10.8 Treatment adaptation and change of treatment

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    10.8.1 Treatment adaptation

    Treatment adaptation may be done by the clinician in case of severe adverse effects (Appendix 17). The following are considered treatment adaptations:

    • For STRs:

      • permanent interruption of linezolid less than 8 weeks before the end of treatment, or

      • permanent interruption of pyrazinamide, or

      • temporary interruption of any individual drug

    • For LTRs:
      • temporary interruption of any individual drug or the whole treatment, or
      • change of one drug class in the regimen (no more than one)

     

    In an LTR, at least 4 to 5 likely effective drugs are needed (Box 10.1). If any of these drugs must be permanently stopped:

    • During the first 6 months, the regimen should be modified while maintaining the required number of likely effective drugs. If a Group A drug is discontinued, it should be replaced by the most effective remaining TB drug (Table 10.3). 
    • After the first 6 months, if the patient clinical status has improved and bacteriological tests are negative, the clinician can decide to continue the treatment if it still includes at least 3 drugs from Group A and/or B.

    These modifications are considered as treatment adaptations (not treatment changes, see Section 10.8.2) as they do not meet the definition of "treatment failure" (Chapter 17).

    10.8.2 Change of treatment

    Change of treatment is defined as the switch from: 

    • a STR to another STR or to an LTR, or

    • an LTR to another LTR

    Treatment should be changed by the clinician in the following circumstances[1]Citation 1.World Health Organization. Meeting report of the WHO expert consultation on drug-resistant tuberculosis treatment outcome definitions, 17-19 November 2020. Geneva: World Health Organization; 2021.
    https://www.who.int/publications/i/item/9789240022195    :

    • Emergence of a new resistance after treatment initiation (e.g. if the DST at Month 2 shows fluoroquinolone resistance, while the DST at baseline showed fluoroquinolone susceptibility, the treatment must be changed).
    • Resistance not detected at baseline for any reason.
    • No bacteriological conversion or bacteriological reversion (Chapter 17).
    • Insufficient clinical response to treatment in patients:
      • with no bacteriologically confirmed TB (e.g. miliary TB, some forms of EPTB, children);
      • with bacteriologically confirmed TB when bacteriological response cannot be assessed, or the result is inconclusive.
    • Drug interruption due to severe adverse effects[2]Citation 2.World Health Organization. WHO operational handbook on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment, 2022 update. Geneva 2022.https://www.who.int/publications/i/item/9789240065116:

      • For STRs:

        • permanent interruption of bedaquiline, pretomanid, delamanid, levofloxacin/moxifloxacin, or clofazimine, or

        • permanent interruption of linezolid more than 8 weeks before the end of treatment.

      • For LTRs: change of at least 2 drug classes in the regimen.

     

    Note: for BPaLM regimen, if moxifloxacin must be interrupted, see the note in Section 10.2.1.

     

    Treatment changes meet the outcome definition of "treatment failure" (Chapter 17), except when the reason for change is a resistance not detected at baseline[1]Citation 1.World Health Organization. Meeting report of the WHO expert consultation on drug-resistant tuberculosis treatment outcome definitions, 17-19 November 2020. Geneva: World Health Organization; 2021.
    https://www.who.int/publications/i/item/9789240022195    .  

     

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