WFRF:(Negredo E.)
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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 07467naa a2201537 4500 | |
| 001 | oai:gup.ub.gu.se/285580 | |
| 003 | SwePub | |
| 008 | 240528s2019 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://gup.ub.gu.se/publication/2855802 URI |
| 024 | 7 | a https://doi.org/10.1016/j.antiviral.2019.1045432 DOI |
| 040 | a (SwePub)gu | |
| 041 | a eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Eron, Joseph J.4 aut |
| 245 | 1 0 | a 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 |
| 264 | 1 | b Elsevier BV,c 2019 |
| 520 | a © 2019 The Authors 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. | |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Mikrobiologi inom det medicinska området0 (SwePub)301092 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Microbiology in the medical area0 (SwePub)301092 hsv//eng |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng |
| 653 | a Darunavir/cobicistat/emtricitabine/TAF | |
| 653 | a Efficacy | |
| 653 | a Safety | |
| 653 | a Single-tablet regimen | |
| 653 | a Switch study | |
| 700 | 1 | a Orkin, C.4 aut |
| 700 | 1 | a Cunningham, Douglas4 aut |
| 700 | 1 | a Pulido, Federico4 aut |
| 700 | 1 | a Post, Frank A.4 aut |
| 700 | 1 | a De Wit, Stéphane4 aut |
| 700 | 1 | a Lathouwers, E.4 aut |
| 700 | 1 | a Hufkens, Veerle4 aut |
| 700 | 1 | a Jezorwski, John4 aut |
| 700 | 1 | a Petrovic, Romana4 aut |
| 700 | 1 | a Brown, Kimberley4 aut |
| 700 | 1 | a Van Landuyt, E.4 aut |
| 700 | 1 | a Opsomer, M.4 aut |
| 700 | 1 | a De Wit, S.4 aut |
| 700 | 1 | a Florence, E.4 aut |
| 700 | 1 | a Moutschen, M.4 aut |
| 700 | 1 | a Van Wijngaerden, E.4 aut |
| 700 | 1 | a Vandekerckhove, L.4 aut |
| 700 | 1 | a Vandercam, B.4 aut |
| 700 | 1 | a Brunetta, J.4 aut |
| 700 | 1 | a Conway, B.4 aut |
| 700 | 1 | a Klein, M.4 aut |
| 700 | 1 | a Murphy, D.4 aut |
| 700 | 1 | a Rachlis, A.4 aut |
| 700 | 1 | a Shafran, S.4 aut |
| 700 | 1 | a Walmsley, S.4 aut |
| 700 | 1 | a Ajana, F.4 aut |
| 700 | 1 | a Cotte, L.4 aut |
| 700 | 1 | a Girardy, P. M.4 aut |
| 700 | 1 | a Katlama, C.4 aut |
| 700 | 1 | a Molina, J. M.4 aut |
| 700 | 1 | a Poizot-Martin, I.4 aut |
| 700 | 1 | a Raffi, F.4 aut |
| 700 | 1 | a Rey, D.4 aut |
| 700 | 1 | a Reynes, J.4 aut |
| 700 | 1 | a Teicher, E.4 aut |
| 700 | 1 | a Yazdanpanah, Y.4 aut |
| 700 | 1 | a Gasiorowski, J.4 aut |
| 700 | 1 | a Halota, W.4 aut |
| 700 | 1 | a Horban, A.4 aut |
| 700 | 1 | a Piekarska, A.4 aut |
| 700 | 1 | a Witor, A.4 aut |
| 700 | 1 | a Arribas, J. R.4 aut |
| 700 | 1 | a Perez-Valero, I.4 aut |
| 700 | 1 | a Berenguer, J.4 aut |
| 700 | 1 | a Casado, J.4 aut |
| 700 | 1 | a Gatell, J. M.4 aut |
| 700 | 1 | a Gutierrez, F.4 aut |
| 700 | 1 | a Galindo, M. J.4 aut |
| 700 | 1 | a Gutierrez, M. D.M.4 aut |
| 700 | 1 | a Iribarren, J. A.4 aut |
| 700 | 1 | a Knobel, H.4 aut |
| 700 | 1 | a Negredo, E.4 aut |
| 700 | 1 | a Pineda, J. A.4 aut |
| 700 | 1 | a Podzamczer, D.4 aut |
| 700 | 1 | a Sogorb, J. Portilla4 aut |
| 700 | 1 | a Pulido, F.4 aut |
| 700 | 1 | a Ricart, C.4 aut |
| 700 | 1 | a Rivero, A.4 aut |
| 700 | 1 | a Santos Gil, I.4 aut |
| 700 | 1 | a Blaxhult, A.4 aut |
| 700 | 1 | a Flamholc, L.4 aut |
| 700 | 1 | a Gisslén, Magnus,d 1962u Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine4 aut0 (Swepub:gu)xgissm |
| 700 | 1 | a Thalme, A.4 aut |
| 700 | 1 | a Fehr, J.4 aut |
| 700 | 1 | a Rauch, A.4 aut |
| 700 | 1 | a Stoeckle, M.4 aut |
| 700 | 1 | a Clarke, A.4 aut |
| 700 | 1 | a Gazzard, B. G.4 aut |
| 700 | 1 | a Johnson, M. A.4 aut |
| 700 | 1 | a Orkin, C.4 aut |
| 700 | 1 | a Ustianowski, A.4 aut |
| 700 | 1 | a Waters, L.4 aut |
| 700 | 1 | a Bailey, J.4 aut |
| 700 | 1 | a Benson, P.4 aut |
| 700 | 1 | a Bhatti, L.4 aut |
| 700 | 1 | a Brar, I.4 aut |
| 700 | 1 | a Bredeek, U. F.4 aut |
| 700 | 1 | a Brinson, C.4 aut |
| 700 | 1 | a Crofoot, G.4 aut |
| 700 | 1 | a Cunningham, D.4 aut |
| 700 | 1 | a DeJesus, E.4 aut |
| 700 | 1 | a Dietz, C.4 aut |
| 700 | 1 | a Dretler, R.4 aut |
| 700 | 1 | a Eron, J.4 aut |
| 700 | 1 | a Felizarta, F.4 aut |
| 700 | 1 | a Fichtenbaum, C.4 aut |
| 700 | 1 | a Gallant, J.4 aut |
| 700 | 1 | a Gathe, J.4 aut |
| 700 | 1 | a Hagins, D.4 aut |
| 700 | 1 | a Henn, S.4 aut |
| 700 | 1 | a Henry, W. K.4 aut |
| 700 | 1 | a Huhn, G.4 aut |
| 700 | 1 | a Jain, M.4 aut |
| 700 | 1 | a Lucasti, C.4 aut |
| 700 | 1 | a Martorell, C.4 aut |
| 700 | 1 | a McDonald, C.4 aut |
| 700 | 1 | a Mills, A.4 aut |
| 700 | 1 | a Morales-Ramirez, J.4 aut |
| 710 | 2 | a Göteborgs universitetb Institutionen för biomedicin, avdelningen för infektionssjukdomar4 org |
| 773 | 0 | t Antiviral Researchd : Elsevier BVg 170q 170x 0166-3542x 1872-9096 |
| 856 | 4 | u https://doi.org/10.1016/j.antiviral.2019.104543 |
| 856 | 4 8 | u https://gup.ub.gu.se/publication/285580 |
| 856 | 4 8 | u https://doi.org/10.1016/j.antiviral.2019.104543 |
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- Yazdanpanah, Y.
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- Arribas, J. R.
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