Drug-resistant tuberculosis treatment

3.6 Monitoring and evaluation
Patients on longer MDR-TB treatment regimens need to be monitored for response to treatment and 
for safety, using reasonable schedules of relevant clinical and laboratory testing (9, 60). The WHO 
framework for aDSM needs to be applied to patients on any type of MDR-TB regimen, to ensure 
46 
This is particularly problematic with the delamanid tablet, the contents of which are very unpalatable (see summaries of unpublished 
data for the 2018 guidelines update in Annex
5).

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Recommendations 
40
appropriate action and an acceptable level of monitoring for and prompt response to adverse events 
– alongside monitoring for treatment outcomes. Electrocardiography may be indicated as more 
regimens in the future may have two or three agents that are expected to prolong the QT interval. 
Audiometry and specific biochemical tests should also be made available whenever certain agents 
are included in the regimens. Treatment in pregnancy with postpartum surveillance for congenital 
anomalies will help to inform future recommendations for MDR-TB treatment during
pregnancy.
A separate recommendation on the use of culture and microscopy to monitor bacteriological response 
during treatment was made in the 2018 update of the guidelines (see 
Section 5
regarding PICO 
question 11 MDR/RR-TB, 2018). Access to DST of medicines for which there are reliable methods, 
and the development of other methods for newer medicines (e.g. sequencing), are critical (and in 
the case of DST, necessary) accompaniments to the treatment recommendations in these
guidelines.
Patients on longer MDR-TB treatment regimens need to be monitored for treatment response and 
for safety, using reasonable schedules of relevant clinical and laboratory testing (9, 60). Response 
to treatment and toxicity are monitored through regular history-taking, physical examination and 
chest radiography; special tests such as audiometry, visual acuity tests and electrocardiography; and 
laboratory monitoring. Using smear microscopy or culture to assess conversion of bacteriological 
status is an important way to assess response, and most patients are expected to have converted 
to a sputum-negative status within the first few months of starting treatment. Persistence of culture 
positivity beyond that point, or close to the expected end of the intensive phase when injectable agents 
are in use, should trigger a review of the regimen and performance of DST. NTPs should also aim for 
complete registration of patients with MDR/RR-TB, through follow-up and monitoring of treatment 
outcomes as part of national surveillance. Regular review of MDR/RR-TB cohort data is essential. 
Frameworks for the surveillance of bacteriological status, drug resistance and assignment of outcomes 
have been standardized in recent years (41). In contrast, systematic monitoring of adverse events during 
and after the end of treatment needs to be strengthened in most NTPs, given the relative novelty of 
active pharmacovigilance within NTPs (59, 60). In the case of this recommendation, it is important 
to monitor for hearing loss and kidney function, especially with the use of the aminoglycosides. The 
rationale for aDSM is largely supported by the increasing use worldwide of combinations of new and 
repurposed medications in MDR-TB treatment regimens. The toxicity of certain agents may increase 
with the duration of use (e.g. nerve damage with linezolid), and may limit their continued use in a 
patient, sometimes resulting in complete cessation of treatment. The prospective collection of accurate 
data for key variables at the case-based level, using an electronic register, is strongly advised in the 
best interests of the individual patient, and to inform local and global policy revisions (88).

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WHO consolidated 
guidelines 
on
tuberculosis: 
drug-resistant tuberculosis treatment
41