Expediting a UNIVERSAL first-line regimen of a dolutegravir-emtricitabine-tenofovir alafenamide fixed-dose ratio for children living with HIV older than 4 weeks: a 24-week, open-label, single-arm, phase 1-2, pharmacokinetic, safety, and antiviral activity trial.
Lancet HIVSep 7, 2026 (epub)
Anne E M Kamphuis, Nicolas Salvadori, Hilda Angela Mujuru et al.
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In 30 seconds
The UNIVERSAL1 trial evaluated the pharmacokinetics, safety, and antiviral activity of a fixed-dose combination of dolutegravir, emtricitabine, and tenofovir alafenamide in children aged 28 days to 10 years with HIV. This open-label, single-arm, phase 1-2 study included 53 participants. Notably, no child had a dolutegravir C trough lower than 0.32 mg/L.
Key findings
- Dolutegravir geometric mean AUC 0-24h was 93.1 h × mg/L.
- Emtricitabine geometric mean AUC 0-24h was 11.1 h × mg/L.
- Adverse events occurred in 58% of participants, with an incidence of 3.7 events per 100 person-weeks.
- Three participants experienced serious adverse events, all unrelated to study drugs.
Why it matters
This study addresses the critical need for effective antiretroviral therapy in pediatric populations, providing evidence for the safety and pharmacokinetics of a new fixed-dose regimen that could improve treatment adherence and outcomes in children living with HIV.