dr TB

National Guidelines for the Management of Drug Resistant TB

  • Release Date: November 2024

  • Organization: National TB Elimination Programme, Central TB Division, Ministry of Health and Family Welfare, Government of India

Contents Overview

  • Acknowledgement

  • Abbreviations

  • Definitions

  • Introduction: Global and national recommendations

  • Case finding and diagnosis

  • Treatment of drug-resistant TB

  • Patient support

  • Treatment outcomes

  • Recording, reporting, and monitoring

  • Annexures

  • Bibliography

Acknowledgement

  • Developed after extensive consultation with national and international experts, including WHO.

  • Key changes in 2022:

    • Introduction of a new 6-month oral MDR/RR-TB regimen (BPaLM).

    • Introduction of Bdq and Dlm for all age groups.

    • Replacement of Eto with Lzd in the 9-month shorter oral regimen.

Abbreviations

  • ADR: Adverse Drug Reaction

  • MDR: Multi-Drug Resistant

  • RR: Rifampicin Resistant

  • BPaLM: Bedaquiline, Pretomanid, Linezolid, Moxifloxacin

  • XDR: Extensively Drug Resistant

Definitions

  • MDR-TB: TB resistant to isoniazid and rifampicin.

  • XDR-TB: Resistant to MDR-TB and at least one fluoroquinolone.

  • Presumptive TB: Individuals showing symptoms who are suspected of having TB.

Introduction to TB in India

  • Progress in TB management with an injection-free oral regimen.

  • 2023 Statistics: 24.38 lakh out of 25.52 lakh TB patients on treatment (95.5% success).

  • The emergence of drug resistance remains a global concern, with India accounting for 27% of MDR/RR-TB cases globally.

Case Finding and Diagnosis

  • Accurate and timely diagnosis crucial to prevent further spread and drug resistance.

  • Use NTEP-endorsed testing methods for diagnosis and treatments, especially for vulnerable groups.

Treatment of Drug-Resistant TB

Evidence and Regimens

  • BPaLM regimen: Optimal for drug-resistant TB, comprising 6 months of treatment.

  • Notable studies indicating treatment success, including NIX-TB trial (90% success rate with newer regimens).

Treatment Regimen Examples

  • Shorter MDR/RR-TB Regimen: Preferred 6-month regimen with newer drugs Bedaquiline, Pretomanid, Linezolid, Moxifloxacin.

  • Longer M/XDR-TB Regimen: For complex cases, potentially lasting up to 20 months.

Patient Support During Treatment

Ambulatory Care and Counseling

  • Outreach and adherence monitoring essential for treatment completion.

  • Use of mobile applications (e.g., TB Aarogya Saathi) for drug adherence support.

Nutritional Support

  • Monthly nutrition assessment; 1000 INR/month support under NPY scheme.

Treatment Outcome Monitoring

Interim and Final Outcomes

  • Bacteriological Conversion: At least two negative cultures or smears taken 7 days apart.

  • Final Outcomes Include: Cured, treatment completed, treatment failed, and lost to follow up.

Recording and Reporting

  • Data management through Ni-Kshay to track patient progress and treatment outcomes.

  • Mandatory entry of all treatment-related information to ensure comprehensive monitoring.

Management of Special Situations

Populations at Risk

  • Pregnant Women: Careful monitoring and regimen adjustments as necessary.

  • Children: Limited safety data for BPaLM; prefer 9-month shorter regimens.

  • PLHIV: Consider interactions with ART and manage under combined care.

Adverse Events Management

  • Common Adverse Reactions: Peripheral neuropathy, hematological abnormalities, etc.

  • Coordinate immediate review and management strategies when adverse events occur.

Supply Chain Management

  • Ensure continuous availability of treatment regimens through efficient procurement and distribution strategies.

Bibliography and References

  • Comprehensive references to guidelines, studies, and reports from WHO and national TB bodies.