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. 2025 Jan;14(1):293-304.
doi: 10.1007/s40121-024-01083-1. Epub 2024 Nov 29.

Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial

Barbara Rossetti  1   2 , Micol Ferrara  3 , Lucia Taramasso  4 , Francesca Bai  5 , Francesca Lombardi  6 , Nicoletta Ciccarelli  7 , Miriam Durante  8 , Francesca Alladio  3 , Federica Bonazza  5 , Ilaria Rancan  9   8 , Francesca Montagnani  9   8 , Antonio Di Biagio  10 , Antonella d'Arminio Monforte  5 , Maurizio Zazzi  8 , Massimiliano Fabbiani  9   8 ; for DOBINeuro study group
Collaborators, Affiliations

Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial

Barbara Rossetti et al. Infect Dis Ther. 2025 Jan.

Abstract

Introduction: Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC).

Methods: DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for > 6 months and with HIV-RNA < 50 cps/ml for > 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus.

Results: A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom.

Conclusions: Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.

Keywords: Bictegravir; HIV; Neuropsychiatric symptoms; Switch.

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Conflict of interest statement

Declarations. Conflict of Interest: Barbara Rossetti, Micol Ferrara, Lucia Taramasso, Francesca Bai, Francesca Lombardi, Nicoletta Ciccarelli, Miriam Durante, Francesca Alladio, Federica Bonazza, Ilaria Rancan, Francesca Montagnani, Antonio Di Biagio, Antonella D’Arminio Monforte, Maurizio Zazzi, and Massimiliano Fabbiani confirm that they have no conflicts of interest to declare. Ethical Approval: The study was conducted in compliance with the Declaration of Helsinki and local review board regulations (protocol number 15045). All participants gave written informed consent to study participation before enrolment. The study was approved by the local ethics committee (protocol number 15045).

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