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Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations
Author(s) -
Martina Penazzato,
Devasena Gnanashanmugam,
Pablo Rojo,
Marc Lallemant,
Linda Lewis,
Francesca Rocchi,
Agnès Saint-Raymond,
Nathan Ford,
Rohan Hazra,
Carlo Giaquinto,
Yodit Belew,
Diana M. Gibb,
Elaine J. Abrams,
David M. Burger,
Jessica Burry,
Diana F. Clarke,
Tim R. Cressey,
Paolo Denti,
Kelsey Mirkovic,
Janice Lee,
Chewe Luo,
Helen McIlleron,
Mark Mirochnick,
Lynne Mofenson,
Atieno Ojoo,
Jorge Pinto,
Natella Rakhmanina,
Nandita Sugandhi,
Marissa Vicari
Publication year - 2017
Publication title -
clinical infectious diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.44
H-Index - 336
eISSN - 1537-6591
pISSN - 1058-4838
DOI - 10.1093/cid/cix194
Subject(s) - human immunodeficiency virus (hiv) , drug development , medicine , intensive care medicine , tuberculosis , process (computing) , antiretroviral therapy , risk analysis (engineering) , drug , computer science , pharmacology , immunology , viral load , pathology , operating system
Globally 1.8 million children are living with human immunodeficiency virus (HIV), yet only 51% of those eligible actually start treatment. Research and development (R&D) for pediatric antiretrovirals (ARVs) is a lengthy process and lags considerably behind drug development in adults. Providing safe, effective, and well-tolerated drugs for children remains critical to ensuring scale-up globally. We review current approaches to R&D for pediatric ARVs and suggest innovations to enable simplified, faster, and more comprehensive strategies to develop optimal formulations. Several approaches could be adopted, including focusing on a limited number of prioritized formulations and strengthening existing partnerships to ensure that pediatric investigation plans are developed early in the drug development process. Simplified and more efficient mechanisms to undertake R&D need to be put in place, and financing mechanisms must be made more sustainable. Lessons learned from HIV should be shared to support progress in developing pediatric formulations for other diseases, including tuberculosis and viral hepatitis.

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