PEPFAR has not undertaken any specific actions in this area but is working with the GAP-f and PAWG to determine where such support is needed to advance priority pediatric drug development. We are looking at opportunities to support practical studies evaluating program experiences with introduction of raltegravir granules for newborns and young infants.
PEPFAR has also been working directly with originator manufacturers (Merck, ViiV, J&J) on their plans to be the direct supplier of optimal pediatric ARV products to in PEPFAR-supported HIV programs until those products are available from other sources.
CHAI is funding generic manufacturer development of pediatric DTG products.
Support and fund clinical and implementation research to inform development and approval as well as use of paediatric formulations included in the PADO list.