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

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

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 the leading cause of death among persons with HIV TB undermining US efforts to save lives from AIDS in Africa TB expedites HIV disease progression TB patients continue to have limited ART access TB is more difficult to diagnose in persons with HIV and is also more challenging to treat

Estimated Tuberculosis Incidence Rates, by Country, in 2007

Estimated HIV Prevalence in new Tuberculosis cases in 2007

Tuberculosis: Antiquated tools for diagnosis, 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

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 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, An Update

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

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

New Legislative Authorities* *Not yet appropriated Comprehensive TB Elimination Act: $200 million for TB prevention, control, and new tools FY 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

Fund the Comprehensive TB Elimination Act : Public Law Authorizes $200 million for TB prevention, control and new tools FY 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

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

HIV/TB: US Response Fund 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

Crisis in Antimicrobial Resistance 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

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!!

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)