Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Eligibility Criteria

Shorter Oral Bedaquiline-containing regimen is recommended for Multidrug-resistant/ Rifampicin-resistant (MDR/RR-TB) patients in whom:

1. Resistance to the component drugs has been excluded; OR
2. No previous treatment for more than one month, with second-line drugs used in shorter oral Bedaquiline-containing MDR/RR-TB regimen, has been given; AND
3. No other exclusion criteria as listed below is present.

Inclusion Criteria

Drug Susceptibility Testing (DST) based inclusion criteria:

• Rifampicin-resistance detected/ inferred
• MDR/ RR-TB with Isoniazid (H) resistance detected/ inferred based on InhA mutation only or based on KatG mutation only (not both)
• MDR/ RR-TB with Fluoroquinolone (FQ) resistance not detected

Other inclusion criteria:

• Children 5 to <18 years of age and weighing at least 15 kg, given their special needs in consultation with the paediatrician
• No history of exposure to previous treatment with second-line medicines in the regimen (Bedaquiline (Bdq), Levofloxacin (Lfx), Ethionamide (Eto) or Clofazamine (Cfz)) for more than 1 month (unless susceptibility to these medicines is confirmed)
• No extensive TB disease
• No severe extrapulmonary TB
• Women who are not pregnant or lactating

Exclusion Criteria

Drug Susceptibility Testing (DST) based exclusion criteria:

• MDR/ RR-TB patients with H resistance detected with both KatG and InhA mutation
• MDR/ RR-TB patients with FQ resistance detected

Other exclusion criteria:

• If results for First Line - Line Probe Assay (FL-LPA), Second Line - Line Probe Assay (SL-LPA) and DST to Pyrazinamide (Z), Bdq and 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 Bdq, Lfx, Eto or Cfz.
• Intolerance to any drug or risk of toxicity from a drug in shorter oral Bdq-containing MDR/ RR-TB regimen (e.g., drug-drug interactions).
• Extensive TB disease found; with presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography. In children aged under 15 years, presence of cavities or bilateral disease on chest radiography.
• Severe Extrapulmonary TB (EP-TB) disease where there is a presence of miliary TB or TB meningitis or Central Nervous System (CNS) TB. In children aged under 15 years, EP forms of disease other than lymphadenopathy (peripheral nodes or isolated mediastinal mass without compression)
• Pregnant and lactating women
• Children below 5 years

Resources:

• Guidelines for Programmatic Management of Tuberculosis in India, 2021. 
• WHO Consolidated Guidelines on Tuberculosis, Module 4 - Treatment: Drug-resistant TB Treatment, 2020.

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