FDA Provides Tentative Approval for HIV Therapy for Children

The FDA have given a tentative approval for a new drug application for a combination therapy abacavir /dolutegravir/lamivudine for the treatment of HIV in the pediatric population.

“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," Rakesh Bamzai, president of India, Emerging Asia & Access Markets at Viatris, said in a statement.

The FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) program means the formulation meets all the agency's quality, safety, and efficacy standards.

Viatris is global healthcare company and has signed a licensing agreement for dolutegravir from the Medicines Patent Pool (MPP) and development agreement with ViiV Healthcare and the Clinton Health Access Initiative (CHAI) for producing and distributing the fixed-dose combination of abacavir/ dolutegravir/lamivudine.

The fixed-dose combination of abacavir/dolutegravir/lamivudine is approved for once-daily treatment of children weighing at least 6 kg to <25 kg with HIV-1 infection and the recommended dose of the fixed-dose combination of abacavir/dolutegravir/lamivudine tablets for oral suspension is determined according to weight. The fixed-dose combination of abacavir/dolutegravir/lamivudine are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLAB*5701-positive patients.

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.

Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI). NRTIs interfere with the action of the reverse transcriptase enzyme and INSTI interferes with the action of integrase enzyme to prevent the virus from replicating.

All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg as severe acute exacerbations of HBV have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued the medication.

The combination therapy was approved in the United States in March 2022 under the brand name Triumeq.