Evidence map›Paper›PMID 36147597›Full record

ArticleOpen forum infectious diseases2022

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.

Alfonso Cabello-Úbeda, Alicia González Baeza, Jesús Troya García, Sara de La Fuente Moral, María Novella Mena, Adriana Pinto Martínez, Rafael Micán, Miguel Górgolas, Guillermo Cuevas Tascón, Alberto Díaz de Santiago and 8 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 1 country.

Alfonso Cabello-ÚbedaDivisión de Enfermedades Infecciosas, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Alicia González BaezaDepartamento de Psicobiología, Facultad de Psicología, Universidad Autónoma de Madrid, Madrid, Spain.
Jesús Troya GarcíaServicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain.ORCID https://orcid.org/0000-0001-7323-114X
Sara de La Fuente MoralServicio de Medicina Interna, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
María Novella MenaServicio de Medicina Interna, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain.
Adriana Pinto MartínezFundación de Investigación i+12, Madrid, Spain.
Rafael MicánServicio de Medicina Interna, Hospital Universitario La Paz-IDIPAZ, Madrid, Spain.
Miguel GórgolasDivisión de Enfermedades Infecciosas, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Guillermo Cuevas TascónServicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain.ORCID https://orcid.org/0000-0001-7875-6359
Alberto Díaz de SantiagoServicio de Medicina Interna, Hospital Universitario Puerta de Hierro, Majadahonda, Spain.
José Sanz MorernoServicio de Medicina Interna, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain.
David Rial CresteloFundación de Investigación i+12, Madrid, Spain.
Carmen Busca ArenzanaServicio de Medicina Interna, Hospital Universitario La Paz-IDIPAZ, Madrid, Spain.
José Ignacio Bernardino SernaServicio de Medicina Interna, Hospital Universitario La Paz-IDIPAZ, Madrid, Spain.ORCID https://orcid.org/0000-0002-3488-7135
Mariana Díaz AlmirónUnidad de Bioestadística, Instituto de Investigación Biomédica Hospital La Paz (IDIPAZ), Madrid, Spain.
Joanna CanoServicio de Medicina Interna, Hospital Universitario La Paz-IDIPAZ, Madrid, Spain.
Herminia EstebanFundación SEIMC-GESIDA, Madrid, Spain.
Ignacio Pérez-ValeroServicio de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III (CIBERINFEC, ISCIII), Córdoba, Spain.
Hospital Universitario La Paz · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario Infanta Leonor · ESHospital Universitario Príncipe de Asturias · ESHospital Universitario Puerta de Hierro Majadahonda · ESFundación Seimc-Gesida · ESHospital La Paz Institute for Health Research · ESInstituto de Salud Carlos III · ESUniversidad Autónoma de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

clinical trialCNSdarunavirdolutegravirneurotoxicity

Identifiers

PMID36147597
PMCPMC9487706
OpenAlexW4290075611

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.