In patients aged 14 years or older with multidrug- or rifampicin-resistant pulmonary tuberculosis — with or without fluoroquinolone resistance — a 6-month BPaL-based regimen is the initial standard approach. When that regimen does not meet its expected response benchmarks, a defined escalation protocol applies.
Pulmonary MDR/RR-TB, with or without fluoroquinolone resistance. Patient is aged 14 years or older and is not pregnant or breastfeeding.
The preceding step uses a 6-month BPaL-based regimen (with moxifloxacin added when fluoroquinolone resistance is absent). This regimen is considered to have not met its targets when culture conversion and clinical or radiological response are not achieved by month 4, and monthly sputum cultures do not convert to negative as expected.
When the above failure criteria are present, the approach involves extending the BPaL regimen, with all component medicines continued throughout the extension. The full conditions, schedule, and decision criteria are in the complete protocol.
Culture conversion should occur soon after month 4. Sputum cultures at months 5 and 6 must be negative. Ongoing culture follow-up is required to confirm that conversion has been achieved and is sustained.
WHO suggests the use of the 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin (BPaLM) rather than 9-month or longer (18-month) regimens in MDR/RR-TB patients.
Adults and adolescents aged 14 years and older.
It is not recommended during pregnancy.
For BPaL, the GDG suggested the possibility of an extension to a total of 9 months (39 weeks) if no culture conversion or clinical response by month 4 (Fig. 2.4.1).
All medicines in the regimen would be used throughout the treatment, including the extension from 26 to 39 weeks (when BPaL is used).
Once a decision has been made to extend treatment beyond 6 months, further sputum culture results must be followed up, to ensure that culture conversion occurs soon after month 4 on treatment.
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