Highlights
– A pharmacokinetic (PK) sub‑study nested in the D3/PENTA 21 trial measured intensive 24‑hour PK profiles of dolutegravir (DTG) and lamivudine (3TC) in 72 virologically suppressed children (2–<15 years) switched to once‑daily DTG/3TC fixed‑dose formulations using WHO weight‑band dosing.
– DTG geometric mean (GM) Ctrough 0.82 mg/L and AUC0‑24h 66.2 h·mg/L were achieved, with only three children below the DTG EC90 (0.32 mg/L) but all above the PA‑IC90 (0.064 mg/L); 3TC GM AUC0‑24h was 16.2 h·mg/L.
– Safety was reassuring through 48 weeks: 3 children experienced 4 serious adverse events (SAEs) and 5 children had 6 grade ≥3 adverse events (AEs); none were attributed to DTG/3TC or led to treatment discontinuation.
