This article was written by Anne Kamphuis and Prof David Burger, Radboud University Medical Centre. It is taken from the Penta 2025 Annual Report.
Despite significant advances in HIV treatment in recent years, these have mainly benefited adults. Children have historically faced delays in both the availability of treatment options, as well as access to child-friendly formulations. To address this persistent paediatric treatment gap, global stakeholders came together to enable more focused and coordinated actions to make age-appropriate, optimised formulations more rapidly available for children living with HIV.
In 2018, the WHO-led Paediatric Antiretroviral Drug Optimization group identified a dispersible fixed-dose combination of dolutegravir (DTG), emtricitabine (FTC), and tenofovir alafenamide fumarate (TAF) as a priority for development. This formulation is highly effective and well-tolerated by adults but despite this, it has never been formulated for children. Currently, children living with HIV have to take multiple medications and follow a complex schedule making adherence difficult. The lack of age-appropriate formulations further complicates treatment and can lead to poor outcomes.
To accelerate the development of this formulation and ensure timely translation of research into regulatory and access pathways, the UNIVERSAL project, part of the EDCTP programme supported by the European Union, was launched under the umbrella of the WHO-established GAP-f network.
Within the project, the UNIVERSAL1 trial demonstrated that pharmacokinetic, safety, and efficacy data support the dose ratio of the paediatric DTG/FTC/TAF fixed-dose combination dispersible tablet for children weighing 3 to less than 20 kg. In parallel, the formulation is being developed in collaboration with generic manufacturers. Once the tablet becomes available, the trial findings may inform licence applications potentially accelerating the availability of this optimised, child-friendly formulation.
The UNIVERSAL project illustrates that working across the entire project lifecycle ensures that all aspects of paediatric drug development are addressed and accelerates access to safe, effective, and affordable medicines for children, because ending the trial phase is a step toward availability, not an endpoint. Overall, the project represents an important step toward harmonising HIV treatment across paediatric and adult populations and closing the treatment gap.