Drug-resistant tuberculosis treatment

PICO question 8 (MDR/RR-TB, 2019) (use of bedaquiline longer than 6 months). To analyse 
treatment success, failure, relapse and death for the use of bedaquiline longer than 6 months, the 
data were derived from the endTB observational study, with the overall dataset comprising a total 
of 1094 patients from 13 countries (69).
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The data analysed to answer this question were patients 
from the endTB observational study cohort who received bedaquiline for at least 6 months, had 
started bedaquiline within the first month of the treatment episode and did not receive delamanid 
concomitantly with bedaquiline during treatment (the subject of PICO question 8), and among patients 
with treatment success, from those who received at least 17.5 months of treatment in total. A total 
of 515 patients met these criteria. The intervention group comprised 242 patients who received 
bedaquiline for more than 203 days
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in total, and they were compared to 273 patients who received 
bedaquiline for a total of 168–203 days. Additional data sources considered by the GDG included a 
cohort of 112 patients from Belarus treated with bedaquiline (of whom two had inadequate treatment 
information and were excluded), and a cohort of 123 patients from a Médecins Sans Frontières (MSF) 
managed clinic in Uzbekistan treated with bedaquiline (with one patient excluded due to inadequate 
treatment information). Of these 232 eligible patients, 65 received bedaquiline for more than 203 days 
and 72 received bedaquiline for 168–203 days. The primary analyses featured the endTB observational 
study data only. 
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These countries are Armenia, Bangladesh, Belarus, Democratic People’s Republic of Korea, Ethiopia, Georgia, Indonesia, Kazakhstan, 
Kenya, Lesotho, Myanmar, Pakistan and Peru. 
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203 days was chosen as a cut-off as the intermodal trough of bedaquiline use for all patients in the endTB observational study was 
203 days. It should be noted that the cut-off was not 6 months exactly, but 203 days. 

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Recommendations 
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