Pharmacokinetics of antiretroviral drug varies with formulation in the target population of children with HIV-1

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 2, 2012, Pages 272-280

  Kasirye, P ^a   Kendall, L ^b   Adkison, K K ^c   Tumusiime, C ^d   Ssenyonga, M ^d   Bakeera Kitaka, S ^a   Nahirya Ntege, P ^e   Mhute, T ^f   Kekitiinwa, A ^a   Snowden, W ^g   Burger, D M ^h   Gibb, D M ^b   Walker, A S ^b  

^a MULAGO HOSPITAL   (Uganda)

^b MRC CLINICAL TRIALS UNIT   (United Kingdom)

^c GLAXOSMITHKLINE   (United States)

^d JOINT CLINICAL RESEARCH CENTRE   (Uganda)

^e MEDICAL RESEARCH COUNCIL   (United Kingdom)

^f UNIV OF ZIMBABWE MEDICAL SCHOOL   (Zimbabwe)

^g GLAXOSMITHKLINE   (United Kingdom)

^h RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; NEVIRAPINE; ZIDOVUDINE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG SOLUTION; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; MALE; MAXIMUM PLASMA CONCENTRATION; PEDIATRICS; PRESCHOOL CHILD; PRIORITY JOURNAL; TABLET; TIME TO MAXIMUM PLASMA CONCENTRATION; UGANDA;

ADMINISTRATION, ORAL; ANTIRHEUMATIC AGENTS; CHEMISTRY, PHARMACEUTICAL; CHILD, PRESCHOOL; DIDEOXYNUCLEOSIDES; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INFANT; LAMIVUDINE; MALE; SOLUTIONS; TABLETS; THERAPEUTIC EQUIVALENCY; ZIDOVUDINE;

EID: 84855956256     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.225     Document Type: Article

References (35)

1. Lewis, L.L. et al. Lamivudine in children with human immunodeficiency virus infection: a phase I/II study. The National Cancer Institute Pediatric Branch-Human Immunodeficiency Virus Working Group. J. Infect. Dis. 174, 16-25 (1996). (Pubitemid 26255550)
2. Sekar, V. et al. Dose selection and pharmacokinetics-pharmacodynamics of darunavir coadministered with low-dose ritonavir in the DELPHI (TMC114-C212) trial in treatment-experienced, HIV-1-infected children and adolescents. AIDS 2008-XVII International AIDS Conference, Mexico City, 3-8 August 2008 (TUPE0078) (2008).
3. Cella, M., Gorter de Vries, F., Burger, D., Danhof, M. & Della Pasqua, O. A modelbased approach to dose selection in early pediatric development. Clin. Pharmacol. Ther. 87, 294-302 (2010).
4. World Health Organization. Antiretroviral therapy for HIV infection in infants and children: towards universal access. Recommendations for a public health approach: 2010 revision (Geneva, Switzerland, 2010).
5. United Nations Programme on HIV/AIDS (UNAIDS) and World Heath Organization. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector. Progress report 2010 〈http://www.who. int/hiv/pub/2010progressreport/report/en/index.html〉 (Geneva, Switzerland, 2010).
6. United Nations Programme on HIV/AIDS (UNAIDS). AIDS epidemic update, December 2009 (2009).
7. Nahirya Ntege, P. et al. Tablets are more acceptable and give fewer problems than syrups among young HIV-infected children in resource-limited settings in the ARROW trial. AIDS 2010-XVIII International AIDS Conference. Vienna, Austria, July 18-23 2010 (Abstract TUPDB206) (2010).
8. Havens, P.L. & Gibb, D.M. Increasing antiretroviral drug access for children with HIV infection. Pediatrics 119(4), 838-845 (2007). (Pubitemid 46556690)
9. World Health Organization. Antiretroviral therapy for HIV infection in infants and children: towards universal access. Recommendations for a public health approach 〈http://www.who.int/hiv/pub/guidelines/paediatric020907. pdf〉 (Geneva, Switzerland, 2006).
10. World Health Organization. Antiretroviral therapy for HIV infection in infants and children: annex E: prescribing information and weight-based dosing of available ARV formulations for infants and children 〈http://www.who. int/hiv/pub/paediatric/paediatric-arv-dosing.pdf〉 (Geneva, Switzerland, 2010).
11. Johnson, M.A., Moore, K.H., Yuen, G.J., Bye, A. & Pakes, G.E. Clinical pharmacokinetics of lamivudine. Clin. Pharmacokinet. 36, 41-66 (1999). (Pubitemid 29056000)
12. Wu, C.Y. & Benet, L.Z. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm. Res. 22, 11-23 (2005). (Pubitemid 40558141)
13. Lindenberg, M., Kopp, S. & Dressman, J.B. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur. J. Pharm. Biopharm. 58, 265-278 (2004). (Pubitemid 39037234)
14. Bergshoeff, A. et al.; PENTA-13 Study Group. Plasma pharmacokinetics of once-versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir. Ther. (Lond.) 10, 239-246 (2005). (Pubitemid 41151030)
15. Musiime, V. et al.; ARROW Trial team. Pharmacokinetics and acceptability of once-versus twice-daily lamivudine and abacavir in HIV type-1-infected Ugandan children in the ARROW Trial. Antivir. Ther. (Lond.) 15, 1115-1124 (2010).
16. Paediatric European Network for Treatment of AIDS (PENTA). Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-
17. Piana, C., Danhof, M. & Della Pasqua, O.E. Population pharmacokinetic analysis of lamivudine in HIV-infected children. 6th International Symposium on Measurement and Kinetics of In Vivo Drug Effects. Noordwijkerhout, The Netherlands (2010).
18. Vanprapar, N. et al.; IMPAACT P1056 Team. A chewable pediatric fixeddose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand. Pediatr. Infect. Dis. J. 29, 940-944 (2010).
19. Chokephaibulkit, K. et al. Pharmacokinetics and safety of a new pediatric fixed-dose combination zidovudine/lamivudine/nevirapine compared to the branded liquid formulations in HIV-infected children. Antivir. Ther. 16, 1287-1295 (2011).
20. Burger, D.M. et al. Age-dependent pharmacokinetics of lamivudine in HIV-infected children. Clin. Pharmacol. Ther. 81, 517-520 (2007). (Pubitemid 46452314)
21. Moore, K.H. et al. Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole. Clin. Pharmacol. Ther. 59, 550-558 (1996).
22. European Medicines Agency. Sustiva: summary of product characteristics 〈http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/000249/human-med-001068.jsp&murl=menus/medicines/medicines. jsp&mid=WC0b01ac058001d125〉 (2011).
23. Wang, L.H. et al. Pharmacokinetics and safety of single oral doses of emtricitabine in human immunodeficiency virus-infected children. Antimicrob. Agents Chemother. 48, 183-191 (2004). (Pubitemid 38040196)
24. ter Heine, R. et al. A pharmacokinetic and pharmacogenetic study of efavirenz in children: dosing guidelines can result in subtherapeutic concentrations. Antivir. Ther. (Lond.) 13, 779-787 (2008).
25. Brundage R.C. et al. Pharmacokinetics of an efavirenz suspension in children.6th Conference on Retroviruses and Opportunistic Infections (abstr 24). Chicago, IL, 31 January-4 February 1999.
26. Chowers, M., Gottesman, B.S., Leibovici, L., Schapiro, J.M. & Paul, M. Nucleoside reverse transcriptase inhibitors in combination therapy for HIV patients: systematic review and meta-analysis. Eur. J. Clin. Microbiol. Infect. Dis. 29, 779-786 (2010).
27. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2010 Revision. WHO Geneva, Switzerland (2010).
28. Burman, W.J., Cotton, M.F., Gibb, D.M., Walker, A.S., Vernon, A.A. & Donald, P.R. Ensuring the involvement of children in the evaluation of new tuberculosis treatment regimens. PLoS Med. 5, e176 (2008).
29. Tremoulet, A.H. et al.; Pediatric AIDS Clinical Trials Group. Population pharmacokinetics of lamivudine in human immunodeficiency virus-exposed and-infected infants. Antimicrob. Agents Chemother. 51, 4297-4302 (2007). (Pubitemid 350209880)
30. Yuen, G.J. et al. Equivalent steady-state pharmacokinetics of lamivudine in plasma and lamivudine triphosphate within cells following administration of lamivudine at 300 milligrams once daily and 150 milligrams twice daily. Antimicrob. Agents Chemother. 48, 176-182 (2004). (Pubitemid 38040195)
31. Crieux, A.C., Katlama, C., Gillotin, C., Demarles, D., Yuen, G.J. & Raffi, F.; AZl10002 Study Group. A comparison of the steady-state pharmacokinetics and safety of abacavir, lamivudine, and zidovudine taken as a triple combination tablet and as abacavir plus a lamivudine-zidovudine double combination tablet by HIV-1-infected adults. Pharmacotherapy 21, 424-430 (2001).
32. Moore, K.H., Yuen, G.J., Hussey, E.K., Pakes, G.E., Eron, J.J. Jr & Bartlett, J.A. Population pharmacokinetics of lamivudine in adult human immunodeficiency virus-infected patients enrolled in two phase III clinical trials. Antimicrob. Agents Chemother. 43, 3025-3029 (1999).
33. Pluda, J.M. et al. A phase I/II study of 2'-deoxy-3'-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J. Infect. Dis. 171, 1438-1447 (1995).
34. Bruno, R. et al. Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV. Clin. Pharmacokinet. 40, 695-700 (2001). (Pubitemid 32954991)
35. Yuen, G.J. et al. Abacavir/lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with each component administered concurrently and the effect of food on absorption. J. Clin. Pharmacol. 41, 277-288 (2001). (Pubitemid 32184980)