Department of Infectious Diseases, Hospital Universitario Reina Sofia, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba (UCO), Córdoba, Spain.
Department of Infectious Diseases, Hospital Universitario Reina Sofia, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba (UCO), Córdoba, Spain; CIBERINFEC, ISCIII - CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III, 28029 Madrid, Spain.
Int J Antimicrob Agents. 2024 Jan;63(1):107016. doi: 10.1016/j.ijantimicag.2023.107016. Epub 2023 Oct 26.
The efficacy of BIC/FTC/TAF in HIV late presenters initiating antiretroviral therapy (ART) has not been sufficiently evaluated.
The aim of this study was to assess the effectiveness and tolerability of BIC/FTC/TAF compared to other first-line antiretroviral regimens in treatment-naïve adult individuals from the CoRIS Cohort starting ART with CD4 counts <200 cells/mm and/or AIDS-defining conditions between January 1st 2019 and November 30th 2020. Logistic regression models were used to estimate odds ratios (ORs) of association between initial regimen and achievement of viral suppression (VS) (primary objective), defined as HIV RNA <50 cop/mL, and immunological recovery (IR) (secondary objective), defined as CD4 count >200 cells/mm, at weeks 24 and 48 after initiation of ART.
We evaluated 314 individuals (84.7% men, median age 40 years). Of them, 158 initiated with BIC/FTC/TAF. At inclusion, 117 had an AIDS-defining condition. In multivariable analyses, individuals with AIDS-defining conditions initiating ART with BIC/FTC/TAF achieved higher rates of VS at 24 weeks than other regimens (aOR: 0.2; 95% CI: 0.06-0.64) and, at 48 weeks, than DTG/ABC/3TC (aOR: 0.06; 95% CI: 0.01-0.76) and DTG + TDF/3TC (aOR: 0.2; 95% CI: 0.47-0.9). No other differences in VS or IR were observed. At 24 and 48 weeks after ART initiation, treatment discontinuations were lower with BIC/FTC/TAF than with other regimens (3.2% and 7.6% vs. 24.4% and 37.8%, respectively; P < 0.005).
Our results suggest that BIC/FTC/TAF could be a preferred regimen as initial therapy in HIV late presenters because of its high effectiveness and good tolerability.
尚未充分评估在开始抗逆转录病毒治疗（ART）时已处于 HIV 晚期的患者中，比克替拉韦/恩曲他滨/丙酚替诺福韦（BIC/FTC/TAF）的疗效。
本研究的目的是评估初治成人个体在开始 ART 时 CD4 计数<200 个细胞/mm³和/或存在 AIDS 定义性疾病的情况下，与其他一线抗逆转录病毒方案相比，BIC/FTC/TAF 的有效性和耐受性。该研究纳入了 2019 年 1 月 1 日至 2020 年 11 月 30 日期间来自 CoRIS 队列的、接受 CD4 计数<200 个细胞/mm³和/或 AIDS 定义性疾病的治疗初治成人个体。采用 logistic 回归模型来估计初始方案与病毒学抑制（VS）（主要终点）和免疫恢复（IR）（次要终点）之间的关联比值比（OR），定义为 HIV RNA<50 拷贝/mL 和 CD4 计数>200 个细胞/mm³。
我们评估了 314 名个体（84.7%为男性，中位年龄 40 岁）。其中，158 名个体起始使用 BIC/FTC/TAF。纳入时，117 名个体存在 AIDS 定义性疾病。多变量分析显示，存在 AIDS 定义性疾病的个体在开始 ART 时使用 BIC/FTC/TAF 治疗时，24 周时的 VS 率高于其他方案（调整比值比[aOR]：0.2；95%置信区间：0.06-0.64），在 48 周时，高于比克替拉韦/恩曲他滨/丙酚替诺福韦（aOR：0.06；95%置信区间：0.01-0.76）和比克替拉韦+替诺福韦/恩曲他滨（aOR：0.2；95%置信区间：0.47-0.9）。未观察到 VS 或 IR 方面的其他差异。在 ART 开始后 24 和 48 周时，BIC/FTC/TAF 治疗中断率低于其他方案（分别为 3.2%和 7.6%，以及 24.4%和 37.8%；P<0.005）。
我们的结果表明，由于 BIC/FTC/TAF 具有高效性和良好的耐受性，因此在 HIV 晚期患者中作为初始治疗方案可能是一种首选方案。
