Manufacturers of heat-stable LPV/r formulations and all relevant stakeholders involved commit to:

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.

Action 24

Mylan commits to double its manufacturing capacity of LPV/r granules by Q4 2019 (to 5-6 million sachets/month)

Action 25

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.

Action 26

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.

Action 27

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

PEPFAR, MSD, and EGPAF commit to:
Action 28

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.

All GAP-f partners commit to:
Action 29

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.

Action 30

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).

Action 31

Collaborate with PAWG to offer technical advice to national ERBs to accelerate the process.