Pregnancy-related effects on nelfinavir-M8 pharmacokinetics: A population study with 133 women

Antimicrobial Agents and Chemotherapy

Volumn 50, Issue 6, 2006, Pages 2079-2086

  Hirt, Déborah ^a,f   Treluyer, Jean Marc ^a   Jullien, Vincent ^a   Firtion, Ghislaine ^b   Chappuy, Hélène ^c   Rey, Elisabeth ^a   Pons, Gérard ^a   Mandelbrot, Laurent ^d   Urien, Saïk ^e  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b Hôpital Necker Enfants Malades ^*  (France)

^c HÔPITAL NECKER ENFANTS MALADES   (France)

^d HÔPITAL LOUIS MOURIER   (France)

^e CENTRE RENÉ HUGUENIN   (France)

^f HÔPITAL SAINT VINCENT DE PAUL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; NELFINAVIR; NELFINAVIR METABOLITE M8; UNCLASSIFIED DRUG;

ADULT; AGE; ARTICLE; BAYES THEOREM; BODY WEIGHT; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG MONITORING; DRUG RESPONSE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; POPULATION RESEARCH; PREGNANCY; PRIORITY JOURNAL; RETROSPECTIVE STUDY;

ADULT; BAYES THEOREM; DELIVERY, OBSTETRIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; FEMALE; HIV PROTEASE INHIBITORS; HUMANS; MODELS, STATISTICAL; NELFINAVIR; PREGNANCY; RETROSPECTIVE STUDIES;

EID: 33744501255     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.01596-05     Document Type: Article

References (25)

1. Acosta, E. P., A. Bardeguez, C. D. Zorrilla, R. Van Dyke, M. D. Hugues, S. Huang, L. Pompeo, A. M. Stek, J. Pitt, D. H. Watts, E. Smith, E. Jimenez, L. Mofenson, and the Pediatric AIDS Clinical Trials Group 386 Protocol Team. 2004. Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women. Antimicrob. Agents Chemother. 48:430-436.
2. Angel, J. B., Y. Khaliq, M. L. Monpetit, D. W. Cameron, and K. Gallicano. 2001. An argument for therapeutic drug monitoring of HIV-1 protease inhibitors during pregnancy. AIDS 15:417-419.
3. Baede-van Dijk, P. A., P. W. Hugen, C. P. Verweij-van Wissen, P. P. Koopmans, D. M. Burger, and Y. A. Hekster. 2001. Analysis of variation in plasma concentrations of nelfinavir and its active metabolite M8 in HIV-positive patients. AIDS 15:991-998.
4. Beal, S. L. 2001. Ways to fit a PK model with some data below the quantification limit. J. Pharmacokinet. Pharmacodyn. 28:481-504.
5. Beal, S. L., and L. B. Sheiner. 1998. NONMEM user's guide: NONMEM project group. University of California at San Francisco, San Francisco, Calif.
6. Chappuy, H., J. M. Treluyer, V. Jullien, J. Dimet, E. Key, M. Fouché, G. Firtion, G. Pons, and L. Mandelbrot. 2004. Maternal-fetal transfer and amniotic fluid accumulation of protease inhibitors in pregnant women who arc infected with immunodeficiency virus. Am. J. Obstet. Gynecol. 191:558-562.
7. Dean, M., B. Stock, R. J. Patterson, and G. Levy. 1980. Serum protein binding of drugs during and after pregnancy in humans. Clin. Pharmacol. Ther. 28:253-260.
8. Hayashi, S., K. P. Beckerman, M. Homma, B. Kosel, and F. Aweeka. 2000. Pharmacokinetics of indinavir in HIV-positive pregnant women. AIDS 14:1061-1063.
9. Hirt, D., S. Urien, V. Jullien, G. Firtion, E. Key, G. Pons, S. Blanche, and J. M. Treluyer. 2006. Age-related effects on nelfinavir and M8 pharmacokinetics: a population study in 182 children. Antimicrob. Agents Chemother. 50:910-916.
10. Ihaka, R., and R. Gentleman. 1996. R: a language for data analysis and graphics. J. Comput. Graphic Stat. 5:299.
11. Kosel, B., K. P. Beckerman, S. Hayashi, M. Homma, and F. Aweeka. 2003. Pharmacokinetics of nelfinavir and indinavir in HIV-1 infected pregnant women. AIDS 17:1195-1199.
12. Krauer, B., F. Krauer, and F. E. Hytten. 1980. Drug disposition and pharmacokinetics in the maternal-placental-fetal unit. Pharmacol. Ther. 10:301-328.
13. Kurowski, M., B. Kaeser, A. Sawyer, M. Popescu, and A. Mrozikiewicz. 2002. Low-dose ritonavir moderately enhances nelfinavir exposure. Clin. Pharmacol. Ther. 72:123-132.
14. Lillibridge, J. H., C. A. Lee, and Y. K. Pithavala. 1998. The role of CYP2C19 in the metabolism of nelfinavir mcsylate. Abstr. XII Annu. Meet. Expo. Am. Assoc. Pharm. Sci., San Francisco, Calif., abstr. 3035.
15. Loebstein, R., A. Lalkin, and G. Keren. 1997. Pharmacokinetics changes during pregnancy and their clinical relevance. Clin. Pharmacokinet. 33:328-343.
16. Marzolini, C., C. Rudin, L. A. Decosterd, A. Telenti, A. Schreyer, J. Biollaz, T. Rudin, and the Swiss Mother + Child HIV Cohort Study. 2002. Transplacental passage of protease inhibitors at delivery. AIDS 16:889-893.
17. McGready, R., K. Stepniewska, E. Seaton, T. Cho, D. Cho, A. Ginsberg, M. D. Edstein, E. Ashley, S. Looareesuwan, N. J. White, and F. Nosten. 2003. Pregnancy and use of oral contraceptives reduces the biotransformation of proguanil to cycloguanil. Eur. J. Clin. Pharmacol. 59:553-557.
18. Mirochnick, M. 2000. Antiretroviral pharmacology in pregnant women and their newborns. Ann. N. Y. Acad. Sci. 918:287-297.
19. Nellen, J. F., I. Schillevoort, F. W. Wit, A. S. Bergshoeff, M. H. Godfried, K. Boer, J. M. Lange, D. M. Burger, and J. M. Prins. 2004. Nelfinavir plasma concentrations are low during pregnancy. Clin. Infect. Dis. 39:736-740.
20. Parke, J., N. H. Holford, and B. Charles. 1999. A procedure for generating bootstrap samples for the validation of nonlinear mixed-effects population models. Comput. Methods Programs Biomed. 59:19.
21. Parry, E., R. Shields, and A. Turnbull. 1970. Transit time in the small intestine in pregnancy. J. Obstet. Gynaecol. Br. Commonw. 77:900-901.
22. Pellegrin, I., D. Breilh, F. Montestruc, A. Caumont, I. Garrigue, P. Morlat, C. Le Camus, M. C. Saux, H. J. Fleury, and J. L. Pellegrin. 2002. Virologic response to nelfinavir-based regimens: pharmacokinetics and drug resistance mutations (VIRAPHAR study). AIDS 16:1331-1340.
23. Treluyer, J. M., J. P. Morini, J. Dimet, I. Gorin, E. Key, J. Deleuze, P. F. Ceccaldi, J. P. Escande, G. Pons, and N. Dupin. 2002. High concentrations of nelfinavir as an independent risk factor for lipodystrophy in human immunodeficiency virus-infected patients. Antimicrob. Agents Chemother. 46:4009-4012.
24. Van Heeswijk, R. P. G., Y. Khaliq, K. D. Gallicano, M. Bourbeau, I. Seguin, E. J. Phillips, and D. W. Cameron. 2004. The pharmacokinetics of nelfinavir and M8 during pregnancy and post partum. Clin. Pharmacol. Ther. 76:588-597.
25. Zhang, K. E., E. Wu, A. K. Patick, B. Kerr, M. Zorbas, A. Lankford, T. Kobayashi, Y. Maeda, B. Shetty, and S. Webber. 2001. Circulating metabolites of the human immunodeficiency virus protease inhibitor nelfinavir in humans: structural identification, levels in plasma, and antiviral activities. Antimicrob. Agents Chemother. 45:1086-1093.