Shorter Injectable-containing MDR/RR-TB Regimen: Eligibility Criteria

Till the complete geographical coverage, the states yet to transition implementing shorter oral bedaquiline-containing MDR/RR-TB regimen will continue to use shorter injectable containing regimen for multi-drug resistant/ Rifampicin resistant TB (MDR/RR-TB).

Exclusion criteria
1. DST-based exclusion criteria
► MDR/RR-TB patients with H resistance detected with both Kat G and Inh A mutation in Line Probe Assay (LPA); and
► MDR/RR-TB patients with Fluoroquinolone (FQ) or Second Line Injectable (SLI) resistance detected.
2. Other exclusion criteria
► If result for First Line, Second Line LPA and Drug sensitivity testing (DST) to Pyrazinamide (Z) & Clofazimine (Cfz)* is not available after pre-treatment evaluation is completed and it is time to initiate the first dose of the regimen, then, exclude those with history of exposure for > 1 month to Kanamycin/Amikacin (Km/Am), high-dose Moxifloxacin (Mfx^h), Ethionamide (Eto) or Clofazimine (Cfz).
► Intolerance to any drug in the shorter MDR-TB regimen or risk of toxicity from a drug in the shorter regimen (e.g. drug–drug interactions)
► Extensive TB disease where bilateral cavitary disease or extensive parenchymal damage on chest radiography is present. In children aged under 15 years, presence of cavities or bilateral disease on chest radiography is seen.
► Severe EP-TB disease where presence of miliary TB or TB meningitis or central nervous system (CNS) TB. In children aged under 15 years, extrapulmonary forms of disease other than lymphadenopathy (peripheral nodes or isolated mediastinal mass without compression) are seen.
► Pregnant and lactating women.

Resources

• Guidelines for programmatic management of Drug Resistant Tuberculosis in India-2021

Assessment