Jointly agree upon and execute next steps to optimize the availability and delivery of these formulations in 2019 including:
Timely and regular information sharing (including orders placed and timelines for deliveries)
Providing best possible demand forecasts
Collaborate on the optimization of limited supply within and among countries and joint prioritization among orders to ensure sustainable supplies to children once initiated
Support product uptake at country level
Regulatory filings as needed to support scale-up, timely responses to queries raised during the review, and implementation (re-validation as required) of post approval changes at risk during the review period.
Mylan commits to double its manufacturing capacity of LPV/r granules by Q4 2019 (to 5-6 million sachets/month)
DNDi commits to continue supporting efforts to improve sustainable in-country access to 2-in-1 LPV/r by providing technical support on use of LPV/r pellets and granules through collaboration with Unitaid, APWG, other GAP-f partners, PEPFAR, MoHs, and HIV stakeholders in country.
DNDi, ICAP, and EGPAF commit to collaborate on product uptake for solid oral dosage forms of LPV/r (2-in-1’s and 4-in-1), including:
Development of healthcare workers’ training tools based on implementation research data generated by DNDi; and
Acceleration of product uptake in selected countries with engagement of all stakeholders including MOH, civil society, FBOs, and communities of people living with HIV, and to share the training toolkit and experience by disseminating information globally.
UNICEF commits to collaborate with GAP-f partners to develop, test, and disseminate training tools for treatment initiation with LPV/r and other optimal pediatric formulations
Partner on the assisted introduction of RAL granules for neonates, starting with the MoH of Eswatini, followed by other countries beginning early 2019, donating sufficient supplies at the outset of the project and then selling at no profit in low income and sub-Saharan African countries to ensure sustainability of the initiative.
Sustain and strengthen collaboration among relevant stakeholders to ensure the most efficient development and uptake of optimal paediatric ARV formulations, in close consultation with the community of people living with HIV.
With the support of Unitaid, provide visibility on the demand for formulations in the pipeline (LPVrsolid formulations, DTG 10 mg scored DT, RAL granules and RTV 25 mg).
Collaborate with PAWG to offer technical advice to national ERBs to accelerate the process.