4.2 Composition and duration of the regimen

The slight differences in the treatment duration of the BPaLM and BPaL regimens, as studied in the TB-PRACTECAL and ZeNix trials, were acknowledged and discussed during the GDG meeting, and the panel suggested standardizing treatment duration of BPaLM to 6 months (26 weeks) during programmatic implementation; for BPaL, the possibility of an extension to a total of 9 months (39 weeks) if sputum cultures are positive between months 4 and 6 was suggested. All medicines in the regimen are to be used throughout treatment duration, including a potential extension from 26 to 39 weeks (when BPaL is used). Ideally, missing doses of all three or four drugs in the regimen should be avoided; however, if doses are missed, any interruption of longer than 7 days should be made up for by extending the treatment duration (for the number of missed doses); therefore, 26 or 39 weeks of prescribed doses should be completed within an overall period of 7 or 10 months, respectively.

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