What are the guidelines for treating drug-resistant tuberculosis (TB) in India?

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Guidelines for Drug-Resistant Tuberculosis Treatment in India

For drug-resistant tuberculosis in India, treatment should follow a standardized regimen of at least five effective drugs in the intensive phase and four drugs in the continuation phase, with bedaquiline and a later-generation fluoroquinolone as core components. 1, 2

Core Treatment Principles

  • The intensive phase should last 5-7 months after culture conversion 1
  • The total treatment duration should be 15-21 months after culture conversion for MDR-TB 1
  • For pre-XDR and XDR-TB, treatment should be extended to 15-24 months after culture conversion 1, 3

Essential Drugs for MDR-TB Regimen

  • First-line (strongly recommended) drugs:

    • Bedaquiline - strongly recommended as a core component 1, 2
    • Later-generation fluoroquinolone (levofloxacin or moxifloxacin) - strongly recommended if susceptibility is confirmed 1, 2
  • Second-line (conditionally recommended) drugs:

    • Linezolid - suggested as an effective component against resistant strains 3, 2
    • Clofazimine - suggested as an important component 3, 2
    • Cycloserine - suggested as an effective component 3, 2
    • Pyrazinamide - include only when susceptibility is confirmed 4

Drug Dosing Considerations

  • Pyrazinamide: 15-30 mg/kg once daily (maximum 2g/day) 4
  • Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg three times weekly 5, 6
  • Linezolid: Initial dose of 600 mg daily with potential reduction to 300 mg daily after 9-13 weeks to reduce toxicity while maintaining efficacy 7
  • Delamanid: 100 mg twice daily 8, 9
  • Clofazimine: 100 mg once daily 5, 9

Drugs to Avoid in Drug-Resistant TB Treatment

  • Kanamycin or capreomycin are not recommended due to poor outcomes 1, 3
  • Macrolides (azithromycin and clarithromycin) are not recommended due to lack of efficacy 1, 3
  • Amoxicillin-clavulanate alone should not be used (only use with carbapenems) 1
  • Ethionamide/prothionamide should be avoided if more effective drugs are available 1, 3
  • p-aminosalicylic acid should be avoided if more effective drugs are available 1, 3

Treatment Monitoring

  • Monitor for sputum culture conversion - a key indicator of treatment efficacy 9, 6
  • QTc interval monitoring is essential when using bedaquiline and delamanid, though combined use appears safe with proper monitoring 8, 6
  • Watch for myelosuppression with linezolid (occurs in approximately 52% of patients) 9, 7
  • Monitor for peripheral neuropathy with linezolid (occurs in approximately 42% of patients) 9, 7

Special Considerations for XDR-TB

  • For XDR-TB, the regimen should include bedaquiline, a later-generation fluoroquinolone (if susceptible), linezolid, and clofazimine as core components 3, 5
  • Treatment duration should be extended to 15-24 months after culture conversion 3, 2
  • Consider surgical intervention (elective partial lung resection) in selected cases where medical therapy alone may be insufficient 3

Common Pitfalls to Avoid

  • Using fewer than five effective drugs in the intensive phase leads to poorer outcomes 1, 3
  • Treating for less than 15 months after culture conversion for MDR/XDR-TB is associated with higher relapse rates 1, 3
  • Failing to adjust linezolid dosing can lead to unnecessary toxicity while structured dose reduction maintains efficacy 7
  • Neglecting to monitor for QTc prolongation when using bedaquiline and/or delamanid 8, 6

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Treatment of Multidrug-Resistant Tuberculosis (MDR TB)

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Treatment of Extensively Drug-Resistant Tuberculosis (XDR TB)

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Bedaquiline, Delamanid, Linezolid and Clofazimine for Treatment of Pre-extensively Drug-Resistant Tuberculosis.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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