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CDC issues provisional guidelines for bedaquiline
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The CDC recommends 24 weeks of treatment with bedaquiline, in addition to a minimum four-drug treatment regimen, in adult patients with multidrug-resistant tuberculosis, when an otherwise effective treatment regimen cannot be given.
It also recommends that the treatment be given only by directly observed therapy.
Bedaquiline (Sirturo, Janssen Therapeutics) was approved by the FDA last year as part of combination therapy for adults with pulmonary MDR-TB when there are no other treatments available. It was given accelerated approval based on phase 2 data.
The CDC also recommends that bedaquiline be given on a case-by-case basis to children, people with HIV, pregnant women, people with extrapulmonary MDR-TB and patients with comorbid conditions on concomitant medications. Lastly, the CDC recommends that bedaquiline can be used, on a case-by-case basis, for more than 24 weeks.
The quality of evidence for these scenarios is insufficient, but these recommendations are based on expert opinion that the possible benefits of bedaquiline outweigh the potential risk, according to the report in MMWR.
The recommended dosage of bedaquiline is 400 mg once daily for 2 weeks, followed by 200 mg three times a week for 22 weeks. Patients should be monitored weekly for nausea, headache, hemoptysis, chest pain, arthralgia and rash, and for hepatotoxicity. All patients receiving bedaquiline should be enrolled in a patient registry.
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