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Switching from efavirenz to rilpivirine improves sleep quality and self-perceived cognition but has no impact on neurocognitive performances

Results from a randomized controlled trial

Lapadula, Giuseppea; Bernasconi, Davide Paolob; Bai, Francescac; Focà, Emanueled; Di Biagio, Antonioe; Bonora, Stefanof; Castelli, Francescod; Squillace, Nicolaa; Bandera, Alessandrag; Monforte, Antonella d’Arminioc; Migliorino, Guglielmo Marcoa; Gori, Andreag for the SWEAR Study Group

doi: 10.1097/QAD.0000000000002377
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Background: Efavirenz (EFV) association with neurocognitive (NC) impairment is debated. Whether switching away from EFV improves NC performances is still controversial.

Methods: In a randomized open-label controlled trial, patients under effective treatment with tenofovir disoproxil-fumarate (TDF), emtricitabine (FTC) and EFV, who had altered NC assessment (Z-transformed score below −1 in ≥1 cognitive domains), depression, anxiety or low sleep-quality, were randomized 1:1 to immediate or delayed (24-weeks) switch to TDF/FTC/rilpivirine (RPV). Treatment efficacy, NC function, symptoms and quality of life were evaluated 12, 24 and 48 weeks after randomization.

Findings: 74 patients were randomized to immediate (36 patients) or delayed switch (38 patients). At baseline, 63% and 25% of patients had z-scores below −1 in ≥1 NC or 2 domains, 31.1%, 17.6% and 44.6% had significant depression or anxiety symptoms or low sleep-quality. At week 24 (primary end-point), overall NC improvement was observed, with no statistically significant differences between arms, neither considering the global z-score (between arms difference +0.1; P=0.458), nor domain-specific z-scores. Patients switching away from EFV had significant greater improvement of sleep quality index (between arms difference −1.5; P = 0.011), self-reported cognitive failures (−6.2; P = 0.001) and CNS symptoms score (−5; P = 0.002), but not of anxiety or depression. No protocol defined virological failure, grade ≥3 lab abnormalities or drug-related serious adverse events were reported.

Conclusions: Our results do not support the hypothesis that switching to RPV improves cognitive function in patient under stable treatment with EFV. Nonetheless, improvements in neuropsychiatric symptoms, sleep quality and self-perceived cognition were observed.

aSC Malattie Infettive, Ospedale San Gerardo, Monza, Italy;

bUniversity of Milano-Bicocca, Milan, Italy;

cOspedale San Paolo, University of Milan, Milan, Italy;

dClinica di Malattie Infettive e Tropicali, ASST Spedali Civili, University of Brescia, Brescia, Italy;

eClinica di Malattie Infettive, Ospedale San Martino, Genoa, Italy;

fClinica di Malattie Infettive, University of Turin, Turin, Italy;

gClinica di Malattie Infettive, IRCCS Fondazione Ca’ Granda Policinico di Milano, University of Milan, Milan, Italy.

Correspondence to Giuseppe Lapadula, M.D., Ph.D., San Gerardo Hospital, Monza, MB Italy. Tel: +g.lapadula@hsgerardo.org

Received 19 May, 2019

Revised 4 August, 2019

Accepted 10 August, 2019

Copyright © 2019 Wolters Kluwer Health, Inc.