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.