Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247). Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load >= 1000 copies/ml; CD4(+) cell count >50 cells/mu l) were ra...

Descripción completa

Detalles Bibliográficos
Autores: Orkin, Chloe, Eron, Joseph J., Rockstroh, Jürgen Kurt, Podzamczer Palter, Daniel, Esser, Stefan, Vandekerckhove, Linos, Van Landuyt, Erika, Lathouwers, Erkki, Hufkens, Veerle, Jezorwski, John, Opsomer, Magda, AMBER study group
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/173691
Acceso en línea:https://hdl.handle.net/2445/173691
Access Level:acceso abierto
Palabra clave:Infeccions per VIH
Antiretrovirals
HIV infections
Antiretroviral agents
id ES_9d4b87fa9f7df35d20c3d9c8a921acbb
oai_identifier_str oai:diposit.ub.edu:2445/173691
network_acronym_str ES
network_name_str España
repository_id_str
spelling Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patientsOrkin, ChloeEron, Joseph J.Rockstroh, Jürgen KurtPodzamczer Palter, DanielEsser, StefanVandekerckhove, LinosVan Landuyt, ErikaLathouwers, ErkkiHufkens, VeerleJezorwski, JohnOpsomer, MagdaAMBER study groupInfeccions per VIHAntiretroviralsHIV infectionsAntiretroviral agentsBackground: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247). Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load >= 1000 copies/ml; CD4(+) cell count >50 cells/mu l) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96. Results: At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load >= 50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control). Conclusion: At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients.Lippincott Williams & Wilkins2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/173691Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1097/QAD.0000000000002463Aids, 2020, vol. 34, num. 5, p. 707-718https://doi.org/10.1097/QAD.0000000000002463cc by-nc-nd (c) Orkin et al., 2020http://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1736912026-05-27T06:46:51Z
dc.title.none.fl_str_mv Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
title Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
spellingShingle Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
Orkin, Chloe
Infeccions per VIH
Antiretrovirals
HIV infections
Antiretroviral agents
title_short Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
title_full Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
title_fullStr Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
title_full_unstemmed Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
title_sort Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients
dc.creator.none.fl_str_mv Orkin, Chloe
Eron, Joseph J.
Rockstroh, Jürgen Kurt
Podzamczer Palter, Daniel
Esser, Stefan
Vandekerckhove, Linos
Van Landuyt, Erika
Lathouwers, Erkki
Hufkens, Veerle
Jezorwski, John
Opsomer, Magda
AMBER study group
author Orkin, Chloe
author_facet Orkin, Chloe
Eron, Joseph J.
Rockstroh, Jürgen Kurt
Podzamczer Palter, Daniel
Esser, Stefan
Vandekerckhove, Linos
Van Landuyt, Erika
Lathouwers, Erkki
Hufkens, Veerle
Jezorwski, John
Opsomer, Magda
AMBER study group
author_role author
author2 Eron, Joseph J.
Rockstroh, Jürgen Kurt
Podzamczer Palter, Daniel
Esser, Stefan
Vandekerckhove, Linos
Van Landuyt, Erika
Lathouwers, Erkki
Hufkens, Veerle
Jezorwski, John
Opsomer, Magda
AMBER study group
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Infeccions per VIH
Antiretrovirals
HIV infections
Antiretroviral agents
topic Infeccions per VIH
Antiretrovirals
HIV infections
Antiretroviral agents
description Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247). Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load >= 1000 copies/ml; CD4(+) cell count >50 cells/mu l) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96. Results: At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load >= 50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control). Conclusion: At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/173691
url https://hdl.handle.net/2445/173691
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1097/QAD.0000000000002463
Aids, 2020, vol. 34, num. 5, p. 707-718
https://doi.org/10.1097/QAD.0000000000002463
dc.rights.none.fl_str_mv cc by-nc-nd (c) Orkin et al., 2020
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by-nc-nd (c) Orkin et al., 2020
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Lippincott Williams & Wilkins
publisher.none.fl_str_mv Lippincott Williams & Wilkins
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869414730949459968
score 15,300724

Similares en LA Referencia