Unit AIDS Research Network Cohort (CoRIS), National Center of Epidemiology (CNE), Health Institute Carlos III (ISCIII).
Hospital Universitario 12 de Octubre, Facultad de Medicina, Universidad Complutense de Madrid, Madrid.
AIDS. 2021 Jul 1;35(8):1283-1293. doi: 10.1097/QAD.0000000000002891.
The aim of this study was to examine the impact of late presentation (CD4+ cell count <350 cells/μl or an AIDS-defining event) on effectiveness and safety of initial antiretroviral therapy (ART) and to evaluate whether treatment response depends on first-line ART regimen in late presenters.
ART-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) starting triple ART between 2010 and 2018.
We used multivariable models to assess differences in viral suppression (viral load <50 copies/ml), immunological response (change in CD4+ cell count, CD4% (>29%) and CD4/CD8 normalization (>0.4 and >1) multiple T-cell marker recovery (MTMR): CD4+ cell count more than 500 cells/μl and CD4% >29% and CD4/CD8 >1), and treatment discontinuation due to adverse events (TDAE) at 48 weeks from ART initiation.
Out of 8002 participants, 48.7% were late presenters. Of them, 45.8% initiated ART with a NNRTI- (mostly TDF/FTC/EFV), 33.9% with a protease inhibitor (mostly TDF/FTC+boosted DRV) and 20.3% with an INI-based regimen (mostly ABC/3TC/DTG). At 48 weeks, late presenters had similar viral suppression, but worse immunological response, than non-late presenters with no difference on TDAE. Late presenters initiating with NNRTI-based regimens were more likely to achieve viral suppression than those starting with INI-based, due to the higher chance of achieving viral suppression observed with TDF/FTC/RPV compared to ABC/3TC/DTG. Initial treatment with NNRTI or protease inhibitor based showed similar immunological response than the INI-based regimens, which showed lower rates of TDAE than NNRTI- and protease inhibitor based regimens.
Despite safety and effectiveness of initial ART in terms of viral suppression, late presenters may not experience complete immunological response. In late presenters, effectiveness and safety depends on both the class and the specific first-line ART regimen.
本研究旨在探讨晚期发病（CD4+细胞计数<350 个/μl 或出现艾滋病定义性事件）对初始抗逆转录病毒治疗（ART）的效果和安全性的影响，并评估在晚期发病者中，治疗反应是否取决于一线 ART 方案。
本研究纳入了 2010 年至 2018 年间在西班牙艾滋病毒/艾滋病研究网络队列（CoRIS）中接受初次三联 ART 的初治成人。
我们使用多变量模型评估病毒抑制（病毒载量<50 拷贝/ml）、免疫反应（CD4+细胞计数变化、CD4%（>29%）和 CD4/CD8 比值正常化（>0.4 和>1）、多种 T 细胞标志物恢复（MTMR）：CD4+细胞计数超过 500 个/μl 且 CD4%>29%和 CD4/CD8>1）以及因不良事件（TDAE）在 ART 开始后 48 周停药的差异。
在 8002 名参与者中，48.7%为晚期发病者。其中，45.8%以非核苷类逆转录酶抑制剂（NNRTI）为基础（主要为 TDF/FTC/EFV），33.9%以蛋白酶抑制剂（主要为 TDF/FTC+ boosted DRV）为基础，20.3%以整合酶抑制剂（INI）为基础（主要为 ABC/3TC/DTG）。在 48 周时，晚期发病者的病毒抑制率与非晚期发病者相似，但免疫反应较差，而 TDAE 无差异。与 ABC/3TC/DTG 相比，NNRTI 为基础的方案中更可能实现病毒抑制，这归因于 TDF/FTC/RPV 方案观察到的病毒抑制率更高。以 NNRTI 或蛋白酶抑制剂为基础的初始治疗与以 INI 为基础的方案具有相似的免疫反应，后者比 NNRTI 和蛋白酶抑制剂为基础的方案具有更低的 TDAE 发生率。
尽管在病毒抑制方面，初始 ART 的安全性和效果良好，但晚期发病者可能无法实现完全的免疫反应。在晚期发病者中，效果和安全性取决于药物类别和特定的一线 ART 方案。
