TABLE 1

Prerequisites and criteria used in this cohort for bedaquiline prolongation beyond 24 weeks

Prerequisites
 Good tolerabilityNo serious side-effects linked to bedaquiline during the first 24 weeks of treatment
 Informed consentPatient should be correctly informed about the potential risks and benefits, as well as about the available evidence on prolonged bedaquiline treatment
 Closely monitored treatmentTreatment should be monitored closely according to available guidance for timely detection and management of adverse events
 Expert opinion by an independent  organisationExpert opinion should be provided by an external organisation (i.e. national or international consilium)
 Pharmacovigilance systemA proper pharmacovigilance system should be in place
Criteria
 Late microbiological responsePatient still sputum culture-positive after ≥3 months of treatment and not meeting the criteria for treatment failure
 Insufficient number of effective drugs in the  treatment regimenLess than four effective drugs# left in the treatment regimen if bedaquiline is discontinued; the paucity of effective drugs in the treatment regimen may be due to drug resistance pattern, adverse events or any other contraindication
 Presence of risk factors for poor treatment  outcomePresence of risk factor for unfavourable treatment outcome, including low BMI (<18.5 kg·m−2), high sputum smear bacillary load (2+/3+), HIV-positivity, extensive/advanced pulmonary disease and contraindication to surgery
  • BMI: body mass index. #: never used before in a failing regimen and susceptible according to a reliable drug susceptibility testing result.