4.2 Remarks

• The bedaquiline, pretomanid⁴⁷ and linezolid (BPaL) regimen, which was used in the Nix-TB study⁴⁸(89), may not be considered for routine programmatic use worldwide until additional evidence on efficacy and safety has been generated. However, in individual patients for whom the design of an effective regimen based on existing WHO recommendations is not possible, the BPaL regimen may be considered as a last resort under prevailing ethical standards.

• The evidence reviewed supports the use of this regimen in certain patient subgroups, such as PLHIV (see Section 4.4).  

⁴⁷ Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazo-oxazines, which possess significant anti-TB activity and a unique mechanism of action.

⁴⁸ The protocol for the Nix-TB study is available at https://clinicaltrials.gov/ct2/show/NCT02333799.https://clinicaltrials.gov/ct2/show/ NCT02333799, and the results of the Nix-TB study have been published (90).

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