FDA Approval Sought for First Dispersible Single Tablet Regimen for Children With HIV

ViiV Healthcare has filed a regulatory submission to the FDA for the approval of a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir, and lamivudine (Triumeq) to extend its current approval and lower the minimum weight at which children can be prescribed this treatment from 40 kg and above to 14 kg and above. This approval will provide further treatment options for younger children living with HIV, according to a ViiV press release.

The availability of HIV testing, continued vertical transmission, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals have been major obstacles for children, according to ViiV Healthcare. The accessibility of age-appropriate treatment options is essential in ensuring children around the world can access optimal care.

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

REFERENCE

ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV. GSK. October 4, 2021. Accessed October 4, 2021. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-submits-fda-application-for-first-dispersible-single-tablet-regimen-containing-dolutegravir-dtg-for-children-living-with-hiv/