HIVCENTER, Department of Infectious Diseases, University Hospital Frankfurt, Frankfurt, Germany.
Infectious Diseases Outpatient Clinic, Hospital Fundación Jiménez Díaz, University Autónoma of Madrid, Madrid, Spain.
HIV Med. 2021 Jan;22(1):47-53. doi: 10.1111/hiv.12962. Epub 2020 Oct 13.
The aim of the study was to investigate the efficacy and safety of first-line antiretroviral therapy (ART) with integrase inhibitor (INI) or protease inhibitor (PI)-based regimens in patients with low CD4 cell counts and/or an AIDS-defining disease.
We conducted a retrospective, multicentre analysis to investigate discontinuation proportions and virological response in patients with CD4 cell counts < 200 cells/µL and/or AIDS-defining disease when starting first-line ART. Proportions of those discontinuing ART were compared using univariate analysis. Virological response was analysed using the Food & Drug Administration (FDA) snapshot analysis (HIV-1 RNA < 50 HIV-1 RNA copies/mL at week 48).
Two hundred and eighteen late presenters were included in the study: 13.8% were women and 23.8% were of non-European ethnicity, and the mean baseline CD4 count was 91 cells/µL (standard deviation 112 cells/µL). A total of 131 late presenters started on INI- and 87 on PI-based treatment. It was found that 86.1% of patients treated with INIs and 81.1% of patients treated with PIs had a viral load < 50 copies/mL at week 48; proportions of discontinuation because of adverse events were 6.1% in the INI group and 11.5% in the PI group. No significant differences in discontinuation proportions were observed at week 12 or 48 between INI- and PI-based regimens (P = 0.76 and 0.52, respectively). Virological response was equally good in those receiving INIs and those receiving PIs (86.1% vs. 81.1%, respectively; P = 0.36).
In a European cohort of late presenters starting first-line INI or PI-based ART regimens, there were no significant differences in discontinuation proportions or virological response at week 48.
本研究旨在调查在 CD4 细胞计数低（<200 个细胞/µL）和/或出现艾滋病定义性疾病的患者中，使用整合酶抑制剂（INI）或蛋白酶抑制剂（PI）为基础的一线抗逆转录病毒治疗（ART）的疗效和安全性。
我们进行了一项回顾性、多中心分析，以调查在开始一线 ART 时 CD4 细胞计数<200 个细胞/µL 和/或出现艾滋病定义性疾病的患者中停药比例和病毒学应答情况。使用单变量分析比较停药比例。使用食品和药物管理局（FDA）快照分析（第 48 周 HIV-1 RNA<50 HIV-1 RNA 拷贝/mL）分析病毒学应答。
共有 218 名晚期患者纳入本研究：13.8%为女性，23.8%为非欧洲裔，基线 CD4 计数的平均值为 91 个细胞/µL（标准差 112 个细胞/µL）。共有 131 名晚期患者开始接受 INI 治疗，87 名患者开始接受 PI 治疗。结果发现，接受 INI 治疗的患者中有 86.1%和接受 PI 治疗的患者中有 81.1%在第 48 周时病毒载量<50 拷贝/mL；因不良反应而停药的比例分别为 INI 组的 6.1%和 PI 组的 11.5%。在第 12 周和第 48 周时，INI 组和 PI 组之间的停药比例没有显著差异（P=0.76 和 0.52）。接受 INI 和 PI 的患者的病毒学应答同样良好（分别为 86.1%和 81.1%；P=0.36）。
在开始一线 INI 或 PI 为基础的 ART 方案的欧洲晚期患者队列中，第 48 周时停药比例或病毒学应答无显著差异。
