INDIVIDUAL COMMITMENTS - 2017 TREATMENT
The US FDA committed to a number of adjustments to the regulatory approval process for paediatric formulations and to make them public on World AIDS Day:
Paediatric formulation development should begin soon after adult Phase 2-b trials and dosing selection;
Adolescents should be included in initial registrational efficacy (Phase 3) trials in adults or adolescent trials should be conducted in parallel with adults;
Studies of drugs across the paediatric spectrum of ages/weights (at least down to age 4 weeks) should be conducted in parallel rather than in series (unless a particular product has a specific safety or drug disposition factor that warrants a different approach).
Drug development studies in children should be based on weight rather than age and should align with the WHO weight bands.
PEPFAR committed to work with countries on a system of shared data and rotating locations for implementation studies; to develop a proposal for further expediting the regulatory approval process; and to fund the procurement of only optimal paediatric ARVs.
CHAI will commit full-time staff to assist EGPAF, WHO, PEPFAR, UNITAID and others to develop, coordinate and implement a detailed work plan to achieve the goals of the initiative; to assist with reaching agreements with companies, governments, donors and regulators to accelerate the introduction of optimal formulations and diagnostics for children and adolescents both short term and long term; and to work with governments and faith based organizations to scale up identification and treatment of HIV infected children and adolescents in the target countries.
UNITAID will continue to invest in development and rapid introduction of priority products for infants and children.
Gilead committed to having clinical data ready for a low-dose TAF based regimen for children 2-12 years by late 2018/early 2019.
Merck & Co., Inc., is committed to make pediatric Raltegravir available at no profit in low income, least developed countries and across Sub-saharan African countries until generics are available.
ViiV Healthcare committed to deploy people, resources and technical expertise to speed up as much as possible the generation of data for regulatory approval of medicines for children living with HIV, including the ongoing development of Dolutegravir for children.
ViiV Healthcare committed to make paediatric Dolutegravir available at cost of production in low income countries, least developed countries and across Sub-Saharan African countries until generics are available.
Cipla committed to scale-up production of Lopinavir/Ritonavir (LPVr) pellets to 30,000 bottles per month in 2018 and to submitting the new “4-in-1” (ABC/3TC/LPV/r) pellets in 2018.
Mylan committed to submitting LPV/r granules for regulatory approval in 2017; “4-in-1” (ABC/3TC/LPV/r) granules in 2018; and a paediatric ABC/3TC/DTG formulation in 2019, subject to the WHO providing paediatric DTG dosing guidance in early 2018.
The Global Network of People living with HIV (GNP+) committed to mobilize their networks, in particular women living with HIV, to increase demand generation, advocacy, and monitoring to increase access to treatment for children living with HIV.
Cardinal Turkson committed the Catholic Church to mobilize their networks of both hospitals, and community structures to distribute paediatric medicines in hard to reach places and in situations of conflict and crisis.