Population pharmacokinetics of nevirapine in combination with rifampicin-based short course chemotherapy in HIV- and tuberculosis-infected South African patients

European Journal of Clinical Pharmacology

Volumn 65, Issue 1, 2009, Pages 71-80

  Elsherbiny, Doaa ^a   Cohen, Karen ^b   Jansson, Britt ^a   Smith, Peter ^b   McIlleron, Helen ^b   Simonsson, Ulrika S H ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

HIV; Nevirapine; Pharmacokinetics; Rifampicin; Tuberculosis

Indexed keywords

'ASPEN'; COTRIMOXAZOLE; DRUG METABOLITE; ETHAMBUTOL; LAMIVUDINE; MULTIVITAMIN; NEVIRAPINE; PYRIDOXINE; RIFAMPICIN; STAVUDINE; UNCLASSIFIED DRUG; VITAMIN B COMPLEX; WARFARIN; ZIDOVUDINE;

12 HYDROXYNEVIRAPINE; ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SHORT COURSE THERAPY; SIMULATION; SOUTH AFRICA; TUBERCULOSIS;

ADMINISTRATION, ORAL; ADULT; ANTIBIOTICS, ANTITUBERCULAR; COMPUTER SIMULATION; CROSS-SECTIONAL STUDIES; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEVIRAPINE; NONLINEAR DYNAMICS; REVERSE TRANSCRIPTASE INHIBITORS; RIFAMPIN; SOUTH AFRICA; TREATMENT OUTCOME; TUBERCULOSIS; YOUNG ADULT;

EID: 57849102502     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-008-0481-y     Document Type: Article

References (44)

1. SK Sharma A Mohan T Kadhiravan 2005 HIV-TB coinfection: epidemiology, diagnosis & management Indian J Med Res 121 4 550 567
2. EL Corbett CJ Watt N Walker D Maher BG Williams MC Raviglione C Dye 2003 The growing burden of tuberculosis: global trends and interactions with the HIV epidemic Arch Intern Med 163 9 1009 1021
3. M Lamson T MacGregor P Riska D Erickson P Maxfield L Rowland M Gigliotti P Robinson S Azzam J Keirns 1999 Nevirapine induces both CYP3A4 and CYP2B6 metabolic pathways Clin Pharmacol Ther 65 2 137
4. A Milinkovic E Martinez 2004 Nevirapine in the treatment of HIV Expert Rev Anti Infect Ther 2 3 367 373
5. B Goodwin LB Moore CM Stoltz DD McKee SA Kliewer 2001 Regulation of the human CYP2B6 gene by the nuclear pregnane X receptor Mol Pharmacol 60 3 427 431
6. JM Rae MD Johnson ME Lippman DA Flockhart 2001 Rifampin is a selective, pleiotropic inducer of drug metabolism genes in human hepatocytes: studies with cDNA and oligonucleotide expression arrays J Pharmacol Exp Ther 299 3 849 857
7. TE de Vries-Sluijs JP Dieleman D Arts AD Huitema JH Beijnen M Schutten ME van der Ende 2003 Low nevirapine plasma concentrations predict virological failure in an unselected HIV-1-infected population Clin Pharmacokinet 42 6 599 605
8. MD de Jong S Vella A Carr CA Boucher A Imrie M French J Hoy S Sorice S Pauluzzi F Chiodo GJ Weverling ME van der Ende PJ Frissen HM Weigel RH Kauffmann JM Lange R Yoon M Moroni E Hoenderdos G Leitz DA Cooper D Hall P Reiss 1997 High-dose nevirapine in previously untreated human immunodeficiency virus type 1-infected persons does not result in sustained suppression of viral replication J Infect Dis 175 4 966 970
9. G Ramachandran AK Hemanthkumar S Rajasekaran C Padmapriyadarsini G Narendran B Sukumar S Sathishnarayan K Raja V Kumaraswami S Swaminathan 2006 Increasing nevirapine dose can overcome reduced bioavailability due to rifampicin coadministration J Acquir Immune Defic Syndr 42 1 36 41
10. E Ribera L Pou RM Lopez M Crespo V Falco I Ocana I Ruiz A Pahissa 2001 Pharmacokinetic interaction between nevirapine and rifampicin in HIV-infected patients with tuberculosis J Acquir Immune Defic Syndr 28 5 450 453
11. GL Dean DJ Back A de Ruiter 1999 Effect of tuberculosis therapy on nevirapine trough plasma concentrations AIDS 13 17 2489 2490
12. RS Autar FW Wit J Sankote A Mahanontharit T Anekthananon P Mootsikapun K Sujaikaew DA Cooper JM Lange P Phanuphak K Ruxrungtham DM Burger 2005 Nevirapine plasma concentrations and concomitant use of rifampin in patients coinfected with HIV-1 and tuberculosis Antivir Ther 10 8 937 943
13. W Manosuthi S Sungkanuparph A Thakkinstian S Rattanasiri A Chaovavanich W Prasithsirikul S Likanonsakul K Ruxrungtham 2006 Plasma nevirapine levels and 24-week efficacy in HIV-infected patients receiving nevirapine-based highly active antiretroviral therapy with or without rifampicin Clin Infect Dis 43 2 253 255
14. W Manosuthi K Ruxrungtham S Likanonsakul W Prasithsirikul Y Inthong T Phoorisri S Sungkanuparph 2007 Nevirapine levels after discontinuation of rifampicin therapy and 60-week efficacy of nevirapine-based antiretroviral therapy in HIV-infected patients with tuberculosis Clin Infect Dis 44 1 141 144
15. P Riska M Lamson T MacGregor J Sabo S Hattox J Pav J Keirns 1999 Disposition and biotransformation of the antiretroviral drug nevirapine in humans Drug Metab Dispos 27 8 895 901
16. J Uetrecht 2005 Role of drug metabolism for breaking tolerance and the localization of drug hypersensitivity Toxicology 209 2 113 118
17. K Cohen G van Cutsem A Boulle H McIlleron E Goemaere PJ Smith G Maartens 2008 Effect of rifampicin-based antitubercular therapy on nevirapine plasma concentrations in South African adults with HIV-associated tuberculosis J Antimicrob Chemother 61 2 389 393
18. J Chi AL Jayewardene JA Stone FT Aweeka 2003 An LC-MS-MS method for the determination of nevirapine, a non-nucleoside reverse transcriptase inhibitor, in human plasma J Pharm Biomed Anal 31 5 953 959
19. Beal SL, Sheiner LS (1994) NONMEM user's guide. NONMEM Project Group, University of California at San Fransisco, San Fransisco
20. EN Jonsson MO Karlsson 1999 Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM Comput Methods Programs Biomed 58 1 51 64
21. EI Ette 1997 Stability and performance of a population pharmacokinetic model J Clin Pharmacol 37 6 486 495
22. HIVPharmcology (2006) Optimising TDM in HIV clinical care. Virology Education BV, Utrecht, the Netherlands. http://hivpharmacology.production. tdclighthouse.com/content.cfm?lang=1&id=573&id2=639&ch=4&cid= 639. Accessed 05 Nov 2007
23. BS Kappelhoff KM Crommentuyn MM de Maat JW Mulder AD Huitema JH Beijnen 2004 Practical guidelines to interpret plasma concentrations of antiretroviral drugs Clin Pharmacokinet 43 13 845 853
24. JP Sabo MJ Lamson G Leitz CL Yong TR MacGregor 2000 Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection AAPS PharmSci 2 1 E1
25. MM de Maat AD Huitema JW Mulder PL Meenhorst EC van Gorp JH Beijnen 2002 Population pharmacokinetics of nevirapine in an unselected cohort of HIV-1-infected individuals Br J Clin Pharmacol 54 4 378 385
26. XJ Zhou LB Sheiner RT D'Aquila MD Hughes MS Hirsch MA Fischl VA Johnson M Myers JP Sommadossi 1999 Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators Antimicrob Agents Chemother 43 1 121 128
27. LZ Benet T Izumi Y Zhang JA Silverman VJ Wacher 1999 Intestinal MDR transport proteins and P-450 enzymes as barriers to oral drug delivery J Control Release 62 1-2 25 31
28. R Ohashi Y Kamikozawa M Sugiura H Fukuda H Yabuuchi I Tamai 2006 Effect of P-glycoprotein on intestinal absorption and brain penetration of antiallergic agent bepotastine besilate. Drug Metab Dispos 34 5 793 799
29. LM Almond D Edirisinghe M Dalton A Bonington DJ Back SH Khoo 2005 Intracellular and plasma pharmacokinetics of nevirapine in human immunodeficiency virus-infected individuals Clin Pharmacol Ther 78 2 132 142
30. DW Haas JA Bartlett JW Andersen I Sanne GR Wilkinson J Hinkle F Rousseau CD Ingram A Shaw MM Lederman RB Kim 2006 Pharmacogenetics of nevirapine-associated hepatotoxicity: an Adult AIDS Clinical Trials Group collaboration Clin Infect Dis 43 6 783 786
31. J Sun ZG He G Cheng SJ Wang XH Hao MJ Zou 2004 Multidrug resistance P-glycoprotein: crucial significance in drug disposition and interaction Med Sci Monit 10 1 RA5 RA14
32. RP van Heeswijk AI Veldkamp JW Mulder PL Meenhorst FW Wit JM Lange SA Danner NA Foudraine MO Kwakkelstein P Reiss JH Beijnen RM Hoetelmans 2000 The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals AIDS 14 8 F77 82
33. SL Glynn M Yazdanian 1998 In vitro blood-brain barrier permeability of nevirapine compared to other HIV antiretroviral agents J Pharm Sci 87 3 306 310
34. B Lemmer 1999 Chronopharmacokinetics: implications for drug treatment J Pharm Pharmacol 51 8 887 890
35. S Zhou E Chan LY Lim UA Boelsterli SC Li J Wang Q Zhang M Huang A Xu 2004 Therapeutic drugs that behave as mechanism-based inhibitors of cytochrome P450 3A4 Curr Drug Metab 5 5 415 442
36. Wilkins JJ, Langdon G, McIlleron H, Pillai G, Smith PJ, Simonsson USH (2005) Challenges in modelling the pharmacokinetics of isoniazid in South African tuberculosis patients (abstr 769). Available at http://www.page-meeting. org/?abstract=769 ]
37. SH Norris HH Silverstein RL St. George JN Johnstone 1992 Nevirapine, an HIV-1 reverse transcriptase inhibitor: absorption, distribution and execretion in rats Pharm Res 9 S263
38. SH Cheeseman SE Hattox MM McLaughlin RA Koup C Andrews CA Bova JW Pav T Roy JL Sullivan JJ Keirns 1993 Pharmacokinetics of nevirapine: initial single-rising-dose study in humans Antimicrob Agents Chemother 37 2 178 182
39. MJ Lamson JP Sabo TR MacGregor JW Pav L Rowland A Hawi M Cappola P Robinson 1999 Single dose pharmacokinetics and bioavailability of nevirapine in healthy volunteers Biopharm Drug Dispos 20 6 285 291
40. J Salomon P de Truchis JC Melchior 2002 Body composition and nutritional parameters in HIV and AIDS patients Clin Chem Lab Med 40 12 1329 1333
41. HO Olawumi PO Olatunji 2006 The value of serum albumin in pretreatment assessment and monitoring of therapy in HIV/AIDS patients HIV Med 7 6 351 355
42. N von Hentig A Carlebach P Gute G Knecht S Klauke M Rohrbacher H Stocker M Kurowski S Harder S Staszewski A Haberl 2006 A comparison of the steady-state pharmacokinetics of nevirapine in men, nonpregnant women and women in late pregnancy Br J Clin Pharmacol 62 5 552 559
43. E Dailly E Billaud V Reliquet S Breurec P Perre S Leautez P Jolliet M Bourin F Raffi 2004 No relationship between high nevirapine plasma concentration and hepatotoxicity in HIV-1-infected patients naive of antiretroviral treatment or switched from protease inhibitors Eur J Clin Pharmacol 60 5 343 348
44. DA Erickson G Mather WF Trager RH Levy JJ Keirns 1999 Characterization of the in vitro biotransformation of the HIV-1 reverse transcriptase inhibitor nevirapine by human hepatic cytochromes P-450 Drug Metab Dispos 27 12 1488 1495