The use of bedaquiline in regimens to treat drug-resistant and drug-susceptible tuberculosis: a perspective from tuberculosis-affected communities

Existing drugs must be taken for months (drug-susceptible tuberculosis) or years (drug-resistant tuberculosis), burdening patients and health systems; even then, cure rates for drug-resistant disease range from 11% to 79% dependent on the extent of resistance.3,4 However, community voices on bedaquiline's use to treat drug-resistant tuberculosis and future development as a potential treatment for drug-susceptible disease have been largely unheard. The TB Alliance has completed a phase 2a study assessing bedaquiline's early bactericidal activity in several drug combinations.8 CRAG members discussed whether bedaquiline should be given to a broader patient population under first-line therapy after a review of the briefing document that Janssen submitted to the FDA2 and completing a thought exercise in which members wrote informed consent forms as if enrolling patients with drug-susceptible tuberculosis into a hypothetical bedaquiline-containing first-line regimen.