Data from the ongoing P1093 and ODYSSEY (PENTA20) studies have led to the successful approval of ViiV Healthcare’s submission to the U.S. Food and Drug Administration (FDA) of the adult formulation for children weighing ≥20kg and dolutegravir (DTG) dispersible tablets for children of 4 weeks of age and older.
The approval of adult 50mg DTG for use for children weighing ≥20kg allows for immediate access to adult DTG formulation procured and available in many countries for the majority of children living with HIV. Dispersible DTG formulations will provide an age-appropriate option for a younger population making it easy for children who are unable to swallow tablets to take this medication. This successful submission is a major step in closing the gap between the HIV treatment options available for adults and children.
DTG tablets can be used in combination with other antiretroviral agents for the treatment of HIV-1 in paediatric patients (treatment-naïve or -experienced who do not harbour INSTI-resistant virus) aged at least four weeks and weighing at least 3kg.
This is a significant milestone, which would not have been possible without the contribution of the ODYSSEY trial, ODYSSEY African trial sites, MRC Clinical Trials Unit at University College London, UK, the ODYSSEY team at Penta, Italy and the PK team at the Radboud Institute for Health Sciences, Nijmegen.
Further information can be found on the ODYSSEY website, along with a short video developed by Picturing Health, explaining how DTG has gained approval for use in children.
You can also take a look at the ViiV Healthcare press release.