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oai:recercat.cat:2072/4400972026-03-21T02:48:01Zcom_2072_98col_2072_378192

00925njm 22002777a 4500 dc Eron, Joseph J. author Orkin, Chloë M. author Cunningham, Douglas author Pulido, Federico author Post, Frank A. author De Wit, Stéphane author Lathouwers, Erkki author Hufkens, Veerle author Jezorwski, John author Petrovic, Romana author Brown, Kimberley author Van Landuyt, Erika author Opsomer, Magda author Florence, Eric author Moutschen, Michel P. author Van Wijngaerden, Eric author Vandekerckhove, Linos author Vandercam, Bernard C. author Brunetta, Jason M. author Conway, Brian author Klein, Marina Barbara author Murphy, Donald G. author Rachlis, Anita Rochelle author Shafran, Stephen D. author Walmsley, Sharon author Ajana, Faïza author Cotte, Laurent author Girardy, P. M. author Katlama, Christine author Molina, Jean Michel author Poizot-Martin, Isabelle author Raffi, François author Rey, David author Reynes, Jacques M. author Teicher, Elina author Yazdanpanah, Yazdan author Gasiorowski, Jacek author Halota, Waldemar author Horban, Andrzéj author Piekarska, Anna M. author Witor, Adam author Arribas, Jose author Pérez Valero, Ignacio author Berenguer, Juan author Casado, José Luis author Gatell, Jose Maria author Gutiérrez, Félix author Galindo, María José author Gutiérrez Macià, Mª Del Mar author Iribarren, José Antonio author Knobel Freud, Hernando author Negredo Puigmal, Eugènia author Pineda, Juan A. author Podzamczer, Daniel author Portilla Sogorb, Joaquín author Pulido, F. author Ricart, C. author Rivero Román, Antonio author de los Santos Gil, Ignacio author Blaxhult, Anders author Flamholc, Leo author Gisslèn, Magnus author Thalme, Anders author Fehr, Jan Sven author Rauch, Andri author Stoeckle, Marcel P. author Clarke, Amanda author Gazzard, B. G. author Johnson, Margaret A. author Orkin, Chole author Post, F. author Ustianowski, Andrew P. author Waters, Laura Jane author Bailey, Justin R. author Benson, Paul author Bhatti, Laveeza author Brar, Indira author Bredeek, Ulf Fritz author Brinson, Cynthia C. author Crofoot, Gordon E. author Cunningham, Douglas author DeJesus, Edwin author Dietz, Craig Allan author Dretler, Robin Henry author Eron, J. author Felizarta, Franco Antonio author Fichtenbaum, Carl author Gallant, Joel E. author Gathe, Joseph Clayton author Hagins, Debbie P. author Henn, Sarah author Henry, William Keith author Huhn, Gregory D. author Jain, Mamta K. author Lucasti, Christopher J. author Martorell, Claudia T. author McDonald, Cheryl Kay author Mills, Anthony author Morales-Ramirez, Javier Osvaldo author Mounzer, Karam C. author Nahass, Ronald G. author Olivet, Hannah author Osiyemi, Olayemi O. author Prelutsky, David James author Ramgopal, Moti N. author Rashbaum, Bruce C. author Richmond, Gary J. author Ruane, Peter Jerome author Scarsella, Anthony John author Scribner, Anita R. author Shalit, Peter author Shamblaw, David J. author Slim, Jihad author Tashima, Karen T. author Voskuhl, Gene W. author Ward, Douglas J. author Wilkin, Aimee M. author de Vente, Jerome author Universitat Autònoma de Barcelona author 2019 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. Darunavir/cobicistat/emtricitabine/TAF Efficacy Safety Single-tablet regimen Switch study 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