ViiV Healthcare Announces FDA Approval of Once-Daily Treatment for Children Living with HIV

ViiV Healthcare, a company specializing in HIV majority-owned by GlaxoSmithKline, Pfizer, and Shionogi, announced that FDA has approved a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir, and lamivudine for the treatment of HIV in pediatric patients weighing 10 kgs to <25 kgs. A new supplemental drug application for Triumeq tablets has also been approved, which lowers the minimum weight that a child must be to be prescribed this medicine from 40 kgs to 25 kgs.

Approximately 1.7 million children globally were living with HIV in 2020, with most AIDS-related deaths among the population occurring within the first five years of life, according to UNAIDS. The approval of this tablet regimen containing dolutegravir increases age-appropriate treatment options for children living with HIV, which is crucial for ensuring young children can access optimal care.

“Children are still disproportionality impacted by the HIV epidemic with only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need and even fewer still reaching viral suppression,” said Chip Lyons, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, in a press release. “An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste and this presents a real challenge to many caregivers’ ability to administer life-saving medicine. Today’s approval of a child-friendly formulation of a single tablet regimen will help meet the urgent needs of this vulnerable population.”

“We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option,” added Deborah Waterhouse, CEO of ViiV Healthcare, in a press release. “Developing paediatric formulations of anti-retroviral treatments is a priority for ViiV Healthcare because we want to ensure that no one living with HIV is left behind and this approval means that we are one step closer to closing the gap between HIV treatment options available for adults and children.”
Source: ViiV Healthcare