ViiV submits FDA application for pediatric HIV treatment

By Jenni Spinner contact

- Last updated on GMT

(Riccardo Lennart Niels Mayer/iStock via Getty Images Plus)
(Riccardo Lennart Niels Mayer/iStock via Getty Images Plus)

Related tags: Hiv, Aids, Fda, Pediatrics, Antivirals

The HIV treatment specialist has sent an application to the agency for tolutegravir, a single-tablet treatment indicated for children living with the virus.

ViiV Healthcare, the global specialist HIV company majority-owned by GSK (with Pfizer and Shionogi as shareholders) has made a regulatory submission to the US Food and Drug Administration (FDA) for approval of an HIV treatment for pediatric patients. The therapy comprises a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir, and lamivudine; it also aims to extend current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg (88.2 lbs) and above to 14kg (30.9 lbs) and above.

Pediatric HIV infections are a matter of increasing global concern, with children being disproportionately affected by the viral epidemic. Findings from global HIV/AIDS organization UNAIDS​ indicate there currently are 1.7m children living with HIV globally; further, most AIDS-related deaths among this group occur before the age of five.

Additionally, pediatric patients are harmed by a number of obstacles, including the lack of access to HIV testing resources, continued vertical transmission, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals. Making age-appropriate treatment options more widely available is important to the health of children impacted by or at risk of HIV infection.

Deborah Waterhouse, CEO of ViiV Healthcare, said, “UNAIDS​ reported that in 2020, 74% of adults living with HIV had access to treatment, compared to only 54% of children. 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​.”

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