Oral suspension of dolutegravir receives US FDA approval for paediatric HIV patientsJune 14, 2020
ViiV Healthcare received US FDA approval for its dispersible tablet formulation of the antiretroviral drug dolutegravir (Tivicay PD) as a tailored approach to the treatment of paediatric patients with human immunodeficiency virus type 1 (HIV-1) infection.
The integrase inhibitor drug is used as a once-daily treatment in children. The oral suspension tablet can be used in children of four weeks of age and weighing at least 3kg, recommends FDA.
Dolutegravir is used in combination with other antiretroviral agents for the treatment of HIV in paediatric patients. Prior to this, dolutegravir was indicated for children from six years of age and weighing more than 30kg.
Through the current approval, younger paediatric patients can receive an age-appropriate formulation of dolutegravir thereby helping overcome the gap between HIV treatment options available for adults and children.
Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic.
According to WHO, there are 1.7 million children living with HIV1, 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.
The FDA approval is based on data from ViiV Healthcare’s ongoing collaborative study P10936 and ODYSSEY7 (PENTA20) studies.