The ODYSSEY trial’s final paper Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children has been published in the New England Journal of Medicine. ODYSSEY, sponsored by Penta and funded by ViiV Healthcare, is the first randomised controlled trial to compare the efficacy and safety of dolutegravir-based regimens to non-dolutegravir-based standard-of-care regimens in children and adolescents.
Dolutegravir (DTG) is a drug shown to be highly effective and safe in treating HIV in adults, and ODYSSEY, enrolling more than 700 children from Uganda, South Africa, Zimbabwe, Thailand, UK, Germany, Spain and Portugal, revealed that DTG based treatments in children were more effective and as safe as standard care regimens, with children experiencing fewer adverse effects and better growth. The results of the ODYSSEY substudies played a role in the Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of once-daily dispersible DTG for children as young as 4 weeks old at a substantially low cost.
There are an estimated 1.7 million children currently living with HIV. Treatment options for children are limited compared to those available to adults. HIV infection in children is a chronic condition, and without access to antiretroviral treatment, the disease progresses rapidly, increasing the likelihood for the development of AIDS and the risk of suffering AIDS-related deaths.
With the new paediatric DTG regimens, ODYSSEY played a part in ensuring children can begin safe and effective treatment against HIV from a young age. A step closer to the realisation of an AIDS-free generation.
Read the press release by UCL here
Watch the animated abstract here