Population pharmacokinetics of lopinavir in combination with rifampicin-based antitubercular treatment in HIV-infected South African children

European Journal of Clinical Pharmacology

Volumn 66, Issue 10, 2010, Pages 1017-1023

  Elsherbiny, Doaa ^a   Ren, Yuan ^b   McIlleron, Helen ^b   Maartens, Gary ^b   Simonsson, Ulrika S H ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

HIV; Lopinavir; Pharmacokinetics; Ritonavir; Tuberculosis

Indexed keywords

LOPINAVIR PLUS RITONAVIR; RIFAMPICIN; RNA DIRECTED DNA POLYMERASE INHIBITOR;

ARTICLE; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG METABOLISM; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; LUNG TUBERCULOSIS; MALE; MIXED INFECTION; MYCOBACTERIUM TUBERCULOSIS; PARALLEL DESIGN; POPULATION RESEARCH; PRESCHOOL CHILD; PRIORITY JOURNAL; SOUTH AFRICA;

AIDS-RELATED OPPORTUNISTIC INFECTIONS; ANTI-HIV AGENTS; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; INFANT; MALE; PYRIMIDINONES; RIFAMPIN; RITONAVIR; SOUTH AFRICA; TIME FACTORS; TREATMENT OUTCOME; TUBERCULOSIS, PULMONARY;

EID: 77957686866     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-010-0847-9     Document Type: Article

References (35)

1. PM Jeena P Pillay T Pillay HM Coovadia 2002 Impact of HIV-1 co-infection on presentation and hospital-related mortality in children with culture proven pulmonary tuberculosis in Durban, South Africa Int J Tuberc Lung Dis 6 672 678 1:STN:280:DC%2BD38vgtFOisg%3D%3D 12150478
2. SD Lawn LG Bekker K Middelkoop L Myer R Wood 2006 Impact of HIV infection on the epidemiology of tuberculosis in a peri-urban community in South Africa: the need for age-specific interventions Clin Infect Dis 42 1040 1047 10.1086/501018 16511773
3. Lopinavir/ritonavir (Kaletra) [package insert]. Abbott Laboratories, Chicago
4. DJ Porche 2001 Lopinavir/ritonavir J Assoc Nurses AIDS Care 12 101 104 1:STN:280:DC%2BD3MvlvFyltQ%3D%3D 10.1016/S1055-3290(06)60137-4 11296724
5. GW Hogeland S Swindells JC McNabb AD Kashuba GC Yee CM Lindley 2007 Lopinavir/ritonavir reduces bupropion plasma concentrations in healthy subjects Clin Pharmacol Ther 81 69 75 1:CAS:528:DC%2BD2sXht1aqsbs%3D 10.1038/sj.clpt. 6100027 17186001
6. WHO (2006) Guidance for National Tuberculosis Programmes on the management of tuberculosis in children. Available from: http://www.who.int/ child-adolescent-health/New-Publications/CHILD-HEALTH/WHO-FCH-CAH-2006.7.pdf. Accessed October 2009
7. 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 299 849 857 1:CAS:528:DC%2BD3MXovVCktr4%3D 11714868
8. 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 RA5 RA14 1:CAS:528:DC%2BD2cXhvFagu7c%3D 14704647
9. M Niemi JT Backman MF Fromm PJ Neuvonen KT Kivisto 2003 Pharmacokinetic interactions with rifampicin: clinical relevance Clin Pharmacokinet 42 819 850 1:CAS:528:DC%2BD3sXntl2htr8%3D 10.2165/00003088-200342090-00003 12882588
10. WHO (2006) Antiretroviral therapy of HIV infection in infants and children: towards universal access. Recommendations for a public health approach. Available from: http://www.who.int/hiv/pub/guidelines/ paediatric020907.pdf. Accessed October 2009
11. CDC (2007) Table 2. Recommendations for coadministering protease inhibitors and non-nucleoside reverse transcriptase inhibitors with RIFAMPIN. Available from: http://www.cdc.gov/tb/publications/guidelines/TB-HIV-Drugs/ Table2.htm. Accessed October 2009
12. CJ La Porte EP Colbers R Bertz DS Voncken K Wikstrom MJ Boeree PP Koopmans YA Hekster DM Burger 2004 Pharmacokinetics of adjusted-dose lopinavir-ritonavir combined with rifampin in healthy volunteers Antimicrob Agents Chemother 48 1553 1560 10.1128/AAC.48.5.1553-1560.2004 15105105
13. JR King DW Kimberlin GM Aldrovandi EP Acosta 2002 Antiretroviral pharmacokinetics in the paediatric population: a review Clin Pharmacokinet 41 1115 1133 1:CAS:528:DC%2BD38XpsFKmsbk%3D 10.2165/00003088-200241140-00001 12405863
14. SU Sankatsing JH Beijnen AH Schinkel JM Lange JM Prins 2004 P-glycoprotein in human immunodeficiency virus type 1 infection and therapy Antimicrob Agents Chemother 48 1073 1081 1:CAS:528:DC%2BD2cXjtVKrur8%3D 10.1128/AAC.48.4.1073-1081.2004 15047504
15. V Jullien S Urien D Hirt C Delaugerre E Rey JP Teglas P Vaz C Rouzioux ML Chaix E Macassa G Firtion G Pons S Blanche JM Tréluyer 2006 Population analysis of weight-, age-, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years Antimicrob Agents Chemother 50 11 3548 3555 1:CAS:528:DC%2BD28XhtFOkt7rL 10.1128/AAC.00943-05 16940058
16. N Rakhmanina J van den Anker A Baghdassarian S Soldin K Williams MN Neely 2009 Population pharmacokinetics of lopinavir predict suboptimal therapeutic concentrations in treatment-experienced human immunodeficiency virus-infected children Antimicrob Agents Chemother 53 6 2532 2538 1:CAS:528: DC%2BD1MXntFGksrg%3D 10.1128/AAC.01374-08 19258274
17. J Moltó MJ Barbanoj C Miranda A Blanco JR Santos E Negredo J Costa P Domingo B Clotet M Valle 2008 Simultaneous population pharmacokinetic model for lopinavir and ritonavir in HIV-infected adults Clin Pharmacokinet 47 10 681 692 10.2165/00003088-200847100-00005 18783298
18. KM Crommentuyn BS Kappelhoff JW Mulder AT Mairuhu EC van Gorp PL Meenhorst AD Huitema JH Beijnen 2005 Population pharmacokinetics of lopinavir in combination with ritonavir in HIV-1-infected patients Br J Clin Pharmacol 60 4 378 389 1:CAS:528:DC%2BD2MXhtFylt73I 10.1111/j.1365-2125.2005.02455.x 16187970
19. Y Ren JJ Nuttall C Egbers BS Eley TM Meyers PJ Smith G Maartens HM McIlleron 2008 Effect of rifampicin on lopinavir pharmacokinetics in HIV-infected children with tuberculosis J Acquir Immune Defic Syndr 47 566 569 1:CAS:528:DC%2BD1cXjs1Gqt7g%3D 10.1097/QAI.0b013e3181642257 18197120
20. Beal SL, Sheiner LS (1994) NONMEM user's guide, NONMEM Project Group. University of California at San Francisco, San Francisco
21. EN Jonsson MO Karlsson 1999 Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM Comput Meth Programs Biomed 58 51 64 1:STN:280:DyaK1M3htVShsw%3D%3D 10.1016/S0169-2607(98) 00067-4
22. EI Ette 1997 Stability and performance of a population pharmacokinetic model J Clin Pharmacol 37 486 495 1:CAS:528:DyaK2sXktlWisbk%3D 9208355
23. Keulen (2006) Recommendations for performing TDM of antiretroviral agents. Available from: http://hivpharmacology.production.tdclighthouse.com/ content.cfm?lang=1&id=573&id2=639&ch=4&cid=639. Accessed October 2009
24. RJ Gass J Gal PW Fogle D Detmar-Hanna JG Gerber 1998 Neither dapsone hydroxylation nor cortisol 6beta-hydroxylation detects the inhibition of CYP3A4 by HIV-1 protease inhibitors Eur J Clin Pharmacol 54 741 747 1:CAS:528:DyaK1cXnvVyntbs%3D 10.1007/s002280050545 9923578
25. D Ouellet A Hsu J Qian CS Locke CJ Eason JH Cavanaugh JM Leonard GR Granneman 1998 Effect of ritonavir on the pharmacokinetics of ethinyl oestradiol in healthy female volunteers Br J Clin Pharmacol 46 111 116 1:CAS:528:DyaK1cXlsFCit74%3D 10.1046/j.1365-2125.1998.00749.x 9723818
26. SM Geletko AD Erickson 2000 Decreased methadone effect after ritonavir initiation Pharmacotherapy 20 93 94 1:STN:280:DC%2BD3c7gsV2ltA%3D%3D 10.1592/phco.20.1.93.34654 10641980
27. G Luo M Cunningham S Kim T Burn J Lin M Sinz G Hamilton C Rizzo S Jolley D Gilbert A Downey D Mudra R Graham K Carroll J Xie A Madan A Parkinson D Christ B Selling E LeCluyse LS Gan 2002 CYP3A4 induction by drugs: correlation between a pregnane X receptor reporter gene assay and CYP3A4 expression in human hepatocytes Drug Metab Dispos 30 795 804 1:CAS:528:DC%2BD38XltVGru78%3D 10.1124/dmd.30.7.795 12065438
28. NI Paton YM Ng CB Chee C Persaud AA Jackson 2003 Effects of tuberculosis and HIV infection on whole-body protein metabolism during feeding, measured by the [15N]glycine method Am J Clin Nutr 78 319 325 1:CAS:528:DC%2BD3sXlvF2isLo%3D 12885716
29. NI Paton YM Ng 2006 Body composition studies in patients with wasting associated with tuberculosis Nutrition 22 245 251 10.1016/j.nut.2005.06.009 16500551
30. BS Kappelhoff AD Huitema KM Crommentuyn JW Mulder PL Meenhorst EC van Gorp AT Mairuhu JH Beijnen 2005 Development and validation of a population pharmacokinetic model for ritonavir used as a booster or as an antiviral agent in HIV-1-infected patients Br J Clin Pharmacol 59 174 182 1:CAS:528: DC%2BD2MXitFOgsLs%3D 10.1111/j.1365-2125.2004.02241.x 15676039
31. Ritonavir (Norvir) [product monograph]. Abbott Laboratories
32. K Venkatakrishnan RS Obach A Rostami-Hodjegan 2007 Mechanism-based inactivation of human cytochrome P450 enzymes: strategies for diagnosis and drug-drug interaction risk assessment Xenobiotica 37 1225 1256 1:CAS:528:DC%2BD2sXht1ahu7vJ 10.1080/00498250701670945 17968744
33. KE Culm-Merdek LL von Moltke L Gan KA Horan R Reynolds JS Harmatz MH Court DJ Greenblatt 2006 Effect of extended exposure to grapefruit juice on cytochrome P450 3A activity in humans: comparison with ritonavir Clin Pharmacol Ther 79 243 254 1:CAS:528:DC%2BD28XitVKhurg%3D 10.1016/j.clpt.2005.11.009 16513448
34. G Verweel DM Burger NL Sheehan AS Bergshoeff A Warris LC van der Knaap G Driessen R de Groot NG Hartwig 2007 Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below Antivir Ther 12 453 458 1:CAS:528:DC%2BD2sXos1Khsbw%3D 17668553
35. EG Chadwick EV Capparelli R Yogev JA Pinto B Robbins JH Rodman J Chen P Palumbo L Serchuck E Smith M Hughes P1030 team 2008 Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results AIDS 22 249 255 1:CAS:528:DC%2BD2sXhsVGgtLvF 10.1097/QAD. 0b013e3282f2be1d 18097227