Report of the meeting to review the paediatric antituberculosis drug optimization priority list

Overview

In May 2016, the 69th World Health Assembly adopted a resolution (WHA69.20) which aims to promote innovation and access to quality, safe, efficacious and affordable medicines for children. This area of work is also a feature of the 2018 Roadmap towards ending TB in children and adolescents. The availability of child-friendly TB medicines is essential to facilitate the implementation of World Health Organization recommendations on the prevention and treatment of TB in children, which in turn will contribute to reaching global targets to end TB in children and adolescents set at the United Nations high-level meeting on the fight against TB.

The Paediatric Antituberculosis Drug Optimization TB (PADO-TB) meetings provide a forum for clinicians, researchers, donors, technical partners and other key stakeholders to work together to ensure that priority paediatric formulations of TB medicines are investigated and developed.

After the first meeting (PADO-TB1) in February 2019, WHO hosted an interim review of the PADO-TB1 priorities. The meeting was attended by more than 50 experts who analysed gaps in the availability of paediatric TB formulations, discussed related paediatric research, and reviewed the list of priority paediatric TB medicines (for drug-susceptible TB, drug-resistant TB and TB Preventive Treatment) for which accelerated development and marketing are considered urgent.

In particular, meeting participants agreed to prioritize the development of a child-friendly rifapentine formulation that is flexible, can serve multiple indications and can allow dosing across age groups. This corresponds to a formulation that is suitable for TB preventive treatment (i.e. 3HP and 1HP) and for the treatment of drug susceptible TB, should shorter rifapentine containing regimens be recommended by WHO in the future for all age groups. A 150 mg scored dispersible tablet formulation was identified as the rifapentine formulation to pursue. As a result of these discussions, WHO will update the WHO Prequalification Expression of Interest to encourage the manufacture of quality-assured preparations of this prioritized formulation.

Despite recent advances, there are still major barriers to timely access for children to improved TB treatments. Reaching consensus among stakeholders on priority paediatric TB formulations is key to ensuring that researchers, funders, donors and manufacturers focus on the timely development of these formulations. PADO-TB meetings provide a unique opportunity to focus and prioritise research and development efforts on TB medicines that are most needed to treat children, aligned to WHO recommendations.