Document resource
In the PETITE-DTG phase 1/2 open-label trial in South Africa, 41 term neonates born to virally suppressed mothers on dolutegravir (DTG)-based ART (Antiretroviral therapy) were randomised to 5 mg DTG as half a dispersible tablet (n=21) or oral dispersible film (n=20) every 48 hours for 2 weeks and then daily to day 28. The first DTG dose was administered at a median of 47 hours after birth, accounting for transplacental DTG exposure and alongside zidovudine postnatal prophylaxis. DTG plasma concentrations at 6–10 days showed similar geometric mean area under the curve (193.2 µg⋅h/mL) and met prespecified paediatric pharmacokinetic targets (geometric-mean C trough 2.1 µg/mL and Cmax 6.4 µg/mL). No adverse events were attributed to DTG; all 39 neonates completing follow-up remained HIV-negative. These data support guideline inclusion of 5 mg DTG from birth in term neonates, aligning with current ART regimens for older children.