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Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

Authors :
Lathouwers, Erkki
Wong, Eric Y
Brown, Kimberley
Baugh, Bryan
Ghys, Anne
Jezorwski, John
Mohsine, El Ghazi
Van Landuyt, Erika
Opsomer, Magda
De Meyer, Sandra
De Wit, S
Florence, E
Vandekerckhove, L
Vandercam, B
Brunetta, J
Klein, M
Murphy, D
Rachlis, A
Walmsley, S
Ajana, F
Cotte, L
Girard, P-M
Katlama, C
Molina, J-M
Poizot-Martin, I
Raffi, F
Rey, D
Reynes, J
Teicher, E
Yazdanpanah, Y
Arasteh, K
Bickel, M
Bogner, J
Esser, S
Faetkenheuer, G
Jessen, H
Kern, W
Rockstroh, J
Spinner, C
Stellbrink, H-J
Stoehr, A
Antinori, A
Castelli, F
Chirianni, A
De Luca, A
Di Biagio, A
Galli, M
Lazzarin, A
Maggiolo, F
Maserati, R
Mussini, C
Garlicki, A
Gasiorowski, J
Halota, W
Horban, A
Parczewski, M
Piekarska, A
Belonosova, E
Chernova, O
Dushkina, N
Kulagin, V
Ryamova, E
Shuldyakov, A
Sizova, N
Tsybakova, O
Voronin, E
Yakovlev, A
Antela, A
Arribas, JR
Berenguer, J
Casado, J
Estrada, V
Galindo, MJ
Garcia Del Toro, M
Gatell, JM
Gorgolas, M
Gutierrez, F
Gutierrez, MDM
Negredo, E
Pineda, JA
Podzamczer, D
Portilla Sogorb, J
Rivero, A
Rubio, R
Viciana, P
De Los Santos, I
Clarke, A
Gazzard, BG
Johnson, MA
Orkin, C
Reeves, I
Waters, L
Benson, P
Bhatti, L
Bredeek, F
Crofoot, G
Cunningham, D
DeJesus, E
Eron, J
Felizarta, F
Franco, R
Gallant, J
Hagins, D
Henry, K
Jayaweera, D
Lucasti, C
Martorell, C
McDonald, C
McGowan, J
Mills, A
Morales-Ramirez, J
Prelutsky, D
Ramgopal, M
Rashbaum, B
Ruane, P
Slim, J
Wilkin, A
deVente, J
Moutschen, M
Van Wijngaerden, E
Vekerckhove, L
Vercam, B
Conway, B
Shafran, S
Janssen Pharmaceutica [Beerse]
Janssen Pharmaceutical Research and Development Titusville
AMBER and EMERALD Study Groups: S De Wit, E Florence, L Vandekerckhove, B Vandercam, J Brunetta, M Klein, D Murphy, A Rachlis, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, K Arastéh, M Bickel, J Bogner, S Esser, G Faetkenheuer, H Jessen, W Kern, J Rockstroh, C Spinner, H-J Stellbrink, A Stoehr, A Antinori, F Castelli, A Chirianni, A De Luca, A Di Biagio, M Galli, A Lazzarin, F Maggiolo, R Maserati, C Mussini, A Garlicki, J Gasiorowski, W Halota, A Horban, M Parczewski, A Piekarska, E Belonosova, O Chernova, N Dushkina, V Kulagin, E Ryamova, A Shuldyakov, N Sizova, O Tsybakova, E Voronin, A Yakovlev, A Antela, J R Arribas, J Berenguer, J Casado, V Estrada, M J Galindo, M Garcia Del Toro, J M Gatell, M Gorgolas, F Gutierrez, Mdm Gutierrez, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, A Rivero, R Rubio, P Viciana, I De Los Santos, A Clarke, B G Gazzard, M A Johnson, C Orkin, I Reeves, L Waters, P Benson, L Bhatti, F Bredeek, G Crofoot, D Cunningham, E DeJesus, J Eron, F Felizarta, R Franco, J Gallant, D Hagins, K Henry, D Jayaweera, C Lucasti, C Martorell, C McDonald, J McGowan, A Mills, J Morales-Ramirez, D Prelutsky, M Ramgopal, B Rashbaum, P Ruane, J Slim, A Wilkin, J deVente, 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 Girard, 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, Mdm 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, M Gisslèn, A Thalme, J Fehr, A Rauch, M Stoeckle, A Clarke, B G Gazzard, M A Johnson, C Orkin, F Post, 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, K W Henry, G Huhn, M Jain, C Lucasti, C Martorell, C McDonald, A Mills, J Morales-Ramirez, K Mounzer, R Nahass, H Olivet, O Osiyemi, D Prelutsky, M Ramgopal, B Rashbaum, G Richmond, P Ruane, A Scarsella, A Scribner, P Shalit, D Shamblaw, J Slim, K Tashima, G Voskuhl, D Ward, A Wilkin, J de Vente
Malbec, Odile
Source :
AIDS Research and Human Retroviruses, AIDS Research and Human Retroviruses, Mary Ann Liebert, 2018, 36 (1), pp.48-57. ⟨10.1089/aid.2019.0111⟩, AIDS RESEARCH AND HUMAN RETROVIRUSES
Publication Year :
2019
Publisher :
MARY ANN LIEBERT, INC, 2019.

Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL

Subjects

Subjects :
0301 basic medicine
[SDV]Life Sciences [q-bio]
efficacy
Human immunodeficiency virus (HIV)
HIV Infections
darunavir
medicine.disease_cause
VIRALLY SUPPRESSED ADULTS
PLUS LAMIVUDINE
DOUBLE-BLIND
0302 clinical medicine
INFECTION
Medicine and Health Sciences
Emtricitabine
030212 general & internal medicine
Darunavir
Emtricitabine tenofovir alafenamide
Alanine
Cobicistat
Single tablet regimen
virus diseases
Viral Load
OPEN-LABEL
3. Good health
[SDV] Life Sciences [q-bio]
Drug Combinations
Infectious Diseases
NON-INFERIORITY
INITIAL TREATMENT
Reverse Transcriptase Inhibitors
Life Sciences & Biomedicine
Tablets
medicine.drug
Adult
TENOFOVIR DISOPROXIL FUMARATE
Anti-HIV Agents
Darunavir/Cobicistat
Immunology
archived RAMs
Tenofovir alafenamide
Drug Administration Schedule
single-tablet regimen
resistance
03 medical and health sciences
deep sequencing
Virology
Drug Resistance, Viral
medicine
darunavir/cobicistat/emtricitabine/TAF
Humans
Clinical Trials/Clinical Studies
Tenofovir
emtricitabine
DRUG-RESISTANCE
Science & Technology
TREATMENT-NAIVE PATIENTS
business.industry
Adenine
cobicistat
030104 developmental biology
TAF
HIV-1
business

Details

Language :
English
ISSN :
08892229 and 19318405
Database :
OpenAIRE
Journal :
AIDS Research and Human Retroviruses, AIDS Research and Human Retroviruses, Mary Ann Liebert, 2018, 36 (1), pp.48-57. ⟨10.1089/aid.2019.0111⟩, AIDS RESEARCH AND HUMAN RETROVIRUSES
Accession number :
edsair.doi.dedup.....8e42fe01a7f12873a66d8baa9c5f7f01

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Authors Abstract Subjects Details