Results from from the ongoing P1093 and ODYSSEY (PENTA20) studies, 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!
They have been used to gain FDA approval for use of the adult dosage of the dolutegravir (50mg) in children weighing ≥20kg, in June 2020. Thus, allowing immediate access to adult dolutegravir formulation procured and available 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 the ODYSSEY team can work to simplify health services and ensure timely access to optimal antiretroviral therapies for children living with HIV around the world.
ODYSSEY is a multi-centre, randomised clinical trial to assess the efficacy and toxicity of dolutegravir plus 2 NRTI versus standard of care among HIV positive children and adolescents. Penta is the sponsor of this study, which is funded by ViiV Healthcare. The study anticipates 700 patients to be enrolled across 30 sites in Europe, Africa and Asia. The results from the main ODYSSEY trial are expected in 2021.
Read the full article in The Lancet HIV and hear directly from Di Gibb and Anna Turkova from the Medical Research Council Clinical Trials Unit at University College London, discussing paediatric HIV treatment and the importance of the ODYSSEY results for children living with HIV in the Lancet HIV podcast.