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Steady-state pharmacokinetics of tenofovir-based regimens in HIV-infected pediatric patients

Jennifer R King1, Ram Yogev, Patrick Jean-Philippe

  • 1University of Alabama at Birmingham, Division of Clinical Pharmacology, 1530 3rd Avenue South, Shelby 1170, Birmingham, AL 35294-0019, USA. jennifer.king@ccc.uab.edu

Antimicrobial Agents and Chemotherapy
|June 15, 2011
PubMed

Insights

This study assessed tenofovir pharmacokinetics in HIV-infected children on combination antiretroviral therapy. Tenofovir exposure was within target ranges across all regimens, though some drug interactions were noted.

Area of Science:

  • Pediatric infectious diseases
  • Pharmacology and toxicology
  • Clinical pharmacology

Background:

  • HIV-infected children require combination antiretroviral therapy (ART).
  • Tenofovir is a key component of pediatric ART regimens.
  • Understanding drug interactions and pharmacokinetic profiles is crucial for optimizing treatment efficacy and safety in children.

Purpose of the Study:

  • To evaluate the pharmacokinetic parameters of tenofovir when co-administered with efavirenz, darunavir-ritonavir, or atazanavir-ritonavir in HIV-infected children.
  • To compare tenofovir exposure in pediatric patients with established adult or pediatric safety and efficacy data.

Main Methods:

  • Enrollment of HIV-infected patients aged 8 to 18 years on tenofovir-based regimens.
  • Plasma sampling over 24 hours to determine area under the concentration-time curve (AUC) and minimum drug concentration (Cmin).
  • Calculation of 90% confidence intervals (90% CI) for pharmacokinetic parameters and comparison with published data.

Main Results:

  • Efavirenz concentrations were higher with fixed-dose combinations compared to individual formulations.
  • Tenofovir and darunavir exposure was lower than anticipated in the darunavir-ritonavir group.
  • Tenofovir and atazanavir exposure was similar to adult levels in the atazanavir-ritonavir group.
  • Tenofovir's 90% CI for AUC and Cmin overlapped the target range in all combinations.

Conclusions:

  • Tenofovir exposure remained within therapeutic ranges across all evaluated combination ART regimens in children.
  • Specific drug interactions may influence the pharmacokinetics of co-administered agents.
  • Further investigation into the exposures achieved with combined antiretroviral agents is warranted to ensure optimal therapeutic outcomes.

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