Published 2025
| Version v1
Publication
Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial
Creators
- Rossetti, Barbara
- Ferrara, Micol
- Taramasso, Lucia
- Bai, Francesca
- Lombardi, Francesca
- Ciccarelli, Nicoletta
- Durante, Miriam
- Alladio, Francesca
- Bonazza, Federica
- Rancan, Ilaria
- Montagnani, Francesca
- Di Biagio, Antonio
- Monforte, Antonella d'Arminio
- Zazzi, Maurizio
- Fabbiani, Massimiliano
- null, null
- De Luca, Andrea
- Lanari, Alessandro
- Masini, Melissa
- Zanelli, Giacomo
- Bianchi, Sabrina
- Girtler, Nicola Giovanni
- Miraglia, Federica
- De Flaviis, Federica
- Di Giambenedetto, Simona
- Lamonica, Silvia
- Bonora, Stefano
- Trentini, Laura
Contributors
Others:
- Rossetti, Barbara
- Ferrara, Micol
- Taramasso, Lucia
- Bai, Francesca
- Lombardi, Francesca
- Ciccarelli, Nicoletta
- Durante, Miriam
- Alladio, Francesca
- Bonazza, Federica
- Rancan, Ilaria
- Montagnani, Francesca
- Di Biagio, Antonio
- Monforte, Antonella d'Arminio
- Zazzi, Maurizio
- Fabbiani, Massimiliano
- Null, Null
- De Luca, Andrea
- Lanari, Alessandro
- Masini, Melissa
- Zanelli, Giacomo
- Bianchi, Sabrina
- Girtler, Nicola Giovanni
- Miraglia, Federica
- De Flaviis, Federica
- Di Giambenedetto, Simona
- Lamonica, Silvia
- Bonora, Stefano
- Trentini, Laura
Description
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.
Additional details
Identifiers
- URL
- https://hdl.handle.net/11567/1224335
- URN
- urn:oai:iris.unige.it:11567/1224335
Origin repository
- Origin repository
- UNIGE