Advocates hail South Africa bedaquiline recommendation, replacing toxic injection for patients with drug-resistant tuberculosis

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Medicine represents third choice over “deaf or dead” for many patients, health worker/tuberculosis survivor-founded organization says

Praising the treatment policy decision of South Africa health officials to replace painful injections that brought irreversible side effects to many tuberculosis patients whose disease was resistant to first line treatments with a newer medicine that had been proven effective had remained out of reach for most patients, TB response advocates are calling the move “historic,” and also hoping it is just a first step.

The medicine, bedaquiline, was the first innovative treatment for tuberculosis in nearly half a century when it was approved by the U.S. Food and Drug Administration and the European Medicines Agency in 2012, but was held out as a drug of last resort for patients with multidrug-resistant tuberculosis, and made available to only a small fraction of those. For many patients with tuberculosis resistant to first and second-line drugs, that meant that lengthy, toxic debilitating treatment regimens, including with painful injections that carried the risk of permanent hearing loss along with other lasting side effects remained the only available options.

The South Africa Department of Health cited data demonstrating that use of bedaquiline reduces deaths and serious serious side effects among patients with tuberculosis when issuing its  announcement Monday that the drug would be made available to all eligible patients resistant even to one drug, rather than the previous policy of making the drug available only to those with extensively resistant disease — not responding to first-line, as well as some second-line treatments — or those with otherwise limited treatment options.

“Not deaf or dead — a third choice for all with drug-resistant TB, thank you!” cheered a release from TB Proof, a nonprofit founded by a physician who, sick with multidrug-resistant tuberculosis, faced a choice of continued use of injected medicine that threatened her hearing — and her career, or dying of the disease until she was granted compassionate use of the still investigational drug in 2011. The decision offered further proof of South Africa’s commitment to effectively responding to its tuberculosis epidemic through patient-centered approaches, the release said. They hope, they said, that the policy indicates a promise of continued progress, including with expanded access to diagnostic tests that can detect drug-resistance, and to improved regimens with other new drugs as well as repurposed drugs.

Treatment Action Group, a leader of efforts to expand access to essential medicines where they are most needed, including through accelerated adoption of bedaquiline and delamanid, the second innovative anti-TB drug to receive approval in the last decade, called for other nations to follow South Africa’s example, and for the drugs makers Janssen/Johnson & Johnson, and Otsuka to reduce prices on their medicines so that they can be used in regimens with an overall cost of $500.

 

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