Perrier Marine, Charpentier Charlotte, Peytavin Gilles, Lê Minh, Blondel Louis, Visseaux Benoit, Joly Véronique, Pinto Adriana, Matheron Sophie, Yazdanpanah Yazdan, Descamps Diane, Landman Roland
IAME, UMR 1137, Univ. Paris Diderot, Sorbonne Paris Cité, Paris F-75018, France.
AP-HP, Hôpital Bichat-Claude Bernard, Laboratoire de Virologie, Paris F-75018, France.
J Antimicrob Chemother. 2017 Jun 1;72(6):1745-1751. doi: 10.1093/jac/dkx018.
To assess, in a clinical cohort, the efficacy of switching current ART in virologically suppressed patients to elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate as a single-tablet regimen (STR) using the PCR signal of the plasma viral load (pVL) assay and determination of plasma drug concentration ( C 24 ).
This was an observational single-centre study enrolling antiretroviral-treated patients with pVL <50 copies/mL initiating elvitegravir-based STR. PCRneg was defined as an undetected PCR signal.
One hundred and fifty-one patients were enrolled. At STR baseline, the median time since first ART and time of virological suppression were 5 years (IQR 3-9) and 24 months (IQR 9-44), respectively. By week (W) 48, 26 (17%) of the patients had discontinued STR due to adverse events. The proportion of patients maintaining pVL <50 copies/mL on treatment was 98%, 96%, 93% and 97% at W12, W24, W36 and W48, respectively. Five patients (3.3%) experienced a virological failure and emergence of resistance was observed in two of them with the selection of M184V and N155H mutations. At baseline, W12, W24, W36 and W48, 70%, 57%, 72%, 61% and 74% of the patients with pVL <20 copies/mL had a PCRneg, respectively. The median elvitegravir plasma C 24 value was 648 ng/mL (IQR 348-989; n = 237), with 84% of elvitegravir C 24 values >45 ng/mL, the protein-adjusted IC 95 .
In this clinical cohort of virologically suppressed patients switching to STR, most subjects had adequate elvitegravir C 24 values with a high proportion maintaining virological suppression with no residual viraemia until W48.
在一个临床队列中，使用血浆病毒载量（pVL）检测的PCR信号和血浆药物浓度（C24）测定，评估将病毒学抑制患者目前的抗逆转录病毒疗法转换为埃替格韦/考比司他/恩曲他滨/替诺福韦酯富马酸盐单片复方制剂（STR）的疗效。
这是一项单中心观察性研究，纳入接受抗逆转录病毒治疗且pVL<50拷贝/mL并开始使用基于埃替格韦的STR的患者。PCR阴性定义为未检测到PCR信号。
共纳入151例患者。在STR基线时，自首次抗逆转录病毒治疗以来的中位时间和病毒学抑制时间分别为5年（四分位间距3 - 9年）和24个月（四分位间距9 - 44个月）。到第48周时，26例（17%）患者因不良事件停用STR。在治疗期间，维持pVL<50拷贝/mL的患者比例在第12周、第24周、第36周和第48周分别为98%、96%、93%和97%。5例患者（3.3%）出现病毒学失败，其中2例观察到耐药性出现，分别选择了M184V和N155H突变。在基线、第12周、第24周、第36周和第48周时，pVL<20拷贝/mL的患者中分别有70%、57%、72%、61%和74%的患者PCR检测呈阴性。埃替格韦血浆C24值的中位数为648 ng/mL（四分位间距348 - 989；n = 237），84%的埃替格韦C24值>45 ng/mL，即蛋白校正后的IC95。
在这个转换为STR的病毒学抑制患者临床队列中，大多数受试者的埃替格韦C24值充足，直到第48周，高比例患者维持病毒学抑制且无残留病毒血症。
