Abstract
The global HIV response aims for widespread availability of affordable, quality-assured long-acting antiretroviral (LA ARV) drugs to achieve sustained epidemic control, particularly in low- and middle-income countries. This report summarizes key discussion points, findings, and outcomes from an international workshop on generic LA ARVs, held in Liverpool, United Kingdom, and co-organized by the Long-Acting/Extended-Release Antiretroviral Resource Program (LEAP) and the Centre of Excellence for Long-acting Therapeutics (CELT). The workshop brought together experts from across disciplines to evaluate the multifaceted challenges and opportunities for faster development and regulatory approval of affordable and accessible generic LA ARVs. Key topics included the application of novel pharmacokinetic end points to reduce study duration, the integration of community preferences into practice-based research in resource-limited settings, intellectual property considerations, formulation and manufacturing complexities that affect cost, scalability and implementation, and the growing role of model-integrated evidence in streamlining bioequivalence assessments. To reach the goal of timely and equitable global access to long-acting medicines, this workshop emphasized the need for strategic public-private engagement to promote data sharing, enhance regulatory efficiencies, and develop robust in vitro-in vivo correlation strategies that meet regulatory guidance for LAI products.