If the company gets approval it would be the first dispersible single tablet regimen containing dolutegravir.
ViiV announced it has submitted an application to the Food and Drug Administration (FDA) for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine, and in addition to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg (88.185 lbs) and above to 14kg (30.865 lbs) and above.
By doing so, this offers a potential new treatment option to younger children living with HIV.
According to UNAIDS Global HIV & AIDS statistics, the latest numbers show there are 1.7 million children living with HIV globally, with most AIDS-related deaths among this group occurring during the first five years of life.
“UNAIDS reported that in 2020, 74% of adults living with HIV had access to treatment, compared to only 54% of children,” ViiV Healthcare CEO Deborah Waterhouse, said. “This is a stark reminder of the gap between treatment options for adults and children and this submission represents another important step in ensuring that we address this disparity. By broadening the treatment options available to children living with HIV, we are one step closer to ending pediatric HIV and AIDS.”
Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine. The therapy is currently indicated for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 40 kg. The most commonly reported adverse reactions (incidence ≥2%, Grades 2-4) in treatment-naïve adults receiving the therapy were insomnia (3%), headache (2%), and fatigue (2%).
No timeline has been set by the FDA to discuss potential approval.