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
2020 HIV TREATMENT
I. Focus on and accelerate research and development of priority ARV drugs and formulations for children living with HIV
WHO commits to:
1. Undertake and launch appropriate update of WHO consolidated guidelines in Q1/2 2021 to reflect approval of new formulations, including dosing recommendations as endorsed by PAWG.
2. Convene PADO5 in Q2 2021 and, in collaboration with GAP-f members, ensure rapid dissemination of its outcomes.
3. Follow generation of ongoing research and consider revision of 2nd and 3rd line recommendations, as needed, by the end of 2021.
GAP-f partners commit to:
4. Facilitate revision of the 2018 Pediatric ARV Optimal Formulary and Limited-use List for submission to the 2021 WHO EML for Children edition.
5. With the support of Unitaid, CHAI will partner with Janssen and generic manufacturers to develop and register DRV/r 120/20 mg.
6. With the support of EDCTP, PENTA will partner with Gilead and CHAI to implement the UNIVERSAL project to inform development and use of DRVr FDC and TAF-containing FDC as prioritized by PADO.
7. CHAI, with support of Unitaid, will collaborate with PENTA and Gilead to advance the development of generic versions of TAF-containing paediatric formulations.
8. Enhance collaboration and facilitate knowledge-sharing to promote development of new technologies to enhance effectiveness and acceptability of paediatric medicines.
DNDi commits to:
10. Set up a clinical study to determine in young children co-infected with HIV and TB to determine if dose adjustments are needed when the 4-in1 is used with a rifampicin-containing regimen
11. Facilitate a clinical study to determine safe and efficacious dosage of the 4-in-1 in neonates.
IMPAACT commits to:
12. A scientific agenda that focuses on PADO priorities and to undertake studies employing best practices to rapidly determine safety and dosing for new agents for infants, children, and adolescents.
13. Determine dosing and safety of DTG in newborns as well as in pediatric specific fixed dose combinations.
14. Determine safety, dosing, and acceptability of long-acting injectable ART with cabotegravir and rilpivirine in adolescents and children.
15. Accelerate work on its commitments despite the challenges posed by the COVID pandemic to ensure that optimal products are available to this vulnerable without added delay.
Unitaid commits to:
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.
Gilead commits to:
21. Using feedback from the Vatican platform to leverage best practices and make earlier changes to development plans.
22. Sharing clinical development and regulatory plans, as well as enabling generic formulations of a TAF containing pediatric fixed-dose combinations, with submission of a formulation for low-dose f/TAF with unboosted third agents for children over 2 years (14-25kg) by end 2020 and continuing to develop a formulation for 3-25kg older than 4 weeks children.
23. Fulfilling ongoing PSPs and PIPs for capsid inhibitors with collaboration and feedback from the GAP-f partners.
24. Advancing discussions with CHAI and Monell to identify a universal bitter blocker appropriate for pediatric formulations.
Johnson & Johnson commits to:
26. Ensure innovation to improve the health of children by supporting CHAI and PENTA in their commitment to accelerate development, registration and catalytic launch of DRV/r 120/20 mg optimal pediatric fixed dose combination and provide DRV API from 2021-23.
27. Support approaches that track access to pediatric patients and to continued transparency around its HIV & TB pediatric work.
28. Enhance collaboration and facilitate knowledge-sharing to promote development of new technologies to enhance effectiveness and acceptability of paediatric medicines, including long-acting injectables for infants and adolescents (Rilpivirine).
ViiV commits to:
29. Support and facilitate long-term follow up in the ODYSSEY trial, including long-term safety profile data.
30. Support the Impaact P2019 study to evaluate ABC/3TC/DTG for children under 12 years including new dispersible tablet formulation.
31. With CHAI and Unitaid, expedite development of a dispersible fixed dose combination of pediatric ABC/3TC/DTG with Aurobindo and Viatris.
32. Supporting rapid product introduction and broad access post-registration for both originator and generic versions of dispersible paediatric DTG.
The Access to Medicine Foundation commits to:
33. Include paediatric R&D and product deployment research and analysis in the next Access to Medicine Index, highlighting critical paediatric treatment R&D issues and actions pharmaceutical companies are taking to address those, by January 2021.
34. Explore additional methods of including paediatric access issues in the following editions of the Access to Medicine Index and to do so as part of the next Access to Medicine Index Methodology review process, by December 2021.
II. Expedite regulatory review of priority ARVs and formulations for children
ViiV commits to :
40. Through novel collaborative approaches, enable marketing authorisation applications in target NRA countries (Botswana, Malawi, Namibia and Zimbabwe) in parallel to the EMA assessment to accelerate national registration of DTG 5mg dispersible tablets
41. Utilise the WHO CRP process in other African countries to enable quickest possible registration of DTG 5mg dispersible tablets.
III. Introduction, Uptake, Procurement and Monitoring
Pharmaceutical companies, donors, and GAP-f partners commit to:
43. Through PENTA and IAS CIPHER, work together to develop an enhanced monitoring and safety data platform for new and existing paediatric ARV drugs.
44. Convene or participate in a series of virtual consultations of key stakeholders in 2020-2021 to develop a model and mobilize resources for the platform.
Johnson & Johnson commits to:
45. In collaboration with EGPAF and other key partners, broaden the impact of the New Horizons Advancing Pediatric HIV Care Collaborative (NHC). The NHC currently provides support to its participating countries with health systems strengthening and access to Darunavir (DRV) & Etravirine (ETR) through donations (from Johnson & Johnson subsidiary Janssen Products LP). Starting in 2021, these two pillars of the program will be enhanced through further expansion of 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. Johnson & Johnson and the NHC team commit to seek additional stakeholders to support the expansion of these critical initiatives.
46. Continue to work with PEPFAR on catalytic procurement of DRV 75mg for children in the developing world.
ARV manufacturers commit to:
48. Guarantee transparency on current and anticipated capacity of all generic formulations listed in the optimal formulary and limited use list as well as notification to APWG within one week of all anticipated supply disruptions.
Unitaid commits to:
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.
PEPFAR commits to:
52. Support DTG global roll-out plan in collaboration with GAP-f partners by placing orders to enable early procurement of the DTG 10mg dispersible tablet formulation to ensure early and widespread roll-out.
53. Provide additional support for country programs to transition, including wastage of legacy products (e.g., NNRTIs) and funds to procure optimal formulations including pediatric DTG, and as needed, LPV/r fomulations.
Global Fund commits to:
54. Support GAP-f partners’ plan for the accelerated introduction and rollout of the DTG 10mg dispersible tablet formulation in priority countries to ensure early and wide uptake.
55. Support stakeholders involved in accelerated introduction and rollout of the 4-in-1 formulation as an alternative regimen for young children.
EGPAF commits to:
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.
ICAP commits to:
60. Collaboratively scale-up optimal pediatric antiretroviral multi-month dispensing and to contribute to the development tools, materials, and guidance to enhance home-based case management and support for ART.
61. Support select countries to rapidly complete the transition to currently available optimal pediatric ARVs (LPV/r and DTG 50 mg) and accelerate the scale-up of new pediatric ARV formulations as they become available in country.
62. Continue the collaboration with DNDi, EGPAF and EVA to develop resources for the introduction of the 4-in-1 including trainings, webinars and country specific technical assistance.
UNICEF commits to:
68. Expand the demand for optimal paediatric ARVs in Western and Central Africa, increasing coverage of ART from 24% to 30% by adding 3,000 children on treatment by end of 2021 through enhanced case identification of children and expanded provider capacity.
69. Through dialogue and negotiation with manufacturers to implement flat pricing for pediatric drugs and to issue voluntary licenses or commitment to non-enforcement of patents with respect to pediatric ARVs.
70. Support national governments to implement targeted and differentiated services deliveries for children and adolescents anchored in continuous quality improvement through the rollout of the service delivery framework.
Faith Based Organizations commit to:
71. Equip, mobilize, and support faith leaders, FBOs, people in places of worship, and the wider community to create awareness of the importance of HIV testing of infants and children of people living with HIV. Demand that national school curricula include scientifically appropriate information on HIV prevention, testing and treatment.
72. Combat stigma and discrimination among faith leaders and within communities of faith around HIV prevention, testing and treatment. Create demand for client-centered and stigma-free care within health facilities as well as access to community-based treatment.
73. Further collaborate and coordinate community mobilization, education and outreach to find otherwise hard-to-reach children, adolescents, youth and adults for age appropriate prevention education, testing, and linkage to and continuity of treatment, health, psycho-social and spiritual support services and integrate into the national system.