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TUBERCULOSIS: Clinical Year in Review

Lee B. Reichman, MD, MPH Turkish Thoracic Society 10 th Annual Conference April 25-29, 2007 Kemer, Antalya, Turkey. TUBERCULOSIS: Clinical Year in Review. The Burden of Tuberculosis, 2007. 1.6 million deaths (28/100,000) - 98% of these deaths in the developing world

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TUBERCULOSIS: Clinical Year in Review

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  1. Lee B. Reichman, MD, MPHTurkish Thoracic Society10th Annual ConferenceApril 25-29, 2007Kemer, Antalya, Turkey TUBERCULOSIS: Clinical Year in Review

  2. The Burden of Tuberculosis, 2007 • 1.6 million deaths (28/100,000) - 98% of these deaths in the developing world • Almost 230,000 deaths due to TB/HIV • 8.8 million new cases (140/100,000)including 674,000 TB/HIV cases, 80% cases in 22 high-burden countries • 15.4 million prevalent cases (245/100,000) • Multi-drug resistance (MDRTB) present in 102 of 109 countries surveyed from 1994-2003

  3. TB Historical Permutation • 17th - 18th centuries TB took 1 in 5 adult lives • 1850 - 1950 one billion people died of TB • Current decade 2000-2010 • 300 million new infections • 90 million new cases • 30 million deaths • More people died from TB last year than any year in history

  4. TB Could Be Eliminated Because We Understand It We know its: • Cause • Transmission • Treatment • Prevention

  5. TB Isn’t Eliminated Because: • Nobody seems to care This wouldn’t be tolerated for any other disease

  6. Deaths Due To: TB (annually) 2 - 3,000,000 SARS 774 Angola Marburg Hemorrhagic Fever 329 Avian Influenza 169 Anthrax 5 Mad Cow Disease 1 (Cow) Smallpox 0

  7. TB Is Unique • With almost any other illness, responsibility for getting cured belongs solely to the patient • With TB, responsibility shifts 180 degrees to the health care provider and ultimately society • A decision to start treatment is a decision and obligation to cure patient

  8. To Start To Treat Is To Commit To Cure “The prescribing physician, be he/she in the public or private sector is carrying out a public health function with responsibility not only for prescribing an appropriate regimen, but also for successful completion of therapy. Prescribing physician responsibility for treatment completion is a fundamental principle in tuberculosis control.” - Am J Respir Crit Care Med 167:603-662, 2003

  9. TB Treatment Assumes An Important Public Health Function All providers who undertake evaluation and treatment of patients with tuberculosis must recognize that, not only are they delivering care to an individual, they are assuming an important public health function that also entails a high level of responsibility to the community, as well as to the individual patient. - TBCTA: International Standards for TB Care, 2006

  10. TB TREATMENT FAILURE IS INVARIABLY DUE TO PATIENT’S LACK OF COMPLIANCE

  11. Annik Rouillion Defaulters and Motivation “ …to default is the natural reaction of normal, sensible people: The person who continues to swallow drugs or have injections with complete regularity in the absence of encouragement and help from others is the abnormal one.” - Bull IUAT 1972; 47:68-75

  12. The Global Burden of TuberculosisHIV • Compounding the impact of TB is the co-epidemic of HIV/AIDS • Susceptibility to TB is one of the earliest manifestation of immunosuppression in HIV infection • TB has been shown to be the attributable cause of death in a third of AIDS patients in Africa • While the risk of developing TB for immunocompetent individuals is approximately 10% lifetime; for HIV infected individuals the risk is markedly increased to 10% annually • HIV/AIDS seriously magnifies any deficiencies in TB control

  13. Estimated HIV Prevalence in TB Cases 2004 WHO, 2006

  14. TB - HIV/AIDSThe Ignored Connection • Most people infected with HIV in developing countries develop TB as the first manifestation of AIDS • TB is clearly a major accelerator of HIV disease • TB is by far the most prevalent infectious disease exacerbated by the HIV epidemic, which is then transmitted to people without HIV • The fact that the medical establishment continues to handle these two conditions separately is not only regrettable but indefensible

  15. The Global Burden of TuberculosisMDR TB • TB resistance to INH and RIF is difficult to treat • Treatment must be individualized and prolonged based on medication history and drug susceptibility studies • Clinicians unfamiliar with treatment of MDR TB should seek expert consultation

  16. Revised WHO Case Definition for XDR TB (Oct 10, 2006) Goals • Public health surveillance • Reliable DST methodology • Clinical relevance • Relatively simple Resistance to at least isoniazid and rifampin (MDR) plus resistance to fluoroquinolones and one of the second-line injectable drugs (amikacin, kanamycin, or capreomycin)

  17. TB Clinical Development Pipeline Diarylquinoline TMC207 Nitroimidazo-oxazole OPC-67683 Nitroimidazole PA-824 Pyrrole LL-3858 *Institut de Recherche pour le Developement World Health Organization, Tropical Disease Research Centers for Disease Control and Prevention Novel compounds, highlighted in blue boxes, are active against MDR/XDR TB

  18. DOTS The WHO strategy for controlling TB is a combination of technical and management components, ensuring availability of a diagnostic and treatment network easily accessible to the population

  19. Anchor of the WHO-Recommended STOP TB Strategy Pursue Quality DOTS Expansion & Enhancement • Political commitment with long-term planning, adequate human resources, expanded & sustainable financing to reach WHA and MDG targets • Case detection through bacteriology (microscopy first, culture/DST)and strengthening of the laboratory network to facilitate detection of SS+, SS-, DR- and MDR- TB cases • Standardized treatment, under proper case management conditions, including DOT to reduce the risk of acquiring drug resistance, and patient support to increase adherence and chance of cure • An effective and regular drug supply system, including improvement of drug management capacity • Efficient monitoring system for programme supervision and evaluation including measurement of impact - Global Plan to Stop TB, 2006-2015

  20. WHO Recommended STOP TB StrategyNext 5 Components • Address TB/HIV, MDR-TB and other challenges, by scaling up specific activities • Contribute to health system strengtheningby collaboration • Involve all care providers, public, nongovernmental and private • Engage people with TB and affected communitiesto demand, and contribute to, effective care • Enable and promote researchfor the development of new drugs, diagnostic and vaccines - Global Plan to Stop TB, 2006-2015

  21. Remedies to Improve Completion Rates – 1 • Early intervention with DOT and other adherence-promoting strategies • Closer monitoring of patients on self-administered therapy and assessment of adherence to therapy • Exclusive use of fixed dose combination preparations of demonstrated bioavailability when therapy is self administered

  22. Remedies to Improve Completion Rates – 2 • Education of health care providers on identifying and addressing patient nonadherence, the use of adherence-promoting strategies, and use of DOT with short-course regimens • Active follow-up by health department or NTP of patients on therapy with complete and timely reporting on completion of therapy from both public and private sectors

  23. Monotherapy EQUALS Resistance DOT prevents monotherapy ... therefore DOT prevents resistance Fixed dose combinations of demonstrated bioavailability prevent monotherapy ... therefore fixed dose combinations prevent resistance

  24. The Global Burden of TuberculosisIncreasing Risks for All • With the globalization of the economy has come a globalization of health risks • There are 500 million international travelers, 5,000 airports supporting international travel, and 49 million international travelers who enter the US each year • An increasing percentage of cases in the US (now 54%)is observed among the foreign-born • Failure to develop measures to prevent and treat tuberculosis everywhere threatens our ability to control the disease anywhere, including the US

  25. World TB Day 2006 - Dr Lee launches the International Standards for TB Care & the Patients' Charter for TB Care

  26. International Standard for TB Care:Diagnosis All persons with otherwise unexplained cough lasting for 2-3 weeks or more should be evaluated for tuberculosis

  27. International Standard for TB Care:Diagnosis Microbiological evaluation (smear ± culture) is essential for all patients (including children, extra-pulmonary, and persons with radiographic abnormalities)

  28. International Standard for TB Care: Treatment The provider is responsible for prescribing an adequate regimen and ensuring adherence

  29. International Standard for TB Care:Treatment A patient-centered, individualized approach to treatment should be developed for all patients. A central element is direct observation by a treatment supporter.

  30. Progress Towards Global Targets70 / 85 by 2005 Case detection rate: 60% (target 70%) Cure rate: 84% (target 85%)

  31. Where Are The Missing Cases? They are not detected due to poor laboratory capacity

  32. Where Are The Missing Cases? At home, if services are not accessible

  33. Where Are The Missing Cases? In other un-connected public systems (prisons)

  34. Where Are The Missing Cases? In the private system

  35. The Patient’s Charter for Tuberculosis Care

  36. The Patient’s Charter for Tuberculosis Care • Initiated and developed by patients from around the world • Outlines rights and responsibilities of people with tuberculosis • Sets out the ways in which patients, the community, health providers (both private and public), and governments can work as partners in a positive and open relationship • Practices principle of Greater Involvement of People with Tuberculosis • Affirms that empowerment is catalyst for effective collaboration with health providers and authorities

  37. Patient’s Rights You have the right to: Care; Dignity; Information; Choice; Confidence; Justice; Organization; Security

  38. Patient’s Responsibilities You have the responsibility to: Share information; Follow treatment; Contribute to Community Health Show Solidarity

  39. Challenges to TB Control, 2007 • Often scarce political will and commitment • Insufficient internal and external financial resources • Insufficient human resources • Primary services not coping with needs • Weak laboratory capacity in many countries • Lack of executive power in decentralised systems • Lack of involvement of all care providers • No social mobilization for TB control • HIV and MDR threats • No New Tools

  40. Reichman’s Prediction • The continued rise of the TB in the world and the leveling off of tuberculosis in the US portends a significant global resurgence of TB followed by a frightening resurgence of MDRTB and XDRTB still diagnosed and treated with old tools • The resurgence will continue unabated followed by subsequent transmission to healthcare workers and through that vector to the community at large • Fear of transmission of XDRTB on the job will vastly compound the human resources issues related to tuberculosis care and control • Subsequent global re-establishment of control of tuberculosis will then entail more staggering costs, both in cash and hysteria than has ever been contemplated • New drugs and New Diagnostics and an effective vaccine will enhance the TB community’s success in turning this around which once again will depend on energizing others to make our case

  41. INFORMATION LINE 1•800•4TB•DOCS (482-3627) www.umdnj.edu/globaltb

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