Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Introduced at the First Clinical Visit: A Real-Life Single-Arm Single-center Retrospective Cohort Study

Abstract Introduction Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral (ART) regimen. Croatia has centralized care for people living with HIV (PLWH) in a single center, with a same-day ART initiation model whenever suitable. This retrospective...

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Main Authors: Josip Begovac, Iva Lisičar, Vanja Romih Pintar, Snježana Židovec-Lepej, Ana Planinić, Šime Zekan
Format: Article
Language:English
Published: Adis, Springer Healthcare 2025-03-01
Series:Infectious Diseases and Therapy
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Online Access:https://doi.org/10.1007/s40121-025-01139-w
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Summary:Abstract Introduction Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral (ART) regimen. Croatia has centralized care for people living with HIV (PLWH) in a single center, with a same-day ART initiation model whenever suitable. This retrospective cohort study aimed to determine whether same-day BIC/FTC/TAF initiation in a real-life setting is an effective regimen for achieving viral suppression. Methods We identified 107 ART-naïve PLWH who started BIC/FTC/TAF between May 2019 and December 2022. BIC/FTC/TAF was initiated within 24 h of the first clinical visit. To emulate a prospective clinical trial, we present our efficacy results for the whole population (intention-to-treat, ITT) and those evaluated (on treatment, OT). Results A total of 107 PLWH were included; the mean age was 38.5 years, 103 (96.3%) were male, and all PLWH were white. The mean CD4 count was 343.8 cells/μl (26.2% had a CD4 count < 200 cells/μl), and the HIV-1 RNA was 4.9 log10 copies/ml (43.9% had > 100,000 copies/ml). Acute/recent infection was diagnosed in 32 (29.9%) PLWH, and 4 (3.7%) were HBsAg positive. At 12 months (range 9–15), the efficacy (HIV-1 RNA < 50 copies/ml) in the ITT analysis was 78.5%, and the OT efficacy was 91.3%. Among the 15 PLWH who did not have viral load (VL) measurements at 12 months, nine had a subsequent undetectable VL, three were lost to follow-up, two moved, and one died. No discontinuations of BIC/FTC/TAF were observed. Conclusions In our real-life clinical setting, same-day treatment with BIC/FTC/TAF was an efficacious and feasible option for achieving viral suppression in treatment-naïve PLWH.
ISSN:2193-8229
2193-6382