RT Journal Article
T1 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.
A1 Cabello-Ubeda, Alfonso
A1 Baeza, Alicia Gonzalez
A1 Garcia, Jesus Troya
A1 de La Fuente Moral, Sara
A1 Mena, Maria Novella
A1 Martinez, Adriana Pinto
A1 Mican, Rafael
A1 Gorgolas, Miguel
A1 Tascon, Guillermo Cuevas
A1 de Santiago, Alberto Diaz
A1 Morerno, Jose Sanz
A1 Crestelo, David Rial
A1 Arenzana, Carmen Busca
A1 Serna, Jose Ignacio Bernardino
A1 Almiron, Mariana Diaz
A1 Cano, Joanna
A1 Esteban, Herminia
A1 Perez-Valero, Ignacio
K1 CNS
K1 Clinical trial
K1 Darunavir
K1 Dolutegravir
K1 Neurotoxicity
AB 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. 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. 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. 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.
PB Oxford University Press
SN 2328-8957
YR 2022
FD 2022-07-01
LK http://hdl.handle.net/10668/19825
UL http://hdl.handle.net/10668/19825
LA en
NO Cabello-Úbeda A, Baeza AG, García JT, de La Fuente Moral S, Mena MN, Martínez AP, et al. 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. Open Forum Infect Dis. 2022 Aug 6;9(9):ofac345
DS RISalud
RD Apr 7, 2025