Pharmacokinetics of lopinavir/ritonavir crushed versus whole tablets in children

Journal of Acquired Immune Deficiency Syndromes

Volumn 58, Issue 4, 2011, Pages 385-391

  Best, Brookie M ^a,b   Capparelli, Edmund V ^a,b   Diep, Huy ^a   Rossi, Steven S ^b   Farrell, Michael J ^b   Williams, Elaine ^c,d   Lee, Grace ^c   Van Den Anker, John N ^c,d   Rakhmanina, Natella ^c,d  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b RADY CHILDREN'S HOSPITAL   (United States)

^c CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^d GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

lopinavir; pediatrics; pharmacokinetics; ritonavir

Indexed keywords

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

ADOLESCENT; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; CRUSHED TABLET; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXPOSURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TABLET; TIME TO MAXIMUM PLASMA CONCENTRATION; WHOLE TABLET;

ADOLESCENT; ANTI-HIV AGENTS; CHILD; CROSS-OVER STUDIES; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HUMANS; LOPINAVIR; MALE; RITONAVIR; TABLETS; TREATMENT OUTCOME;

EID: 80255129370     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e318232b057     Document Type: Article

References (29)

1. World Health Organization. Antiretroviral Therapy of HIV Infection in Infants and Children: Towards Universal Access: Recommendations for a Public Health Approach-2010 Revision. 2010: Geneva, Switzerland: WHO.
2. Panel on Antiretroviral Therapy and Medical Management of HIVInfected Children Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Available at: http://aidsinfo.nih.gov/contentfiles/- PediatricGuidelines.pdf. Accessed January 01, 2011. Updated August 16, 2010.
3. Welch S, Sharland M, Lyall EG, et al. PENTA 2009 guidelines for the use of antiretroviral therapy in paediatric HIV-1 infection. HIV Med 2009;10:591-613.
4. Boxwell D, Cao K, Lewis L, et al. Neonatal toxicity of Kaletra oral solution-LPV, ethanol or propylene glycol? Poster #708 Presented at: 18th Conference on Retroviruses and Opportunistic Infections; March 2, 2011; Boston, MA.
5. Kaletra product labeling [package insert]. North Chicago, IL: Abbott Laboratories; 2005.
6. Liu W, Klein CE, March K, et al. Predicted pharmacokinetics of lopinavir after multiple-dose administration of lopinavir/ritonavir tablet to pediatric patients [poster #366] Presented at: 8th International Congress on Drug Therapy in HIV Infection; November 12-16, 2006; Glasgow, United Kingdom.
7. Reddington C, Cohen J, Baldillo A, et al. Adherence to medication regimens among children with human immunodeficiency virus infection. Pediatr Infect Dis J 2000;19:1148-1153. (Pubitemid 32003357)
8. Byrne M, Honig J, Jurgrau A, et al. Achieving adherence with antiretroviral medications for pediatric HIV disease. AIDS Read 2002;12: 151-154, 161-164.
9. Gibb DM, Goodall RL, Giacomet V, et al. Adherence to prescribed antiretroviral therapy in human immunodeficiency virus-infected children in the PENTA 5 trial. Pediatr Infect Dis J 2003;22:56-62. (Pubitemid 36091779)
10. Gavin PJ, Yogev R. The role of protease inhibitor therapy in children with HIV infection Paediatr Drugs2002;4:581-607. (Pubitemid 34983405)
11. Van Dyke RB, Lee S, Johnson GM, et al. Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection. Pediatrics 2002;109:e61.
12. King JR, Kimberlin DW, Aldrovandi GM, et al. Antiretroviral pharmacokinetics in the paediatric population: a review. Clin Pharmacokinet 2002;41:1115-1133. (Pubitemid 35398689)
13. Rakhmanina NY, van den Anker JN, Soldin SJ, et al. Can therapeutic drug monitoring improve pharmacotherapy of HIV infection in adolescents? Ther Drug Monit 2010;32:273-281.
14. Bunupuradah T, Wannachai S, Chuamchaitrakool A, et al. Use of tastemasking product, FLAVORx, to assist Thai children to ingest generic antiretrovirals. AIDS Res Ther 2006;3:30.
15. Holland DT, DiFrancesco R, Stone J, et al. Quality assurance program for clinical measurement of antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and adult pharmacology laboratories. Antimicrob Agents Chemother 2004;48:824-831. (Pubitemid 38280331)
16. Barigye H, Luyirika E. The challenges of paediatric ARV formulations in resource-poor countries-the Ugandan experience [abstract #1080]. Presented at: 2nd IAS Conference on HIV Pathogenesis and Treatment; July 13-16, 2003; Paris, France.
17. O'Brien DP, Sauvageot D, Zachariah R, et al. In resource-limited settings good early outcomes can be achieved in children using adult fixed-dose combination antiretroviral therapy. AIDS 2006;20: 1955-1960. (Pubitemid 44427613)
18. Corbett AH, Hosseinipour MC, Nyirenda J, et al. Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children. Antivir Ther 2010;15:83-90.
19. Phelps B, Rakhmaina N. Antiretroviral drugs in pediatric HIV-infected patients: pharmacokinetic and practical challenges. Pediatr Drugs 2011; 13:175-192.
20. Chandler B, Almond L, Ford J, et al. The effects of protease inhibitors and nonnucleoside reverse transcriptase inhibitors on p-glycoprotein expression in peripheral blood mononuclear cells in vitro. J Acquir Immune Defic Syndr 2003;33:551-556. (Pubitemid 36975841)
21. Hartkoorn RC, Kwan WS, Shallcross V, et al. HIV protease inhibitors are substrates for OATP1A2, OATP1B1 and OATP1B3 and lopinavir plasma concentrations are influenced by SLCO1B1 polymorphisms. Pharmacogenet Genomics 2010;20:112-120.
22. Rakhmanina NY, Neely MN, Van Schaik RH, et al. CYP3A5, ABCB1 and SLCO1B1 polymorphisms and pharmacokinetics and virologic outcome of lopinavir/ritonavir in HIV-infected children. Ther Drug Monit 2011;33:417-424.
23. Lubomirov R, di Iulio J, Fayet A, et al. ADME pharmacogenetics: investigation of the pharmacokinetics of the antiretroviral agent lopinavir coformulated with ritonavir. Pharmacogenet Genomics 2010;20:217-230.
24. la Porte C, van Heeswijk R, Mitchell CD, et al. Pharmacokinetics and tolerability of once-versus twice-daily lopinavir/ritonavir treatment in HIV-1-infected children. Antivir Ther 2009;14:603-606.
25. Rakhmanina N, van den Anker J, Baghdassarian A, et al. Population pharmacokinetics of lopinavir predict suboptimal therapeutic concentrations in treatment-experienced human immunodeficiency virus-infected children. Antimicrob Agents Chemother 2009;53:2532-2538.
26. Bouillon-Pichault M, Jullien V, Piketty C, et al. A population analysis of weight-related differences in lopinavir pharmacokinetics and possible consequences for protease inhibitor-naive and-experienced patients. Antivir Ther 2009;14:923-929.
27. Rakhmanina NY, Capparelli EV, van den Anker JN. Personalized therapeutics: HIV treatment in adolescents. Clin Pharmacol Ther 2008;84: 734-740.
28. van der Lee M, Verweel G, de Groot R, et al. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther 2006;11:439-445. (Pubitemid 44024851)
29. Foissac F, Urien S, Hirt D, et al. Pharmacokinetics and virologic efficacy after switch to once daily lopinavir/r in treatment-experienced HIV-1 infected children. Antimicrob Agents Chemother 2011 [e-pub].