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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 is available.

2.4 Subgroup considerations

Based on research evidence and expert experience, the panel identified subpopulations of people who might be affected differently than most by this recommendation; these subpopulations were PLHIV, children, pregnant women, breastfeeding women, patients with extrapulmonary TB and patients with extensive TB disease. The recent new recommendation for use of bedaquiline in children with MDR/RR-TB aged below 6 years was considered (31). The panel noted specific considerations for the subpopulations listed below.

People living with HIV

2.3 Evidence to recommendations: considerations

In 2022, new evidence from programmatic implementation in South Africa was made available to WHO where the regimen was modified to include 2 months of linezolid (600 mg) instead of 4 months of ethionamide.

Based on an assessment of the certainty of the evidence, carried out using predefined criteria and documented in the GRADEpro software, the certainty of the evidence was rated as very low for both comparisons.

2.2 Summary of evidence

This section provides the PICO questions posed, the data and studies considered to answer the questions, the methods used for analysis and data synthesis, a summary of evidence on desirable and undesirable effects and certainty of evidence, and a summary of other evidence considered during development of the recommendation. Additional detail on the evidence is available in the web annexes containing the GRADE evidence summary tables (Web Annex 3) and GRADE evidence-to-decision tables (Web Annex 4).

PICO questions

1.6 Monitoring and evaluation

Patients who receive BPaLM/BPaL need to be tested at baseline and then monitored during treatment using schedules of relevant clinical and laboratory testing. If feasible, it is also important to follow up patients 12 months after the completion of treatment for possible relapse, including with sputum culture and smear.

1.5 Implementation considerations

High treatment success rates shown for the BPaLM and BPaL regimens in the Nix-TB study and in the ZeNix and TB-PRACTECAL trials, and favourable comparison with the current SoC regimens led to thorough discussions during the GDG meeting of an overall recommendation for implementation under routine programmatic conditions and of the implementation considerations for this regimen.