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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 Eron, Joseph J. Orkin, Chloë M. Cunningham, Douglas Pulido, Federico Post, Frank A. De Wit, Stéphane Lathouwers, Erkki Hufkens, Veerle Jezorwski, John Petrovic, Romana Brown, Kimberley Van Landuyt, Erika Opsomer, Magda Florence, Eric Moutschen, Michel P. Van Wijngaerden, Eric Vandekerckhove, Linos Vandercam, Bernard C. Brunetta, Jason M. Conway, Brian Klein, Marina Barbara Murphy, Donald G. Rachlis, Anita Rochelle Shafran, Stephen D. Walmsley, Sharon Ajana, Faïza Cotte, Laurent Girardy, P. M. Katlama, Christine Molina, Jean Michel Poizot-Martin, Isabelle Raffi, François Rey, David Reynes, Jacques M. Teicher, Elina Yazdanpanah, Yazdan Gasiorowski, Jacek Halota, Waldemar Horban, Andrzéj Piekarska, Anna M. Witor, Adam Arribas, Jose Pérez Valero, Ignacio Berenguer, Juan Casado, José Luis Gatell, Jose Maria Gutiérrez, Félix Galindo, María José Gutiérrez Macià, Mª Del Mar Iribarren, José Antonio Knobel Freud, Hernando Negredo Puigmal, Eugènia Pineda, Juan A. Podzamczer, Daniel Portilla Sogorb, Joaquín Pulido, F. Ricart, C. Rivero Román, Antonio de los Santos Gil, Ignacio Blaxhult, Anders Flamholc, Leo Gisslèn, Magnus Thalme, Anders Fehr, Jan Sven Rauch, Andri Stoeckle, Marcel P. Clarke, Amanda Gazzard, B. G. Johnson, Margaret A. Orkin, Chole Post, F. Ustianowski, Andrew P. Waters, Laura Jane Bailey, Justin R. Benson, Paul Bhatti, Laveeza Brar, Indira Bredeek, Ulf Fritz Brinson, Cynthia C. Crofoot, Gordon E. Cunningham, Douglas DeJesus, Edwin Dietz, Craig Allan Dretler, Robin Henry Eron, J. Felizarta, Franco Antonio Fichtenbaum, Carl Gallant, Joel E. Gathe, Joseph Clayton Hagins, Debbie P. Henn, Sarah Henry, William Keith Huhn, Gregory D. Jain, Mamta K. Lucasti, Christopher J. Martorell, Claudia T. McDonald, Cheryl Kay Mills, Anthony Morales-Ramirez, Javier Osvaldo Mounzer, Karam C. Nahass, Ronald G. Olivet, Hannah Osiyemi, Olayemi O. Prelutsky, David James Ramgopal, Moti N. Rashbaum, Bruce C. Richmond, Gary J. Ruane, Peter Jerome Scarsella, Anthony John Scribner, Anita R. Shalit, Peter Shamblaw, David J. Slim, Jihad Tashima, Karen T. Voskuhl, Gene W. Ward, Douglas J. Wilkin, Aimee M. de Vente, Jerome Universitat Autònoma de Barcelona Darunavir/cobicistat/emtricitabine/TAF Efficacy Safety Single-tablet regimen Switch study Altres ajuts: This study was sponsored by Janssen. 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 < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52-96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF. 2019 Article Antiviral Research ; Vol. 170 (october 2019), p. 104543 open access Aquest document està subjecte a una llicència d'ús Creative Commons. 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