Population pharmacokinetic analysis for nelfinavir and its metabolite M8 in virologically controlled HIV-infected patients on HAART

British Journal of Clinical Pharmacology

Volumn 60, Issue 4, 2005, Pages 390-403

  Panhard, Xavièr ^a   Goujard, C ^a   Legrand, M ^a   Taburet, A M ^a   Diquet, B ^a   Mentre F ^a  

^a BICHAT HOSPITAL   (France)

Author keywords

Joint model; Metabolite; Nelfinavir; Population pharmacokinetics

Indexed keywords

DRUG METABOLITE; NELFINAVIR; ZIDOVUDINE;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFECT; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INHIBITION; DRUG METABOLISM; DRUG MONITORING; DRUG RESPONSE; FEMALE; FOLLOW UP; GENETIC VARIABILITY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; MATHEMATICAL ANALYSIS; POPULATION MODEL; PRIORITY JOURNAL; VIRUS LOAD;

ADULT; AGED; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; MALE; MIDDLE AGED; MODELS, CHEMICAL; NELFINAVIR; PROSPECTIVE STUDIES;

EID: 26444470406     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2005.02456.x     Document Type: Article

References (32)

1. Khaliq Y, Gallicano K, Seguin I, Fyke K, Carignan G, Bulman D, Badley A, Cameron DW. Single and multiple dose pharmacokinetics of nelfinavir and CYP2C19 activity in human immunodeficiency virus-infected patients with chronic liver disease. Br J Clin Pharmacol 2000; 50: 108-15.
2. Zhang MH, Pithavala YK, Lee CA, Lillibridge JH, Wu EY, Sandoval TM, Daniels RG, Kerr BM. Apparent genetic polymorphism in nelfinavir metabolism: evaluation of clinical relevance. 12th International Symposium on Microsomes and Drug Oxidations. Montpellier, France 1998, Abstract 264.
3. Zhang KE, Wu E, Patick AK, Kerr BM, Zorbas M, Lankford A, Kobayashi T, Maeda Y, Shetty B, Webber S. Circulating metabolites of the human immunodeficiency virus protease inhibitor nelfinavir in humans: structural identification, levels in plasma, and antiviral activities. Antimicrob Agents Chemother 2001; 45: 1086-93.
4. Barry M, Mulcahy F, Merry C, Gibbons S, Back D. Pharmacokinetics and potential interactions amongst antiretroviral agents used to treat patients with HIV infection. Clin Pharmacokinet 1999; 36: 289-304.
5. Burger DM Hugen PWH Aarnouste RE Hoetelmans RMW. Treatment failure of nelfinavir-containing triple therapy can largely be explained by low nelfinavir plasma concentrations. AIDS 2003; 17: 1157-65.
6. Le Moing V Peytavin G Journot V, Cottalorda J, Bouvet E, Chĉne G, Préau M, Merle de Boever C, Leport C, Raffi F and the APROCO Cohort Study Group. Plasma levels of indinavir and nelfinavir at time of virologic response may have a different impact on the risk of further virologic failure in HIV-infected patients. J Acquir Immune Defic Syndr 2003; 34: 497-9.
7. Back DJ, Khoo SH, Gibbons SE, Merry C. The role of therapeutic drug monitoring in treatment of HIV infection. Br J Clin Pharmacol 2001; 51: 301-8.
8. Aarnoutse RE, Schapiro JM, Boucher CA, Hekster YA, Burger DM. Therapeutic drug monitoring: an aid to optimising response to antiretroviral drugs? Drugs 2003; 63: 741-53.
9. Burger DM, Hugen PWH, Reiss P, Gyssens I, Schneider M, Kroon F, Schreij G, Brinkman K, Richter C, Prins J, Aarnoutse R, Lange J and the ATHENA Cohort Study Group. Therapeutic drug monitoring of nelfinavir and indinavir in treatment-naive HIV-1-infected individuals. AIDS 2003; 17: 1157-65.
10. Jackson KA, Rosenbaum SE, Kerr BM, Pithavala YK, Yuen G, Dudley MN. A population pharmacokinetic analysis of nelfinavir mesylate in human immunodefficiency virus-infected patients enrolled in a phase III clinical trial. Antimicrob Agents Chemother 2000; 44: 1832-7.
11. Baede-van Dijk PA, Hugen PWH, Verweij-van Wissen CPWGM, Koopmans PP, Burger DM, Hekster YA. Analysis of variation in plasma concentrations of nelfinavir and its active metabolite M8 in HIV-positive patients. AIDS 2001; 15: 991-8.
12. Spire B, Duran S, Souville M, Leport C, Raffi F, Moatti JP and the APROCO cohort study group. Adherence to highly active antiretroviral therapies (HAART) in HIV-infected patients: from a predictive to a dynamic approach. Soc Sci Med 2002; 54: 14981-96.
13. Akaike H. Statistical predictor identification. Ann Inst Statist Math 1973; 22: 203-17.
14. Legrand M, Taburet AM, Diquet B. Interlaboratory quality control for PI quantifications in multicentric trial. 2nd International Workshop on Clinical Pharmacology of HIV Therapy. Noordwijk, the Netherlands, 2001: Abstract 8.3.
15. Lamotte C, Peytavin G, Farinotti R. Determination of nelfinavir, a potent protease inhibitor and its metabolite M8 in human plasma sample by high-performance liquid chromatography with photodiode-array detection. J Chromatogr B 1999; 735: 159-70.
16. Aymard G, Legrand M, Trichereau N, Diquet B. Determination of twelve antiretroviral agents in human plasma sample using reverse-phase high-performance liquid chromatography. J Chromatogr B 2000; 744: 227-40.
17. Proust V, Toth K, Hulin A, Taburet AM, Gimenez F, Singlas E. Simultaneous high-performance liquid chromatographic determination of the antiretroviral agents amprenavir, nelfinavir, ritonavir, saquinavir, delavirdine and efavirenz in human plasma. J Chromatogr B 2000; 742: 453-8.
18. Dailly E, Thomas L, Kergueris MF, Jolliet P, Bourin M. High-performance liquid chromatographic assay to determine the plasma levels of HIV-protease inhibitors (amprenavir, nelfinavir, ritonavir, saquinavir) and the non-nucleoside reverse transcriptase inhibitor (nevirapine) after liquid-liquid extraction. J Chromatogr B 2001; 758: 129-35.
19. Bouley M, Briere C, Padoin C, Petitjean O, Tod M. Sensitive and rapid method for the simultaneous quantification of the HIV-protease inhibitors indinavir, nelfinavir, ritonavir and saquinavir in human plasma by reversed-phase liquid chromatography. Ther Drug Monit 2001; 23: 56-60.
20. Houston JB. Drug metabolite kinetics. Pharmacol Ther 1981; 15: 521-52.
21. Rowland M, Tozer TN. Clinical Pharmacokinetics, Concepts and Applications, 3rd edn. Baltimore: Lippincott. Williams & Wilkins, 1995.
22. Mentré F, Escolano S, Diquet B, Golmard JL, Mallet A. Clinical pharmacokinetics of zidovudine: inter and intraindividual variability and relationship to long term efficacy and toxicity. Eur J Clin Pharmacol 1993; 45: 397-407.
23. Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn 2001; 28: 481-504.
24. Lindström MJ, Bates DM. Nonlinear mixed-effects models for repeated measures data. Biometrics 1990; 46: 673-87.
25. Pinheiro JC, Bates DM. Mixed-Effect Models in S and Splus. New York: Springer-Verlag 2000.
26. Karlsson MO, Sheiner LB. The importance of modelling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 1993; 21: 735-50.
27. Kerbusch T, Wahlby U, Milligan PA, Karlsson MO. Electronic monitoring of variation in drug intakes can reduce bias and improve precision in pharmacokinetic/pharmacodynamic population studies. Br J Clin Pharmacol 2003; 56: 639-52.
28. Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data. I. Best-case performance. J Pharmacokinet Pharmacodyn 2003; 30: 387-404.
29. Moghadamnia AA, Rostami-Hodjegan A, Abdul-Manap R, Wright CE, Morice AH, Tucker GT. Physiologically based modelling of inhibition of metabolism and assessment of the relative potency of drug and metabolite: dextromethorphan vs. dextrorphan using quinidine inhibition. Br J Clin Pharmacol 2003; 56: 57-67.
30. DiCenzo R, Forrest A, Fischl MA, Collier A, Feinberg J, Ribaudo H, DiFrancecso R, Morse GD and the AIDS Clinical Trials Group 388/ 733/5060 Study Team. Pharmacokinetics of indinavir and nelfinavir in treatment-naive, human immunodeficiency virus-infected subjects. Antimicrob Agents Chemother 2004; 48: 918-23.
31. Brendel K, Legrand M, Taburet AM, Baron G, Goujard C, Mentré F and the Cophar 1-ANRS 102 Study Group. Population pharmacokinetic analysis of indinavir in HIV-patients treated with stable antiretroviral therapy. Fundam Clin Pharmacol 2005; in press.
32. Vrijens B, Goetghebeur E. Electronic monitoring of variation in drug intakes can reduce bias and improve precision in pharmacokinetic/pharmacodynamic population studies. Stat Med 2004; 23: 531-44.