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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum
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Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum

机译：妊娠期妇女肾中Nelfinavir血浆浓度增加的药代动力学

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Abstract This study aims to evaluate the safety, acceptability, and pharmacokinetics (PK) of an increased dose of nelfinavir (NFV) during the third trimester of pregnancy. The study was registered as part of the International Maternal Pediatric Adolescent AIDS Clinical Trials network (IMPAACT‐P1026s), an ongoing multicenter prospective cohort study of antiretroviral PK during pregnancy (NCT00042289). NFV intensive PK evaluations were performed at steady state during the third trimester of pregnancy and 2–3?weeks postpartum. Plasma concentrations of NFV and its active metabolite, hydroxyl‐ tert ‐butylamide (M8) were measured using high‐performance liquid chromatography with ultraviolet detection. A total of 18 women are included in the analysis. NFV area under the concentration‐time curve (AUC) with the increased dose during the third trimester was nearly identical to the standard dose postpartum, with a geometric mean ratio for third trimester to postpartum AUC of 0.98 (90%CI 0.71–1.35). Despite the increased dose, M8 AUC was lower during the third trimester compared to postpartum (0.53, IQR [0.38–0.75]), as was the M8/NFV AUC ratio (0.51, IQR [0.42–0.63]). NFV AUC 0–12 was above target in 15 of 18 (83%) of participants during the third trimester compared to 14 of 16 (88%) postpartum. No major safety concerns were noted. Increasing the NFV dose to 1875?mg twice daily during the third trimester achieved similar concentrations postpartum compared to standard dosing (1250?mg twice daily). Increased NFV dose regimens may still have some benefit to human immunodeficiency virus (HIV)‐positive pregnant women living in countries where novel protease inhibitors are currently unavailable or in individuals who are intolerant to ritonavir‐boosted HIV medications.
机译：摘要本研究旨在在怀孕三个三个月期间评估Nelfinavir（NFV）增加剂量的安全性，可接受性和药代动力学（PK）。该研究被注册为国际孕产妇儿科青少年艾滋病临床试验网络（IMPAACT-P1026S），妊娠期间抗逆转录病毒PK的持续多中心前瞻性队列研究（NCT00042289）。 NFV密集的PK评估在怀孕三个三个月的稳定状态下进行，2-3个月产后。使用高性能液相色谱法测定使用具有紫外检测的高效液相色谱法测定NFV及其活性代谢物，羟基叔丁胺（M8）的血浆浓度。分析中共有18名妇女。 NFV区域在第三三个月期间增加的剂量增加的浓度 - 时间曲线（AUC）几乎与标准剂量产后几乎相同，对于产后AUC的第三三个月的几何平均比率为0.98（90％CI 0.71-1.35）。尽管剂量增加，但与产后的第三个三个月（0.53，IQR [0.38-0.75]）相比，M8 AUC较低，如M8 / NFV AUC比率（0.51，IQR [0.42-0.63]）。在第三个三个月期间，NFV AUC 0-12在18个（83％）的参与者中的目标高于18个（83％），而产后的14个（88％）。没有注意到主要的安全问题。在第三个三个月期间每天两次将NFV剂量增加到1875毫克，与标准剂量（每日两次1250毫克）达到类似浓度的产后。增加的NFV剂量方案仍可能对生活在新的蛋白酶抑制剂目前无法使用的国家/地区的人类免疫缺陷病毒（HIV） - 阳性孕妇的益处仍然有益于，这些孕妇无法与Ritonavir - 增强HIV药物不耐受的个体。

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