20 Dec, 2019
Using data from the ongoing P1093 and the ODYSSEY (PENTA20) study, ViiV Healthcare has filed submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV.
If approved, this new formulation of dolutegravir will be the first integrase inhibitor available as a dispersible tablet for children living with HIV, closing the gap between treatment options available for adults and children.
Data to support the submissions has been generated from ViiV Healthcare’s collaborations with the U.S. National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093 and Penta for ODYSSEY.
A full press release from ViiV can be found here.
ODYSSEY is a pragmatic strategy trial evaluating the efficacy and safety of once daily dolutegravir-based antiretroviral therapy compared with standard of care in children and adolescents starting first- or second-line antiretroviral therapy in resource-limited and well-resourced settings.
To know more about our study, visit the ODYSSEY website.