| Title: |
Effect of pregnancy on emtricitabine pharmacokinetics |
| Authors: |
Stek, AM; Best, BM; Luo, W; Capparelli, E; Burchett, S; Hu, C; Li, H; Read, JS; Jennings, A; Barr, E; Smith, E; Rossi, SS; Mirochnick, M |
| Source: |
HIV Medicine ; volume 13, issue 4, page 226-235 ; ISSN 1464-2662 1468-1293 |
| Publisher Information: |
Wiley |
| Publication Year: |
2011 |
| Collection: |
Wiley Online Library (Open Access Articles via Crossref) |
| Description: |
Objectives The aim of the study was to describe emtricitabine pharmacokinetics during pregnancy and postpartum. Methods The I nternational M aternal P ediatric and A dolescent AIDS C linical T rials ( IMPAACT ), formerly P ediatric AIDS C linical T rials G roup ( PACTG ), study P 1026s is a prospective pharmacokinetic study of HIV ‐infected pregnant women taking antiretrovirals for clinical indications, including a cohort taking emtricitabine 200 mg once daily. Intensive steady‐state 24‐hour emtricitabine pharmacokinetic profiles were performed during the third trimester and 6–12 weeks postpartum, and on maternal and umbilical cord blood samples collected at delivery. Emtricitabine was measured by liquid chromatography–mass spectrometry with a quantification limit of 0.0118 mg/ L . The target emtricitabine area under the concentration versus time curve, from time 0 to 24 hours post dose ( AUC 0‐24 ), was ≥7 mg h/ L (≤30% reduction from the typical AUC of 10 mg h/ L in nonpregnant historical controls). Third‐trimester and postpartum pharmacokinetics were compared within subjects. Results Twenty‐six women had pharmacokinetics assessed during the third trimester (median 35 weeks of gestation) and 22 postpartum (median 8 weeks postpartum). Mean [90% confidence interval ( CI )] emtricitabine pharmacokinetic parameters during the third trimester vs . postpartum were, respectively: AUC : 8.0 (7.1–8.9) vs . 9.7 (8.6–10.9) mg h/ L ( P = 0.072); apparent clearance ( CL/F ): 25.0 (22.6–28.3) vs . 20.6 (18.4–23.2) L/h ( P = 0.025); 24 hour post dose concentration ( C 24 ): 0.058 (0.037–0.063) vs . 0.085 (0.070–0.010) mg/ L ( P = 0.006). The mean cord:maternal ratio was 1.2 (90% CI 1.0–1.5). The viral load was |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1111/j.1468-1293.2011.00965.x |
| Availability: |
http://dx.doi.org/10.1111/j.1468-1293.2011.00965.x; https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fj.1468-1293.2011.00965.x; https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1468-1293.2011.00965.x |
| Rights: |
http://onlinelibrary.wiley.com/termsAndConditions#vor |
| Accession Number: |
edsbas.B536B95D |
| Database: |
BASE |