Today, the FDA approved the abacavir, dolutegravir, and lamivudine single tablet formulation Triumeq, a once-daily HIV treatment for children.
Today, ViiV Healthcare announced that the US Food and Drug Administration (FDA) approved a new drug application (NDA) for their abacavir, dolutegravir, and lamivudine treatment (Triumeq PD) for children living with HIV.
Pediatric HIV-1 patients weighing 10-25 kg now have an age-appropriate, single-tablet HIV regimen. UNAIDS estimates 1.7 million children were living with HIV in 2020. Globally, most deaths among pediatric HIV patients occur in children under 5 years of age. As of 2020, UNAIDS reported 74% of adults living with HIV had access to treatment, but only 54% of children had access to HIV treatment.
“We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option,” ViiV Healthcare CEO, Deborah Waterhouse, said in a statement. “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.”
ViiV Healthcare submitted an FDA application for Triumeq in early October 2021. The proposal sought to lower the minimum weight at which a child can be prescribed the treatment, from 40 kg to 14 kg. Triumeq, the dispersible tablet formulation of a fixed dose combination of abacavir, dolutegravir, and lamivudine, is now available for pediatric patients 10 kg to <25 kg.
“Today’s approval of a child-friendly formulation of a single tablet regimen will help meet the urgent needs of this vulnerable population,” said Chip Lyons, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). EGPAF is a nonprofit organization that works to prevent and eliminate pediatric AIDS.
Triumeq is a fixed-dose combination of the INSTI dolutegravir and the NRTIs abacavir and lamivudine. The HIV virus relies on replicating its RNA into DNA and integrating its DNA into the DNA of a host cell. NRTIs and integrase inhibitors disrupt the reverse transcriptase and integrase enzymes, inhibiting the HIV virus from continuing its cycle of replication and integration.
ViiV Healthcare is a global HIV specialist company, majority owned by GlaxoSmithKline (GSK), with majority shareholders Pfizer Inc. and Shionogi Limited. The company was established in November 2009 to advance care and treatment for people living with HIV or people at high risk of contracting HIV.