A randomised trial of dolutegravir (DGT)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART
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, with 700 patients to be enrolled in 30 sites in Europe, Africa and Asia.
ODYSSEY includes a pharmacokinetics substudy in children 2 to 6 years of age. On June 2020, the preliminary results of this study led to approval by the U.S. Food and Drug Administration (FDA) of the use of the dolutegravir adult film-coated tablet in children weighing more than 20kgs as well as the use of new ViiV Healthcare dolutegravir tablets for oral suspension in patients aged at least four weeks and weighing at least 3kg.
The FDA regulatory approval is a cornerstone on which further work can be built towards timely access to optimal antiretroviral therapies (ART) for children living with HIV around the world.