The World Health Organization’s (WHO) Odyssey Trial has demonstrated superior treatment efficacy for dolutegravir (DTG) in children with AIDS. DTG, sold under the brand name Tivicay, is antiretroviral therapy (ART) used, together with other medication, to treat HIV/AIDS. The drug may also be used as part of post-exposure prophylaxis, to prevent HIV infection following potential exposure.
The trial found that among the children tested, with a median age of 1.4 years, an estimated 28% had treatment failure by 96 weeks in the DTG arm vs 48% in the standard-of-care (SOC) arm. DTG-based ART was superior to SOC (predominantly protease inhibitor-based ART) in young children starting first or second-line therapy.
These new findings from the ODYSSEY trial also confirm that DTG-based regimens can significantly improve virological suppression in young children. In the light of these findings, WHO encouraged countries to plan a rapid introduction of DTG-containing HIV treatment as the preferred first-line regimen for all infants and children who are as young as four weeks of age and weighing more than 3kg.
Dr Meg Doherty, Director of the WHO Global HIV, Hepatitis and STI Programmes, said: “These new findings from the ODYSSEY trial confirm once and for all the superiority of DTG-based regimens compared to existing regimens. We have a moral imperative to ensure that children are not denied this better regimen available in child-friendly formulations: country programmes have the tools to ensure sustained viral suppression for children.”
WHO also reiterated that it has recommended DTG-based HIV treatment for all infants and children since 2018 and provided dosing recommendations for infants and children over four weeks of age and more than 3kg in July 2020. It also drew attention to the issue of children living with HIV continuing to be left behind by the global AIDS response. In 2020, only 54% of the 1.7 million children living with HIV received antiretroviral therapy compared to 74% among adults living with HIV, the organization said.