Download Report of the Meeting of the Paediatric Working Group Developing an Optimized List of Paediatric ARV Formulations, Geneva, Switzerland, May 5, 2011 Book in PDF, Epub and Kindle
"The number of paediatric options available for global programmes has increased markedly in the last 5 years with the approval of many new formulations, including child-friendly fixed dose combinations. Paradoxically, this has not increased the number of regimen options that can be given to children, only the number of dosage forms and strengths available to deliver any one particular regimen. For example, a provider who wishes to prescribe a combination of AZT, 3TC and NVP to her 5 year old patient has a perplexing range of options, including dual and triple fixed dose combinations and a number of single drug formulations, such as tablets, capsules, and syrup. The global demand for paediatric antiretrovirals (ARVs) is low, as children account for only 7% of all individuals on treatment, and when this low demand is distributed over not only the large number of products available but the numerous dosage forms and strengths as well, demand for any particular product is dramatically reduced. This can result in disruptions in supply chain and threatens the sustainability of the paediatric market. Furthermore, market uncertainty serves as a disincentive to investment into future paediatric drug research and development. In order to address this issue, the Paediatric Working Group (PWG) of the Inter-Agency Task Team on prevention and treatment of HIV infection in pregnant women, mothers and their children (IATT) met to discuss an optimal paediatric formulary to serve as guidance to national programmes, procurement agencies, funders and manufacturers. The PWG defined the criteria for optimization and then evaluated all available paediatric products against these criteria. This process resulted in three related lists: Optimal products, Limited-use products and Non-essential products. This meeting report outlines the process of optimization and presents the product list for public comment. It is recognized that this list cannot be static over time and must evolve to incorporate new formulations when these become available. The World Health Organization (WHO) and its partners within the IATT commit to a regular re-evaluation of this list in order to ensure that the recommendations continue to offer the best treatment options for infants and children living with HIV."--Executive summary.