Pharmacokinetics of Darunavir and Cobicistat in Pregnant and Postpartum Women with HIV
| Autor: | Impaact P s Protocol Team, Mary E. Paul, Sandra K. Burchett, Jeremiah D. Momper, Nahida Chakhtoura, Edmund V. Capparelli, Derek Z Yang, Irma Febo, Kittipong Rungruengthanakit, Kathleen George, Kayla Denson, Alice Stek, Jiajia Wang, Gwendolyn B. Scott, Elizabeth Smith, David Shapiro, Mark Mirochnick, Brookie M. Best |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Infectious Disease Transmission Placenta darunavir HIV Infections Reproductive health and childbirth Medical and Health Sciences 0302 clinical medicine Pregnancy Vertical Immunology and Allergy Medicine 030212 general & internal medicine Prospective Studies Prospective cohort study Child Darunavir Pediatric Obstetrics Cobicistat Postpartum Period Biological Sciences Infectious Diseases 6.1 Pharmaceuticals perinatal transmission IMPAACT P1026s Protocol Team Female pharmacokinetics medicine.drug Pediatric Research Initiative medicine.medical_specialty Anti-HIV Agents Immunology Fixed-dose combination Article protease inhibitor 03 medical and health sciences Pharmacokinetics Clinical Research Virology Humans business.industry Prevention Psychology and Cognitive Sciences Evaluation of treatments and therapeutic interventions Perinatal Period - Conditions Originating in Perinatal Period cobicistat HIV infection medicine.disease Confidence interval Infectious Disease Transmission Vertical Good Health and Well Being 030104 developmental biology business Postpartum period |
| Zdroj: | AIDS AIDS (London, England), vol 35, iss 8 |
| Popis: | OBJECTIVE To evaluate darunavir 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 darunavir and cobicistat pharmacokinetics in pregnant women with HIV and their children in the United States. METHODS Intensive steady-state 24-h pharmacokinetic profiles were performed after administration of 800 mg of darunavir and 150 mg of cobicistat orally in fixed dose combination once-daily during the second trimester, third trimester, and postpartum. Infant washout samples were collected after birth. Darunavir and cobicistat were measured in plasma by validated HPLC-UV and liquid chromatography with tandem mass spectrometry detection (LC-MS)/MS assays, respectively. A two-tailed Wilcoxon signed-rank test (α = 0.10) was employed for paired within-participant comparisons. RESULTS A total of 29 pregnant women receiving darunavir and cobicistat once-daily enrolled in the study. Compared with paired postpartum data, darunavir AUC0--24 was 53% lower in the second trimester [n = 12, P = 0.0024, geometric mean of ratio (GMR)=0.47, 90% confidence interval (CI) 0.33 - 0.68] and 56% lower in the third trimester (n = 18, P |
| Databáze: | OpenAIRE |
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