Bibliographic information
GuidelineWHO consolidated guidelines on tuberculosis: module 4: treatment and care
Year of Publication2025
Issuing InstitutionWorld Health Organization
Recommendation
New
WHO suggests the use of a 6-month treatment regimen composed of bedaquiline, delamanid, linezolid (600 mg), levofloxacin, and clofazimine (BDLLfxC) in MDR/RR-TB patients with or without fluoroquinolone resistance.
Recommended in favor
Conditional
Certainty of evidence
Very low
Notes and Remarks
- 1.Drug susceptibility testing (DST) for fluoroquinolones is strongly encouraged in people with MDR/ RR-TB. Although it should not delay the initiation of the BDLLfxC, the test results should guide the decision on whether levofloxacin or clofazimine should be retained.
- 2.This recommendation applies to the following: a. People with MDR/RR-TB or pre-XDR-TB (i.e. MDR/RR-TB and resistance to fluoroquinolones). b. Patients with less than 1 month of previous exposure to bedaquiline, linezolid, delamanid or clofazimine. When exposure is greater than 1 month, these patients may still receive the regimen if resistance to the specific medicines involved in such exposure has been ruled out. c. People with diagnosed pulmonary TB of all ages, including children, adolescents, PLHIV, and pregnant and breastfeeding women. d. People with all forms of extrapulmonary TB except for TB involving the CNS, osteoarticular TB, or disseminated forms of TB with multiorgan involvement. e. Children and adolescents who do not have bacteriological confirmation of TB or resistance patterns but who do have a high likelihood of MDR/RR-TB (based on clinical signs and symptoms of TB, in combination with a history of contact with a patient with confirmed MDR/ RR-TB).
- 3.When resistance to fluoroquinolones is unknown, the regimen should be started as BDLLfxC and then adjusted based on the DST results. In cases of quinolone susceptibility, clofazimine should be dropped and the regimen started or continued as bedaquiline, delamanid, linezolid and levofloxacin (BDLLfx). In cases of resistance to fluoroquinolones, levofloxacin should be dropped and the regimen started or continued as bedaquiline, delamanid, linezolid and clofazimine (BDLC)