Drug-resistant tuberculosis treatment

2.6 Monitoring and evaluation 
Patients who receive a shorter MDR-TB treatment regimen need to be monitored during treatment 
using schedules of relevant clinical and laboratory testing, which have been successfully applied 
in previous studies of shorter regimens under field conditions and in the programmatic setting in 
South Africa. 
The GDG emphasized the need to strengthen and increase access to DST, and the need to monitor 
and undertake surveillance for emerging drug resistance, including for bedaquiline and for all second-
line medicines in the shorter regimen for which reliable DST are available. This should not delay 
implementation of the shorter regimen; however, monitoring and surveillance will become increasingly 
necessary as the use of the shorter regimen increases, as does the use of bedaquiline as part of 
the longer regimens. Resistance mutations to fluoroquinolones detected using MTBDRsl should be 
considered a contraindication for the shorter regimen. 

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Recommendations 
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The WHO framework for aDSM needs to be applied, to ensure appropriate action and prompt response 
to adverse events, and an acceptable level of monitoring for such events, alongside monitoring for 
treatment outcomes. Additional information about aDSM is available in the relevant chapter of the 
operational handbook. 
If feasible, it is also important to follow up patients after the completion of treatment, for possible 
relapse. Although this was not carried out routinely in the programmatic setting in South Africa, the 
data used to inform this PICO question were from 2017, and the EDRWeb data were reviewed again 
in 2019, which allowed detection of TB recurrence. Therefore, some post-treatment outcomes were 
available, even though follow-up post-treatment completion was not routinely carried out. Of the 653 
patients who received the shorter all-oral bedaquiline-containing regimen in South Africa, 22 (3.4%) 
had an outcome of failure and recurrence combined. Although evidence from the STREAM trial did 
not inform this PICO question, the interim results from the STREAM trial indicated that relapse occurred 
in 3.3% of those in the study arm – a figure that was higher than that inferred from observational 
studies. However, the final results of the STREAM trial did not demonstrate a statistically significant 
higher rate of reversion, relapse or lack of conversion in patients using the shorter regimen. 
The schedule of bacteriological monitoring in South Africa included both smear and culture, carried 
out on a monthly basis. Therefore, the response to treatment should be monitored by using monthly 
sputum smear microscopy, and culture (ideally at the same frequency). This is similar to the schedule 
of bacteriological monitoring recommended for the longer regimens (
Section 5
). 

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WHO consolidated 
guidelines 
on
tuberculosis: 
drug-resistant tuberculosis treatment
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