简报：每日口服替诺福韦二吡呋酯预防暴露前用药的 HIV 未感染者肾功能监测频率。
Brief Report: Frequency of Monitoring Kidney Function in HIV-Uninfected Persons Using Daily Oral Tenofovir Disoproxil Fumarate Pre-exposure Prophylaxis.
机构信息
Department of Global Health, University of Washington, Seattle, WA.
Division of Disease Control, School of Public Health, Makerere University, Kampala, Uganda.
出版信息
J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):206-211. doi: 10.1097/QAI.0000000000001575.
BACKGROUND
Wide-scale implementation of oral tenofovir-based pre-exposure prophylaxis (PrEP) for HIV prevention is now policy in many settings. However, the optimal frequency for monitoring kidney function remains uncertain. We investigated the impact of 6-monthly compared with 3-monthly creatinine clearance (CrCl) monitoring on the identification of moderate kidney dysfunction, defined as CrCl <60 mL/min.
METHODS
Data were from 2 prospective daily oral PrEP studies in Kenya and Uganda: the Partners PrEP Study, a randomized safety, and efficacy trial of PrEP that conducted 3-monthly CrCl monitoring (n = 4404) and the Partners Demonstration Project (n = 954), an open-label delivery study of PrEP that used 6-monthly monitoring. CrCl ≥60 mL/min was required for enrollment in both studies. Abnormal results were followed with confirmatory testing within approximately 1 week. Follow-up was for up to 24 months.
RESULTS
Of 5358 participants included in the analysis, 87% were younger than 45 years, a third were female, and 21% had a baseline CrCl between 60 and 90 mL/min. Confirmed CrCl <60 mL/min events were rare, occurring in 52 individuals (<1%) in 24 months. The 12-month cumulative proportion of persons with CrCl <60 mL/min was 0.2% with 3-monthly screening and 0.5% with 6-monthly screening. Older age (>45 years), lower weight (<55 kg), elevated blood pressure (>140 mm Hg), and baseline CrCl between 60 and 90 mL/min were independently associated with CrCl decline <60 mL/min during follow-up.
CONCLUSIONS
In these 2 PrEP studies, with generally young participants, the occurrence and pattern of clinically relevant decline in CrCl were not qualitatively different based on 3- or 6-monthly CrCl monitoring schedule. These data suggest that for most persons receiving PrEP for up to 24 months, less frequent CrCl monitoring would be safe and reduce required expenditures for repeat confirmatory testing.
背景
在许多地方，广泛实施基于口服替诺福韦的暴露前预防（PrEP）以预防艾滋病毒已成为政策。然而，监测肾功能的最佳频率仍不确定。我们研究了每 6 个月与每 3 个月监测肌酐清除率（CrCl）对识别中度肾功能障碍的影响，中度肾功能障碍定义为 CrCl<60 mL/min。
方法
数据来自肯尼亚和乌干达的两项前瞻性每日口服 PrEP 研究：伙伴关系 PrEP 研究，这是一项随机安全性和 PrEP 疗效试验，每 3 个月监测一次 CrCl（n=4404）和伙伴关系示范项目（n=954），这是一项开放标签的 PrEP 交付研究，每 6 个月监测一次。CrCl≥60 mL/min 是这两项研究入组的要求。异常结果在大约 1 周内通过确认性检测进行随访。随访时间最长为 24 个月。
结果
在纳入分析的 5358 名参与者中，87%年龄小于 45 岁，三分之一为女性，21%基线 CrCl 在 60 至 90 mL/min 之间。在 24 个月内，确认的 CrCl<60 mL/min 事件很少，仅 52 人（<1%）发生。每 3 个月筛查的 12 个月累积 CrCl<60 mL/min 比例为 0.2%，每 6 个月筛查的为 0.5%。年龄较大（>45 岁）、体重较低（<55 kg）、血压升高（>140 mm Hg）和基线 CrCl 在 60 至 90 mL/min 之间与随访期间 CrCl 下降<60 mL/min 独立相关。
结论
在这两项 PrEP 研究中，参与者普遍年轻，基于 3 个月或 6 个月的 CrCl 监测方案，CrCl 临床相关下降的发生和模式并无本质区别。这些数据表明，对于大多数接受 PrEP 治疗长达 24 个月的人来说，较少的 CrCl 监测频率是安全的，并减少了重复确认性检测所需的支出。
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