[Ip-health] Innovation but slow uptake of improved pediatric ARV formulations

Waning, Brenda bwaning at bu.edu
Sun Oct 17 11:52:33 PDT 2010

Dear All,

BMC Pediatrics today published a new study describing the market evolution of pediatric ARVs. The study shows that much progress has been made in the development and production of better-adapted, fixed-dose combination ARVs for children, but global uptake has been slower than anticipated. A better understanding of barriers to uptake is needed to ensure new technologies reach those in need and to ensure manufacturers remain engaged in formulating low-demand medicines. Please find the abstract pasted below, and full article available open access at:


We welcome your comments,
Brenda Waning
Abstract (provisional)


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.


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.


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 higher than half of an adult FDC.


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 low uptake of new, improved formulations outside of UNITAID and what can be done to accelerate children's access to HIV/AIDS care. A close dialogue is needed between clinicians making selection and prescribing decisions, supply chain staff dealing with logistics, donors, international organizations, and pharmaceutical manufacturers to better match country-based demand with global supply and donor policies.

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