Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project
Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project
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DOI：
10.1097/qad.0000000000002135
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发表时间：
2019-04-01
期刊：
影响因子：
3.8
通讯作者：
Gandhi, Monica
中科院分区：
文献类型：
--
作者：
Spinelli, Matthew A.;Glidden, David, V;Gandhi, Monica
目的：在一个大型暴露前预防（PrEP）示范项目中，我们研究了用一种新的免疫测定法测量的尿液替诺福韦（TFV）水平与HIV血清转化和客观依从性指标之间的关系，该免疫测定法允许即时检测。设计：对来自开放标签PrEP队列研究的储存标本进行二次分析。我们使用广义估计方程检查了iPrEx开放标签扩展中不可检测的尿液TFV水平与HIV血清转换之间的关联。我们检查了尿液、干血斑（DBS）和头发中TFV和恩曲他滨水平之间的等级相关性，并确定了无法检测到的尿液TFV预测DBS剂量截止值的敏感性和特异性。（n = 105;四分位数范围：1000- 45000）; 5500在最终血清转换的患者中（n = 11;四分位数范围：1000- 12500）;并且所有在血清转换时均检测不到（n = 9; P
Objective: We examined the relationship between urine tenofovir (TFV) levels measured with a novel immunoassay, which permits point-of-care testing, with HIV seroconversion and objective adherence metrics in a large preexposure prophylaxis (PrEP) demonstration project.Design: Secondary analysis of stored specimens from an open-label PrEP cohort study.Methods: We examined the association between undetectable urine TFV levels and HIV seroconversion in iPrEx open-label extension using generalized estimating equations. We examined rank correlations between levels of TFV and emtricitabine in urine, dried blood spots (DBS), and hair and determined the sensitivity and specificity of undetectable urine TFV for predicting dosing cut-offs in DBS.Results: The median urinary TFV level was 15 000 ng/ml in those who remained HIV-negative (n = 105; interquartile range: 1000-45 000); 5500 in those who eventually seroconverted (n = 11; interquartile range: 1000-12 500); and all were undetectable at seroconversion (n = 9; P