| Title: |
Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum |
| Authors: |
Read, JS; Best, BM; Stek, AM; Hu, C; Capparelli, EV; Holland, DT; Burchett, SK; Smith, ME; Sheeran, EC; Shearer, WT; Febo, I; Mirochnick, M |
| Source: |
HIV Medicine ; volume 9, issue 10, page 875-882 ; ISSN 1464-2662 1468-1293 |
| Publisher Information: |
Wiley |
| Publication Year: |
2008 |
| Collection: |
Wiley Online Library (Open Access Articles via Crossref) |
| Description: |
Objectives Our objective was to evaluate the pharmacokinetics of nelfinavir (NFV) (625 mg tablets) 1250 mg twice daily during pregnancy and postpartum. Methods The participants were HIV‐1‐infected pregnant women enrolled in P1026s and receiving NFV (625 mg tablets) 1250 mg twice daily as part of routine clinical care. Intensive steady‐state 12‐h NFV pharmacokinetic profiles were performed during pregnancy and postpartum. The target NFV area under the plasma concentration–time curve (AUC 0–12 ) was ≥10th percentile NFV AUC 0–12 in non‐pregnant historical controls (18.5 μg h/mL). Results Of 27 patients receiving NFV, pharmacokinetic data were available for four (second trimester), 27 (third trimester) and 22 (postpartum) patients. The NFV maximum concentration ( C max ), 12‐h post‐dose concentration ( C 12 ) and AUC 0–12 were significantly lower during the third trimester compared to postpartum ( P ≤0.03). The metabolite hydroxyl‐ tert ‐butylamide (M8) AUC 0–12 and the M8/NFV AUC ratio were lower during the third trimester compared to postpartum ( P |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1111/j.1468-1293.2008.00640.x |
| Availability: |
http://dx.doi.org/10.1111/j.1468-1293.2008.00640.x; https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fj.1468-1293.2008.00640.x; https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1468-1293.2008.00640.x |
| Rights: |
http://onlinelibrary.wiley.com/termsAndConditions#vor |
| Accession Number: |
edsbas.D8C5F989 |
| Database: |
BASE |