Tuberculosis Update. Topics to be Addressed

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1 Tuberculosis Update Robert M. Jasmer, M.D. University of California, San Francisco TB Control Section, San Francisco Department of Public Health Topics to be Addressed TB in the USA Screening recommendations Blood tests for TB infection Treatment and monitoring Audience participation questions Reported TB Cases United States, No. of Cases 28,000 26,000 24,000 22,000 20,000 18,000 16,000 14,000 12,000 10, Year 1

2 A Tale of Two TBs Tuberculosis Screening Flowchart At-risk person Interferon-Gamma Assay (or TST) + symptom review Negative Positive Chest X-ray Treatment not indicated Normal Candidate for Rx of latent TB Abnormal Evaluate for active TB 2

3 Goals of Targeted Screening for Latent TB Infection Identify recently acquired TB infection Identify those who are at increased risk of developing active TB once infected Risk of Infection Contacts of infectious TB cases Foreign-born persons from TB endemic countries Healthcare workers Correctional facilities (inmates and staff) Nursing homes Long-term care facilities Renal dialysis units Medically underserved groups Risk of Progression HIV infection and other medical conditions Individuals with abnormal chest X-ray compatible with past TB (high rate of reactivation: 10% per year) Infants and children <5 yrs of age (sentinels of transmission) 5% risk of disease in first 2 years among contacts/converters 3

4 Which of the following persons should NOT be screened for TB? 1. Insulin-requiring diabetic 2. End-stage renal disease pt on dialysis 3. Rheumatoid arthritis pt on chronic prednisone and methotrexate 4. COPD pt on multiple inhalers 5. New immigrant to the US from India Which of the following persons should NOT be screened for TB? 1. Insulin-requiring diabetic 2. End-stage renal disease pt on dialysis 3. Rheumatoid arthritis pt on chronic prednisone and methotrexate 4. COPD pt on multiple inhalers 5. New immigrant to the US from India Risk of Progression (2) Medical conditions: Immunosuppression Lymphoma, leukemia Injection drug use Diabetes Malnutrition Renal failure Silicosis Alcoholism Immunosuppressive agents: Steroids Cancer chemotherapy Cyclosporine New: Tumor necrosis agents -Etanercept (Enbrel ) -Infliximab (Remicade ) -Adalimumab (Humira TM ) 4

5 Evaluation of LTBI" Calcified Granulomas " Evaluation of LTBI:" Stable Fibrotic Lesions" Diagnosis of Latent Tuberculosis Infection TB Skin Test (TST) QuantiFERON Blood Test (QFT) or ELISPOT T-SPOT TB Test 5

6 SCREENING FOR LTBI Tuberculin Skin Test 5 TU of PPD Read at hrs False positives Non-tuberculous mycobacteria Recent BCG vaccination Interpretation depends on person s risk factors Tuberculin Skin Test Interpretation: CDC/ATS Cut-Off Points > 5 mm HIV co-infection Immune compromise Recent contact to TB Suspected disease > 10 mm Foreign-born from a HR country Drug users Living in HR congregate setting Specific HR groups Children < 4 yrs old (AAP) >15 mm All others (low risk groups) Why did you test? Tuberculin Skin Testing Boosting Induration (mm)" 20" 15" 10" 5" 14 mm" 11 mm" 12 mm" 0" 0 " 5 " 10 " 15 " 20 " 30 " 31" Infection" TST" TST" TST" TST" Years" 6

7 Interferon-Gamma Assays: The First Alternative to the Tuberculin Test Interferon-γ release assays have emerged as the only alternative to the tuberculin test QuantiFERON-TB (Cellestis, Australia) T-SPOT-TB (Oxford Immunotec, UK) Interferon-γ assays measure cell-mediated immunity by quantifying IFN-γ released from sensitized T cells in whole blood/pbmcs incubated with TB antigens Interferon vs. TST In vitro Multiple antigens No boosting 1 patient visit Minimal inter-reader variability Results in 1 day Stimulate w/i 12 hrs In vivo Single antigen Boosting 2 patient visits Inter-reader variability Results in 2-3 days Read in hrs Advances in IFN-γ Technology Early assays employed PPD (same specificity problems as the TST) Newer assays (e.g., QFT-Gold) employ TB-specific antigens: ESAT-6 and CFP-10 Proteins encoded within the region of difference 1 of M. tuberculosis Not shared with the BCG sub-strains and most NTM species (except: M. kansasii, M. szulgai, M. marinum) 7

8 Species Specificity of ESAT-6 and CFP-10 Tuberculosis complex ESAT Antigens CFP M tuberculosis + + M africanum + + M bovis + + BCG substrain gothenburg - - moreau - - tice - - tokyo - - danish - - glaxo - - montreal - - pasteur - - Environmental strains Antigens ESAT CFP M abcessus - - M avium - - M branderi - - M celatum - - M chelonae - - M fortuitum - - M gordonii - - M intracellulare - - M kansasii + + M malmoense - - M marinum + + M oenavense - - M scrofulaceum - - M smegmatis - - M szulgai + + M terrae - - M vaccae - - M xenopi - - QuantiFERON-TB Gold In-Tube Add 1 ml of blood to each of the 3 tubes Incubate for hours at 37, then do ELISA Which of the following is the best way to rule out active TB (e.g., pre-hospital admission)?: 1. Tuberculin skin test 2. QuantiFERON-TB test 3. Chest X-ray 4. Symptom checklist (e.g cough/sweats/weight loss) 5. Call Dr. Oz on the Oprah TV show 8

9 Which of the following is the best way to rule out active TB (e.g., pre-hospital admission)?: 1. Tuberculin skin test 2. QuantiFERON-TB test 3. Chest X-ray 4. Symptom checklist (e.g cough/sweats/weight loss) 5. Call Dr. Oz on the Oprah TV show Sensitivity of QuantiFERON-TB Gold Test Pooled sensitivity of TST: 77%" Pai et al Clin Infect Dis 2007;44:74" Current Guidelines for Using Interferon- Gamma Release Assays for TB Recommended for use in ALL circumstances in which the tuberculin skin test is currently used Includes contact investigations, immigrant evaluation, surveillance (e.g. healthcare workers) Mazurek et al MMWR 2005;54:15" 9

10 QFT and Contact Investigation Expect maximum benefit: Populations with poor return rates (homeless) Foreign-born with high background prevalence of BCG vaccination Example: SF SRO hotel drug-resistance investigation Prior QFT results easy to track down in database 9/31 converters found! (6 QFT conversions and 1 case found) 4 negative TSTs positive QFT 2 negative QFTs positive QFT 3 negative TSTs positive TST Discordant Results: One Approach When pre-test probability is HIGH: if either TST or QFT is positive, consider as infected When pre-test probability is LOW (no risk factors for progression): Use QFT to improve the specificity of the TST If both TST and QFT testing are done, draw blood before doing TST to avoid sensitization Future Use of QuantiFERON-TB Testing 10

11 ATS/CDC Guidelines for Latent TB Infection Rating HIV- HIV+ Isoniazid for 9 months AII AII Rifampin for 4 months BII BIII Rifampin/pyrazinamide DII DII for 2 months (daily) Rifampin/pyrazinamide DII DIII for 2 months (twice-weekly) Ratings Guide! A=Strong evidence of efficacy!i=randomized trial! B=Moderate evidence!!ii=cohort/case control! C=Insufficient evidence!iii=expert opinion" AJRCCM 2000;161:221 MMWR 2003;52:735" Treatment of Latent TB Infection: Age is NOT an Issue No more 35 year old cut-off Treat irrespective of age! Why? 1) Focus is on those at increased risk of either recent infection or progression to active TB, so the benefits exceed the risk 2) Risk of hepatitis is much less now Duration of INH Therapy Stable Fibrotic Lesions Population Duration Reduction in TB All participants INH 12 mo 75% INH 6 mo 65% INH 3 mo 21% Completer/compliers INH 12 mo 93% INH 6 mo 69% INH 3 mo 31%!!!!! Int Union Agst TB. Bull WHO 1982;60:555" 11

12 Treatment of Latent TB Infection How long is enough? 5" 4" Calculated curve" Calculated values" Observed values" Lower TB rates among those who took 0-9 mo! Cases per 100" 3" 2" 1" 0" 0 "6 "12 " 18 " 24" Months of Treatment" No extra increase among those who took >9 mo! Comstock Int J Tuberc Lung Dis. 1999;10:847! New TB Guidelines for INH A Numbers Game HIV Co-Infection Children 9 Prior TB on CXR (TB-4) Regular Folks Treatment of LTBI" Stable Fibrotic Lesions" 12

13 30 year old woman with TST 12 mm and no symptoms What would you do next? 1. Collect 3 sputum for AFB smear/cultures 2. Begin treatment for latent TB infection with INH 3. Repeat the TST 4. Repeat the radiograph in 6 months What would you do next? 1. Collect 3 sputum for AFB smear/cultures 2. Begin treatment for latent TB infection with INH 3. Repeat the TST 4. Repeat the radiograph in 6 months 13

14 After 2 months of INH/RIF/EMB/PZA Which is the best next step? 1. Obtain a chest CT scan 2. Continue multidrug therapy for TB 3. Perform a fine-needle aspiration of the nodule 4. Refer for bronchoscopy to obtain better specimens Which is the best next step? 1. Obtain a chest CT scan 2. Continue multidrug therapy for TB 3. Perform a fine-needle aspiration of the nodule 4. Refer for bronchoscopy to obtain better specimens 14

15 Treatment of Culture-Negative and Inactive Tuberculosis Treatment of Latent TB in Special Situations Intermittent dosing: always Directly Observed Contacts of INH-resistant TB: 4-6 months of rifampin (longer for children and immunocompromised) Use rifabutin in HIV-infected patients on protease inhibitors For persons intolerant of INH, use 4 months of rifampin Monitoring Patients Baseline laboratory testing not needed except for: 1) HIV infection 2) pregnancy 3) hx of liver disease/heavy EtOH use Evaluate monthly for: 1) adherence 2) symptoms of hepatitis 15

16 Isoniazid-Induced Hepatitis N=13,838! N=11,141! Age (yr)!!hepatitis!!cases/1000" Age (yr)!!hepatitis!!cases/1000" < 20 " " 0.0" " " 3.0" " " 12.0" " " 23.0" > 64 " " 8.0" 0-14 " " 0.0 " " " 0.8" " " 2.1" 65 " " 2.8" Kopanoff et al. Am Rev Resp Dis 1976;117:991" Nolan CL et al. JAMA 1999;281:1014" Future Treatment for Latent TB Infection? Tuberculosis Trials Consortium Study 26 Prospective, randomized phase III study Compares the effectiveness of 3 months of weekly rifapentine and INH to 9 months of daily INH Eligible patients: HIV-infected, infected contacts, tuberculin converters, and radiographic evidence of prior TB 8,00 enrolled, results expected in 2011" TB will remain a primary care issue until better control is established outside of the U.S. The specificity of the new blood test for TB is an advance in our ability to accurately diagnose LTBI 9 months now preferred for isoniazid Questions? Call the TB Warmline at

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