Integration of data from multiple sources for simultaneous modelling analysis: Experience from nevirapine population pharmac okinetics

British Journal of Clinical Pharmacology

Volumn 74, Issue 3, 2012, Pages 465-476

  Svensson, Elin ^a   van der Walt, Jan Stefan ^a,b   Barnes, Karen I ^b   Cohen, Karen ^b   Kredo, Tamara ^b,c   Huitema, Alwin ^d   Nachega, Jean B ^b,e   Karlsson, Mats O ^a   Denti, Paolo ^b  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^d SLOTERVAART HOSPITAL   (Netherlands)

^e JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Missing covariates; Nevirapine; NONMEM; Population pharmacokinetics; Prediction and variability corrected visual predictive check; Simultaneous modelling analysis

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; ETHAMBUTOL; ISONIAZID; NEVIRAPINE; RIFAMPICIN; TUBERCULOSTATIC AGENT;

ADULT; ALLOMETRY; ARTICLE; BODY SIZE; CLINICAL RESEARCH; COMPARTMENT MODEL; DATA ANALYSIS SOFTWARE; DATA PROCESSING; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG MONITORING; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL MODEL; MATHEMATICAL PARAMETERS; PREDICTIVE VALIDITY; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE ANALYSIS; REGRESSION ANALYSIS; STEADY STATE; TUBERCULOSIS; VALIDATION STUDY;

ADULT; AGED; ANTI-HIV AGENTS; BIOLOGICAL AVAILABILITY; DRUG INTERACTIONS; FEMALE; FOOD-DRUG INTERACTIONS; GASTROINTESTINAL TRANSIT; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEVIRAPINE; NONLINEAR DYNAMICS; REGRESSION ANALYSIS; SOUTH AFRICA; YOUNG ADULT;

EID: 84864794086     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04205.x     Document Type: Article

References (54)

1. Henning S. Population 'meta-/mega-'models; challenges and solutions. Novartis Modeling and Simulation Symposium; 2011; Cape Town, South Africa.
2. Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. Br Med J 2010; 340: c221.
3. Dokoumetzidis A, Aarons L. Propagation of population PK and PD information using a Bayesian approach: dealing with non-exchangeability. J Pharmacokinet Pharmacodyn 2006; 33: 29-48.
4. Gisleskog PO, Karlsson MO, Beal SL. Use of prior information to stabilize a population data analysis. J Pharmacokinet Pharmacodyn 2002; 29: 473-505.
5. World Health Organization. Towards Universal Access: Scaling up Priority HIV/AIDS Interventions in the Health Sector. Progress Report. Geneva: The Organization, 2009.
6. de Maat MM, Huitema AD, Mulder JW, Meenhorst PL, van Gorp EC, Beijnen JH. Population pharmacokinetics of nevirapine in an unselected cohort of HIV-1-infected individuals. Br J Clin Pharmacol 2002; 54: 378-85.
7. Dailly E, Raffi F, Perre P, Martin J, Deslandes G, Jolliet P. Influence of darunavir coadministration on nevirapine pharmacokinetics in HIV-infected patients: a population approach. HIV Med 2009; 10: 586-9.
8. Elsherbiny D, Cohen K, Jansson B, Smith P, McIlleron H, Simonsson US. Population pharmacokinetics of nevirapine in combination with rifampicin-based short course chemotherapy in HIV- and tuberculosis-infected South African patients. Eur J Clin Pharmacol 2009; 65: 71-80.
9. Chou M, Bertrand J, Segeral O, Verstuyft C, Borand L, Comets E, Le Tiec C, Becquemont L, Ouk V, Mentre F, Taburet AM. Population pharmacokinetic-pharmacogenetic study of nevirapine in HIV-infected Cambodian patients. Antimicrob Agents Chemother 2010; 54: 4432-9.
10. Zhou XJ, Sheiner LB, D'Aquila RT, Hughes MD, Hirsch MS, Fischl MA, Johnson VA, Myers M, Sommadossi JP. 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 1999; 43: 121-8.
11. Sabo JP, Lamson MJ, Leitz G, Yong CL, MacGregor TR. Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection. AAPS PharmSci 2000; 2: E1.
12. Kappelhoff BS, van Leth F, MacGregor TR, Lange J, Beijnen JH, Huitema AD. Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study. Antivir Ther 2005; 10: 145-55.
13. Schipani A, Wyen C, Mahungu T, Hendra H, Egan D, Siccardi M, Davies G, Khoo S, Fatkenheuer G, Youle M, Rockstroh J, Brockmeyer NH, Johnson MA, Owen A, Back DJ. Integration of population pharmacokinetics and pharmacogenetics: an aid to optimal nevirapine dose selection in HIV-infected individuals. J Antimicrob Chemother 2011; 66: 1332-9.
14. Lehr T, Yuan J, Hall D, Zimdahl-Gelling H, Schaefer HG, Staab A, Macgregor TR, Jayadev S. Integration of absorption, distribution, metabolism, and elimination genotyping data into a population pharmacokinetic analysis of nevirapine. Pharmacogenet Genomics 2011; 21: 721-30.
15. Murphy RL, Sommadossi JP, Lamson M, Hall DB, Myers M, Dusek A. Antiviral effect and pharmacokinetic interaction between nevirapine and indinavir in persons infected with human immunodeficiency virus type 1. J Infect Dis 1999; 179: 1116-23.
16. Lamson MJ, Sabo JP, MacGregor TR, Pav JW, Rowland L, Hawi A, Cappola M, Robinson P. Single dose pharmacokinetics and bioavailability of nevirapine in healthy volunteers. Biopharm Drug Dispos 1999; 20: 285-91.
17. Riska P, Lamson M, MacGregor T, Sabo J, Hattox S, Pav J, Keirns J. Disposition and biotransformation of the antiretroviral drug nevirapine in humans. Drug Metab Dispos 1999; 27: 895-901.
18. Erickson DA, Mather G, Trager WF, Levy RH, Keirns JJ. Characterization of the in vitro biotransformation of the HIV-1 reverse transcriptase inhibitor nevirapine by human hepatic cytochromes P-450. Drug Metab Dispos 1999; 27: 1488-95.
19. Rotger M, Colombo S, Furrer H, Bleiber G, Buclin T, Lee BL, Keiser O, Biollaz J, Decosterd L, Telenti A. Influence of CYP2B6 polymorphism on plasma and intracellular concentrations and toxicity of efavirenz and nevirapine in HIV-infected patients. Pharmacogenet Genomics 2005; 15: 1-5.
20. Saitoh A, Sarles E, Capparelli E, Aweeka F, Kovacs A, Burchett SK, Wiznia A, Nachman S, Fenton T, Spector SA. CYP2B6 genetic variants are associated with nevirapine pharmacokinetics and clinical response in HIV-1-infected children. AIDS 2007; 21: 2191-9.
21. Wyen C, Hendra H, Vogel M, Hoffmann C, Knechten H, Brockmeyer NH, Bogner JR, Rockstroh J, Esser S, Jaeger H, Harrer T, Mauss S, van Lunzen J, Skoetz N, Jetter A, Groneuer C, Fatkenheuer G, Khoo SH, Egan D, Back DJ, Owen A. Impact of CYP2B6 983T>C polymorphism on non-nucleoside reverse transcriptase inhibitor plasma concentrations in HIV-infected patients. J Antimicrob Chemother 2008; 61: 914-8.
22. Chelule PK, Gordon M, Palanee T, Page T, Mosam A, Coovadia HM, Cassol S. MDR1 and CYP3A4 polymorphisms among African, Indian, and white populations in KwaZulu-Natal, South Africa. Clin Pharmacol Ther 2003; 74: 195-6.
23. Gounden V, van Niekerk C, Snyman T, George JA. Presence of the CYP2B6 516G> T polymorphism, increased plasma Efavirenz concentrations and early neuropsychiatric side effects in South African HIV-infected patients. AIDS Res Ther 2010; 7: 32.
24. van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, Cahn P, Lalloo UG, van der Westhuizen IP, Malan DR, Johnson MA, Santos BR, Mulcahy F, Wood R, Levi GC, Reboredo G, Squires K, Cassetti I, Petit D, Raffi F, Katlama C, Murphy RL, Horban A, Dam JP, Hassink E, van Leeuwen R, Robinson P, Wit FW, Lange JM. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363: 1253-63.
25. Boulle A, Van Cutsem G, Hilderbrand K, Cragg C, Abrahams M, Mathee S, Ford N, Knight L, Osler M, Myers J, Goemaere E, Coetzee D, Maartens G. Seven-year experience of a primary care antiretroviral treatment programme in Khayelitsha, South Africa. AIDS 2010; 24: 563-72.
26. Hoffmann CJ, Charalambous S, Thio CL, Martin DJ, Pemba L, Fielding KL, Churchyard GJ, Chaisson RE, Grant AD. Hepatotoxicity in an African antiretroviral therapy cohort: the effect of tuberculosis and hepatitis B. AIDS 2007; 21: 1301-8.
27. Richman DD, Havlir D, Corbeil J, Looney D, Ignacio C, Spector SA, Sullivan J, Cheeseman S, Barringer K, Pauletti D etal. Nevirapine resistance mutations of human immunodeficiency virus type 1 selected during therapy. J Virol 1994; 68: 1660-6.
28. Boulle A, Van Cutsem G, Cohen K, Hilderbrand K, Mathee S, Abrahams M, Goemaere E, Coetzee D, Maartens G. Outcomes of nevirapine- and efavirenz-based antiretroviral therapy when coadministered with rifampicin-based antitubercular therapy. JAMA 2008; 300: 530-9.
29. Cohen K, van Cutsem G, Boulle A, McIlleron H, Goemaere E, Smith PJ, Maartens G. Effect of rifampicin-based antitubercular therapy on nevirapine plasma concentrations in South African adults with HIV-associated tuberculosis. J Antimicrob Chemother 2008; 61: 389-93.
30. Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS 2010; 24: 1273-80.
31. Kredo T, Mauff K, Van der Walt JS, Wiesner L, Maartens G, Cohen K, Smith P, Barnes KI. The interaction between artemether-lumefantrine and nevirapine-based antiretroviral therapy in HIV-1 infected patients. Antimicrob Agents Chemother 2011; 55: 5616-23.
32. van Heeswijk RP, Veldkamp AI, Mulder JW, Meenhorst PL, Wit FW, Lange JM, Danner SA, Foudraine NA, Kwakkelstein MO, Reiss P, Beijnen JH, Hoetelmans RM. The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals. AIDS 2000; 14: F77-82.
33. Chi J, Jayewardene AL, Stone JA, Aweeka FT. An LC-MS-MS method for the determination of nevirapine, a non-nucleoside reverse transcriptase inhibitor, in human plasma. J Pharm Biomed Anal 2003; 31: 953-9.
34. van Heeswijk RP, Hoetelmans RM, Meenhorst PL, Mulder JW, Beijnen JH. Rapid determination of nevirapine in human plasma by ion-pair reversed-phase high-performance liquid chromatography with ultraviolet detection. J Chromatogr B Biomed Sci Appl 1998; 713: 395-9.
35. Savic RM, Jonker DM, Kerbusch T, Karlsson MO. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn 2007; 34: 711-26.
36. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008; 48: 303-32.
37. Jackson CH, Best NG, Richardson S. Bayesian graphical models for regression on multiple data sets with different variables. Biostatistics 2009; 10: 335-51.
38. Sinxadi PZ, van der Walt JS, McIlleron HM, Badri M, Smith PJ, Dave JA, Levitt NS, Maartens G. Lack of association between stavudine exposure and lipoatrophy, dysglycaemia, hyperlactataemia and hypertriglyceridaemia: a prospective cross sectional study. AIDS Res Ther 2010; 7: 23.
39. Price PS, Conolly RB, Chaisson CF, Gross EA, Young JS, Mathis ET, Tedder DR. Modeling interindividual variation in physiological factors used in PBPK models of humans. Crit Rev Toxicol 2003; 33: 469-503.
40. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 2011; 13: 143-51.
41. Beal S, Sheiner LB, Boeckmann A, Bauer RJ. NONMEM user's guides. (1989-2010). Ellicott City, MD, USA: Icon Development Solutions 2010.
42. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 2004; 75: 85-94.
43. Keizer RJ, van Benten M, Beijnen JH, Schellens JH, Huitema AD. Pirana and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed 2011; 101: 72-9.
44. Jonsson EN, Karlsson MO. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 1999; 58: 51-64.
45. Molto J, Valle M, Miranda C, Cedeno S, Miranda J, Santos JR, Negredo E, Vilaro J, Costa J, Clotet B. Once- or twice-daily dosing of nevirapine in HIV-infected adults: a population pharmacokinetics approach. J Antimicrob Chemother 2008; 62: 784-92.
46. Almond LM, Edirisinghe D, Dalton M, Bonington A, Back DJ, Khoo SH. Intracellular and plasma pharmacokinetics of nevirapine in human immunodeficiency virus-infected individuals. Clin Pharmacol Ther 2005; 78: 132-42.
47. Laporte-Simitsidis S, Girard P, Mismetti P, Chabaud S, Decousus H, Boissel JP. Inter-study variability in population pharmacokinetic meta-analysis: when and how to estimate it? J Pharm Sci 2000; 89: 155-67.
48. Dokoumetzidis A, Aarons L. Propagation of population pharmacokinetic information using a Bayesian approach: comparison with meta-analysis. J Pharmacokinet Pharmacodyn 2005; 32: 401-18.
49. Wakefield J, Rahman N. The combination of population pharmacokinetic studies. Biometrics 2000; 56: 263-70.
50. Cohen K, Grant A, Dandara C, McIlleron H, Pemba L, Fielding K, Charalombous S, Churchyard G, Smith P, Maartens G. Effect of rifampicin-based antitubercular therapy and the cytochrome P450 2B6 516G>T polymorphism on efavirenz concentrations in adults in South Africa. Antivir Ther 2009; 14: 687-95.
51. Greiner B, Eichelbaum M, Fritz P, Kreichgauer HP, von Richter O, Zundler J, Kroemer HK. The role of intestinal P-glycoprotein in the interaction of digoxin and rifampin. J Clin Invest 1999; 104: 147-53.
52. Rae JM, Johnson MD, Lippman ME, Flockhart DA. Rifampin is a selective, pleiotropic inducer of drug metabolism genes in human hepatocytes: studies with cDNA and oligonucleotide expression arrays. J Pharmacol Exp Ther 2001; 299: 849-57.
53. Janneh O, Chandler B, Hartkoorn R, Kwan WS, Jenkinson C, Evans S, Back DJ, Owen A, Khoo SH. Intracellular accumulation of efavirenz and nevirapine is independent of P-glycoprotein activity in cultured CD4 T cells and primary human lymphocytes. J Antimicrob Chemother 2009; 64: 1002-7.
54. Lamson M, Cort S, Macy H, Love J, Korpalski D, Pav J, Keirns J. Effects of food or antacid on the bioavailability of nevirapine 200mg tablets. International Conference on AIDS; 1996 July 7-12; Vancover, Canada.