19. Continue supporting the pediatric diagnostic agenda as per the Plan of Action through implementing partners (including, for year 2021, CHAI) and WHO’s Prequalification Program and WHO HIV/Hepatitis/STIs department.

20. Further generate evidence on optimal deployment models, impact and cost-effectiveness of new and existing technologies.

21. Support optimal use of technologies across different laboratory tiers and disease areas (including integration with TB and coinfections/comorbidities services).

22. Support further discussions with manufacturers of relevant diagnostics products to optimize pricing and supply terms towards affordable and accessible options.

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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.

October 2020

Commitment 56: 

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.  

 

Commitment 58:

 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. 

Previous

Commitment 12:

WHO PQ support extended; WHO enabler grant support potentially extended as well.

Commitment 14:

With CHAI and UNICEF, further directed the existing grant to support a number of laboratory network optimization exercises, including in Cameroon, DRC and Zimbabwe.

Commitment 56:

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.  

Commitment 57:

No further support to in-country performance evaluations exists in Unitaid Dx grants.

Support to the integration event led by WHO (July 2019)

Commitment 58:

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.

16. Support the development of a competitive, healthy, and sustainable market for point-of-care and laboratory-based testing for TB infection and disease as well as digital x-ray technologies.

 

17. Consider increasing investments in diagnostic research and development, case-finding, and scale-up of product procurement in high TB burden countries.

 

18. Support country level roll-out of new tools for pediatric TB detection, including testing of nasopharyngeal aspirates, stool, urine, and other non-sputum specimens.

 

19. Consider support to build evidence base for product development, evaluation, and WHO guidance.

 

20. Add paediatric-specific diagnostics and associated specimen collection devices/consumables to available diagnostics catalogues.

 

21. Include TB-LAM and other urine-based lateral flow assays in procurement considerations in all countries but especially for high HIV burden countries.

 

22. Support the development of pediatric X-ray libraries to facilitate the development of machine learning algorithms for the interpretation of pediatric chest X-rays.

 

23. Support more coordinated diagnostic network strengthening and optimization exercises, led by national governments, across diseases (TB and HIV as well as other key diagnostics).

 

24. Support the development of biomarker-based tests for infants and children, as well as tests and/or testing procedures that use alternative (non-sputum-based) specimens.

 

25. Facilitate appropriate budgeting and access to quality-assured TB diagnostics at affordable prices and ensure a sustainable market and supplier accountability.

47. Supporting the TB diagnostic agenda through our grants (TB Speed – Université de Bordeaux and all consortium members and target countries, Seq&Treat – FIND, and WHO).

48. Identify and establish effective collaboration and funding support to advance the application of new technologies for delivery of improved paediatric diagnosis, using other samples than sputum, such as stools and nasopharyngeal aspirate.

49. Promote integration of different services to increase detection and treatment of children with TB.

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16. Continue supporting the paediatric agenda as per the Plan of Action through the grants with different partners (including, for year 2021, CHAI, EGPAF, Medicines Patent Pool, Research- institutions such as University of Liverpool or Stellenbosch, WHO’s Prequalification Program and WHO HIV/Hepatitis/STIs department).

17. Identify and establish effective collaboration and funding support to advance the application of new technologies for delivery of improved pediatric formulations.

18. Support GAP-f partners’ plan for the accelerated introduction and rollout of the generic DTG 10mg dispersible tablet formulation in 13 priority countries.

19. Provide funding for the development, regulatory review, and accelerated introduction of generic formulations of a TAF-containing pediatric FDC, in collaboration with Gilead, and advance on the work on DRV/r f and ALD pediatric formulation.

50. Support stakeholders involved in accelerated introduction and rollout of the 4-in-1 formulation as an alternative regimen for young children in priority countries.

51. Continue to support, with WHO and partners, the introduction of optimal ARV formulations, the roll out of a pediatric Advanced HIV DISEASE (AHD) package of care – including associated treatment literacy and training, and enhanced monitoring &safety data platform for new and existing paediatric ARV drugs.

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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.

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.

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.

Individual Commitment: UNITAID will continue to invest in development and rapid introduction of priority products for infants and children.

Individual Commitment:

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.

October 2020

  • EGPAF SPAAN has been merged into CHAI Optimal with both focusing on supporting a number of countries in the adoption of optimized pediatric ARVs, which will be available and rolled out early 2021. Further, it supports transition to more optimal regimens in view of the rapidly-evolving ARV landscape. This Unitaid-funded Optimal ARV grant has been extended to the end of December 2022.

  • Unitaid/CHAI launched an RFP on 14 September requesting proposals to accelerate access to Darunavir/ritonavir (DRV/r) the best-in-class second-line treatment for HIV in children aged 3 (>10kg) and older in low- and middle-income countries. RFP closes this week on 16 October. 

  • As a result of Unitaid/CHAI collaboration, together with industry, Generic DTG 10mg with access pricing is expected to be available by the end of November 2020. 

  • Unitaid is funding the BENEFIT kids 4-in-1 sub-study to assess the use of the new 4-in-1 formulation (ABC/3TC/LPV/r”) in HIV-exposed and infected neonates. Enrolment for the neo PK study commenced in Q3 2020.

June 2020

  • 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.

22. Support, strengthen, and expand clinical and implementation research to inform development, approval and use of paediatric formulations included in the priority list, including early PK modelling and palatability studies.

98. Supporting the TB treatment agenda through our grants (TB Speed – Université de Bordeaux, Cap-TB – EGPAF, Benefit Kids – Stellenbosch University, IMPAACT4TB – Aurum Institute, and WHO).

99. Identify and establish effective collaboration and funding support to advance the application of new technologies for delivery of improved paediatric formulations for TB treatment for susceptible and resistant TB.

100. Promote integration of different services to increase detection and treatment of children with TB.

101. Continue to support, with WHO and partners, the introduction of optimal paediatric formulations for treatment, and also preventive treatment (3RH and 3HP).

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