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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has expanded approval of dolutegravir (Tivicay PD) to cover newborns with HIV — the youngest patients yet. Previously limited to infants 4 weeks and older weighing at least 3 kg, the drug can now be used from birth for babies weighing as little as 2 kg. The decision was backed by phase 1 data showing comparable drug levels and a consistent safety profile with older patients.
The FDA just opened the door for treating HIV in the tiniest patients. The agency has expanded its approval of dolutegravir tablets for oral suspension (Tivicay PD, ViiV Healthcare) to include newborns with HIV — specifically, infants weighing at least 2 kg from birth up to 4 weeks of age. Previously, the drug was only approved for infants aged 4 weeks and older weighing at least 3 kg, as well as adults.
The expanded approval is supported by phase 1 clinical data from 48 newborns, which showed that drug exposure levels with Tivicay PD were comparable to those associated with efficacy in adults. The safety profile in newborns also aligned with what's been observed in older infants and adults — a reassuring signal for clinicians.
Key Takeaways:
Why it matters: Early HIV treatment in newborns is critical to preventing disease progression and improving long-term outcomes. This approval gives clinicians a proven, well-characterized antiretroviral option for one of the most vulnerable patient populations.
