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2022 Rome Action Plan on Paediatric HIV & TB



GAP-f partners commit to:

253. Sustain and strengthen collaboration among relevant stakeholders to ensure the most efficient development and uptake of novel paediatric ARV formulations, in close consultation with the community of people living with HIV.

254. Collaborate with PAWG to offer technical advice to national Ethics Review Boards to accelerate the process of ethical approval in high burden countries contributing to key paediatric clinical trials.

255. With Penta and IMPAACT scientific leadership, rapidly develop and implement research actions (including carrying out specific studies to generate high quality evidence for regulatory submissions and high-quality pharmacovigilance studies where needed) to accelerate access to

innovative, high quality, and affordable drugs for children worldwide.

256. By the end of 2025 and with the support of EDCTP, Penta will partner with Gilead and CHAI to implement the UNIVERSAL project to inform development and use of DRV/r FDC and TAFcontaining FDC as prioritized by PADO.

257. With CHAI leadership and the support of Unitaid, partner with Janssen and generic manufacturers to develop and register paediatric DRV/r 120/20 mg tablet by mid-2024.

258. CHAI, with support of Unitaid, will collaborate with PENTA and Gilead to advance the development of generic versions of TAF-containing paediatric formulations.

259. Enhance collaboration and facilitate knowledge-sharing to promote development of new technologies (i.e., Micro Array Patches and dissolvable oral films) to enhance administration, effectiveness and acceptability of paediatric medicines.

260. Identify and facilitate the most suitable financial incentive for a given product included in PADO list, possibly including one or more of the following:

i. Support to development upon timely achievement of key milestones

ii. Catalytic procurement

iii. Advance market commitments.

261. Continue to seek and direct funding to support the additional research and development required to inform development and use of PADO priority products included in GAP-f 2022-2024 business plan.

262. Continue to promote donor coordination to cover the full spectrum of activities required to ensure accelerated research, development, registration, commercialization, roll-out, and appropriate monitoring of PADO priority products.

263. With CHAI leadership, advance research on bitter sensing and bitter blockers in collaboration with Monell, Medicines Malaria Venture, and donors to identify a universal “bitter blocker” that can be used in paediatric formulations to improve palatability.

264. With Stellenbosch University leadership under the PETITE collaboration with Chang Mai University, to design and set up a platform to enable rapid investigation of neonatal PK of new antiretrovirals as well as key antibiotics and antivirals for inclusion in AHD package.

265. Design and pilot test an enhanced monitoring and safety data platform for new and existing paediatric ARV drugs, in collaboration with WHO HIV (HHS) Department.

266. Implement a coordinated plan, in consultation with the community of people living with HIV, to provide technical assistance in support of ALD and co-formulated DRV/r introduction to ensure rapid policy update and effective uptake in priority countries.

267. Carry out a critical review and identify solutions to improve stockout management and “last mile” distribution, in particular for stocks of low volume drug products (e.g., LPVr and DRV/r formulations, neonatal ARV formulations) including ways to improve forecasting, clinical and supply chain collaboration




GAP-f and partners commit to:

417. Provide a platform to support work led by key TB stakeholders in order to accelerate investigation, development, introduction and roll out of paediatric TB priority formulations when needed.

418. Promote coordination and collaboration and, mobilize resources if needed, to cover the full spectrum of activities required to ensure accelerated research, development, registration, commercialization, roll-out, sustainable access to paediatric TB priority formulations.

419. Support the CHEETA Task Force to engage with key stakeholders including donors, researchers, industry partners, regulators to accelerate paediatric clinical trials of TB drugs, including through an innovative platform trial.



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