Bedaquiline effective, safe, manageable across wide range of settings, five-continent data show

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Data on patients treated with one of the two newest tuberculosis medicines in 15 countries across five continents show that the treatment, which represents a last resort for hundreds of thousands of people with drug-resistant strains of disease, can be administered safely in a wide range of settings, and bring greatly improved outcomes compared to patients without access to the medicine, according to a recent study.

Researchers examined records of 428 patients treated with bedaquiline, at 25 facilities across Africa, Asia, Europe, Oceania and South America in what they say is the largest study of the drug’s safety, acceptability and effectiveness, and the first report of drug’s use in five continents outside of clinical trials. The drug, developed by Janssen pharmaceutical company and marketed as Sirturo, represented the first new approach to tuberculosis treatment when it was approved by the U.S. Food and Drug Administration at the end of 2012. Approval of bedaquiline for patients with tuberculosis that did not respond to previous existing treatments was followed by approval of delamanid, developed by Otsuka pharmaceutical company and sold as Deltyba, but access to both has been limited, with regulators in countries even with high burdens of drug-resistant disease voicing concern about whether their health systems could safely administer the drugs, and with the companies voicing concern that if the drugs weren’t well managed or well tolerated, new strains of resistance would develop and the new drugs would cease to be effective.

But, researchers found, side effects were manageable, and treatment completion rates for patients treated with regimens that included bedaquiline — in Argentina, Australia, Belarus, Belgium, Greece, India, Italy, the Netherlands, Peru, Portugal, Russia, South Africa, Spain, Sweden and then United Kingdom — compared favorably with those of patients treated with regimens without the drug. In addition, outcomes for patients treated with the drug were significantly better, with treatment success — cure and completion — for a little more than 71 percent of the patients with extensively drug-resistant, or XDR-TB, compared to a 43 percent success rate for XDR-TB patients treated without bedaquiline whose outcomes were tracked in an earlier study.

“What we’re seeing is that the time for reluctance to use these drugs is well past,” said Erica Lessem of the Treatment Action Group, which has strongly urged accelerated and wider access to the medicines.

The World Health Organization estimates that more than half a million people needed treatment for drug-resistant tuberculosis in 2015 and at least a quarter million people died of the disease.

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