Action 5. Focus research efforts on optimal drugs and formulations as defined by PADO.
Action 19. Undertake studies that use weight-based dosing, enroll all paediatric weight-band groups concurrently irrespective of age, and maximize opportunities to accelerate enrollment of subjects.
PENTA and IMPAACT research networks have disseminated the Rome Action Plan to their members which is being considered for planning of future research projects.
IMPAACT and PENTA are continuing collaborative work on the P1093 and ODYSSEY studies to expedite the determination of appropriate dosing for DTG in children below 30 kg. Both studies are investigating WHO weight bands- based dosing.
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.
PENTA has been working very closely with CHAI, WHO, EGPAF and other within the GAPf framework. Plans for studies are ongoing on TAF/xTC/DTG and DRV/r FDC.
PENTA and IMPAACT contributed data to ViiV that lead to successful approval of the DTG dispersible tablet formulation by the FDA on June 18, 2020. IMPAACT, PENTA and ViiV collaborated closely with FDA to accelerate review and approval of DTG dispersible tablet formulation.
PENTA and IMPAACT completed a new modeling work which will inform the dosing estimates for the neonatal DTG protocol which is moving quickly in development.
Building on two ongoing clinical trials, performed mostly in Africa, ODYSSEY and CHAPAS-4, PENTA has initiated with the support of UNITAID & WHO sample collection, drug levels evaluations, and analyses to model DTG, TAF and FTC exposure in young children with HIV and assess the feasibility of a DTG/TAF/FTC fixed dose combination. A similar work has been initiated to support the use of DRV/r 120/20 once and twice a day for children in need for a second line regimen. In parallel, PENTA has developed the clinical research protocols necessary to assess the short- and longer-term safety (including pharmacovigilance), pharmacokinetics, and effectiveness of all components of these fixed dose combinations. This clinical research program recently received 5 years funding from the EDTCP and will start implementation early 2021. Notably, parallel to the modelling and clinical research work described above and in collaboration with PENTA, CHAI has mapped out the formulation development program that will allow generic manufacturers to produce the formulations to be assessed as well as the regulatory support necessary for accelerating approval, registration and access to these products. This program involves the originator companies that have developed the product, Gilead, Janssen and ViiV, for TAF/FTC, DRV and DTG, respectively