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
INDIVIDUAL COMMITMENTS - 2018 TREATMENT
32. Collaborate with WHO to house and incubate the GAP-f partnership through its start-up phase.
33. Inform all countries in the paediatric license group on the status of paediatric ARV patents.
34. Rapidly develop and implement research actions (including carrying out specific studies to generate high quality evidence for regulatory submissions and high quality pharmacovigilance studies where needed) in the framework of GAP-f to accelerate access to innovative, high quality, and affordable drugs for children worldwide.
35. Ensure appropriate evidence generation from ongoing DTG studies to enable ViiV regulatory submissions by end 2019.
36. Bring RTV 25 mg to the market, producing first batch beginning in June 2019.
37. Prioritize development of low dose F/TAF dispersible tablet and complete investigation of low dose paediatric dose for 15-25kg by end of 2019
38. Undertake a bioavailability study for dispersible tablets of F/TAF by mid-2019 and begin enrolment of children under 15kg by end 2019, using parallel enrolment of weight bands where feasible.
39. Submit LPV/r taste-masked pellets before end 2019
40. Begin development of DTG/3TC/ABC when data available to inform dosing and ratio.
41. Ensure availability of DRV paediatric formulations in LMIC countries until DRVr FDC is available, and partner with GAP-f partners to develop transition plans to generic products once the generic FDC is available (expected in Q4 2020).
42. Submit the dossier for DTG 10mg scored dispersible tablet in Q1 20201
43. Continue to work closely with FDA & EMA, IMPAACT and PENTA to strive to meet target submission date of December 2019 for DTG 5mg dispersible tablet and expanded weight band indication for 50mg.
44. Develop pediatric ARV products at a scale that will meet ultimate market demand as provided by GAP-f partners.
45. Contribute to the funding of the secretariat of the Global accelerator for 2 years, plus additional funding upon achievement of milestones.
46. Contribute to the funding of the secretariat of the Global Accelerator and its activities as outlined in the product portfolio of the GAP-f business plan
Provide financial incentives for the development of child-friendly formulations for ARVs, including DTG 10 mg dispersible tablet and LPV/r fixed-dosed combinations
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.
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.
49. Support Ministries of Health to expand paediatric care and treatment within broader MCH services
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.
52. Ensure FBO participation in local and national forecasting of optimal paediatric drug formulations.
53. Collaborate with GAP-f partners to develop, test, and disseminate training tools for treatment initiation with LPV/r and other optimal pediatric formulations.
54. Support and increase family treatment initiation and retention for children, adolescents, and
Increasing identification and provision of same-day/same-appointment mother/infant pair treatment through FBO clinics;
Promoting male/father engagement in EMTCT programmes; and
Increasing stigma reduction interventions through mobilized faith leaders and faith communities
Providing social work interventions to assist fathers to support treatment and adherence of their partners and children living with HIV.
55. Foster and more actively participate in coordinated and collaborative advocacy to:
Increase funding for research & development, introduction and scale-up of priority pediatric drugs and formulations;
Accelerate regulatory processes for rapid adoption and uptake of optimal paediatric drugs and formulations; and
Ensure sustainable access to optimal testing and treatment for infants and children.
56. Support treatment preparedness programs, ensure improvement of treatment awareness among caregivers of children of all ages and adolescents, and work jointly with other stakeholders on treatment literacy and demand creation for new pediatric formulations.
57. Advocate for and support Ministries of Health to quickly adopt and implement WHO Pediatric HIV Testing and Treatment Guidelines
58. Advocate for and support Ministries of Health to rapidly transition to optimal paediatric formulations as outlined by the 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.
59. Tackle the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment.
60. Promote awareness of, political and financial support for, and full implementation of the Action Plan among all relevant stakeholders.