Tb management plan latest as per india
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tuberculosis management India NTEP RNTCP treatment guidelines 2023
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MDR-TB XDR-TB treatment regimen India BPaL bedaquiline pretomanid linezolid
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Based on retrieved content and current India NTEP (National TB Elimination Programme) guidelines (updated through 2023), here is a comprehensive TB management plan as per India:
TB Management Plan — India NTEP 2023
1. Programme Framework
India's TB control operates under the National TB Elimination Programme (NTEP) (formerly RNTCP), with the goal of TB Elimination by 2025 (5 years ahead of the global 2030 target). Key platforms:
- Nikshay portal — mandatory notification of all TB cases (public + private)
- Nikshay Poshan Yojana — ₹500/month nutritional support to all TB patients
- Pradhan Mantri TB Mukt Bharat Abhiyan — community support (Ni-kshay Mitras)
2. Diagnosis
Microbiological Confirmation (Preferred)
| Test | Use |
|---|---|
| CBNAAT/GeneXpert MTB/RIF | First-line; detects MTB + rifampicin resistance |
| TrueNat MTB/MTB Plus/RIF Dx | Point-of-care at peripheral labs |
| Culture (LJ / MGIT 960) | Gold standard; needed for DST |
| Line Probe Assay (LPA) | Rapid detection of MDR/XDR — FL-LPA (H, R), SL-LPA (FQ, SLI) |
| Whole Genome Sequencing (WGS) | Emerging; reference labs |
Clinical Diagnosis
- Chest X-ray, AFB smear (not preferred for initiation)
- Clinical + radiological in smear-negative cases after ruling out differentials
All diagnosed cases must be notified on Nikshay within 24 hours.
3. TB Classification (NTEP)
| Category | Definition |
|---|---|
| New | Never treated or treated <1 month |
| Previously Treated | Relapse, Treatment After Failure, Treatment After LTFU |
| Drug-Susceptible TB (DS-TB) | Sensitive to at least H + R |
| Rifampicin-Resistant TB (RR-TB) | Resistant to rifampicin (with/without H) |
| MDR-TB | Resistant to both H + R |
| Pre-XDR-TB | MDR + resistant to any fluoroquinolone |
| XDR-TB | MDR + resistant to fluoroquinolone + bedaquiline or linezolid |
4. Treatment Regimens
4A. Drug-Susceptible TB (DS-TB) — All New & Previously Treated
Standard Regimen:
2HRZE / 4HR (Daily, fixed-dose combination tablets)| Phase | Duration | Drugs | FDC Tablet |
|---|---|---|---|
| Intensive Phase (IP) | 2 months | Isoniazid (H) + Rifampicin (R) + Pyrazinamide (Z) + Ethambutol (E) | 4-drug FDC |
| Continuation Phase (CP) | 4 months | Isoniazid (H) + Rifampicin (R) | 2-drug FDC |
Dosing (weight-based):
| Weight | IP (4-drug FDC) | CP (2-drug FDC) |
|---|---|---|
| <25 kg | Pediatric dosing | Pediatric dosing |
| 25–54 kg | 3 tablets/day | 3 tablets/day |
| 55–69 kg | 4 tablets/day | 4 tablets/day |
| ≥70 kg | 5 tablets/day | 5 tablets/day |
- Pyridoxine (B6) 10 mg/day given alongside to all patients
- Treatment Outcome Monitoring at 2 months (smear/culture) and end of treatment
Extended CP to 7 months (2HRZE/7HR) for:
- Cavitary pulmonary TB with positive culture at 2 months
- Extensive bilateral disease
4B. Drug-Resistant TB (DR-TB)
MDR-TB / RR-TB — Shorter Oral Regimen (SORegimen) (Preferred)
4-6 Bdq-Lfx-Cfz-Z-E-Hh-Pto / 5 Lfx-Cfz-Z-E| Phase | Duration | Drugs |
|---|---|---|
| IP | 4–6 months | Bedaquiline (Bdq) + Levofloxacin (Lfx) + Clofazimine (Cfz) + Pyrazinamide (Z) + Ethambutol (E) + High-dose Isoniazid (Hh) + Prothionamide (Pto) |
| CP | 5 months | Levofloxacin + Clofazimine + Pyrazinamide + Ethambutol |
| Total | 9–11 months |
Eligibility for Short regimen: No prior exposure to fluoroquinolones or second-line injectables, FQ-sensitive, no resistance to bedaquiline/clofazimine
MDR-TB with FQ Resistance / Pre-XDR-TB — BPaLM Regimen (2023 Update)
6 BPaL-M — Bedaquiline + Pretomanid + Linezolid 600 mg + Moxifloxacin- Duration: 6 months
- Based on TB-PRACTECAL trial: 88% treatment success vs 59% standard of care
- India has adopted BPaL/BPaLM under NTEP for pre-XDR and XDR-TB
- Linezolid dose: 600 mg/day (reduced from 1200 mg to minimize peripheral neuropathy)
XDR-TB — BPaL Regimen
6-9 BPaL — Bedaquiline + Pretomanid + Linezolid- Duration: 6–9 months
- Monitor for: peripheral neuropathy, myelosuppression (linezolid), QTc prolongation (bedaquiline)
Longer MDR-TB Regimen (Individualized, when short regimen ineligible)
Minimum 5 effective drugs:
- Group A (all 3 preferred): Levofloxacin/Moxifloxacin, Bedaquiline, Linezolid
- Group B (add 1–2): Clofazimine, Cycloserine/Terizidone
- Group C (if needed): Ethambutol, Delamanid, Pyrazinamide, Imipenem-cilastatin, Amikacin, Ethionamide/Prothionamide, PAS
Duration: 18–20 months
5. Monitoring During Treatment
| Timepoint | Assessment |
|---|---|
| Baseline | Weight, LFT, RFT, CBC, blood sugar, HIV, visual acuity, ECG (for bedaquiline) |
| 2 months | Sputum smear + culture (DS-TB); weight; LFT if symptomatic |
| 5 months | Sputum smear (DS-TB); culture for DR-TB |
| End of treatment | Sputum culture; CXR; clinical assessment |
| Monthly (DR-TB) | Culture, ECG (QTc), audiometry (if injectable used), visual acuity |
6. Special Populations
TB-HIV Co-infection
- ART within 2–8 weeks of starting ATT (regardless of CD4 count)
- If CD4 <50: ART within 2 weeks
- Preferred ART: Dolutegravir (DTG)-based regimen
- Rifampicin reduces DTG levels — DTG 50 mg twice daily when on rifampicin
- Avoid rifampicin with PI-based ART (use rifabutin if PI needed)
- Co-trimoxazole prophylaxis for all TB-HIV patients
TB in Pregnancy
- 2HRZE/4HR is safe in pregnancy
- Avoid: Streptomycin (ototoxic to fetus), ethionamide (teratogenic — relatively contraindicated)
- Pyridoxine supplementation essential
- DR-TB in pregnancy: individualize; bedaquiline/linezolid — risk-benefit discussion; delamanid data limited
Pediatric TB
- Same 2HRZE/4HR regimen; weight-based dosing
- Child-friendly dispersible FDC tablets available under NTEP
- Ethambutol included in all ages (not contraindicated <5 years at standard doses)
- BCG vaccination at birth; TB preventive therapy (TPT) for contacts
Hepatic Disease
- Avoid PZA (most hepatotoxic); modify to 2HRE/7HR or 9HR
- Severe hepatic failure: 9RE (rifampicin + ethambutol)
Renal Disease
- H, R, Z: safe (use with caution in severe CKD)
- E: reduce dose or thrice-weekly dosing; monitor visual acuity
- Avoid aminoglycosides in renal failure
7. TB Preventive Treatment (TPT)
Indications (NTEP):
- HIV-positive individuals without active TB
- Children <5 years who are household contacts of bacteriologically confirmed TB
- Other high-risk contacts (immunosuppressed, transplant, anti-TNF therapy)
Regimens available under NTEP:
| Regimen | Duration | Drugs |
|---|---|---|
| 6H | 6 months | Daily Isoniazid |
| 3HP | 3 months | Weekly Isoniazid + Rifapentine (under rollout) |
| 1HP | 1 month | Daily Isoniazid + Rifapentine |
8. Adverse Drug Reactions — Key Points
| Drug | Major ADR | Action |
|---|---|---|
| Isoniazid | Peripheral neuropathy, hepatotoxicity | B6 supplementation; hold if LFT >3× ULN with symptoms |
| Rifampicin | Hepatotoxicity, orange discolouration, drug interactions | Caution with OCP, ART |
| Pyrazinamide | Hepatotoxicity, hyperuricaemia, arthralgia | Stop if gout or LFT >5× ULN |
| Ethambutol | Optic neuritis | Baseline + monthly visual acuity |
| Bedaquiline | QTc prolongation | ECG at baseline, 2 wks, monthly |
| Linezolid | Peripheral neuropathy, myelosuppression | CBC monthly, B6 supplementation |
| Clofazimine | Skin pigmentation, GI intolerance | Counsel patient |
DILI Management: If LFT >3× ULN + symptoms, or >5× ULN asymptomatic → stop all hepatotoxic drugs → restart sequentially (R → H → Z) after normalization.
9. Treatment Outcomes (NTEP Definitions)
| Outcome | Definition |
|---|---|
| Cured | Bacteriological confirmation of negative smear/culture at end of treatment |
| Treatment Completed | Completed treatment without bacteriological evidence of failure |
| Treatment Failed | Positive smear/culture at 5 months or later |
| Died | Died during treatment |
| LTFU | Interrupted ≥2 consecutive months |
| Not Evaluated | No outcome assigned |
10. Key India-Specific Initiatives (2023)
- Universal Drug Susceptibility Testing (UDST) — GeneXpert/TrueNat for all diagnosed TB cases
- Free diagnosis and treatment at all public health facilities
- 99DOTS / digital adherence tools — video-observed therapy (VOT) replacing directly observed therapy (DOT)
- Nikshay Mitra — community volunteer program for nutritional and social support
- Bedaquiline and Delamanid — available free through NTEP for DR-TB
- BPaLM rollout — being scaled up nationally for pre-XDR/XDR TB
- TB Harega Desh Jeetega — national campaign for awareness and elimination
Sources: Harrison's Principles of Internal Medicine (21st ed., p. 5163); WHO Consolidated Guidelines on TB Module 4 (2022); NTEP Technical and Operational Guidelines (2023); Prevention and Treatment of OIs in Adults with HIV (p. 496); TB-PRACTECAL and ZeNix trial data.
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