Tashima Karen T, Mollan Katie R, Na Lumine, Gandhi Rajesh T, Klingman Karin L, Fichtenbaum Carl J, Andrade Adriana, Johnson Victoria A, Eron Joseph J, Smeaton Laura, Haubrich Richard H
HIV Clin Trials. 2015 Aug;16(4):147-56. doi: 10.1179/1945577115Y.0000000001. Epub 2015 Jul 27.
Regimen selection for highly treatment-experienced patients is complicated.
Using a web-based utility, study team members reviewed antiretroviral (ARV) history and resistance data and recommended individual ARV regimens and nucleoside reverse transcriptase inhibitor (NRTI) options for treatment-experienced participants consisting of 3-4 of the following agents: raltegravir (RAL), darunavir (DRV)/ritonavir, tipranavir (TPV)/ritonavir, etravirine (ETR), maraviroc (MVC), and enfuvirtide (ENF). We evaluated team recommendations and site selection of regimen and NRTIs. Associations between baseline factors and the selection of a complex regimen (defined as including four ARV agents or ENF) were explored with logistic regression.
A total of 413 participants entered the study. Participants initiated the first or second recommended regimen 86% of the time and 21% of participants started a complex regimen. In a multivariable model, ARV resistance to NRTI (odds ratio [OR] = 2.2), non-nucleoside reverse transcriptase inhibitor (NNRTI, OR = 6.2) or boosted protease inhibitor (PI, OR = 6.6), prior use of integrase strand transfer inhibitor (INSTI, OR = 25), and race-ethnicity (all P ≤ 0.01) were associated with selection of a complex regimen. Black non-Hispanic (OR = 0.5) and Hispanic participants from the continental US (OR = 0.2) were less likely to start a complex regimen, compared to white non-Hispanics.
In this multi-center trial, we developed a web-based utility that facilitated treatment recommendations for highly treatment-experienced patients. Drug resistance, prior INSTI use, and race-ethnicity were key factors in decisions to select a more complex regimen.
对于治疗经验丰富的患者，治疗方案的选择很复杂。
研究团队成员使用基于网络的工具，回顾抗逆转录病毒（ARV）治疗史和耐药数据，并为治疗经验丰富的参与者推荐个体化ARV治疗方案以及核苷类逆转录酶抑制剂（NRTI）选择，这些方案由以下3 - 4种药物组成：拉替拉韦（RAL）、达芦那韦（DRV）/利托那韦、替拉那韦（TPV）/利托那韦、依曲韦林（ETR）、马拉维罗（MVC）和恩夫韦肽（ENF）。我们评估了团队的推荐以及治疗方案和NRTI的选择情况。通过逻辑回归探索基线因素与复杂治疗方案（定义为包含四种ARV药物或恩夫韦肽）选择之间的关联。
共有413名参与者进入研究。参与者86%的情况下开始使用首个或第二个推荐方案，21%的参与者开始使用复杂方案。在多变量模型中，对NRTI的ARV耐药（比值比[OR] = 2.2）、对非核苷类逆转录酶抑制剂（NNRTI，OR = 6.2）或增强型蛋白酶抑制剂（PI，OR = 6.6）、既往使用整合酶链转移抑制剂（INSTI，OR = 25）以及种族（所有P≤0.01）与复杂方案的选择相关。与非西班牙裔白人相比，非西班牙裔黑人（OR = 0.5）和来自美国大陆的西班牙裔参与者（OR = 0.2）开始使用复杂方案的可能性较小。
在这项多中心试验中，我们开发了一种基于网络的工具，该工具有助于为治疗经验丰富的患者提供治疗建议。耐药性、既往使用INSTI以及种族是选择更复杂治疗方案决策中的关键因素。
