Tuberculosis (TB)

A 2016 review of available evidence on the use of bedaquiline in the treatment of multidrug-resistant tuberculosis

Authors:
WHO

Multidrug-resistant tuberculosis (MDR-TB) is a public health challenge of growing concern. Without effective treatment, MDR-TB is associated with substantial morbidity and mortality.

The TB drug pipeline has evolved with promising new anti-TB drugs, including bedaquiline, a novel oral diarylquinoline antimycobacterial agent. Bedaquiline was approved for use in the treatment of MDR-TB under the United States Food and Drug Administration (U.S FDA) accelerated-approval regulations. Subsequently, the World Health Organization (WHO) issued conditional recommendations for its use through an interim policy guidance published in 2013.

Three years after the release of the recommendations, and in view of new evidence from countries implementing bedaquiline, WHO convened a Guideline Development Group meeting to advise on the interpretation of new evidence on the use of bedaquiline for treatment of multidrug-resistant tuberculosis (MDR-TB).

Based on the assessment made by the Guideline Development Group, the WHO has decided to maintain the 2013 recommendations for the use of bedaquiline in patients who are not eligible for the WHO-recommended shorter regimen, and to place it within the context of the recently revised WHO drug-resistant TB guidelines.