Preferred antiretroviral medicines for treating and preventing HIV infection in younger children

Report of the WHO paediatric antiretroviral working group

20 January 2008

ISBN 978 92 4 159661 9

There is an urgent need for affordable, safe, quality antiretroviral (ARV) formulations appropriate for paediatric use, particularly solid fixed dose combination (FDC) formulations to facilitate programme planning, improve adherence and accelerate the pace of ART scale up using simplified standardized treatment approaches as outlined in the public health approach of WHO. Pharmaceutical industry and regulatory authorities are requesting guidance on the range and characteristics of the required antiretroviral products, including on formulation strength for single antiretroviral products and proportions of active pharmaceutical ingredients for fixed dose combination (FDC) antiretroviral products. Recently a number of antiretroviral FDC products for paediatric use have been developed. The WHO paediatric antiretroviral working group (PAWG) initially constituted to develop dosing recommendations for the WHO Paediatric ART guidelines has since met to prioritize single and fixed dose antiretroviral formulations needed, and agree upon key research and pharmacovigilance activities that are urgently required. This is a summary report of the working group findings and recommendations from 2006-2007.