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Introduction <p>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.</p> Methods <p>We identified 107 ART-naïve PLWH who started BIC/FTC/TAF between May 2019 and December 2022. BIC/FTC/TAF was initiated within 24&#xa0;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).</p> Results <p>A total of 107 PLWH were included; the mean age was 38.5&#xa0;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 &lt; 200 cells/μl), and the HIV-1 RNA was 4.9 log10 copies/ml (43.9% had &gt; 100,000 copies/ml). Acute/recent infection was diagnosed in 32 (29.9%) PLWH, and 4 (3.7%) were HBsAg positive. At 12&#xa0;months (range 9–15), the efficacy (HIV-1 RNA &lt; 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&#xa0;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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

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  • 发表日期：

    2025年3月28日

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  • Josip Begovac,
  • Iva Lisičar,
  • Vanja Romih Pintar,
  • Snježana Židovec-Lepej,
  • Ana Planinić,
  • Šime Zekan

摘要

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.