The pharmacokinetics, safety and efficacy of boosted saquinavir tablets in HIV type-1-infected pregnant women
| Autor: | M. E. Van Der Ende, Christoph Wyen, Malte Schutz, Clemens Richter, Martin Vogel, Petra C. Koopmans, José Moltó, Angela Colbers, J. van der Lugt, David M. Burger, Kiat Ruxrungtham, D Hawkins |
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| Přispěvatelé: | Medical Microbiology & Infectious Diseases |
| Rok vydání: | 2009 |
| Předmět: |
Pharmacology
Pregnancy business.industry Poverty-related infectious diseases [N4i 3] Area under the curve medicine.disease Dosage form Infectious Diseases SDG 3 - Good Health and Well-being Pharmacokinetics Medicine Gestation Pharmacology (medical) Ritonavir Protease inhibitor (pharmacology) business Saquinavir medicine.drug |
| Zdroj: | Antiviral Therapy, 14, 443-50 Antiviral Therapy, 14(3), 443-450. International Medical Press Ltd Antiviral Therapy, 14, 3, pp. 443-50 |
| ISSN: | 1359-6535 |
| Popis: | Background Pregnancy affects the pharmacokinetics of most protease inhibitors. Saquinavir, when administered in a tablet formulation, has not been studied extensively in this setting. Methods A pharmacokinetic, prospective, multicentre trial of HIV type-1-infected pregnant women treated with saquinavir (500 mg tablets) boosted with ritonavir at a dose of 1,000/100 mg twice daily plus a nucleoside backbone was conducted. Pharmacokinetic curves were recorded for 12 h in the second trimester (week 20 ±2), the third trimester (week 33 ±2) and post-partum (weeks 4–6). Blood was sampled pre-dosing and at 1, 2, 3, 4, 6, 8, 10 and 12 h post-dosing. Pharmacokinetic parameters were calculated using WinNonlin software version 4.1. Results A total of 37 women were included in the analysis. Mean (±sd) values for saquinavir area under the curve (AUC0–12h) were 23.47 h•mg/l (11.92) at week 20 ( n=16), 23.65 h•mg/l (9.07) at week 33 ( n=31) and 25.00 h•mg/l (11.81) post-partum ( n=9). There was no significant difference in the saquinavir AUC0–12h when comparing the data during pregnancy and post-partum. Subtherapeutic plasma concentrations of saquinavir (defined as Conclusions Saquinavir exposure in the new tablet formulation generates adequate saquinavir concentrations throughout the course of pregnancy and is safe to use; therefore, no dose adjustment during pregnancy is needed. |
| Databáze: | OpenAIRE |
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