Accelerating Generic Long‐Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access
Year: 2026
Type: article
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.
DOI: 10.1002/cpt.70238
Authors: Usman Arshad, Lobna Gaayeb, Henry Pertinez, Rajith K. R. Rajoli, Melynda Watkins, Parag Nimbolkar, Simone Perazzolo, Bharat Pagi, Annemarie Wensing, Saye Khoo, Marta Boffito, René Holm, Zack Panos, Imelda Mahaka, Francois Venter, Benny Kottiri, Keith W. Crawford, Rodney J. Y. Ho, Polly Clayden, Paul Domanico, Kimberly Struble, Andrew Owen, Charles Flexner
Institutions: University of Liverpool, Centre of Excellence for Long-acting Therapeutics, Medicines Patent Pool, Clinton Health Access Initiative, University of Washington, University Medical Center Utrecht, Chelsea and Westminster Hospital NHS Foundation Trust, Chelsea and Westminster Hospital, Imperial College London, University of Southern Denmark, Children's Investment Fund Foundation, University of the Witwatersrand, United States Agency for International Development, National Institute of Allergy and Infectious Diseases, United States Food and Drug Administration, Center for Drug Evaluation and Research, Johns Hopkins University
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,410
OpenAlex ID: W7130322035