1. Scale up appropriate, timely, high quality, cost-effective early infant diagnosis, using comprehensive laboratory mapping and optimized use of all available diagnostic resources, recognizing the patient benefits of Point of Care (POC) Early Infant Diagnosis (EID) for timely diagnosis and ART initiation.

2. Prioritize effective, evidence-based case-finding strategies to increase demand for testing of children of all ages and improve patient identification, including testing all children attending nutrition, TB, and inpatient wards, testing of mother-infant pairs in immunization clinics, scaling up index testing, etc.

3. Develop strategies to optimize the use of new technologies and interventions in countries.

4. Work with national regulatory authorities to streamline procedures and strengthen the use of WHO prequalification listing when considering national regulatory approval.

5. Develop more accurate, transparent, and consolidated forecasts to support manufacturing and reagent availability.

6. Support multiplexing of available diagnostic technologies across programs for more optimal utilization of available platforms and wider access to testing.

7. Work towards eliminating user fees from diagnostic and health services in the public sector.

8. Prioritize fast track national regulatory approval of EID and viral load (VL) products that have stringent international regulatory approval and/or WHO prequalification listing.

9. Accept WHO guidance suggesting countries should refrain from requiring national evaluation studies that would be duplicative, but instead adopt a rapid and streamlined registration and national approval process for EID and viral load products.

10. Prioritize the development and operationalization of collaborative regional registration schemes and take part in the collaborative registration procedure for diagnostics, to be developed by the WHO.

11. Develop and implement post market surveillance of diagnostic products.

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23. 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.

50. Accelerate transition to more optimal regimens and formulations as described in WHO Guidelines
and 2018 Optimal formulary by:

  • Developing transition plans by Q1 2019

  • Introducing DTG 50 mg for children above 25 kg by Q2 2019

  • Fully phasing out NVP based regimens by Q3 2019 in children older than 3 years and by Q2 2020 in children younger than 3 years.

  • Optimizing the use of LPVr solid formulations by prioritizing infants and children that most need them as well as using LPVr tablets as soon as a child can swallow them

  • Transitioning stable children to optimal regimens as outlined by in the WHO treatment guidelines and in the Optimal Formulary and Limited Use List

51. Increase viral load monitoring of children and ensure linkage of children failing first line drugs to 2nd and 3rd line drugs, working with donors and manufacturers to ensure availability of drugs in line with WHO guidelines.

Commitment 23

The APWG issued an updated memo on 10 January 2019 to Suppliers of paediatric LPV/r formulations, HIV program managers, and ARV logistics divisions “to provide information on global coordination efforts to ensure paediatric LPV/r formulations are appropriately distributed and utilized.” The APWG also continues to meet monthly with manufacturers and to develop a plan for increased supply by end 2019. It plans to develop a dashboard on the supply situation of LPV/r granules and pellets for the APWG website.

Commitment 50

RAL granules monitored introduction to take place in Zimbabwe as a result of work from FASTER/EGPAF, Minister of Health Zimbabwe and Merck