Dolutegravir from Birth: PETITE‑DTG Shows Safe, Targeted Neonatal Dosing for Term Newborns

Highlight

– The PETITE‑DTG phase 1/2 randomized trial provides the first multidose pharmacokinetic and safety data for dolutegravir in term neonates from birth to 4 weeks of life.

– A regimen of 5 mg dolutegravir (half a 10 mg scored dispersible tablet or a 5 mg oral dispersible film) every 48 hours for the first 2 weeks, then daily until day 28, achieved geometric mean trough concentrations above the pre-specified target (0.67 μg/mL) and Cmax below the safety threshold (17.0 μg/mL).