The Global Pediatric Antiretroviral Market: Analyses of Product Availability and Utilization Reveal Challenges for Development of Pediatric Formulations and HIV/AIDS Treatment in Children

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dc.contributor.author Waning, Brenda en_US
dc.contributor.author Diedrichsen, Ellen en_US
dc.contributor.author Jambert, Elodie en_US
dc.contributor.author Bärnighausen, Till en_US
dc.contributor.author Li, Yun en_US
dc.contributor.author Pouw, Mieke en_US
dc.contributor.author Moon, Suerie en_US
dc.date.accessioned 2011-12-29T23:30:23Z
dc.date.available 2011-12-29T23:30:23Z
dc.date.copyright 2010 en_US
dc.date.issued 2010-10-17 en_US
dc.identifier.citation Waning, Brenda, Ellen Diedrichsen, Elodie Jambert, Till Bärnighausen, Yun Li, Mieke Pouw, Suerie Moon. "The global pediatric antiretroviral market: analyses of product availability and utilization reveal challenges for development of pediatric formulations and HIV/AIDS treatment in children" BMC Pediatrics 10:74. (2010) en_US
dc.identifier.issn 1471-2431 en_US
dc.identifier.uri http://hdl.handle.net/2144/2647
dc.description.abstract BACKGROUND: Important advances in the development and production of quality-certified pediatric antiretroviral (ARV) formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV/AIDS activists, civil society organizations, and international organizations. Research on uptake and dispersion of these improved products across countries and international organizations has not been conducted but is needed to inform next steps towards improving child health. METHODS: We used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of pediatric formulations and used 7,989 donor-funded, pediatric ARV purchase transactions from 2002-2009 to measure uptake and dispersion of new pediatric ARV formulations across countries and programs. Prices for new pediatric ARV formulations were compared to alternative dosage forms. RESULTS: Fewer ARV options exist for HIV/AIDS treatment in children than adults. Before 2005, most pediatric ARVs were produced by innovator companies in single-component solid and liquid forms. Five 2-in1 and four 3-in-1 generic pediatric fixed-dose combinations (FDCs) in solid and dispersible forms have been quality-certified since 2005. Most (67%) of these were produced by one quality-certified manufacturer. Uptake of new pediatric FDCs outside of UNITAID is low. UNITAID accounted for 97-100% of 2008-2009 market volume. In total, 33 and 34 countries reported solid or dispersible FDC purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these FDCs in 2008. Prices for pediatric FDCs were considerably lower than liquids but typically higher than half of an adult FDC. CONCLUSION: Pediatric ARV markets are more fragile than adult markets. Ensuring a long-term supply of quality, well-adapted ARVs for children requires ongoing monitoring and improved understanding of global pediatric markets, including country-based research to explain and address low uptake of new, improved formulations. Continued innovation in pediatric ARV development may be threatened by outdated procurement practices failing to connect clinicians making prescribing decisions, supply chain staff dealing with logistics, donors, international organizations, and pharmaceutical manufacturers. Perceptions of global demand must be better informed by accurate estimates of actual country-level demand. en_US
dc.description.sponsorship United Kingdom Department for International Development; National Institute of Child Health and Human Developement (1R01-HD058482-01) en_US
dc.language.iso en en_US
dc.publisher BioMed Central en_US
dc.rights Copyright 2010 Waning et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. en_US
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_US
dc.title The Global Pediatric Antiretroviral Market: Analyses of Product Availability and Utilization Reveal Challenges for Development of Pediatric Formulations and HIV/AIDS Treatment in Children en_US
dc.type article en_US
dc.identifier.doi 10.1186/1471-2431-10-74 en_US
dc.identifier.pubmedid 20950492 en_US
dc.identifier.pmcid 2964660 en_US

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