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Week 96 efficacy and safe… - University of Gothenburg, Sweden Till startsida
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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

Journal article
Authors Joseph J. Eron
C. Orkin
Douglas Cunningham
Federico Pulido
Frank A. Post
Stéphane De Wit
E. Lathouwers
Veerle Hufkens
John Jezorwski
Romana Petrovic
Kimberley Brown
E. Van Landuyt
M. Opsomer
S. De Wit
E. Florence
M. Moutschen
E. Van Wijngaerden
L. Vandekerckhove
B. Vandercam
J. Brunetta
B. Conway
M. Klein
D. Murphy
A. Rachlis
S. Shafran
S. Walmsley
F. Ajana
L. Cotte
P. M. Girardy
C. Katlama
J. M. Molina
I. Poizot-Martin
F. Raffi
D. Rey
J. Reynes
E. Teicher
Y. Yazdanpanah
J. Gasiorowski
W. Halota
A. Horban
A. Piekarska
A. Witor
J. R. Arribas
I. Perez-Valero
J. Berenguer
J. Casado
J. M. Gatell
F. Gutierrez
M. J. Galindo
M. D.M. Gutierrez
J. A. Iribarren
H. Knobel
E. Negredo
J. A. Pineda
D. Podzamczer
J. Portilla Sogorb
F. Pulido
C. Ricart
A. Rivero
I. Santos Gil
A. Blaxhult
L. Flamholc
Magnus Gisslén
A. Thalme
J. Fehr
A. Rauch
M. Stoeckle
A. Clarke
B. G. Gazzard
M. A. Johnson
C. Orkin
A. Ustianowski
L. Waters
J. Bailey
P. Benson
L. Bhatti
I. Brar
U. F. Bredeek
C. Brinson
G. Crofoot
D. Cunningham
E. DeJesus
C. Dietz
R. Dretler
J. Eron
F. Felizarta
C. Fichtenbaum
J. Gallant
J. Gathe
D. Hagins
S. Henn
W. K. Henry
G. Huhn
M. Jain
C. Lucasti
C. Martorell
C. McDonald
A. Mills
J. Morales-Ramirez
Published in Antiviral Research
Volume 170
ISSN 0166-3542
Publication year 2019
Published at Institute of Biomedicine, Department of Infectious Medicine
Language en
Links doi.org/10.1016/j.antiviral.2019.10...
Keywords Darunavir/cobicistat/emtricitabine/TAF, Efficacy, Safety, Single-tablet regimen, Switch study
Subject categories Virology, Infectious Medicine

Abstract

© 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.

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