Begovac Josip, Lisičar Iva, Romih Pintar Vanja, Židovec-Lepej Snježana, Planinić Ana, Zekan Šime
University Hospital for Infectious Diseases, Mirogojska 8, 10000, Zagreb, Croatia.
School of Medicine, University of Zagreb, Šalata 3, 10000, Zagreb, Croatia.
Infect Dis Ther. 2025 Apr;14(4):867-880. doi: 10.1007/s40121-025-01139-w. Epub 2025 Mar 28.
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.
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).
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.
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.
比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）是一种推荐的一线抗逆转录病毒（ART）方案。克罗地亚在单一中心为艾滋病毒感染者（PLWH）提供集中护理，只要合适就采用当日启动抗逆转录病毒治疗的模式。这项回顾性队列研究旨在确定在现实生活环境中当日启动BIC/FTC/TAF是否是实现病毒抑制的有效方案。
我们确定了107名初治PLWH，他们在2019年5月至2022年12月期间开始使用BIC/FTC/TAF。BIC/FTC/TAF在首次临床就诊后24小时内启动。为模拟前瞻性临床试验，我们展示了整个人群（意向性治疗，ITT）和接受评估者（接受治疗，OT）的疗效结果。
共纳入107名PLWH；平均年龄为38.5岁，103名（96.3%）为男性，所有PLWH均为白人。平均CD4细胞计数为343.8个/μl（26.2%的患者CD4细胞计数<200个/μl），HIV-1 RNA为4.9 log10拷贝/ml（43.9%的患者>100,000拷贝/ml）。32名（29.9%）PLWH被诊断为急性/近期感染，4名（3.7%）为HBsAg阳性。在12个月时（范围为9至15个月），ITT分析中的疗效（HIV-1 RNA<50拷贝/ml）为78.5%，OT疗效为91.3%。在12个月时未进行病毒载量（VL）测量的15名PLWH中，9名随后病毒载量不可检测，3名失访，2名迁移，1名死亡。未观察到BIC/FTC/TAF停药情况。
在我们的现实临床环境中，当日使用BIC/FTC/TAF治疗是初治PLWH实现病毒抑制的有效且可行的选择。
