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, Chloe; 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; EMERALD study group

doi:10.1016/j.antiviral.2019.104543

Article (Scientific journals)

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, Chloe; Cunningham, Douglas et al.

2019 • In Antiviral Research, 170, p. 104543

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/308413

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10.1016/j.antiviral.2019.104543

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31279073

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Keywords :

Darunavir/cobicistat/emtricitabine/TAF; Efficacy; Safety; Single-tablet regimen; Switch study; Anti-HIV Agents; Drug Combinations; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Protease Inhibitors; Tablets; Tenofovir; tenofovir alafenamide; Emtricitabine; Adenine; Cobicistat; Alanine; Darunavir; Adenine/analogs & derivatives; Adenine/therapeutic use; Adult; Aged; Anti-HIV Agents/therapeutic use; Cobicistat/therapeutic use; Darunavir/therapeutic use; Emtricitabine/therapeutic use; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/therapeutic use; Female; HIV Infections/drug therapy; HIV-1/drug effects; Humans; Male; Middle Aged; Protease Inhibitors/therapeutic use; Sustained Virologic Response; Tablets/therapeutic use; Tenofovir/analogs & derivatives; Treatment Outcome; Viral Load/drug effects; Drug Substitution; HIV Infections; HIV-1; Viral Load; Pharmacology; Virology

Abstract :

[en] 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.

Disciplines :

Immunology & infectious disease

Author, co-author :

Eron, Joseph J; University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: jeron@med.unc.edu

Orkin, Chloe; Queen Mary University, London, UK

Cunningham, Douglas; Pueblo Family Physicians, Phoenix, AZ, USA

Pulido, Federico; HIV Unit, Hospital 12 de Octubre, imas12, UCM, Madrid, Spain

Post, Frank A; King's College Hospital NHS Foundation Trust, London, United Kingdom

De Wit, Stéphane; Saint-Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium

Lathouwers, Erkki; Janssen Pharmaceutica NV, Beerse, Belgium

Hufkens, Veerle; Janssen Pharmaceutica NV, Beerse, Belgium

Jezorwski, John; Janssen Research & Development, Pennington, NJ, USA

Petrovic, Romana; Janssen Pharmaceutica NV, Beerse, Belgium

More authors (4 more)

Other collaborator :

Moutschen, Michel ; Centre Hospitalier Universitaire de Liège - CHU > > Service des maladies infectieuses - médecine interne

Language :

English

Title :

Publication date :

2019

Journal title :

Antiviral Research

ISSN :

0166-3542

Publisher :

Elsevier B.V., Netherlands

Volume :

170

Pages :

104543

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://api.elsevier.com/content/article/PII:S0166354219302475?httpAccept=text/xml

Funders :

Merck [DE]
Gilead Sciences [GB]
Janssen Pharmaceuticals [BE]

Funding text :

No patient developed resistance to any of the study drugs through week 96 despite a cumulative 1648 patient-years of exposure to D/C/F/TAF. This is consistent with previous DRV and D/C/F/TAF studies (Eron et al., 2018; Lathouwers et al., 2017), further supporting the high genetic barrier to resistance of DRV.J.J.E. has received research grants from Janssen, Gilead Sciences and ViiV Healthcare and has served as a consultant to BMS, Merck, Janssen, Gilead Sciences and ViiV Healthcare. C.O. has received speaker honoraria or consulting fees for attending speakers’ bureaus or advisory boards and research grants from Janssen, Merck, ViiV Healthcare, and Gilead Sciences. D.C. has received research grants from Janssen, Merck, ViiV Healthcare and Gilead Sciences. F. Pulido has received speaker honoraria or consulting fees for attending advisory boards and research grants from Janssen, Merck, ViiV Healthcare, and Gilead Sciences. F. Post has received consulting fees from Gilead Sciences, Janssen, ViiV Healthcare and Merck and research grants from Gilead Sciences and ViiV Healthcare. S.D.W. has received consulting fees for attending advisory boards and research grants from Janssen, Merck, ViiV Healthcare and Gilead Sciences. E.L., V.H., K.B., and E.V.L. are all full-time employees of Janssen and potential stockholders of Johnson and Johnson. R.P. was a contractor for Janssen. We thank the patients and their families for their participation and support during the study, the central and local Janssen EMERALD study teams, study center staff, and the principal investigators. We also thank other Janssen staff members for their input into this manuscript. We also acknowledge Ian Woolveridge (Zoetic Science, an Ashfield company, Macclesfield, UK) for assistance in drafting the manuscript and coordinating and collating author contributions, which was funded by Janssen. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available athttps://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site athttp://yoda.yale.edu.J.J.E. has received research grants from Janssen, Gilead Sciences and ViiV Healthcare and has served as a consultant to BMS , Merck , Janssen, Gilead Sciences and ViiV Healthcare . C.O. has received speaker honoraria or consulting fees for attending speakers’ bureaus or advisory boards and research grants from Janssen, Merck , ViiV Healthcare , and Gilead Sciences . D.C. has received research grants from Janssen, Merck , ViiV Healthcare and Gilead Sciences . F. Pulido has received speaker honoraria or consulting fees for attending advisory boards and research grants from Janssen, Merck , ViiV Healthcare , and Gilead Sciences . F. Post has received consulting fees from Gilead Sciences , Janssen, ViiV Healthcare and Merck and research grants from Gilead Sciences and ViiV Healthcare . S.D.W. has received consulting fees for attending advisory boards and research grants from Janssen, Merck , ViiV Healthcare and Gilead Sciences . E.L., V.H., K.B., and E.V.L. are all full-time employees of Janssen and potential stockholders of Johnson and Johnson . R.P. was a contractor for Janssen.This study was sponsored by Janssen.

Commentary :

EMERALD principal investigators for Belgium: S De Wit, E Florence, M Moutschen, E Van Wijngaerden, L Vandekerckhove, B Vandercam

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