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. 2025 Mar 1;39(3):270-275.
doi: 10.1097/QAD.0000000000004043. Epub 2024 Oct 24.

Impact of switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate to bictegravir/emtricitabine/tenofovir alafenamide on psychiatric symptoms and neurocognition

Alessandra Vergori  1 , Giulia Del Duca  1 , Patrizia Lorenzini  2 , Anna Clelia Brita  3 , Ilaria Mastrorosa  1 , Marisa Fusto  1 , Marta Camici  1 , Sandrine Ottou  1 , Roberta Gagliardini  1 , Jessica Paulicelli  1 , Federico De Zottis  1 , Elisabetta Grilli  1 , Rozenn Esvan  1 , Maria Maddalena Plazzi  1 , Valentina Mazzotta  1 , Rita Bellagamba  1 , Andrea Antinori  1 , Carmela Pinnetti  1
Affiliations

Impact of switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate to bictegravir/emtricitabine/tenofovir alafenamide on psychiatric symptoms and neurocognition

Alessandra Vergori et al. AIDS. .

Abstract

Objectives: The aim was to investigate whether switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/F/TDF) to bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) may improve neuropsychiatric symptoms and neurocognition.

Design: Pilot, single-arm, prospective study of persons with HIV (PWH) on the efficacy and safety of switching from EFV/F/TDF to BIC/F/TAF.

Methods: Participants underwent neuropsychological assessment (NPA) at switch (T0) and after 48 weeks (T1). NPA was carried out through a standardized battery of 12 tests. Neurocognitive impairment (NCI) was defined by a score of at least 1 standard deviation (SD) below the normal mean on at least two tests or ≥2 SD below on one test. Individual z scores were determined, NPZ-12 was calculated as the average of 12 test z scores and change of NPZ-12 was the outcome. HIV-associated neurocognitive disorder (HAND) was classified by Frascati's criteria. Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II), and Pittsburgh Sleep Quality Index (PSQI) were administered. Paired-Wilcoxon and McNemar tests were used for comparisons, and logistic regression for associations with NCI changes.

Results: Out of 126 participants, BAI, BDI-II, and PSQI questionnaires revealed an improvement at T1. NPA revealed NCI in 40.5% of persons at T0 and 42.1% at T1 ( P = 0.746). Specifically, at T0, among participants with NCI, 35% improved; among those without, 26% worsened at T1; NPZ-12 score worsened at T1. 5.6% of ANI was observed at T0 and 7.9% at T1. No factor associated with these changes was found.

Conclusion: Our results suggest switching from EFV/F/TDF to B/F/TAF significantly improves psychiatric symptoms and sleep quality. Neurocognitive performance remained stable, although a decline in NPZ-12 and in specific domains was observed.

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Conflict of interest statement

A.A. has served as a paid consultant to Astra-Zeneca, Gilead Sciences, GlaxoSmithKline, Janssen- Cilag, Merck, Moderna, Mylan, Pfizer, Sharp and Dohme, Roche, Theratotecnologies, and ViiV Healthcare and received research institutional grants from Gilead Sciences, Janssen-Cilag, and ViiV Healthcare, payment or honoraria from Gilead Science and ViiV Healthcare and support for attending meetings and/or travel from ViiV Healthcare and AbbVie. R.B. received grant for speaker's honoraria/advisory board by ViiV Healthcare, MSD, Janssen-Cilag, and Gilead Sciences. M.C. received institutional grant, support for attending meetings and/or travel and speakers’ honoraria from Gilead Sciences. R.G. reports payments to her institution from Gilead Sciences, speakers’ honoraria for ViiV Healthcare, Merck Sharp and Dohme and Gilead Sciences, advisor for Theratechnologies, Janssen-Cilag, and Gilead Sciences. I.M. received institutional research grant and support for attending meetings and/or travel from Gilead Sciences. C.P. received personal fee from Gilead Sciences for a case presentation and a travel grant and served on an advisory board for Janssen-Cilag. A.V. received an institutional grant from Gilead Sciences, speakers’ honoraria/educational activities from Merck Sharp & Dohme, Janssen-Cilag, Gilead Sciences, AstraZeneca, and served an advisor for Janssen-Cilag. The other co-authors declare no conflicts of interests for this work.

Figures

Fig. 1
Fig. 1
(a) Comparison of patients’ proportion with Beck Anxiety Inventory greater than 95%, Beck Depression Inventory (BDI-II SA, somatic-affective, BDI-II C, cognitive, BDI-II T, total) greater than 95%; (b) the presence of sleep disturbance according with Pittsburgh Sleep Quality Index (PSQI); (c) NPZ12 score at the time of switch (T0) and after 48 weeks (T1); (d) Mean z score of 12 cognitive tests through 5 different domains at the time of switch (T0) and after 48 weeks (T1).
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