World Health Organization · 2025 consolidated edition · 358 pages
Comprehensive WHO recommendations for treating drug-susceptible and drug-resistant TB in all age groups with updated regimens and patient care approaches.
- Issuer
- World Health Organization
- Edition
- 2025 consolidated edition
- Audience
- National TB programme managers, policy-makers, clinicians treating TB, public health professionals in Georgia, Caucasus and worldwide
- Evidence
- GRADE-rated recommendations based on systematic reviews and RCTs (TB-PRACTECAL, ZeNix, BEAT-TB, endTB, SHINE, STREAM trials)
- Reviewed
- 15 Oct 2026 · GMJ
What this guideline says
GMJ summary
This 2025 consolidated guideline brings together all current WHO recommendations for treating tuberculosis, covering drug-susceptible TB (DS-TB), drug-resistant TB (DR-TB) including multidrug-resistant TB (MDR-TB), and rifampicin-resistant TB (RR-TB). The document represents a major advancement in TB treatment, introducing shorter, more effective regimens that reduce treatment duration from 18–24 months to as little as 6 months for many patients.
For drug-susceptible TB, the guideline maintains the standard 6-month regimen (2HRZE/4HR) while introducing new 4-month options for eligible adults (rifapentine-based) and children with non-severe disease. For drug-resistant TB, the 2024 update introduces two new 6-month all-oral regimens: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) and BDLLfxC (bedaquiline, delamanid, linezolid, levofloxacin, clofazimine), alongside modified 9-month regimens. These shorter regimens achieve treatment success rates of 85–89% compared to 52–68% with older regimens, while significantly reducing pill burden and adverse events.
The guideline applies GRADE methodology throughout and includes specific recommendations for people living with HIV, children and adolescents, pregnant women (with noted restrictions for pretomanid), and patients with extensive disease or comorbidities. Implementation considerations address drug susceptibility testing, treatment support, monitoring, and the critical need for accessible chest radiography and laboratory capacity.
Key points
For clinicians — doses and thresholds as stated in the guideline
- For DS-TB: 6-month regimen (2HRZE/4HR) remains standard; 4-month rifapentine regimen (2HPMZ/2HPM with rifapentine 1200 mg daily) conditionally recommended for ages ≥12 years
- Children 3 months–16 years with non-severe TB: use 4-month regimen 2HRZ(E)/2HR instead of 6 months (strong recommendation)
- For MDR/RR-TB without fluoroquinolone resistance: 6-month BPaLM or BDLLfxC regimen preferred over 9-month or 18-month regimens (linezolid 600 mg daily)
- Modified 9-month regimens for MDR/RR-TB: BLMZ preferred over BLLfxCZ, which is preferred over BDLLfxZ; DCLLfxZ and DCMZ not recommended
- Longer regimens (18–20 months): include all three Group A agents (bedaquiline, levofloxacin/moxifloxacin, linezolid) plus Group B agents; kanamycin and capreomycin no longer used
- For Hr-TB (rifampicin-susceptible, isoniazid-resistant): 6-month regimen of rifampicin, ethambutol, pyrazinamide and levofloxacin
- People living with HIV: start ART within 2 weeks of TB treatment regardless of CD4 count; same TB treatment duration as HIV-negative patients
- TB meningitis: adjuvant dexamethasone or prednisolone tapered over 6–8 weeks (strong recommendation); delay ART 4–8 weeks in HIV co-infection
WHO classification of anti-TB medicines for longer MDR/RR-TB regimens
Table extracted from the guideline
| Group | Medicines | Recommendation strength |
|---|---|---|
| Group A | Levofloxacin or moxifloxacin | Strong (include) |
| Group A | Bedaquiline | Strong (include) |
| Group A | Linezolid | Strong (include) |
| Group B | Clofazimine | Conditional (may include) |
| Group B | Cycloserine or terizidone | Conditional (may include) |
| Group C | Ethambutol, Delamanid, Pyrazinamide, Imipenem-cilastatin or meropenem, Amikacin or streptomycin, Ethionamide or prothionamide, p-aminosalicylic acid | Conditional (various) |
Source: World Health Organization, Consolidated guidelines on tuberculosis: Module 4: Treatment and care. Reproduced in summary form.
What changed in this edition
Versus the previous edition
- NEW 6-month BDLLfxC regimen (bedaquiline, delamanid, linezolid 600mg, levofloxacin, clofazimine) for MDR/RR-TB introduced in 2024
- NEW modified 9-month regimens (BLMZ, BLLfxCZ, BDLLfxZ) with hierarchy of preference; DCLLfxZ and DCMZ regimens recommended against
- Linezolid dosing for BPaLM regimen reduced from 1200mg to 600mg daily based on ZeNix and TB-PRACTECAL trial data showing fewer adverse events with maintained efficacy
- 4-month regimen for children 3 months–16 years with non-severe TB upgraded from conditional to strong recommendation based on SHINE trial
- Treatment duration for MDR/RR-TB reduced from 18–24 months to 6 months for eligible patients using BPaLM or BDLLfxC regimens
- Kanamycin and capreomycin formally excluded from longer MDR/RR-TB regimens due to permanent toxicity effects
From the guideline
Verbatim
“Data from an RCT showed much improved treatment success rates with the BPaLM regimen (89%) of 6 months duration compared with the current SoC regimens (52%), as well as lower levels of treatment failure, death and loss to follow-up.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As someone who has worked with WHO on health systems strengthening and reviewed Georgia's TB programme performance, I consider these updated guidelines a critical opportunity for the Caucasus region. The shift to 6-month all-oral regimens for MDR-TB addresses our most pressing challenge: the 30% pre-treatment loss to follow-up we see with lengthy injectable-based regimens that require prolonged hospitalization. I would particularly stress to Georgian colleagues the strong recommendation for 4-month treatment in children with non-severe TB, which aligns with our national push to decentralize paediatric TB care to the primary level. However, successful implementation will require honest assessment of two gaps: first, our capacity for quality chest radiography and interpretation outside Tbilisi remains inconsistent, which is essential for determining disease severity in children; second, procurement and pharmacovigilance systems must be upgraded to handle the new medicines, especially linezolid monitoring for neuropathy and haematological toxicity, which demands monthly laboratory capacity that many rural facilities currently lack. The Global Fund support ending in 2025 makes domestic financing of these diagnostics and monitoring systems the immediate priority.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 15 Oct 2026
Applicability
Georgia and the South Caucasus
For Georgia and the South Caucasus, these guidelines are immediately relevant given the region’s intermediate TB burden and documented drug resistance. Georgia reported approximately 2,500 TB cases annually with MDR-TB rates of 11% among new cases and 30% among previously treated cases. The new 6-month regimens (BPaLM, BDLLfxC) offer transformative potential but require national programmes to ensure: (1) universal access to rapid molecular DST for rifampicin and fluoroquinolones at diagnosis (Xpert MTB/RIF is available but fluoroquinolone testing less widespread); (2) procurement of bedaquiline, pretomanid, delamanid and linezolid through Global Drug Facility; (3) enhanced pharmacovigilance for linezolid-associated peripheral neuropathy and myelosuppression, requiring baseline and monthly monitoring; and (4) investment in paediatric diagnostic capacity including quality chest radiography at primary care level to identify children eligible for 4-month regimens. The shift from injectable-based regimens aligns with Georgia’s move toward ambulatory DR-TB care but necessitates training for community-level treatment support and toxicity monitoring.
Questions this guideline answers
Quick answers
Which patients with MDR/RR-TB are eligible for the new 6-month BPaLM or BDLLfxC regimens?
Adults and adolescents ≥14 years with confirmed pulmonary MDR/RR-TB (with or without fluoroquinolone resistance) and most forms of extrapulmonary TB except CNS, osteoarticular or disseminated disease. Patients must have <1 month prior exposure to bedaquiline, linezolid, pretomanid or delamanid. Pregnant and breastfeeding women are excluded from BPaLM (contains pretomanid) but may use BDLLfxC if benefits outweigh risks.
What is the recommended linezolid dose for the 6-month regimens and how should toxicity be monitored?
Use linezolid 600 mg once daily (not 1200 mg) for both BPaLM and BDLLfxC based on trial evidence showing equal efficacy with fewer adverse events. Monitor for peripheral neuropathy and myelosuppression with baseline full blood count, then monthly or more frequently if symptoms develop. Dose may be reduced to 300 mg daily or given 3 times weekly if Grade 2 toxicity occurs.
Can children under 12 years receive the 4-month rifapentine-based regimen for DS-TB?
No, the 4-month rifapentine regimen (2HPMZ/2HPM) is only for ages ≥12 years as no children were included in the Study 31 trial. However, children 3 months–16 years with non-severe TB should receive the different 4-month regimen 2HRZ(E)/2HR (strong recommendation). This requires chest X-ray to confirm non-severe disease: peripheral lymph nodes, intrathoracic nodes without obstruction, uncomplicated pleural effusion, or paucibacillary non-cavitary disease in one lobe.
How should drug susceptibility testing guide regimen selection for MDR/RR-TB?
DST for rifampicin and isoniazid is mandatory before starting any MDR/RR-TB regimen. DST for fluoroquinolones is strongly encouraged and should guide whether to use moxifloxacin in BPaLM (if fluoroquinolone-resistant, use BPaL without moxifloxacin or switch to BDLLfxC). Results should not delay treatment initiation but should inform regimen modification. For longer regimens, DST for all Group A and B medicines helps optimize composition.
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- Issuer
- World Health Organization
- Type
- Guideline
- Edition
- 2025 consolidated edition
- Replaces
- WHO consolidated guidelines on tuberculosis. Module 4: Treatment – drug-resistant tuberculosis treatment, 2022
- Status
- Current
- Published
- 2025-04-15
- Languages
- English
- Scope
- All forms of tuberculosis: drug-susceptible pulmonary and extrapulmonary TB, MDR/RR-TB, pre-XDR-TB, Hr-TB; all age groups from 3 months upward
- Audience
- National TB programme managers, policy-makers, clinicians treating TB, public health professionals in Georgia, Caucasus and worldwide
- Pages
- 358
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-4-010724-3
- Evidence
- GRADE-rated recommendations based on systematic reviews and RCTs (TB-PRACTECAL, ZeNix, BEAT-TB, endTB, SHINE, STREAM trials)
- Next review
- Not specified; updated as new evidence emerges
- Record history
- Created 15 Oct 2026 · updated 15 Oct 2026 · next check Apr 2027
World Health Organization. WHO consolidated guidelines on tuberculosis: Module 4: Treatment and care. Geneva: World Health Organization; 2025. 358 p. ISBN 978-92-4-010724-3.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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