ViiV submits FDA application for pediatric HIV treatment

ViiV Healthcare, the global specialty HIV company majority-owned by GSK (with Pfizer and Shionogi as shareholders), has filed a regulatory application with the US Food and Drug Administration (FDA) for approval of an HIV treatment for pediatric patients. The therapy includes a novel dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir and lamivudine; it is also intended to extend the current approval for Triumeq (abacavir/dolutegravir/lamivudine) to lower the minimum weight at which this drug may be prescribed to a child from 40 kg (88.2 lbs) and more to 14 kg (30 .9 lbs) and more.

Childhood HIV infections are a matter of growing global concern, with children being disproportionately affected by the viral epidemic. Findings from the global HIV/AIDS organization UNAIDS indicate that there are currently 1.7 million children living with HIV worldwide; furthermore, most AIDS-related deaths among this group occur before the age of five.

In addition, pediatric patients are harmed by a number of obstacles, including lack of access to HIV testing agents, continued vertical transmission, slow treatment initiation, and poor availability of optimized pediatric formulations of antiretroviral agents. It is important for the health of children affected by or at risk of HIV infection.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “UNAIDS reported that by 2020, 74% of adults living with HIV had access to treatment, compared to just 54% of children. This is a stark reminder of the divide between treatment options for adults and children, and this entry is another important step to ensure we address this inequality. By broadening treatment options for children with HIV, we are one step closer to ending HIV and AIDS in children.”

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