On 31 May 2023, the 2022 Rome Action Plan for Paediatric HIV and TB was published, marking a significant milestone in the global fight against HIV and tuberculosis (TB) in children. This important document contains a series of commitments made by a group of stakeholders, including Penta, to reduce morbidity and mortality among children living with HIV and TB.
For the 2022 Rome Action Plan, partners agreed on a set of commitments focused on improving research and development, registration, introduction and roll-out of HIV and TB preventive tools, as well as diagnostics and optimal treatment for children living with these conditions. Penta made substantial commitments to the Plan, such as to:
- Establish a collaboration with the Ministry of Health of Uganda to create a data collection system that monitors the safety and effectiveness of dolutegravir in the paediatric population
- Conduct studies to examine the pharmacokinetics, safety, and virological/immunological impact of monoclonal anti-HIV antibodies combined with antiviral drugs in children responding to therapy
- Promote the use of real-world data alongside clinical trial data for regulatory purposes.
Additionally, as part of the GAP-f Network, Penta pledged to:
- Rapidly develop and implement research initiatives to speed up access to innovative, high-quality, and affordable drugs for children globally
- Collaborate with Gilead and CHAI to implement the UNIVERSAL project, with the aim to inform the development and use of Darunavir/ritonavir (DRV/r) fixed-dose combination and Tenofovir alafenamide (TAF)-containing fixed-dose combination as prioritised by the WHO Paediatric Antiretroviral Drug Optimization (PADO), by the end of 2025
- Partner with Gilead and CHAI to advance the development of generic versions of TAF-containing paediatric formulations.
The 2022 Rome Action Plan was the result of a high-level dialogue convened by His Excellency Archbishop Vincenzo Paglia, President of the Pontifical Academy for Life, and organised by the Elizabeth Glaser Pediatric AIDS Foundation, the World Health Organization, the President’s Emergency Plan for AIDS Relief, the Joint United Nations Programme on HIV/AIDS, in collaboration with the Stop TB Partnership, faith-based organisations and other global partner organisations.
This high-level dialogue, which took place in December 2022, provided an opportunity to evaluate the progress made so far in the treatment of paediatric HIV and TB, and to chart a path towards a brighter future for these children. Representatives from private and public sectors, governments, regulatory authorities, pharmaceutical and medical technology companies, civil society, faith-based organisations, and other partners, came together to strategise on ways to accelerate the research and development of safe, affordable, and effective HIV and TB diagnostics and medicines for the children who need them.
Penta’s involvement in the Rome Action Plan reflects our dedication to improving the health outcomes of children living with HIV and other infectious diseases. We acknowledge the importance of collaborations and partnerships in accelerating research for the benefit of children. Our participation in the Rome Action Plan will significantly contribute to the collective efforts to prevent, diagnose and treat HIV and TB in this vulnerable population.