Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418

Background. Although switching antiretroviral therapy (ART) in people with human immunodeficiency virus experiencing insomnia due to dolutegravir-related neurotoxicity is well founded upon evidence, there is a lack of proof in regard to the outcome of stopping dolutegravir-based ART in people withou...

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Autores: Cabello Úbeda, Alfonso, González Baeza, Alicia, Troya García, Jesús, Fuente Moral, Sara de la, Novella Mena, María, Pinto Martínez, Adriana, Micán, Rafael, Cuevas Tascón, Guillermo, Díaz de Santiago, Alberto, Sanz Morerno, José, Rial Crestelo, David, Busca Arenzana, Carmen, Bernardino Serna, José Ignacio, Díaz Almirón, Mariana, Cano, Joanna, Esteban, Herminia, Pérez Valero, Ignacio, Górgolas Hernández-Mora, Miguel
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/715327
Acceso en línea:http://hdl.handle.net/10486/715327
https://dx.doi.org/10.1093/ofid/ofac345
Access Level:acceso abierto
Palabra clave:clinical trial
CNS
darunavir
dolutegravir
neurotoxicity
Medicina
Psicología
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spelling Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418Cabello Úbeda, AlfonsoGonzález Baeza, AliciaTroya García, JesúsFuente Moral, Sara de laNovella Mena, MaríaPinto Martínez, AdrianaMicán, RafaelCuevas Tascón, GuillermoDíaz de Santiago, AlbertoSanz Morerno, JoséRial Crestelo, DavidBusca Arenzana, CarmenBernardino Serna, José IgnacioDíaz Almirón, MarianaCano, JoannaEsteban, HerminiaPérez Valero, IgnacioGórgolas Hernández-Mora, Miguelclinical trialCNSdarunavirdolutegravirneurotoxicityMedicinaPsicologíaBackground. Although switching antiretroviral therapy (ART) in people with human immunodeficiency virus experiencing insomnia due to dolutegravir-related neurotoxicity is well founded upon evidence, there is a lack of proof in regard to the outcome of stopping dolutegravir-based ART in people without insomnia but reporting poor sleep quality. Methods. This is a randomized, multicenter, open-label study to evaluate the reversibility of patient-reported sleep disturbances in patients on dolutegravir/lamivudine/abacavir without insomnia after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants were randomized to switch ART at baseline or at week 4 and then completed 8 weeks of darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Our primary objective was to compare changes in sleep quality between arms at week 4. Secondary objectives were to compare changes in mood and neuropsychiatric symptoms (NS) at week 4 and 4 and 8 weeks after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants completed a survey, including the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression scale (HADS), and specific questions to explore NS, at each visit to assess those objectives. Results. We included 72 participants. The results show that study arms were similar at baseline; however, at week 4, PSQI scores remained unchanged with dolutegravir/lamivudine/abacavir, whereas patients improved significantly after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Similar differences between arms were also observed in HADS and NS changes. At weeks 4 and 8 after all participants switched to darunavir/cobicistat/emtricitabine/tenofovir alafenamide, we have observed significant improvements in PSQI and HAD scores and in NS. Conclusions. In patients reporting subclinical sleep disturbances without insomnia, switching from dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide was associated with better sleep quality and improvements in mood and NSThis work was funded by an unrestricted grant from Janssen Cilag S.A (Spain)Oxford University PressDepartamento de Psicología Biológica y de la SaludFacultad de Psicología20222022-08-06research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/715327https://dx.doi.org/10.1093/ofid/ofac345reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7153272026-06-23T12:46:27Z
dc.title.none.fl_str_mv Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
title Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
spellingShingle Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
Cabello Úbeda, Alfonso
clinical trial
CNS
darunavir
dolutegravir
neurotoxicity
Medicina
Psicología
title_short Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
title_full Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
title_fullStr Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
title_full_unstemmed Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
title_sort Changes in quality of sleep, mood, and other neuropsychiatric symptoms after switching dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a randomized study of people with Human Immunodeficiency Virus with poor sleep quality: GESIDA 10418
dc.creator.none.fl_str_mv Cabello Úbeda, Alfonso
González Baeza, Alicia
Troya García, Jesús
Fuente Moral, Sara de la
Novella Mena, María
Pinto Martínez, Adriana
Micán, Rafael
Cuevas Tascón, Guillermo
Díaz de Santiago, Alberto
Sanz Morerno, José
Rial Crestelo, David
Busca Arenzana, Carmen
Bernardino Serna, José Ignacio
Díaz Almirón, Mariana
Cano, Joanna
Esteban, Herminia
Pérez Valero, Ignacio
Górgolas Hernández-Mora, Miguel
author Cabello Úbeda, Alfonso
author_facet Cabello Úbeda, Alfonso
González Baeza, Alicia
Troya García, Jesús
Fuente Moral, Sara de la
Novella Mena, María
Pinto Martínez, Adriana
Micán, Rafael
Cuevas Tascón, Guillermo
Díaz de Santiago, Alberto
Sanz Morerno, José
Rial Crestelo, David
Busca Arenzana, Carmen
Bernardino Serna, José Ignacio
Díaz Almirón, Mariana
Cano, Joanna
Esteban, Herminia
Pérez Valero, Ignacio
Górgolas Hernández-Mora, Miguel
author_role author
author2 González Baeza, Alicia
Troya García, Jesús
Fuente Moral, Sara de la
Novella Mena, María
Pinto Martínez, Adriana
Micán, Rafael
Cuevas Tascón, Guillermo
Díaz de Santiago, Alberto
Sanz Morerno, José
Rial Crestelo, David
Busca Arenzana, Carmen
Bernardino Serna, José Ignacio
Díaz Almirón, Mariana
Cano, Joanna
Esteban, Herminia
Pérez Valero, Ignacio
Górgolas Hernández-Mora, Miguel
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Psicología Biológica y de la Salud
Facultad de Psicología
dc.subject.none.fl_str_mv clinical trial
CNS
darunavir
dolutegravir
neurotoxicity
Medicina
Psicología
topic clinical trial
CNS
darunavir
dolutegravir
neurotoxicity
Medicina
Psicología
description Background. Although switching antiretroviral therapy (ART) in people with human immunodeficiency virus experiencing insomnia due to dolutegravir-related neurotoxicity is well founded upon evidence, there is a lack of proof in regard to the outcome of stopping dolutegravir-based ART in people without insomnia but reporting poor sleep quality. Methods. This is a randomized, multicenter, open-label study to evaluate the reversibility of patient-reported sleep disturbances in patients on dolutegravir/lamivudine/abacavir without insomnia after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants were randomized to switch ART at baseline or at week 4 and then completed 8 weeks of darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Our primary objective was to compare changes in sleep quality between arms at week 4. Secondary objectives were to compare changes in mood and neuropsychiatric symptoms (NS) at week 4 and 4 and 8 weeks after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. The participants completed a survey, including the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression scale (HADS), and specific questions to explore NS, at each visit to assess those objectives. Results. We included 72 participants. The results show that study arms were similar at baseline; however, at week 4, PSQI scores remained unchanged with dolutegravir/lamivudine/abacavir, whereas patients improved significantly after switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Similar differences between arms were also observed in HADS and NS changes. At weeks 4 and 8 after all participants switched to darunavir/cobicistat/emtricitabine/tenofovir alafenamide, we have observed significant improvements in PSQI and HAD scores and in NS. Conclusions. In patients reporting subclinical sleep disturbances without insomnia, switching from dolutegravir/lamivudine/abacavir to darunavir/cobicistat/emtricitabine/tenofovir alafenamide was associated with better sleep quality and improvements in mood and NS
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-08-06
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 http://hdl.handle.net/10486/715327
https://dx.doi.org/10.1093/ofid/ofac345
url http://hdl.handle.net/10486/715327
https://dx.doi.org/10.1093/ofid/ofac345
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-NonCommercial-NoDerivatives 4.0 International
http://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
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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