Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.

Introduction: When darunavir (DRV) 800 mg is boosted with 150 mg cobicistat (DRVcobi), DRV trough concentration (Ctrough) is about 30% lower as compared to 100 mg ritonavir (DRVrtv). DRVcobi shows similar virological efficacy as DRVrtv when combined with two nucleos(t)ide analogue reverse-transcript...

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Autores: Gutierrez-Valencia, Alicia, Trujillo-Rodriguez, Maria, Fernandez-Magdaleno, Tamara, Espinosa, Nuria, Viciana, Pompeyo, López-Cortés, Luis F
Tipo de recurso: artículo
Fecha de publicación:2018
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/25242
Acceso en línea:https://hdl.handle.net/20.500.12105/25242
Access Level:acceso abierto
Palabra clave:Ctrough
Darunavir
Cobicistat
Monotherapy
Pharmacokinetic
Ritonavir
Adult
Anti-HIV Agents
Drug Therapy, Combination
Female
HIV Infections
Humans
Male
Middle Aged
Prospective Studies
Reverse Transcriptase Inhibitors
Viral Load
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oai_identifier_str oai:repisalud.isciii.es:20.500.12105/25242
network_acronym_str ES
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repository_id_str
spelling Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.Gutierrez-Valencia, AliciaTrujillo-Rodriguez, MariaFernandez-Magdaleno, TamaraEspinosa, NuriaViciana, PompeyoLópez-Cortés, Luis FCtroughDarunavirCobicistatMonotherapyPharmacokineticRitonavirAdultAnti-HIV AgentsCobicistatDarunavirDrug Therapy, CombinationFemaleHIV InfectionsHumansMaleMiddle AgedProspective StudiesReverse Transcriptase InhibitorsRitonavirViral LoadIntroduction: When darunavir (DRV) 800 mg is boosted with 150 mg cobicistat (DRVcobi), DRV trough concentration (Ctrough) is about 30% lower as compared to 100 mg ritonavir (DRVrtv). DRVcobi shows similar virological efficacy as DRVrtv when combined with two nucleos(t)ide analogue reverse-transcriptase inhibitors, but it is unknown whether a lower DRV Ctrough would undermine the effectiveness of DRVcobi when given as monotherapy (mtDRVcobi). Methods: Prospective observational study on virologically suppressed HIV-infected subjects who switched to mtDRVcobi . Virological failure was defined as two consecutive HIV-RNA >200 copies/mL. Efficacy was evaluated by intention-to-treat (ITT) and on-treatment (OT) analyses, and compared with data from a previous cohort of subjects on mtDRVrtv conducted at our centre. Plasma DRV Ctrough was measured using LC-MS/MS. Results: A total of 234 subjects were enrolled. At week 96, the efficacy rates were 67.8% (CI95 , 61.8 to 73.7) by ITT and 86.9% (CI95 , 78.0 to 87.7) by OT analyses. The corresponding rates in our historical DRVrtv controls were 67.6% (CI95 , 60.0 to 75.2) and 83.6% (CI95 : 77.2 to 90.0). A total of 135 DRV determinations were performed in 83 subjects throughout the follow-up period, with a median plasma DRV Ctrough of 1305 ng/mL (range, 150 to 5895) compared with 1710 ng/mL (range, 200 to 3838) in subjects on monotherapy with DRVrtv (p = 0.05). Conclusions: DRV Ctrough was lower in HIV-infected subjects receiving DRVcobi than with DRVrtv . However, this did not appear to influence the efficacy of DRVcobi , when administered as monotherapy.20242024-10-2320182018-01-0120182018-01-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articlehttps://hdl.handle.net/20.500.12105/25242reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/252422026-06-12T12:43:37Z
dc.title.none.fl_str_mv Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
title Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
spellingShingle Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
Gutierrez-Valencia, Alicia
Ctrough
Darunavir
Cobicistat
Monotherapy
Pharmacokinetic
Ritonavir
Adult
Anti-HIV Agents
Cobicistat
Darunavir
Drug Therapy, Combination
Female
HIV Infections
Humans
Male
Middle Aged
Prospective Studies
Reverse Transcriptase Inhibitors
Ritonavir
Viral Load
title_short Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
title_full Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
title_fullStr Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
title_full_unstemmed Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
title_sort Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations.
dc.creator.none.fl_str_mv Gutierrez-Valencia, Alicia
Trujillo-Rodriguez, Maria
Fernandez-Magdaleno, Tamara
Espinosa, Nuria
Viciana, Pompeyo
López-Cortés, Luis F
author Gutierrez-Valencia, Alicia
author_facet Gutierrez-Valencia, Alicia
Trujillo-Rodriguez, Maria
Fernandez-Magdaleno, Tamara
Espinosa, Nuria
Viciana, Pompeyo
López-Cortés, Luis F
author_role author
author2 Trujillo-Rodriguez, Maria
Fernandez-Magdaleno, Tamara
Espinosa, Nuria
Viciana, Pompeyo
López-Cortés, Luis F
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Ctrough
Darunavir
Cobicistat
Monotherapy
Pharmacokinetic
Ritonavir
Adult
Anti-HIV Agents
Cobicistat
Darunavir
Drug Therapy, Combination
Female
HIV Infections
Humans
Male
Middle Aged
Prospective Studies
Reverse Transcriptase Inhibitors
Ritonavir
Viral Load
topic Ctrough
Darunavir
Cobicistat
Monotherapy
Pharmacokinetic
Ritonavir
Adult
Anti-HIV Agents
Cobicistat
Darunavir
Drug Therapy, Combination
Female
HIV Infections
Humans
Male
Middle Aged
Prospective Studies
Reverse Transcriptase Inhibitors
Ritonavir
Viral Load
description Introduction: When darunavir (DRV) 800 mg is boosted with 150 mg cobicistat (DRVcobi), DRV trough concentration (Ctrough) is about 30% lower as compared to 100 mg ritonavir (DRVrtv). DRVcobi shows similar virological efficacy as DRVrtv when combined with two nucleos(t)ide analogue reverse-transcriptase inhibitors, but it is unknown whether a lower DRV Ctrough would undermine the effectiveness of DRVcobi when given as monotherapy (mtDRVcobi). Methods: Prospective observational study on virologically suppressed HIV-infected subjects who switched to mtDRVcobi . Virological failure was defined as two consecutive HIV-RNA >200 copies/mL. Efficacy was evaluated by intention-to-treat (ITT) and on-treatment (OT) analyses, and compared with data from a previous cohort of subjects on mtDRVrtv conducted at our centre. Plasma DRV Ctrough was measured using LC-MS/MS. Results: A total of 234 subjects were enrolled. At week 96, the efficacy rates were 67.8% (CI95 , 61.8 to 73.7) by ITT and 86.9% (CI95 , 78.0 to 87.7) by OT analyses. The corresponding rates in our historical DRVrtv controls were 67.6% (CI95 , 60.0 to 75.2) and 83.6% (CI95 : 77.2 to 90.0). A total of 135 DRV determinations were performed in 83 subjects throughout the follow-up period, with a median plasma DRV Ctrough of 1305 ng/mL (range, 150 to 5895) compared with 1710 ng/mL (range, 200 to 3838) in subjects on monotherapy with DRVrtv (p = 0.05). Conclusions: DRV Ctrough was lower in HIV-infected subjects receiving DRVcobi than with DRVrtv . However, this did not appear to influence the efficacy of DRVcobi , when administered as monotherapy.
publishDate 2018
dc.date.none.fl_str_mv 2018
2018-01-01
2018
2018-01-01
2024
2024-10-23
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/25242
url https://hdl.handle.net/20.500.12105/25242
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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