Lancet: 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 ART trial

UNIVERSAL1 was a Phase 1/2, open-label study evaluating the pharmacokinetics, safety, and antiviral activity of a novel fixed-dose combination (FDC) of dolutegravir (DTG), emtricitabine (FTC), and tenofovir alafenamide (TAF) in 53 children with HIV weighing 3 to <25 kg.

The study demonstrated that the proposed weight-based dosing regimen achieved drug exposures within target ranges across all weight bands. No participant had dolutegravir concentrations below the efficacy threshold, and tenofovir exposure remained well below toxicity thresholds. Only three children had TAF exposure below the predefined antiviral target.

The treatment was generally well tolerated. Adverse events were mostly mild, with three serious adverse events reported, all considered unrelated to study treatment. Only one grade 3 laboratory abnormality was considered possibly treatment-related, and no participants discontinued treatment due to drug-related adverse events.

Conclusion: The results support the proposed dosing of the dispersible DTG/FTC/TAF fixed-dose combination for children weighing 3 to <20 kg and support extending the use of the currently licensed film-coated DTG/FTC/TAF tablet to children weighing ≥20 kg.

Additional information to the following link: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018%2826%2900168-2/abstract