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首页> 外文期刊>PLoS One >Sub-therapeutic nevirapine concentration during antiretroviral treatment initiation among children living with HIV: Implications for therapeutic drug monitoring
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Sub-therapeutic nevirapine concentration during antiretroviral treatment initiation among children living with HIV: Implications for therapeutic drug monitoring

机译：感染艾滋病毒的儿童在开始抗逆转录病毒治疗期间的亚治疗性奈韦拉平浓度：监测治疗药物的意义

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Nevirapine, a component of antiretroviral therapy (ART) in resource-limited settings, known for auto-induction of metabolism, is initiated at half therapeutic dose until day 14 (‘lead-in period’), and subsequently escalated to full dose. However, studies have shown that this dosing strategy based on adult studies may not be appropriate in children, given that younger children have higher drug clearance rates. In this prospective cohort study, we studied trough plasma nevirapine levels by high performance liquid chromatography (HPLC) at days 7, 14 (lead-in period) and 28 (full dose period) after ART initiation amongst HIV-1 infected children initiating nevirapine-based ART in southern India. Among the 20 children (50% male, median age 9 years) included in the study, sub-therapeutic trough plasma nevirapine concentration (4μg/ml) was seen in 65% (13/20) of children during the lead-in period within two weeks of ART initiation and among 10% of children at 4 weeks during full-dose nevirapine. Adherence was documented as ≥95% in all children by both caregiver self-report and pill count. Median nevirapine concentrations achieved at week 1 was 4.8 μg/ml, significantly lower than 8 μg/ml, the concentration achieved at week 4 (p = 0.034). Virological failure at one year of ART was observed in six children, and was not associated with median nevirapine concentration achieved during week 1, 2 or 4. We conclude that the dose escalation strategy currently practiced among young children living with HIV-1 resulted in significant subtherapeutic nevirapine concentration (≤4μg/ml) during the lead-in period. We call for a closer look at pediatric-focused dosing strategies for nevirapine initiation in young children. Further studies to establish age-appropriate threshold nevirapine concentration are warranted in young children to corroborate the role of therapeutic drug monitoring in predicting virological outcome.
机译：奈韦拉平是一种资源有限的抗逆转录病毒疗法（ART）的组成部分，以自动诱导新陈代谢着称，它以一半的治疗剂量开始治疗直至第14天（“导入期”），然后逐步增加至全剂量。但是，研究表明，基于成年研究的这种给药策略可能不适用于儿童，因为年龄较小的儿童的药物清除率更高。在这项前瞻性队列研究中，我们在接受HIV-1感染的儿童（开始接受奈韦拉平治疗）期间，在接受抗逆转录病毒治疗后第7天，第14天（导入期）和第28天（满剂量治疗）通过高效液相色谱（HPLC）研究了低谷血浆奈韦拉平水平。在印度南部的ART。在纳入研究的20名儿童（50％男性，中位年龄9岁）中，进入治疗期的亚治疗谷血浆奈韦拉平浓度（<4μg/ ml）在65％（13/20）儿童中被发现在全剂量奈韦拉平治疗期间，开始抗病毒治疗的两周内以及在4周时的10％的儿童中。照护者自我报告和服药计数均证明所有儿童的依从性均≥95％。在第1周时达到的中性奈韦拉平浓度为4.8μg/ ml，显着低于第4周时达到的8μg/ ml（p = 0.034）。在6名儿童中观察到一年ART时出现病毒学衰竭，并且与在第1、2或4周内达到的中性奈韦拉平浓度无关。我们得出结论，目前在HIV-1感染的幼儿中实施的剂量递增策略导致显着导入期亚治疗性奈韦拉平浓度（≤4μg/ ml）。我们呼吁对幼儿使用奈韦拉平的小儿用药剂量策略进行仔细研究。在幼儿中进行进一步研究以建立适合年龄的奈韦拉平阈值浓度，以证实治疗药物监测在预测病毒学结果中的作用。

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