美国暴露前预防项目中，每日使用替诺福韦二吡呋酯/恩曲他滨对肾功能变化的影响。
Changes in Kidney Function Associated With Daily Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Preexposure Prophylaxis Use in the United States Demonstration Project.
机构信息
Department of Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, CA.
出版信息
J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):193-198. doi: 10.1097/QAI.0000000000001566.
BACKGROUND
HIV preexposure prophylaxis (PrEP) using daily oral tenofovir-disoproxil-fumarate/emtricitabine (TDF/FTC) is effective for preventing HIV acquisition, but concerns remain about its potential kidney toxicity. This study examined kidney function in individuals using PrEP in real-world clinical settings.
SETTING
Demonstration project in 2 sexually transmitted infection clinics and a community health center.
METHODS
We evaluated kidney function among men who have sex with men and transgender women taking tenofovir-disoproxil-fumarate/emtricitabine PrEP for up to 48 weeks. Serum creatinine and urine dipstick for protein were obtained at 12-week intervals. Kidney function was estimated using creatinine clearance (CrCl) (Cockcroft-Gault) and estimated glomerular filtration rate (eGFR) (CKD-EPI).
RESULTS
From October 2012 to January 2014, we enrolled 557 participants (median age 33). Mean creatinine increased from baseline to week 12 by 0.03 mg/dL (4.6%) (P < 0.0001); mean CrCl decreased by 4.8 mL/min (3.0%) (P < 0.0001). These changes remained stable through week 48 (P = 0.81, P = 0.71 respectively). There were 75/478 (15.7%) participants who developed worsening proteinuria at week 12 compared with baseline (P < 0.0001), and this percent remained stable through week 48 (P = 0.73). Twenty-five participants (5.1%) developed new-onset eGFR <70 mL/min/1.73 m; independent predictors of this outcome were age ≥40 years (OR 3.79, 95% CI: 1.43 to 10.03) and baseline eGFR <90 mL/min/1.73 m (OR 9.59, 3.69-24.94).
CONCLUSIONS
In a demonstration setting, daily tenofovir-disoproxil-fumarate/emtricitabine PrEP leads to reduced CrCl and eGFR; however, these eGFR changes are based on very small changes in serum creatinine and seem to be nonprogressive after the first 12 weeks. Future studies are needed to understand the prognostic significance of these small changes.
背景
每日口服替诺福韦酯/恩曲他滨（TDF/FTC）进行 HIV 暴露前预防（PrEP）对于预防 HIV 感染是有效的，但人们仍对其潜在的肾毒性表示担忧。本研究在真实临床环境中评估了使用 PrEP 的个体的肾功能。
地点
两家性传播感染诊所和一家社区健康中心的示范项目。
方法
我们评估了在长达 48 周的时间内使用替诺福韦酯/恩曲他滨 PrEP 的男男性行为者和跨性别女性的肾功能。每 12 周采集血清肌酐和尿液试纸检测蛋白。使用肌酐清除率（Cockcroft-Gault）和估算肾小球滤过率（CKD-EPI）估计肾功能。
结果
从 2012 年 10 月至 2014 年 1 月，我们纳入了 557 名参与者（中位年龄 33 岁）。与基线相比，第 12 周时肌酐平均增加 0.03mg/dL（4.6%）（P<0.0001）；CrCl 平均降低 4.8mL/min（3.0%）（P<0.0001）。这些变化在第 48 周时仍保持稳定（P=0.81，P=0.71）。与基线相比，第 12 周时 75/478（15.7%）名参与者出现蛋白尿恶化（P<0.0001），而这一比例在第 48 周时保持稳定（P=0.73）。25 名参与者（5.1%）出现新诊断的 eGFR<70mL/min/1.73m；该结果的独立预测因素为年龄≥40 岁（OR 3.79，95%CI：1.43 至 10.03）和基线 eGFR<90mL/min/1.73m（OR 9.59，3.69 至 24.94）。
结论
在示范环境中，每日口服替诺福韦酯/恩曲他滨 PrEP 可导致 CrCl 和 eGFR 降低；然而，这些 eGFR 变化是基于血清肌酐的微小变化，并且在第 12 周后似乎没有进展。需要进一步的研究来了解这些微小变化的预后意义。
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