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

Abstract

Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir-containing three-drug antiretroviral regimens. The aim of the study was 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 bictegravir/emtricitabine/tenofovir alafenamide (B/F/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% CI, 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in 3 participants, none with documented resistance and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in CD4 cell count was observed from the baseline (+ 59 cells/mmc, 95% confidence interval, 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 excellent safety profile.