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In addition to summarizing the available evidence, the reviews undertaken for these consolidated guidelines revealed several gaps in current knowledge about critical areas in DR-TB treatment and care. The estimates of effect for patient studies were commonly assigned a low or very low certainty rating, which explains why most of the recommendations in these guidelines are conditional. Some gaps persist from those identified in previous TB treatment guidelines (11, 12).
Table 3.1 gives details of the grouping of medicines recommended for use in longer MDR-TB regimens; the groups are summarized here for clarity:
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.
Patient selection and decisions to start the 9-month regimens
Patient selection and decisions to start the 9-month regimens in newly diagnosed patients should be made through an informed decision-making process that includes patient preference and clinical judgement, and DST results available before the start of treatment.
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 People with HIV, 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
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.
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.
