Diagnosis and Medical Management of LTBI

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1 TB Nurse Case Management San Antonio, Texas December 8-10, 2009 Diagnosis and Medical Management of LTBI Barbara Seaworth, MD December 8, 2009 CLINICAL DIAGNOSIS AND MANAGEMENT OF LATENT TB INFECTION Barbara J Seaworth MD Barbara J Seaworth MD Medical Director Heartland National TB Center Professor of Medicine University of Texas Health Center Tyler 1

2 Guidelines on Diagnosis and Treatment of Latent TB Infection (LTBI) ATS/CDC. Treatment of Latent TB April 2000 American Academy of Pediatrics. Targeted Tuberculin Skin Testing and Treatment of LTBI in Children & Adolescents. Pediatrics 2004; 114:No4 October 2004 ATS/CDC/IDSA. Controlling Tuberculosis in the U.S. November 2005 NTCA/CDC. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis. December 2005 CDC. Guidelines for Using the QuantiFERON-TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States. December 2005 Objectives Identify the diagnostic tools used to screen for TB disease and infection Identify populations and persons at risk Describe the clinical approach to and assessment of persons at risk of TB Identify classical and atypical presentations of these individuals 2

3 Examples of Possible Referrals: Asymptomatic patient with reactive TST or (+) serum QFN Abnormal CXR in patient living in / from high TB endemic area Asthma and a positive TST in a foreign born person Contact investigation or screening referral Latent TB Infection Quiescent infection with M. tuberculosis Tuberculin skin test (TST) or Interferon Gamma Release Assay (IGRA) positive No signs/symptoms or physical findings suggestive of TB A normal or stable CXR Negative sputum smears and cultures NOT INFECTIOUS Dormant TB bacilli place person at risk for development of TB disease 3

4 Tuberculosis Disease Active infectious process involving the lungs and/or other areas of the body Patients are often sick unless they are identified as part of the contact investigation When disease involves the lungs, the person is usually infectious Assessing the Possible Risk EXPOSED LATENT TB INFECTION (LTBI) DISEASE 4

5 Pathogenesis of TB Progression to Disease Exposure (LTBI) ~0.1% per year thereafter 2-3% Second Year 5% First Year Disease No Disease (90%) INFECTION -LTBI: Class Two Those at risk of TB who are: TST Positive, CXR normal, asymptomatic Sputum, if done, negative New guidelines - no mention of age as a factor TREATMENT RECOMMENDED for: Positive at 5 and 10 mm cut-points unless contraindication Close Contacts of active case TST Converter (10 mm increase) 5

6 Who Should be Tested for LTBI? Contacts of persons with active TB HIV positive individuals Persons with medical risk factors that increase risk of progression to disease Targeted testing of high risk persons to identify those at risk of recent infection Populations at High Risk for TB Contacts of infectious persons HIV-infected persons Foreign-born persons Homeless persons Those in congregate living situations Persons who inject illicit drugs Detainees and prisoners 6

7 Tuberculosis and Substance Abuse in the United States, Oeltmann et al Arch Int Med 2008, 169; 189 Substance abuse is the most commonly reported behavioral risk factor among patients with TB in the U.S. Patients who abuse substances are more contagious and remain contagious longer because treatment failure extends periods of infectiousness Number and Rate * of Tuberculosis Cases Among U.S.- and Foreign-born Persons United States, Number (in thousands) No. of TB cases among U.S.-born persons No. of TB cases among foreign-born persons TB rate among foreign-born persons TB rate among U.S.-born persons Year Rate * Per 100,000 population. Data are updated as of February 18, Data for 2008 are provisional. 7

8 Percentage of Foreign Born TB by Years in U.S., TX Percent < Years in the U.S. 37.8% in U.S. <5yrs, 45.7% in U.S. 10 yrs or more Contacts of Active TB Case Among close contacts approximately 30% have LTBI and 1-3% have active TB disease Without treatment, approximately 5% of contacts with newly acquired LTBI progress to TB disease within 2 years Examination of contacts is one of the most important activities for identifying persons with disease and with LTBI 8

9 Medical Conditions Which Increase Risk for Progression to Active TB HIV infection Chronic renal failure Diabetes mellitus Malignancy Immunosuppressive Rx TNF Alpha blocker therapy > 15 mg Prednisone/day Transplant recipients Silicosis Why Is TB Testing Recommended Only For Select Groups? Declining TB resources led to need to focus on those activities that are most likely to be effective and lead to a decrease in the incidence of tuberculosis Identification of those with LTBI most at risk of progression to disease limits treatment to those most likely to benefit Treatment of those whose risk of disease is greater than the risk of toxicity from medication 9

10 Priorities for Targeted Testing and Treatment of LTBI Persons working in or served by clinics or CHOs providing care to HIV-infected persons Prisoners and other detainees Immigrants, and refugees Well defined groups in congregate living facilities Persons enrolled in substance abuse treatment programs Reading the TB Skin Test 10

11 Induration of 5mm Considered a Positive TST HIV positive persons Recent contacts of TB cases Fibrotic Changes on CXR c/w old (not treated) TB Patients with organ transplants or other immunosuppression Prednisone therapy 15 mg/day > 1 month Induration of 10mm Considered a Positive TST Recent arrivals (<5 yrs) high prevalence countries IVDU Residents/employees - high-risk congregate facilities (health care, prisons, shelters, etc.) TB lab personnel Persons with high-risk medical conditions Child 4 d t d lt t 11

12 Induration of 15mm Considered a Positive TST Persons with no risk factors Usually shouldn t be tested unless as part of baseline assessment for those at risk due to jobs in high risk settings Interferon Gamma Release Assays Blood tests for detecting M. tuberculosis infection Sensitized white blood cells will release IFNgamma in response to contact with TB antigens Do not differentiate latent infection from Do not differentiate latent infection from active disease 12

13 Interferon Gamma Release Assays Measures release of interferon gamma after exposure of blood to specific TB proteins in the laboratory ESAT 6 and CFP 10 (and TB 7.7) Proteins not contained in BCG vaccine or most non tuberculous mycobacteria More specific than TST Sensitivity approximately the same Probably more sensitive in immune suppressed No Cross-reactivity to BCG and Most NTMs Tuberculosis Complex Antigens Environmental Strains Antigens ESAT-6 CFP 10 ESAT-6 CFP 10 M. tuberculosis + + M. abcessus - - M. africanum + + M. avium - - M. bovis + + M. branderi - - BCG substrain M. celatum - - gothenburg - - M. chelonae - - moreau - - M. fortuitum - - tice - - M. gordonae + + tokyo - - M. intracellulare - - danish - - M. kansasii + + glaxo - - M. malmoense - - montreal - - M. marinum + + pasteur - - M. oenavense - - M. scrofulaceum - - M. smegmatis - - M. szulgai + + M. terrae - - M. vaccae - - M. xenopii

14 BLOOD TESTS FOR LTBI Quantiferon (Cellestis) Quantiferon TB-GOLD (Cellestis) T-SPOT TB (Oxford Immunotec) Quantiferon TB-Gold In-Tube (Cellestis) QuantiFERON-TB Gold (ELISA) Nil Control ESAT-6 CFP-10 Mitogen Control Obtain blood Transfer blood to wells and add antigens Culture overnight. TBinfected individuals secrete IFN- COLOR TMB OD Standard Curve Harvest supernatants and perform ELISA Wash, add substrate, incubate 30 min IFN- IU/ml Measure OD and determine IFN- levels 14

15 QuantiFERON-TB Gold In Tube Stage One Blood Incubation and Harvesting Nil Control ESAT-6 CFP-10 Mitogen Control 1. Collect blood. Incubate at 37ºC for hrs. Stage Two Human IFN-γ ELISA 2. Centrifuge tubes for 5 minutes. IFN- stable refrigerated for at tleast t8 weeks. 3. Add plasma and conjugate to ELISA plate. Incubate for 120 mins. 4. Wash and add substrate. Read absorbance after 30 min. Quantiferon Interpretation Positive: ESAT-6 and/or CFP-10 level > 035i 0.35 iu and d50% > placebo (negative) control Negative: ESAT-6 and/or CFP-10 level < 0.35 iu Indeterminate: low mitogen (positive) control or high placebo (negative) control 15

16 INDETERMINATE IGRA RESULTS 1) Poor response to mitogen that resolves with repeat assay - Delayed specimen processing - Technical errors 2) Persistent poor response to mitogen - Anergy from immunosuppression - May occur in healthy persons 3) High background - Often persistent, reasons unclear - IGRA not useful T-SPOT TB Test Also based on ESAT-6 andcfp-10 stimulation of primed lymphocytes. Does not quantitate INFγ in supernatants of cells. Assay Quantitates the number of INFγ producing cells. Currently requires separation of cells from blood (Automated system developed). 16

17 T-SPOT TB (ELISPOT) Add cells to wells coated with anti-ifn-gamma antibodies IFN-gamma binds to antibodies Each spot represents one IFN-gamma-producing cell Add second antibody and substrate, which gives color change Interpretation of Results Results are interpreted by subtracting the spot count in the NIL control well from the spot count in each of the antigens, according to the following algorithm: The test result is Positive if (ESAT-6 minus NIL) and/or (CFP-10 minus NIL) 8 spots The test result is Borderline (equivocal) where the highest of (ESAT-6 minus NIL) or (CFP-10 minus NIL) spot count is 5, 6 or 7 and retesting by collecting another sample is recommended The test result is Negative if (ESAT-6 minus NIL) and/or (CFP-10 minus NIL) 4 spots. This includes values less than zero. 17

18 Update on IGRAs: review of 38 studies on performance of IGRAs CI = confidence interval Who Should be Treated for LTBI? A decision to test is a decision to treat! Tests should only be placed on persons who would benefit from treatment Occasional tests placed for administrative p reasons and these individuals should be evaluated on a case by case basis regarding initiation of treatment 18

19 Before Treatment of LTBI: Exclude Active Tuberculosis Absence of symptoms Negative CXR Negative medical evaluation Order and wait for sputum culture if any question Standard Components of TB/TLBI Evaluation Patient History Symptoms History, co morbidities, demographics, family history Physical examination Radiologic evaluation CXR, CT, MRI Laboratory testing Tuberculin Skin Test (TST), Interferon Gamma Release Assays (IGRA): QTF Gold, QTF Gold In Tube, TSpot TB If available: CBC, LFTs,, sputum smears/cultures, Tissue histology 19

20 Clinical Evaluation: CXR Obtain CXR if new TST + or symptoms of TB May be indicated d in some asymptomatic, ti TST negative contacts at increased risk Children 4 years and younger HIV infected Immunosuppressed Clinical Evaluation: CXR Findings associated with higher risk of TB (require further evaluation and possible treatment for TB) Noncalcified nodular lesions Fibrotic scars Findings consistent with TB disease (require further evaluation and possible treatment for TB) Enlarged hilar, mediastinal or subcarinal lymph nodes Atelectasis Alveolar consolidation Interstitial infiltrates, cavitary and non-cavitary Pleural effusion Focal mass Hyperinflation in children 20

21 Beyond the Guidelines Unknown Does treatment of LTBI need to be completed prior to use of TNF- antagonist? Unknown Does a person at risk of TB who is TST negative need to be treated? Consider treatment of high risk TST negative patients No need to continue INH after completion of treatment for LTBI Duration of therapy What is the duration of therapy that provides the maximum degree of protection against developing TB? 21

22 How Much Isoniazid Is Needed for the Prevention of Tuberculosis? Ca ase rate % Longer durations of therapy corresponded to lower TB rates among those who took 0-9 mo No extra increase in protection among those who took >9 months Months of therapy Community based study, Bethel Alaska Comstock GW, Int J Tuberc. Lung Dis 3: Duration of INH Therapy for LTBI IUAT study of INH 3, 6 or 9 months Reduction in culture positive TB at 5 years all participants 6 months therapy 65% 12 months therapy 75% Bulletin WHO,

23 Duration of INH Therapy for LTBI IUAT study of INH 3, 6 or 9 months Reduction in culture positive TB at 5 years in the group of completer-compliers 6 months therapy 69% 12 months therapy 93% Bulletin WHO, 1982 Treatment of LTBI Treatment regimens: INH x 9 months Rifampin 600mg daily x 4 months for adults, Rifampin daily for 6 months for children Possible alternate: INH & Rifampin x 3 to 4 months INH, Rifampin, EMB & PZA x 2 months Has been: Rifampin/PZA x 2 months New? Rifapentine & INH weekly x 12 mo 23

24 Management of Contacts Who Have an Initial Negative TST Close Contacts Asymptomatic with a negative e CXR Treatment with INH should be started for: HIV Infected Children < 5 Significant Immunosuppressant Repeat TST in 8 12 weeks for all others Symptomatic Evaluate for Active TB CXR, smears and culture If a TB suspect, treat for TB disease Management of LTBI in Pregnancy in HIV negative women Evaluate patients at risk of progression during pregnancy with TST Asymptomatic TST positive women should have CXR after first trimester S t ti h ld h i di t CXR t Symptomatic women should have immediate CXR to exclude active disease even in first trimester 24

25 Women should be counseled that x-ray exposure from a single diagnostic procedure does not result in harmful fetal effects. Specifically, exposure to less than 5 rad has not been associated with an increase in fetal anomalies or pregnancy loss. ACOG, Committee on Obstetric Practice, Guidelines for diagnostic i imaging i during pregnancy. ACOG opinion no.158. Washington DC; ACOG, 1995 TREATMENT of LTBI DURING PREGNANCY Or WHILE BREASTFEEDING During gpregnancy treat only those at high risk of progression to active disease INH daily or twice weekly Pyridoxine supplementation Treatment while breast-feeding safe Avoid PZA during pregnancy Increased risk of hepatotoxicity first 3 months postpartum 25

26 HIV+ Pregnant Women at Risk of Tuberculosis Increased morbidity and mortality in HIV TB in pregnant women noted in US and developing world HIV infected women with LTBI at risk of rapid progression to active disease Treatment t of both LTBI and Disease should be aggressive and instituted when diagnosis is made. LTBI with abnormal CXR CLASS 4 - TB Not Clinically Active Exclude active disease Abnormal but stable CXR findings (>2-3 mo) NODULES/ FIBROTIC LESIONS OF OLD TB PLEURAL THICKENING CALCIFIED GRANULOMA BRONCHIECTASIS Sputum smear and cultures negative Isolated CXR with nodules/fibrotic lesions 4 drug therapy until CXR stable & cultures negative 26

27 Evaluation and Management of Refugee CXR in US: abnormalities in right apex, age and significance undetermined Medical evaluation: unremarkable Sputum smear and culture: negative INH treatment for LTBI ordered for 9 months Evaluation and Management of Refugee Hemoptysis 6 months after arrival New abnormality on CXR History of dental abscess Diagnosed with lung abscess and treated with penicillin Sputum smear and culture negative for TB 27

28 Evaluation of a B1 Refugee Young woman from Uzbekistan TST positive Abnormal CXR prior to immigration Negative sputum smear prior to immigration Denies symptoms of tuberculosis Denies prior treatment for tuberculosis Husband and 2 young children also TST + How should she be evaluated and managed? March 8, 2005: 30 yr old refugee from Uzbekistan 28

29 Sept 1, 2005: 30 yr old refugee from Uzbekistan Nov 22, 2005: 30 yr old refugee from Uzbekistan 29

30 December 2005 December

31 Evaluation and Management of Refugee Refugee health nurse goes to patient s home to awaken her at 6:00 am. Sputum positive on smear < 1 and culture grows M TB resistant to INH Management of TST + Persons With an Abnormal CXR Isolated CXR with nodules and or fibrotic lesions: Collect sputum culture Evaluate for symptoms If no symptoms - wait Repeat CXR If CXR stable at 2 3 months and cultures negative, treat LTBI Isolated CXR with nodules and or fibrotic lesions: If patient has any signs or symptoms of TB disease: the patient is a TB Suspect Start 4 drugs Never start t a single drug in a patient with possible active TB 31

32 History Ask about how they are now compared to: Last Christmas? Last summer, fall, etc? Their birthday? Ask what they do for exercise if they deny current symptoms, if none ask if that has changed and why, how far can they walk, etc Evaluation: Sputum Collection Collect sputum specimens if: Abnormal CXR consistent with TB Presence of respiratory symptoms even if normal CXR Minimum of 3 specimens collected at least 8 Minimum of 3 specimens collected at least 8 hours apart with at least one specimen collected in the early AM 32

33 Evaluation: Sputum Collection Each patient should have at least one specimen sent for nucleic acid amplification (NAA) Even if smear negative > 50 60% of smear negative persons with active TB will be NAA positive NAA helps to identify M Tb complex from smear Mycobacterial Cultures Three initial sputum cultures within 24 hours At least one first morning At least one observed Cultures should be obtained monthly until negative on two consecutive months Determine length of therapy Identify delayed response (+ > 2 to 3 months) Identify treatment failure ( + at 4 months) 80% should convert by 2 mo, 95% by 3 mo 33

34 How Should Immunosuppressed Persons at Risk of TB Be Managed? Empiric treatment for LTBI is warranted even when TST or QTF-G Gis negative on repeat testing 8-10 weeks after exposure Advanced HIV infected contacts Children < 5 years who are contacts Contacts with other causes of immunosuppresion Persons at risk for exposure to TB who are to receive treatment with TNF alpha antagonists TNF alpha Antagonists Block TNF alpha activity which is required for granuloma formation and control of M TB infection Used for rheumatoid arthritis, Chron s disease, psoriasis and a variety of other immune mediated diseases Remicaid (inflixamab) Embril (entanercept) Humira (adalimubab) Cimzia (certolizumab) 34

35 Warning: Risk Of Infections Infliximab Tuberculosis (frequently disseminated or extrapulmonary at clinical i l presentation), ti and other opportunistic infections have been observed in patients receiving Remicade some of these infections have been fatal. Patients should be evaluated for LTBI with a TST. Treatment of LTBI should be initiated prior to therapy with Remicade. SEE WARNINGS» PDR 2004 CONTACTS OF INH RESISTANT TUBERCULOSIS Four month regimen daily Rifampin for adults Six month regimen daily Rifampin for HIV infected Six month regimen daily Rifampin for children 35

36 A Complete Assessment Is Essential to Good Patient and Public Health Outcomes! 36

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