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首页> 外文期刊>Antimicrobial agents and chemotherapy. >Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates.
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Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates.

机译：奈韦拉平在HIV-1感染的孕妇及其新生儿中的群体药代动力学。

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摘要

The aim of the present study was to describe the nevirapine (NVP) pharmacokinetics (PK) in pregnant women and their neonates and to evaluate the transplacental drug transfer and administration scheme for the prevention of mother-to-child transmission. Thirty-eight HIV-1-infected pregnant women were administered one tablet of NVP (200 mg) and two tablets of tenofovir-emtricitabine (Truvada) at the initiation of labor. Children were given NVP syrup (2 mg/kg of body weight) as a single dose (sdNVP) on the first day of life. By pair, NVP concentrations were measured in 11 maternal, 1 cord blood, and 2 neonatal plasma samples and analyzed by a population approach. A one-compartment model was used for mothers and neonates; the absorption rate constants for mothers and neonates were 0.95 h(-1) (intersubject variability, 111%) and 0.39 h(-1), respectively; the apparent elimination clearances were 1.42 liter.h(-1) (intersubject variability, 22%) and 0.035 liter.h(-1), respectively; and apparent volumes of distribution were 87.3 liters (intersubject variability, 25%) and 5.65 liters, respectively. An effect compartment was linked to maternal circulation by mother-to-cord and cord-to-mother rate constants of 1.10 h(-1) and 1.43 h(-1), respectively. Placental transfer, expressed as the fetal-to-maternal area under the curve ratio, was 75%. Neonates had a very long half-lives (110 h) compared to adults. In the 38 mothers, the simulated median individual predicted time during which the NVP concentration remained above the half-maximal inhibitory concentration (IC(50)) was 13.2 days (range, 12 to 19.2 days). Thus, the administration of tenofovir-emtricitabine for at least 3 weeks after delivery should be considered to prevent the emergence of resistant viruses. The neonate must receive sdNVP immediately after birth when the infant is born less than 30 min after maternal drug intake to keep NVP concentrations above the IC(50).
机译：本研究的目的是描述奈韦拉平（NVP）在孕妇及其新生儿中的药代动力学（PK），并评估经胎盘的药物转移和给药方案，以防止母婴传播。 38例受HIV-1感染的孕妇在分娩开始时服用了1片NVP（200 mg）和2片替诺福韦-恩曲他滨（Truvada）。在生命的第一天，给儿童单剂量（sdNVP）的NVP糖浆（2 mg / kg体重）。按对，在11个母体，1个脐带血和2个新生儿血浆样本中测量NVP浓度，并通过人群方法进行分析。一室模型用于母亲和新生儿。母亲和新生儿的吸收速率常数分别为0.95 h（-1）（受试者间差异，111％）和0.39 h（-1）;表观消除间隙分别为1.42升·h（-1）（受试者间差异22％）和0.035升·h（-1）;表观分布量分别为87.3升（受试者间差异为25％）和5.65升。通过母婴至脐带对母亲的速率常数和母婴至脐带间的速率常数分别为1.10 h（-1）和1.43 h（-1）将效应区与母亲的血液循环联系起来。胎盘转移，表示为曲线比率下的胎儿与母亲的面积，为75％。与成人相比，新生儿的半衰期很长（110小时）。在38位母亲中，NVP浓度保持在半数最大抑制浓度（IC（50））以上的模拟的个人预测中位时间为13.2天（范围为12至19.2天）。因此，应考虑在分娩后给予替诺福韦-恩曲他滨至少3周，以防止产生抗药性病毒。当婴儿在母亲服药后30分钟以内出生时，新生儿必须在出生后立即接受sdNVP，以使NVP浓度保持在IC之上（50）。

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