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

Twice-daily dosing of Dolutegravir is approved for adults with HIV and integrase strand transfer inhibitor resistance, but not for children. Population pharmacokinetic modeling and simulations identified a weight-tiered twice-daily dose for children, predicted to yield dolutegravir exposures within the therapeutic window and provide similar efficacy and safety as seen in adults with HIV-1 and first-generation integrase strand transfer inhibitor resistance.

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Publication Details

Journal
The Pediatric Infectious Disease Journal
Published
2026-02-04
DOI
https://doi.org/10.1097/inf.0000000000005158
Primary Topic
HIV/AIDS drug development and treatment
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Rashmi Mehta, Theodore Ruel, Hardik Chandasana, Michael J. McKenna et al.
The Pediatric Infectious Disease Journal
HIV/AIDS drug development and treatment
article

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

Rashmi Mehta, Theodore Ruel, Hardik Chandasana, Michael J. McKenna, M. Bush, Lionel Tan, Cindy Brothers, Ana Cristina Puga, Cassidy Henegar, Cindy Vavro, Linda Lewis
article en

Abstract

Twice-daily dosing of Dolutegravir is approved for adults with HIV and integrase strand transfer inhibitor resistance, but not for children. Population pharmacokinetic modeling and simulations identified a weight-tiered twice-daily dose for children, predicted to yield dolutegravir exposures within the therapeutic window and provide similar efficacy and safety as seen in adults with HIV-1 and first-generation integrase strand transfer inhibitor resistance.

The Pediatric Infectious Disease Journal
University of California, San Francisco (US), Baylor College of Medicine (US), ViiV Healthcare (Spain) (ES), Clinton Health Access Initiative (US), ViiV Healthcare (United Kingdom) (GB), Simulation Technologies (United States) (US), System Simulation (United Kingdom) (GB), Health and Safety Executive (GB)
Good health and well-being
Openalex Percentile: Top 67%
HIV/AIDS drug development and treatment
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Model-informed Dolutegravir Dose Selection in Pediatrics With First-generation INSTI Resistance — Rashmi Mehta, Theodore Ruel, et al. · The Pediatric Infectious Disease Journal (2026) | TGRS Research Map | TGRS