Pharmacokinetics and safety of a new paediatric fixed-dose combination of zidovudine/lamivudine/nevirapine in HIV-infected children

Antiviral Therapy

Volumn 16, Issue 8, 2011, Pages 1287-1295

  Chokephaibulkit, Kulkanya ^a   Cressey, Tim R ^b,c,d   Capparelli, Edmund ^e   Sirisanthana, Virat ^f   Muresan, Petronella ^c   Hongsiriwon, Suchat ^g   Ngampiyaskul, Chaiwat ^h   Limwongse, Chanin ^a   Wittawatmongkol, Orasri ^a   Aurpibul, Linda ^f   Kabat, Bill ⁱ   Toye, MariPat ^j   Smith, Mary Elizabeth ^k   Eksaengsri, Achara ^l   McIntosh, Kenneth ^c,m   Yogev, Ram ⁱ  

^a MAHIDOL UNIVERSITY   (Thailand)

^b CHIANG MAI UNIVERSITY   (Thailand)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d INSTITUT DE RECHERCHE POUR LE DÉVELOPPEMENT   (France)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f Faculty of Medicine Chiang Mai University   (Thailand)

^g CHONBURI HOSPITAL   (Thailand)

^h PRAPOKKLAO HOSPITAL   (Thailand)

ⁱ CHILDREN'S MEMORIAL HOSPITAL   (United States)

^j BAYSTATE MEDICAL CENTER   (United States)

^k NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^l Thailand Government Pharmaceutical Organization   (Thailand)

^m BOSTON CHILDREN S HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2B6; LAMIVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS ZIDOVUDINE; NEVIRAPINE; ZIDOVUDINE;

ADOLESCENT; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CYTOCHROME P450 2B6 GENE; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYELID EDEMA; FEMALE; GASTROINTESTINAL SYMPTOM; GENE; GENOTYPE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERAMYLASEMIA; MALE; NEUTROPENIA; OUTCOME ASSESSMENT; PHARMACOGENOMICS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SINGLE NUCLEOTIDE POLYMORPHISM; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANTI-HIV AGENTS; AREA UNDER CURVE; ARYL HYDROCARBON HYDROXYLASES; BIOLOGICAL AVAILABILITY; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG DOSAGE CALCULATIONS; DRUG THERAPY, COMBINATION; DRUG TOXICITY; FEMALE; HIV; HIV INFECTIONS; HUMANS; INFANT; LAMIVUDINE; MALE; NEVIRAPINE; OXIDOREDUCTASES, N-DEMETHYLATING; REVERSE TRANSCRIPTASE INHIBITORS; TABLETS; ZIDOVUDINE;

EID: 83455163806     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: 10.3851/IMP1931     Document Type: Article

References (35)

1. World Health Organization, UNAIDS. Estimated number of children (<15 years) newly infected with HIV, 2007. (Updated December 2007. Accessed 23 September 2010.) Available at: http://data.unaids.org/pub/EPISlides/2007/071118- epicore2007-slides-en.pdf
2. Chokephaibulkit K, Plipat N, Cressey TR, et al. Pharmacokinetics of nevirapine in HIV-infected children receiving an adult fixed-dose combination of stavudine, lamivudine and nevirapine. AIDS 2005; 19:1495-1499. (Pubitemid 41400695)
3. Puthanakit T, Aurpibul L, Sirisanthana T, Sirisanthana V. Efficacy of non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy in Thai HIV-infected children aged two years or less. Pediatr Infect Dis J 2009; 28:246-248.
4. Puthanakit T, Aurpibul L, Oberdorfer P, et al. Sustained immunologic and virologic efficacy after four years of highly active antiretroviral therapy in human immunodeficiency virus infected children in Thailand. Pediatr Infect Dis J 2007; 26:953-956. (Pubitemid 47494171)
5. World Health Organization. Summary statement on WHO recommendations on ARV medicines for treating and preventing HIV infections in younger children. (Updated 30 November 2006. Accessed 23 September 2010.) Available from http://www.who.int/hiv/mediacentre/news63/en/
6. L'homme RF, Kabamba D, Ewings FM, et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS 2008; 22:557-565.
7. Vanprapar N, Cressey TR, Chokephaibulkit K, et al. A chewable pediatric fixed-dose 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 2010; 29:940-944.
8. World Health Organization. Preferred antiretroviral medicines for treating and preventing HIV infection in younger children: report of the WHO Paediatric Antiretroviral Working Group. Geneva: World Health Organization 2008.
9. World Health Organization. Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents: November 2009 version. November 2009 (Updated 23 February 2010. Accessed 23 September 2010.) Available from http://www.who.int/hiv/pub/arv/rapid-advice-art.pdf
10. Puthanakit T, Tangsathapornpong A, Anaworanich J, et al. Thai national guidelines for the use of antiretroviral therapy in pediatric HIV infection in 2010. Asian Biomedicine 2010; 4:505-513.
11. Mahungu T, Smith C, Turner F, et al. Cytochrome P450 2B6 516G->T is associated with plasma concentrations of nevirapine at both 200 mg twice daily and 400 mg once daily in an ethnically diverse population. HIV Med 2009; 10:310-317.
12. Saitoh A, Sarles E, Capparelli E, et al. CYP2B6 genetic variants are associated with nevirapine pharmacokinetics and clinical response in HIV-1-infected children. AIDS 2007; 21:2191-2199. (Pubitemid 350287217)
13. Droste JA, Verweij-Van Wissen CP, Burger DM. Simultaneous determination of the HIV drugs indinavir, amprenavir, saquinavir, ritonavir, lopinavir, nelfinavir, the nelfinavir hydroxymetabolite M8, and nevirapine in human plasma by reversed-phase high-performance liquid chromatography. Ther Drug Monit 2003; 25:393-399. (Pubitemid 36638188)
14. Holland DT, DiFrancesco R, Connor JD, Morse GD. Quality assurance program for pharmacokinetic assay of antiretrovirals: ACTG proficiency testing for pediatric and adult pharmacology support laboratories, 2003 to 2004: a requirement for therapeutic drug monitoring. Ther Drug Monit 2006; 28:367-374. (Pubitemid 44314924)
15. Jacob RM, Johnstone EC, Neville MJ, Walton RT. Identification of CYP2B6 sequence variants by use of multiplex PCR with allele-specific genotyping. Clin Chem 2004; 50:1372-1377. (Pubitemid 38970644)
16. Veldkamp AI, Weverling GJ, Lange JM, et al. High exposure to nevirapine in plasma is associated with an improved virological response in HIV-1-infected individuals. AIDS 2001; 15:1089-1095. (Pubitemid 32549859)
17. Acosta EP, Gerber JG. Position paper on therapeutic drug monitoring of antiretroviral agents. AIDS Res Hum Retroviruses 2002; 18:825-834. (Pubitemid 35034663)
18. Crémieux AC, Katlama C, Gillotin C, Demarles D, Yuen GJ, Raffi F. 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 2001; 21:424-430. (Pubitemid 32275270)
19. Wang LH, Chittick GE, McDowell JA. Single-dose pharmacokinetics and safety of abacavir (1592U89), zidovudine, and lamivudine administered alone and in combination in adults with human immunodeficiency virus infection. Antimicrob Agents Chemother 1999; 43:1708-1715. (Pubitemid 29331252)
20. Moore KH, Barrett JE, Shaw S, et al. The pharmacokinetics of lamivudine phosphorylation in peripheral blood mononuclear cells from patients infected with HIV-1. AIDS 1999; 13:2239-2250. (Pubitemid 29531443)
21. Burger DM, Verweel G, Rakhmanina N, et al. Age-dependent pharmacokinetics of lamivudine in HIV-infected children. Clin Pharmacol Ther 2007; 81:517-520. (Pubitemid 46452314)
22. Gitta PK, Kendall L, Musiime V, et al. Pharmacokinetics of lamivudine, abacavir, and zidovudine administered twice daily as syrups versus scored tablets in HIV-infected Ugandan children. J Int AIDS Soc 2010; 13 Suppl 4:176.
23. Hosseinipour MC, Corbett AH, Kanyama C, et al. Pharmacokinetic comparison of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian adults. AIDS 2007; 21:59-64. (Pubitemid 44912537)
24. Vezina HE, Henry K, Ravindran GD, et al. A randomized crossover study to determine bioequivalence of generic and brand name nevirapine, zidovudine, and lamivudine in HIV-negative women in India. J Acquir Immune Defic Syndr 2006; 41:131-136.
25. Bruno R, Regazzi MB, Ciappina V, et al. Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV. Clin Pharmacokinet 2001; 40:695-700. (Pubitemid 32954991)
26. European Medicines Agency (EMEA). Annex I: summary of product characteristics. Viramune 200 mg tablets. (Updated 6 August 2010. Accessed 23 September 2010.) Available from http://www.ema.europa.eu/docs/en-GB/document- library/EPAR---Product-Information/human/000183/WC500051481.pdf
27. Clinical pharmacology review: NDA: 20-636 SE5 027 &20-933 SE5 017. (Updated 8 September 2008. Accessed 24 February 2011.) Available from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/ucm072778.pdf
28. Mulenga V, Fillekes Q, Kabamba D, et al. Pharmacokinetics of nevirapine in 3- to 6-kg, HIV-infected infants taking pediatric fixed-dose combination tablets. 16th Conference on Retroviruses and Opportunistic Infections. 8-10 February 2009, Montreal, QC, Canada. Abstract 881.
29. Mosha LB, Musoke P, Parsons T, et al. Nevirapine concentrations in HIV-infected Ugandan children on adult fixed-dose combination tablet ART, with and without rifampicin-based treatment for active M. Tuberculosis infection. 16th Conference on Retroviruses and Opportunistic Infections. 8-10 February 2009, Montreal, QC, Canada. Abstract 909.
30. Luzuriaga K, Bryson Y, McSherry G, et al. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis 1996; 174:713-721. (Pubitemid 26325885)
31. WHO paediatric antiretroviral working group. Preferred antiretroviral medicines for treating and preventing HIV infection in younger children. (Updated 20 January 2008. Accessed 23 September 2010.) Available from http://www.who.int/hiv/pub/paediatric/antiretroviral/en/index.html
32. Capparelli E, Kabamba D, Cressey TR, Burger DM. Nevirapine exposure with WHO pediatric weight band dosing - enhanced therapeutic concentrations predicted based on extensive international pharmacokinetic experience. 15th Conference on Retroviruses and Opportunistic Infections. 3-6 February 2008, Boston, MA, USA. Abstract 576.
33. Fellay J, Marzolini C, Meaden ER, et al. Response to antiretroviral treatment in HIV-1-infected individuals with allelic variants of the multidrug resistance transporter 1: a pharmacogenetics study. Lancet 2002; 359:30-36. (Pubitemid 34119193)
34. Haas DW, Ribaudo HJ, Kim RB, et al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS 2004; 18:2391-2400. (Pubitemid 40065906)
35. Puthanakit T, Tanpaiboon P, Aurpibul L, Cressey TR, Sirisanthana V. Plasma efavirenz concentrations and the association with CYP2B6-516G >T polymorphism in HIV-infected Thai children. Antivir Ther 2009; 14:315-320.