Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
CIBER de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
Front Immunol. 2022 Mar 31;13:873408. doi: 10.3389/fimmu.2022.873408. eCollection 2022.
The initiation of antiretroviral treatment based on a 2-drug regimen (2DR) with dolutegravir plus lamivudine has demonstrated non-inferior efficacy than dolutegravir-based three-drug regimens (3DR). We aimed to assess whether the treatment initiation with this 2DR has a different impact on the CD4/CD8 ratio recovery than INSTI-based 3DR.
We emulated a target trial using observational data from the Spanish HIV Research Network cohort (CoRIS). The outcomes of interest were the normalization of the CD4/CD8 ratio at 48 weeks using three different cutoffs: 0.5, 1.0, and 1.5. We matched each participant who started 2DR with up to four participants who received 3DR. Subsequently, we fitted generalized estimating equation (GEE) models and used the Kaplan-Meier method for survival curves.
We included 485, 805, and 924 participants for cutoffs of 0.5, 1.0, and 1.5, respectively. At 48 weeks, 45% of participants achieved a CD4/CD8 ratio >0.5, 15% achieved a ratio >1.0, and 6% achieved a ratio >1.5. GEE models yielded a similar risk of reaching a CD4/CD8 ratio >0.5 (OR 1.00, 95% CI 0.67 - 1.50), CD4/CD8 >1.0 (OR 1.03, 95% CI 0.68 - 1.58), and CD4/CD8 >1.5 (OR 0.86, 95% CI 0.48 - 1.54) between both treatment strategies. There were no differences between 2DR and 3DR in the incidence ratio of CD4/CD8 ratio normalization at 0.5, 1.0 and 1.5 cut-offs.
In this large cohort study in people with HIV, ART initiation with dolutegravir plus lamivudine vs. dolutegravir or bictegravir-based triple antiretroviral therapy showed no difference in the rates of CD4/CD8 normalization at 48 weeks.
基于二联疗法（2DR）的达拉韦林加拉米夫定抗逆转录病毒治疗的启动已证明与基于二联替诺福韦的三联疗法（3DR）的疗效非劣效。我们旨在评估这种 2DR 的治疗启动是否对 CD4/CD8 比值的恢复有不同于 INSTI 为基础的 3DR 的影响。
我们使用西班牙艾滋病毒研究网络队列（CoRIS）的观察性数据模拟了一个目标试验。我们感兴趣的结局是在 48 周时使用三种不同的截止值（0.5、1.0 和 1.5）使 CD4/CD8 比值正常化。我们将每个开始使用 2DR 的参与者与最多 4 名接受 3DR 的参与者相匹配。随后，我们拟合广义估计方程（GEE）模型，并使用 Kaplan-Meier 方法绘制生存曲线。
我们分别纳入了截止值为 0.5、1.0 和 1.5 的 485、805 和 924 名参与者。在 48 周时，45%的参与者达到 CD4/CD8 比值>0.5，15%的参与者达到比值>1.0，6%的参与者达到比值>1.5。GEE 模型得出了相似的达到 CD4/CD8 比值>0.5（OR 1.00，95%CI 0.67-1.50）、CD4/CD8>1.0（OR 1.03，95%CI 0.68-1.58）和 CD4/CD8>1.5（OR 0.86，95%CI 0.48-1.54）的风险，这两种治疗策略之间没有差异。在 0.5、1.0 和 1.5 截止值处，2DR 和 3DR 在 CD4/CD8 比值正常化的发生率比值上没有差异。
在这项针对艾滋病毒感染者的大型队列研究中，与基于二联替诺福韦或比克替拉韦的三联抗逆转录病毒治疗相比，达拉韦林加拉米夫定的 ART 启动在 48 周时 CD4/CD8 正常化率没有差异。
