Researchers: bedaquiline can be used safely in MDR TB patients 12 and older, and should be considered for younger children
The innovative anti-tuberculosis drug that represents a reprieve for adults whose disease does not respond to other treatments should also be made available to children aged 12 or older, according to findings from a study reported in the U.S. Centers for Disease Control and Prevention Emerging Infectious Diseases journal.
The findings, which, researchers write, indicate the drug should be considered for younger children as well, fill a gap in understanding and options for a population facing a challenging landscape in tuberculosis screening, diagnosis and treatment. Among the estimated half million people infected with multidrug-resistant tuberculosis in 2015, about 32,000 were children younger than 15, the researchers, led by Jay Achar of Médecins Sans Frontières, note. Limited efforts to find and screen children, to diagnose their disease and its responsiveness to treatments, as well as limited options for treatment all contribute to drug resistance, the authors point out. And, research has shown, the current treatment for multidrug-reistant tuberculosis delivered by injection has led to permanent hearing loss in about at least a quarter of children receiving it.
The Food and Drug Administration’s approval of bedaquiline in 2012 opened an opportunity to improve the odds for children sick with drug-resistant disease. But limited evidence of the drug’s safety and effectiveness among children, the authors write, led to “the perceived age restriction on the use of bedaquiline [that] has resulted in children failing to benefit from drugs that are being used safely and effectively in adults.” And, they note, studies needed to supply the missing evidence “have been slow to materialize.”
For this study, researchers collected data on 27 children and adolescents aged 10 to 17 treated for tuberculosis in programs in South Africa, Tajikistan, Uzbekistan, and Belarus between November 2014 and 2017. With evidence or confirmation that their disease would not respond to other regimens, they were treated with bedaquiline. While five of the 27 experienced heart rhythm irregularities associated with the use of bedaquiline in combination with other anti-tuberculosis drugs in adults, none had to discontinue the bedaquiline. By early 2017 tests indicated treatment had been successful for the 23 patients on whom data was available.
The findings indicate that the drug should be considered for use among younger children, and support recommendations from the CDC, the authors conclude.