Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk

To compare the efficacy, safety, and impact on lipid fractions of switching from a ritonavir-boosted protease inhibitor (PI/r) to a dolutegravir (DTG) regimen. HIV type 1-infected adults more than 50 years or with a Framingham score more than 10% were eligible if plasma HIV RNA less than 50 copies p...

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Autores: Gatell, José Mª|||0000-0002-4705-3244, Assoumou, Lambert, Moyle, Graeme, Waters, Laura, Johnson, Margaret, Domingo Pedrol, Pedro|||0000-0003-1138-5770, Fox, Julie, Martinez, Esteban, Stellbrink, Hans-Jürgen, Guaraldi, Giovanni|||0000-0002-5724-3914, Masia, Mar, Gompels, Marl, De Wit, Stéphane, Florence, Eric|||0000-0002-7004-9120, Esser, Stefan, Raffi, François, Pozniak, Anton L.
Tipo de recurso: artículo
Fecha de publicación:2017
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:288447
Acceso en línea:https://ddd.uab.cat/record/288447
https://dx.doi.org/urn:doi:10.1097/QAD.0000000000001675
Access Level:acceso abierto
Palabra clave:Cardiovascular risk
Cholesterol
Dolutegravir
HIV-1
Lipids
Protease inhibitors
Randomized clinical trials
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spelling Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular riskGatell, José Mª|||0000-0002-4705-3244Assoumou, LambertMoyle, GraemeWaters, LauraJohnson, MargaretDomingo Pedrol, Pedro|||0000-0003-1138-5770Fox, JulieMartinez, EstebanStellbrink, Hans-JürgenGuaraldi, Giovanni|||0000-0002-5724-3914Masia, MarGompels, MarlDe Wit, StéphaneFlorence, Eric|||0000-0002-7004-9120Esser, StefanRaffi, FrançoisPozniak, Anton L.Cardiovascular riskCholesterolDolutegravirHIV-1LipidsProtease inhibitorsRandomized clinical trialsTo compare the efficacy, safety, and impact on lipid fractions of switching from a ritonavir-boosted protease inhibitor (PI/r) to a dolutegravir (DTG) regimen. HIV type 1-infected adults more than 50 years or with a Framingham score more than 10% were eligible if plasma HIV RNA less than 50 copies per ml for at least 24 weeks while on a PI/r regimen. Patients were randomized to switch to DTG or to remain on PI/r. Primary endpoints were: proportion maintaining HIV RNA less than 50 copies per ml and percentage change from baseline of total cholesterol at week 48. In total, 415 patients (32 sites in six European countries) were randomized: 205 to DTG and 210 to continue PI/r. About 89% were men, 87% more than 50 years, 74% had a Framingham score more than 10%, with a median CD4 + cell count of 617 cells per μl and suppressed viremia for a median of 5 years. At week 48, in the intent-to-treat analysis, treatment success rate was 93.1% in DTG group and 95.2% in PI/r group (difference -2.1%, 95% confidence interval -6.6 to 2.4, noninferiority demonstrated). There were four virological failures with DTG and one with PI/r with no emergent resistance mutations. There was no significant difference in severe adverse events or grade 3 or 4 adverse events or treatment modifying adverse events. Total cholesterol and other lipid fractions (except high-density lipoprotein cholesterol) improved significantly (P < 0.001) in the DTG group regardless of PI/r at baseline. Switching to a DTG regimen in virologically suppressed HIV type 1 patients with high cardiovascular disease risk was noninferior, and significantly improved lipid profiles.Universitat Autònoma de Barcelona 22017-01-0120172017-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/288447https://dx.doi.org/urn:doi:10.1097/QAD.0000000000001675reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengMinisterio de Economía y Competitividad https://doi.org/10.13039/501100003329 RD12/0017open accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2884472026-06-06T12:50:31Z
dc.title.none.fl_str_mv Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
title Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
spellingShingle Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
Gatell, José Mª|||0000-0002-4705-3244
Cardiovascular risk
Cholesterol
Dolutegravir
HIV-1
Lipids
Protease inhibitors
Randomized clinical trials
title_short Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
title_full Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
title_fullStr Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
title_full_unstemmed Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
title_sort Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk
dc.creator.none.fl_str_mv Gatell, José Mª|||0000-0002-4705-3244
Assoumou, Lambert
Moyle, Graeme
Waters, Laura
Johnson, Margaret
Domingo Pedrol, Pedro|||0000-0003-1138-5770
Fox, Julie
Martinez, Esteban
Stellbrink, Hans-Jürgen
Guaraldi, Giovanni|||0000-0002-5724-3914
Masia, Mar
Gompels, Marl
De Wit, Stéphane
Florence, Eric|||0000-0002-7004-9120
Esser, Stefan
Raffi, François
Pozniak, Anton L.
author Gatell, José Mª|||0000-0002-4705-3244
author_facet Gatell, José Mª|||0000-0002-4705-3244
Assoumou, Lambert
Moyle, Graeme
Waters, Laura
Johnson, Margaret
Domingo Pedrol, Pedro|||0000-0003-1138-5770
Fox, Julie
Martinez, Esteban
Stellbrink, Hans-Jürgen
Guaraldi, Giovanni|||0000-0002-5724-3914
Masia, Mar
Gompels, Marl
De Wit, Stéphane
Florence, Eric|||0000-0002-7004-9120
Esser, Stefan
Raffi, François
Pozniak, Anton L.
author_role author
author2 Assoumou, Lambert
Moyle, Graeme
Waters, Laura
Johnson, Margaret
Domingo Pedrol, Pedro|||0000-0003-1138-5770
Fox, Julie
Martinez, Esteban
Stellbrink, Hans-Jürgen
Guaraldi, Giovanni|||0000-0002-5724-3914
Masia, Mar
Gompels, Marl
De Wit, Stéphane
Florence, Eric|||0000-0002-7004-9120
Esser, Stefan
Raffi, François
Pozniak, Anton L.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Cardiovascular risk
Cholesterol
Dolutegravir
HIV-1
Lipids
Protease inhibitors
Randomized clinical trials
topic Cardiovascular risk
Cholesterol
Dolutegravir
HIV-1
Lipids
Protease inhibitors
Randomized clinical trials
description To compare the efficacy, safety, and impact on lipid fractions of switching from a ritonavir-boosted protease inhibitor (PI/r) to a dolutegravir (DTG) regimen. HIV type 1-infected adults more than 50 years or with a Framingham score more than 10% were eligible if plasma HIV RNA less than 50 copies per ml for at least 24 weeks while on a PI/r regimen. Patients were randomized to switch to DTG or to remain on PI/r. Primary endpoints were: proportion maintaining HIV RNA less than 50 copies per ml and percentage change from baseline of total cholesterol at week 48. In total, 415 patients (32 sites in six European countries) were randomized: 205 to DTG and 210 to continue PI/r. About 89% were men, 87% more than 50 years, 74% had a Framingham score more than 10%, with a median CD4 + cell count of 617 cells per μl and suppressed viremia for a median of 5 years. At week 48, in the intent-to-treat analysis, treatment success rate was 93.1% in DTG group and 95.2% in PI/r group (difference -2.1%, 95% confidence interval -6.6 to 2.4, noninferiority demonstrated). There were four virological failures with DTG and one with PI/r with no emergent resistance mutations. There was no significant difference in severe adverse events or grade 3 or 4 adverse events or treatment modifying adverse events. Total cholesterol and other lipid fractions (except high-density lipoprotein cholesterol) improved significantly (P < 0.001) in the DTG group regardless of PI/r at baseline. Switching to a DTG regimen in virologically suppressed HIV type 1 patients with high cardiovascular disease risk was noninferior, and significantly improved lipid profiles.
publishDate 2017
dc.date.none.fl_str_mv 2
2017-01-01
2017
2017-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
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://ddd.uab.cat/record/288447
https://dx.doi.org/urn:doi:10.1097/QAD.0000000000001675
url https://ddd.uab.cat/record/288447
https://dx.doi.org/urn:doi:10.1097/QAD.0000000000001675
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 RD12/0017
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/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
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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