Accelerating access and scale-up of optimized antiretroviral therapy in low-income and middle-income countries: results of a coordinated end-to-end approach.

The global HIV community invested in multiple, high-profile partnerships and shepherded unprecedented political support to expedite the transition to dolutegravir (DTG)-based regimens. The goal? To accelerate access to simpler, safer, more robust, and more affordable HIV treatment by harnessing the collective power of scientists, regulators, drug companies, donors, implementers, advocates, and people with HIV (PWH). The inspiration? End-to-end approaches to introducing new products that mitigate risk and encourage early planning and resource allocation for all aspects of product introduction and preparation for scale-up. This approach of planning with the 'end-in-mind' - and the belief that this end-to-end mindset can facilitate healthy markets, catalyze the application of new health technologies, and accelerate the development of improved products - is increasingly being applied across HIV prevention, care, and treatment (e.g. for biomedical prevention), and across health sectors (e.g. in maternal and child health, food security and water, and sanitation). This review of antiretroviral treatment (ART) optimization efforts from 2015 through 2020 discusses what worked, what is next, and how the learnings from HIV treatment can inform the broader global health community looking for innovative partnership models to accelerate adoption and enable scale-up of promising new products and programs.

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.

INTRODUCTION: Despite 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. DISCUSSION: The 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. CONCLUSIONS: GAP-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.