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Setting the Stage for TB Elimination: Lessons from Smallpox Eradication

12 th Annual Conference, TB Education and Training Network 4 th Annual Conference, TB Program Evaluation Network Atlanta, GA, September 18, 2012. Setting the Stage for TB Elimination: Lessons from Smallpox Eradication. Kenneth G. Castro, M.D. RADM, U.S. Public Health Service Director.

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Setting the Stage for TB Elimination: Lessons from Smallpox Eradication

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  1. 12th Annual Conference, TB Education and Training Network 4th Annual Conference, TB Program Evaluation Network Atlanta, GA, September 18, 2012 Setting the Stage for TB Elimination:Lessons from Smallpox Eradication Kenneth G. Castro, M.D. RADM, U.S. Public Health Service Director Division of Tuberculosis Elimination National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention

  2. Overview • Smallpox eradication and its lessons • Strategic plan to eliminate TB in the U.S. • Resurgence, response, and recent TB trends in U.S. • Challenges to TB elimination • Mathematical modeling to inform high-yield interventions • Budgetary reductions leading to formula revisions and accelerated implementation • Smallpox lessons revisited

  3. Smallpox Eradication Lessons • Political commitment, coordination, and implementation • Decision by 1959 WHA, ratified in 1966 WHA with new resources • Special program • Specifically targeted and time-limited • Adapted to local epidemiology and different local conditions • Identify and address set-backs • Defined objectives and goals • Complete disease reporting and nil incidence • Discover cases and contain outbreaks within 2 weeks • Quality control and program management • Network of professional staff: “many thousands of health staff received training in the execution of vaccination programmes and in field epidemiology” • Research • Better methods for quality vaccine production and targeted delivery • Certification, Costs

  4. Strategic Plan to Eliminate Tuberculosis in the United States (Target ≤ 1 case per million population by 2010) Step 1. More effective use of existing prevention and control methods, especially in high-risk populations Step 2. Development and evaluation of new technologies for diagnosis, treatment, and prevention Step 3. Rapid assessment and transfer of newly developed technologies into clinical and public health practice. MMWR 1989; 38 (suppl No. S-3):1-25

  5. Resurgent TB in U.S.Trends reversal, excess morbidity, 1985-1992 • Associated • Conditions • Deficient • infrastructure • HIV epidemic • Immigration • Institutional • transmission • MDR-TB Cantwell MF, et al. JAMA 1994; 272:535-539

  6. CDC TB Appropriations, FY1967–FY2000 and Reported TB Case Rates, 1967–1999 Response to Resurgent TB Categorical TB Grants Ceased 1972-1982* * Categorical funding reappeared via emergency grants in 1980, but amounted to only $3.6M in 1980 and $3.7M in 1981. “It was not until 1989 that funding reached the level at which it had peaked in 1969, before the institution of block grants.” IOM. Ending Neglect: the elimination of tuberculosis in the United States. NatlAcad Press, 2000

  7. U.S. Response to TB Resurgence Rebuilt Infrastructure & Training to Improve Case Identification National MDR-TB Action Plan, Political Will & New Resources Focus on DOT, Outreach, Improved Rx Completion Updated Diagnostic Labs, Real-time DST & Fingerprinting Rebuilt Research Capacity Updated Infection Control & Treatment Recommendations

  8. Reported TB Cases United States, 1982–2011* 2011 Data 10,521 Cases (Rate 3.4/100,000) No. of Cases • Resurgence • Associated w/ • Deficient • infrastructure • HIV epidemic • Immigration • Institutional • transmission • MDR TB Year *Provisional 2011 data, updated February, 2012

  9. Estimated HIV Coinfection, Persons Reported with TB, U.S., 1993 – 2010* 29 % Coinfection 15 9 6 *Updated as of July 21, 2011 Note: Minimum estimates based on reported HIV-positive status among all TB cases in the age group

  10. Primary MDR TBUnited States, 1993 – 2010* Percentage No. of Cases *Updated as of July 21, 2011 Note: Based on initial isolates from persons with no prior history of TB. MDR TB defined as resistance to at least isoniazid and rifampin.

  11. Asian/Pacific Islander American Indian/Alaska Native Black or African-American White Hispanic TB Case Rates by Race/Ethnicity* United States, 1993–2010** 41.2 28.5 Cases per 100,000 22.4 19.9 14.0 7.0 3.6 6.4 1.1 *All races are non-Hispanic. In 2003, Asian/Pacific Islander category includes persons who reported race as Asian only and/or Native Hawaiian or Other Pacific Islander only

  12. Number and Rate of Reported TB Cases by Race/ethnicity, 2011 Provisional TB surveillance data reported to DTBE/NCHHSTP/CDC. Updated Feb 2012

  13. TB Case Rates in U.S.-born vs. Foreign-born Persons, U.S., 1993–2011 TB Cases per 100,000 (Log Scale) Provisional 2011 Data 17.4 3.4 1.5 Provisional 2011 data, Feb 2012

  14. Primary MDR TB in U.S.-born vs. Foreign-born PersonsUnited States, 1993 – 2010* 2.5 2.2 % Resistant 1.5 0.5 *Updated as of July 21, 2011 Note: Based on initial isolates from persons with no prior history of TB. MDR TB defined as resistance to at least isoniazid and rifampin.

  15. Proportion of Reported TB Cases in U.S., by U.S.-born or Foreign-born, 1993 and 2011 1% 0.4% 30% U.S.-born Foreign-born Unknown/missing Provisional 2011data, Feb 2012

  16. Countries of Birth of Foreign-born Persons Reported with TB, United States, 2011 Provisional 2011data, Feb 2012.

  17. NEJM 2005;353:1008-20

  18. TB Incidence Projections for (a) Eliminating Transmission and (b) Increases in LTBI Treatment 2022 2035 Hill AN, et al. Modelling TB Trends in the USA. Epidemiology and Infection, online Jan. 2012

  19. Examples of CDC/DTBE-Sponsored Research and Key Findings • Clinical Trials: TBTC Studies #22-34 • Efficacy of rifapentine (P) once/week • Risk of rif-resistant relapses in HIV+ • Risk of highly intermittent Rx in HIV+ • Efficacy of 12-dose HP in latent TB • NTBGSN evaluation of role of genotyping, later Universal TBGIMS, and TBESC (Task Orders #2-32) • TB disease due to recent infections • 30-40% in USB vs. 15-25% in FB • Importance of contact investigations • Risk factors in FB and HIV-infected • Risks and barriers in US-born blacks • Role of IGRAs for HCW screening • Outbreak Investigations Castro KG, Jaffe HW. EID 2002; 8:1188-1191 Mitruka K, et al. EID 2011;17:425-431

  20. Annual CDC TB Budget, FY 1990–FY 2013* 50% drop in purchasing power in FY 2012 vs FY 1994 US $ (millions) Enacted Proposed Actual $ CPI-Adjusted Year *1990 Dollars, Adjusted by Consumer Price Index for Medical Care. Includes TB/HIV and lab dollars. Updated 4/9/2012

  21. Challenges to the Elimination of Tuberculosis in U.S. • Declining trends and changing epidemiology, leading to • Complacency (“no longer a problem”) • Loss of proficiency and expertise • Increasingly difficult-to-reach groups (foreign-born, homeless, substance abusers, racial/ethnic minorities) • Limited local emergency response capacity for sporadic outbreaks • Decreasing resources, requiring reductions in expenditures • Formula-based funding to track trends • Maintaining focus on high-impact program activities and research • Risk of moving from elimination goal to focus on control

  22. Other Challenges to TB Elimination (2) • Providing prevention through healthcare(PTHC) in context of ACA while maintaining safety net for foreign-born persons with limited documentation, and disadvantaged populations (homeless/unemployed/uninsured ) • Supporting contact investigations functions (>112,000 contacts/year) by health departments – not part of PTHC • Retaining national response: CDC increasingly called upon to assist in response to outbreaks because of limited jurisdictional capacity (homelessness/incarceration) • Continue development of innovations and improvements to programs • Strengthen alignment of global & domestic activities to reduce importation of TB

  23. TB Elimination Requires Bridging 3 Gaps (≤ 1 case/ million population) Implementation Knowledge Ambition Castro KG, LoBue P. Emerg Infect Dis2011;17:337-342

  24. ≤ 1 TB case per million by 2035 would yield • 253,000 fewer TB cases • 15,200 fewer TB-related deaths • $1.3 billion less in treatment costs (in 2006 dollars)

  25. 2011-2015 Returns on Global Stop TB Plan Investment NB: in HIV 2011-2020 investment framework, 7.4 million lives saved, 29.4 million life years gained over 10 years, for additional investment of US$46.5 billion and cost per life year gained of about US$ 1,000 Source: Floyd K. WHO Stop TB Department, Jan 2012

  26. Foege’s Observations on Smallpox Eradication • “Thousands of people participated in the smallpox global eradication effort…they were optimists…they were risk takers; there was no shortage of people telling them that the effort was futile…” • “It wasn't science that threatened to stop us. It wasn't even nature per se. Rather, it was human nature: the human factors that involve strikes, job security, political concerns, turf.” Foege WH. House on Fire. University of California Press. 2011

  27. Maintain control while adapting to declining incidence Accelerate the decline through increased treatment of latent infection Develop tools needed for ultimate elimination: diagnostics, new drugs, vaccine Increase U.S. involvement in global efforts Mobilize support and measure progress Institute of Medicine Report on the Elimination of Tuberculosis in the United States. National Academy Press, 2000

  28. Acknowledgements • Partners in state and local TB programs, RTMCCs, • TBETN, TBPEN, TBGIMS, NTCA, Stop TB USA • Collaborators in research consortia (TBTC, TBESC) • Academic collaborators, ATS, IDSA, AAP, APHL • Professionals staff in CDC/DTBE, other CDC partners Thank You

  29. CDC received emergency funds for TB prevention, control, research, and laboratory strengthening in FY 1993 and FY 1994 Largest funding amounts went to big cities to address HIV/TB, multi-drug resistant TB, institutional transmission, and basic infrastructure Epidemiology of TB in the U.S. has changed since 1993 and continues to evolve (60% FB cases, 2010) Funding amounts have remained relatively static Starting in FY 2005 ACET, CDC, NTCA agreed to shift funding from legacy levels to cost-per-case Rationale for TB Funding Formula

  30. *CoAgs includes P&C, lab, RTMCC’s, and HRD resources. Contractual includes but is not limited to TBTC, TBESC, and contract staff resources. Other includes IT licenses, rent and utilities, maintenance agreements, and other miscellaneous expenditures.

  31. Division of TB Elimination Cooperative Agreement Funding Levels, FY 2012 * FY 2013 PB for TB reduces budget by $4.607 million * * CoAgs exclude DA awards & travel

  32. Outcome of DTBE and “Funding Formula” Workgroup Deliberations Summary • Needs-based component 80% • Relies on weighted TB morbidity variables • Performance-based component 20% • Pay per case completing treatment in 12 months (15%) and drug susceptibility test results reported (5%) • Restrict resources and provide technical support (performance improvement plans) to sites not meeting performance goals Use past performance (previous 3 years) to determine allocation

  33. Needs-Based Component (80%) of New TB Prevention and Control Formula: Weighted by Average Number of Cases and Complexity

  34. TB Laboratory Formula: Weighted by Workload *Lab performance indicator will be phased in by FY2015 **Base amount and distribution by no. patients for whom clinical specimen is received with remaining funds distributed by no. positive by direct detection for M. tuberculosis

  35. Percent of TB Prevention & Control Funding Formula Redistribution, FY 2004 – FY 2015 Fiscal Year (FY) Goal: Redistribute all funds on basis of formula to align with data-driven epidemiologic needs and performance Original Funding Formula implemented FY 2005

  36. TB Prevention and Control Formula Weights by 3-year average number cases and complexity 3-year average number of cases. For FY 2013, cases from 2008–2010

  37. TB Laboratory Funding Formula * Base amount determined by number of patients for whom clinical specimen is received with remaining funds distributed by number of patients positive by direct detection for M. tuberculosis

  38. Human Resource Development: Funding Amount to Area by TB Incidence Strata TB Incidence Strata,Funding Amount Annual No. Casesin $USD • 0 – 49 20,000 • 50 – 499 30,000 • ≥500 50,000

  39. National TB Initiatives: Ongoing and Under Consideration • Monitor progress by national TB indicators project (NTIP) • Support laboratory capacity for molecular detection of drug resistance and evaluate impact on outcomes • Establish prognostic value of IGRAs for latent TB (LTBI) • Assess use of reminders (vs DOT) for 12-dose LTBI regimen • Clinical trials to identify shorter safe and efficacious treatment regimens • Forecast, prevent, and respond to 2nd-line drug shortages • Promote prevention through healthcare (PTHC) while protecting ability to investigate contacts (est. 110,000) • Surveillance for latent TB infection (est. 9-11 million) • Use of genotyping to predict and prevent outbreaks • Focus on improving TB P&C in homeless populations

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