A comparison of the steady-state pharmacokinetics of nevirapine in men, nonpregnant women and women in late pregnancy

British Journal of Clinical Pharmacology

Volumn 62, Issue 5, 2006, Pages 552-559

  Von Hentig, Nils ^a,d   Carlebach, Amina ^a   Gute, Peter ^b   Knecht, Gaby ^b   Klauke, Stefan ^b   Rohrbacher, Maren ^a   Stocker, Hartmut ^c   Kurowski, Michael ^c   Harder, Sebastian ^a   Staszewski, Schlomo ^a   Haberl, Annette ^a  

^a GOETHE UNIVERSITY   (Germany)

^b Auguste Viktoria Hospital Berlin ^*  (Germany)

^c Vivantes Auguste Viktoria Klinikum   (Germany)

^d UNIVERSITY HOSPITAL FRANKFURT   (Germany)

Author keywords

Nevirapine; Pharmacokinetics; Pregnancy

Indexed keywords

ABACAVIR; DIDANOSINE; LAMIVUDINE; NEVIRAPINE; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ADULT; AGE; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BODY WEIGHT; CONFIDENCE INTERVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG METABOLISM; EVALUATION; FEMALE; GENDER; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; MULTIVARIATE ANALYSIS; NORMAL HUMAN; PRIORITY JOURNAL; STEADY STATE; STEADY STATE PHARMACOKINETICS; TANDEM MASS SPECTROMETRY; THIRD TRIMESTER PREGNANCY;

ADULT; ANTI-HIV AGENTS; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; NEVIRAPINE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY TRIMESTER, THIRD; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 33749990555     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02664.x     Document Type: Article

References (43)

1. Centers for Disease Control. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States. 24 February 2005. Available at http://AIDSinfo.nih.gov Last accessed 15 March 2005 .
2. Centers for Disease Control. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States. Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy. 24 February 2005. Available at http://AIDSinfo.nih.gov Last accessed15 March 2005.
3. Deutsche AIDS-Gesellschaft (DAIG), Österreichische AIDS-Gesellschaft (ÖAG), Robert Koch Institut et al. Deutsch-Österreichische Empfehlungen zur HIV-Therapie in der Schwangerschaft. May 2003. Available at http://rki.de Last accessed 15 March 2005.
4. Penzak SR, Acosta EP, Turner M, Tavel JA, Masur H. Analysis of generic nevirapine products in developing countries. JAMA 2003; 289: 2648-9.
5. Mirochnick M, Clarke DF, Dorenbaum A. Nevirapine: pharmacokinetic considerations in children and pregnant women. Clin Pharmacokinetics 2000; 39: 281-93.
6. Mirochnick M. Antiretroviral pharmacology in pregnant women and their newborns. Ann NY Acad Sci 2000; 918: 287-97.
7. Nevirapine Product Information. Ridgefield, USA: Boehringer Ingelheim Pharmaceuticals, Inc. Version revised 27 March 2002.
8. Boehringer-Ingelheim. Viramune. Summary of Product Characteristics. Available at http://www.viramune.com (last accessed: February 2005).
9. Change of the Product Information for Nevirapine 200mg Tablets. Ingelheim: Boehringer Ingelheim Pharma 12 February 2004.
10. Milinkovic A, Martinez E. Nevirapine in the treatment of HIV. Expert Rev Anti-Infect Ther 2004; 2: 367-73.
11. Gonzalez de Requena D, Bobora S, Garazzino S, Sciandra M, d'Avolio A, Raiteri R, Marrone R, Boffito M, De Rosa FG, Sinicco A, Di Perri G. Nevirapine plasma exposure affects both durability of viral suppression and selection of nevirapine primary resistance mutations in a clinical setting. Antimicrob Agents Chemother 2005; 49: 3966-9.
12. Sanne I, Mommeja-Marin H, Hinkle J, Bartlett JA, Lederman MM, Maartens G, Wakeford C, Shaw A, Quinn J, Gish RG, Rousseau F. Severe hepatotoxicity associated with nevirapine use in HIV-1 infected subjects. J infect Dis 2005; 191: 825-9.
13. Kappelhoff BS, van Leth F, MacGregor TR, Lange J, Beijnen JH, Huitema AD; 2NN Study Group. Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study. Antiviral Ther 2005; 10: 145-55.
14. Haberl A, von Hentig N, Carlebach A, Kurowski M, Harder S, Staszewski S. Nevirpaine plasma exposure is decreased in pregnant women. In: 15th International AIDS Conference, July 2004, Bangkok, Thailand. Abstract published in eJIAS 2004; 1: Tu PeB4644.
15. Lyons FE, Coughlan S, Byrne CM, Hopkins SM, Hall WW, Mulcahy FM. Emergence of antiretroviral resistance in HIV-positive women receiving combination antiretroviral therapy in pregnancy. AIDS 2005; 19: 63-7.
16. Muro E, Droste J, ter Hofstede H, Bosch M, Dolmans W, Burger D. Nevirapine plasma concentrations are still detectable after more than 2 weeks in the majority of women receiving single-dose NVP. Implications for intervention studies. In: 11th Conference on Retroviruses and Opportunistic Infections, 8-11 February 2004, San Francisco, USA. Abstract 891.
17. Mackie NE, Fidler S, Tamm N, Clarke JR, Back D, Weber JN, Taylor GP. Clinical implications of stopping nevirapine-based antiretroviral therapy: relative pharmacokinetics and avoidance of drug resistance. HIV Med 2004; 5: 180-4.
18. Stocker H, Kruse G, Kreckel P, Herzmann C, Arasteh K, Claus J, Jessen H, Cordes C, Hintsche B, Schlote F, Schneider L, Kurowski M. Nevirapine significantly reduces the levels of racemic methadone and (R)-methadone in human immunodefficiency virus-infected patients. Antimicrob Agents Chemother 2004; 48: 4148-53.
19. Heinzel G, Woloszczak R, Thomann P. TOPFIT 2.0 Pharmacokinetic and Pharmacodynamic Data Analysis System for the PC. Stuttgart: Gustav Fischer Verlag 1993.
20. De Maat MM, Nellen JF, Huitema AD, Wit FW, Mulder JW, Prins JM, Beijnen JH. Race is not associated with nevirapine pharmacokinetics. Therapeut Drug Monit 2004; 26: 456-8.
21. SPSS for Windows®, Version 11.5 (German). 2005.
22. Graphpad Prism®, Version 4.01. 2004.
23. Nettles R, Kieffer T, Parsons T, Johnson J, Quinn T, Jackson B, Cofranesco J, Gallant J, Carson K, Siliciano R, Flexner C. Frequent sampling in virologically suppressed patients taking HIV protease inhibitors or non-nucleoside reverse transcriptase inhibitors defines intra-individual pharmacokinetic variability. In: 12th Conference on Retroviruses and Opportunistic Infections, 22-25 February 2005, Boston, USA. Abstract 642.
24. van Leth F, Kappelhoff B, Johnson D, Losso M, Boron-Kaczmarska A, Saag M, Livrozet JM, Hall D, Huitema A, Wit F, Beijnen J, Lange J, and the 2NN Study Group. Minimum plasma coincentrations of nevirapine and efavirenz in relation to virologic failure in antiretroviral-naïve patients. In: 12th Conference on Retroviruses and Oprtunistic Infections 2005 February 22-25, Boston, USA. Abstract 8025.
25. Anderson GD. Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach. Clin Pharmacokinet 2005; 44: 989-1008.
26. Wadelius M, Darj E, Frenne G, Rane A. Induction of CYP2D6 in pregnancy. Clin Pharmacol Ther 1997; 62: 400-7.
27. Hogstedt S, Lindberg B, Peng DR, Regardh CG, Rane A. Pregnancy-induced increase in metoprolol metabolism. Clin Pharmacol Ther 1985; 37: 688-92.
28. Heikkinen T, Ekblad U, Palo P, Laine K. Pharmacokinetics of fluoxetine and norfluoxetine in pregnancy and lactation. Clin Pharmacol Ther 2003; 73: 330-7.
29. Tomson T, Lindbom U, Ekqvist B, Sundqvist A. Disposition of carbamazepine and phenytoin in pregnancy. Pilepsia 1994; 35: 131-5.
30. Ohkita C, Goto M. Increased 6-hydrocortisol excretion in pregnant women: implication of drug-metabolizing enzyme induction. DICP 1990; 24: 814-6.
31. Kosel BW, Beckermann KP, Hayashi S, Homma M, Aweeka FT. Pharmacokinetics of nelfinavir and indinavir in HIV-1 infected pregnant women. AIDS 2003; 17: 1195-9.
32. Anderson GD. Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach. Clin Pharmacokinet 2005; 44: 989-1008.
33. Martinez E, Blanco JL, Arnaiz JA, Perez-Cuevas JB, Mocroft A, Cruceta A, Marcos MA, Milinkovic A, Garcia-Viejo MA, Mallolas J, Carne X, Phillips A, Gatell JM. Hepatotoxicity in HIV-1 infected patients receiving nevirapine-containing antiretroviral therapy. AIDS 2001; 15: 1261-8.
34. Sulkowski MS, Thomas DL, Mahta SH, Chisson RE, Moore RD. Hepatotoxicity associated with nevirapine- or efavirenz-containing antiretroviral therapy: role of hepatitis C and B infections. Hepatology 2002; 35: 182-9.
35. De Maat MM, Mathot RA, Veldkamp AI, Huitma AD, Mulder JW, Meenhorst PL, Van Gorp EC, Carlier H, Beijnen JH. Hepatotoxicity following nevirapine-containing regimens in HIV-1 infected individuals. Pharmacol Res 2002; 46: 295-300.
36. Stern JO, Robinson PA, Love J, Lanes S, Imperails MS, Mayers DL. A comprehensive hepatic safety analysis of nevirapine in different populations of HIV infected patients. J Acquir Immune Def Syndr 2003; 34 (Suppl. 1): S21-33.
37. Clendennen N, Barry C, McConkey S. Hepatotoxicity occuring in the second pregnancy of a patient on longterm nevirapine. In: 10th European AIDS Conference 17-20 November 2005, Dublin, Ireland. Abstract PS 8/1.
38. Devitt E, Jackson A, Sheehan G, Powderly WG. Nevirapine associated hepatitis occuring after prior successful nevirapine therapy in a pregnant woman. In: 10th European AIDS Conference 17-20 November 2005, Dublin, Ireland. Abstract PS 8/2.
39. Haas DW, Bartlett J, Andersen J, Sanne I, Wilkinson G, Quinn J, Rousseau F, Ingram C, Shaw A, Lederman M, Kim R. Pharmacogenetics of nevirapine and hepatotoxicity: NWCS220, an ACTG Collaborative Study. In: 12th Conference on Retroviruses and Opportunistic Infections, 22-25 February 2005, Boston, USA. Abstract 833.
40. Crommentuyn KM, Huitema AD, Brinkman K, van der Ende ME, de Wolf F, Beijnen JH. Therapeutic drug monitoring of nevirapine reduces pharmacokinetic variability but does not affect toxicity or virologic success in the ATHENA study. J AIDS 2005; 39: 249-50.
41. Back D, Blaschke T, Boucher C, Burger D, Fletcher C, Flexner C, Gerber J, Schapiro J. Optimising TDM in HIV Clinical Care: a Practical Guide to Performing Therapeutic Drug Monitoring (TDM) for Antiretroviral Agents, Version 1.0 2003. Available at: http:// www.hivpharmacology.com Last accessed 14 March 2005.
42. van Heeswijk RPG, Veldkam A, Mulder JW, Meenhorst PL, Lange JM, Beijnen JH, Hoetelmans RM. Combination of protease inhibitors for the treatment of HIV-1-infected patients: a review of pharmacokinetics and clinical experience. Antiviral Ther 2001; 6: 201-29.
43. Barrett JS, Labbe L, Pfister M. Application and impact of population pharmacokinetics in the assessment of antiretroviral pharmacotherapy. Clin Pharmacokinetics 2005; 44: 591-625.