California TB program updates

California TB program updates CAPHLD Conference Nov 6, 2017 Pennan Barry, M.D., M.P.H. Chief, Surveillance and Epidemiology Section Lead MD, California MDR TB Service pennan.barry@cdph.ca.gov

Outline California TB Epidemiology California TB Elimination Plan Electronic reporting of IGRA results Vision for LTBI surveillance system Work with commercial laboratories Other brief updates Molecular DSTs by ELR Universal WGS 2

California TB Epidemiology Review 3

CA Tuberculosis Epidemic 1930 2016 100 years ago: 1 in 9 died of TB 12,000 200 Number of TB Cases 10,000 8,000 6,000 4,000 2,000 0 180 160 140 120 100 80 60 40 20 0 1930 Case Rate per 100,000 1935 1940 1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 TB Cases TB Rate 4

Tuberculosis Cases and Case Rates 6,000 California, 1991 2016 20 5,000 18 16 Number of TB Cases 4,000 3,000 2,000 1,000 2062 5.2 14 12 10 8 6 4 2 Case Rate per 100,000 0 1991 1996 2001 2006 2011 2016 0 TB Cases TB Rate 5

Tuberculosis Cases and Case Rates Number of TB Cases 6,000 5,000 4,000 3,000 2,000 1,000 California, 1991 2016 Average annual change in case rate -6.2% -4.3% 2131 2133-2.2% 20 18 16 14 12 10 8 6 4 2 Case Rate per 100,000 0 1991 1996 2001 2006 2011 2016 0 TB Cases TB Rate 6

Why aren t we satisfied? Decline has slowed TB is diagnosed every four hours Every other day a Californian dies with TB Each week at least one child under 5 found to have TB 7

Human impact of TB disease 20 year old foreign-born man with smear positive pulmonary TB Transmitted to niece and nephew 6 yo with pulmonary and bone TB 1 yo with pulmonary and meningeal TB poor neurologic outcome, now in long term care facility far from family >20 other infected persons (12 children) in 2 households This is preventable! 8

Year of TB elimination in California Extrapolation based on current rate of decline* Rate per 1 Million 1000 100 10 1 Actual Current decline (-4%) 2040 Elimination (-14%) Elimination 2114 0 2040 1985 1995 2005 2015 2025 2035 2045 2055 Year 2065 2075 2085 2095 2105 2115 2125 * Average annual decline in case rate 2005-2014 9

California Tuberculosis Elimination Plan 2016 2020 A Five-Year Action Plan https://www.cdph.ca.gov/programs/cid/dcdc/cdph%20 Document%20Library/TBCB-TB-Elimination-Plan-2016-2020.pdf

California TB Elimination Task Force Insert photo of task force meeting 11

TB Elimination Plan Recommendations Focus on Latent TB Infection (LTBI) PRIORITIZE screening and testing for LTBI Find and engage populations at risk for TB Use Risk Assessment; IGRA for BCG vaccinated OPTIMIZE treatment for LTBI Treat routinely; Use shorter regimens PARTNER and EDUCATE Public and private; providers and community groups MEASURE monitor and evaluate screening and treatment LTBI reportable? RESOURCE Funding, drug supply, expertise

TB Risk Assessment at https://cdph.ca.gov/tbcb 13

TB Elimination Plan Recommendations Focus on Latent TB Infection (LTBI) PRIORITIZE screening and testing for LTBI Find and engage populations at risk for TB Use Risk Assessment; IGRA for BCG vaccinated OPTIMIZE treatment for LTBI Treat routinely; Use shorter regimens PARTNER and EDUCATE Public and private; providers and community groups MEASURE monitor and evaluate screening and treatment LTBI reportable? RESOURCE Funding, drug supply, expertise

California TB Elimination Plan: LTBI Reporting http://www.cdph.ca.gov/programs/tb/documents/tbeliminationplan_9-2-16c.pdf

Current Status of IGRA Reporting IGRA can be reported by ELR (not required) Available to local and state TB programs for: following up contact investigation IGRA results for active TB cases (required for CDC reporting) following up on LTBI cases

IGRA by ELR July 2016 June 2017 38 laboratories; 43 jurisdictions; 230 healthcare facilities, 754 ordering providers >10,000 results reported Nearly 5,000 positive results Among laboratories reporting all results: positivity 17% (n=7162) (likely not testing a low risk population) 17

Survey of CA TB Programs IGRA by ELR Of respondents aware of IGRAs in CalREDIE: 36% reported use for public health action Of all respondents: 75% support mandatory reporting 62.5% support reporting of positive and negative results 18

Adding IGRA by ELR to 2505 PROS Feasible Uses existing system Little burden on programs/providers: Electronic Can be ignored by LHJ until needed Enough data for Suspected LTBI case definition Increasing IGRA use CONS Ignores TST results Limited patient data Less than needed for LTBI confirmed case definition

Principles for developing LTBI surveillance in California Minimize work of reporting for LHJs and providers Build on existing systems and efforts Incremental work toward reportability and complete surveillance Sync (as much as reasonable) with national surveillance to allow reporting to CDC

LTBI Surveillance: Vision Current LTBI Data Streams EDN (Immigrants - B notification) RHEIS (refugee health) CAIR/RIDE (immunization registry) IGRA by ELR CalREDIE Contacts -- CalREDIE (new tab) STEMS (CDC/TBESC LTBI Case management) Future LTBI Data Streams LTBI report form -- CalREDIE Electronic case reporting from EHRs -- CalREDIE Civil surgeon data Harmonization Deduplication CDPH LTBI Surveillance Registry (SQL) Identifiers TB risks LTBI test results CXR LTBI treatment LTBI treatment outcome CDC TBLISS US LTBI Surveillance Analysis /Reports Performance measures State and local use Program improvement

If Vision Realized Data-Driven: Accurate estimates of untreated LTBI burden Increased awareness of LTBI and treatment Metrics for improvement Progress toward elimination

Work with Commercial Laboratories 24

Pulmonary sputum culture positive TB cases by laboratory type 2010 2015 % Cases 70 60 50 40 30 20 10 0 Commercial & Other Public Health 2010 2011 2012 2013 2014 2015 Year 25

What Could Go Wrong is not unique Santa Clara County data, 2012 2013 (n=148): TAT from specimen to DST results Regional labs 28-37 days (median) National/commercial labs 62-78 days (median) Data courtesy Wen Lin 26

Contributors to delays Delays reporting Not reporting results to health department, only to provider* Not reporting preliminary results Complex communication procedures Logistical procedures Transport between facilities Batching of cultures and DSTs Sub-culturing each time isolates arrive Not performing DSTs unless ordered* Underutilization of rapid tests such as molecular detection of drug resistance *Required by CA Code of Regulations 27

How to address challenges Improve communication Establish direct lines of communication Exchange challenges and contact info Provide information to labs (webinar Nov 2016) Regulations Role of public health programs Resources in public health labs Assist local TB programs Toolkit with information and tips for communicating with commercial labs Case by case assistance 28

CDPH and CDC Molecular Testing for Drug Resistance Known or suspected drug-resistant TB Pyrosequencing (PSQ) at CA lab detect resistance to INH, rifampin, fluoroquinolones, or injectable drugs culture or smear-positive specimen MDDR at CDC (PSQ and Sanger) Adds ethambutol and pyrazinamide Both 1-2 day turnaround time Provided without charge

Pyrosequencing Speeds time to effective MDR treatment 60 50 PSQ done (n=60) PSQ not done (n=38) 40 30 20 10 23 51 0 Days from specimen collection to MDR treatment California MDR cases August 2012-December 2016 30

Indication for Pyrosequencing: Higher Risk of MDR-TB Xpert with RIF resistant result History of previous TB treatment Known exposure to MDR-TB case HIV (+)

Indication for Pyrosequencing: Higher Risk of MDR-TB Arrival in U.S. within last 2 years Immigration /recent extended travel to country with > 2% MDR among cases diagnosed in California/U.S.: India Laos Russia and other former Soviet states Korea Peru Central America Burma Ecuador Dominican Republic Other state or locally identified risk groups, including: Hmong refugees Persons of Tibetan origin *California data from 2011-2015 and U.S. data from 2010-2013 Current U.S. data are available from the CDC, Division of TB Elimination (DTBE) (www.cdc.gov/tb) 32

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Other Brief Updates 34

Universal WGS in 2018 New National Tuberculosis Molecular Surveillance Center at Michigan PHL Universal WGS start in 2018 Both conventional and WGS for 3 years No change in shipping processing practices Complete submission of isolates important https://www.cdc.gov/media/releases/2017/p0804-200-million.html 35

Molecular Susceptibility Reporting Voluntary CDC reporting now APHL/CDC collaboration for ELR of Xpert MTB/RIF results Required CDC reporting in 2020 36

Summary Working toward TB Elimination Vision: LTBI reporting / surveillance system including ELR for IGRA results Ongoing work between public health and commercial labs Universal WGS for TB in 2018 Reporting of molecular tests for resistance including Xpert 37

Acknowledgments Jenny Flood Christy Pak Grace Lin Ed Desmond Wen Lin Lisa True Carol Greene Donald Baird Hava Phillips Neha Shah Yasser Bakhsh Varsha Hampole Phil Lowenthal California TB Elimination Advisory Committee California TB Controller s Association Commercial laboratory partners Dale Schwab, Kamran Azad Adam Readhead Janice Westenhouse Tessa Mochizuki Lisa Pascopella Melissa Ehman 38

Resources Local TB Program Directory http://www.ctca.org/locations.html Local Public Health Lab Directory http://www.caphld.org under laboratory listing Microbial Diseases Laboratory (MDL) https://cdph.ca.gov/mdl TBCB Website: https://cdph.ca.gov/tbcb MDR TB Service: https://www.cdph.ca.gov/programs/cid/dcdc/cdph%20document%20library/tbcb-mdr-fact-sheet.pdf Risk Assessments: https://www.cdph.ca.gov/programs/cid/dcdc/pages/tb-risk-assessment.aspx TB Data: https://www.cdph.ca.gov/programs/cid/dcdc/cdph%20document%20library/tbcb_report_2016_tables.xlsx https://www.cdph.ca.gov/programs/cid/dcdc/cdph%20document%20library/tbcb_report_2016.pdf APHL mycobacteriology best practices https://www.aphl.org/aboutaphl/publications/documents/id_2013aug_mycobacterium-tuberculosis- Assessing-Your-Laboratory.pdf Laboratory reporting regulations http://www.cdph.ca.gov/healthinfo/documents/title17section2505list.pdf Curry International TB Center http://www.currytbcenter.ucsf.edu/ Warmline: 1-877-390-6682 Drug Resistant TB Survival Guide (Lab Chapter) http://www.currytbcenter.ucsf.edu/products/cover-pages/drug-resistant-tuberculosis-survival-guideclinicians-3rd-edition Pennan Barry: pennan.barry@cdph.ca.gov 39