Michael J. Huey, MD. NYSCHA Annual Meeting WE-2, October 19, 2016

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1 Michael J. Huey, MD Assistant Vice President and Executive Director Emory University Student Health Services Associate Professor, Family and Preventive Medicine Emory University School of Medicine President-elect American College Health Association NYSCHA Annual Meeting WE-2, October 19, 2016

2

3 At the conclusion of this presentation, attendees should be able to: Describe the pathophysiology of latent tuberculosis infection. Describe the strengths and weaknesses of available testing options for latent TB infection (LTBI). List the four current treatment options for prophylaxis of latent tuberculosis and describe their pros and cons, including Directly Observed Therapy (DOT). Leave slightly less confused...

4 Neither I nor my spouse have a financial interest, arrangement or affiliation with any organization or business entity (including self-employment or sole proprietorship) that could be perceived as a conflict of interest or source of bias in the context of this presentation. Butchart Gardens Victoria, British Columbia

5 A 27 y/o public health graduate international student is referred by your immunization clinic to your primary care provider with a + PPD. The PPD measures 15 mm of induration. He does not recall ever having had a PPD done before, but he thinks he may have had a blood test for TB at his undergraduate institution last year. He thinks the result may have been negative. He comes from Thailand, a country where 99% of infants receive a BCG dose. He has not returned to Thailand since last year s blood test and he has not been involved in patient care. He is asymptomatic for active TB symptoms.

6 What should your provider do? 1. Order a chest x-ray. 2. Order an IGRA blood test (T-spot or Quantiferon Gold TB). 3. Request the blood test result from the previous institution. 4. Take the patient s word for the negative blood test and clear him. 5. Repeat the PPD. 6. 1, 2 and 3 above. 7. It depends...

7 What should your provider do? 1. Order a chest x-ray. 2. Order an IGRA blood test (T-spot or Quantiferon Gold TB). 3. Request the blood test result from the previous institution. 4. Take the patient s word for the negative blood test and clear him. 5. Repeat the PPD. 6. 1, 2 and 3 above. 7. It depends...

8 What should your provider do? 8. I DON T KNOW! That is why I came to this presentation, for heaven s sake!

9 Therefore, many nurses and providers continue to lack confidence in both the diagnosis and approach to treatment (including me!). Today, we will try to improve our understanding of the strengths and weaknesses of available testing for latent TB, and become familiar with prophylaxis/therapeutic options.

10 Tuberculosis (TB) is a disease caused by the bacillus Mycobacterium tuberculosis. Most commonly affects the lungs, although it can affect other parts of the body (e.g. bones, CNS). Spread by airborne droplets from a person who is ill with active TB that involves the lungs or airways. The contact person does not usually develop active TB immediately, unless significantly immunosuppressed. In some cases, the person's immune system is able to remove the bacteria and he/she does not develop the disease at all. Murphy, C and Bernardo, J, UpToDate 2016

11 Latent TB The person develops an immune response that controls the bacteria by "walling it off" inside the body, causing the bacteria to become dormant. The person does not develop active TB or become ill at this time but is said to have Latent TB Infection (LTBI). During this latent stage of TB, the person is well and cannot spread the infection to others. If the person is treated at this stage, active TB can usually be prevented. Up to 1/3 of the world's population is infected with LTBI. Murphy, C and Bernardo, J, UpToDate 2016

12 Active TB Active TB may develop if latent infection is not fully treated. This reactivation TB occurs in 5 to 10 percent of people with latent infection at a later time in their lives. The greatest risk for developing reactivation TB disease is within the first two years following the initial infection. Cavitary RUL disease with hilar adenopathy Crapo JD, Glassroth J, Karlinsky JB, King TE. Baum's Textbook of Pulmonary Diseases, 7th Edition. Philadelphia: Lippincott Williams & Wilkins, Murphy, C and Bernardo, J, UpToDate 2016

13 No. of Cases 30, : 79,775 cases 25,000 20,000 15,000 10,000 5,000 Why? 0 *Updated as of June 5, Year

14 *Cases per 100,000 Atlanta GA

15 No. of Cases 20,000 15,000 10,000 5,000 0 U.S.-born Foreign-born *Updated as of June 5, 2015.

16 A 27 y/o public health graduate international student from BCG country PPD =15 mm of induration (positive) No previous PPD Asymptomatic for active TB symptoms Patient with no return home and no presumptive exposures Past result arrives from previous school: T-spot = Positive Now your Quantiferon Gold TB returns = Negative NOW WHAT DO YOU DO?

17 What should your provider do? 1. Call him positive and recommend LTBI prophylaxis 2. Call him positive and recommend annual CXRs 3. Call him negative and recommend annual IGRA tests 4. Call him negative and recommend annual CXRs 5. Send him to Infectious Diseases Clinic (or at least consult by phone) and let them decide! 6. Scream!

18 What should your provider do? 1. Call him positive and recommend LTBI prophylaxis 2. Call him positive and recommend annual CXRs 3. Call him negative and recommend annual IGRA tests 4. Call him negative and recommend annual CXRs 5. Send him to Infectious Diseases Clinic (or at least consult by phone) and let them decide! 6. Scream!

19 Treatment of individuals with active tuberculosis (TB) is the first priority for tuberculosis control An important second priority is identification and treatment of individuals with latent tuberculosis infection (LTBI). Two major tests for identification of latent tuberculosis infection: the tuberculin skin test (TST) and the interferon gamma release assay blood tests (IGRA). Both tests evaluate cell-mediated immunity. The goal of testing for LTBI is to identify individuals who are at increased risk for the development of tuberculosis (TB) and therefore would benefit from treatment of LTBI. Pai, M and Menzies, D, UpToDate 2016

20 TST skin test interpretation depends on two factors: Measurement in millimeters of induration Person s risk of being infected with TB and of progression to disease if infected An induration of 5 or more millimeters is considered positive in HIV-infected persons A recent contact of a person with TB disease Persons with fibrotic changes on chest radiograph consistent with prior TB (e.g. Ghon Complex) Patients with organ transplants Persons who are immunosuppressed (e.g. equivalent of >15 mg/day of prednisone for 1 month or longer)

21 An induration of 10 or more millimeters is considered positive in Recent immigrants (< 5 years) from high-prevalence countries Injection drug users Healthcare workers/healthcare students in patient-care settings Mycobacteriology laboratory personnel Persons with clinical conditions that place them at high risk Children < 4 years of age Infants, children, and adolescents exposed to adults in high-risk categories An induration of 15 or more millimeters is considered positive in Any person, including persons with no known risk factors for TB (however, targeted skin testing programs should only be conducted among high-risk groups)

22 Some persons may react to the TST even though they are not infected with M. tuberculosis. The causes of these false-positive reactions may include, but are not limited to, the following: Infection with non-tuberculosis mycobacteria (e.g. MAC and M kansasii) Previous BCG vaccination Incorrect method of TST administration Incorrect interpretation of reaction Incorrect bottle of antigen used

23 Cutaneous anergy (anergy is the inability to react to skin tests because of a weakened immune system) Recent TB infection (within 8-10 weeks of exposure) Very old TB infection (many years) Very young age (less than 6 months old) Recent live-virus vaccination (e.g., measles and smallpox) Overwhelming TB disease Some viral illnesses (e.g., measles and chicken pox) Incorrect method of TST administration Incorrect interpretation of reaction NOW WHAT?!?

24 Why does a nurse who reads 10 PPDs a day bring a patient to a physician to make the final call on a questionable PPD reading, when the physician reads one PPD every 6 months?!?

25 Interferon Gamma Release Assays (IGRAs) Blood test that can be used in all circumstances where the TST is used Currently QuantiFERON-TB Gold and T-spot Do not cross-react with BCG or non-tuberculous mycobacteria MMWR 2010; 59 (RR-5), 1-25.

26 Measure a cell-mediated immune response. The tests are based on the principle that the T cells of an individual who carries an active infection will respond to the antigens and secrete interferon-gamma, which is measured using ELISA technology Sensitivities and specificities are similar to each other and to the TST/PPD. Information from manufacturers websites

27 When the student comes from a BCG country: The initial TST test is negative, and the person is at high risk for progression to TB disease and bad outcomes (e.g. HIV). TST test is positive, the patient is at low risk, and patient/clinician are hesitant to proceed with prophylaxis. Ill patient has evidence of active TB (sputums pending) and TST is negative. When a single visit is all you have available. When cost is no barrier...

28 BCG WORLD ATLAS

29 A US-born third-year (M3) medical student is referred to your SHS primary care with a 12 mm + PPD done last week and a negative CXR. She had three previous negative PPDs: one while volunteering in the university hospital as a senior undergraduate student; a negative two-step PPD as an M1; and a negative PPD as an M2. She has been in several clinical settings, both inpatient and out-patient, and went to Haiti this summer to work in a healthcare clinic. What would you do?

30 What should your provider do? 1. Do a Quantiferon TB Gold or a T-spot to confirm the (+) PPD. 2. Treat for LTBI with no further testing. 3. Refer to Infectious Diseases. 4. None of the above/other.

31 What should your provider do? 1. Do an IGRA test (Quantiferon TB Gold or a T-spot) to confirm the (+) PPD. 2. Treat for LTBI with no further testing. 3. Refer to Infectious Diseases. 4. None of the above/other

32 There are several treatment regimens available for the treatment of latent TB infection (LTBI) Providers should choose the appropriate regimen based on the following: Drug-susceptibility results of the presumed source case (if known) Coexisting medical illness Potential for drug-drug interactions

33 Drugs Duration Interval Minimum doses Isoniazid (INH) 9 months Daily 270 Twice weekly* 76 Isoniazid (INH) 6 months Daily 180 Isoniazid (INH) and Rifapentine Twice weekly* 52 3 months Once weekly* 12 Rifampin 4 months Daily 120 * Use Directly Observed Therapy (DOT)

34 Drugs Duration Interval Minimum doses Isoniazid (INH) 9 months Daily 270 Twice weekly* 76 Isoniazid (INH) 6 months Daily 180 Isoniazid (INH) and Rifapentine Twice weekly* 52 3 months Once weekly* 12 Rifampin 4 months Daily 120 * Use Directly Observed Therapy (DOT)

35 Immunocompromised students should receive INH daily for 9 months. Immunocompetent students have a choice of: INH daily for 9 months (or 6 months) INH/Rifapentine once a week by DOT for 12 weeks Rifampin daily for 4 months In three clinical trials, completion rates for INH for 9 months was 69%; completion rate for INH/Rifapentine for 12 weeks was 82% and was equally effective in preventing re-activated TB. Rifampin daily for 4 months is recommended when the M. tuberculosis is presumed to be INH-resistant and RIF-susceptible or when INH is contraindicated or is not tolerated by the patient. Rifampin/Rifapentine reduce effectiveness of hormonal contraceptives MMWR December 9, 2011 / 60(48);

36 Asymptomatic elevation of liver enzyme concentrations occurs in 10% 20% of people taking INH LFTs usually return to normal even when treatment is continued. Withhold INH be if LFTs exceeds 3 times the upper limit of normal if associated with symptoms or 5 times the upper limit of normal if the patient is asymptomatic. Clinical hepatitis in about 0.1% of people taking INH; more common when INH combined with other hepatotoxic agents. Factors that may increase severity of hepatitis include daily alcohol consumption, underlying liver disease and concurrent use of other medications which are metabolized in the liver.

37 Peripheral neuropathy occurs in less than 0.2% of people taking INH at conventional doses. More likely in the presence of other conditions associated with neuropathy such as diabetes, HIV, renal failure, and alcoholism. Pyridoxine (vitamin B6) supplementation is recommended only in such conditions or to prevent neuropathy in pregnant or breastfeeding women.

38 INH 300mg daily for 9 months (270 doses), but for at least 6 months (180 doses) CDC: The 9-month regimen is preferred because it is more efficacious. Treatment for LTBI for 6 months rather than 9 months may be more cost-effective and result in greater adherence by patients; therefore, health care providers may prefer to implement the 6-month regimen rather than the 9-month regimen. Every effort should be made to ensure that patients adhere to LTBI treatment for at least 6 months. The preferred regimen for children aged 2 to 11 years is 9 months of daily INH.

39 Patients should visit the health care provider who is managing their treatment on a monthly basis to be assessed for the following: Signs of hepatitis Adherence to medication regimen Symptoms of possible adverse drug reactions or interactions Patients being treated for LTBI who experience possible adverse reactions should be advised to stop medication and consult their health care provider immediately. Do you need lab testing? Well, we do it... At least baseline LFTs (How do you know they are elevated if you don t check!?)

40 INH (50 kg +) 900 mg (3 X 300 mg tablets) + Rifapentine 900 mg (6 X 150 mg tablets) weekly for 12 weeks At Emory SHS, student fills the 12 week Rx and brings the meds to Student Health, where we hold the meds for the 12 weeks We aim for 5-9 day intervals; CDC data is based upon a completion of the 12 doses within 16 weeks. Screen for side effects at each visit. If symptoms, do labs before giving the dose. We contact our Infectious Diseases colleagues if questions or concerns

41 A 24 y/o NP student is diagnosed with LTBI. He has a negative CXR and he is asymptomatic for active TB symptoms. He starts Directly Observed Therapy (DOT) at your Student Health Service. At his week #2 visit, he notes that his urine is dark like tea, which has him concerned. He otherwise feels well, and specifically denies weakness, decreased appetite, abdominal pain, or pale stools. He is tanned from a summer in South America, but you do not think he has scleral icterus (yellow sclera). What do you do?

42 What should you do? 1. Immediately stop treatment for LTBI. 2. Immediately stop treatment for LTBI and order Hepatic Function Tests (LFTs). 3. Reassure patient and give this week s dose of DOT medications. 4. Immediately stop treatment for LTBI and refer to Infectious Diseases. 5. None of the above/other.

43 What should you do? 1. Immediately stop treatment for LTBI. 2. Immediately stop treatment for LTBI and order Hepatic Function Tests (LFTs). 3. Reassure patient and give this week s dose of DOT medications. 4. Immediately stop treatment for LTBI and refer to Infectious Diseases. 5. None of the above/other.

44 Transient hepatitis, sometimes with increased bilirubin; same rules as with INH. Cutaneous reactions, such as pruritis (with or without a rash), may occur in 6% of persons, generally self-limited. Rare hypersensitivity reactions associated with rash, fever, myalgia, and sometimes nephritis and thrombocytopenia. Change in urine color to orange/red, staining of contact lenses. Women using hormonal contraceptives should be advised to consider an alternative method (e.g. a barrier method).

45 Since your last visit, have you had any of the following? Fever Weakness Decreased appetite Nausea Vomiting Stomach pain Yellowing of skin Pale stools Dark urine (like tea) Burning pain in feet Chills Fever Muscle aches Rash PROBLEMS: NON-SPECIFIC QUESTIONS! Rifapentine turns urine orange/red!

46 LTBI DOT 12 week regimen Reason for Treatment: Weight (<50kg adjust dosage) Week Zero, 4 and 8: Hepatic Function Isoniazid (INH) 300mg; 3 tabs PO Rifapentine (RPT) 150mg; 6 tabs PO Labs at 4 & 8 wks Observed DOT Panel (LFTs); CBC Week 1 We use a flow sheet 2 3 template in our EMR (PnC) 4 Labs Due 5 6 Problem: Vacations 7 8 Labs Due and Breaks!

47 A 26 y/o public health/mph student and Registered Nurse had a positive PPD conversion 2 years ago following a medical missionary trip to Central Africa. She had a normal CXR. She was treated for 9 months with INH for LTBI and did well. She has applied to work part-time at a local nursing home while she completes her MPH studies. The employee health nurse told her that she needs a CXR now for TB clearance and that she will need a CXR every year in perpetuity. She has come to Student Health for the CXR and will need a report to take back to the nursing home. She is asymptomatic.

48 What should your provider do? 1. Do the CXR and send the report with the student. 2. Tell the student that she does not need a CXR now or in the future and that she should only be screened annually for TB symptoms. 3. Call the Employee Health Nurse and try to intercede for the student. 4. Refer the student to Infectious Diseases and 2 or 2 and 3 or 1, 2 and 3 6. None of the above/other.

49 What should your provider do? 1. Do the CXR and send the report with the student. 2. Tell the student that she does not need a CXR now or in the future and that she should only be screened annually for TB symptoms. 3. Call the Employee Health Nurse and try to intercede for the student. 4. Refer the student to Infectious Diseases and 2 or 2 and 3 or 1, 2 and 3 6. None of the above/other.

50 A first year nursing student from the US had an 11 mm (+) PPD (prior to a 2-step). He had never been in a clinical setting and had no known prior exposures to TB, including no foreign travel. He needed to start clinicals the next day, so your provider did a CXR (negative) and cleared the student based upon a negative CXR. The provider also ordered a Quantiferon Gold-TB test, which returned negative 5 days later. The student returned 1 year later for a nurse visit for annual TB screening.

51 What should your nurse do? 1. Do a CXR and send the report with the student. 2. Tell the student that she does not need a CXR now or in the future and that she should only be screened annually for TB symptoms. 3. Order a Quantiferon Gold-TB and tell the student that he needs annual IGRA testing for screening, but no CXR. 4. Order a Quantiferon Gold-TB and a CXR. 5. None of the above/other.

52 What should your nurse do? 1. Do a CXR and send the report with the student. 2. Tell the student that she does not need a CXR now or in the future and that she should only be screened annually for TB symptoms. 3. Order a Quantiferon Gold-TB and tell the student that he needs annual IGRA testing for screening, but no CXR. 4. Order a Quantiferon Gold-TB and a CXR. 5. None of the above/other. This student does not have LTBI, and he is working in a clinical setting, so he needs annual screening for LTBI, not for TB reactivation.

53 CDC no longer recommends annual chest x-rays for patients diagnosed with LTBI and given a prophylaxis regimen (actually, hasn t recommended CXRs for many years), including healthcare workers Patients should be screened with an annual questionnaire regarding symptoms of active/re-activated TB Unfortunately, many of our hospitals and healthcare organizations refuse to change their annual CXR policies, and our students get caught in the middle!

54 In the past year have you experienced any of the following for greater than three weeks? Excessive sweating at night? Excessive weight loss? Coughing up blood? Excessive fatigue? Hoarseness? Persistent coughing? Persistent fever? Yes No Yes No Yes No Yes No Yes No Yes No Yes No

55 A student originally from India (a country where 99% of infants receive a BCG dose) is referred to your SHS primary care with a 15 mm + PPD done last month (elsewhere), and a negative CXR. She will be in a health sciences setting. She had a follow-up T-spot done last week in your SHS immunization clinic that is Borderline.

56 What should your provider do? 1. Do a Quantiferon Gold TB. 2. Repeat the T-spot. If Negative or borderline again, continue doing periodic T-spots and consider her negative for now. 3. Treat for LTBI with no further testing. 4. None of the above/other 5. I STILL DON T KNOW, DESPITE YOUR TALK! AND THAT WAS WHY I CAME TO THIS PRESENTATION, FOR HEAVEN S SAKE!

57 What should your provider do? 1. Do a Quantiferon Gold TB. 2. Repeat the T-spot. If Negative or borderline again, continue doing periodic T-spots and consider her negative for now. 3. Treat for LTBI with no further testing. 4. None of the above/other 5. I STILL DON T KNOW, DESPITE YOUR TALK! AND THAT WAS WHY I CAME TO THIS PRESENTATION, FOR HEAVEN S SAKE!

58 The additional LTBI testing modalities can make life confusing! It is extremely common for results to be discordant. The only situation in which one test is considered more accurate than the other is for persons with BCG, in whom the IGRA tests are more specific than the TST. If a patient has a (+) PPD but has a history of BCG vaccine, do an IGRA. You do not need a CXR if the IGRA is (-). If a patient with occupational exposure (e.g. healthcare student) has one or more previous, documented (-) PPDs, and then has a (+) PPD, diagnose them with LTBI, get a CXR and treat. Do not do an IGRA.

59 None of the tests have adequate specificity in a population with a low likelihood of TB exposure (and that would be virtually all of our HCWs who get annual screening without any known exposures). Most positives are false positives when testing low risk people. CDC no longer recommends annual chest x-rays for patients diagnosed with LTBI and given a prophylaxis regimen, including healthcare workers. These patients should be screened with an annual questionnaire regarding symptoms of active/reactivated TB.

60 Michael J. Huey, MD Assistant Vice President & Executive Director Emory University Student Health Services President-elect, ACHA

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