On Jun. 12, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the FDA had approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for treatment of human immunodeficiency virus type 1 infection in paediatric patients (treatment-naive or -experienced but INSTI- naive) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life. Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals.

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg. Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg. This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children.