FDA approved ViiV Healthcare’s Tivicay PD for treating HIV-1 in newborns weighing at least 2 kg, the agency announced.
Expanded pediatric indication
The original approval in August 2013 covered adults and adolescents 12 years or older who weighed 40 kg or more. A dispersible form received clearance in 2020 for patients at least four weeks old and weighing 3 kg.
Now the label removes the minimum-age requirement and lowers the weight threshold to 2 kg, roughly 4.4 pounds, allowing treatment from birth.
Clinical evidence behind the decision
Data came from the NIH-funded IMPAACT 2023 study, a multicenter phase-1 trial that enrolled 48 mother-infant pairs across South Africa, Thailand and the United States.
All infants received Tivicay PD alongside standard antiretroviral prophylaxis from birth for up to six weeks. Researchers followed them for 16 weeks, finding drug concentrations comparable to adult efficacy levels and a safety profile similar to older patients.
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Preliminary findings presented at CROI 2025 detailed a 15-infant cohort. Full-term babies weighing 2.3-3.6 kg started a 5-mg tablet every other day for two weeks, then switched to daily dosing.
“For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible,” said Diana F. Clarke, Pharm.D. She added the approval was “an important advance for the care of newborns.”
The expanded label permits dolutegravir in combination with other antiretrovirals. Eligible patients may be treatment-naïve or experienced, provided they have not previously used an integrase strand transfer inhibitor.
Market impact
Commercially, the standalone Tivicay brand showed a modest decline, with GSK reporting £1.323 billion in sales for 2025, down 2% at actual exchange rates. The modest drop in the single-product line contrasts with growth in the company’s broader HIV portfolio.
First-half 2026 sales totaled £629 million, a 3% decrease on a reported basis. Meanwhile, the broader HIV portfolio grew to £7.687 billion in 2025, an 11% rise driven by products such as Dovato, Cabenuva and Apretude.
