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TB Alliance and University of Stellenbosch Announce Launch of Study to Determine Proper TB Treatment for Babies with TB

Data will guide development of improved TB treatment for infants

March 23, 2014

TB Alliance, an international non-profit working to develop improved TB treatments, and the Desmond Tutu TB Center, an academic research center of the University of Stellenbosch, South Africa, today announced the launch of a new clinical study that seeks to determine, for the first time, the correct treatment for babies with tuberculosis (TB).

Despite the fact that TB is a top 10 killer of children, today there are no appropriate TB treatments for children. Critically, little evidence exists to guide proper treatment of TB in newborns and babies. Instead, thousands are treated each year based on guidelines for larger children, without knowing if the dosing is safe or effective.

Led by Dr. Anneke Hesseling, Director of the Paediatric TB Research Program at the Desmond Tutu TB Centre, the study will monitor the treatment of at least 30 infants receiving TB treatment. “We need to know if we’re treating babies with TB correctly,” said Dr. Hesseling. “This study is important to determine whether new guidelines and products are needed for treating the youngest and most vulnerable TB patients.”

The study is part of a larger effort, led by TB Alliance and primarily supported by UNITAID, to improve TB treatment for children with the initial goal of delivering optimized first-line TB drugs for children. Data from this study will help determine whether distinct products will be required to treat children with drug-sensitive TB that weigh 5kg and lighter.

“The goal of our pediatric TB program is to ensure that proper treatments are available for the largest number of children possible,” said Dr. Mel Spigelman, President and CEO of TB Alliance. “This study is critical in determining the path forward to meet the needs of infants with tuberculosis.”

Treatment for drug-sensitive TB children consists of four drugs administered over the course of six months, but dosing varies by weight. Treatment guidelines exist to ensure each of the four drugs in the regimen are given in proper concentrations. However, newborns and small babies don’t always process drugs the same way older children or adults do and need formulations that are suitable for them. Such dynamics suggest that a special study of the pharmacokinetic activity of TB drugs in infants is needed.

This study will be linked with a larger pediatric TB/HIV study undertaken by Helen McIlleron at the University of Cape Town. The two studies will realize efficiencies by sharing assay costs and exchanging data for additional analyses using pharmacokinetic modelling.

About the TB Alliance

The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from Australia Aid, Bill & Melinda Gates Foundation, European Commission, Global Health Innovative Technology Fund, Irish Aid, National Institute of Allergy and Infectious Disease, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration. For more information please visit www.tballiance.org.

About the Desmond Tutu TB Centre

The Desmond Tutu TB Centre is an academic research centre at Stellenbosch University, South Africa, which conducts high quality, innovative research and provides global leadership and expertise in the field of TB, including TB in children. It¹s vision is a TB-free world for the next generation.