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Model-informed Dolutegravir Dose Selection in Pediatrics With First-generation INSTI Resistance

Hardik Chandasana1, Ann M Buchanan2, Cassidy A Henegar3

  • 1From the Clinical Pharmacology Modeling Simulation, GSK, Collegeville, PA.

The Pediatric Infectious Disease Journal
|February 4, 2026
PubMed

Insights

A new weight-tiered, twice-daily Dolutegravir dose is proposed for children with HIV. This dosing aims to achieve therapeutic Dolutegravir exposures, ensuring similar efficacy and safety as observed in adults.

Area of Science:

  • Pharmacology
  • Infectious Diseases
  • Pediatrics

Background:

  • Dolutegravir is an integrase strand transfer inhibitor used for HIV treatment.
  • Current dosing is approved for adults but not for pediatric populations.
  • HIV-1 resistance to integrase strand transfer inhibitors is a growing concern.

Purpose of the Study:

  • To establish a weight-tiered, twice-daily Dolutegravir dosing regimen for children.
  • To predict Dolutegravir exposures in pediatric patients using population pharmacokinetic modeling.
  • To evaluate the potential for similar efficacy and safety in children compared to adults.

Main Methods:

  • Population pharmacokinetic modeling was employed.
  • Simulations were conducted to assess dosing outcomes.
  • Weight-tiered dosing strategies were analyzed.

Main Results:

  • A weight-tiered, twice-daily Dolutegravir dose was identified for pediatric use.
  • Simulations predicted Dolutegravir exposures within the therapeutic window.
  • The proposed dosing is expected to provide efficacy and safety comparable to adults.

Conclusions:

  • The identified weight-tiered dosing regimen offers a potential solution for pediatric Dolutegravir treatment.
  • Pharmacokinetic modeling supports the use of this regimen in children with HIV.
  • Further clinical validation is warranted to confirm efficacy and safety in pediatric populations.

Keywords:
HIV-1INSTI resistancedolutegravirexposure–responsepediatrics

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