Christine Lubinski Vice President for Global Health Infectious Diseases Society of America

1. Germs Go Global Tuberculosis and HIV/TB Co-Infection Christine Lubinski Vice President for Global Health Infectious Diseases Society of America April 17, 2009

2. Global Tuberculosis Pandemic • Second leading infectious disease killer • worldwide • One-third of the world’s population is • infected • 9.27 million new cases in 2007 • An estimated 1.37 million of these cases • were HIV-positive • 79% of HIV+ cases in Africa • 1.8 million deaths in 2007, including almost • 500,000 among HIV infected persons • 500,000 cases of MDR-TB in 2007 • By the end of 2008, 55 countries reported • at least one case of XDR-TB

3. HIV/TB Co-Infection: Deadly Synergy • HIV infection facilitates active • TB disease in those with latent TB • IPT effective but not available to • most in need • HIV epidemic has amplified the • TB epidemic in dual burden • countries- expanded TB risk to the • community at large • TB is more difficult to diagnose in • persons with HIV and is also more • challenging to treat • TB expedites HIV disease • progression • TB patients continue to have • limited ART access • TB is the leading cause of death • among persons with HIV • TB undermining US efforts to • save lives from AIDS in Africa

4. Estimated Tuberculosis Incidence Rates, by Country, in 2007

5. Estimated HIV Prevalence in new Tuberculosis cases in 2007

6. Tuberculosis: Antiquated tools fordiagnosis, treatment and prevention • Diagnostics- • Detect only half of people tested and • fewer than 20% of HIV patients with • active TB • Tests for drug resistant • strains not available in • most of the developing • world • Drugs- • 4 drugs must be taken for 6-9 months– • significant side effects, not compatible • with important anti-HIV drugs • Drug resistant TB requires • 2 years of treatment with • highly toxic drugs, which are • frequently not available in • developing countries • Vaccine- • existing vaccine does not protect past • infancy, and is not recommended in infants • with HIV infection

7. Tuberculosis Research & Development • $482.5 million spent worldwide in 2007, far short of • WHO goals of $900 million per year • TB drugs received highest level of funding at $170 mil • US diagnostic research is grossly underfunded at • $41.9 million, as is operational research at $36.8 • million • Top Funder– NIAID/NIH at $160 million • No.2 funder– Bill & Melinda Gates Foundation at • $124 million in 2007. Gates Foundation funding • outpaced NIH in all categories except for basic • research Treatment Action Group: TB Research and Development: A Critical Analysis of Funding Trends, 2005-2007 An Update

8. Tuberculosis in the United States 12,898 new cases were reported in 2008 125 cases of MDR-TB 58% of cases were foreign born; Among US-born populations blacks have TB rate 7 times higher than whites Progress toward TB elimination has slowed down Over the last 3 years, more than 1000 jobs have been lost in state TB control programs

9. Annual CDC TB Budget, FY 1990–FY 2008 (2008 budget 40% lower than 1994, in CPI-Adjusted dollars*) Actual $ CPI-Adjusted Source: Center for Disease Control and Prevention * Adjusted to 1990 dollars by Consumer Price Index for Medical Care, includes TB/HIV and lab dollars

10. New Legislative Authorities* • Comprehensive TB Elimination Act: • $200 million for TB prevention, control, and new tools FY 2009-2013 • Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act: • $4 billion for global TB prevention FY 2009-2013 *Not yet appropriated

11. Fund the Comprehensive TB Elimination Act : Public Law 110-392 • Authorizes $200 million for TB prevention, control • and new tools FY 2009-2013 • Shore up state TB control programs • Enhance US capacity to address drug-resistant • TB • Facilitate development of new “tools”- drugs, • diagnostics, vaccines • Current TB funding is inadequate for testing • diagnostics, drugs, and vaccines currently in • pipeline in Phase III trials

12. Advancing TB R&D and Global TB Control • Double TB research Spending to $320 million at • NIH, providing resources for clinical trials, • diagnostics and research agenda for drug-resistant • TB • $100 million for CDC TB R & D • Provide $2.7 Billion to the Global Fund– largest • funding of global TB control • Enhance USAID TB Spending to $650 million to • Implement Lantos/Hyde • Increase operational research through USAID • and OGAC • Implement recommendations of the Federal TB • Task force to respond to MDR-TB domestically • and globally

13. HIV/TB: US ResponseFund Lantos-Hyde • Continue scale-up of HIV treatment, which • reduces TB morbidity/mortality in PWHIV • Fund the Global Fund to Fight HIV, TB and • Malaria at $2.7 billion- leading global funder • of TB control. • Ensure that TB screening, treatment and • preventive therapy are standard of care at • PEPFAR-funded HIV clinics • Stop TB transmission in HIV clinics by • Implementing infection control strategies

14. Antimicrobial-Resistant Strains Spread Rapidly MRSA = methicillin-resistant Staphylococcus aureus; VRE = Vancomycin-resistant enteroccoci; FQRP =Fluoroquinolone-resistant Pseudomonas aeruginosa Source: Centers for Disease Control and Prevention Crisis in Antimicrobial Resistance

15. Strategies to Address Antimicrobial Resistance (STAAR) Act To Strengthen Federal Antimicrobial Resistance Surveillance, Research and Prevention & Control Working Together We Can Enact the STAAR Act!!

16. IDSA’s 2004 Report: “Bad Bugs, No Drugs (BBND): As Antibiotic Discovery Stagnates, A Public Health Crisis Brews” “Only 16 new antibacterials are in late-stage clinical development at this time.” -- Bad Bugs, No Drugs: No ESKAPE! An Update from the Infectious Diseases Society of America (Clinical Infectious Disease 2009:48; January 1, 2009)