Anti-TB drug could offer new hope for TB patients with limited treatment options
Today the Ministry of Health and the United States Agency for International Development (USAID) announced that a new treatment for multidrug-resistant tuberculosis (MDR-TB), Bedaquiline, is available in Swaziland via a donation program through USAID and Janssen Therapeutics, Division of Janssen Products, LP (Janssen), an affiliate of Johnson & Johnson. This announcement follows a December 2014 agreement between USAID and Janssen Therapeutics to help address the global health threat of multidrug resistant tuberculosis.
MDR-TB is a global public health concern that infected approximately 480,000 people worldwide in 2014. The treatment of MDR TB is much more complex than non-drug resistant TB, with higher treatment costs, a longer treatment time, potentially severe side effects, and an increased treatment failure. In Swaziland, the TB incidence rate is 733 per 100 000 people and the MDR TB prevalence is 7.7%. Among newly infected cases, 407 patients were placed on MDR TB treatment in 2014 with a treatment success rate of 58%, and 50 patients have extensively drug-resistant tuberculosis (XDR-TB).
The Principal Secretary in the Ministry of Health at a breakfast meeting with donors and TB professionals and partners said that access to Bedaquiline “marks one of the key successes in the Ministry’s endeavors to protect public health,” as it will help reduce deaths from TB—currently one of the leading causes of mortality in Swaziland. Following treatment successes in the initial phases of clinical trials, the medicine has been approved for use by the United States Food and Drug Administration (FDA) in 2012 and the European Medicines Agency (EMA) in 2013. Bedaquiline is used in countries such as South Africa with good treatment outcomes.
“For the first time in over 40 years, we have new hope for patients for whom current treatment options have stopped working,” says Mr. Themba Dlamini, program manager for the National TB Control Programme.
With support from a USAID funded initiative, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program, Bedaquiline will be used in four treatment sites in Swaziland including the National TB Hospital, Matsapha Comprehensive Care, Nhlangano Health Centre, and Mankanyane Government Hospital. Eligible XDR and MDR-TB patients will be treated with Bedaquiline over a period of six months, in combination with other TB medicines, under closely monitored conditions by healthcare professionals.
Based on the initial donation, it is estimated that at least 120 patients in Swaziland will receive Bedaquiline over the next year, with the potential to expand access to even more patients. Under the agreement between USAID and Janssen, Janssen will contribute an estimated 30,000 courses of treatment worldwide. USAID will work with National TB programs its implementing partners to provide reasonable access and ensure appropriate use of Bedaquiline in accordance with the World Health Organization guidance. The donation program will enable appropriate and responsible introduction of Bedaquiline in more than 100 low and middle-income, Global Fund-eligible countries worldwide.
USAID is the lead U.S. Government agency that works to end extreme global poverty and enable resilient, democratic societies to realize their potential. USAID is the largest institutional donor and participant in the global TB effort, with hands-on presence in most high burden (MDR-TB) countries, and supports activities ranging from global advocacy and policy-shaping to assistance in programmatic scale-up and tool development.
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