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DST for fluoroquinolones is strongly encouraged in people with MDR/RR-TB, and although it should not delay initiation of the BPaLM, results of the test should guide the decision on whether moxifloxacin can be retained or should be dropped from the regimen – in cases of documented resistance to fluoroquinolones, BPaL without moxifloxacin would be initiated or continued. The BPaLM/BPaL regimen may be offered to patients with MDR/RR-TB in the following situations:
This section refers to the new short, 6-month (or 26-week) treatment regimen for MDR/RR-TB: the bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM) regimen. This regimen should be the initial choice for all eligible patients diagnosed with MDR/RR-TB. The recommendation in the updated 2022 WHO guidelines states:
The World Health Organization (WHO) has produced this operational handbook on tuberculosis (TB) to provide practical advice to complement the latest WHO consolidated guidelines on tuberculosis, drug-resistant tuberculosis treatment, 2022 update (hereafter referred to as the “WHO consolidated guidelines”). This document provides information on the choice and design of regimens for the treatment of drug-resistant TB (DR-TB), including multidrug- or rifampicin-resistant TB (MDR/RR-TB), and confirmed rifampicin-susceptible, isoniazid-resistant TB (Hr-TB) (1).
All treatment offered to people with MDR/RR-TB should align with WHO-recommended standards, including patient-centred care and support, informed consent where necessary, principles of good clinical practice, active TB drug safety monitoring and management (aDSM), and regular patient monitoring to assess regimen effectiveness. Health care providers must offer careful clinical and bacteriological follow-up to assess the TB treatment response, with general laboratory support to monitor and manage adverse events and comorbidities.
The current guidelines for treatment of DR-TB stress the need for access to reliable, quality-assured drug susceptibility testing (DST), to be provided by national TB programmes (NTPs) and associated laboratories, to inform the use of the WHO-recommended regimens. Rapid molecular testing is making it increasingly feasible for NTPs to detect MDR/RR-TB and other types of resistance quickly, and to use the results to guide treatment decisions (8, 9).
This section briefly describes some of the main terms that are used in this module and elsewhere.
Bacteriologically confirmed: when a biological specimen is positive by smear microscopy, culture or a rapid diagnostic test for TB recommended by WHO.
Clinically diagnosed: when a person who does not fulfil the criteria for bacteriological confirmation has been diagnosed with TB disease by a medical practitioner who has decided to give the person a full course of TB treatment.
This operational handbook was prepared by Fuad Mirzayev, Medea Gegia and Linh Nguyen under the overall direction of Matteo Zignol and Tereza Kasaeva.
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