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Introduction to Public Health/Communicable Diseases/Tuberculosis Tuberculosis An Old Disease – New Twists A Continuing Public Health Challenge Jane Moore, RN, MHSA Director, TB Control & Prevention Program - VHD, 2013 Tuberculosis – Old Disease • May have evolved from M bovis; acquired by humans from domesticated animals ~15,000 years ago • Endemic in humans when stable networks of 200-440 people established (villages) ~ 10,000 years ago; Epidemic in Europe after 1600 (cities) • 354-322 BC - Aristotle – “When one comes near consumptives… one does contract their disease… The reason is that the breath is bad and heavy…In approaching the consumptive, one breathes this pernicious air. One takes the disease because in this air there is something disease producing.” Tuberculosis • 1882 – Robert Koch – “one seventh of all human beings die of tuberculosis and… if one considers only the productive middle-age groups, tuberculosis carries away one-third and often more of these…” M tuberculosis as causative agent for tuberculosis Robert Koch 1886 TB as a Worldwide Public Health Issue • • • • World population ~ 6 billion ~ 1in 3 people in world infected ~ 9.4 million new cases of active TB/year 1.7 million deaths/year • • • • US population 280 million ~ 3-5% infected Now < 10,000 cases/year ~ 5-7% mortality TB in the US – 1882-2012 • 1900-1940 TB rates decreased in the US and Western Europe before TB drugs available – Better nutrition, less crowded housing – Public health efforts • Earlier diagnosis • Limit transmission to close contacts – TB sanatoria – Surgery TB in the US – 1882-2012 • 1940s-1960s TB specific antimicrobial agents – Single drugs – use produced resistance – Multiple drugs • 1960s-1980s TB considered a non-problem – TB treatment moved to private sector – Loss of TB-specific public health infrastructure TB in the US – 1882-2012 • 1990s TB re-emerges as a threat – TB-HIV co-infection – Drug-resistant TB – Globalization allows TB to travel • 1990s Increased support for TB prevention and control – Funding for public health efforts (case management, contact investigation, directly observed therapy – Better diagnostic and patient management tools • 2012 – Lowest number of reported cases in US - <10,000 • One-third of the world is infected with TB, an average of one new infection per second • Two million people died from tuberculosis in 2010, 1 every 20 seconds • TB is the leading killer of those with HIV • TB is the 2nd leading killer from an infectious disease *Estimated TB in Virginia: 1990-2012 Number of Cases 500 400 300 200 235 100 0 1990 1993 1996 1999 2002 Year 2005 2008 2011 Virginia TB Cases - 2012 Place of Origin Race and Ethnicity Other (1%) Mexico White 7% (22%) Asian (51%) Other Countries (39%) Philippines Black (15%) (11%) Hispanic (26%) Vietnam Haiti (3%) Guatemala (3%) China (6%) India (8%) (8%) TB Case Rate per 100,000 VA and US: 2007-2012 Year Virginia TB Cases Virginia TB Rate US TB Cases US,521TB Rate 2008 292 3.8 12,906 4.2 2009 273 3.5 11,545 3.8 2010 268 3.4 11,181 3.6 2011 221 2.7 10,521 3.4 2012 235 2.9 9,951 3.2 Number of Cases VA TB Cases by Region: 2007-2012 200 180 160 140 120 100 80 60 40 20 0 2007 2008 2009 2010 2011 2012 Northwest Southwest Central Eastern Northern TB: Airborne Transmission TB Invades/Infects the Lung Effective immune response Infection limited to small area of lung Immune response insufficient TB – A Multi-system Infection Natural History of TB Infection Exposure to TB No infection (70-90%) Infection (10-30%) Latent TB (90%) Never develop Active disease Die within 2 years Active TB (10%) Untreated Survive Treated Die Cured Latent TB vs. Active TB Latent TB (LTBI) (Goal = prevent future active disease) = TB Infection = No Disease = NOT SICK = NOT INFECTIOUS Active TB (Goal = treat to cure, prevent transmission) = TB Infection which has progressed to TB Disease = SICK (usually) = INFECTIOUS if PULMONARY (usually) = NOT INFECTIOUS if not PULMONARY (usually) Treatment • Most TB is curable, but… – – – – Four or more drugs required for the simplest regimen 6-9 or more months of treatment required Person must be isolated until non-infectious Directly observed therapy to assure adherence/completion recommended – Side effects and toxicity common • May prolong treatment • May prolong infectiousness – Other medical and psychosocial conditions complicate therapy • TB may be more severe • Drug-drug interactions common TB – continues as a public health issue in the United States • Old public health concepts (isolation of infectious individuals, closely monitored treatment, recognition and preventive treatment for infected contacts,) are still critical, but will not eradicate TB • Care providers not familiar with signs/symptoms of TB – Diagnosis delayed – Inappropriate treatment – Drug resistance due to improper use of drugs • Must address both US born and newcomer populations – Older, remote exposure – Incarcerated, homeless, history of drug , alcohol use – Newcomers from high TB prevalence areas Challenges to Public Health System • Public health workers must: – Educate, coordinate care with private sector – Identify support services (food, housing) – Treat TB in geriatric populations – Treat TB in children – Deal with alcohol, drug abusing, incarcerated and/or homeless patients – Manage TB in patients with underlying medical conditions – Provide culturally appropriate care for non-English speaking/non-literate populations – Treat TB cases with drug- resistant TB Addressing the Challenges – TB Control in the US - 2012 • Local, state and federal programs have separate but closely related activities • Guidelines, Laws and Regulations – Guidelines – treatment, contact investigation, prevention – data driven/expert opinion – Laws – local or state – case reporting, isolation of infectious individuals – Regulations - local or state – implement laws – Federal laws/regulations – travel restrictions, entry into the US – no interstate restrictions – International travel regulations – WHO – limited Elements of a Tuberculosis Control Program Targeted testing/ LTBI treatment Inpatient care Medical evaluation and follow-up Non-TB medical services Home evaluation Case Management Follow-up/treatment of contacts Pharmacy Laboratory Technical assistance Training Funding Outbreak Data analysis Investigation Program evaluation & QA, QI for case planning management Consultation on Data for local, state, national Training difficult cases surveillance reports Federal TB Control Program National surveillance 11/01/07 Clinical Services Social HIV testing and Interpreter/ services counseling Occupational health, translator school, jail, shelter, services Patient LTCF screening Data collection education Coordination of Documentation Epidemiology medical care Contact DOT investigation and Surveillance Housing Isolation, detention Guidelines X-ray State TB Control Program Funding State statutes, regulations, policies, guidelines Information for public VDH/DDP/TB Jan 2007 VDH TB Prevention and Control Policies and Procedures • Based on USPHS/CDC, ATS, IDSA and Pediatric “Red Book” guidelines • Adapted to address uniquely Virginia issues • DDP TB Prevention and Control Activities • Core activities – Identification and treatment of TB cases – Identification, evaluation and treatment of high risk close contacts of cases – Surveillance/case reporting – TB laboratory services – Targeted testing and LTBI treatment for high risk populations – Training/continuing education for health care providers – Program evaluation 26 TB Control provided funding for TBrelated activities at Local Health Departments – PHN/ORW/Epi Reps (VDH/DDP employees and contracts) – TB clinic physicians (contracts) – Chest x-rays and laboratory tests – TB medications for uninsured case patients – Incentives and enablers – Training for HDs, PHNs, ORW 27 Services directly provided by Central Office (Richmond) – Case reporting, surveillance activities • Site visits to review case records, collect data • Data entry/management/analysis/reports • Feedback to local health departments • Data for national TB surveillance system • Information for local/state/federal government officials 28 Services directly provided by Central Office – Technical support/consultation • Case management • Contact investigations • Expert clinical consultation available through partnerships with EVMS and UVA • Case review conferences (QA, QI) • TB prevention/control in congregate living facilities, health care facilities 29 Services provided by Central Office – Educational activities for public and private sector HCPs, patients and the public • VDH conferences for public health workers • Speakers at private sector HCP meetings • Distribution of guidelines • Website 30 Currently Available Laboratory Services • DCLS – Standard TB Bacteriology • Smear, DNA Preliminary Culture, Standard Culture, Susceptibility – Molecular testing • MTD – Mycobacterium tuberculosis Direct • Cephid testing in validation process Currently Available Laboratory Services • Other Laboratories – Florida State Laboratory • HAIN testing – molecular susceptibility for INH/RIF – Centers for Disease Control and Prevention • First and second-lined molecular drug susceptibility testing • Genotyping of isolates – University of Florida Pharmacokinetics Laboratory • Serum drug level testing Current Programmatic Initiatives • Statewide availability of Interferon Gamma Release Assay for testing for latent TB infection – Blood test • 2 commercial products • QuantiFeron Gold InTube • T-Spot-TB – Chosen for Virginia for logistical reasons Current Programmatic Initiatives • New Treatment for latent TB infection (LTBI) – 12 week course of isoniazid and rifapentine (3HP) • Virginia Guidelines document developed – Pros • Shortens treatment course from 9 months to 12 weeks • Weekly instead of daily or twice weekly treatment – Cons • Requires directly observed treatment – observe dose ingestion • Costly – but price is coming down • Number of pills – but new formulations under development Current Programmatic Initiatives • Routine serum level drug testing of all diabetic TB cases early in treatment – A study of slow to respond to treatment TB cases showed statistical significance for diabetes – Pilot demonstrated high percentage of diabetics had low serum levels for TB drugs • Next phase – impact on sputum conversion – Goal – Shorten infectious period and potential for community transmission – Shorter treatment duration with resulting lower cost Programmatic Initiatives • Increased focus on contact investigation activities – Monitoring ongoing evaluation of contacts, especially children and immunocompromised contacts – Monitoring treatment of infected contacts Programmatic Initiatives • Focus on program evaluation activities – Ongoing case reviews of current cases – Cohort Review of prior year cases for 6 selected national indicators • Completion of treatment, HIV testing, Sputum collection, sputum conversion, susceptibility results, and initiation of treatment with 4 anti-TB drugs – District program review and record audit Current Needs for TB in the US • General – Continued support for TB prevention/control especially with health care reform • Sequestration and future federal budget reductions will have impact – New drugs and/or drug combinations to allow shorter courses of treatment • New drug bedaquiline approved by FDA • Use limited to multi-drug resistant pulmonary cases who cannot be treated with other drugs Current Needs for TB in the US – Shorter, simpler, less expensive treatment regimens – Vaccine (beyond BCG) • Still waiting – Support for global TB prevention and control activities • Federal funding reductions for global TB activities Current Needs for TB in the US • Reliable access to anti-tuberculosis drugs – Isoniazid – ongoing national shortage since Fall 2012 • Use in Virginia now limited to certain persons – PPD Solution – not a diagnostic – classified as a Schedule VI drug in Virginia • Started as national shortage of Tubersol, now spread to alternative product , Aplisol – Multiple injectible agents used for drug resistant TB in short supply • National shortage for several years Assessing the Impact • TB currently at lowest number and rate for both US and Virginia since records kept – Current drug shortages have the potential to hamper further progress in TB control and elimination – Priority on identifying and treating contacts to known cases • Using T-Spot.TB for testing contacts > age 12, skin test for younger children • Using isoniazid and rifapentine to treat contacts – Isoniazid sparing regimen • Others at high risk – testing & treatment deferred Thank you Questions? Jane Moore [email protected] 804 864 7920