Shortening the decade‐long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low‐ and middle‐income countries

Abstract

IntroductionDespite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower. Therefore, accelerating processes for developing and commercializing optimal paediatric drug formulations for HIV and other disease areas is urgently needed.DiscussionThe Global Accelerator for Paediatric Formulations (GAP‐f) is an innovative collaborative model that will accelerate availability of optimized treatment options for infectious diseases, such as HIV, tuberculosis and viral hepatitis, affecting children in low‐ and middle‐income countries (LMICs). It builds on the HIV experience and existing efforts in paediatric drug development, formalizing collaboration between normative bodies, research networks, regulatory agencies, industry, supply and procurement organizations and funding bodies. Upstream, the GAP‐f will coordinate technical support to companies to design and study optimal paediatric formulations, harmonize efforts with regulators and incentivize manufacturers to conduct formulation development. Downstream, the GAP‐f will reinforce coordinated procurement and communication with suppliers. The GAP‐f will be implemented in a three‐stage process: (1) development of a strategic framework and promotion of key regulatory efficiencies; (2) testing of feasibility and results, building on the work of existing platforms such as the Paediatric HIV Treatment Initiative (PHTI) including innovative approaches to incentivize generic development and (3) launch as a fully functioning structure.ConclusionsGAP‐f is a key partnership example enhancing North‐South and international cooperation on and access to science and technology and capacity building, responding to Sustainable Development Goal (SDG) 17.6 (technology) and 17.9. (capacity‐building). By promoting access to the most needed paediatric formulations for HIV and high‐burden infectious diseases in low‐and middle‐income countries, GAP‐f will support achievement of SDG 3.2 (infant mortality), 3.3 (end of AIDS and combat other communicable diseases) and 3.8 (access to essential medicines), and be an essential component of meeting the global Start Free, Stay Free, AIDS Free super‐fast‐track targets.

STACKing the odds for adolescent survival: health service factors associated with full retention in care and adherence amongst adolescents living with HIV in South Africa

“…Health systems face multiple fiscal, logistic and operational challenges in ensuring supply chain reliability and availability of paediatric formulations, and enormous progress has been made in South Africa in a rapid time . Initiatives such as the Global Accelerator for Paediatric Formulations (GAP‐f) have the potential to support state services across the region .…”

Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children

“…1 Worldwide, children under the age of 15 make up approximately 5% of all people living with HIV, 9% of all new HIV infections and 14% of AIDS-related deaths. 2 Early and prompt antiretroviral therapy (ART) influences morbidity and mortality in people living with HIV, 3,4 and there is an urgent need for optimal and age-appropriate antiretroviral pediatric formulations. 5,6 UNAIDS proposed 90-90-90 and Fast-track's 95-95-95 targets to reach HIV epidemic control are the central pillars for treating HIV worldwide.…”

Immune Dysfunction and Antiretroviral Therapy Challenges in Children and Adolescents Living with Human Immunodeficiency Virus

“…• The Global Accelerator for Paediatric Formulations (GAP-f), a new mechanism working to support and formalise collaboration across sectors, and accelerate both upstream (strict drug regulatory authority filing and approvals, formulation development by innovators and generics, and generic manufacturing) and downstream processes (national treatment policy, management of supply chains and market uptake) to ensure that children are able to access the new optimal paediatric antiretroviral medications [26].…”