Consolidated Guidelines

5.3 Subgroup considerations

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

5.2 Justification and evidence

The recommendation in this section addresses the following PICO question:

PICO question (MDR/RR-TB, 2018). In patients with MDR/RR-TB treated with longer or shorter regimens composed in accordance with WHO guidelines, is monitoring using monthly cultures, in addition to smear microscopy, more likely to detect non-response to 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 (10, 39). The WHO framework for aDSM needs to be applied to patients on any type of MDR/RR-TB regimen, to ensure appropriate action and an acceptable level of monitoring for adverse events and prompt response to such events – alongside monitoring for treatment outcomes.

3.5 Implementation considerations

The new recommendations signal an important departure from previous approaches to treating MDR/RR-TB. The implementation of MDR/RR-TB treatment on a large scale is feasible under programmatic conditions, as has been shown by the global expansion in the use of standardized and individualized MDR-TB regimens in low-, middle- and high-income countries worldwide, particularly in the past decade (1).

6.5 Risks

The successful implementation of this recommendation will depend on the availability of more providers trained specifically in the care of HIV and DR-TB, and drug–drug interactions. A substantial increase in the availability of and patient’s access to treatment, and additional support for ensuring adherence would probably be needed. The need for increased integration of HIV and TB care for effective patient management, prompt evaluation of adverse events and case-holding throughout treatment will necessitate more resources.

6.4 Benefits

The strong recommendation for the use of ART is based in part on indirect evidence from its use in any patient with active TB, which shows large beneficial effects and a very high mortality when ART is not employed (120) particularly in highly immunocompromised patients (CD4 cell count <50 cells/mm3) (121, 122). In the absence of other data specific to patients with DR-TB receiving second-line antituberculosis medication, the decision on when to start ART should be no different from the approach to a patient living with HIV with drug-susceptible TB.