INFERIORITY ,Female ,Safety ,Viral load ,Life Sciences & Biomedicine ,medicine.drug ,Tablets ,Adult ,medicine.medical_specialty ,Efficacy ,Anti-HIV Agents ,RITONAVIR ,TENOFOVIR ALAFENAMIDE ,LAMIVUDINE ,Tenofovir alafenamide ,Single-tablet regimen ,03 medical and health sciences ,Internal medicine ,Virology ,medicine ,VIH (Virus) ,Humans ,Switch study ,Protease Inhibitors ,Tenofovir ,Aged ,Pharmacology ,Science & Technology ,030306 microbiology ,business.industry ,HIV (Viruses) ,Adenine ,Darunavir/cobicistat/emtricitabine/TAF ,Antiretroviral agents ,COBICISTAT ,MAINTENANCE ,chemistry ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,HIV-1 ,Ritonavir ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,RESISTANCE - 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
- Published
- 2019
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