Results from a sub-study of the ODYSSEY trial, published in The Lancet HIV journal, show that children over 20kg in weight can safely take adult doses (50mg) of the anti-HIV drug dolutegravir. With over half of children living with HIV globally weighing at over 20kg, this expands treatment options and simplifies treatment for children.
These data have already had impact! In June 2020, these results were used to gain FDA approval for use of the adult dosage of the drug (50mg) in children weighing ≥20kg. Thus, allowing immediate access to adult dolutegravir formulation in many countries for the majority of children living with HIV. Further dolutegravir paediatric submissions are currently under review by the European Medicines Agency (EMA) and other regulatory approvals around the world. These results have also informed the WHO 2019 dolutegravir paediatric dosing guidelines.
The results uncovered are pivotal in the fight against HIV! Building on these results we can work to simplify health services and ensure timely access to optimal antiretroviral therapies (ART) for children living with HIV around the world.
Hear directly from Prof Di Gibb and Dr Anna Turkova from the Medical Research Council Clinical Trials Unit at University College London, discussing paediatric HIV treatment and the importance of these dolutegravir results for children living with HIV in the Lancet HIV podcast.
Visit the publications section of our website to read the full article in the Lancet.