High prevalence of subtherapeutic plasma concentrations of efavirenz in children

Journal of Acquired Immune Deficiency Syndromes

Volumn 45, Issue 2, 2007, Pages 133-136

  Ren, Yuan ^a   Nuttall, James J C ^a   Egbers, Claire ^b,c   Eley, Brian S ^a   Meyers, Tammy M ^b,c   Smith, Peter J ^a   Maartens, Gary ^a   McIlleron, Helen M ^a,d  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

Antiretroviral treatment; Children; Pharmacokinetics; Therapeutic drug monitoring; Treatment failure; Trough level

Indexed keywords

EFAVIRENZ; LAMIVUDINE; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; ZIDOVUDINE;

ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE TITRATION; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LINEAR REGRESSION ANALYSIS; LIQUID CHROMATOGRAPHY; MALE; PREVALENCE; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; TANDEM MASS SPECTROMETRY; VIRUS DETECTION; VIRUS LOAD;

ADOLESCENT; ANTI-HIV AGENTS; BENZOXAZINES; CHILD; CHILD, PRESCHOOL; FEMALE; HIV INFECTIONS; HUMANS; MALE; VIRAL LOAD;

EID: 34249865640     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e31805c9d52     Document Type: Article

References (18)

1. World Health Organization. Antiretroviral Therapy of HIV Infection in Infants and Children in Resource-Limited Settings: Towards Universal Access. Recommendations for a Public Health Approach. Geneva, Switzerland: World Health Organization; 2006.
2. Brundage RC, Yong FH, Fenton T, et al. Intrapatient variability of efavirenz concentrations as a predictor of virologic response to antiretroviral therapy. Antimicrob Agents Chemother. 2004;48:979-984.
3. Marzolini C, Telenti A, Decosterd LA, et al. Efavirenz levels can predict treatment failure and central nervous system side effects in HIV-1 infected patients. AIDS. 2001;15:71-75.
4. Csajka C, Marzolini C, Fattinger K, et al. Population pharmacokinetics and effects of efavirenz in patients with human immunodeficiency virus infection. Clin Pharmacol Ther. 2003;73:20-30.
5. Joshi AS, Barrett JS, Fiske WD. Population pharmacokinetics of efavirenz in phase II studies and relationship with efficacy [poster 1201]. Presented at: 39th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1999; San Francisco.
6. Van Leth F, Kappelhoff BF, Johnson D, et al, for the 2NN Study Group. Pharmacokinetic parameters of nevirapine and efavirenz in relation to antiretroviral efficacy. AIDS Res Hum Retroviruses. 2006;22:232-239.
7. Stahle L, Moberg L, Svensson JO, et al. Efavirenz plasma concentrations in HIV-infected patients: inter-and intraindividual variability and clinical effects. Ther Drug Monit. 2004;26:267-270.
8. Gonzalez de Requena D, Gallego O, Corral A, et al. Higher efavirenz concentrations determine the response to viruses carrying non-nucleoside reverse transcriptase resistance mutations. AIDS. 2004;18:2091-2094.
9. la Porte CJL, Back DJ, Blaschke T, et al. Updated guideline to perform therapeutic drug monitoring for antiretroviral agents. Reviews in Antiviral Therapy. 2006;3:4-14.
10. Keulen W. Updated TDM guidelines. www.hivpharmacology.com. Accessed February 15, 2007.
11. Efavirenz (Stocrin) [product information leaflet]. Halfway House, South Africa: Merck Sharp & Dohme Limited; 1999.
12. Chi J, Jayewardene AL, Stone JA, et al. Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir and amprenavir in human plasma by LC/MS/MS. J Pharm Biomed Anal. 2002;30:675-684.
13. Kappelhoff BS, Van Leth F, MacGregor TR, et al, for the 2NN Study Group. Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study. Antivir Ther. 2005;10:145-155.
14. Haas D, Ribaudo H, Kim R, et al. A common CYP2B6 variant is associated with efavirenz pharmacokinetics and central nervous system side effects: AACTG NWCS214 [abstract 133]. Presented at: 11th Conference on Retroviruses and Opportunistic Infections; 2004; San Francisco.
15. Tsuchiya K, Gatanaga H, Tachikawa N, et al. Homozygous CYP2B6 *6 (Q172H and K262R) correlates with high plasma efavirenz concentrations in HIV-1 patients treated with standard efavirenz-containing regimens. Biochem Biophys Res Commun. 2004;319:1322-1326.
16. Wang J, Sonnerborg A, Rane A, et al. Identification of a novel specific CYP2B6 allele in Africans causing impaired metabolism of the HIV drug efavirenz. Pharmacogenetic Genomics. 2006;16:191-198.
17. Starr SE, Fletcher CV, Spector SA, et al, for the Pediatric AIDS Clinical Trials Group 382 Team. Combination therapy with efavirenz, nelfinavir, and nucleoside reverse-transcriptase inhibitors in children infected with human immunodeficiency virus type 1. N Engl J Med. 1999;341:1874-1881.
18. Starr SE, Fletcher CV, Spector SA, et al, for the Pediatric AIDS Clinical Trials Group 382 Team. Efavirenz liquid formulation in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2002;21:659-663.