Individual Commitment: UNITAID will continue to invest in development and rapid introduction of priority products for infants and children.
Action 8: Support and fund clinical and implementation research to inform development and approval as well as use of paediatric formulations included in the PADO list.
Action 9: Only fund the procurement of drugs and formulations recommended by WHO that are included in the Optimal Formulary.
Action 21: Provide funding to support actions required for quickly introducing and scale-up new, optimal paediatric formulations.
WHO PQ support extended; WHO enabler grant support potentially extended as well. Other projects: in 2019 Unitaid is working on new targeted investments for pediatrics (research,product development, access and early product introduction), and extensions of our current commitments.
12. Discourage and refrain from funding national evaluation studies that would be duplicative of studies done for WHO PQ listing or SRA approval.
13. Fund impactful technologies and interventions quickly.
14. Support in a transparent manner the procurement of commodities and operational costs to maintain and further scale-up POC EID, as well as viral load testing for infants, children, and pregnant and breastfeeding women, as an integral part of optimized and integrated national laboratory networks and in accordance with national EID and VL plans and targets.
15. Support the development of a competitive, healthy, and sustainable market for POC and laboratory technologies.
16. Continue to support WHO PQ to shorten timelines for dossier review and minimize time to national registration.
56. Support the expansion of the WHO-led Collaborative Registration Process to diagnostics, and leverage existing projects in diagnostics to support the roll out of the procedure for key diagnostics.
57. Remove duplicative in-country performance evaluations from operational budgets of ongoing investments and grants.
58. Support implementing partners (including CHAI) to address outstanding barriers on diagnostics optimal uptake and scale.
WHO PQ support extended; WHO enabler grant support potentially extended as well.
With CHAI and UNICEF, further directed the existing grant to support a number of laboratory network optimization exercises, including in Cameroon, DRC and Zimbabwe.
Unitaid continues to provide support on the WHO collaborative registration procedure (CRP) for IVDs, and the pilot has been completed for the initial molecular POC product.
No further support to in-country performance evaluations exists in Unitaid Dx grants.
Support to the integration event led by WHO (July 2019)
Unitaid has extended funding for the CHAI/UNICEF Molecular grant to include support for COVID-19 diagnostics. This support will also ensure continuity of EID testing services in focal countries the context of the pandemic.
22. Incentivize commercialization of new pediatric ARV products “at risk” to accelerate introduction and scale up of new paediatric ARV product such that product is available at time of approval/tentative approval/prequalification.
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.
47. Provide financial incentives for the development of child-friendly formulations for ARVs, including DTG 10 mg dispersible tablet and LPV/r fixed-dosed combinations
48. Continue to strategically support GAP-f and the relevant participation of Unitaid-partners, and engage with Unitaid Executive Board in 2019 to explore funding new investment cases for paediatric ARV optimization and access.
21. Support catalytic procurement of all or part of initial validation batches from manufacturers such that product availability is not delayed once approval or tentative approval is achieved.
Adoption: UNITAID continues working with key partners (Global Fund, PEPFAR, …) and supporting WHO (including WHO HIV/STIs/Hepatitis department enabler grant and WHO PQ) and implementer grantees (EGPAF and CHAI) to support a number of countries for rapid adoption of the emerging products, including 4-in-1 (ABC/3TC/LPV/r) and DTG 10 mg, both coming to market in Q1 2021.
Product availability: UNITAID IS exploring to launch the paediatric DRV/r incentive program, implement the ALD market accelerator, and the launch of a new accelerator program for paediatric TAF-DTG. The 4in1 developed with DNDi, and the DTG10 mg dispersible generic tablet developed through the Optimal program, in collaboration with generic companies and ViiV, have now reached a key milestone with products’ submission for regulatory approval.
Evidence gaps : UNITAID supported DoLPHIN 2 clinical trial by the University of Liverpool was reprogrammed and extended to include an infant safety follow-up component, which is monitoring neuroinflammatory abnormalities among HIV-Exposed but Uninfected (HEU) infants whose mothers received ART. In addition, three of UNITAID supported clinical trials including DoLPHIN 2, ADVANCE and NAMSAL were extended to pool data with an aim to answer important safety questions around DTG use and weight gain and hyperglycaemia – this includes follow up on pregnancies with increased weight gain. UNITAID HAS a project with Stellenbosch University evaluating the use of LPV/r/ABC/3TC among HIV positive infants.
UNITAID is working closely with WHO, EGPAF and CHAI in developing a policy and a package of care for paediatric Advanced HIV Disease.
Commitments 47 & 48:
Considering reprogramming of grants for increase impact of grants to address new priorities in PADO4 and GAP-f funding situation. New projects under consideration, as well as reprogramming current ones, to increase impact of grants to address new priorities in PADO4 (targeted investments for research, product development, access and early product introduction).
The Unitaid grant to EGPAF has been reprogrammed and extended to focus on supporting a number of countries in the adoption of optimized pediatrics ARV. Further, it supports transition to more optimal regimens in view of the rapidly-evolving ARV landscape. This work builds upon the existing Unitaid-CHAI Optimal ARV grant.
A new grant from Unitaid has been approved in September 2019 to Stellenbosch University as part of the BENEFIT Kids project (Better Evidence and Formulations for Improved MDR-TB Treatment for Children). The pediatric HIV component considers the use of the 4in1 (LPV/r-ABC-3TC) among HIV-exposed neonates, exploring both safety and pharmacokinetics. The inclusion of the HIV infant study component responds directly to the research gaps identified at PADO4 in December 2018 on the use of LPV/r in this population.
The Unitaid Enabler grant to the World Health Organization has been expanded with an additional output focused to support pediatric ARV prioritization.