FDA Issues Tentative Approval to Abacavir/Dolutegravir/Lamivudine Combo to Treat HIV in Pediatric Patients

The FDA has issued a tentative approval to a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg (Viatris) oral suspension tablets to treat HIV-1 infection in pediatric patients. The fixed-dose abacavir/dolutegravir/lamivudine combination is indicated for the once-daily treatment of children weighing at least 6 kg to <25 kg with HIV-1 infection.¹

“Over the years, we have continued to seek improvements to existing molecules to better meet patient needs—we have introduced novel heat-stable generic formulations, more convenient packaging options, and pediatric therapies,” Rakesh Bamzai, president of India, Emerging Asia and Access Markets at Viatris, said in a press release.¹ “We have also built strong partnerships with multiple stakeholders to improve access to ARVs, with particular attention to vulnerable populations like children. The approval of this single tablet regimen—the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg—will reduce the pill burden for children living with HIV.”

Viatris noted that treating pediatric patients with HIV can be difficult because they require unique medication formulations. The recommended dose of the fixed-dose, strawberry-flavored combination of abacavir/dolutegravir/lamivudine tablets for oral suspension is determined according to weight. The combination is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLAB*5701-positive patients.¹

Abacavir/dolutegravir/lamivudine contains 2 nucleoside reverse transcriptase inhibitors (NRTIs) and an integrase strand transfer inhibitor (INSTI). The NRTIs inhibit the action of the reverse transcriptase enzyme, whereas INSTI inhibits the action of the integrase enzyme to stop the virus from replicating.

Prior to or when initiating the abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg fixed-dose combination, patients with HIV-1 should be tested for hepatitis B virus (HBV) because severe acute exacerbations of HBV have been observed in individuals coinfected with HBV and HIV-1 and have discontinued the treatment.

Abacavir/dolutegravir/lamivudine previously received FDA approval in March 2022 under the brand name Triumeq PD (ViiV Healthcare).² This approved indication is for a single-tablet regimen in pediatric patients with HIV-1.

Triumeq treats 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.

Triumeq is a fixed-dose combination of dolutegravir and 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

The 3 components 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.

The tentative approval facilitates regulatory authority submissions, production, and distribution of the new child friendly formulation across 123 low- and middle-income countries as per the license agreement.

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.²

References

1. Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV. Viatris. News release. September 5, 2023. https://newsroom.viatris.com/2023-09-05-Viatris-Announces-U-S-FDA-Tentative-Approval-of-a-Paediatric-Formulation-of-Abacavir-ABC-Dolutegravir-DTG-Lamivudine-3TC-,-a-Once-daily-Treatment-for-Children-Living-with-HIV

2. Staff report. FDA Approves Triumeq PD for Children With HIV. Pharmacy Times. March 31, 2022. https://www.pharmacytimes.com/view/fda-approves-triumeq-pd-for-children-with-hiv