The US Food and Drug Administration (FDA) has received a regulatory submission for a new dispersible tablet formulation of Triumeq’s fixed-dose combination (abacavir/dolutegravir/lamivudine), as well as an extension of a current approval to lower the minimum weight at which a child can be prescribed this medicine from 40kg and above to 14kg and above.If approved, ViiV Healthcare’s filing will result in more treatment options for younger HIV-positive children.
“Pediatric HIV continues to be a global issue, with children being disproportionately affected by the HIV epidemic.” According to the most recent statistics, there are 1.7 million children living with HIV worldwide, with the majority of AIDS-related deaths occurring during the first five years of life.
For children, major challenges remain, such as the lack of HIV testing, the persistence of vertical transmission, the slow initiation of treatment, and the scarcity of optimised paediatric antiretroviral formulations. The availability of age-appropriate treatment options is critical in ensuring that children all over the world have access to the best possible care.
Deborah Waterhouse is the CEO of ViiV Healthcare, an HIV company majority-owned by the UK drugmaker GlaxoSmithKline (LSE: GSK), with Pfizer and Shionogi (TYO: 4507) also having a stake.“UNAIDS reported that in 2020, 74% of adults living with HIV had access to treatment, compared to only 54% of children,” she said.“This is a stark reminder of the disparity in treatment options for adults and children, and this submission represents another important step toward addressing this disparity. We are one step closer to eradicating paediatric HIV and AIDS by expanding the treatment options available to children living with HIV.
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