Impact of pregnancy on abacavir pharmacokinetics
Impact of pregnancy on abacavir pharmacokinetics
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DOI：
10.1097/01.aids.0000210609.52836.d1
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发表时间：
2006-02-28
期刊：
影响因子：
3.8
通讯作者：
Connor, JD
中科院分区：
文献类型：
--
作者：
Best, BM;Mirochnick, M;Connor, JD
目的：描述阿巴卡韦在怀孕期间和产后的药代动力学;怀孕期间的生理变化已知会影响抗逆转录病毒药物disposition.Design：The Pediatric AIDS Clinical Trials Group P1026 s study是一项正在进行的、前瞻性的、非盲法的药代动力学研究，研究对象是接受一种或多种抗逆转录病毒药物进行常规临床护理的孕妇，包括接受阿巴卡韦300 mg每日两次的队列。系列血浆样品（给药前、给药后1、2、4和6小时）产前获得（妊娠30-36周）和产后结果：25名妇女[平均年龄28.6岁（SD，6）;平均妊娠晚期体重92 kg（SD，35.4）;和人种/种族52%黑人，28%西班牙裔，16%白色，4%亚洲人]，阿巴卡韦浓度-时间曲线下面积（AUC）的几何平均值为5.9 mg.h/l [90%置信区间（CI），5.2-6.8]，最大血浆浓度（C-max）为1.9 mg/l（90% CI，1.6-2.2）。17名妇女完成了产后采样，产前产后AUC和C-max的比值分别为1.04（90%CI，0.91-1.18）和0.79（90%CI，0.65-0.98），respectively.Conclusions：阿巴卡韦AUC在妊娠期间是类似的，在6-12周产后和非妊娠的历史对照（5.8 mg.h/l）。因此，妊娠似乎不会显著影响阿巴卡韦的总体暴露量或需要调整剂量。(C)2006年利平科特威廉姆斯&威尔金斯。
Objective: To describe abacavir pharmacokinetics during pregnancy and postpartum; physiological changes during pregnancy are known to affect antiretroviral drug disposition.Design: The Pediatric AIDS Clinical Trials Group P1026s study is an on-going, prospective, non-blinded pharmacokinetic study of pregnant women receiving one or more antiretroviral drugs for routine clinical care, including a cohort receiving abacavir 300 mg twice daily.Methods: Serial plasma samples (predose, 1, 2, 4, and 6 h postdose) obtained antepartum (30-36 weeks of gestation) and again postpartum (6-12 weeks after delivery) were assayed for abacavir concentration by reversed-phase high-performance liquid chromatography.Results: Antepartum evaluations were available for 25 women [mean age, 28.6 years (SD, 6); mean third-trimester weight 92 kg (SD, 35.4); and race/ethnicity 52% black, 28% Hispanic, 16% white, 4% Asian], with geometric mean abacavir area under the concentration-time curve (AUC) of 5.9 mg.h/l [90% confidence interval (CI), 5.2-6.8] and maximum plasma concentration (C-max) of 1.9 mg/l (90% CI, 1.6-2.2). Seventeen women completed postpartum sampling, and the ratios of antepartum to postpartum AUC and C-max were 1.04 (90% CI, 0.91-1.18) and 0.79 (90% CI, 0.65-0.98), respectively.Conclusions: Abacavir AUC during pregnancy was similar to that at 6-12 weeks postpartum and to that for non-pregnant historical controls (5.8 mg.h/l). Consequently, pregnancy does not appear to affect overall abacavir exposure significantly or to necessitate dose adjustments. (C) 2006 Lippincott Williams & Wilkins.