International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025
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).
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Gagliardini Roberta, Camici Marta, Lanini Simone, Bellagamba Rita, Ottou Sandrine, Plazzi Maria Maddalena, Vergori Alessandra, Mazzotta Valentina, Mondi Annalisa, Fusto Marisa, Paulicelli Jessica, Tempestilli Massimo, Pinnetti Carmela, Grilli Elisabetta, Mastrorosa Ilaria, De Zottis Federico, Duca Giulia Del, Antinori Andrea
Аннотация
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.
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.
Предметные рубрики MeSH
HumansHIV InfectionsMaleFemaleAdultEmtricitabineAnti-HIV AgentsTenofovirMiddle AgedProspective StudiesCyclopropanesViral LoadAdeninePyridonesPilot ProjectsAlaninePiperazinesHeterocyclic Compounds, 4 or More RingsAlkynesAmidesTreatment OutcomeDrug SubstitutionBenzoxazinesDrug CombinationsHIV-1CD4 Lymphocyte CountHeterocyclic Compounds, 3-Ring