Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)

Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)

Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/...

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Main Authors: Roberta Gagliardini, Marta Camici, Simone Lanini, Rita Bellagamba, Sandrine Ottou, Maria Maddalena Plazzi, Alessandra Vergori, Valentina Mazzotta, Annalisa Mondi, Marisa Fusto, Jessica Paulicelli, Massimo Tempestilli, Carmela Pinnetti, Elisabetta Grilli, Ilaria Mastrorosa, Federico De Zottis, Giulia Del Duca, Andrea Antinori
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:International Journal of Infectious Diseases
Subjects:
ART optimization
Integrase strand transfer inhibitor
Antiretroviral therapy
ART-experienced
Bictegravir
EFV-based regimen
Online Access:http://www.sciencedirect.com/science/article/pii/S1201971225001857
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Summary:Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH). Methods: A pilot, single-arm, prospective study was conducted. Results: Overall, 234 PWH were enrolled. 217 of 234 (92.7%, 95% confidence interval [CI], 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in three participants, none with documented resistance, and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in cluster of differentiation (CD)4 cell count was observed from the baseline (+ 59 cells/mmc, 95% CI, 31; 86, P <0.001), but not in CD4/CD8 ratio. A slight increase in creatinine (mean change +0.11 mg/dl, 95% CI 0.10; 0.13, P <0.001) and a decrease in total cholesterol (mean change −8 mg/dl, 95% CI −14; −3, P = 0.001) were also observed. Conclusions: Our data showed that BIC/FTC/TAF demonstrated high virologic and immunologic efficacy and an excellent safety profile.
ISSN:1201-9712

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