7.1 Eligibility

A patient is eligible for treatment with the BPaL regimen if he or she:

• is diagnosed with bacteriologically confirmed pulmonary TB and has laboratory-confirmed resistance to rifampicin and fluoroquinolones with or without resistance to injectable agents; and

• is aged at least 14 years at the time of enrolment; and

• weighs 35 kg or more; and

• is willing and able to provide informed consent to be enrolled in the operational research project and to adhere to the follow-up schedule (signed or witnessed consent if the patient is illiterate, signed or witnessed consent from a child’s parent or legal guardian); and

• if the patient is a premenopausal woman, is not pregnant or breastfeeding and is willing to use effective contraception; and

• has no known allergy to any of the BPaL component drugs; and

• has no evidence in DST results of resistance to any of the component drugs, or has not been previously exposed to any of the component drugs for 2 weeks or longer; and

• has no extrapulmonary TB (including meningitis, other CNS TB, or TB osteomyelitis).

Patients who are not eligible for the BPaL regimen can benefit from the individualized longer treatment regimen that is composed of medicines using the priority grouping of medicines shown in Table 6.1.

Contraindications: There are no absolute contraindications for the use of any drug in the treatment of MDR-TB and MDR-TB with fluoroquinolone resistance (a disease that poses serious risk of death or debilitation to the patient if treated inadequately). However, there are relative contraindications for the BPaL regimen, and some of the most relevant of these are listed in Table 7.1. If the clinician judges that the potential benefits outweigh the potential risk (also taking into account alternative treatment options), then treatment may proceed with caution. In these situations, advice should be sought from the assigned TB expert committee.

Relative contraindications

ALT: alanine transaminase; AST: aspartate transaminase; BPaL: bedaquiline, pretomanid and linezolid for 6–9 months; CYP: cytochrome; MDR/RR-TB: multidrug- or rifampicin-resistant TB; PI: protease inhibitor; ULN: upper limits of normal.

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