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.

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.

Commitment 25:

LPV/r uptake:

  • DNDi has received feedback on use of LPV/r pellets in the national programs in Uganda, Kenya and Malawi. It is currently working with Baylor’s College in Malawi to adapt video of administration of pellets to local context and for wide dissemination by mobile phone. 

  • DNDi is working with ICAP on feedback of recent visit in Uganda and Kenya to improve further training messages of LPV/r pellets and future introduction of LPV/r granules.

  • DNDi has worked with Baylor’s College in Malawi to adapt video of administration of pellets to local context, in local language (chichewe), for wide dissemination by mobile phone. Malawi is now transitioning to LPV/r granules.

  • DNDi is supporting the introduction of LPV/r granules in Tanzania via collaboration with EGPAF starting November 2019.

Commitment 26:. 

4-in-1 development:

  • Two 4-in-1 relative bioavailability studies in adult healthy volunteers, required for USFDA filing of the 4-in-1, started in May 2019 and were completed in July 2019. Filing expected to occur in October 2019.

  • A study with 4-in-1 in HIV-infected 3-25kg children is ongoing in Uganda to generate PK data in the target population as well as data on acceptability of the formulation. A Data Safety Monitoring Board will review data from the first 16 children in October 2019.

  • DNDi is working with Stellenbosch University (Cape Town, South Africa) and Cipla on a study to assess the pharmacokinetics of 4-in-1 in the neonatal population.

  • Starting November 2019, DNDi will collaborate with EGPAF, ICAP and EVA in 6 countries (Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroun)  to continue supporting the uptake of the LPV/r heat-stable formulations in country and to ensure smooth and rapid transition from 2-in-1 to 4-in-1 when 4-in-1 receives USFDA tentative approval.