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- Eron, Joseph J. (author)
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
- Article/chapterEnglish2019
Publisher, publication year, extent ...
- Elsevier BV,2019
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- LIBRIS-ID:oai:gup.ub.gu.se/285580
- https://gup.ub.gu.se/publication/285580URI
- https://doi.org/10.1016/j.antiviral.2019.104543DOI
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- Language:English
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- © 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.
Subject headings and genre
- MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Mikrobiologi inom det medicinska området hsv//swe
- MEDICAL AND HEALTH SCIENCES Basic Medicine Microbiology in the medical area hsv//eng
- MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Infektionsmedicin hsv//swe
- MEDICAL AND HEALTH SCIENCES Clinical Medicine Infectious Medicine hsv//eng
- Darunavir/cobicistat/emtricitabine/TAF
- Efficacy
- Safety
- Single-tablet regimen
- Switch study
Added entries (persons, corporate bodies, meetings, titles ...)
- Orkin, C. (author)
- Cunningham, Douglas (author)
- Pulido, Federico (author)
- Post, Frank A. (author)
- De Wit, Stéphane (author)
- Lathouwers, E. (author)
- Hufkens, Veerle (author)
- Jezorwski, John (author)
- Petrovic, Romana (author)
- Brown, Kimberley (author)
- Van Landuyt, E. (author)
- Opsomer, M. (author)
- De Wit, S. (author)
- Florence, E. (author)
- Moutschen, M. (author)
- Van Wijngaerden, E. (author)
- Vandekerckhove, L. (author)
- Vandercam, B. (author)
- Brunetta, J. (author)
- Conway, B. (author)
- Klein, M. (author)
- Murphy, D. (author)
- Rachlis, A. (author)
- Shafran, S. (author)
- Walmsley, S. (author)
- Ajana, F. (author)
- Cotte, L. (author)
- Girardy, P. M. (author)
- Katlama, C. (author)
- Molina, J. M. (author)
- Poizot-Martin, I. (author)
- Raffi, F. (author)
- Rey, D. (author)
- Reynes, J. (author)
- Teicher, E. (author)
- Yazdanpanah, Y. (author)
- Gasiorowski, J. (author)
- Halota, W. (author)
- Horban, A. (author)
- Piekarska, A. (author)
- Witor, A. (author)
- Arribas, J. R. (author)
- Perez-Valero, I. (author)
- Berenguer, J. (author)
- Casado, J. (author)
- Gatell, J. M. (author)
- Gutierrez, F. (author)
- Galindo, M. J. (author)
- Gutierrez, M. D.M. (author)
- Iribarren, J. A. (author)
- Knobel, H. (author)
- Negredo, E. (author)
- Pineda, J. A. (author)
- Podzamczer, D. (author)
- Sogorb, J. Portilla (author)
- Pulido, F. (author)
- Ricart, C. (author)
- Rivero, A. (author)
- Santos Gil, I. (author)
- Blaxhult, A. (author)
- Flamholc, L. (author)
- Gisslén, Magnus,1962Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för infektionssjukdomar,Institute of Biomedicine, Department of Infectious Medicine(Swepub:gu)xgissm (author)
- Thalme, A. (author)
- Fehr, J. (author)
- Rauch, A. (author)
- Stoeckle, M. (author)
- Clarke, A. (author)
- Gazzard, B. G. (author)
- Johnson, M. A. (author)
- Orkin, C. (author)
- Ustianowski, A. (author)
- Waters, L. (author)
- Bailey, J. (author)
- Benson, P. (author)
- Bhatti, L. (author)
- Brar, I. (author)
- Bredeek, U. F. (author)
- Brinson, C. (author)
- Crofoot, G. (author)
- Cunningham, D. (author)
- DeJesus, E. (author)
- Dietz, C. (author)
- Dretler, R. (author)
- Eron, J. (author)
- Felizarta, F. (author)
- Fichtenbaum, C. (author)
- Gallant, J. (author)
- Gathe, J. (author)
- Hagins, D. (author)
- Henn, S. (author)
- Henry, W. K. (author)
- Huhn, G. (author)
- Jain, M. (author)
- Lucasti, C. (author)
- Martorell, C. (author)
- McDonald, C. (author)
- Mills, A. (author)
- Morales-Ramirez, J. (author)
- Göteborgs universitetInstitutionen för biomedicin, avdelningen för infektionssjukdomar (creator_code:org_t)
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