What are the latest National Tuberculosis Elimination Programme (NTEP) guidelines for Anti-Tuberculosis Treatment (ATT) of skeletal tuberculosis?

Latest NTEP Guidelines for Skeletal Tuberculosis ATT

According to the most recent evidence, skeletal tuberculosis should be treated with a standard 6-month regimen consisting of 2 months intensive phase (HRZE) followed by 4 months continuation phase (HR), with extension to 9-12 months only in cases showing inadequate clinical response at 6 months. 1

Standard Treatment Regimen for Skeletal Tuberculosis

Intensive Phase (First 2 Months)

• Four drugs daily:
  • Isoniazid (H): 5 mg/kg up to 300 mg daily 2
  • Rifampicin (R): 10 mg/kg up to 600 mg daily 3
  • Pyrazinamide (Z): 15-30 mg/kg daily 4
  • Ethambutol (E): 15-20 mg/kg daily 4

Continuation Phase (Next 4 Months)

• Two drugs daily:
  • Isoniazid (H): 5 mg/kg up to 300 mg daily
  • Rifampicin (R): 10 mg/kg up to 600 mg daily

Duration of Treatment

While traditional practice has been to extend treatment for skeletal TB to 12-18 months, recent evidence challenges this approach:

• Recent studies show that 6 months of ATT is sufficient for most cases of skeletal tuberculosis when complete clinical healing occurs 1
• Extension to 9-12 months should be considered only if:
  • No signs of clinical healing by 6 months
  • Persistent fever, loss of appetite, or weight loss
  • Suspicion of drug resistance

Monitoring Treatment Response

• Clinical parameters to monitor:

  • Fever subsidence (typically within 1-6 months, mean 3.5 months)
  • Appetite improvement (typically within 1-7 months, mean 3.5 months)
  • Weight gain (typically within 1-8 months, mean 4.5 months)
  • Pain resolution

• Radiological monitoring:

  • MRI with gadolinium enhancement at 6 months may show:
    • Complete resolution (12%)
    • Partial resolution (72%)
    • No resolution (16%)
  • Even with partial radiological resolution, if clinical healing is complete, treatment can be stopped at 6 months 1

Special Considerations

Drug Resistance

• If drug resistance is suspected:
  • At least 5 drugs should be used in the intensive phase and 4 drugs in the continuation phase 5
  • For MDR-TB, treatment duration should be 15-21 months after culture conversion 5
  • For pre-XDR-TB and XDR-TB, treatment duration should be 15-24 months after culture conversion 5

Adjunctive Therapy

• Surgical intervention plus chemotherapy may be required for:

  • Spinal cord compression
  • Spinal instability
  • Large abscesses requiring drainage 4

• Corticosteroids:

  • Recommended during first 6-8 weeks in spinal TB with evidence of spinal cord compression
  • Prednisone 60 mg/day initially, tapered over several weeks 4

Important Caveats

1. Persistent Back Pain: Up to 31.8% of patients may experience persistent back pain even after successful treatment and bony healing. This does not necessarily indicate treatment failure or need for extension 1

2. Drug Resistance: Rather than empirically extending treatment beyond 6-9 months for non-responding cases, investigate for drug resistance 1

3. Directly Observed Therapy (DOT): Should be implemented to ensure adherence and prevent development of resistance 2

4. Pyridoxine Supplementation: Administer pyridoxine (vitamin B6, 25-50 mg/day) with isoniazid to prevent peripheral neuropathy, especially in at-risk patients 4

5. Pregnancy: Streptomycin should be avoided due to risk of congenital deafness. Pyrazinamide is generally not recommended in pregnancy due to inadequate teratogenicity data 2