Prerequisites and criteria used in this cohort for bedaquiline prolongation beyond 24 weeks
| Prerequisites | |
| Good tolerability | No serious side-effects linked to bedaquiline during the first 24 weeks of treatment |
| Informed consent | Patient should be correctly informed about the potential risks and benefits, as well as about the available evidence on prolonged bedaquiline treatment |
| Closely monitored treatment | Treatment should be monitored closely according to available guidance for timely detection and management of adverse events |
| Expert opinion by an independent organisation | Expert opinion should be provided by an external organisation (i.e. national or international consilium) |
| Pharmacovigilance system | A proper pharmacovigilance system should be in place |
| Criteria | |
| Late microbiological response | Patient 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 regimen | Less 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 outcome | Presence 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.