international tb management practices and their impact on ... · • boosting effect. bcg – the...
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International TB Management Practices and their Impact on
TB in the U.S. Eric Bihler
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Disclosure• BioMarck Pharmaceuticals
• Scientific advisory board
• Insmed Pharmaceutical• Speaker bureau
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Outline/learning objectives• TB basics- crash course
• BCG vaccine- US recommendations
• Challenges when mothers from international countries deliver their babies in the U.S. and then return to their home country
• Testing for latent infection• Indications for and limitations of IGRA
• Assessing risks of international patients and what an ideal screening process looks like
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TB basics• Genus Mycobacterium
• over 190 species• Mycobacterium avium
• Mycobacterium Tuberculosis complex• M. tuberculosis, Mycobacterium bovis, and Mycobacterium
africanum• Mycobacterium microti, Mycobacterium pinnipedii, and
Mycobacterium caprae
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Factors associated with Transmission
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Factors associated with Transmission
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Factors associated with Transmission
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How infection is established
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How infection is established
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Countries of Birth Among Non-U.S.–Born Persons Reported with TB, United States, 2017
Mexico 19%
Philippines 13%
India 9%
Vietnam 8%China …Guatemala 3%
Haiti 3%
Other 39%
*Percentages are rounded.
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• TB basics- crash course
• BCG vaccine- US recommendations
• Challenges when mothers from international countries deliver their babies in the U.S. and then return to their home country
• Testing for latent infection• Indications for and limitation of IGRA
• Assessing risks of international patients and what an ideal screening process looks like
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BCG vaccination• Bacillus of Calemette and Guerin
• Live attenuated strain on M bovis
• Derived by serial passage until less virulent• 231 times 1906- 1919
• 5 main strains account > 90%• All have different efficiency
• Most common vaccination in the world• >4 billion
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BCG vaccination- cutaneous reaction
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BCG vaccine – the good• Highly efficient in children• TB meningitis
• 73% protective• Milliary Tuberculosis
• 77% protective• Most effective when given at birth
• Decreased effectiveness in exposed to TB/NTM prior• Decreases all cause mortality
• 40% reduction in low birth wt• Decreased rates of sepsis/PNA• Association with scar formation
• Immunomodulary effects• Bladder cancer• Type I DM
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BCG vaccine- the unknown• Efficiency in Preventing adult pulmonary TB/infection
• Highly variable• Difference in strains• Location
• Duration of protection• 10-15 years• ? Lifelong
• Interpretation of TST• Within 3 months- 3-19 mm• Less than 10 at ten years post vaccination• CDC – should not influence interpretation after 10 years• Boosting effect
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BCG – the bad• Serious reactions are rare• Localized skin reaction
• Common/expected• Blue/red pustule ulceration scar
• Serious – less common• Lymphadenitis/abscess formation (1-2%)
• Can have drainage secondary to tract formation• Osteitis and osteomyelitis
• 30 per million vaccines• 4- 24 months after vaccination• Direct extension or dissemination• Treatment
• Surgical debridement – INH RIF 6-12 months• Disseminated disease
• Mostly seen in immunosuppression• HIV-infected infants ranges from 403 to 1300 per 100,000 doses
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BCG the don’t s• Contraindications
• Immunosuppression• HIV infection, congenital immunodeficiency, malignancy, or
immunosuppressive drugs such as corticosteroids and tumor necrosis factor-alpha blockers
• Pregnancy
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BCG the USA• Generally not recommended• Exceptions
• Children of adults with TB disease• Negative TST• Adult has lack of therapy/ineffective therapy/MDR TB
• Child can not take LTBI prophylaxis
• Healthcare workers• Work frequently with MDR TB and infection control policies have
been ineffective
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BCG the WHO• Countries with high burden disease
• Top 20 countries • Accounts for 80% TB
• Vaccination at birth• Not recommended for immunosuppressed• If exposed to smear positive TB at birth
• IPT for six months followed by BCG• Health care workers optional
• MDR TB• No evidence that revaccination is protective
• Not recommended• Countries with low burden disease
• < 10 per 100,000• Consideration to BCG in high risk groups
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• TB basics- crash course
• BCG vaccine- US recommendations
• Challenges when mothers from international countries deliver their babies in the U.S. and then return to their home country
• Testing for latent infection• Indications for and limitation of IGRA
• Assessing risks of international patients and what an ideal screening process looks like
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• TB basics- crash course
• BCG vaccine- US recommendations
• Challenges when mothers from international countries deliver their babies in the U.S. and then return to their home country
• Testing for latent infection• Indications for and limitation of IGRA
• Assessing risks of international patients and what an ideal screening process looks like
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TB elimination
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Testing for latent infection• No Gold Standard
• Diagnosis is indirect and based on detecting host immune response to infection (cell-mediated immunity)– Tuberculin skin test (TST)– Interferon gamma release assays (IGRA)
• Not able to accurately predict risk of reactivation
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Who to Test• Identify groups at highest risk:
– High prevalence of latent infection– More likely to reactivate or progress to disease once latently
infected
• Reduce screening groups at low risk to lessen false positives– Low risk groups likely to be exposed in future (e.g., HCW) is
one exception
• Decision to test = decision to treat
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Define high risk• Close contacts of patients with TB disease
– Over half lifetime risk of reactivation occurs in 1-2 years post-conversion
• Foreign-born (recent immigrants <5 years)– In one series, 43% of foreign-born cases with TB disease had no
indication for testing by current guidelines, 65% had been in US > 5 years
• Injection drug users
• Homeless
• Prisoners
• Other epidemiologically defined high-risk groups, may vary based on area
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Approved tests for LTBI• QuantiFERO
QuantiFeron goldT spot
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• Inject 0.1 ml of 5 TU PPD tuberculin solution intradermal on volar surface of lower arm
• Produce a wheal 6 to 10 mm in diameter
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• Measure reaction in 48 to 72 hours
• Measure induration, not erythema
• Forearm: Transversely to the long axis of the forearm
– Record in mm
• Ensure trained health care professional measures and interprets the TST
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• False positive– BCG vaccination– Non-tuberculous mycobacteria infection– Improper administration or interpretation
• False negative– Very young (<6months)– Inability to mount an immune response (e.g., HIV or TB
itself)– Recent infection (<10 weeks since exposure)– Very remote infection– Recent live virus vaccination– Improper administration or interpretation
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Interferon gama release assays• Approved by FDA
– QuantiFERON®-TB GOLD In Tube (QFT-GIT)
– T-SPOT ®.TB
• In vitro blood test
• Use antigens not found in BCG or most nontuberculous mycobacteria (ESAT-6, CFP-10, TB7.7)
• More specific, less cross-reaction with NTM
• Can cross-react with M. kansasii, M. marinum, M. szulgai
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ELISAQuantiFERON®-TB Gold In-Tube
IFN-γNil
Negative control
IFN-γPHA
Positive control
16-24 hour incubation
ESAT-6
CFP-10
TB 7.7 IFN-γ
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QuantiFERON®-TB to QFT-Plus: Evolution of QFT Technology
QuantiFERON technology: only LTBI diagnostic aid with multiple generations
1st generationQuantiFERON®-TB
2nd generationQuantiFERON®-TB Gold
(liquid antigen)
3rd generationQuantiFERON®-TB Gold
(QFT® in tube)
2001: FDA approval 2004: FDA approval 2007: FDA approval
4th generationQuantiFERON®-TB Gold Plus
(QFT®-Plus)
Q4 2014: CE-IVD 2017: FDA approved
• Measured cell-mediated immunity to tuberculin purified protein derivative (PPD)
• Breakthrough: TST becomes a blood test
• “Liquid antigen” version• Antigens specific for M.tb
with 99% specificity• New benchmark: No cross
reactivity with BCG
• Logistical advantage –remote incubation
• New benchmark: Scalable and easily automated
• >1200 peer reviewed publicatoins
• >30 million tests sold
Addition of patented CD8 antigens – potential biomarker of intracellular TB burden
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QuantiFERON®-TB Gold PlusSAME test principle-procedure …..SAME technology of QFT
QFT-Plus is an improved version of QFT, :• Sensitivity of ~94% in registration trials• Maintains high specificity • NEW: Innovative CD8+ T-cell technology
– Optimized for CD4+ and CD8+ response• Improvements in test formulation and manufacturingNEW OPTIONS:• One Li-heparin tube draw approved for transfer into QFT-Plus
tubes • 53 hour extended processing time when using single tube blood draw (requires refrigeration of
specimen between 2-8 degrees C)
QFT-Plus: potential test evolution – CD8 antigens
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T-SPOT®.TB
ESAT-6
ELISPOT
PHA
Positive control
Nil
Negative control
CFP-10CFP-10
ESAT-6
Overnight incubation
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QFT-GIT Interpretation
Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010. MMWR Vol 59, RR-5
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QFT Plus Interpretation
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T-Spot®.TB Interpretation
Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States, 2010. MMWR Vol 59, RR-5
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General Recommendations for Using IGRAs• May be used in place of (but not in addition to) a TST
in all situations for which CDC recommends tuberculin skin testing
• IGRA preferred• Hard to reach populations (e.g., homeless, migrant workers)
• Only one visit required
• People who have received BCG (either as vaccine or cancer therapy)
• TB specificity higher
MMWR, June 25, 2010/59
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General Recommendations for Using IGRAs• Both TST and IGRA may be considered
• At high risk for infection or progression (e.g., HIV) • Suspicion for TB disease exists• Further evaluation of positive TST results in individuals at
low risk for infection and progression• Confirming questionable TST results
• Other reasons: immediate hypersensitivity to PPD, convincing high risk patient with strongly positive TST to take LTBI treatment, indeterminate/borderline IGRA
MMWR, June 25, 2010/59
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General Recommendations for Using IGRAs• Use either TST or IGRA
• Contacts• Periodic screening for those with occupational
exposure, surveillance programs etc.• TST preferred
• Children < 5 yrs
MMWR, June 25, 2010/59
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• 2418 HCW screened for LTBI• TST, QTF, T spot
• Baseline, 6, 12, 18 months• At baseline – only 30 positive for all three (1%)
• + QTF 3.8%• + T spot 5%• + TST 1.8%
• 50% converted to negative on subsequent testing• Converting to positive during study common
• No one converted all three test• Majority of positive conversions subsequently neg at f/u
• Wobble effect
• Take home point – a positive test in low risk population is likely false positive
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• TB basics- crash course
• BCG vaccine- US recommendations
• Challenges when mothers from international countries deliver their babies in the U.S. and then return to their home country
• Testing for latent infection• Indications for and limitation of IGRA
• Assessing risks of international patients and what an ideal screening process looks like
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