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Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV.


ABSTRACT: OBJECTIVE:To evaluate elvitegravir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery. DESIGN:Nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and their children in the United States. METHODS:Intensive steady-state 24-h pharmacokinetic profiles after 150?mg of elvitegravir and 150?mg of cobicistat given orally in fixed dose combination once-daily were performed during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Elvitegravir and cobicistat were measured in plasma by a validated liquid chromatography with tandem mass spectrometry assay with a lower quantitation limit of 10?ng/ml. A two-tailed Wilcoxon signed-rank test (??=?0.10) was employed for paired within-participant comparisons. RESULTS:Thirty pregnant women taking elvitegravir and cobicistat once-daily enrolled in the study. Compared with paired postpartum data, elvitegravir AUC0-24 was 24% lower in the second trimester [n?=?14, P?=?0.058, geometric mean ratios (GMR)?=?0.76, 90% confidence interval (CI) 0.57-1.0] and 44% lower in the third trimester (n?=?24, P?=?0.0001, GMR?=?0.56, 90% CI 0.42-0.73), while cobicistat AUC0-24 was 44% lower in the second trimester (n?=?14, P?=?0.0085, GMR?=?0.56, 90% CI 0.37-0.85) and 59% lower in the third trimester (n?=?24, P?

SUBMITTER: Momper JD 

PROVIDER: S-EPMC6209536 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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<h4>Objective</h4>To evaluate elvitegravir and cobicistat pharmacokinetics during pregnancy compared with postpartum and in infant washout samples after delivery.<h4>Design</h4>Nonrandomized, open-label, parallel-group, multicenter phase-IV prospective study of antiretroviral pharmacokinetics in HIV-infected pregnant women and their children in the United States.<h4>Methods</h4>Intensive steady-state 24-h pharmacokinetic profiles after 150 mg of elvitegravir and 150 mg of cobicistat given orally  ...[more]

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