innovative interventions from HIV activists

Important advances in the development and production of quality-certified paediatric antiretroviral drug formulations have recently been made despite significant market disincentives for manufacturers. This progress resulted from lobbying and innovative interventions from HIV 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. Waning and colleagues used information from the World Health Organization Prequalification Programme and the United States Food and Drug Administration to describe trends in quality-certification of paediatric formulations and used 7,989 donor-funded, paediatric antiretroviral drugs purchase transactions from 2002-2009 to measure uptake and dispersion of new paediatric antiretroviral drug formulations across countries and programs. Prices for new paediatric antiretroviral drug formulations were compared to alternative dosage forms. Fewer antiretroviral drug options exist for HIV treatment in children than adults. Before 2005, most paediatric antiretroviral drugs were produced by innovator companies in single-component solid and liquid forms. Five 2-in-1 and four 3-in-1 generic paediatric fixed-dose combinations 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 paediatric fixed-dose combinations 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 fixed-dose combination purchases in 2008 and 2009, respectively, but most purchases were made through UNITAID. Only three Global Fund country recipients reported purchase of these fixed-dose combinations in 2008. Prices for paediatric fixed-dose combinations were considerably lower than liquids but higher than half of an adult fixed-dose combination. Paediatric antiretroviral drug markets are more fragile than adult markets. Ensuring a long-term supply of quality, well-adapted antiretroviral drugs for children requires ongoing monitoring and improved understanding of global paediatric 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 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.