Viiv Healthcare gets European Marketing Authorisation for children's HIV drug

This is the first dispersible single tablet regimen containing dolutegravir, and the company says it is an important step to meet its commitment of bringing pediatric formulations to children living with HIV.  

Deborah Waterhouse, CEO at ViiV Healthcare, said: “We are delighted to have received the EU Marketing Authorisation for Triumeq PD, expanding the options for child-friendly HIV treatments available in Europe. We are committed to pushing the boundaries to develop medicines that address the unmet needs of the estimated 1.7 million children living with HIV, bringing us closer to achieving our mission of ensuring no one living with HIV – regardless of their age - is left behind.”

The global specialist HIV company is majority owned by GSK, with Pfizer and Shionogi as shareholders. The tablet is a fixed dose combination of abacavir, dolutegravir and lamivudine for paediatric patients weighing 14kgs to more than 25kgs with human immunodeficiency virus type 1 (HIV-1).

This authorisation includes the label extension of Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine from 40kg to 25kg.

Despite significant advances in HIV treatment and care, only 52% of children living with HIV (under 14 years old) had access to optimised pediatric formulations of antiretrovirals in 2021. The EMA follows the US Food and Drug Administration (FDA) approval of Triumeq PD in 2022. This provides access to age-appropriate formulations of dolutegravir for a younger population and helps to close the gap between HIV treatment options available for adults and children living with HIV.

Currently, around the world, a child dies from AIDS related causes every five minutes, HIV and AIDS organisation, UNAIDS, reports.

They said that children living with HIV are on life-saving treatment, far behind adults of whom three quarters (76%) are receiving antiretrovirals.

UNAIDS says that in 2021, there was 160,000 children who had newly acquired HIV. Children accounted for 15% of all AIDS-related deaths, even though only 4% of the total number of people living with HIV are children.

Amanda Ely is the CEO of the Children’s HIV Association (CHIVA), an organization that provides support to children living with HIV in the United Kingdom and Ireland and their families.

She said: “Currently, young children face significant challenges due to limited age-appropriate treatment and therefore fewer children are achieving viral suppression, compared to adults.1

“Through improved treatment options, increased access, and community support, we can increase the number of children living with HIV achieving viral suppression. Furthermore, by successfully initiating young children onto age-appropriate treatments, it can help them foster a positive relationship with their lifelong treatment regimen early on.”

In October, 2021, Outsourcing Pharma​ reported on the company’s application for the treatment of children to the US Food and Drug Administration (FDA) and in April last year, it was reported​ that the FDA had approved to make the company’s oral lead for adults Cabenuva, a once every other month drug optional.