The Food and Drug Administration (FDA) has approved Triumeq PD (abacavir, dolutegravir and lamivudine), tablets for oral suspension, for the treatment of pediatric patients weighing 10kg to less than 25kg with HIV-1 infection.
The FDA has also approved the supplemental NDA for Triumeq tablets to include pediatric patients weighing 25kg to 40kg with HIV-1 infection. Previously, Triumeq tablets were approved only for patients weighing at least 40kg.
The efficacy of the individual components of Triumeq and Triumeq PD for the treatment of HIV-1 infection was evaluated in pediatric patients enrolled in the phase 4 ARROW trial (ClinicalTrials.gov Identifier: NCT02028676) and the ongoing open-label, dose-finding phase 1/2 IMPAACT P1093 trial (ClinicalTrials.gov Identifier: NCT01302847).
In the ARROW trial, treatment-naive patients 3 months to 17 years of age with HIV-1 infection who weighed at least 25kg were randomly assigned to receive once-daily dosing of abacavir 600mg and lamivudine 300mg, as either single entities or as Epzicom, in combination with a third antiretroviral drug. Results showed that 67% of patients who received abacavir and lamivudine plus a third antiretroviral drug achieved HIV-1 RNA less than 80 copies/mL at week 96.
The IMPAACT P1093 trial evaluated dolutegravir (Tivicay or Tivicay PD) in combination with other antiretroviral drugs in treatment naive or treatment-experienced, INSTI-naive, HIV-1–infected patients aged at least 4 weeks to 18 years. Patients weighing at least 10kg were stratified by age cohort: cohort I (12 to less than 18 years of age); cohort IIA (6 to less than 12 years of age); and cohort III-DT (2 to less than 6 years of age). Results showed that across all 3 cohorts, 67% of patients who weighed at least 10kg achieved HIV-1 RNA less than 50 copies/mL at week 48.
Triumeq is a fixed dose combination of abacavir, dolutegravir, and lamivudine. Triumeq tablets are supplied in 30-count bottles with each film-coated tablet containing abacavir 600mg, dolutegravir 50mg, and lamivudine 300mg.
Triumeq PD tablets for oral suspension will be supplied in 90-count bottles with each tablet containing abacavir 60mg, dolutegravir 5mg, and lamivudine 30mg in a strawberry cream flavor.
The film-coated tablets and dispersible tablets for oral suspension are not interchangeable on a milligram per milligram basis due to differing pharmacokinetic profiles.
- 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. News release. ViiV healthcare. March 30, 2022. Accessed March 31, 2022. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/march/viiv-healthcare-announces-us-fda-approval/
- Triumeq and Triumeq PD. Package insert. ViiV healthcare; 2022. Accessed March 31, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Triumeq/pdf/TRIUMEQ-PI-MG.PDF#page=1