Data from IMPAACT 2019 Contribute to FDA Approval of a Once-Daily Dispersible HIV Drug for Young Children

The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) is pleased to announce that, based on IMPAACT study data, the U.S. Food and Drug Administration (FDA) has approved Triumeq PD® for infants and children as young as 3 months of age who weigh at least 6 kg.  

Triumeq PD® is a child-friendly dispersible tablet that contains three medicines for HIV: dolutegravir, abacavir, and lamivudine. The tablet is dispersed in drinking water for children who cannot swallow whole tablets. Data from the IMPAACT 2019 study showed that the tablets are safe, well tolerated, and effective for controlling HIV when taken once per day. This represents an important advance for young children, who might otherwise need to be given multiple tablets or liquid medicines twice per day. The primary results of the study were published yesterday in The Lancet HIV.

HIV treatment with dolutegravir is now recommended globally. Triumeq PD® is the only combination tablet that contains a full treatment regimen that can be used in small children. This new formulation could significantly help improve adherence and treatment outcomes and reduce the challenges many caregivers face when giving medicines for HIV to children.

IMPAACT 2019 was a Phase I/II open-label, multicenter, multiple-dose study of Triumeq® and Triumeq PD® in children living with HIV in Botswana, South Africa, Thailand, and the United States. Fifty-seven children one to less than 12 years of age took part in the study. The IMPAACT Network gratefully acknowledges these children and the family members and caregivers who supported their participation in the study. The Network also thanks IMPAACT site staff, community advisory board members, and protocol team members for their efforts leading to the approval of a new treatment option for children.