10/3/2017. Updates in Tuberculosis. Global Tuberculosis, WHO 2015 report. Objectives. Disclosures. I have nothing to disclose

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1 Disclosures Updates in Tuberculosis I have nothing to disclose Chris Keh, MD Assistant Clinical Professor, Division of Infectious Diseases, UCSF TB Controller, TB Prevention and Control Program, Population Health Division, SFDPH Objectives Demonstrate and apply the USPSTF guidelines for latent TB infection in practice List three benefits of molecular testing and identify the settings in which to order this test Describe at least one treatment regimen to treat latent tuberculosis infection Global Tuberculosis, WHO 2015 report 10.4 million new cases* 1.8 million deaths Leading Infectious Killer in the World and Leading Killer of People Living with HIV * Additional one-third of the world s population are infected 4 1

2 TB in the U.S.- what lies beneath How far are we from elimination? million persons with LTBI 9557 cases 1 out of 5 non-u.s. born has LTBI 1 out of 8 Asian-born has LTBI TB elimination: <1 case per million United States, cases per million (all) 12 cases per million (U.S. born) 151 cases per million (non U.S. born) San Francisco, cases per million (all) 23 cases per million (U.S. born) 291 cases per million (non U.S. born) 6 Cut in transmission Incidence Projections to 2060 Increase LTBI treatment, 2x or 4x more USPSTF, Update for LTBI 2016 Recommendation: Screen for latent tuberculosis infection in asymptomatic adults at increased risk of infection B Grade: Hill et al., Epidemiol Infect,

3 TB as a spectrum of disease Diagnostics Evidence of progression / regression of FDG-avid granulomas in non-human primates Re-think binary definitions: LTBI vs Active Disease Nomenclature change?: (Latent) Tuberculosis Infection 10 Screening Tools for LTBI Rapid Molecular Testing (Active TB) TST (e.g. PPD) Potential for false positive in BCG vaccinated individuals Subjective Booster effect Injection, 2 visits IGRA (e.g. QFT, T-spot) Preferred in prior BCG vaccinated individuals Less subjective (although issue with indeterminate) No booster effect Blood draw, single visit Limited in young (2-5 yo) Examples: GeneXpert, PCR, Pyrosequencing Provides rapid identification Cultures are still necessary for drug susceptibilities Rapid turnaround time (2-3 hours compared to 4-6 weeks for culture) Earlier initiation of effective tx Decreased period of infectiousness Improved pt outcome Earlier involvement of MDR expert Earlier request for 1 st /2 nd line susceptibilities Potential use in discontinuation of airborne isolation us_statement_final.pdf 12 3

4 Xpert MTB/RIF Test Performance Xpert MTB/RIF Report Sensitivity Specificity Smear pos. TB 95-98% 99% Smear neg. TB 60-72% Rifampin R 98-99% % MTB DETECTED or NOT DETECTED Rif Resistance DETECTED or NOT DETECTED NEJM 361:1005, 2010; Am J Crit Care Med 184:132, 2011 Provides both MTB identification and detection of RIF resistance (rpob) Send on any patient with moderate-high suspicion for active TB Can remain positive for months-years after adequate tx LTBI Treatment Options Treatment Regimens for Latent TB Infection Drug(s) Duration Interval Minimum Doses Isoniazid 9 months Daily 270 Twice weekly 76 6 months Daily 180 Isoniazid Isoniazid + Rifapentine (3HP) Rifampin Isoniazid + Rifampin Isoniazid & Rifapentine Twice weekly 52 3 months Once weekly 12 Rifampin 4 months Daily 120 4

5 INH + Rifapentine (3HP) Once weekly x 12 weeks (12 doses) Recommended as an equal alternative to INH x 9 mo Current recommendation for directly observed therapy (may change in the next year) Not recommended in: Children <2yo HIV-infected patients on ART Pregnant or planning to become pregnant Contact to INH/RIF resistant cases Prior adverse events / hypersensitivity to INH/RIF INH RPT INH No. of patients 3,986 3,745 Administration Directly observed therapy Self administered therapy Frequency Weekly Daily Duration 12 weeks 9 months Sterling TR, et al; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med Dec 8;365(23): Prevent TB Study Results Side effects- 3HP INH RPT INH P value Recommendations for Use of an Isoniazid Rifapentine Regimen with Direct Observation to Treat Latent Mycobacterium tuberculosis Infection. MMWR 2011;60: INH RIF LTBIfact sheet.pdf Effectiveness 1.9 per 1, per 1,000 Noninferior Completion rate 82.1% 69.0% P<0.001 Hepatotoxicity 0.4% 2.7% P<0.001 Sterling TR, et al; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med Dec 8;365(23): Possible hypersensitivity (3.8%) Rash (0.8%) Hepatotoxicity (0.4%) Thrombocytopenia (rare) Other toxicities (3.2%) Monitoring- similar to INH or RIF RFP drug-drug interactions similar to RIF Recommendations for Use of an Isoniazid Rifapentine Regimen with Direct Observation to Treat Latent Mycobacterium tuberculosis Infection. MMWR 2011;60: INH RIF LTBIfact sheet.pdf 5

6 Evaluate for active TB disease with a chest x-ray, symptom screen, and if indicated, sputum AFB smears, cultures and nucleic acid amplification testing. A negative tuberculin skin test or interferon gamma release assay does not rule out active TB disease. Includes any country other than the United States, Canada, Australia, New Zealand, or a country in western or northern Europe If resources require prioritization within this group, prioritize patients with at least one medical risk for progression (see the California Adult Tuberculosis Risk Assessment User Guide for this list) Interferon Gamma Release Assay is preferred over Tuberculin Skin Test for foreign- HIV infection, organ transplant recipient, treated with TNF-alpha antagonist (e.g., infliximab, etanercept, others), steroids day Provider: Assessment Date: Patient Name: Date of Birth: (Place sticker here if applicable) To ensure you have the most current version, go to the RISK ASSESSMENT page at: June /3/2017 Risk Assessment Tools Additional New Tools CA Risk Assessment Adult, Pediatric, College/University Students, School Staff / Volunteers BCG Atlas ( Database of BCG practices California Tuberculosis Risk Assessment Adults Use this tool to identify asymptomatic adults for latent TB infection (LTBI) testing. Re-testing should only be done in persons who previously tested negative, and have new risk factors since the last assessment. For TB symptoms or abnormal chest x-ray consistent with active TB disease: Evaluate for active TB disease Check appropriate risk factor boxes below. LTBI testing is recommended if any of the 3 boxes below are checked. If LTBI test result is positive and active TB disease is ruled out, LTBI treatment is recommended. Foreign-born person from a country with an elevated TB rate Immunosuppression, current or planned Close contact to someone with infectious TB disease at any time See the California Adult Tuberculosis Risk Assessment User Guide for more information about using this tool. Assessment.aspx Estimates risk of active TB Limited to up to age 80 Accounts for risk factors TST / IGRA Interpreter Results Slide 23 Slide 24 6

7 Video Directly Observed Therapy Summary Observation of medication ingestion by video Live vs Recorded Smartphone application, cloud based Can be used for active disease and LTBI Cost-effective and ensures adherence Asians have one of the highest case rates in the U.S. (30x higher than Caucasians) Patients born / residing in Asia have a high risk of TB infection TB Elimination Movement- national, state, local Newer tools can assist in TB elimination Rapid diagnostics IGRA Shorter-course treatments LTBI toolkits (e.g. CDC, CTCA/CDPH, in development) LTBI registry (in development) Updated guidelines Risk assessment tools VDOT Assistance is right around the corner TB Warmline Consultation (Curry International TB Center): Local Public Health Dept / TB Control California Dept of Public Health, TB Control Branch, ms/cid/dcdc/pages/tbcb.aspx (510) (or your State TB Control Branch) 7

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