---

Tuberculosis Treatment Guidelines in India (NTEP/RNTCP) - 2024

---

Guiding Principles

• All TB patients (public and private sector) must follow the Standards for TB Care in India (STCI) guidelines.
• Fixed Dose Combinations (FDCs) are used for all DS-TB treatment - no loose drugs except for ADR substitutions.
• Treatment is given daily (not thrice weekly) under Directly Observed Therapy (DOT).
• Universal Drug Susceptibility Testing (UDST) is performed for all patients using CBNAAT (CB-NAAT/GeneXpert) at diagnosis.
• All patients are notified on the Nikshay portal.

---

1. Drug-Sensitive TB (DS-TB)

Standard Regimen: 2HRZE / 4HRE

• Applies to all new and previously treated TB cases that are DS or where sensitivity pattern cannot be established.
• No extension of IP is needed as a routine.
• Pyrazinamide is stopped in the continuation phase.

FDC Tablet Composition (Adults):

• IP: HRZE = Rifampicin 150 mg + Isoniazid 75 mg + Pyrazinamide 400 mg + Ethambutol 275 mg
• CP: HRE = Rifampicin 150 mg + Isoniazid 75 mg + Ethambutol 275 mg
• Doses are weight band-based (3 weight bands in adults).

Adult Weight Band Dosing:

---

2. Clinical Forms and Special Situations (DS-TB)

Pulmonary TB

CNS TB (TB Meningitis / TB Encephalitis)

• Regimen: 2HRZE + 10HRE (total 12 months)
• CP extended up to 24 weeks (6 months) for TBM.
• Corticosteroids: Dexamethasone 0.4 mg/kg/day IV for 4 weeks, then taper.
• Streptomycin may be added in TBM in select situations.

Skeletal TB (Spinal/Pott's Disease, Osteoarticular TB)

• Adult: Standard 2HRZE/4HRE with CP extension up to 24 weeks for spinal TB.
• Paediatric osteoarticular TB: 2HRZE + 10HRE (total 12 months)
• Follow-up: Monthly during treatment, then every 3 months (with X-ray or MRI for Pott's spine).

Miliary / Disseminated TB

• Standard regimen; CP may be extended on a case-by-case basis depending on response.

TB Pleural Effusion

• Standard 6-month regimen; thoracocentesis as needed for symptom relief.

Abdominal / Peritoneal TB

• Standard 6-month regimen.

Genitourinary TB

• Standard 6-month regimen; surgical management as needed (e.g., ureteric strictures).

Pericardial TB

• Standard regimen + corticosteroids (Prednisolone 60 mg/day, tapered over 11 weeks).

---

3. Paediatric TB

• Children ≤18 years and <39 kg: 6 weight bands using dispersible FDCs.
• Children >39 kg: adult weight bands.

Paediatric FDCs:

• IP: Dispersible HRZ (Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg) + Ethambutol 100 mg separately
• CP: Dispersible HR (Rifampicin 75 mg + Isoniazid 50 mg) + Ethambutol 100 mg separately

Paediatric TB Meningitis:

• Regimen: 2HRZE + 10HRE
• Corticosteroids: Prednisolone 2 mg/kg/day for 4 weeks, then taper over 4 weeks.
• Pyridoxine: 10 mg/day throughout treatment.

Paediatric Osteoarticular TB:

• 2HRZE + 10HRE (total 12 months)

Drug Doses in Children:

---

4. Drug-Resistant TB (DR-TB) - NTEP November 2024 Guidelines

Classification of DR-TB:

---

A. MDR-TB / RR-TB - Shorter Oral Regimen (9-11 months)

• BPaLM = fully oral, injection-free.
• In August 2024, India's NTEG officially recommended BPaLM introduction under programmatic conditions following a positive ICMR health technology assessment.
• Pyridoxine (100 mg/day for adults) is co-administered with linezolid.

B. MDR-TB / Pre-XDR-TB / XDR-TB - Longer Oral Regimen (18-20 months)

• Levofloxacin (Lfx) OR Moxifloxacin (Mfx)
• Bedaquiline (Bdq)
• Linezolid (Lzd)

• Clofazimine (Cfz)
• Cycloserine (Cs)

• Delamanid (Dlm) - used especially in children, pregnant women
• Amikacin (Am) - injectable, only if oral regimen cannot be formed
• Pyrazinamide (Z), Ethionamide (Eto)

Adult Drug Dosing (Longer Regimen - by weight band):

---

5. Isoniazid-Monoresistant TB (Hr-TB)

• Regimen: Rifampicin (R) + Ethambutol (E) + Pyrazinamide (Z) + a fluoroquinolone (Moxifloxacin or Levofloxacin) for 6 months.
• PZA may be given for only the first 2 months if low initial disease burden or PZA intolerance.
• This addresses the ~8-20% of TB cases with INH monoresistance (higher in Asian countries).

---

6. TB-HIV Co-infection

• All PLHIV should be started on ATT first, then ART (ideally within 2-8 weeks, immediately in those with CD4 <50 cells/µL).
• Preferred ART: Efavirenz-based regimen (rifampicin is a strong CYP inducer; avoid nevirapine and protease inhibitors unless using rifabutin).
• All PLHIV without active TB should receive Isoniazid Preventive Therapy (IPT) 6H or 3HP (3 months of weekly Isoniazid + Rifapentine) regardless of TST/IGRA result.
• CBNAAT is mandatory for all PLHIV with presumptive TB.

---

7. Latent TB Infection (LTBI) / TB Preventive Therapy (TPT)

• All PLHIV (regardless of TST/IGRA)
• Children under 5 years who are household contacts of pulmonary TB cases
• Other household contacts who test positive for LTBI

Recommended TPT Regimens:

• NTEP scaled TPT to 31% of eligible household contacts in 2023 (Global TB Report 2024).

---

8. Treatment Outcomes (India 2023 Data)

---

9. Nikshay Poshan Yojana (Nutritional Support)

• All TB patients under NTEP receive ₹1000/month direct benefit transfer for nutritional support throughout treatment (doubled in November 2024 from the original ₹500).
• Malnutrition is a major TB risk factor; NTEP directly addresses the social determinants.

---

10. Key Recent Updates (2024)

1. BPaLM adopted for MDR-TB programmatically (NTEG recommendation, August 2024 ICMR health technology assessment confirms cost-effectiveness).
2. Injection-free DR-TB regimens fully implemented across India.
3. CBNAAT M.tb/XDR test introduced for rapid molecular detection of resistance to H, fluoroquinolones, SLI, and Ethionamide (August 2024).
4. Bedaquiline and Delamanid now approved for use in all age groups including children.
5. Lzd replacing Eto (Ethionamide) in the shorter 9-11 month MDR regimen.

---

Summary Table: TB Treatment Regimens at a Glance

---