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Stop TB Partnership WHO

Tuberculosis

March 25, 2008 Shu-Hua Wang, MD, MPH&TM

Assistant Professor of Medicine Medical Director, Ben Franklin TB Program The Ohio State University [email protected]

Who had TB?

Famous Actress who died of TB in 1967?

h eig L en i Viv

Famous People with TB

King Tutankhamen* John Keats* Ralph Waldo Emerson Elizabeth Barrett Browning* Edgar Allan Poe* Frederic Chopin* Eleanor Roosevelt* Adolf Hitler George Orwell* Vivien Leigh* Egyptian pharaoh English poet American essayist/poet English poet American writer/poet Polish composer/pianist American humanitarian/first lady German dictator English novelist/essayist English actress Ca 1358-1340 B 1795-1821 1803-1882 1803-1861 1809-1849 1810-1849 1884-1962 1889-1945 1903-1950 1913-1967

*Those who die from TB http://www.dhss.delaware.gov/dhss/dph/dpc/tbfamouspeople.html

Estimated TB incidence rate, 2005

8.8 million new TB cases in 2005 1.6 million deaths are caused by TB in 2005 4400 people each day in 2005 Every one second someone in the world is newly infected with TB bacilli

Estimated new TB cases (all forms) per 100 000 population No estimate 0­24 25­49 50­99 100­299 300 or more

The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. © WHO 2006. All rights reserved

4

Reported TB Cases* United States, 1982­2006

No. of Cases

28,000 26,000 24,000 22,000 20,000 18,000 16,000 14,000 12,000 10,000

1982 1986 1990 1994 1998 2002 2006

2007 13,293 cases 4.4 cases/100,000

Year 1953 84,304 cases of TB. Rate 52.6 cases per 100,000

*Updated as of April 6, 2007.

TB Case Rates,* United States, 2006

1274 569 2781 Year 2006 2005 2004 2003 D.C. Ohio rate # 2.1 239 2.3 260 1.9 219 2.0 229

1585 1038

< 3.5 (year 2000 target) 3.6­4.6 > 4.6 (national average)

*Cases per 100,000.

Reported TB Cases by Age Group, United States, 2006

>65 yrs (19%) <15 yrs (6%) 15­24 yrs (11%)

45­64 yrs (29%)

25­44 yrs (34%)

Reported TB Cases by Origin and Race/Ethnicity,* United States, 2006

U.S.-born

American Indian or Alaska Native (3%) Asian (2%) Hispanic or Latino (39%)

Foreign-born**

White (5%)

White (33%)

Asian (40%)

Native Hawaiian/Other Pacific Islander (<1%) Hispanic or Latino (17%)

Black or African American (44%) Black or African American (14%)

*All races are non-Hispanic. Persons reporting two or more races accounted for less than 1% of all cases. **American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander accounted for less than 1% of foreign-born cases and are not shown.

Number of TB Cases in U.S.-born vs. Foreign-born Persons United States, 1993­2006*

No. of Cases

20000 15000 10000 5000 0

1994

1996

1998 2000

2002

2004

2006

U.S.-born

Foreign-born

*Updated as of April 6, 2007.

TB-HIV Co-infection 2003

Rate per 100 000 <5 5 - 9.9 10 - 99 100 - 999 1000 - 4999 5000 or more No estimate

10 million people co-infected with TB and HIV TB is the leading killer among HIV-infected people About one third of persons with HIV are infected with TB

Source: WHO and Corbett EL, Watt CJ, Walker N, Maher D, Raviglione MC, Williams B, Dye C. (Arch 5/03)

10

Estimated HIV Coinfection in Persons Reported with TB, United States, 1993­2005* % Coinfection

30 20 10 0 1993 1995 1997 1999 2001 2003 2005

All Ages

15% 7% *Updated as of April 6, 2007.

Aged 25­44

29% 13%

Note: Minimum estimates based on reported HIV-positive status among all TB cases in the age group.

Fresh Air School opened in 1913

· Hudson Street & Neil Avenue ·Children in homes where there were one or more cases of TB

Slide courtesy of Martin A Valdivia, MD

The Franklin County Sanatorium was opened in 1914 (Alum Creek Dr. SE Columbus)

TB Hospital opened in 1941 Columbus, Ohio

Slide courtesy of Martin A Valdivia, MD

Procedures performed at the Ohio TB hospital (now Means Hall)

Slide courtesy of Martin A Valdivia, MD

U.S., Ohio and Franklin County TB case rates per 100,000 population: 2000 - 2006

9 8

Ohio Franklin Co. USA

7.7 7.3 7.1 7.8

C a s e ra te p e r 1 0 0 ,0 0 0 p o p u la tio n

7 6 5 4 3 2 1 0

2000 2001 2002 2003 2004 5.8

5.6

5.5 5.2

5.6 5.1

5.1 4.9 4.8 4.6

3

2.7

2.7 2.0 1.9

2.3

2.1

2005

2006

E Ganon OSUMC Clin Epi

Percent Active TB Cases in Franklin County by Birth Country, 2006

Somalia United States Kenya Mexico

5%

Ethiopia

39%

Benin Egypt El Salvador India Jordan Laos Liberia Pakistan Philippines Sierra Leone Tanzania Thailand

6%

34%

Characteristics of TB Cases in Franklin County, 2006

HIV Positive HealthCare Worker

Drug Use in Last Year

IDU in Last Year Long Term Care Facility Correctional Facility

Homeless

Non-US Born

Transmission of Tuberculosis and Progression from Latent Infection to Reactivated Disease

1-5µ

Small & Fujiwara NEJM 2001 345:192

Tuberculin Skin Test (TST)

Administering TST Inject 0.1 ml of 5 TU PPD tuberculin solution intradermally on volar surface of lower arm Produce a wheal 6 to 10 mm in diameter

No Tape or band aids

Tuberculin Skin Test (TST)

Reading TST Measure 48 to 72 hours Induration, not erythema Record reaction in mm, not "negative" or "positive"

Question 1

Gabriel 20 years old TST = 5 mm, CXR = NAPD, No Symptoms Question: True or False? Gabriel's tuberculin skin test is positive and he should be started treatment for Latent TB Infection.

TST > 5 mm

High-risk groups Recent contacts of a TB case HIV-infection Fibrotic changes on chest radiograph consistent with old TB Organ transplant recipient Other immunosuppressed patients

­ Equivalent >15 mg/day of prednisone for >1 month ­ Anti-TNF medication

August 2003 http://www.cdc.gov/tb (404) 639-8140 Document # 250110

TST > 10 mm

Foreign born from countries with high TB prevalence Injection drug users Residents and employees of high-risk congregate settings ­ correctional facilities , homeless shelters ­ nursing homes, hospitals, health care facilities Mycobacteriology laboratory personnel Chronic illness: DM, ESRD, Heme disorder, malignancy, loss > 10% IBW, Silicosis

August 2003 http://www.cdc.gov/tb (404) 639-8140 Document # 250110

Question 2

Rosa 40 year old nurse from the Philippines No significant past medical history Needs tuberculin skin test (TST) for work She states that she has been vaccinated with BCG which will cause her TST result positive, so she should be exempt from getting a TST. True or False?

BCG Vaccination Program

Does BCG affect TST results and interpretations?

False positive result initially Tuberculin reactivity wanes after 5 ­ 10 years Boosted by subsequent TST TST > 20mm not usually caused by BCG U.S. guidelines: ­ Positive TST in person who receive BCG should be interpreted as indicating LTBI.

MMWR 2005, Vol 54 RR17p83

Question 3

Rosa's skin test was positive at 19mm No symptoms and CXR is normal HIV negative Rosa should receive which of the following regimen for her LTBI treatment a. 2 months of PZA and Rifampin b. 4 months of INH and Rifampin c. 6 months of INH d. 9 months of INH

Question 3

Answer: d. Treatment of Latent TB Infection for HIV positive and negative is the same. Recommend 9 months of INH Acceptable alternative ­ 4 months of Rifampin ­ 6 months INH PZA and RIF is no longer recommended due to hepatotoxicity

Diagnosis

delayed-type hypersensitivity reaction in persons with M. tuberculosis infection

Mantoux tuberculin skin test (TST)

Interferon gamma release assay (IFGR)

Blood test that measures and compares amount of interferongamma (IFN-) released by blood cells in response to antigens

QuantiFERON® - Gold

Anderson et al., Lancet

IFGR

in vitro test

Specific antigens

Not affected by prior BCG

TST

in vivo test

Less specific PPD Boosting 2 patient visits Results in 2-3 days TST placement skills Inter-reader variability

No boosting single patient visit Results possible in 1 day Requires phlebotomy Error in collecting, transporting, lab

IFGR = interferon gamma release assay, blood test for TB TST = tuberculin skin test (PPD)

New CDC Guidelines

December 2005

QFT-G may be used in all circumstances in which the TST is currently used

Cautions and Limitations

­ Immunocompromised: HIV, transplant, high dose steroid, TNF blockers ­ Hematological disorders (myeloproliferative disease, leukemias, and lymphoma) ­ Malignancies (carcinoma of head and neck, or lung) ­ Diabetes, silicosis, chronic renal failure ­ < 17 year old, pregnant

MMWR 54/RR-15 49- Guidelines for Using the QFT-Gold Test for Detecting Mycobacterium tuberculosis infection, United States.

Latent TB Infection NHANES 1999-2000

Overall prevalence 4.2% PPD >10mm

­ White 1.9% ­ African Americans 7% ­ Hispanics 9.4%

US born-1.8%

­ 4,154,000

Foreign born 18.7%

­ 6,888,000

Tuberculosis screening ­ Chest Radiography

In 1895 Wilhelm Conrad Roentgen discovered X rays.

For 30 years beginning in 1941 chest radiography was the linchpin for tuberculosis case finding programs in the US.

Slides courtesy of Dr. Thomas Daniels and ALA

Common Sites of Active TB Disease

·

Photo CDC and ADAM

Laboratory Diagnosis

PAP-R Positive Air Pressure Respirator

OSUMC AFB Smear and Culture

Specimen collection and processing

AFB Smear

MGIT

(Liquid medium, automated system)

Agar Plate

M H 711

NAA

No Growth

Incubate for 6 weeks

Positive Growth

No Growth

Incubate for 4 weeks

Gen-Probe

MTB, MAC, M kansasii, M gordonae

NAA = nucleic acid amplification

MTB Susceptibility Testing

RIF, INH, EMB, PZA, Strep

Liquid Cx, Solid Media, AFB smear

Acid Fast Bacilli (AFB) Stain

Ziehl-Neelsen X 1,125

Ziehl-Neelsen stain Kinyoun stain Regular light microscope Higher magnification

beaded rods 2 to 4 µm long and 0.2 to 5 µm wide X 1440 x2000

Nucleic Acid Amplification (NAA) Tests

Direct, rapid, detection of Mycobacterium tuberculosis complex ­ Patients suspected of TB ­ Takes about 4 to 5 hours ­ Approved for respiratory specimens only Smear positive and smear negative ­ Non-respiratory specimen (validated by labs) ­ Can detect fewer than 10 organisms ­ Does not distinguish live vs dead organism

MMWR July 7, 2000

Solid growth media for culture

Organisms (colonies) can be seen on the surface of the media 3 to 6 weeks

L-J

Rough colonies Irregular boundary Beige or tan

Liquid Medium

Growth can be detected in ~7 to 21 days

Treatment

Slide courtesy of Martin A Valdivia, MD

Antimyobacterial Drugs

First-Line Drugs Isoniazid (INH) Rifampin (RIF) Pyrazinamide (PZA) Ethambutol (EMB)

Ethambutol 1961

Second-Line Drugs

Streptomycin Cycloserine p-Aminosalicylic acid Ethionamide Amikacin or kanamycin* Capreomycin Levofloxacin* Moxifloxacin* Gatifloxacin*

* Not approved FDA for tx TB

Isoniazid 1952 Rifampin 1966 Pyrazinamide 1952

Vitamin B6

Primary Isoniazid Resistance in U.S.-born vs. Foreign-born Persons United States, 1993­2006* % Resistant

14 12 10 8 6 4 2 0 1994 1996 1998 2000 2002

12.3% 4.3%

2004

2006

U.S.-born

6,8% 4.3%

Foreign-born

*Updated as of April 6, 2007. Note: Based on initial isolates from persons with no prior history of TB.

Treatment of Culture-Positive TB

(Rated: AI in HIV-negative, AII in HIV-positive patients)

Initial Phase 2 months - INH, RIF, PZA, EMB daily (DOT: 56 doses, 8 weeks) - INH, RIF, PZA, EMB 5x/wk (DOT: 40 doses, 8 weeks) Continuation Phase Options 1) 4 months - INH, RIF daily 2) 4 months - INH, RIF 5 x / wk 4 months - INH, RIF 2X/ wk For HIV + with CD4 > 100 Other Initial Continuation Phase Options: 1) First 2 weeks: daily RIPE then remainder 2X/wk (AII/BII) 2) First 2 months RIPE 3x/wk then 4 months - INH, RIF 3X / week (BI/BII)

Directly Observed Therapy

Ethambutol 1961

Isoniazid 1952 Rifampin 1966 Pyrazinamide 1952

Vitamin B6

www.who.int/mapLibrary

Contact Investigation

Risk Assessment

O M E

W K OR

H

Low

h ig H

Hi gh

gh Hi

Index Index case Case

Low

High High Low LEISURE

REPORT ALL TB SUSPECTS to TB Control Program ­Franklin County TB Hotline: 614 293-1823

Case Studies

Case Study (1)

Patient history 17 year old Hispanic male No significant past medical history 8 week history of cough Associated with pleuritic retrosternal CP, DOE, fever, night sweats, chills, 10# weight loss TST 2 weeks ago = 0 mm

Question

No AFB smear is needed because the patient does not have TB: TST is negative and CXR does not have an infiltrate. Answer False. False. False. Active TB patients can be TST negative. HIV (+) or HIV (-). Hilar adenopathy can be suggestive of TB HIV infected persons may have normal CXR and still have TB. AFB sputum smear should be obtained

Case 1

Admitted Airborne Infection Isolation (AII) precautions AFB sputum smear negative X 3 New diagnosis of HIV:

­ CD4 41/mm3 (3.8%)

Hepatitis B/C negative Blood/urine cx negative

TB-HIV Co-infection 2003

Rate per 100 000 <5 5 - 9.9 10 - 99 100 - 999 1000 - 4999 5000 or more No estimate

10 million people co-infected with TB and HIV TB is the leading killer among HIV-infected people About one third of persons with HIV are infected with TB

Source: WHO and Corbett EL, Watt CJ, Walker N, Maher D, Raviglione MC, Williams B, Dye C. (Arch 5/03)

54

Estimated HIV Coinfection in Persons Reported with TB, United States, 1993­2005* % Coinfection

30 20 10 0 1993 1995 1997 1999 2001 2003 2005

All Ages

15% 7% *Updated as of April 6, 2007.

Aged 25­44

29% 13%

Note: Minimum estimates based on reported HIV-positive status among all TB cases in the age group.

HIV-TB

High mortality rate in patients with HIV-TB in pre-HAART era (20-50%) per year After the first month of therapy, most deaths among patients with HIV-related TB are due to AIDS, not TB HAART dramatically decrease deaths and OIs among patients with advanced AIDS HAART should be able to decrease HIV disease progression among patients with advanced HIV complicated by TB

Recommendation for Use of ART during TB treatment

CD4 cell count at TB DX

­ <200 ­ <50 Start ART during TB TX within 2 weeks

50-200

after 2 months

200-350 Monitor, start if rapid decrease CD4 >350 Follow CD4 and clinical status

Complexities of TX HIV-TB

Need to coordinate 2 separate, vertically integrated programs Challenge of adherence to multi-drug therapy for both diseases Overlapping drug toxicities Drug interactions Paradoxical reactions

Case Study B - Questions

HAART initiated 2 months later ­readmitted with increasing SOB, Chest pain, fever, cough Which of the following is the most likely explanation for his current symptoms?

a. b. c. d.

He has developed multi-drug resistant TB He has developed PCP He is experiencing side effects to his anti-TB medication He has developed a "paradoxical reaction" to his anti-TB and HAART

Case Study 1 - Answer

Answer: d Patient has developed a "paradoxical reaction" S/SX include high fevers, lymphadenopathy, worsening CXR, worsening of original TB lesion Diagnosis of exclusion Some may require steroids

Management Challenge: Clinical Deterioration

CC: Increasing SOB & CP PE: T 104.3°F RR 40 BP 84/52 Neck extended JVD Decreased heart tone

Case Study 1:

pulsus paradoxus 12 mm Hg

Interval Development of Large Pericardial Effusion

3 months prior

Admission

Resolution of Pericardial Effusion

Response to Corticosteroids:

Day - 1

Day of Corticosteroids

Day + 8

Resolution of Pericardial Effusion

Response to Corticosteroids:

Day - 1

Day of Corticosteroids

Day + 17

Clinical Case #2

HOPI · 28 year old Chinese female, 32 week pregnant · Presented to OSH ER with hemoptysis · C/O cough X 2 days, associated with mild SOB · No fever, chills, night sweat, appetite loss, fatigue, or weight loss · Denies any history contact with known active tuberculosis · History positive TST ~ 9 months ago, no latent TB therapy · Received BCG vaccine in China as a child

PMHx · No significant PMHx ROS · Appropriate weight gain with pregnancy · Right upper back discomfort X 3 months Allergy: NKDA Medication: Vitamins

Social History · Arrived in US 3 years ago · Columbus X 1 year · No travel outside area · Unemployed · No tobacco, alcohol, or illicit drug use

Physical examination

Temp 98.4, BP 130/80 HEENT: oral pharynx clear Lungs : CTA bilaterally CV: RRR no m/g/r Abd: gravid Ext: no c/c/e Skin: warm, no rash Neuro: grossly intact

Hospital course

Laboratory · WBC 6.1, Hgb 10.1gm/dL, Platelets 192, Cr. 0.5, AST 41, ALT 51, HIV negative Radiology CXR · Mild asymmetric patchy opacity in the left upper lobe CT scan · NO pulmonary embolus · Extensive diffuse nodular air-space disease with peripheral distribution Hospital Course: · Admitted for Community Acquired Pneumonia and · Rule out TB - in Negative Air Isolation · Azithromycin and ceftriaxone · Infectious Disease consult day 2: ­ Antituberculosis therapy with Isonaizid, Rifampin, and Ethambutol

· PPD 17mm · Interferon gamma release assay (QuantiFERON®

TB Gold )

­ Positive

Specimen Sputum day 1 Sputum day 2 Sputum day 3 BAL day 4 Smear Negative Negative Negative Negative

·Discharge home on INH for Latent TB Treatment ·Follow up at BFC

· PPD 17mm · Interferon gamma release assay (QuantiFERON®

TB Gold )

­ Positive

Specimen Sputum day 1 Sputum day 2 Sputum day 3 BAL day 4 Smear Negative Negative Negative Negative Culture

·Add - Nucleic acid amplification test:

­Positive

· PPD 17mm · Interferon gamma release assay (QuantiFERON-TB Gold®)

­ Positive

· Nucleic acid amplification test:

­ Positive Specimen Sputum day 1 Sputum day 2 Sputum day 3 BAL day 4 Sputum day 9* · Smear Negative Negative Negative Negative Negative Culture M. tb M. tb M. tb Negative Negative

*All subsequent sputum smear and culture negative

· PPD 17mm · Interferon gamma release assay (QuantiFERON-TB Gold®)

­ Positive

· Nucleic acid amplification test:

­ Positive Specimen Sputum day 1 Sputum day 2 Sputum day 3 BAL day 4 Sputum day 9* Smear Negative Negative Negative Negative Negative Culture M. tb M. tb M. tb Negative Negative

·Drug susceptibility:

Resistant to Rifampin, Isoniazid, and Streptomycin

Primary MDR TB in U.S.-born vs. Foreign-born Persons, United States, 1993­2006*

% Resistant

3 2 1 0

1994 1996 1998 2000 2002 2004 2006

U.S.-born

Foreign-born

WHO estimates there are 300,000 to 600,000 cases of MDR-TB world wide. *Updated as of April 6, 2007. Note: Based on initial isolates from persons with no prior history of TB. MDR TB defined as resistance to at least isoniazid and rifampin.

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