Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Triumeq PD, the first dispersible single tablet regimen with dolutegravir, for children living with HIV.
Today, ViiV Healthcare announced the European Medicines Agency (EMA) issued a positive opinion in recommendation of marketing authorization for Triumeq PD, their HIV treatment for children.
Triumeq PD is a dispersible tablet formulation of a fixed dose of abacavir, dolutegravir, and lamivudine. The once-daily treatment is the first dispersible single tablet regimen with dolutegravir.
“We know that children and young people living with HIV have specific treatment needs, and options that work for them can be limited,” said ViiV Healthcare CEO Deborah Waterhouse. “Today’s CHMP positive opinion brings us one step closer to closing that treatment gap, and ensure we leave no one living with HIV behind.”
The positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) follows the US Food and Drug Administration (FDA) approval for Triumeq PD in March 2022.
The single-tablet daily treatment was FDA-approved for pediatric HIV-1 patients weighing 10-25 kg. In Europe, the minimum weight for a child to be prescribed Triumeq PD was 40 kg, but this will be lowered to 25 kg with the CHMP’s positive opinion.
“Around the world today, an estimated 1.7 million children are currently living with HIV,” Waterhouse said. Unfortunately, data from UNAIDS suggest only 52% of children living with HIV are on antiretroviral therapy (ART). This falls far behind the 76% of adults receiving ART.
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.