6.4 Prolonged use of bedaquiline and concurrent use of bedaquiline and delamanid

The current WHO policy does not have any recommendations on the concomitant use of bedaquiline and delamanid in the same patient, or on their individual or combined administration for longer than 6 months. No GRADE recommendation in favour or against such use has been made, given the limited experience with such situations and limited evidence from observational studies (46, 48, 50, 84, 85). However, in 2019, new evidence on the safety profile of the prolonged use of bedaquiline became available that supports its safe use beyond 6 months in patients who receive appropriate schedules of baseline and follow-up monitoring. The added benefit of the use of bedaquiline beyond 6 months remains unclear (1).

The data on concurrent use of bedaquiline and delamanid are also sparse (49, 86), and did not allow for meaningful analysis; hence, there is no formal WHO recommendation on this subject. However, both medicines may be used concurrently among patients who have limited treatment options, provided that appropriate treatment monitoring (including baseline and follow-up ECG and electrolyte monitoring) is in place.

In cases where all other avenues have been exhausted, clinicians may sometimes be compelled to offer treatment options that have a plausible basis even if published evidence is lacking. Given the serious consequences that patients with MDR/RR-TB with fluoroquinolone resistance face under such circumstances, programmes and clinicians may opt to use bedaquiline and delamanid together or beyond 6 months on a case-by-case basis

It is advised that the NTP develop a practical document with criteria for use when the minimum number of effective agents cannot be attained, or the patient is at risk for a poor outcome by stopping the medicine at 6 months or not taking both agents (i.e. bedaquiline and delamanid) together. This document should also provide detail on how to monitor safety (especially QT interval prolongation) and treatment response, and what to do if adverse events occur (8).

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