FDA Approves Triumeq PD for Children With HIV

The FDA has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir, and lamivudine treatment (Triumeq PD; ViiV Healthcare) for children living with HIV. The approved indication is for a single-tablet regimen in pediatric patients with HIV-1 weighing 10 kg-25 kg.¹

In a ViiV press release, the company noted that UNAIDS estimates 1.7 million children were living with HIV in 2020, with most deaths among pediatric patients with HIV in children under 5 years of age. Further, 74% of adults living with HIV had access to treatment, whereas only 54% of children with HIV had access to treatment, according to UNAIDS.

“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 press release. “Developing pediatric 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.”

Triumeq is a fixed-dose combination of the integrase strand transfer inhibitor dolutegravir and the nonnucleoside reverse transcriptase inhibitors abacavir and lamivudine. Together, these 3 medications form a complete regimen for the management of HIV-1 infection.

Triumeq tablets contain 50 mg of dolutegravir, 600 mg of abacavir, and 300 mg of lamivudine. Triumeq can be taken either with or without food and unlike other regimens for HIV-1, no boosting agent is required.^2,3

The 3 components of Triumeq have different pharmacokinetic properties. Abacavir has an elimination half-life of 1.5 hours, dolutegravir has a half-life of 14 hours, and lamivudine has a half-life ranging from 5 to 7 hours. Although exposure to lamivudine is unaffected, exposure to abacavir may be slightly lower and exposure to dolutegravir slightly higher in patients taking Triumeq with a high-fat meal—but not to a clinically significant degree.²

“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.”

This was the second significant HIV drug approval this week for ViiV Healthcare. On March 29, the FDA approved an expanded indication for the HIV therapy cabotegravir and rilpivirine (Cabenuva) in adolescents.⁴

The expanded indication is for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]), 12 years of age or older, who weigh at least 35 kg (~77 lbs), and who are on a stable antiretroviral regimen, with no history of treatment failure or known or suspected resistance to either cabotegravir or rilpivirine.

References

1. ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV. ViiV Healthcare. [news release]. March 30, 2022. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-triumeq-pd-the-first-dispersible-single-tablet-regimen-containing-dolutegravir-a-once-daily-treatment-for-children-living-with-hiv/

2. Triumeq (abacavir, dolutegravir, and lamivudine) tablets [package insert]. Research Triangle Park, NC: Viiv Healthcare; 2014.

3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. US Department of Health and Human Services. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Updated November 13, 2014.

4. Pharmacy Times. FDA Approves Cabenuva to Treat HIV in Adolescents 12 Years of Age or Older. March 30, 2022. https://www.pharmacytimes.com/view/fda-approves-cabenuva-to-treat-hiv-in-adolescents-12-years-of-age-or-older