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DOTS Regimen / RNTCP / NTEP — TB Treatment

Note: Davidson's Medicine is not in the library database. The content below is drawn from Park's Textbook of Preventive and Social Medicine (the gold-standard Indian PSM reference for RNTCP/NTEP) and Lippincott Illustrated Reviews: Pharmacology, which together cover all the topics you asked about.

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1. DOTS — What It Is

Three Core Components of DOTS:

1. Appropriate medical treatment (standard short-course chemotherapy)
2. Supervision and motivation by a health or non-health worker (DOT provider/agent)
3. Monitoring of disease status by the health services

Five Pillars of the DOTS Strategy (original RNTCP):

1. Political will and administrative commitment
2. Diagnosis by quality-assured sputum smear microscopy
3. Adequate supply of quality-assured short-course chemotherapy drugs
4. Directly observed treatment
5. Systematic monitoring and accountability

• During the intensive phase: the DOT provider watches the patient swallow every dose
• During the continuation phase: patient gets one week's supply in a multiblister combipack; first dose is taken in front of the health worker; empty blister pack is returned when collecting next week's supply
• Drugs are supplied in patient-wise boxes (coloured by category — red for Cat I, blue for Cat II)

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2. RNTCP → NTEP

Objectives of RNTCP:

1. Achieve at least 85% cure rate of infectious (smear-positive) TB cases through DOTS
2. Detect at least 70% of estimated cases through quality sputum microscopy

Key Programme Features:

• NIKSHAY — case-based web IT system for TB surveillance (launched May 2012); mandatory notification of ALL TB cases (Govt. of India order, May 2012)
• 99-DOTS — IT-enabled adherence monitoring tool
• GeneXpert / CBNAAT — rapid molecular diagnostics scaled up to all districts
• Universal DST — drug susceptibility testing offered to all notified TB cases
• Nikaya direct benefit transfer — patients linked with Aadhaar for financial support

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3. First-Line Therapy for Pulmonary TB

Drugs Used (First-Line):

Standard 6-Month Short-Course Regimen (Drug-Sensitive TB):

The old thrice-weekly intermittent regimen under RNTCP has been replaced by a daily fixed-dose combination (FDC) regimen under NTEP (Technical & Operational Guidelines 2016).

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4. Intensive Phase and Continuation Phase

Intensive Phase (IP) — 2 months:

• 4 drugs: H + R + Z + E (Isoniazid + Rifampicin + Pyrazinamide + Ethambutol)
• Duration: 2 months (8 weeks)
• ALL doses are directly observed (DOT provider present)
• Each blister pack contains one day's medication
• Targets rapidly multiplying bacteria; rapid bacteriological conversion occurs
• Sputum smear checked at end of IP — negative result indicates good prognosis

Continuation Phase (CP) — 4 months:

• 2 drugs: H + R (Isoniazid + Rifampicin)
• Duration: 4 months
• Each blister pack contains one week's supply
• First dose of each week taken in front of DOT provider; empty pack returned to collect next week's supply

Summary Table:

Adult FDC Dosing by Weight Band:

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5. Treatment for MDR-TB

• Prevalence: ~2.84% in new cases; ~11.60% in retreatment cases

NTEP Classification of Drug-Resistant TB:

MDR-TB Regimen (NTEP/WHO):

• Intensive phase (6–8 months): Fluoroquinolone (levofloxacin/moxifloxacin) + cycloserine + ethionamide/prothionamide + pyrazinamide ± injectable (kanamycin/amikacin)
• Continuation phase: Fluoroquinolone + cycloserine + ethionamide + pyrazinamide

Newer Drugs (added to MDR regimens):

Key MDR-TB Principles:

• Regimens must contain at least 4 effective drugs
• Services scaled nationally since March 2013
• All DR-TB patients managed through DR-TB Centres (20–30 bedded tertiary facilities serving ~10 million population; airborne infection control compliant)
• Universal DST before starting any regimen
• Extension of treatment allowed in extensive disease, extra-pulmonary TB, uncontrolled comorbidities, or positive smear at end of month 4

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Quick Reference Summary

DOTS = Supervised treatment + Community support + Monitoring

RNTCP/NTEP First-Line (Drug-Sensitive Pulmonary TB):
  ┌─────────────────────────────────────┐
  │ Intensive Phase:  2 months  HRZE   │  ← All doses supervised (DOT)
  │ Continuation Phase: 4 months HR    │  ← Weekly supervised
  │ Total: 6 months                    │
  └─────────────────────────────────────┘

MDR-TB (resistant to H + R):
  ┌─────────────────────────────────────────────────────────┐
  │ Fluoroquinolone + Cycloserine + Ethionamide + Z         │
  │ ± Bedaquiline / Delamanid / Linezolid                   │
  │ BPaL (Bedaquiline + Pretomanid + Linezolid) for XDR-TB  │
  │ Duration: 9–12 months (short) or 18–20 months (long)    │
  └─────────────────────────────────────────────────────────┘

• Park's Textbook of Preventive and Social Medicine, pp. 482–485
• Lippincott Illustrated Reviews: Pharmacology, pp. 1053–1054