Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing

The Pediatric Infectious Disease Journal
Linda AurpibulKulkanya Chokephaibulkit

Abstract

Tenofovir disoproxil fumarate (TDF) is approved for children but concerns remain about long-term renal and bone toxicity. We evaluated the efficacy, safety and pharmacokinetics of TDF in treatment-experienced children during 96 weeks. This was a prospective, open-label study in HIV-infected children 3-18 years of age (≥15 kg), with viral suppression on their first-line regimen without tenofovir. Children were given TDF/lamivudine/efavirenz once daily at entry; TDF was prescribed according to weight bands. Age-, gender- and CD4-matched controls receiving TDF-sparing regimens were concomitantly enrolled. Tenofovir pharmacokinetic assessment was performed at week 4. CD4 counts, HIV-1 RNA viral load and safety assessments were determined at baseline, 24, 48 and 96 weeks. Eighty children were enrolled (40 per group); 35 (44%) were male. Median age was 12.2 (range 3.1-17.7) years. The median administered dose was 214 mg/m. Tenofovir geometric mean AUC0-24 hours, Cmax and C24 hours were 2.66 [90% confidence interval (CI) 2.49-2.84] μg hours/mL, 0.26 (0.24-0.29) μg/mL and 0.057 (0.052-0.062) μg/mL, respectively. Estimated glomerular filtration rate did not significantly change overtime. The fractional excretion of calcium slightly incr...Continue Reading

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Citations

May 29, 2016·Current HIV/AIDS Reports·Allison Ross EckardTerry C Dixon
Oct 13, 2016·Current HIV/AIDS Reports·Michael T Yin, Todd T Brown
Dec 23, 2016·The Pediatric Infectious Disease Journal·Beatriz JiménezUNKNOWN Madrid Cohort of HIV-Infected Children and Adolescents Integrated in the Pediatric Branch of the Spanish National AIDS Resea
Sep 2, 2017·The Journal of Pharmacology and Experimental Therapeutics·Rachel A Murphy, Monica A Valentovic
Feb 19, 2016·Current Opinion in HIV and AIDS·Allison R Eckard, Stefano Mora
Sep 10, 2015·Current Opinion in HIV and AIDS·Raziya BobatMelissa Lawler
Dec 29, 2015·Current Pediatrics Reports·Maria H KimElaine J Abrams
Jan 20, 2015·The Pediatric Infectious Disease Journal·Peter L Havens, Rohan Hazra
Oct 8, 2020·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Atupele P Kapito-TemboSam Phiri

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