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Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen: Eligibility Criteria
Learning Objectives- Understand the eligibility criteria for initiating treatment with shorter oral bedaquiline-containing regimens for multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis (TB) patients.
- Recognize the DST based inclusion criteria and other criteria.
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Shorter Oral Bedaquiline-containing regimen is recommended for Multidrug-resistant/ Rifampicin-resistant (MDR/RR-TB) patients in whom:
- Resistance to the component drugs has been excluded; OR
- 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
- 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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drharshshah Mon, 06/05/2024 - 15:25
The similar page is available with more valid information and content: Eligibility Criteria for the Use of Bedaquiline [Bdq] in MDR/RR-TB Treatment​ | Knowledge Base (ntep.in). The current page can be depreciated. The above mentioned page can be renamed.
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drharshshah Mon, 06/05/2024 - 15:28
In reply to Content Curation by drharshshah
Or can be merged with additional information summarised from both pages.