6.1 Eligibility

A longer treatment regimen should be proposed mainly when the BpaLM/BpaL or 9-month all-oral regimen cannot be used. Chapter 4 and Chapter 5 discuss the eligibility criteria for these shorter regimens.

A longer regimen is expected to be used in the following situations:

  • severe extrapulmonary TB;
  • additional resistance to key medicines of the BPaLM/BPaL regimen (except moxifloxacin) or the 9-month all-oral regimen;
  • lack of response to shorter treatment regimens (e.g. treatment failure due to no bacteriological conversion, no clinical response, emerging resistance or loss to follow-up);
  • drug intolerance to the component medicines of the BPaLM/BPaL regimen (except moxifloxacin) or 9 months shorter all-oral treatment regimen; and
  • pregnant and lactating women who could not benefit from the 9-month shorter all-oral regimen owing to certain clinical conditions or children aged below 14 years who could not be treated with BpaLM/BpaL or who, for any reason, cannot opt for a 9-month regimen.

There is limited or no evidence of BpaLM/BpaL use in some patient groups; thus, a longer regimen could also be considered as an option for patients with low BMI (<17 kg/m2), altered hepatic enzymes (3 times greater than the upper limit of normal), baseline anaemia (haemoglobin <8 g/ dL), thrombocytopenia (platelet count <150 000/mm3) or pre-existing peripheral neuropathy of Grade 3–4 (62–64).

Any patient eligible for a longer regimen should undergo a pretreatment assessment to optimize the drug selection, reduce the chances of adverse events and thus increase the probability of the favourable treatment outcomes. The pretreatment assessment includes:

  • a detailed clinical history (including all comorbidities, medications and known intolerances), a physical examination, a blood test, chest X-ray or other imaging and bacteriological tests; and
  • a list of current effective TB medicines available based on a clinical history of drugs taken before this treatment episode and guided by the DST results or sequencing of the most recent sample from the patient (or the index case).

In addition to the eligibility criteria and preclinical assessment, a clinician should also consider:

  • • development of a personalized treatment approach (patient-centred approach) and close follow-up, including food support if needed, to increase bioavailability of drugs, improve nutritional status and facilitate adherence;
  • provision of advice on contraception for women of childbearing age;
  • availability of ancillary medications (e.g. corticosteroids in the case of disseminated TB or TB meningitis or pericarditis, pretreatment blood transfusion in the case of severe anaemia and nutritional support) and other interventions (e.g. intravenous [IV] medication in the case of severe malnutrition and malabsorption, insertion of peripherally inserted central catheter, or surgery in the case of restricted options and meeting criteria for intervention); and
  • provision of counselling, depending on the patient’s comorbidities (e.g. HIV or diabetes) or preexisting conditions needing to be treated to optimize TB treatment outcomes.

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