ODYSSEY trial data confirm superiority of dolutegravir-based ART in young children

SWITZERLAND – New findings from the ODYSSEY trial confirm that dolutegravir -based regimens can significantly improve virological suppression in young children.

Country programmes are being encouraged to plan a rapid introduction of dolutegravir -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.

The ODYSSEY trial, a multi-country randomized trial sponsored by Penta, has previously demonstrated superior treatment efficacy for dolutegravir plus two nucleoside analogues versus standard-of-care (SOC) in 707 children ≥14kg (median age 12 years) starting first- or second-line ART.

Among these children, with median age of 1.4 years, an estimated 28% had treatment failure by 96 weeks in the dolutegravir arm vs 48% in the SOC arm.

Dolutegravir -based ART was superior to SOC (predominantly protease inhibitor-based ART) in young children starting first or second-line therapy, judged on treatment failure by 96 weeks.

WHO 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.

The Upcoming WHO 2021 consolidated guidelines on HIV and the newly released policy brief on transitioning to the 2021 optimal formulary for antiretroviral drugs for children provide further guidance on how to transition dolutegravir -containing regimens as well as how to best dose it when treatment for tuberculosis is required.

Since the beginning of the epidemic, 76 million people have been infected with the HIV virus and about 33 million people have died of HIV. Globally, 38.0 million (31.6–44.5 million) people were living with HIV at the end of 2019.

An estimated 0.7% (0.6-0.9%) of adults aged 15–49 years worldwide are living with HIV, although the burden of the epidemic continues to vary considerably between countries and regions.

The WHO African region remains most severely affected, with nearly 1 in every 25 adults (3.7%) living with HIV and accounting for more than two-thirds of the people living with HIV worldwide.

Children living with HIV continue to be left behind by the global AIDS response and in 2020, only 54% of the 1.7 million children living with HIV received antiretroviral therapy compared to 74% among adults living with HIV.

Among the focus countries, only 40% of children living with HIV (or 74% of children receiving antiretroviral therapy) achieved viral suppression in 2020.

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