Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Institute of Biomedicine of Seville/Virgen del Rocio University Hospital/The Spanish National Research Council (CSIC)/University of Seville, Seville, Spain.
Department of Clinical Biochemistry, Institute of Biomedicine of Seville/Virgen del Rocio University Hospital/The Spanish National Research Council (CSIC)/University of Seville, Seville, Spain.
Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024.
To compare the long-term effects on immune parameters, inflammation, and HIV-1 reservoir after switching to a two-drug (2DR) versus maintaining an integrase inhibitor (InSTI)-based three-drug regimen (3DR).
Cross-sectional study in which HIV-1 treatment-naïve people started and maintained an InSTI-based 3DR or, at different times, switched to 2DR (dolutegravir or darunavir/cobicistat + lamivudine). CD4 and CD8 T-cell activation and exhaustion, plasma concentrations of hs-CRP, D-dimer, P-selectin, IL-1β, IL-6, TNF-α, IFN-γ, IP-10, sTNFR-I/II, MIP-1α/β, I-FABP, LBP, sCD14, sCD163, MCP-1, and cellular-associated HIV-1-DNA and -RNA were quantified by flow cytometry, different immunoassays, and droplet digital PCR, respectively. The U de Mann-Whitney test evaluated differences between 3DR and 2DR. Immune recovery was evaluated using a general linear model for repeated measures adjusted for different co-variables.
Fifty participants per group were included. The median time on 3DR was 82 months for the 3DR group and 30 months for the 2DR group, after which it switched to 2DR for a median of 57 months. We did not find differences between both groups in any of the parameters analyzed. Specifically, some values in 3DR and 2DR were hs-CRP, 0.92 mg/L (0.45-2.23) vs. 1.23 (0.61-2.38); D-dimer, 190.0 µg/L (150.0-370.0) vs. 190.0 (150.0-397.5); IL-6, 2.8 pg/mL (1.3-5.3) vs. 3.2 (2.1-4.7); sCD14, 4.5 ng/mL (3.3-6.2) vs. 5.0 (3.6-6.1), respectively, all p ≥ 0.399.
In the long term, switching to 2DR does not negatively affect immunologic parameters, inflammatory markers, or HIV-1 reservoir.
identifier NCT04076423.
比较切换至二联疗法（2DR）与维持整合酶抑制剂（InSTI）三联疗法（3DR）对免疫参数、炎症和 HIV-1 储存库的长期影响。
本研究为一项横断面研究，其中 HIV-1 初治人群开始并维持 InSTI 三联疗法（3DR），或在不同时间切换至 2DR（多替拉韦或达芦那韦/考比司他+拉米夫定）。通过流式细胞术、不同的免疫测定法和液滴数字 PCR 分别定量测定 CD4 和 CD8 T 细胞激活和耗竭、血浆 hs-CRP、D-二聚体、P-选择素、IL-1β、IL-6、TNF-α、IFN-γ、IP-10、sTNFR-I/II、MIP-1α/β、I-FABP、LBP、sCD14、sCD163、MCP-1 和细胞相关 HIV-1-DNA 和 -RNA 的浓度。采用 U 曼-惠特尼检验比较 3DR 和 2DR 之间的差异。采用重复测量的一般线性模型调整不同协变量评估免疫恢复情况。
每组纳入 50 名参与者。3DR 组的中位 3DR 治疗时间为 82 个月，2DR 组为 30 个月，之后中位时间切换至 2DR 治疗 57 个月。我们未发现两组在分析的任何参数上存在差异。具体而言，3DR 和 2DR 中的一些值为 hs-CRP，0.92mg/L（0.45-2.23）与 1.23（0.61-2.38）；D-二聚体，190.0μg/L（150.0-370.0）与 190.0（150.0-397.5）；IL-6，2.8pg/mL（1.3-5.3）与 3.2（2.1-4.7）；sCD14，4.5ng/mL（3.3-6.2）与 5.0（3.6-6.1），所有 p 值均≥0.399。
长期来看，切换至 2DR 不会对免疫参数、炎症标志物或 HIV-1 储存库产生负面影响。
标识符 NCT04076423。
