Safety and Pharmacokinetics of Nelfinavir During the Second and Third Trimesters of Pregnancy and Postpartum

REFERENCES

• Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. January 12, 2009. http://www.aidsinfo.nih.gov/contentfiles/adultadolescentgI.pdf. Accessed October 12,2009.
   Google Scholar
• Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55:1–17.
   PubMedGoogle Scholar
• Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331:1173–1180.
   PubMed Web of Science ®Google Scholar
• Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard anti-retroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA. 2002288: 189–198.
   Google Scholar
• Volmink J, Siegfried NL, van der ML, et al. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection. Cochrane Database Syst Rev. 2007; CD003510.
   PubMed Web of Science ®Google Scholar
• Kaeser B, Charoin JE, Gerber M, et al. Assessment of the bioequivalence of two nelfinavir tablet formulations under fed and fasted conditions in healthy subjects. Int J Clin Pharmacol Ther. 2005;43:154–162.
   PubMed Web of Science ®Google Scholar
• Perry CM, Frampton JE, McCormack PL, et al. Nelfinavir: a review of its use in the management of HIV infection. Drugs. 2005;65:2209–2244.
   PubMed Web of Science ®Google Scholar
• Zhang KE, Wu E, Patick AK, et al. Circulating metabolites of the human immunodeficiency virus protease inhibitor nelfinavir in humans: structural identification, levels in plasma, and antiviral activities. Antimicrob Agents Che-mother 2001;45:1086–1093.
   PubMed Web of Science ®Google Scholar
• Boffito M, Back DJ, Blaschke TF, et al. Protein binding in antiretroviral therapies. AIDS Res Hum Retroviruses. 2003;19:825–835.
   PubMed Web of Science ®Google Scholar
• Back DJ, Khoo SH, Gibbons SE, et al. The role of therapeutic drug monitoring in treatment of HIV infection. Br J Clin Pharmacol. 200151: 301–308.
   Google Scholar
• Mirochnick M, Capparelli E. Pharmacokinetics of anti-retrovirals in pregnant women. Clin Pharmacokinet. 2004;43:1071–1087.
   PubMed Web of Science ®Google Scholar
• van Heeswijk RP, Khaliq Y, Gallicano KD, et al. The phar-macokinetics of nelfinavir and M8 during pregnancy and post partum. Clin Pharmacol Ther 2004;76:588–597.
   PubMed Web of Science ®Google Scholar
• Acosta EP, Zorrilla C, Van DR et al. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001;2:460–465.
   PubMedGoogle Scholar
• Stek AM, Mirochnick M, Capparelli E, et al. Reduced lopinavir exposure during pregnancy. AIDS. 2006;20: 1931–1939.
   PubMed Web of Science ®Google Scholar
• Unadkat JD, Wara DW, Hughes MD, et al. Pharmacokinet-ics and safety of indinavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Che-mother 2007;51:783–786.
   PubMed Web of Science ®Google Scholar
• Notarianni Li. Plasma protein binding of drugs in pregnancy and in neonates. Clin PharmacokineL 1990;18:20–36.
   Google Scholar
• Wood M, Wood AJ. Changes in plasma drug binding and alpha 1-acid glycoprotein in mother and newborn infant. Clin Pharmacol Ther 1981;29:522–526.
   PubMed Web of Science ®Google Scholar
• Bryson YJ, Mirochnick M, Stek A, et al. Pharmacokinetics and safety of nelfinavir when used in combination with zid-ovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353. HIV Clin Trials. 2008;9:115–125.
   PubMed Web of Science ®Google Scholar
• Hirt D, Treluyer JM, Jullien V et al. Pregnancy-related effects on nelfinavir-M8 pharmacokinetics: a population study with 133 women. Antimicrob Agents Chemother. 2006;50:2079–2086.
   PubMed Web of Science ®Google Scholar
• Nellen JF, Schillevoort I, Wit RN, et al. Nelfinavir plasma concentrations are low during pregnancy. Clin Infect Dis. 2004;39:736–740.
   PubMed Web of Science ®Google Scholar
• Villani P, Floridia M, Pirillo MF, et al. Pharmacokinetics of nelfinavir in HIV-1-infected pregnant and nonpregnant women. Br J Clin PharmacoL 2006;62:309–315.
   PubMed Web of Science ®Google Scholar
• Kosel BW, Beckerman KP, Hayashi S, et al. Pharmacoki-netics of nelfinavir and indinavir in HIV-1-infected pregnant women. AIDS. 2003;17:1195–1199.
   PubMed Web of Science ®Google Scholar
• Read JS, Best BM, Stek AM et al. Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum. HIV Med. 2008;9:875–882.
   PubMed Web of Science ®Google Scholar
• Stek AM, Mirochnick M, Capparelli E, et al. Reduced lopinavir exposure during pregnancy. AIDS. 2006;20:1931–1939.
   PubMed Web of Science ®Google Scholar
• Acosta EP, Bardeguez A, Zorrilla CD, et al. Pharmacokinet-ics of saquinavir plus low-dose ritonavir in human immu-nodeficiency virus-infected pregnant women. Antimicrob Agents Chemother 2004;48:430–436.
   PubMed Web of Science ®Google Scholar
• Division of AIDS Regulatory Support Center. Division of AIDS table for grading of severity of adult adverse experiences. 1992. Division of AIDS Regulatory Support Center Web site. http://rsc.tech-res.com/safetyandpharmacovigilance/
   Google Scholar
• Rowland M, Tozer T. Clinical Pharmacokinetics: Concepts and Applications. Philadelphia: Lippincott Williams & Wilkins; 1995.
   Google Scholar
• Justesen US, Pedersen C, Klitgaard NA. Simultaneous quantitative determination of the HIV protease inhibitors indinavir, amprenavir, ritonavir, lopinavir, saquinavir, nel-finavir and the nelfinavir active metabolite M8 in plasma by liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;783:491–500.
   PubMed Web of Science ®Google Scholar
• Department of Health and Human Services. Guidelines for the use of antiretroviral agents in pediatric HIV infec-tion. 2006. http://aidsinfo.nih.gov/ContentFiles/Pediatric-Guidelines11032005052.pdf. Accessed January 1,2006.
   Google Scholar
• Hill JB, Sheffield JS, Zeeman GG, et al. Hepatotoxicity with antiretroviral treatment of pregnant women. Obstet Gynecol. 200198: 909–911.
   Google Scholar
• Stohl HE, Silva AM, Argani CH, et al. Fulminant hepatic failure associated with antiretroviral therapy in a pregnant woman. Int J Gynaecol Obstet. 2009;106:260–261.
   PubMed Web of Science ®Google Scholar
• Hitti J, Frenkel LM, Stek AM, et al. Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. J Acquir Immune Defic Syndr 2004;36:772–776.
   PubMed Web of Science ®Google Scholar
• Pfizer Inc. Pfizer data on file: Pfizer safety database. 2008.
   Google Scholar
• Baylor M, Truffa M, Gibbs N. Hepatic toxicity of antiret-rovirals in HIV-infected pregnant women: a review of the FDA's adverse event reporting system. Presented at: 10th Conference on Retroviruses and Opportunistic Infections; 2004. Poster 944.
   Google Scholar
• Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15:241–243.
   PubMed Web of Science ®Google Scholar
• Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for January 1989 through 31 July 2010. 2010. http://www.apregistry.com/. Accessed February 15,2011.
   Google Scholar
• Gandhi M, Aweeka F, Greenblatt RM, et al. Sex differences in pharmacokinetics and pharmacodynamics. Annu Rev Pharmacol Toxicol. 2004;44:499–523.
   PubMed Web of Science ®Google Scholar
• Garcia PM, Kalish LA, Pitt J, et al. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999;341:394–402.
   PubMed Web of Science ®Google Scholar
• Hirt D, Urien S, Jullien V, et al. Pharmacokinetic modelling of the placental transfer of nelfinavir and its M8 metabo-lite: a population study using 75 maternal-cord plasma samples. Br J Clin PharmacoL 2007;64:634–644.
   PubMed Web of Science ®Google Scholar
• Gingelmaier A, Kurowski M, Kastner R, et al. Placental transfer and pharmacokinetics of lopinavir and other pro-tease inhibitors in combination with nevirapine at delivery. AIDS. 2006;20:1737–1743.
   PubMed Web of Science ®Google Scholar
• Miotti PG, Liomba G, Dallabetta GA, et al. T lymphocyte subsets during and after pregnancy: analysis in human immunodeficiency virus type 1-infected and -uninfected Malawian mothers. J Infect Dis. 1992;165:1116–1119.
   PubMed Web of Science ®Google Scholar