Brief Report: Frequency of Monitoring Kidney Function in HIV-Uninfected Persons Using Daily Oral Tenofovir Disoproxil Fumarate Pre-exposure Prophylaxis.
Brief Report: Frequency of Monitoring Kidney Function in HIV-Uninfected Persons Using Daily Oral Tenofovir Disoproxil Fumarate Pre-exposure Prophylaxis.
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DOI：
10.1097/qai.0000000000001575
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发表时间：
2018-02-01
期刊：
影响因子：
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通讯作者：
Partners PrEP Study and Partners Demonstration Project Teams
中科院分区：
文献类型：
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作者：
Mugwanya KK;Baeten JM;Wyatt C;Mugo NR;Celum CL;Ronald A;Kiarie J;Katabira E;Heffron R;Partners PrEP Study and Partners Demonstration Project Teams
广泛实施基于口服替诺福韦的暴露前预防 (PrEP) 来预防艾滋病毒现已成为许多国家的政策。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 个月肌酐清除率 (CrCl) 监测对识别中度肾功能障碍（定义为 CrCl <60 mL/min）的影响。数据来自肯尼亚和乌干达的两项前瞻性每日口服 PrEP 研究：Partners PrEP 研究是一项 PrEP 随机安全性和有效性试验，进行每 3 个月的 CrCl 监测 (n=4404)；Partners 示范项目 (n=954) 是一项开放标签的 PrEP 研究，每 6 个月进行一次监测。两项研究的入组要求 CrCl ≥60 mL/min。异常结果在大约 1 周内进行确认测试。随访时间长达 24 个月。在参与分析的 5358 名参与者中，87% 的年龄<45 岁，三分之一是女性，21% 的基线 CrCl 介于 60-90 mL/min 之间。确认的 CrCl <60 mL/min 事件很少见，在 24 个月内发生在 52 名个体 (<1%) 中。每 3 个月筛查一次的 CrCl <60 mL/min 患者的 12 个月累积比例为 0.2%，每 6 个月筛查一次为 0.5%。年龄较大（>45 岁）、体重较低（<55 kg）和基线 CrCl 介于 60-90 mL/min 之间与随访期间 CrCl 下降 <60 mL/min 独立相关。在这两项 PrEP 研究中，参与者普遍年轻，根据 3 个月或 6 个月的 CrCl 监测计划，临床相关的 CrCl 下降的发生和模式没有本质上的差异。这些数据表明，对于大多数接受 PrEP 长达 24 个月的人来说，不太频繁的 CrCl 监测是安全的，并且可以减少所需的支出。
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 to 3-monthly creatinine clearance (CrCl) monitoring on the identification of moderate kidney dysfunction, defined as CrCl <60 mL/min. Data were from two 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. Of 5358 participants included in the analysis, 87% were <45 years, a third were female, and 21% had a baseline CrCl between 60–90 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), and baseline CrCl between 60–90 mL/min were independently associated with CrCl decline <60 mL/min during follow up. In these two PrEP studies, with a 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.