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 secondline 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.

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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