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...

Full description

Bibliographic Details
Authors: 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
Format: article
Publication Date:2022
Country:España
Institution:Universidad Autónoma de Madrid
Repository:Biblos-e Archivo. Repositorio Institucional de la UAM
Language:English
OAI Identifier:oai:repositorio.uam.es:10486/715327
Online Access:http://hdl.handle.net/10486/715327
https://dx.doi.org/10.1093/ofid/ofac345
Access Level:Open access
Keyword:clinical trial
CNS
darunavir
dolutegravir
neurotoxicity
Medicina
Psicología
Description
Summary: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

Similar Items