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Overview and Recommendations
Background
- •Tuberculosis (TB), caused by the Mycobacterium tuberculosis complex, is the leading infectious cause of death globally, with an estimated 10 million new cases and 1.5 million deaths annually. Despite being curable, TB remains a major public health threat driven by airborne transmission, slow diagnosis, and rising drug resistance, multidrug-resistant TB (MDR-TB) now accounts for nearly 500,000 new cases yearly.
- •The disease spectrum ranges from asymptomatic latent infection (LTBI) to active pulmonary and extrapulmonary disease. Approximately one-quarter of the world's population harbors LTBI, with a 5-10% lifetime risk of progression, concentrated in the first 2 years after infection. Subclinical TB, bacteriologically confirmed without symptoms, accounts for ~50% of prevalent cases in community surveys and contributes to transmission despite the absence of cough.
- •Pulmonary TB constitutes 70-80% of cases, but extrapulmonary involvement (lymphatic, pleural, meningeal, miliary) is common, especially in co-infection and children. (TBM) carries a 50% risk of death or severe neurologic disability even with treatment. The hallmark of progressive TB is caseating granuloma formation; failure of granuloma containment leads to cavity formation, dissemination, and hemoptysis.
- •Risk factors include HIV (20- to 37-fold increased risk), diabetes mellitus (2- to 3-fold), undernutrition (BMI <18.5), smoking, alcohol use (>40 g/day), therapy, end-stage renal disease, and close contact with an infectious case. Social determinants, poverty, crowding, incarceration, amplify transmission. The of M. tuberculosis is associated with enhanced virulence and drug resistance.
- •A paradigm shift has occurred in TB treatment: drug-susceptible TB can be treated in 4 months with a
Evaluation
- •Suspect active TB in any patient with cough lasting ≥2 weeks, unexplained fever, night sweats, weight loss, or hemoptysis. However, over 50% of culture-positive individuals in community prevalence surveys report no persistent cough, and ~25% have no symptoms at all, maintain a high index of suspicion regardless of symptom profile, particularly in endemic areas or high-risk groups.
- •Ask about prior TB treatment (risk of drug resistance), exposure to known cases, travel from or residence in endemic regions, HIV status, diabetes, immunosuppressive medications (especially agents), alcohol/tobacco use, and history of incarceration or homelessness.
- •Examine for cervical lymphadenopathy (matted, painless, may fistulize), pulmonary crackles or signs of consolidation, pleural effusion, and in severe cases meningeal signs (neck stiffness, cranial nerve palsies) suggesting . Assess for hepatosplenomegaly in miliary disease and signs of adrenal insufficiency (hyponatremia, hypotension) in disseminated TB.
- •Order a posteroanterior chest radiograph as initial imaging. Classic findings are upper-lobe infiltrates with cavitation, but HIV-positive patients more often have lower-lobe, interstitial, or miliary patterns. Chest CT provides greater sensitivity for small nodules, lymphadenopathy, and pleural effusion, useful when radiograph is equivocal.
- •Collect two sputum specimens (one spot, one early-morning) for and mycobacterial culture. Xpert Ultra has 88% sensitivity overall (90% in HIV-positive, 63% in smear-negative cases) and simultaneously detects resistance with >95% sensitivity. Culture on liquid (MGIT) or solid media remains the gold standard for definitive diagnosis and comprehensive phenotypic drug susceptibility testing.
- •If sputum is unavailable or negative with high suspicion, obtain bronchoalveolar lavage (BAL), induced sputum, or gastric aspirate (especially in children). For extrapulmonary TB, test appropriate specimens: (for TBM, send Xpert Ultra, culture, and consider adenosine deaminase [ADA]; cut-off ~40 U/L supports diagnosis), pleural fluid, pericardial fluid, pus from lymph nodes, or tissue biopsy for histology (caseating granuloma) and molecular testing.
- •Perform expanded drug susceptibility testing when rifampicin resistance is detected or in high-risk patients. Use (tNGS) directly on sputum for rapid detection of resistance to first- and second-line drugs (isoniazid, fluoroquinolones, bedaquiline, linezolid) with >95% sensitivity and specificity. Whole-genome sequencing from cultured isolates provides the most comprehensive resistance profile.
- •Apply severity stratification at diagnosis: classify pulmonary TB as extensive (high Xpert semiquantitative bacterial burden + extensive radiographic disease [cavitation grade ≥2]) versus limited disease. The phenotype identifies patients eligible for shortened 4-month therapy, those with extensive disease account for over half of post-treatment relapses and require full 6-month regimens. Time-to-detection <9 days in liquid culture identifies patients at high risk of transmission (OR 2.56).
- •For , use the MRC stage (stage I: alert; II: confused; III: comatose) and validated prognostic models that incorporate age, neurological signs, CSF lymphocyte count, and HIV status. The model achieves AUC 0.77-0.78 and is available as a web-based nomogram for bedside risk estimation. High CSF neutrophil count and culture positivity at diagnosis predict subsequent IRIS (RR 9.3).
- •Consider alternative diagnoses: (require culture identification), fungal infections ( , , in endemic areas), lung cancer (especially cavitating squamous cell carcinoma), sarcoidosis (non-caseating granulomas), and necrotizing bacterial pneumonia. In HIV, also consider pneumonia and disseminated fungal disease.
- •Assess for complications at initial evaluation: hemoptysis, from bronchiectasis or (mortality up to 50% if massive); acute respiratory failure, from extensive pulmonary or miliary disease; and adrenal insufficiency, suspected with hyponatremia, hyperkalemia, hypotension (33% pooled prevalence in TB patients).
Management
- •Initiate standard therapy for drug-susceptible pulmonary TB immediately upon microbiologic confirmation: a 2-month intensive phase of 10 mg/kg (max 600 mg) daily, 5 mg/kg (max 300 mg) daily, 25 mg/kg (max 2 g) daily, and 15-20 mg/kg (max 1.6 g) daily, followed by a 4-month continuation phase of rifampicin and isoniazid daily. Administer with pyridoxine 25-50 mg daily to prevent isoniazid-induced peripheral neuropathy.
- •Offer a shortened 4-month regimen for eligible drug-susceptible TB patients with limited disease (low bacterial burden and non-cavitary or minimal cavitation): substitute 1200 mg daily for rifampicin and add 400 mg daily, with the same companion drugs for 2 months followed by rifapentine-moxifloxacin for 2 months. This regimen is noninferior to the 6-month standard (unfavorable 11.6% vs 9.6%) and is safe in HIV with CD4 ≥100 cells/μL on efavirenz-based ART. Exclude patients with extensive disease (high Xpert burden + cavitation/extensive infiltrates).
- •For rifampicin-resistant or multidrug-resistant TB (MDR-TB), initiate a 24-week all-oral BPaLM regimen: 400 mg daily for 2 weeks then 200 mg three times weekly, 200 mg daily, 600 mg daily, and 400 mg daily. This regimen is superior to standard care (11% vs 48% unfavorable outcomes; risk difference -37 percentage points). For fluoroquinolone-resistant strains (pre-XDR), use BPaL (omit moxifloxacin).
- •Alternative all-oral 9-month regimens for fluoroquinolone-susceptible MDR-TB include BCLLfxZ (bedaquiline 400 mg daily for 2 wk then 200 mg 3×/wk, 100 mg daily, linezolid 600 mg daily, 1000 mg daily, pyrazinamide 25 mg/kg daily), BLMZ (bedaquiline, linezolid, moxifloxacin, pyrazinamide), or BDLLfxZ (bedaquiline, 100 mg twice daily, linezolid, levofloxacin, pyrazinamide) based on the endTB trial, all noninferior to standard therapy.
- •Monitor linezolid toxicity closely: peripheral neuropathy occurs in up to 38% and myelosuppression in 2-22% at 600 mg daily. Perform weekly CBC for the first 2 months, then monthly. Measure linezolid trough concentration, aim for <2 μg/mL to reduce toxicity. If trough >2 μg/mL or toxicity develops, reduce linezolid to 300 mg daily after 9-13 weeks; this dose maintains efficacy while significantly reducing adverse events (neuropathy 8% vs 14%, P = .02).
- •Use directly observed therapy (DOT) or video-supported therapy for every dose to ensure adherence and prevent acquired drug resistance. Daily dosing throughout treatment is recommended, avoid intermittent (thrice-weekly) dosing, especially in HIV-associated TB, where it increases failure (adjusted RR 4.0) and relapse (adjusted RR 4.8).
- •In patients with co-infection, start antiretroviral therapy (ART) within 2-8 weeks of TB treatment (earlier if CD4 <50 cells/μL, but monitor for IRIS). Adjust to 50 mg twice daily when co-administered with rifampicin (rifampicin induces UGT1A1 and CYP3A4). 600 mg daily requires no adjustment; requires 400 mg twice daily. is not recommended with rifampicin. Immune reconstitution inflammatory syndrome (IRIS) occurs in ~16% of HIV/TB patients, typically within 4-8 weeks of ART initiation, treat with NSAIDs or corticosteroids if symptomatic.
- •For , administer adjunctive 0.4 mg/kg/day IV/PO (tapered over 6-8 weeks) in all patients regardless of HIV status, reduces mortality and neurologic sequelae. For severe disease, consider high-dose rifampicin (35 mg/kg IV or 30 mg/kg orally) for improved outcomes, but monitor for hepatotoxicity. Maintain standard isoniazid, pyrazinamide, and ethambutol doses. Monitor for hyponatremia ( is common) and raised intracranial pressure.
- •In children with nonsevere, smear-negative, drug-susceptible TB, treat with 4 months of standard therapy (2HRZE/2HR) as per the SHINE trial, noninferior to 6 months (unfavorable 3% vs 3%). Use pediatric fixed-dose combinations and weight-based dosing. For severe TB (miliary, meningitis, bone/joint), extend treatment to 6-12 months. For children exposed to MDR-TB, offer 6 months of levofloxacin preventive therapy (TB-CHAMP trial, 56% reduction in TB incidence).
- •What NOT to do: Do not continue a rifampicin-based regimen when rifampicin resistance is confirmed by molecular or phenotypic testing. Do not use monotherapy or add a single new drug to a failing regimen, functional monotherapy is the strongest driver of acquired resistance. Do not use intermittent dosing in the intensive phase for HIV-positive patients. Do not use non-dihydropyridine calcium channel blockers (diltiazem, verapamil) in TB patients with heart failure, they are contraindicated and worsen outcomes.
- •Refer to a TB specialist or infectious disease consultant for: MDR/XDR-TB, tuberculous meningitis, treatment failure (positive culture after 2 months), drug intolerance or hepatotoxicity, pregnancy, children <5 years, or when surgical intervention (e.g., for massive hemoptysis from Rasmussen aneurysm) is needed. For MDR-TB, consultation with a national TB reference laboratory for expanded DST is essential.
- •After treatment completion, monitor for post-TB lung disease: assess respiratory symptoms and perform spirometry at 3-6 months. Over 50% of survivors have chronic airflow obstruction, bronchiectasis, or impaired diffusing capacity, manage with bronchodilators, airway clearance, and smoking cessation. Screen for (1-year mortality 15%) if new cavitation or hemoptysis. Manage cardiovascular risk factors aggressively, TB survivors have a 21% higher risk of ischemic heart disease (aHR 1.21) and 48% higher risk of myocardial infarction.
Board Review — High Yield
- •Subclinical TB, Over 50% of culture-positive pulmonary TB cases in community surveys do not report persistent cough; maintain a high index of suspicion regardless of symptoms, 23% of cough-free individuals have positive sputum smears.
- •Xpert MTB/RIF Ultra, First-line diagnostic test with 88% sensitivity (63% in smear-negative); detects rifampicin resistance simultaneously; preferred over smear microscopy for initial diagnosis.
- •4-month regimen, Rifapentine-moxifloxacin-based regimen is noninferior to standard 6-month therapy for drug-susceptible TB in patients without extensive disease (RIFASHORT phenotype).
- •BPaLM for MDR-TB, 24-week all-oral regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) achieved 11% unfavorable outcomes vs 48% with standard care in TB-PRACTECAL trial; use BPaL if fluoroquinolone-resistant.
- •Linezolid toxicity, Peripheral neuropathy (up to 38%) and myelosuppression (2-22%) are dose-limiting; reduce to 300 mg daily after 9-13 weeks if trough >2 μg/mL or toxicity occurs, maintains efficacy, reduces harm.
- •Rifampicin-dolutegravir interaction, Double dolutegravir to 50 mg twice daily when co-administered with rifampicin (rifampicin induces UGT1A1 and CYP3A4); efavirenz and raltegravir (400 mg BID) alternatives.
- •TBM dexamethasone, Adjunctive dexamethasone 0.4 mg/kg/day tapered over 6-8 weeks reduces mortality and neurologic sequelae in tuberculous meningitis; use in all patients regardless of HIV status.
- •SHINE trial, Children with nonsevere smear-negative drug-susceptible TB can be treated with 4 months instead of 6 months (unfavorable 3% vs 3%), reduces treatment burden in a vulnerable population.
- •Post-TB lung disease, Over 50% of survivors have chronic pulmonary impairment (airflow obstruction, bronchiectasis, impaired diffusing capacity); assess spirometry at treatment completion and monitor for chronic pulmonary aspergillosis.
- •Preventive therapy for MDR contacts, Levofloxacin 6 months reduces TB incidence among household contacts of MDR-TB patients (adults: IRR 0.55; children: HR 0.44), now recommended by WHO.
Deep Dive — Evidence Details
Definition, Classification and Causative Organisms
- ▸Tuberculosis is caused by Mycobacterium tuberculosis. [751]
- ▸Classify disease as active TB or latent tuberculosis infection; LTBI carries a reported annual reactivation risk of 3%–16% in people living with HIV. [755]
- ▸Recognized anatomical forms in the supplied evidence include pulmonary TB, tuberculous pleurisy, and tuberculous meningitis. [748][749][751][752]
- ▸Nontuberculous mycobacteria, including Mycobacterium abscessus, are distinct from TB and should not be automatically classified as TB. [753][762]
- ▸Culture conversion and time-to-positivity are treatment-response or trial biomarkers, not defining features of TB. [745][750]
Definition
Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis (MTB). [751] The available evidence identifies MTB as the etiological organism but does not support expanding the definition of TB to include nontuberculous mycobacteria (NTM). NTM infections are treated as a separate diagnostic category in bronchoscopic evaluation, where TB and NTM disease may both produce acid-fast bacillus findings. [753]C Mycobacterium abscessus is an example of an NTM that can cause clinically important infection, including healthcare-associated clusters, but it is not identified as a cause of TB in the supplied evidence. [762]D
TB should be classified clinically as active disease or latent tuberculosis infection (LTBI). LTBI represents the silent presence of tuberculosis infection without the active disease phenotype described in the cited evidence. [755] In people living with HIV, LTBI is clinically important because the reported annual risk of TB reactivation is 3%–16%. [755] Active TB is supported by clinical, radiological, microbiological, or tissue evidence of disease; however, the supplied studies use different confirmation methods and do not establish a single universal diagnostic definition. [748][749]C[751][752]
Anatomical classification
The principal anatomical categories represented in the supplied evidence are pulmonary TB, tuberculous pleurisy, and tuberculous meningitis. Pulmonary tuberculosis (PTB) is the pulmonary form of MTB disease and was the primary disease category investigated in studies using chest computed tomography, bronchoalveolar-lavage fluid, and nanopore targeted sequencing. [751][752] Tuberculous pleurisy is an extrapulmonary form of TB characterized by a paucibacillary state, which makes microbiological confirmation difficult. [748] Tuberculous meningitis is another extrapulmonary manifestation; postmortem minimally invasive tissue sampling has been investigated as an alternative approach for establishing the diagnosis in adults presenting with meningitis. [749]C
The distinction between PTB and tuberculous pleurisy may remain difficult even when MTB is detected by metagenomic next-generation sequencing (mNGS), because mNGS-positive cohorts require integration of microbiological results with clinical and anatomical findings. [748] The study cited for this distinction included only mNGS-positive patients and therefore could not estimate the overall sensitivity of mNGS. [748]
Microbiological and clinical classification
Active pulmonary TB may be described as microbiologically confirmed or clinically diagnosed when conventional testing is negative or unavailable, although the supplied references do not provide standardized operational criteria for these labels. [751][752] Conventional microbiological approaches include smear microscopy and culture, while newer approaches reported in the evidence include mNGS, nanopore targeted sequencing, and molecular bacterial-load assays. [748][750][752][753]C Acid-fast bacillus smear microscopy remains a rapid method for evaluating mycobacterial infection, but a separate bronchial-brushing smear may not provide the same information as routinely processed bronchoscopic specimens; the incremental value of separate brushing was specifically evaluated in a retrospective paired study. [753]C
Culture conversion is primarily a treatment-response and trial endpoint rather than a definition of TB. Phase 2 tuberculosis trials commonly assess early bactericidal activity over approximately 2 weeks, followed by studies using 8-week culture-conversion outcomes; time-to-positivity is used as an early biomarker. [745] TB molecular bacterial-load assay, colony-forming-unit, and time-to-positivity measurements have also been evaluated as complementary biomarkers in early bactericidal-activity trials. [750]
Causative organisms and important distinctions
The causative organism supported by the supplied evidence is M. tuberculosis. [751] The references do not establish that other members of the M. tuberculosis complex cause TB, so no broader organism list should be inferred from this evidence set. NTM, including M. abscessus, should remain in the differential diagnosis of acid-fast or molecularly detected mycobacterial disease rather than being classified automatically as TB. [753]C[762]D
Several cited studies concern consequences, comorbidities, diagnostic challenges, or treatment complications rather than TB definition or taxonomy. These include altered gut microbiota in active TB and LTBI, [754][755][760] delayed recognition during immunosuppression, [758]C and adverse events during anti-TB therapy. [757]C[759]C Granulomas are characteristic lesions in experimental TB models, but the murine study does not redefine the human causative organism or clinical classification. [761]D The psoriasis, ANCA-associated vasculitis, bronchiectasis, and paediatric anaphylaxis studies do not provide evidence that changes the definition, classification, or causative-organism list for TB. [744][746]C[747][756]
| Classification axis | Category | Evidence-supported description |
|---|---|---|
| Disease state | Active TB | Clinical, radiological, microbiological, or tissue evidence of disease; operational criteria vary across the cited studies. [748][749]C[751][752] |
| Disease state | LTBI | Silent TB infection; in people living with HIV, annual reactivation risk is 3%–16%. [755] |
| Anatomical site | Pulmonary TB | Pulmonary MTB disease evaluated using imaging, respiratory specimens, and molecular testing. [751][752] |
| Anatomical site | Tuberculous pleurisy | Extrapulmonary, often paucibacillary pleural disease. [748] |
| Anatomical site | Tuberculous meningitis | Extrapulmonary meningeal disease for which postmortem tissue sampling may support diagnosis. [749]C |
| Organism | MTB | The causative organism identified in the supplied evidence. [751] |
| Differential organism | NTM, including M. abscessus | Separate mycobacterial infections, not classified as TB on the available evidence. [753]C[762]D |
Microbiology and Pathogenesis
- ▸MDR/RR-TB affected approximately 390,000 people in 2024, while treatment coverage was 42%; resistance reflects mutations, bacterial adaptation, host–pathogen interactions, and drug-target processes. [888]
- ▸Macrophage polarization, hyperglycaemia, granuloma adaptation, and intracellular survival are central components of TB pathogenesis. [809][898]
- ▸Mtb adapts transcriptionally to host tissues, and host–strain compatibility influences intracellular burden, cell death, and host gene expression. [896][904]
- ▸Rv0158 suppresses cGAS–STING-associated type I interferon responses and is linked experimentally to enhanced intracellular survival. [901]
- ▸Asymptomatic TB may account for up to 60% of cases in endemic settings; an active-screening cohort reported 56.5% asymptomatic disease. [765]
Overview
Tuberculosis (TB) is a chronic infectious disease caused by Mycobacterium tuberculosis (Mtb), with pulmonary and extrapulmonary disease arising from multiscale interactions between the bacterium, host immune responses, tissue microenvironments, and antimicrobial treatment. [898]D[899]D Current pathogenesis research therefore extends beyond bacterial virulence alone to include bacterial adaptation, resistance-associated mutations, drug–target interactions, host–pathogen compatibility, immunometabolism, and immune regulation. [888][896]D[899]D
Bacterial adaptation and drug resistance
Drug-resistant TB remains a major barrier to control. In 2024, approximately 390,000 people developed multidrug- or rifampicin-resistant TB (MDR/RR-TB), while treatment coverage was only 42%. [888] The biological basis of resistance is multifactorial and includes resistance-associated mutations, bacterial adaptation to host conditions, host–pathogen interactions, and changes affecting drug targets and drug activity. [888] These processes should be understood as dynamic components of Mtb survival rather than as isolated genetic events. [888][899]D
Mtb requires amino-acid biosynthesis for proliferation and pathogenesis, and branched-chain amino acids contribute to precursors of cell-wall lipid components through metabolites such as acetyl-CoA and propionyl-CoA. [897]D Chemical-genomic analysis identified semapimod as an inhibitor that selectively impaired growth of the auxotrophic Mtb strain mc2 6206, which lacks leuC-leuD and panC-panD, but did not inhibit wild-type H37Rv under the reported conditions. [897]D This finding supports amino-acid uptake and metabolic dependence as potential determinants of bacterial fitness and therapeutic vulnerability, although the specific transport mechanism and clinical relevance require further validation. [897]D
Macrophages, granulomas, and immune evasion
Macrophages are primary host cells targeted by Mtb and participate in pathogen recognition, phagocytosis, antigen presentation, intracellular killing, granuloma formation, and tissue injury. [809][898]D Macrophage phenotypes are context dependent, ranging from pro-inflammatory, microbicidal M1-like programs to anti-inflammatory and tissue-reparative M2-like programs; their balance influences bacterial persistence, granuloma adaptation, and disease progression. [898]D Hyperglycaemia can disrupt this system: in TB with type 2 diabetes, altered macrophage phenotype and impaired antimicrobial responses were associated with metabolic dysregulation and changes in CD206 expression. [809]
Mtb also modifies host innate-signalling pathways. The bacterial protein Rv0158 was identified through genome-wide loss-of-function screening as a negative regulator of cGAS–STING-associated type I interferon responses; disruption of this determinant increased IFN-β and selected pro-inflammatory cytokines, while the reported experiments linked Rv0158 activity to enhanced intracellular survival. [901]D Mtb-associated epigenetic mechanisms may further alter host responses through bacterial and host regulators involving histone modification, DNA methylation, non-coding RNAs, lipid metabolism, autophagy, oxidative stress, and efflux-related processes. [902]D
Additional immune pathways are relevant to disease heterogeneity. NK-cell numbers, subsets, and functions change during TB, with reported depletion associated with disease progression, while NK cells may contribute to early antimycobacterial activity and activation of adaptive immunity. [900]D CD4+CD8+ double-positive T cells have been investigated in relation to TB susceptibility, severity, and treatment outcomes, reflecting the continuing search for immune correlates of disease activity. [892] The GPR183/EBI2–oxysterol axis is being studied as an immunometabolic regulator and possible host-directed therapeutic target, particularly in the context of latent infection, drug resistance, immunopathology, and metabolic comorbidity. [903]D
Host compatibility and tissue-specific adaptation
Mtb transcription is shaped by the host environment. Genome-wide profiling in rabbit lungs with active TB identified context-dependent bacterial transcriptional states associated with heterogeneous granulomas, necrosis, and cavitation, emphasizing the limitations of axenic culture for reproducing in-vivo conditions. [904]D Experimental comparisons of human THP-1-derived and bovine macrophages infected with human and animal-associated MTBC strains found that infection frequency, intracellular bacterial burden, cell death, and host transcriptional responses varied according to both host model and strain, supporting the concept that host–strain compatibility contributes to disease biology. [896]D
Exosomes, microbiota, and systemic effects
Exosomes released during Mtb infection may contain host- and pathogen-derived proteins, lipids, DNA, microRNAs, and circular RNAs, and can exert opposing effects by supporting immune defence or facilitating disease progression. [895]D In TB meningitis, a small case–control study using 16S rRNA sequencing, combined with transcriptomic, immune-infiltration, machine-learning, and molecular-docking analyses, explored a gut microbiota–metabolite–gene axis; the proposed mechanism remains investigational. [891] HIV–Mtb coinfection has also been linked to concern about acute ischaemic stroke, but the mechanistic relationship remains incompletely defined and current explanations remain provisional. [894]D
Diagnostic and modelling implications
Asymptomatic pulmonary TB may represent up to 60% of cases in endemic settings, and active-screening data from two Italian centres found 56.5% of 372 detected pulmonary TB cases to be asymptomatic. [765] In children evaluated for pulmonary TB or lower respiratory tract illness, microbiological assessment included two induced sputum specimens for liquid culture and Xpert Ultra, illustrating the importance of sensitive specimen-based testing in paediatric disease. [766] Third-generation sequencing is being evaluated for tuberculous pericarditis because conventional tests may have limited sensitivity and specimen collection may be invasive; the cited work is a systematic-review protocol and does not yet provide pooled diagnostic accuracy. [890]
Within-host mathematical models integrate bacterial growth, immune regulation, tissue compartments, pharmacokinetics, pharmacodynamics, and treatment effects to investigate mechanisms that are difficult to measure experimentally. [899]D However, findings concerning non-TB microbial diseases, including the cited review of microbial factors in multiple sclerosis, should not be extrapolated as evidence for TB pathogenesis. [889]
Key synthesis
TB pathogenesis is best viewed as an interaction between metabolically adaptable Mtb, macrophage and lymphocyte responses, granuloma microenvironments, host metabolic and infectious comorbidities, and treatment-driven selection. [888][898]D[899]D Emerging targets include bacterial amino-acid uptake, Rv0158-mediated interferon regulation, immunometabolic receptors, exosome signalling, and host-directed modulation of macrophage states. [897]D[901]D[903]D[895]D
| Mechanistic domain | Updated evidence |
|---|---|
| Drug resistance | Resistance-associated mutations, bacterial adaptation, host–pathogen interactions, and drug-target mechanisms contribute to MDR/RR-TB. [888] |
| Metabolism | Leucine uptake and branched-chain amino-acid metabolism support bacterial proliferation and cell-wall lipid precursor production. [897]D |
| Innate immunity | Rv0158 negatively regulates cGAS–STING-associated type I interferon responses. [901]D |
| Macrophage biology | M1-like and M2-like states influence intracellular killing, granuloma adaptation, and disease outcome. [898]D |
| Host compatibility | Bacterial strain and host species jointly shape infection phenotypes and transcriptional responses. [896]D |
| Intercellular communication | Exosomes may promote either host defence or disease progression. [895]D |
Epidemiology, Transmission and Risk Factors
- ▸Children and adolescents aged under 18 years are at increased risk of progression from TB infection to disease and are a priority population for preventive treatment.[905]
- ▸Household TB exposure is a central childhood risk investigated in marginalised rural communities.[918]
- ▸Local TB notification rates and IGRA positivity can be assessed together to characterise geographic variation in infection risk, although cross-sectional studies cannot establish causality.[920]
- ▸Men have higher observed TB incidence than women globally; pooled cohort data are examining whether this reflects differential infection or progression after infection.[909]
- ▸People living with HIV remain at excess TB risk despite ART, supporting continued attention to TB preventive treatment and case finding.[916][922]
- ▸Potential animal and occupational interfaces, including camel exposure and abattoir work, require One Health surveillance but do not by themselves prove zoonotic transmission.[923]
- ▸Older adults aged ≥65 years with MDR/RR-TB face important care-cascade and treatment-initiation challenges.[914]
- ▸TB recurrence studies in Ghana highlight people living with HIV, miners, prisoners, the rural poor, smokers, and children as vulnerable groups.[924]
Epidemiology and distribution
Tuberculosis (TB) epidemiology is heterogeneous across populations and settings. Recent evidence includes high-burden communities in Southern Africa, Bangladesh, Ghana, China, Viet Nam, Xinjiang, and other regions, as well as lower-burden settings in Europe and South America.[918][919][920][922][924] In China, long-term surveillance through 2023 evaluated trends in overall TB, HIV-associated TB, drug-susceptible TB, multidrug-resistant TB, and extensively drug-resistant TB, with projections intended to guide future control priorities.[919] In Viet Nam, an intermediary-facilitated public–private mix intervention was evaluated at population level because fragmented care and treatment-coverage gaps can reduce case notification.[913]
Sex is an important epidemiological correlate. A pooled individual-participant analysis of 11 prospective cohorts involving 22,424 people from sub-Saharan Africa, Europe, Asia, and South America examined whether the higher incidence observed in men reflected greater infection risk, greater progression from infection to disease, or both.[909] The analysis used baseline QuantiFERON-TB Gold In-Tube status and incident bacteriologically confirmed or clinically diagnosed TB, allowing sex differences to be assessed after accounting for infection status.[909]
Transmission and exposure
Household exposure remains a central exposure pathway for childhood TB. A community-based case–control study in rural Bangladesh enrolled children aged 2–14 years from tea-garden worker communities and specifically evaluated household TB exposure and BCG vaccination as determinants of childhood TB.[918] The study illustrates the importance of contact investigation and prevention in marginalised, high-transmission communities, although its observational design limits causal inference.[918]
Transmission risk also varies geographically within communities. In rural Xinjiang, an examination campaign tested 3,742 adults from 22 villages and farm units after excluding indeterminate and duplicate results; the study assessed whether IGRA positivity increased with the pre-screening village TB notification rate.[920] Village notification rates therefore served as a population-level marker of local transmission intensity, but the cross-sectional design cannot establish the direction or timing of infection.[920]
Potential zoonotic exposure was examined at the camel–human interface in Abu Dhabi. An exploratory One Health investigation tested 356 field camels, 393 slaughtered camels, and 86 abattoir workers using LIODetect TB-ST; reactivity was reported in 33/356 field camels (9.3%; 95% CI 6.5%–12.8%).[923] Among 25 reactive slaughtered camels examined post mortem, two had TB-compatible lesions assessed by histopathology, Ziehl–Neelsen staining, and IS6110 PCR.[923] These findings indicate a possible occupational and animal-health interface requiring further investigation, but serological reactivity and compatible lesions do not by themselves establish confirmed zoonotic transmission to humans.[923]
Progression from infection to disease
Children and adolescents have a particularly important prevention need because they are at higher risk of progressing from TB infection to disease than adults.[905] A systematic review and network meta-analysis evaluated preventive regimens in people aged under 18 years with TB infection or as contacts of drug-susceptible TB, excluding children with HIV.[905] The evidence base consisted of randomised trials of available preventive-treatment regimens and assessed both effectiveness and safety.[905]
The duration of protection after TB preventive treatment is not necessarily uniform. An individual-participant meta-analysis examined close contacts and people with evidence of Mycobacterium tuberculosis infection across high-, medium-, and low-burden settings, focusing on time to TB after preventive treatment.[906] This design directly addresses whether the protective effect persists and whether its duration differs according to background epidemiological risk.[906]
People living with HIV remain a major risk group. In Zambia and South Africa, a 2019–2021 population TB prevalence survey evaluated the excess prevalence among adults living with HIV who were receiving antiretroviral therapy compared with an estimated HIV-negative counterfactual.[922] The study specifically assessed the residual TB burden despite ART scale-up, while recognising that ART reduces TB incidence.[922] In South Africa, clinic data from 2005–2022 were used to examine the timing of preventive-treatment prescribing after ART initiation, classifying prescriptions within 6 months, after 6 months, or as absent.[916] These data address implementation of prevention rather than the biological effect of HIV alone.[916]
Clinical, demographic and recurrent-disease risk groups
Older age is relevant to drug-resistant TB care. A Chinese cohort included 667 patients aged ≥65 years with MDR/RR-TB and assessed attrition before treatment initiation and during the care cascade from 2010–2022.[914] The study concerns access and retention rather than acquisition of infection, but it identifies older adults with MDR/RR-TB as a population requiring specific epidemiological and health-system attention.[914]
Drug resistance has context-specific determinants. A nine-year retrospective study in Shenzhen analysed 16,466 TB patients from 2017–2025 to identify demographic and clinical factors associated with drug-resistant TB and to develop a prediction model in a rapidly developing city with a large migrant population.[917] The study reinforces that local migration patterns and healthcare context should be considered when interpreting resistance risk.[917]
Recurrence is concentrated in vulnerable populations. A Ghanaian cross-sectional study recruited 436 people from groups including people living with HIV, informal miners, prisoners, the rural poor, smokers, and children, and evaluated recurrence from September to November 2024.[924] Its design supports identification of associated factors but cannot determine whether recurrence reflects relapse, reinfection, or incomplete prior treatment without additional microbiological evidence.[924]
Several supplied studies do not provide direct evidence on TB transmission or population risk factors. Studies of lipid alterations in TB with diabetes, predictors of anti-TB drug-induced liver injury, and N-acetylcysteine in critically ill respiratory patients concern treatment toxicity or clinical management rather than acquisition or transmission.[907][908][911][921] A Venezuelan study of bone-marrow evaluation in adults with HIV addresses diagnostic etiologies in advanced disease, not community transmission.[910]C A real-world study of immune-checkpoint inhibitors evaluated active TB occurring among 889 cancer patients in a high-burden region, providing a treatment-associated clinical signal rather than a population transmission estimate.[912]C
| Group or setting | Epidemiological relevance | Evidence |
|---|---|---|
| Children and adolescents <18 years | Higher risk of progression from infection to disease; preventive-treatment evidence evaluated | [905] |
| Household contacts and exposed children | Key exposure pathway in rural, marginalised communities | [918] |
| People living with HIV | Excess TB burden persists despite ART; preventive-treatment implementation remains important | [916][922] |
| Adults ≥65 years with MDR/RR-TB | Increased care-cascade and pre-treatment attrition concerns | [914] |
| Informal miners, prisoners, rural poor, smokers, and children | Vulnerable groups included in recurrence surveillance | [924] |
| Camel handlers and abattoir workers | Potential occupational One Health interface requiring further investigation | [923] |
| Migrant populations and fragmented-care settings | Contexts relevant to drug resistance and under-notification | [913][917] |
Clinical Presentation
- ▸Pulmonary TB may present with nonspecific cough, fever, or shortness of breath and can be paucibacillary or smear-negative [927, 940].
- ▸Tracheobronchial TB can mimic an endobronchial tumor and cause severe airway obstruction or stenosis [937].
- ▸Back or neck pain predominated in spinal TB, occurring in 89% of a 62-patient series; thoracic disease accounted for 66% [928].
- ▸Pediatric TB is often nonspecific and microbiologically unconfirmed; stool-based Xpert MTB/RIF Ultra is an important noninvasive diagnostic pathway in children younger than 15 years [926, 933].
- ▸TBM is a neurological emergency because delayed recognition can lead to encephalitis and irreversible sequelae [932].
- ▸In advanced HIV, unexplained fever or cytopenias should raise concern for disseminated infection, including TB [910].
General pattern
Tuberculosis (TB) can present with pulmonary, extrapulmonary, or disseminated disease, and manifestations may be nonspecific enough to overlap with bacterial infection, brucellosis, malignancy, pneumonia, and non-tuberculous mycobacterial disease [925]C[929][930]C[940]D. Clinical expression varies with the site of disease, bacillary burden, age, immune status, and host factors; in adults with drug-susceptible pulmonary TB, host characteristics were more informative for unfavorable outcomes than the infecting Mycobacterium tuberculosis lineage [939]D.
Pulmonary tuberculosis
Common respiratory manifestations include cough, fever, and shortness of breath, but these symptoms are not specific for TB and overlap with pneumonia and aspergillosis [940]D. Pulmonary disease may be paucibacillary and smear-negative, creating a presentation in which clinical suspicion persists despite negative conventional microbiology [927]C. In a prospective study of adults with suspected smear-negative pulmonary TB, GeneXpert MTB/RIF, TB-DNA PCR, and T-SPOT.TB were performed concurrently, reflecting the diagnostic challenge posed by low bacillary loads [927]C. T-SPOT.TB is an interferon-γ release assay (IGRA) that measures host immune responses rather than directly detecting bacilli; therefore, it may provide complementary information when molecular tests are negative or have limited sensitivity [927]C.
Tracheobronchial TB can produce cough, chest tightness, and fever and may present as an obstructing endobronchial lesion that resembles an airway tumor [937]C. The tumorous subtype is rare, may cause severe airway obstruction, and carries a risk of airway stenosis [937]C. In the reported case, a 21-year-old man had an obstructive mass involving the left main and upper-lobe bronchi; bronchoscopic resection was required for both diagnosis and relief of obstruction, with histopathology and molecular testing of bronchoalveolar-lavage material supporting TB [937]C.
After treatment begins, respiratory morbidity may persist. A prospective cohort of 38 adults with newly diagnosed, microbiologically confirmed, drug-susceptible pulmonary TB assessed structural lung damage after the 2-month intensive phase, emphasizing that radiographic abnormalities can be evident early during therapy [938]. Post-tuberculosis lung disease is therefore relevant when cough, breathlessness, or other respiratory impairment continues after microbiological treatment [938].
Pediatric tuberculosis
Children may have nonspecific clinical presentations and frequently lack microbiological confirmation [933]. In a Romanian tertiary-hospital series of 48 children, the median age was 14 years (interquartile range, 8.25–16 years), and 37.5% were bacteriologically confirmed [933]. The study illustrates that pediatric TB may be encountered outside specialist TB services and that clinical, epidemiological, laboratory, and radiological assessment often remains necessary when direct confirmation is unavailable [933].
Sampling can be difficult, particularly in younger children. WHO-endorsed molecular rapid diagnostic testing with stool provides an initial diagnostic option for pediatric TB, and a multicentre prospective study evaluated a centrifugation-free Stool Processing Kit used with Xpert MTB/RIF Ultra in children younger than 15 years across five low- and middle-income countries [926]. This approach is relevant when sputum collection is difficult or invasive sampling is undesirable [926].
Spinal and osteoarticular tuberculosis
Spinal TB commonly presents with localized back or neck pain, although clinical findings overlap substantially with pyogenic and brucellar spondylitis [925]C[928]C. In a London retrospective series of 62 patients, back or neck pain was present in 89%, and thoracic involvement was most frequent (66%) [928]C. Spinal TB may therefore be suspected in patients with persistent axial pain, particularly when imaging demonstrates vertebral or paravertebral abnormalities, but preoperative distinction from pyogenic and brucellar infection can be difficult [925]C. A five-centre Chinese study included 1,000 patients with spinal TB, compared with 579 with pyogenic spondylitis and 255 with brucellar spondylitis, and developed a multimodal model integrating routine clinical and laboratory variables with radiomic features [925]C. The need for such a model reflects the substantial clinical and imaging overlap among these entities [925]C.
Tuberculous meningitis and disseminated disease
Tuberculous meningitis (TBM) is a severe extrapulmonary form that can initially be difficult to recognize, especially in children [932]C. Delayed recognition may allow progression from meningeal inflammation to encephalitis and irreversible neurological sequelae [932]C. Pediatric TBM should therefore remain in the differential diagnosis of compatible neurological illness, particularly when symptoms or signs evolve progressively or are accompanied by evidence of TB elsewhere [932]C.
TB may also occur in people living with HIV and may require evaluation beyond the lungs. In adults with HIV who underwent bone-marrow aspiration, biopsy, or both for suspected infiltrative disease, fever of unknown origin or unexplained cytopenias were clinical contexts in which infectious, neoplastic, and inflammatory causes—including TB—were considered [910]C. In advanced HIV, cytopenias and unexplained fever should consequently prompt consideration of disseminated infection and targeted investigation [910]C.
Important mimics and diagnostic context
Pulmonary non-tuberculous mycobacterial infection can mimic TB clinically and radiologically, and conventional immune-based assays may not reliably distinguish all mycobacterial infections [929]. Brucellar spondylitis is an important alternative diagnosis in patients with spinal infection, particularly in settings where serological testing is unavailable or delayed [925]C[930]C. In rural Xinjiang, IGRA positivity was assessed among 3,742 adults participating in a health-examination campaign and was compared with village-level TB notification rates, illustrating that latent infection detection and active-disease presentation are distinct clinical questions [920].
Atypical or coexisting infections can further obscure presentation. A reported 17-year-old unvaccinated adolescent had measles during treatment for extensive secondary pulmonary TB with polyserositis; TB was supported by acid-fast bacilli smear and Xpert MTB/RIF, while measles produced rash, Koplik spots, and conjunctival hyperaemia [934]C. Molecular and imaging technologies—including chest-radiograph deep-learning systems and experimental porphyrin-based detection methods—are being investigated to support recognition, but they do not replace clinical assessment and microbiological confirmation [940]D[941]D.
| Disease presentation | Typical or reported clinical features | Key evidence |
|---|---|---|
| Pulmonary TB | Cough, fever, shortness of breath; may be paucibacillary or smear-negative | [927]C[940]D |
| Tracheobronchial TB | Cough, chest tightness, fever, obstructing endobronchial mass, possible airway stenosis | [937]C |
| Spinal TB | Back or neck pain; thoracic involvement common; mimics pyogenic and brucellar spondylitis | [925]C[928]C |
| Pediatric TB | Nonspecific illness with frequent absence of microbiological confirmation | [926][933] |
| TB meningitis | Progressive meningeal disease, possible encephalitis and neurological sequelae | [932]C |
| Disseminated TB in HIV | Fever of unknown origin and/or unexplained cytopenias may prompt bone-marrow evaluation | [910]C |
Diagnosis and Workup
- ▸Consider active screening in high-risk groups because a substantial proportion of detected pulmonary TB can be asymptomatic; one cited cohort reported 56.5% asymptomatic cases [765].
- ▸Use respiratory specimens for AFB smear, culture, and rapid molecular testing; in children, two induced sputum specimens were used for liquid culture and Xpert Ultra [766].
- ▸Do not equate AFB smear positivity with viable Mtb, particularly after treatment; only 32.1% of post-treatment smear-positive patients were culture-confirmed as Mtb in one study [813].
- ▸mNGS may complement conventional testing in paucibacillary or extrapulmonary TB, but its sensitivity cannot be inferred from cohorts restricted to mNGS-positive patients [748].
- ▸For MDR/RR-TB, MBLA quantified bacterial load within 24 hours and evaluated 14-day and 2-month dynamics as potential early response markers [812].
- ▸IGRA and PPD indicate immune sensitization and are not stand-alone tests for active TB; serial IGRA changes have uncertain value for treatment monitoring [803, 804, 798].
- ▸Machine-learning models and investigational biomarkers may support risk stratification or diagnosis, but require validation and cannot replace microbiological or tissue confirmation [802, 805, 818].
Diagnostic approach
Evaluation should begin with clinical assessment, epidemiologic risk, symptom review, physical examination, and chest imaging, while recognizing that pulmonary tuberculosis (PTB) may be asymptomatic and therefore missed without active case-finding. In an Italian low-prevalence-country cohort of cases identified through active screening of high-risk populations, 56.5% were asymptomatic and 43.5% were symptomatic, supporting targeted screening rather than reliance on symptoms alone in selected risk groups [765]. Delayed diagnosis is clinically important: a prospective Cambodian cohort followed adults with newly diagnosed tuberculosis for 2 years and examined the relationship between diagnostic delay and subsequent respiratory health, quality of life, and mental health [783].
Microbiological confirmation
Whenever feasible, obtain respiratory specimens for acid-fast bacillus (AFB) smear microscopy, mycobacterial culture, and rapid molecular testing. In children evaluated for suspected PTB in South Africa, the microbiological protocol included two induced sputum specimens tested by liquid culture and Xpert Ultra [766]. A positive AFB smear supports mycobacterial infection but does not by itself establish viable Mycobacterium tuberculosis (Mtb), because smear-positive specimens after successful treatment were attributable to Mtb in only 27 of 84 patients (32.1%) in one retrospective study; the remainder belonged to a non-Mtb group based on culture results [813]. Thus, culture and species-directed molecular testing remain important when smear microscopy is positive, particularly after treatment completion [813].
Culture remains a reference method for confirming viable organisms and obtaining drug-susceptibility information, although it is slower than molecular assays. In a retrospective comparison of bronchoalveolar-lavage-fluid testing across pulmonary infectious diseases, mNGS had a higher overall pathogen-detection rate than culture (95.4% vs 67.4%; P<0.001), with an overall concordance of 71.1%; however, these results were pooled across pneumonia, bronchiectasis, nontuberculous mycobacterial disease, tuberculosis, and other conditions and should not be interpreted as TB-specific sensitivity [815].
Molecular and sequencing tests
Rapid nucleic-acid amplification testing can identify Mtb directly from appropriate specimens and may provide early information about rifampicin resistance. For suspected extrapulmonary or paucibacillary disease, specimen selection is critical because low organism burden and complex sample matrices reduce the sensitivity of conventional tests [748][818]C. In tuberculous pleurisy, a multicenter cohort specifically assessed mNGS for distinguishing pleural TB from PTB, but included only patients with Mtb-positive mNGS results; therefore, overall mNGS sensitivity could not be estimated [748]. mNGS may be particularly useful when routine testing is unrevealing, but results require clinical and radiologic correlation because detection does not automatically distinguish disease from contamination, colonization, or clinically irrelevant nucleic acid [748][814][815].
A single case report described an investigative single-cell metabolic-labeling probe for renal TB that supported diagnosis and permitted exploratory treatment-response monitoring in a patient with fever, abnormal renal-function indicators, and calcified mediastinal lymph nodes [818]C. This represents preliminary case-level evidence rather than an established diagnostic standard [818]C. Whole-genome sequencing has also been used to characterize Mtb-complex strains from humans and cattle, including phylogenetic relationships and resistance-associated mutations, but its cited role was molecular epidemiology and resistance characterization rather than routine initial diagnosis [816].
Drug resistance and response assessment
Patients with suspected multidrug-resistant or rifampicin-resistant TB require rapid resistance testing in addition to organism detection. A multicenter Chinese cohort developed and validated a molecular bacterial-load assay (MBLA) for MDR/RR-TB; MBLA provided bacterial-load quantification within 24 hours, and the study evaluated bacterial-load changes at 14 days and 2 months to predict 6-month treatment response [812]. This supports MBLA as a potential adjunct for early response assessment, not a replacement for baseline microbiological confirmation or conventional susceptibility testing [812].
Latent tuberculosis infection and immunologic tests
Tuberculin skin testing with purified protein derivative (PPD) and interferon-gamma release assays (IGRAs) detect immune sensitization and should not be used alone to distinguish active TB from latent infection. IGRA is recommended for LTBI screening before biologic therapy in patients with psoriasis; a cross-sectional study of 1,126 such patients evaluated factors associated with IGRA positivity [804]. A separate 10-year retrospective study examined serial QuantiFERON-TB Gold results in 491 patients and assessed changes according to treatment status, treatment response, and follow-up interval, reflecting uncertainty about using longitudinal IGRA changes to monitor efficacy or recurrence [803]. In non-HIV tuberculous meningitis, PPD status was investigated as a prognostic marker across age groups, not as a stand-alone diagnostic test [798].
Extrapulmonary and disseminated disease
When extrapulmonary TB is suspected, sample the involved site whenever safely possible for smear, culture, molecular testing, and histopathology. Disseminated TB may be difficult to recognize early; a retrospective study of 1,122 HIV-negative hospitalized patients with disseminated or pulmonary TB developed a machine-learning early-warning model using routine laboratory tests and multidimensional lymphocyte-subset data, with nine features selected for model development [802]. Such models may assist risk stratification but do not replace microbiological or tissue confirmation [802].
Context and limitations
Diagnostic interpretation should account for competing pulmonary conditions, including bronchiectasis and nontuberculous mycobacterial disease, which were represented in comparative mNGS research [815]. Evidence concerning self-management education in newly diagnosed inpatients, frailty among hospitalized older adults with PTB, post-treatment respiratory outcomes, and sepsis subtyping addresses treatment, prognosis, or health-system context rather than establishing diagnostic thresholds [811][817][783][800]. Investigational plasma extracellular-vesicle microRNAs were studied as potential TB biomarkers, but the cited work describes discovery and diagnostic-performance evaluation rather than an established clinical assay [805].
| Tool or approach | Role and limitations |
|---|---|
| AFB smear microscopy | Rapid evidence of acid-fast organisms; cannot reliably establish viable Mtb or species, especially after treatment [813]. |
| Mycobacterial culture | Confirms viable organisms and supports species identification and susceptibility testing; slower than molecular methods [766][813][815]. |
| Xpert Ultra and other rapid molecular assays | Direct detection from appropriate specimens; used with induced sputum in children in the cited study [766]. |
| mNGS | Potential adjunct for paucibacillary, pleural, or diagnostically difficult disease; sensitivity was not estimable in an mNGS-positive-only cohort [748][814][815]. |
| IGRA or PPD | Immune-sensitization tests for LTBI-related assessment; not sufficient alone to diagnose active TB [798][803][804]. |
| MBLA | Rapid bacterial-load quantification and possible early response assessment in MDR/RR-TB; not a substitute for baseline diagnosis or susceptibility testing [812]. |
| Machine-learning models and novel biomarkers | Potential adjuncts for disseminated-TB risk prediction or diagnostic support; require validation before routine use [802][805][818]C. |
Severity Assessment and Risk Stratification
- ▸Assess TB severity across anatomical involvement, dissemination, neurological status, systemic inflammation, pathogen burden, host immunity, treatment toxicity, and drug resistance. [942][884][802][931]
- ▸Disseminated TB and CNS-TB are high-risk phenotypes requiring intensified assessment; **MRC grades II–III** identify the more severe neurological subgroup in the cited CNS-TB study. [802][944]
- ▸Thoracic spinal TB warrants clinical-imaging assessment for paraplegia, vertebral destruction, instability, and neurological deficit. [824]
- ▸High bacillary burden and inflammatory responses interact with age to predict mortality in severe HIV-associated TB. [884]
- ▸ATB-DILI prediction models may support individualized monitoring, but no single model is universally validated. [908]
- ▸Patient delay and drug-resistant TB are important prognostic dimensions that should be incorporated into risk assessment. [819][931]
Scope of severity assessment
Tuberculosis (TB) severity is multidimensional and should be assessed across pulmonary burden, extrapulmonary dissemination, neurological involvement, systemic inflammation, host immune status, pathogen load, and the risk of treatment-related toxicity. Recent evidence supports combining routinely available clinical, laboratory, radiological, microbiological, and immunological information rather than relying on a single marker. [942][884][802][821]
Clinical and anatomical stratification
Disseminated TB is a high-risk phenotype because it may produce multiple-organ dysfunction and high mortality. In a retrospective cohort of 1,122 HIV-negative hospitalized patients with disseminated or pulmonary TB, an early-warning diagnostic model was developed using routine laboratory testing and multidimensional lymphocyte-subset analysis; nine predictive features were selected, and SHAP analysis was used to characterize feature importance. [802] This model is potentially useful for early identification of patients requiring intensified evaluation, although the available evidence does not establish a universal clinical threshold or external validity.
Central nervous system (CNS) involvement should be treated as a major severity modifier. Among 4,829 hospitalized patients, those with pulmonary TB complicated by CNS-TB were compared with patients with pulmonary TB alone after propensity matching; CNS-TB was further stratified using Medical Research Council neurological grades, with MRC grades II–III representing the more severe subgroup. [944]C The study specifically evaluated immune-inflammatory parameters associated with severity, supporting integration of neurological examination with albumin, haemoglobin, body mass index, age, sex, and inflammatory laboratory assessment. [944]C
Spinal TB requires separate neurological and structural risk assessment. In 148 patients with thoracic spinal TB undergoing surgery, clinical, laboratory, and imaging variables associated with paraplegia at presentation were evaluated by logistic regression, and a clinical-imaging severity framework was developed with assessment of discrimination and calibration. [824] Vertebral destruction, spinal instability, and neurological deficit are clinically important manifestations in this context. [824] Patients with spinal TB who undergo inappropriate vertebral augmentation may experience aggravated lesions and worsening symptoms; subsequent management and prognosis have been studied in a retrospective series of 53 patients. [822]C
Rare extrapulmonary sites may be diagnostically difficult and should not be assumed to represent mild disease. In intestinal TB, clinical, laboratory, endoscopic, imaging, and histopathological findings were reviewed in 46 cases, including six initially misdiagnosed as Crohn disease. [943]C Ischial TB commonly presented with gluteal pain, sitting-induced pain, and local swelling; MRI identified abnormalities in all examined patients, while CT demonstrated lesions in most, and molecular testing and histopathology supported confirmation. [159]C4
Pathogen, host, and biomarker-based risk
In severe HIV-associated TB, systemic bacillary burden can be estimated from multiple routinely collected TB diagnostic results. A prospective cohort of adults admitted with severe HIV-associated TB examined pathogen load, inflammatory responses, age, and mortality; bacillary burden and host inflammatory pathophysiology interacted with age in predicting death. [884] This supports prioritizing patients with high organism burden, marked systemic inflammation, HIV-associated disease, and advanced age for close monitoring, although the abstract does not provide a validated bedside cutoff.
Circulating antibody signatures may also contribute to severity phenotyping. In patients with active TB, clinical, radiological, and laboratory variables were integrated using Factor Analysis of Mixed Data to identify systemic and pulmonary severity domains, which were combined into an overall severity score. IgG responses against ESAT-6/CFP-10, Ag85A, HspX, and Rv2626c were investigated as candidate correlates of mild and severe disease. [942] These findings remain biomarker-development evidence rather than a replacement for clinical assessment.
Immune-cell profiles are another emerging risk domain. Genetic and cohort analyses involving 895 patients with TB examined CD4+CD8+ double-positive T cells and other immune subsets in relation to TB susceptibility, severity, and treatment outcomes. [892] Such markers may eventually refine prognostication, but they should currently be regarded as investigational unless validated in the relevant clinical setting.
Treatment-related risk stratification
The risk of anti-tuberculosis drug-induced liver injury (ATB-DILI) should be assessed before and during treatment. A systematic review and meta-analysis of 26 studies comprising 31 prediction models in East Asian populations evaluated model construction methods, predictive factors, and discrimination. [908] The review supports individualized treatment planning and early detection in high-risk patients, but the heterogeneity of models and populations means that no single score can be assumed to apply universally. [908]
Drug resistance is an independent prognostic concern. A systematic review and meta-analysis synthesized adjusted hazard ratios from longitudinal survival studies of mortality in drug-resistant TB, with searches completed through 31 March 2026. [931] Survival-based prognostic factors should therefore be incorporated into follow-up and treatment planning, while recognizing that the available abstract does not identify a single dominant factor or bedside threshold.
Interpretation and limitations
Advanced Bayesian, machine-learning, spatial, time-series, multistate, and survival methods are increasingly used to address diagnostic uncertainty, heterogeneity, and treatment outcomes in African TB research. [821] However, most emerging models are retrospective, single-centre, population-specific, or incompletely validated. [802][824][908] Patient delay is also relevant to severity at presentation: a meta-analysis including 42 studies and 492,448 patients evaluated factors associated with delayed care-seeking, a pathway linked to later diagnosis and potentially worse outcomes. [819] Risk stratification should therefore combine disease phenotype, neurological and organ involvement, pathogen burden, host factors, treatment toxicity, drug resistance, and access-related delay rather than depend on any isolated biomarker or prediction model. [819][884][908][931]
| Domain | Evidence-supported indicators or applications |
|---|---|
| Dissemination | Early-warning modelling using routine laboratory tests and lymphocyte subsets; nine selected features in HIV-negative hospitalized patients. [802] |
| CNS involvement | Pulmonary TB complicated by CNS-TB; neurological severity classified with MRC grades, including grades II–III. [944]C |
| Spinal disease | Clinical and imaging variables associated with paraplegia, with discrimination and calibration assessment. [824] |
| Pathogen and host response | Systemic bacillary load, inflammatory responses, HIV status, and age in severe HIV-associated TB. [884] |
| Immunological biomarkers | Antibody responses to ESAT-6/CFP-10, Ag85A, HspX, and Rv2626c; CD4+CD8+ double-positive T-cell profiles. [942][892] |
| Treatment and prognosis | ATB-DILI prediction models and survival-based prognostic factors in drug-resistant TB. [908][931] |
| Health-system factors | Patient delay, evaluated in a meta-analysis of 42 studies involving 492,448 patients. [819] |
Definitive Therapy: Dosing, PK/PD, Duration and De-escalation
- ▸Standard DS-PTB therapy is described as a 6-month multidrug regimen, while randomized evidence evaluates 4-month and intended 8-week approaches alongside rifamycin-intensified and structurally modified regimens. [946]
- ▸Shortening should be judged by relapse prevention and regimen-specific trial evidence, not by duration alone. [946]
- ▸Ethambutol PK/PD analysis included 1,493 participants and 3,077 plasma samples but the supplied abstract does not provide numeric exposure targets or a dosing algorithm. [950]
- ▸Efavirenz PK was evaluated across the second trimester, third trimester, and 2–8 weeks postpartum during concomitant rifampin/isoniazid therapy, with or without ethambutol and pyrazinamide. [949]
- ▸A review identified 26 studies and 31 anti-tuberculosis drug-induced liver injury prediction models in East Asian populations, without establishing one universal validated stopping threshold. [908]
- ▸Contezolid evidence in tuberculosis meningitis is retrospective and small, including nine switches from linezolid because of intolerance; it does not establish routine substitution or duration rules. [951]
Scope of the updated evidence
The supplied literature primarily updates treatment duration, pharmacokinetic/pharmacodynamic (PK/PD) assessment, toxicity-risk stratification, and selected special-population evidence; it does not provide a complete replacement for established weight-band dosing tables. The most directly relevant evidence is a network meta-analysis of randomized trials in adolescents and adults with drug-susceptible pulmonary tuberculosis (DS-PTB), together with a phase 3 ethambutol PK/PD analysis and a pregnancy PK study involving efavirenz and first-line tuberculosis drugs. [946–950]
Duration and treatment shortening
Conventional DS-PTB therapy is described as a 6-month multidrug regimen. [946] The updated network meta-analysis classified randomized regimens into standard 6-month therapy, rifamycin-intensified strategies, structurally modified 6-month regimens, 4-month treatment-shortening approaches, and intended 8-week multidrug regimens. [946] This classification is clinically important because shortening therapy is not a simple calendar reduction: regimens must be compared by both treatment success and their ability to prevent relapse. [946]
The available abstract does not provide regimen-specific effect estimates, relapse percentages, noninferiority margins, or a recommendation that any individual shortened regimen should replace standard therapy. [946] Accordingly, de-escalation should not be inferred from duration alone; it should remain contingent on the regimen architecture studied, eligibility criteria, microbiologic drug susceptibility, clinical response, and the trial-defined relapse outcomes. [946] The evidence base concerns adolescents and adults with DS-PTB and should not automatically be extrapolated to drug-resistant disease, tuberculosis meningitis, spinal tuberculosis, pregnancy, or other complicated extrapulmonary presentations. [946][948]C[951]C[932]C
PK/PD and dosing considerations
Ethambutol PK was evaluated using nonlinear mixed-effects modeling in 1,493 participants and 3,077 plasma samples from Study 31/ACTG A5349. [950] The analysis was designed to identify covariates associated with lower exposure, quantify exposure–efficacy and exposure–safety relationships, and explore dosing considerations that optimize benefit and risk. [950] These data support exposure-aware review of ethambutol dosing rather than assuming that a uniform dose produces equivalent exposure in every patient. [950] However, the supplied abstract does not report the final covariate coefficients, target exposure thresholds, dose-adjustment algorithm, or a validated therapeutic-drug-monitoring protocol; therefore, no new numeric ethambutol dose or PK target can be responsibly assigned from this reference alone. [950]
Efavirenz PK was studied prospectively in pregnant women living with HIV receiving daily efavirenz with rifampin and isoniazid, with or without ethambutol and pyrazinamide. [949]C Intensive 24-hour sampling was performed during the second trimester, third trimester, and 2–8 weeks postpartum when eligible, with assessment of AUC0–24, Cmax, Cmin, and apparent oral clearance. [949]C These findings are relevant when tuberculosis therapy is coadministered with antiretroviral treatment during pregnancy, but the supplied abstract does not report the numerical PK results or establish a tuberculosis-drug dose modification. [949]C
De-escalation, toxicity, and special forms of TB
A systematic review of anti-tuberculosis drug-induced liver injury prediction models in East Asian populations identified 26 studies and 31 models. [908] This supports structured baseline risk assessment and active toxicity surveillance when considering continuation, modification, or de-escalation, but the supplied abstract does not identify a single validated model or provide a universal stopping threshold. [908]
For tuberculous meningitis, a retrospective comparison included 16 patients treated with contezolid-containing regimens and 32 treated with linezolid-containing regimens; nine patients in the contezolid group had switched from linezolid because of intolerance. [951]C The report characterized contezolid as having comparable efficacy and favorable safety, but its retrospective design and small sample do not establish a standard dose, duration, or routine substitution strategy. [951]C
Spinal tuberculosis in pregnancy remains supported mainly by case reports and small series, and a 2026 systematic review explicitly noted that the evidence is insufficient for evidence-based management guidance. [948]C Pediatric tuberculosis meningitis likewise remains a severe condition with diagnostic and outcome challenges in a small retrospective series, limiting direct extrapolation of adult DS-PTB shortening strategies. [932]C
Practical evidence boundary
The current evidence supports evaluating shortened regimens only within validated DS-PTB populations and trial-defined architectures, using relapse control—not treatment duration alone—as the decisive endpoint. [946] It supports attention to ethambutol exposure variability, pregnancy-related and drug-interaction PK, and individualized toxicity surveillance, while confirming that the supplied references do not justify new universal numeric dosing, PK targets, or de-escalation rules. [908–950]
| Domain | Updated evidence | Clinical implication |
|---|---|---|
| DS-PTB duration | Randomized-trial network meta-analysis classified standard 6-month, rifamycin-intensified, structurally modified 6-month, 4-month, and intended 8-week regimens. [946] | Use only regimen-specific evidence; prioritize relapse control. [946] |
| Ethambutol PK/PD | Nonlinear mixed-effects analysis: 1,493 participants and 3,077 plasma samples from Study 31/ACTG A5349. [950] | Consider exposure variability; no numeric target or adjustment algorithm is reported in the supplied abstract. [950] |
| Pregnancy and ART interaction | Efavirenz PK was measured during rifampin/isoniazid therapy, with or without ethambutol/pyrazinamide, in the second trimester, third trimester, and postpartum. [949]C | Pregnancy-specific PK assessment is relevant; no dose change can be derived from the abstract. [949]C |
| Hepatotoxicity | Review of 26 studies and 31 prediction models in East Asian populations. [908] | Risk stratification may inform monitoring and treatment modification, but no universal threshold is established here. [908] |
| TB meningitis | Retrospective contezolid cohort: 16 patients versus 32 receiving linezolid; 9 contezolid patients switched because of linezolid intolerance. [951]C | Potential alternative when intolerance occurs, but not a standard de-escalation pathway. [951]C |
History and Evolution of Treatment
- ▸Contemporary TB treatment is evolving from antimicrobial delivery alone toward regimen optimization, adherence support, individualized risk assessment, and post-treatment care.[745][811][831][845][844]
- ▸Time-to-positivity and pharmacometric machine-learning models may support earlier prediction of **2-month culture conversion** during drug development.[745]
- ▸Digital adherence tools can combine daily reporting, bidirectional communication, education, and biochemical dose verification.[831]
- ▸DR-TB care increasingly uses risk prediction to prevent loss to follow-up and its consequences for transmission and resistance.[845]
- ▸Positive acid-fast bacilli smears after treatment require culture and clinical confirmation because not all represent recurrent *M. tuberculosis*.[813]
- ▸Modern TB pathways incorporate latent-TB screening, active case finding, contact investigation, genomic resistance analysis, toxicity surveillance, and recognition of mimicking diseases.[765][836][804][816][757][807]
Scope of the current evidence
The supplied literature does not provide a conventional chronological account of tuberculosis (TB) treatment from the pre-antibiotic era onward. Instead, it documents the contemporary evolution of care from prolonged antimicrobial therapy alone toward integrated, risk-adapted, digitally supported, and biologically informed management. The evidence spans drug-susceptible TB, drug-resistant TB (DR-TB), pediatric care, treatment monitoring, adherence support, toxicity recognition, and post-treatment evaluation.[811][831][845][839]D[813][769]D
From antimicrobial treatment to treatment optimization
Modern TB drug development increasingly emphasizes shortening effective therapy, improving bacteriological response, and selecting regimens using early predictive biomarkers. Phase 2a studies traditionally evaluate early bactericidal activity over approximately 2 weeks, frequently using time-to-positivity, whereas subsequent phase 2b studies assess culture conversion over approximately 8 weeks.[745] Pharmacometric and machine-learning analyses are now being used to connect early time-to-positivity trajectories with the probability and timing of 2-month culture conversion, potentially allowing ineffective regimens to be identified earlier in development.[745] This represents a shift from relying solely on final treatment outcomes toward using quantitative, model-informed indicators to accelerate regimen evaluation.[745]
The treatment paradigm is also expanding beyond direct antimicrobial activity. Multidrug-resistant and extensively drug-resistant TB require prolonged and complex regimens that may have limited efficacy, substantial toxicity, and difficult adherence demands.[769]D Current research therefore considers the gut microbiota as a contributor to systemic immunity, metabolism, drug disposition, and treatment response, with microbiota-directed strategies proposed as a future adjunct to antimicrobial therapy.[769]D The cGAS–STING pathway has likewise been identified as a therapeutically relevant regulator of pulmonary infectious and sterile inflammation, although the available review describes therapeutic implications rather than an established TB treatment.[846]D
Adherence and patient-centred treatment support
A major evolution in TB care is the recognition that treatment success depends not only on drug selection but also on sustained engagement with care. A randomized controlled trial in newly diagnosed pulmonary TB evaluated LEARNS model-based self-management education across six domains: self-management capacity, TB prevention and control knowledge, anxiety, depression, social support, and treatment efficacy.[811] This approach reflects a movement from instruction based primarily on medication delivery toward structured education addressing psychological and social determinants of adherence.[811]
Digital adherence technologies represent a further development. In a pragmatic randomized trial of 555 adults with newly diagnosed drug-susceptible TB in Argentina, a patient-centred TB Treatment Support Tools intervention was added to standard care.[831] The intervention combined daily adherence reporting, bidirectional messaging with treatment supporters, educational material, and weekly urine-based isoniazid testing for adherence verification.[831] These functions illustrate an evolution from episodic clinic-based supervision toward continuous, two-way monitoring that can identify missed doses and provide timely support.[831]
Risk stratification is also becoming more prominent in DR-TB services. A multicentre retrospective study of 1,097 patients treated between 2010 and 2025 in Ethiopia developed and internally validated a clinical risk score for loss to follow-up.[845] Such prediction tools are intended to identify patients needing early intervention because loss to follow-up can promote ongoing transmission, additional drug resistance, and increased morbidity and mortality.[845]
More differentiated diagnosis and treatment pathways
Treatment planning increasingly depends on distinguishing active disease, latent infection, asymptomatic disease, relapse, and non-TB mimics. Active screening in two Italian regional centres identified 56.5% of pulmonary TB cases as asymptomatic and 43.5% as symptomatic, supporting earlier detection among high-risk groups rather than waiting for symptoms to trigger investigation.[765] Household-contact investigation remains important: adult contacts of patients with smear-positive pulmonary TB experience increased risk because of prolonged, close exposure in shared environments.[836]
The interpretation of microbiological results after treatment has also become more nuanced. Among patients with previously successfully treated pulmonary TB who later had positive acid-fast bacilli smears, only 32.1% belonged to the group with culture-confirmed M. tuberculosis; the remainder had non-M. tuberculosis findings.[813] This supports confirmatory culture and clinical assessment before assuming recurrent active TB or restarting therapy.[813] Screening before biologic treatment has similarly become integrated into personalized care: in a psoriasis cohort without documented prior TB, 285 of 1,126 patients were interferon-gamma release assay positive, emphasizing the role of latent-TB assessment before immunosuppression.[804] Patients with inborn errors of immunity require tailored evaluation using exposure history, symptoms, tuberculin skin testing, repeat testing when initially nonreactive, and chest imaging where available.[793]C
Safety, special populations, and outcomes after treatment
Contemporary treatment evolution includes more systematic recognition of adverse effects. A case of nephrotic syndrome with minimal-change disease developed during rifapentine, isoniazid, ethambutol, and tiopronin therapy; withdrawal of the suspected agents was part of management.[757]C This illustrates the need to investigate new renal or systemic findings rather than attributing all complications to TB itself.[757]C
Pediatric services increasingly use standardized outcome definitions and process audits. In a French tertiary-centre cohort of 123 children treated from 2014 to 2024, 60.9% achieved successful treatment; unfavorable outcomes were associated with suboptimal adherence, dosing errors, and incomplete follow-up.[839]D Post-treatment care is also evolving because pulmonary TB survivors may remain at increased risk of chronic respiratory symptoms and chronic obstructive pulmonary disease, according to a systematic review and meta-analysis.[844]C
Finally, treatment selection must account for zoonotic transmission, resistance, and diagnostic mimics. Whole-genome sequencing of Mycobacterium tuberculosis complex isolates from humans and cattle in northern Tanzania was used to characterize circulating strains, resistance-associated mutations, and phylogenetic relationships.[816] Paragonimiasis may imitate pulmonary TB, and direct visualization of live worms during thoracoscopy allowed antiparasitic rather than anti-TB treatment in a reported case.[807]C The supplied studies on postpartum HIV care, vitiligo, lung cancer, and hepatic granulomas from ANCA-associated vasculitis do not provide direct evidence for TB treatment evolution.[843][830][794][746]C
| Treatment-era emphasis | Current evidence and implication |
|---|---|
| Antimicrobial efficacy | Early bactericidal activity and culture-conversion endpoints remain central, with modeling used to predict response earlier.[745] |
| Adherence supervision | Self-management education and digital tools address knowledge, mental health, communication, and dose verification.[811][831] |
| DR-TB retention | Clinical risk scores aim to identify patients at risk of loss to follow-up.[845] |
| Diagnostic precision | Active screening, contact investigation, confirmatory culture, and latent-TB testing refine treatment pathways.[765][836][813][804] |
| Safety and survivorship | Recognition of renal toxicity and chronic respiratory sequelae extends care beyond completion of therapy.[757]C[844]C |
| Precision public health | Genomic characterization supports surveillance of resistance and transmission across human–animal interfaces.[816] |
Antimicrobial Resistance and Stewardship
- ▸In 2024, approximately 390,000 people developed MDR/RR-TB, while treatment coverage was only 42% [888].
- ▸WGS identified at least rifampicin resistance in 74.8% of 4,162 pretreatment isolates analyzed in Ukraine during 2019–2023 [958].
- ▸Molecular resistance testing should distinguish exact-variant detection, drug-level inference, and the clinical decision impact of a result [965].
- ▸Monthly audiometry is important when injectable agents are used; treatment-emergent hearing loss occurred in 45.4% of monitored patients in a prospective study [960].
- ▸Resistance surveillance should integrate phenotypic DST, molecular testing, WGS, lineage analysis, and care-cascade indicators [958][959][965].
Global burden and surveillance
Drug-resistant tuberculosis (DR-TB) remains a major obstacle to tuberculosis control. Approximately 390,000 people developed multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2024, while treatment coverage was only 42%, indicating substantial gaps in diagnosis, linkage to care, and treatment delivery [888]. Resistance reflects resistance-associated mutations, bacterial adaptation, host–pathogen interactions, and drug–target processes; contemporary research increasingly examines these mechanisms through genomic, molecular, and systems-level approaches [888].
Drug-resistance surveillance should distinguish phenotypic susceptibility from molecularly inferred resistance and should monitor both individual resistance profiles and transmission. In Ukraine, whole-genome sequencing (WGS) was performed on 4,162 pretreatment Mycobacterium tuberculosis complex isolates collected from 18 regions during 2019–2023; 74.8% (3,112/4,162) were at least rifampicin resistant [958]. The study specifically assessed resistance prediction, phylogenetic structure, genomic clustering, and temporal trends during the COVID-19 pandemic, large-scale displacement, health-system disruption, and changes in DR-TB policy [958]. WGS-based surveillance in Lebanon similarly evaluated population structure, resistance-associated mutations, and transmission dynamics in isolates collected during 2018–2024, comparing genomic predictions with phenotypic drug-susceptibility testing and line-probe assays [966]D.
Resistance patterns and mechanisms
Pre-XDR-TB and XDR-TB remain important concerns among patients with MDR-TB. A systematic review and meta-analysis was undertaken to estimate their pooled prevalence among Ethiopian MDR-TB patients using PRISMA methods and a restricted-maximum-likelihood random-effects model; the supplied evidence does not report the pooled numerical estimates [957]. Regional estimates should therefore be interpreted alongside local testing coverage, laboratory methods, and changing resistance definitions [957].
The Beijing lineage is globally distributed and has been associated with high transmissibility and multidrug resistance. A systematic review and meta-analysis evaluated its prevalence through genotyping-based studies published before December 2024, with subgroup analyses by molecular-typing method, WHO region, and time period [959]. These findings support lineage-aware surveillance, although lineage assignment alone should not replace individual drug-susceptibility testing [959].
Resistance determinants continue to be identified for individual drugs. Analysis of 6,547 clinical M. tuberculosis whole-genome sequences identified 29 coding-region single-nucleotide polymorphisms in dfrA and eight mutations in the upstream thyA–dfrA region; selected variants were evaluated with thermal-stability analysis, reporter assays, and para-aminosalicylic-acid susceptibility testing [969]D. This work is relevant to stewardship because resistance interpretation must account for regulatory and coding mutations rather than relying only on a limited catalog of established variants [969]D. Fluoroquinolone resistance is also clinically important: moxifloxacin use is limited by resistance, and DNA gyrase remains an attractive target because M. tuberculosis lacks topoisomerase IV [967]D.
Diagnostics and treatment decisions
Rapid molecular testing and sequencing should be used to identify resistance early and to guide regimen selection, with phenotypic confirmation or broader testing when molecular results are uncertain. A review of CRISPR-enabled diagnostics proposed a mutation-to-drug-to-decision framework separating assay validity, exact-variant detection, drug-level inference, and clinical decision impact [965]D. It emphasized target accessibility, minority-allele preservation, multiplexing, direct-specimen testing, and sequencing enrichment; however, the current evidence base remains dominated by analytical studies, isolate-based evaluations, and small direct-specimen investigations rather than prospective multicentre outcome studies [965]D.
Stewardship requires an effective care cascade, not simply an accurate resistance result. Among older patients with MDR/RR-TB, a retrospective Chinese cohort of 667 patients aged ≥65 years assessed attrition across diagnosis, treatment initiation, and subsequent retention stages, highlighting the need to identify age-specific barriers [914]. In rural Eastern Cape facilities, routine DR-TB outcome data from 2020–2024 were examined as governance signals because increasing proportions of outcomes classified as “not evaluated” can undermine the validity of reported treatment-success estimates [962]. Survival-based evidence is being synthesized to identify prognostic factors for mortality across DR-TB populations using adjusted hazard ratios from longitudinal studies; the supplied abstract does not provide the pooled estimates [931].
Safety and responsible antimicrobial use
Active safety monitoring is integral to DR-TB stewardship. In a nationwide prospective study of patients with rifampicin-resistant TB receiving injectable agents, monthly audiometry found treatment-emergent hearing loss in 45.4% (89/196) of patients without severe baseline hearing loss, including treatment-emergent severe hearing loss in 23.5% (46/196); cumulative and weight-standardized cumulative doses were examined as risk factors [960]. These findings support baseline and serial hearing assessment when injectable drugs are used and careful reassessment of whether their risks outweigh benefits [960].
Evidence for special populations remains limited. A review of 20 congenital-TB cases treated with levofloxacin-containing regimens found that at least 80% (16/20) were preterm infants; the evidence consisted of two new cases plus 18 cases from 17 reports and should not be generalized to routine pediatric practice without susceptibility and safety considerations [953]C. Other supplied reports address pediatric tuberculous meningitis, tuberculous pleural empyema, and postoperative spondylodiscitis mimicking TB, but do not provide comparative evidence for antimicrobial-resistance stewardship [932]C[961]C[963]C. A curated knowledgebase integrating 75,170 associations from 1,246 publications may support future evidence retrieval, but it is a resource rather than clinical-outcome evidence [968]D.
| Priority | Evidence and implication |
|---|---|
| Detect resistance early | Molecular assays, WGS, and phenotypic DST provide complementary information; molecular results may require confirmatory or broader testing [958][965]D[966]D |
| Interpret variants carefully | Resistance may involve coding and upstream regulatory mutations, including dfrA and thyA–dfrA variants [969]D |
| Monitor transmission | Beijing-lineage prevalence, genomic clustering, and population structure can inform surveillance, but lineage does not replace individual DST [958][959] |
| Protect treatment continuity | Diagnosis-to-treatment attrition and “not evaluated” outcomes identify health-system weaknesses [914][962] |
| Monitor toxicity | Baseline and serial audiometry are necessary when injectable agents are prescribed [960] |
Complications
- ▸TBM may cause hydrocephalus, vasculitic infarcts, cranial-nerve palsies, encephalitis, death, and permanent neurological sequelae [978][932][951].
- ▸Paradoxical reactions occur in approximately **30%** of TBM patients in the cited prospective study and may cause clinical deterioration or vasculitic infarction [978].
- ▸PTLD can persist after microbiological cure; cited spirometric impairment thresholds were **FEV1/FVC <70%** or **FVC <80% predicted** [974].
- ▸Spinal TB during pregnancy may produce maternal neurological and obstetric complications, but available evidence is limited mainly to case reports and small series [948].
- ▸TPT safety requires particular attention during pregnancy, childhood, and treatment with immunosuppressive medications [905][973][976].
- ▸The supplied evidence supports monitoring for treatment toxicity but does not provide complete numeric estimates for several regimen-specific adverse events [950][972][973].
Overview
Tuberculosis (TB) complications arise from direct tissue invasion, immune-mediated inflammation, dissemination to extrapulmonary sites, comorbidity, or toxicity of treatment. The supplied contemporary evidence particularly addresses tuberculous meningitis (TBM), spinal TB in pregnancy, post-tuberculosis lung disease (PTLD), HIV-associated disease, and adverse events related to preventive or therapeutic regimens.
Neurological and central nervous system complications
TBM is among the most severe forms of extrapulmonary TB and is associated with substantial mortality and persistent neurological disability [951]C[891]. Inflammation may produce basal meningeal exudates, cerebral vasculitic infarcts, hydrocephalus, cranial-nerve palsies, encephalitis, and irreversible neurological sequelae [978][932]C. In a retrospective pediatric series of 21 patients aged 3 months to 17 years, delayed recognition was specifically associated with progression from meningeal inflammation to brain-parenchymal involvement and potentially permanent neurological injury [932]C.
Paradoxical reaction (PR)—clinical or radiological deterioration during otherwise appropriate TB treatment—is an important complication of TBM. A prospective study of 151 treatment-naïve patients reported that PR occurs in approximately 30% of patients and contributes to clinical deterioration; the study evaluated baseline serum and cerebrospinal-fluid inflammatory biomarkers as predictors of PR and vasculitic infarction [978]. A large retrospective comparison also specifically examined disease severity in patients with pulmonary TB complicated by CNS TB, including grading by the Medical Research Council system, supporting the clinical importance of CNS involvement as a distinct severe phenotype [944]C.
Treatment-related neurological complications may also influence management. Linezolid is used in TBM because of its central nervous system penetration but is limited by significant adverse events; in a retrospective study, contezolid was evaluated as an alternative in 16 patients, including 9 who switched from linezolid because of intolerance [951]C. The available abstract reports comparable efficacy and favorable safety for contezolid but does not provide sufficient detail to define comparative rates of individual toxicities [951]C.
Respiratory sequelae
Microbiological cure does not always restore normal pulmonary function. PTLD is characterized by persistent respiratory impairment after completed TB treatment and may include obstructive or restrictive ventilatory abnormalities, reduced exercise capacity, respiratory-muscle weakness, and impaired quality of life [974]. In a randomized trial of 120 adults with confirmed PTLD and spirometric impairment—defined as FEV1/FVC <70% or FVC <80% predicted—pulmonary rehabilitation with inspiratory-muscle training was assessed against standard care for functional capacity, respiratory-muscle strength, and health-related quality of life [974].
Airway-clearance problems can complicate severe respiratory disease. N-acetylcysteine (NAC) has mucolytic and antioxidant properties, and a randomized trial in newly diagnosed pulmonary TB evaluated nebulized or oral NAC alongside standard HRZE therapy, measuring sputum conversion, liver-function indices, inflammatory and oxidative-stress markers, and adverse events [972]. A separate systematic review assessed NAC in critically ill patients with respiratory disease, including mortality, duration of mechanical ventilation, and intensive-care length of stay [921]. These studies evaluate possible interventions and outcomes but, from the supplied abstracts, do not establish NAC as standard treatment for TB complications [972][921].
Spinal, obstetric, and fetal complications
Spinal TB in pregnancy can create simultaneous diagnostic, neurological, and obstetric challenges [948]C. The available systematic review comprised case reports and small series and descriptively pooled reported maternal neurological recovery and live births; because the evidence was based on reported cases rather than comparative studies, the findings should not be interpreted as reliable population-level risks [948]C.
TB preventive treatment (TPT) during pregnancy has also been evaluated in women living with HIV. A propensity-score-weighted Ugandan routine-care cohort examined isoniazid monotherapy exposure during pregnancy and a composite of miscarriage, stillbirth, low birth weight, neonatal complications, or maternal or neonatal death [976]. The supplied abstract does not provide the final effect estimates, so it cannot establish whether isoniazid increased or decreased these outcomes [976].
Treatment-related and comorbidity-associated complications
TPT safety is particularly relevant in people receiving or preparing to start immunosuppressive medication. A systematic review and meta-analysis of 27 studies involving 3,184 participants evaluated adverse-event-related discontinuation across TPT regimens using random-effects models [973]. The abstract identifies discontinuation as the primary safety outcome but does not provide regimen-specific pooled estimates in the supplied information [973]. In children and adolescents younger than 18 years with TB infection or drug-susceptible TB exposure, a systematic review and network meta-analysis evaluated the effectiveness and safety of available preventive regimens, including randomized trials updated through 12 December 2024 [905].
Ethambutol remains associated with the need for exposure and safety monitoring. A phase 3 pharmacokinetic/pharmacodynamic analysis of 1,493 participants evaluated factors associated with exposure and relationships between ethambutol exposure, efficacy, and safety outcomes [950]. The supplied abstract does not report the specific incidence of toxicities or a definitive exposure threshold [950]. In patients with TB and diabetes, lipid abnormalities have been systematically compared with TB-only and diabetes-only groups, indicating that metabolic comorbidity may accompany additional biochemical disturbances, although the supplied abstract does not provide the pooled lipid estimates [907].
Clinical implications
Complication assessment should therefore include neurological examination and brain or spinal evaluation when indicated, pulmonary-function and functional assessment after treatment, obstetric and fetal surveillance in pregnancy, and active review of drug toxicity and comorbidities [932]C[948]C[974][973][950]. Evidence strength varies substantially: randomized trials and meta-analyses inform rehabilitation, preventive-treatment safety, and pharmacokinetics, whereas spinal TB in pregnancy and several CNS-TB outcomes remain supported mainly by retrospective studies, case series, or observational cohorts [948]C[951]C[932]C[944]C.
| Domain | Documented or evaluated complications | Evidence |
|---|---|---|
| CNS TB/TBM | Hydrocephalus, vasculitic infarcts, cranial-nerve palsies, encephalitis, neurological sequelae, paradoxical reaction | [932]C[978][944]C |
| Pulmonary sequelae | Persistent ventilatory impairment, reduced exercise capacity, respiratory-muscle weakness, impaired quality of life | [974] |
| Pregnancy | Maternal neurological and obstetric complications; miscarriage, stillbirth, low birth weight, neonatal complications, maternal or neonatal death evaluated with TPT | [948]C[976] |
| Treatment and comorbidity | Adverse-event discontinuation with TPT, ethambutol safety outcomes, metabolic lipid alterations | [973][950][907] |
Prognosis and Natural History
- ▸TPT effectiveness was studied across high-, medium-, and low-burden settings, but the supplied evidence does not provide pooled duration-of-protection estimates; protection should not be presumed uniform. [906]
- ▸For drug-susceptible pulmonary TB, standard therapy is framed as 6 months; shorter regimens require regimen-specific evidence for relapse prevention. [946]
- ▸In a Peruvian DR-TB cohort, 49.5% had an unsuccessful outcome, including 34.1% loss to follow-up, 3.6% treatment failure, and 11.8% death. [982]
- ▸Incomplete evaluation and loss to follow-up can distort apparent programme success and are themselves clinically important prognostic signals. [962][982]
- ▸The supplied abstracts do not provide numerical outcome estimates for several high-risk groups, including children living with HIV, pregnant women living with HIV, people receiving immunosuppressive medications, and patients receiving immune-checkpoint inhibitors. [973][976][979][985]
Overview
Tuberculosis (TB) has a variable natural history determined by the transition from Mycobacterium tuberculosis infection to active disease, the site and extent of disease, antimicrobial susceptibility, host immune status, treatment adherence, and access to effective care. The supplied updated evidence does not provide a single contemporary population-wide mortality estimate for all TB; instead, it clarifies how prognosis is influenced by preventive-treatment durability, regimen duration, drug resistance, treatment continuity, immunosuppression, cancer therapy, and health-system performance. [906][931][982]
Latent infection and progression to disease
Tuberculosis preventive treatment (TPT) is intended to reduce progression from evidence of M. tuberculosis infection to active TB. A systematic review and individual-participant meta-analysis specifically evaluated the time to TB among close contacts and people with evidence of infection across high-, medium-, and low-burden settings, with the objective of determining how long protection persists and whether effectiveness varies by epidemiological context. [906] The supplied abstract describes the study question and eligible evidence but does not provide the pooled duration of protection or setting-specific effect estimates; therefore, the durability of protection should not be represented as uniform across populations on the basis of the available extract. [906]
The prognostic balance of TPT also depends on safety and competing clinical risks. A systematic review examined adverse events among people receiving or about to initiate immunosuppressive medications, including pooled adverse-event-related discontinuation stratified by regimen, but the supplied abstract does not include the numerical pooled estimates. [973] A Ugandan routine-care cohort evaluated isoniazid monotherapy during pregnancy among women living with HIV and assessed miscarriage, stillbirth, low birth weight, neonatal complications, and maternal or neonatal death; the available extract does not report the adjusted outcome estimates. [976] These studies support individualized assessment of preventive-treatment safety but do not establish that pregnancy, HIV, or immunosuppressive therapy independently determines long-term TB prognosis. [973][976]
Drug-susceptible pulmonary TB
For drug-susceptible pulmonary TB, the conventional treatment duration remains 6 months in the randomized-trial evidence framework evaluated by a network meta-analysis. The analysis compared standard therapy with rifamycin-intensified strategies, structurally modified 6-month regimens, 4-month treatment-shortening approaches, and regimens involving an intended 8-week intensive phase, with particular emphasis on long-term effectiveness and relapse prevention. [946] The supplied abstract does not provide comparative relapse estimates; consequently, shorter treatment should not be assumed to have equivalent relapse protection unless supported by the specific regimen and trial evidence. [946]
Treatment continuity is an important modifiable determinant of outcome. In a Kampala cohort of 71 people assigned to video directly observed therapy, investigators measured time to first and recurrent missed video submissions and analyzed associated factors using survival models. [981] The abstract confirms that missed submissions occur during digitally monitored treatment, but it does not provide the reported median times or adjusted associations in the supplied evidence. [981] Missed monitoring events are therefore indicators of adherence risk rather than proof of treatment failure or relapse. [981]
Drug-resistant TB
Drug-resistant TB (DR-TB) carries substantial mortality despite advances in diagnosis and treatment. [931] A 2026 systematic review and meta-analysis synthesized adjusted hazard ratios from survival analyses to identify prognostic factors for all-cause mortality across forms of DR-TB; the supplied abstract does not list the pooled hazard ratios or identify which factors remained independently associated with death. [931] In Loreto, Peru, a retrospective cohort of 417 DR-TB cases recorded an unsuccessful composite outcome in 49.5%: loss to follow-up accounted for 34.1%, treatment failure for 3.6%, and death for 11.8%. [982] These data illustrate that poor outcomes are driven not only by microbiological failure but also by treatment disengagement and mortality. [982]
Routine programme statistics may underestimate or obscure prognosis when outcomes are incompletely evaluated. In rural Eastern Cape, South Africa, investigators examined DR-TB outcomes from 2020–2024 and highlighted an increasing proportion classified as “not evaluated,” interpreting routine outcome data as signals of governance and data-management performance as well as clinical performance. [962]
High-risk clinical contexts
Children living with HIV have particularly difficult TB diagnostic pathways because microbiological tests are limited; an external validation study assessed a treatment-decision algorithm in children aged 1 month to 14 years across four African countries. [979] The supplied abstract does not report diagnostic accuracy or mortality outcomes, so it cannot quantify prognosis. [979] Similarly, a cohort study evaluated active TB among lung-cancer patients receiving immune-checkpoint inhibitors, including patients with latent or previous TB, but the supplied extract does not provide the incidence or outcome estimates. [985]
A prospective Chinese cohort followed people with latent TB infection for 10 years to examine cancer-specific, all-cause, and non-cancer mortality after excluding active pulmonary TB at baseline; the available abstract does not report the hazard estimates. [980] Evidence concerning intestinal TB in the supplied case series is descriptive and focuses on clinical features and initial misdiagnosis as Crohn disease rather than long-term prognosis. [943]C
Health-system effects on prognosis
Population-level TB notification improved after an intermediary-facilitated public–private mix intervention in Viet Nam was evaluated using a quasi-experimental design, but the supplied abstract does not provide patient-level mortality or relapse outcomes. [913] A systematic review assessed the effect of COVID-19 on TB and HIV service delivery and outcome severity in low- and middle-income countries, but the extract does not provide the pooled estimates. [984]C Accordingly, disruptions in diagnosis, notification, treatment delivery, and follow-up should be recognized as potential threats to prognosis, while the magnitude of their effect cannot be quantified from the provided evidence. [913][984]C
Practical prognostic interpretation
Prognosis is best assessed using a multidimensional approach: infection risk and TPT durability, disease susceptibility and immune status, drug susceptibility, regimen-specific relapse evidence, adherence and retention, treatment toxicity, and completeness of outcome ascertainment. [906][946][931][973][981][962] The available updated studies reinforce that “treatment success” is not synonymous with microbiological cure when loss to follow-up, death, relapse, or “not evaluated” outcomes are substantial. [946][982][962]
| Prognostic domain | Updated evidence | Interpretation |
|---|---|---|
| Prevention of progression | TPT effectiveness was evaluated across high-, medium-, and low-burden settings. [906] | Duration and setting-specific protection require direct review of pooled estimates. |
| Treatment duration | Standard drug-susceptible pulmonary TB therapy was compared with 4-month and intended 8-week strategies. [946] | Shortening treatment must be judged by relapse outcomes for the exact regimen. |
| DR-TB outcomes | 49.5% unsuccessful outcomes in 417 Peruvian cases; 34.1% loss to follow-up, 3.6% failure, and 11.8% death. [982] | Retention and mortality may contribute more to poor outcomes than treatment failure alone. |
| Outcome ascertainment | Increasing “not evaluated” classifications were highlighted in rural Eastern Cape. [962] | Programme-level success rates may be unreliable when outcome completeness is poor. |
Prevention and Infection Control
- ▸BCG remains the only licensed TB vaccine, but protection against adult pulmonary TB, infection and transmission is variable or inconsistent. [989]
- ▸VPM1002 has been evaluated against BCG in a phase 3 newborn non-inferiority trial in sub-Saharan Africa; the supplied evidence does not report the final result. [877]
- ▸In immunologically vulnerable patients, TB screening may require exposure and symptom assessment, TST, repeat testing after **1–4 weeks** for an initial **0–4 mm** result, and chest imaging. [793]
- ▸A TST threshold of **≥15 mm** has been studied for context-dependent risk stratification in adolescents already meeting a **≥10 mm** threshold in a high-BCG-coverage setting. [879]
- ▸GeneXpert-guided discontinuation of airborne isolation has been systematically reviewed, but the supplied evidence does not establish a universal de-isolation threshold. [987]
- ▸TB prevention must be integrated with MDR-TB risk reduction, transplant-recipient prophylaxis planning, HIV care, refugee screening and routine vaccination. [868] [764] [870] [871] [934]
Vaccination and prevention
BCG remains the only licensed tuberculosis (TB) vaccine, although its protection against pulmonary TB in adolescents and adults is variable and its protection against infection and transmission is limited or inconsistent. [989]D In a community-based case-control study in rural Bangladesh, investigators evaluated BCG vaccination and household TB exposure among children aged 2–14 years with confirmed TB and neighborhood-matched controls; the study was specifically designed to quantify their protective effects in a high-transmission, resource-limited setting. [918] The abstract supports BCG and exposure reduction as central childhood-control strategies but does not provide the adjusted effect estimate in the available evidence. [918]
VPM1002, a recombinant BCG vaccine, was compared with standard BCG in a multicentre, double-blind, randomised phase 3 non-inferiority trial involving healthy newborns at sites across sub-Saharan Africa. [877]C The trial addressed prevention of Mycobacterium tuberculosis infection in infants; earlier phase 1 adult and phase 2 South African newborn studies had shown manageable toxicity and immunogenicity. [877]C The supplied abstract does not report the final non-inferiority result, so VPM1002 should not be described as superior to BCG on the available evidence. [877]C Experimental work in BCG-vaccinated mice found that cholesterol 25-hydroxylase deficiency enhanced dendritic-cell activation, increased CD80/CD86 expression and IL-12p70 production, and improved vaccine-induced protective T-helper-1 immunity through the IL-12–IL-2 axis; this is mechanistic preclinical evidence rather than a clinical prevention strategy. [989]D Candidate vaccines tested in goats included heat-inactivated M. bovis, phage-inactivated M. caprae and live M. microti; all were compatible with interferon-γ release-assay diagnosis using defined antigens, although standard tuberculin testing was slightly affected. [990]D
Inactivated COVID-19 vaccination has been evaluated in patients with pulmonary TB who had completed at least 3 months of anti-TB therapy. [947] A phase IV multicentre randomised trial compared these patients with healthy participants and used systems vaccinology rather than humoral responses alone; the study was designed to assess whether antibody responses reflected coordinated multi-omic immune activation. [947] The evidence therefore supports caution in interpreting antibody titres as a complete measure of vaccine responsiveness during TB treatment. [947] A separate cohort examined whether baseline SARS-CoV-2 anti-receptor-binding-domain antibody levels influenced outcomes during the first 2 months of TB treatment in newly diagnosed patients; the available abstract does not provide the outcome estimate. [878]
Screening and contact-risk assessment
TB screening in people with inborn errors of immunity included exposure history, symptom assessment, tuberculin skin testing, repeat testing after 1–4 weeks when the initial induration was 0–4 mm, and chest imaging, including radiography and computed tomography when available. [793]C This approach reflects the potential for an initially negative or weak TST response in immunologically vulnerable patients; the study evaluated 117 adults with inborn errors of immunity and followed those requiring TB treatment. [793]C In school screening in Hangzhou, China, a historical cohort assessed whether a TST induration threshold of ≥15 mm added risk stratification among adolescents aged 12–18 years who already had induration of at least 10 mm, including routine screening, outbreak-contact and previously cured-TB contexts. [879] Threshold interpretation was explicitly context-dependent in this high-BCG-coverage setting. [879]
A systematic review and meta-analysis examined demographic, clinical, socioeconomic and behavioural characteristics associated with multidrug-resistant TB in sub-Saharan Africa, using evidence published from 2000 through November 2025. [868] Its purpose was to support targeted resistance-control interventions, but the supplied abstract does not provide pooled associations. [868] A scoping review of infectious complications in African kidney-transplant recipients identified TB as an important concern in a population exposed to immunosuppression, endemic pathogens, constrained microbiological surveillance and limited access to standard prophylactic antivirals. [764] The review focused on context-adapted prophylaxis strategies and systemic gaps rather than a single TB prophylaxis regimen. [764]
Airborne infection control
A 2026 systematic review and meta-analysis evaluated whether GeneXpert MTB/RIF nucleic-acid amplification testing could guide discontinuation of airborne isolation in hospitalised patients suspected of pulmonary TB, compared with traditional acid-fast-bacillus smear microscopy. [987] GeneXpert was assessed because of its higher diagnostic accuracy and operational convenience, but the supplied abstract does not state the pooled isolation duration or establish a universal de-isolation rule. [987] Decisions should therefore remain linked to the complete clinical, microbiological and infection-control assessment rather than to an unreported threshold. [987]
Special populations and associated prevention priorities
Among people with HIV and TB in a low-incidence Italian setting, 5 of 21 patients developed TB-associated immune reconstitution inflammatory syndrome: 2 unmasking and 3 paradoxical cases. [870] Disseminated TB and shorter intervals between TB treatment and antiretroviral therapy were more common in IRIS, and inflammatory markers could assist diagnosis; these findings support close follow-up after treatment and antiretroviral initiation rather than prevention by vaccine or isolation alone. [870] Refugee-child screening data from Switzerland included 517 Ukrainian children and assessed infectious-disease testing and vaccination status; the available abstract reports test-positivity data for selected infections but does not provide a TB-specific prevalence estimate. [871] An unvaccinated 17-year-old with secondary pulmonary TB developed measles during intensive TB treatment, illustrating the importance of maintaining routine vaccination coverage alongside TB control. [934]C BCG was also studied as an immunomodulatory treatment for type 1 diabetes in a small double-blind randomised trial of 33 patients receiving 2 doses four weeks apart; this does not establish a TB-prevention indication. [869] Advanced pulmonary drug-delivery systems may enable targeted lung administration, but formulation, aerosol-performance, clearance and regulatory limitations mean that this review does not establish a prevention or infection-control intervention. [975] TB and post-TB lung changes were associated with exacerbations and mortality in a population-based COPD cohort, supporting long-term respiratory follow-up after TB, although the supplied abstract does not quantify the associations. [828]
| Area | Evidence and operational implication |
|---|---|
| Vaccination | BCG remains licensed; VPM1002 has phase 3 newborn-trial evidence, but the supplied abstract does not report the outcome. [989]D [877]C |
| Immunocompromised screening | Use exposure history, symptoms, TST, repeat testing for an initial 0–4 mm result, and imaging when indicated. [793]C |
| School screening | ≥15 mm has been evaluated as an additional, context-dependent threshold among adolescents with ≥10 mm induration. [879] |
| Airborne isolation | GeneXpert versus smear-guided de-isolation has been meta-analysed, but no universal stopping rule is reported here. [987] |
| High-risk settings | MDR-TB characteristics, kidney-transplant infections and HIV-associated IRIS require setting-specific control pathways. [868] [764] [870] |
Special Hosts and Populations
- ▸Offer TB preventive treatment as part of HIV care, including for people initiating ART in the contemporary treat-all era, after excluding active TB. [782]
- ▸Advanced HIV disease is associated with severe HIV-associated TB and high mortality; systematic screening and rapid evaluation are essential. [784][884][886]
- ▸One month of rifapentine plus isoniazid has pharmacokinetic implementation data with dolutegravir-based ART, but evidence is limited by a sample of 15 participants and a single-arm design. [832]
- ▸Integrate TB screening into antenatal care and maintain HIV treatment engagement during the postpartum period. [885][843]
- ▸Recognize paradoxical reactions in children with CNS TB after at least 10 days of treatment and evaluate deterioration comprehensively. [785]
- ▸Use age-sensitive approaches for older adults and risk-stratification tools for HIV-negative disseminated TB only after appropriate validation. [795][802]
- ▸Prevent medicine stock-outs because interruptions can compromise integrated HIV–TB services. [883]
People living with HIV
People living with HIV remain a priority population for tuberculosis (TB) prevention, screening, diagnosis, and treatment because advanced HIV disease is associated with severe illness and high mortality from TB. [784][884] In a prospective cohort study emulating six randomized clinical trials, Shah and colleagues evaluated the programmatic effectiveness of TB preventive treatment (TPT) among people with HIV who were initiating antiretroviral therapy (ART) in Haiti, Kenya, Nigeria, Uganda, Ukraine, and Zimbabwe between 2018 and 2021. [782] The study was designed to address the contemporary context in which ART is offered regardless of CD4-cell count, rather than the earlier trial context in which ART eligibility was more restricted. [782] TPT should therefore be considered an integral component of HIV care and not limited to individuals with advanced immunosuppression, subject to exclusion of active TB and local guideline criteria. [782]
Severe HIV-associated TB is frequently encountered among adults hospitalized with severe febrile illness in Uganda; it affected 18% of participants in the urban discovery cohort described by Ross and colleagues, with validation conducted in a rural cohort. [784] Proteomic analyses identified immune signatures associated with severe HIV-associated TB, supporting the concept that severe disease represents a distinct inflammatory and immunopathological phenotype rather than uncomplicated pulmonary TB. [784] In another prospective cohort of adults admitted with severe HIV-associated TB, quantified systemic Mycobacterium tuberculosis pathogen load, inflammatory responses, and age interacted in relation to mortality. [884] Age should therefore be considered alongside pathogen burden and inflammatory severity when assessing prognosis in adults with HIV-associated TB. [884]
People with advanced HIV disease require systematic TB screening because TB remains a leading cause of death in this group in high HIV-burden settings. [886] A retrospective implementation analysis in Maputo, Mozambique, evaluated digital chest radiography with computer-aided detection among 487 new patients with advanced HIV disease; 238 underwent digital chest radiography with computer-aided interpretation as part of systematic TB screening. [886] This experience supports the operational use of digital radiography and computer-aided detection where trained radiology personnel are limited, although the study assessed implementation in a specialized clinic and should not be generalized without local validation. [886]
Short-course TPT can be useful in advanced HIV disease, where adherence and drug interactions may influence regimen selection. [832] In a single-arm pharmacokinetic study of 15 adults with advanced HIV disease, once-daily dolutegravir-based ART was administered with 1 month of daily rifapentine plus isoniazid (1HP) while participants also received fluconazole for cryptococcal meningitis. [832] The study specifically addressed concern about rifapentine–ART interactions and measured dolutegravir, rifapentine, and fluconazole concentrations during intensive pharmacokinetic sampling. [832] Because this was a small, single-arm pharmacokinetic study, its findings support feasibility but do not establish comparative clinical effectiveness or safety for all patients with advanced HIV disease. [832]
Pregnancy and the postpartum period
Pregnancy is an important setting for TB screening because maternal TB threatens maternal and neonatal health, particularly in low- and middle-income countries. [885] A systematic review of policies, practices, and perceptions across global settings found that implementation of TB screening within antenatal care remains inconsistent despite promotion of antenatal integration by WHO. [885] Antenatal programs should therefore define screening pathways, ensure access to diagnostic evaluation, and address implementation barriers rather than relying solely on policy availability. [885]
Postpartum women living with HIV may require differentiated ART delivery to sustain engagement and viral suppression, which is relevant to reducing the risk of HIV-associated TB. [843] An individual-participant-data network meta-analysis compared adherence clubs and integrated maternal and child healthcare with standard primary-health-care ART clinics in two randomized trials from Cape Town, South Africa, assessing viral suppression at 6 and 12 months postpartum. [843] These models should be interpreted as HIV-care strategies that may support continuity of treatment; the cited study evaluated viral suppression, not TB incidence directly. [843]
Children and newborns
Children with central nervous system TB may develop paradoxical reactions, defined in one prospective cohort as new or worsening TB lesions or symptoms after initial improvement following at least 10 days of anti-TB treatment. [785]C In this study, children aged 6 months to 14 years with newly diagnosed CNS TB were followed with clinical assessment, cerebrospinal-fluid analysis, and neuroimaging, and functional outcomes were assessed at 6 months using the Pediatric Cerebral Performance Category scale. [785]C Clinical deterioration after initial improvement should therefore prompt assessment for paradoxical reaction while also excluding treatment failure, drug resistance, complications, and alternative diagnoses. [785]C
BCG vaccination protects infants against severe forms of TB, although protection against pulmonary TB, infection, and transmission is variable or limited. [877]C A multicentre, double-blind, phase 3 non-inferiority trial in sub-Saharan African newborns compared recombinant BCG vaccine VPM1002 with conventional BCG for prevention of M. tuberculosis infection. [877]C The trial included 10 main sites and 4 satellite sites across rural and urban settings, providing evidence directly relevant to newborn populations in high-burden African settings. [877]C
Older adults and HIV-negative patients
Older adults remain an important TB population because age modifies disease burden, risk factors, and outcomes. [795][884] In Chinese adults aged 60 years and older, analysis of Global Burden of Disease 2021 data examined TB incidence, prevalence, mortality, disability-adjusted life-years, age-standardized rates, attributable risk factors, and projected trends through 2041. [795] Age-specific prevention and case-finding strategies should therefore be incorporated into population TB planning rather than treating older adults as a homogeneous extension of younger adult populations. [795]
Disseminated TB can cause multiple-organ dysfunction and high mortality even in HIV-negative patients. [802] A retrospective study of 1,122 hospitalized HIV-negative patients with disseminated or pulmonary TB developed a machine-learning early-warning model using routine laboratory tests and multidimensional lymphocyte-subset analysis. [802] Such models may assist risk stratification, but retrospective single-setting development means external validation is required before routine clinical adoption. [802]
Programmatic vulnerabilities
Medicine stock-outs affect HIV, TB, and malaria programs in low- and middle-income countries and can adversely affect health systems and patient outcomes. [883] A systematic review covering studies published from 2000 to March 17, 2026 synthesized causes, consequences, and mitigation strategies for antiretroviral and anti-TB medicine stock-outs. [883] Continuity of preventive and therapeutic TB care therefore requires procurement resilience, stock monitoring, and mitigation plans, particularly for populations dependent on integrated HIV–TB services. [883]
| Population | Key concern | Evidence-informed consideration |
|---|---|---|
| People living with HIV | Increased risk of TB and severe outcomes | Integrate TPT with ART initiation and HIV care after excluding active TB. [782] |
| Advanced HIV disease | Severe disease, mortality, and diagnostic constraints | Use systematic screening; digital chest radiography with computer-aided detection may help where radiology capacity is limited. [784][886] |
| Pregnant women | Maternal and neonatal consequences of TB | Integrate screening into antenatal care and address implementation barriers. [885] |
| Postpartum women with HIV | ART disengagement may compromise viral suppression | Consider adherence clubs or integrated maternal–child healthcare models; TB-specific effects remain unmeasured. [843] |
| Children | CNS TB and paradoxical reactions | Investigate clinical worsening after initial improvement, including paradoxical reaction and treatment failure. [785]C |
| Newborns | Severe TB prevention | BCG remains relevant; VPM1002 was evaluated against BCG in a phase 3 newborn trial. [877]C |
| Older adults | Age-related burden and mortality | Use age-specific prevention, detection, and prognostic approaches. [795][884] |
| HIV-negative disseminated TB | Multiorgan dysfunction and high mortality | Early-warning models are investigational pending external validation. [802] |
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