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Patients who receive the (H)REZ–levofloxacin regimen need to be monitored during treatment, using schedules of clinical and laboratory testing. The definitions to use when assigning outcomes are the same as those used for drug-susceptible TB (79). Signs of non-response or treatment failure should be followed up with DST for rifampicin resistance and, if possible, for fluoroquinolones and pyrazinamide.
Case scenarios
Implementing these recommendations requires the (H)REZ–levofloxacin regimen to be administered only in patients in whom resistance to isoniazid has been confirmed and resistance to rifampicin has been excluded. Preferably, testing for resistance to fluoroquinolones (and, if possible, to pyrazinamide) is also done before starting treatment. It is envisaged that the treatment regimen for Hr-TB will apply in the following situations:
Children
In the IPD review, only 2% of Hr-TB patients were children; thus, a separate estimate of effect for paediatric patients was not possible. However, there is no reason why the results and recommendations cannot be extrapolated from adults to children, considering that the regimen components have been standard paediatric TB medicines for many years.
Patients with extensive disease
The recommendations in this section address one PICO question:
PICO question (Hr-TB, 2018): In patients with isoniazid-resistant TB (other than MDR-TB), which treatment regimen composition and duration, when compared with 6 months or more of rifampicin–pyrazinamide–ethambutol, leads to a higher likelihood of success with least possible risk of harm?
Culture and microscopy results for tests performed in patients on MDR-TB treatment should be captured in the second-line TB treatment register as well as the respective laboratory registers (79). Sometimes these registers may exist as part of an electronic laboratory or patient information system, which makes it much easier for multiple users to access the data in real time and can also help to limit errors.
Good-quality sputum specimens are necessary to ensure that laboratories can diagnose TB properly. In addition, laboratories should have sufficient space to ensure the quality, safety and efficiency of the services provided to clients whose samples are tested, and to ensure the safety of laboratory personnel, patients and visitors (107). Some countries experience difficulties with the implementation and quality assurance of sputum culture, which affects this recommendation because it is dependent on access to quality-assured laboratories that can offer TB culture.
The recommendation would apply to any longer regimen, regardless of the number of Group A, B or C agents used and whether an injectable (intensive) phase was used or not. The GDG considered that the findings may apply to other key patient subgroups.
Patients aged below 15 years with MDR/RR-TB
