Open Access

Analysis of the 2‑year real‑world efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV

  • Authors:
    • Ylenia Russotto
    • Antonino Gaspare Saia
    • Laura Santoro
    • Emmanuele Venanzi Rullo
    • Giovanni Francesco Pellicanò
  • View Affiliations

  • Published online on: August 13, 2025     https://doi.org/10.3892/wasj.2025.385
  • Article Number: 97
  • Copyright : © Russotto et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY 4.0].

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Abstract

Integrase strand transfer inhibitors (INSTIs) have proven to be effective and relatively safe drugs for people living with human immunodeficiency virus (HIV; PLWH). However, they have been found to be associated with an increased risk of developing cardiovascular events and weight gain. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a relatively recent INSTI that has exhibited optimal efficacy in controlling the HIV viral load and restoring the immune system. The present study collected data from HIV‑positive patients (n=38), 10 PLWH naïve to treatment and 28 experienced PLWH, in current therapy with B/F/TAF, comparing three different time points (T0, T1 and T2) in order to evaluate effectiveness, safety, lipid profile, hepatic and renal function, in a 2‑year observational study since the commencement of the antiretroviral therapy regimen. The results revealed a statistically significant improvement in the lymphocyte CD4+ count from T0 to T1 (P‑value 0.011) and T2 vs. T0 (P‑value ≤0.001) in naïve PLWH, as well as an increase in cholesterol low‑density lipoprotein levels (P‑value 0.043) and weight gain (T2 vs. T0 P‑value 0.003). No significant differences were found in experienced PLWH. During the study, numerous cases of HIV viraemia >50 cps/ml, but <500 cps/ml were observed. On the whole, the findings presented herein may add value to the literature regarding the efficacy of B/F/TAF, particularly due to numerous cases exhibiting low‑level viraemia. 
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November-December 2025
Volume 7 Issue 6

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Spandidos Publications style
Russotto Y, Saia A, Santoro L, Venanzi Rullo E and Pellicanò GF: Analysis of the 2‑year real‑world efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV. World Acad Sci J 7: 97, 2025.
APA
Russotto, Y., Saia, A., Santoro, L., Venanzi Rullo, E., & Pellicanò, G.F. (2025). Analysis of the 2‑year real‑world efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV. World Academy of Sciences Journal, 7, 97. https://doi.org/10.3892/wasj.2025.385
MLA
Russotto, Y., Saia, A., Santoro, L., Venanzi Rullo, E., Pellicanò, G. F."Analysis of the 2‑year real‑world efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV". World Academy of Sciences Journal 7.6 (2025): 97.
Chicago
Russotto, Y., Saia, A., Santoro, L., Venanzi Rullo, E., Pellicanò, G. F."Analysis of the 2‑year real‑world efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in people living with HIV". World Academy of Sciences Journal 7, no. 6 (2025): 97. https://doi.org/10.3892/wasj.2025.385