HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
47. Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards.
48. Support broader uptake of new sample types for laboratory systems and multiplex testing to improve cost efficiencies.
49. Support case-finding through contact tracing and testing, including at the community level.
47. Worked with MoH in Unitaid-funded POC EID project countries to ensure transition to national management and new funding sources. Funding now secured in almost all project countries.
13. Work with civil society, communities, governments and multilaterals to scale up access to POC EID through advocacy and technical leadership.
14. Work with governments, FBOs, and health care workers to implement evidence-based strategies for pediatric HIV case finding, especially for older children, and increase demand through community-led education to ensure that all children along the continuum of care are reached.
15. Optimize POC EID by promoting integrated disease testing for childhood HIV and TB on the same platform.
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50. Through its Unitaid-funded project CAP-TB, improve pediatric TB care, finding more children with latent or active TB, and putting them on appropriate treatment. This includes improving the increased access and use of TB preventive Treatment in the high-risk population of child contacts <5 and CLHIV.
Commitment 50:
June 2022
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The revised WHO pediatric TB guidelines and handbook were launched by WHO on March 21, 2022. CaP TB was very active in providing support and information to the revision of those guidelines. Project evidence – including preliminary evidence from the INPUT and CONTACT studies – was shared with the guideline development committee. Additionally, lessons learned and case studies were shared with the team in charge of developing the chapter on models of care of the operational handbook that was developed in parallel to the revised guidelines. Finally, the Technical Director of the project was part of the external reviewers for these guidelines.
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Finding has been shared with key stakeholder. In Kenya dissemination meetings were done at county level in April and May. A scientific conference will be held in Uganda on June 30th, and in Cameroon on July 6th and 7th.
March 2022
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The CaP TB project is coming to an end. The project has shown impact of innovative models of care on childhood TB, through decentralization and integration of services. A recent policy assessment showed an improvement in the childhood TB policy landscape compared to 2018 in the 10 countries assessed. It stresses the importance of Political leadership and advocacy to ensuring specific budget lines, the inclusion of childhood TB targets within countries’ national plans and highlights policy gaps on TB screening, diagnosis, prevention and treatment. As the project ends, new evidence on impact of decentralization, case management is being developed and will be out very soon.
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The project contributed to the revision of the WHO pediatric TB guidelines. And lessons learned and case studies are informing the chapter on models of care of the operational handbook that is developed in parallel to the revised guidelines. EGPAF looks forward to the launch of both the guidelines and operational handbook by WHO during the WTB Day.
October 2021
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Through our Unitaid-funded project CAP-TB, we are finalizing a childhood TB policy landscape in nine African countries and India. This includes the revision of more than 100 indicators in seven areas, including case finding, diagnostics and treatment, including TPT. The results are being discussed with NTPs in the ten countries, and they will be publicly available in the coming weeks. This policy assessment is aimed at looking at the policy changes between 2019 and 2021 but also identify gaps and opportunities to improve the childhood TB policy landscape and preparedness.
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Besides that, EPGAF supported the introduction of 3RH for children in Cameroon, DRC, Kenya and Zimbabwe; and plays an active role to accelerate the revision of guidelines to allow for the use of shorter TPT regimen in all project countries.
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Finally, we are sharing our evidence gathered from the CaP TB project regarding acceleration of TPT will be shared in the up-coming Union conference.
56. Through the Unitaid Optimal grant, accelerating access to optimal pediatric ARVs for children, including DTG 10 mg dispersible tablets, across focal countries.
58. Support MOHs to accelerate the introduction and roll out of optimized formulations in at least 6 countries: Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroon.
59. Support health system strengthening and access to DRV and ETR as part of the New Horizons Advancing Pediatric HIV Care Collaborative (NHC) supported by J&J. This will be achieved through technical assistance in identifying and managing HIV treatment failure in children and adolescents, capacity building, evidence generation, supply chain management, and support for harmonized TB co-infection screening.
Commitment 56:
June 2022
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Cote d'Ivoire, Eswatini, Lesotho and Mozambique are currently rolling out pDTG 10mg for children <20kg. They expect to transition 90% of eligible children by July 2022.
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By the end of March 2022, Cote d’Ivoire, Eswatini and Mozambique had transition more than 60% of eligible children to pDTG in (82% in Cote d’Ivoire, 92% in Eswatini, and 61% in Mozambique). Lesotho began transitioning eligible children to pDTG in April 2022. All four countries expect to complete transition of at least 90% of eligible children to pDTG by September 2022.
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All four countries have reported difficulties with dispensing 90-count bottles of pDTG to children 3kg to 10kg, because the size of the package represents a two- to six-month supply of ARVs for children in this weight range, and national policies do not recommend multi-month dispensing for children under 2 years old. To address this challenge, in April the Global Accelerator for Pediatric ARV Formulations (GAP-f) released guidance for national programs (https://www.pedaids.org/wp-content/uploads/2022/05/2022GapfDTGGuidance_English.pdf), and in June 2022 EGPAF published guidance and algorithm that can be adapted at country level for following up children after starting on or switching to pDTG (https://www.pedaids.org/resource/guidance-and-algorithm-for-follow-up-of-children-after-starting-or-transitioning-to-paediatric-dtg-10-mg-based-art-dispensed-in-90-tablet-bottles/)
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In addition, all four countries are facing challenges in maintaining adequate supplies of low-volume pediatric ARV products, such as LPV/r granules for second-line and alternative treatment, and AZT/3TC as a second-line backbone. Following a presentation on this topic by EGPAF and DNDi to the global ARV procurement working group (APWG) annual meeting in March 2022, the APWG formed a tasks team to explore ways to support countries in ensuring access to the full range of WHO-recommended pediatric ARV formulations. EGPAF also published guidance on quantification and supply planning for the full range of WHO-recommended pediatric ARVs (https://www.pedaids.org/resource/ensuring-access-to-the-full-range-of-who-recommended-optimal-pediatric-antiretroviral-regimens/)
March 2022
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Cote d'Ivoire, Eswatini, Lesotho and Mozambique are currently rolling out pDTG 10mg for children <20kg. They expect to transition 90% of eligible children by July 2022.
October 2021
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Through the Unitaid Optimal project, EGPAF supports the government in Cote d'Ivoire, Eswatini, Lesotho and Mozambique in the transition to DTG 10 mg scored dispersible tablets. Two countries began transitioning children under 20kg to Pediatric DTG 10 mg in June/July 2021. And the two other countries are planning to transition in 2022. We are collaborating in all four countries in the guidelines review, as well as a number of other key activities, such as updating essential medicines lists, developing and implementing a pDTG transition plan, strengthening DSD models for children, as well as PSM and pharmacovigilance for pediatric ARVs.
Commitment 58:
June 2022
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Kenya, Uganda and Tanzania are introducing pDTG 10mg for children under 20kg. The LPV/r 4-in-1 formulation is still not approved by US FDA. DNDi supports Senegal, Burkina Faso and Cameroon.
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The LPV/r 4-in-1 fixed-dose combination granule formulation (ABC/3TC/LPV/r), for children weighing less than 20kg, is still awaiting approval from US FDA. The US FDA inspection of the Cipla manufacturing facility in Goa, India has been delayed for over a year. Meanwhile, in June 2022, the South African Health Products Regulatory Authority (SAHPRA) approved LPV/r 4-in-1 for use in the country.
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Kenya, Uganda and Tanzania included LPV/r granules in their national guidelines for second-line and alternative regimens, but did not mention the LPV/r 4-in-1 formulation specifically in the guidelines. All three countries are finalizing updates to national guidelines to include pDTG 10mg. Kenya began transitioning eligible children to pDTG in July 2021, Uganda started in October 2021, and Tanzania in June 2022.
March 2022
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Kenya, Uganda and Tanzania are introducing pDTG 10mg for children under 20kg. The LPV/r 4-in-1 formulation is still not approved by US FDA. DNDi supports Senegal, Burkina Faso and Cameroon.
October 2021
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EGPAF supported Tanzania in its successful transition of all CLHIV under 20kg on first-line treatment to LPV/r granules; and supported two countries (Uganda and Kenya) to transition to LPV/r pellets.
Commitment 59:
June 2022
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EGPAF's work under New Horizons collaboration launched the campaign on disseminating the technical tools for the introduction of the generic 400/100 mg DRV/r for the second- and third-line line into national guidelines (discussing with MOH, assisting with national guidelines revision). The collaborative held a successful virtual Technical Workshop in November 2021 and continued to deliver TA to country participants on the optimization of the second- and third- line ART for children and adolescents. The corresponding study funded by J&J has analyzed the resistance profiles for children and youth receiving DRV/r-based ART and the manuscript is in final stages for submission. Collaborative supported technical south-to-south exchange between Uganda and Nigeria MOH on the national drug resistance databases and treatment working groups with focus on pediatric and adolescent populations. The most recently added country member Republic of Congo has established the platform for national treatment working group discussions and is scheduled to launch them in July 2022.
March 2022
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On New Horizons agenda EGPAF continues to work with countries to advance TA and eventually setting up the stage for some TB work and introduction of generic DRV/r once it becomes available.
October 2021
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New Horizons stage 2, supported by J&J, was successfully launched in July 2021 with expanding EGPAF’s role as an implementor going forward. The landscape of DRV (donated product) is changing quickly and the generic formulation is very close to be introduced to the countries: in adults within 1-2 years and then children in ~2-3 years. EGPAF is very well positioned to support this transition.
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:
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Development of healthcare workers’ training tools based on implementation research data generated by DNDi; and
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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.
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.
Commitment 26
ICAP is developing training tools, EGPAF is reviewing and providing feedback.
With support of Unitaid and DNDi, working in 8 countries on scale-up of LPV/r 2-in-1 solid formulations and DTG 50mg and new dispersible DTG products
Commitment 28
Working with CDC, CRS, Zimbabwe MoH and Merck to introduce RAL granules for use among neonates.
Action 22. Support the early adoption of priority formulations and diagnostics and take steps to facilitate their wider roll-out, including by developing introductory guidance, materials, and other tools for health facilities.
Action 27: Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 27: Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 29: Promote uptake by mobilizing their networks of hospitals and community structures to distribute paediatric medicines in hard to reach places and in situations of conflict and crisis.
Action 34: Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Action 37. Take responsibility for monitoring implementation of the Action Plan and holding actors to account, including monthly calls of principals, tracking progress towards milestones, and regularly communicating with participants about progress on their commitments and overall implementation of the Plan.
Action 38. Develop a set of milestones in 2018 to highlight progress on the Action Plan and establish opportunities for stakeholders to take on more specific commitments.
Action 41. Organize a follow-up meeting focused on diagnostics for children in Q1 2018.
Action 22
GAP-f partners have been discussing with ViiV and regulatory authorities to determine the best regulatory pathways for pediatric DTG (10 mg scored and 50 mg scored tablets) and ways to accelerate registration and introduction of DTG and RAL at country level.
EGPAF and CHAI are beginning preparations for introduction of DTG and RAL (EGPAF), including production of a DTG introduction toolkit. DNDi is working with in-country partners on expand uptake of LPV/r solid formulations for the roll-out of introductory materials.
Action 37
Chairs of the AIDS free working group regularly update all stakeholders about the implementation of the action plan via email.
Notes: For updated information on communication please view update section of the website.
Project management team, active since December 2017 (WHO, EGPAF, PEPFAR, WCC-EAA). Project management team regularly reaches to stakeholders to gain updates and promote progress on the commitments.
Notes: Sub-action completed
For regular updates see updates section in the website. First webinar took place on 24 April 15:00-16:30 CET. Second webinar scheduled to take place 17 October 14:30-15:30 CET. Regular calls of the AIDS Free working Group partners helped to advance the Action Plan and review progress.
Action 38
Set of milestones to highlight progress on the action plan, available on https://www.paediatrichivactionplan.org/. Tracker website: https://www.paediatrichivactionplan.org/. Progress Report on Implementation Rome Action Plan (June 2018) available in Updates and Library sections. First webinar scheduled took place 24 April 2018 15:00-16:30 CET. Second webinar scheduled to take place 17 October 2018 14:30-15:30 CET.
Concept Paper developed and planning ongoing.
Action 41
WHO, EGPAF, PEPFAR and WCC-Ecumenical Advocacy Alliance (WCC-EAA) have begun discussions on more additional meetings on pediatric diagnostics in Q1 and Q2 of 2018; and about a high-level dialogue on diagnostics in december 2018.
Notes: Diagnostics concept paper prepared. To be discussed amongst AIDS Free partners.
Pre-AIDS 2018 joint meeting with manufacturers, partners, and countries. Hosted by WHO, EGPAF and AIDS Free Partners.
Rome 4: High Level Dialogue Vatican 6-7 December 2018
109. Through its Unitaid-funded project CAP-TB, improve pediatric TB care, finding more children, and putting them in treatment, including improving the increased access and use of TB preventive Treatment in the high risk population of child contacts < 5 and CLHIV.
119. Advocate for and support Ministries of Health to rapidly transition to optimal paediatric formulations as outlined by the latest WHO guidelines, provide coordinated support for the development and implementation of transition plans, inform clinicians and patients of the value of transitioning to new formulations, and ensure communication of reliable information on the availability of new formulations in-country.
120. Support the scale up of access to priority formulations and diagnostics and take steps to facilitate their wider roll-out, including by performing operational research, developing introductory guidance and education, materials, and other tools for health facilities and local community health structures.
121. Promote the revision of national procurement plans to align with WHO recommended regimens and the EML-C, and support the provision of reliable forecasts and the consolidation of orders.
122. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to TB diagnosis and treatment among children in close collaboration with other stakeholders.
123. Raise awareness in local, national, and global fora about the unmet diagnostic and treatment and prevention needs of children with or at risk for TB.
124. Foster and more actively participate in coordinated and collaborative advocacy to:
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Increase funding for TB research & development, introduction and scale-up of priority paediatric drugs and formulations;
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Accelerate regulatory processes for rapid adoption and uptake of optimal paediatric TB drugs and formulations; and
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Ensure sustainable access to optimal TB testing and treatment for infants and children.
125. Tackle the TB stigma and discrimination in communities, schools, and healthcare settings that prevent children and adolescents living with TB or at risk of TB from accessing testing and treatment, including promotion of awareness of the difference between infection and disease and include messages of hope regarding treatment of both HIV and TB.
126. Promote uptake by mobilizing their networks of hospitals and community structures to distribute paediatric medicines in hard to reach places and in situations of conflict and crisis.
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