Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates

Antimicrobial Agents and Chemotherapy

Volumn 55, Issue 1, 2011, Pages 331-337

  Benaboud, Sihem ^a,b   Ekouévi, Didier K ^c   Urien, Saik ^a,b   Rey, Elisabeth ^d   Arrivé, Elise ^e   Blanche, Stéphane ^f   Gray, Glenda ^g   Sim, Kruy Leang ^h   Avit, Divine ^c   McIntyre, James ^g   Nerrienet, Eric ⁱ   Dabis, François ^e   Tréluyer, Jean Marc ^a,b,d   Hirt, Déborah ^a,b  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b Paris Descartes University   (France)

^c Programme PAC CI   (Côte d’Ivoire)

^d ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^e INSERM   (France)

^f HÔPITAL NECKER ENFANTS MALADES   (France)

^g UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^h Hopital Calmette   (Cambodia)

ⁱ INSTITUT PASTEUR DU CAMBODGE   (Cambodia)

Author keywords

[No Author keywords available]

Indexed keywords

EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; NEVIRAPINE; ZIDOVUDINE;

ADULT; ARTICLE; COMPARTMENT MODEL; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MAJOR CLINICAL STUDY; MATERNAL BLOOD; MINIMUM INHIBITORY CONCENTRATION; NEWBORN; PLACENTAL TRANSFER; PREGNANCY; PRIORITY JOURNAL; UMBILICAL CORD BLOOD; VERTICAL TRANSMISSION;

ADENINE; ADULT; ANTI-HIV AGENTS; DEOXYCYTIDINE; FEMALE; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; NEVIRAPINE; PHOSPHONIC ACIDS; PREGNANCY; TREATMENT OUTCOME; YOUNG ADULT; ZIDOVUDINE;

EID: 78650633650     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00631-10     Document Type: Article

References (24)

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. Arrivé, E., M. L. Newell, D. K. Ekouevi, M. L. Chaix, R. Thiebaut, B. Masquelier, V. Leroy, P. V. Perre, C. Rouzioux, F. Dabis, and the Ghent Group on HIV in Women and Children. 2007. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int. J. Epidemiol. 36:1009-1021.
3. Beal, S. L. 2001. Ways to fit a PK model with some data below the quantification limit. J. Pharmacokinet. Pharmacodyn. 28:481-504.
4. Beal, S. L., and L. B. Sheiner. 1998. NONMEM user's guide. NONMEM Project Group, University of California, San Francisco, San Francisco, CA.
5. Best, B. M., A. M. Stek, M. Mirochnick, C. Hu, H. Li, S. K. Burchett, S. S. Rossi, E. Smith, J. S. Read, E. V. Capparelli, and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s Study Team. 2010. Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J. Acquir. Immune Defic. Syndr. 54:381-388.
6. Chi, B. H., M. Sinkala, F. Mbewe, R. A. Cantrell, G. Kruse, N. Chintu, G. M. Aldrovandi, E. M. Stringer, C. Kankasa, J. T. Safrit, and J. S. Stringer. 2007. Single-dose tenofovir and emtricitabine for reduction of viral resistance to nonnucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomized trial. Lancet 370:1698-1705.
7. Coffie, P. A., D. K. Ekouevi, M. L. Chaix, B. Tonwe-Gold, A. B. Clarisse, R. Becquet, I. Viho, T. N′dri-Yoman, V. Leroy, E. J. Abrams, C. Rouzioux, and F. Dabis. 2008. Maternal 12-month response to antiretroviral therapy following prevention of mother-to-child transmission of HIV type 1, Ivory Coast, 2003-2006. Clin. Infect. Dis. 46:622-624.
8. Cooper, C. L., and R. P. G. van Heeswijk. 2007. Once-daily nevirapine dosing: a pharmacokinetics, efficacy and safety review. HIV Med. 8:1-7.
9. Cressey, T. R., G. Jourdain, M. J. Lallemant, S. Kunkeaw, J. B. Jackson, P. Musoke, E. Capparelli, and M. Mirochnick. 2005. Persistence of nevirapine exposure during the postpartum period after intrapartum single-dose nevirapine in addition to zidovudine prophylaxis for the prevention of motherto-child transmission of HIV-1. J. Acquir. Immune Defic. Syndr. 38:283-288.
10. Eshleman, S. H., D. R. Hoover, S. Chen, S. E. Hudelson, L. A. Guay, A. Mwatha, S. A. Fiscus, F. Mmiro, P. Musoke, J. B. Jackson, N. Kumwenda, and T. Taha. 2005. Nevirapine (NVP) resistance in women with HIV-1 subtype C, compared with subtypes A and D, after the administration of single-dose NVP. J. Infect. Dis. 192:30-36.
11. Eun Ahn, J., M. O. Karlsson, A. Dunne, and T. M. Ludden. 2008. Likelihood based approaches to handling data below the quantification limit using NONMEM VI. J. Pharmacokinet. Pharmacodyn. 35:401-442.
12. Hirt, D., S. Urien, D. K. Ekouévi, E. Rey, E. Arrivé, S. Blanche, C. Amani-Bosse, E. Nerrienet, G. Gray, M. Kone, S. K. Leang, J. McIntyre, F. Dabis, and J. M. Tréluyer. 2009. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). ANRS 12109. Clin. Pharmacol. Ther. 85:182-189.
13. Hirt, D., S. Urien, E. Rey, E. Arrivé, D. K. Ekouévi, P. Coffié, S. K. Leang, S. Lalsab, D. Avit, E. Nerrienet, J. McIntyre, S. Blanche, F. Dabis, and J. M. Tréluyer. 2009. Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Antimicrob. Agents Chemother. 53:1067-1073.
14. Jackson, J. B., G. Becker-Pergola, L. A. Guay, P. Musoke, M. Mracna, M. G. Fowler, L. M. Mofenson, M. Mirochnick, F. Mmiro, and S. H. Eshleman. 2000. Identification of the K103N resistance mutation in Ugandan women receiving nevirapine to prevent HIV-1 vertical transmission. AIDS 14:F111-F115.
15. Jourdain, G., N. Ngo-Giang-Huong, S. Le Coeur, C. Bowonwatanuwong, P. Kantipong, P. Leechanachai, S. Ariyadej, P. Leenasirimakul, S. Hammer, M. Lallemant, and the Perinatal HIV Prevention Trial Group. 2004. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N. Engl. J. Med. 351:229-240.
16. Reference deleted.
17. Kunz, A., M. Frank, K. Mugenyi, R. Kabasinguzi, A. Weidenhammer, M. Kurowski, C. Kloft, and G. Harms. 2009. Persistence of nevirapine in breast milk and plasma of mothers and their children after single-dose administration. J. Antimicrob. Chemother. 63:170-177.
18. Leeder, J. S., and G. L. Kearns. 1997. Pharmacogenetics in pediatrics: implications for practice. Pediatr. Clin. North Am. 44:55-77.
19. Lockman, S., R. L. Shapiro, L. M. Smeaton, C. Wester, I. Thior, L. Stevens, F. Chand, J. Makhema, C. Moffat, A. Asmelash, P. Ndase, P. Arimi, E. van Widenfelt, L. Mazhani, V. Novitsky, S. Lagakos, and M. Essex. 2007. Response to antiretroviral therapy after a single, peripartum dose of nevirapine. N. Engl. J. Med. 356:135-147.
20. Mirochnick, M., T. Fenton, P. Gagnier, J. Pav, M. Gwynne, S. Siminski, R. S. Sperling, K. Beckerman, E. Jimenez, R. Yogev, S. A. Spector, and J. L. Sullivan for the Pediatric AIDS Clinical Trials Group Protocol 250 Team. 1998. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. J. Infect. Dis. 178:368-374.
21. Musoke, P., L. A. Guay, D. Bagenda, M. Mirochnick, C. Nakabiito, T. Fleming, T. Elliott, S. Horton, K. Dransfield, J. W. Pav, A. Murarka, M. Allen, M. G. Fowler, L. Mofenson, D. Hom, F. Mmiro, and J. B. Jackson. 1999. A phase I/II study of safety and pharmacokinetics of nevirapine in pregnant Ugandan women and their neonates (HIVNET 006). AIDS 13: 479-486.
22. Riska, P., M. Lamson, T. Macgregort, J. Sabo, S. Hattox, J. Pav, and J. Keirns. 1999. Disposition and biotransformation of the antiretroviral drug nevirapine in humans. Drug Metab. Dispos. 27:895-901.
23. Stek, A. M., M. Mirochnick, E. Capparelli, B. M. Best, C. Hu, S. K. Burchett, C. Elgie, D. T. Holland, E. Smith, R. Tuomala, A. Cotter, and J. S. Read. 2006. Reduced lopinavir exposure during pregnancy. AIDS 20:1931-1939.
24. Reference deleted.