1. US TB Treatment Guidelines and DOT
Drew L. Posey, MD, MPH
Team Leader, Medical Assessment and Policy Team
Immigrant, Refugee, and Migrant Health Branch
Intergovernmental Panel Physicians Training Summit
March 28, 2017

2. Question 1
A 45-year-old man has a cough, infiltrate on CXR, negative sputum smears, and one out of three cultures positive. The isolate is pansusceptible. Which of the following is a goal of treatment?
Follow CDC Technical Instructions
Rapidly reduce the number of actively growing bacilli
Prevent development of miliary tuberculosis
Convert TST to negative
Prevent peripheral neuropathy

3. One Out of Three Cultures Positive – Is This TB?
Yes!
When there is clinical suspicion for TB
Abnormal CXR
Signs and symptoms
HIV infection
Close epidemiologic contact
Among U.S. panel physicians, there is a high rate of smear-negative but culture-positive cases
In 2015, 1,214 culture-positive cases
877 (72%) smear-negative but culture-positive

4. Objectives of Antituberculosis Therapy
Rapidly reduce the number of actively growing bacilli
Reduce severity of disease
Prevent death
Halt transmission
Eradicate populations of persistent bacilli
Achieve cure (prevent relapse)
Prevent acquisition of drug resistance during therapy
ATS/CDC/IDSA guidelines, page 2

5. Question 2
For this same 45-year-old patient with culture-confirmed, pansusceptible tuberculosis, which guidelines do you follow?
CDC Technical Instructions
American Thoracic Society (ATS)/CDC/Infectious Diseases Society of America (IDSA) guidelines
Curry International TB Center’s “Drug-Resistant Tuberculosis: A Survival Guide for Clinicians”
World Health Organization’s “Treatment of Tuberculosis : Guidelines for National Programmes”

6. ATS/CDC/IDSA Guidelines
Published August 10, 2016
Endorsed by
European Respiratory Society (ERS)
U.S. National Tuberculosis Controllers Association (NTCA)
Recommendations on clinical and public health management of tuberculosis
Children and adults
Where the following are available
Cultures
Molecular and phenotypic drug susceptibility tests
Radiographic studies
ATS/CDC/IDSA guidelines, page 1

7. Expectations for Panel Sites
All U.S. panel physicians read the guidelines
All treating physicians for U.S. panel sites
Read the guidelines
Have them on hand as a reference
Follow them when treating U.S.-bound cases

8. Question 3
Which of the following is stated in the ATS/CDC/IDSA guidelines as a benefit of directly observed therapy (DOT) over self-administered therapy (SAT)?
Reduced mortality
Higher rates of treatment completion
Lower rates of relapse
Early recognition of adverse drug reactions

9. Self-administered Therapy
Patients take medications without supervision

10. Directly Observed Therapy
Practice of observing the patient swallow the medications
Standard of care in the United States and Europe
ATS/CDC/IDSA guidelines, page 3

11. SAT vs. DOT No significant differences Mortality Treatment completion
Relapse
DOT better
Cure
Sputum smear conversion
Early recognition of adverse events
Establishment of rapport
ATS/CDC/IDSA guidelines, pages 3-4

12. Question 4
Which of the following are considered equivalent regimens for the initiation phase?
7 days/week for 56 doses and 2 days/week for 16 doses
7 days/week for 56 doses and 3 days/week for 24 doses
7 days/week for 56 doses and 5 days/week for 40 doses
7 days/week for 56 doses and 7 days/week for 14 doses followed by 2 days/week for 12 doses

13. Doses Per Week Initiation Phase
Therapy should be administered once daily
7-days-a-week and 5-days-a-week are both considered “daily” dosing
3-days-a-week therapy needs special approval from CDC
ATS/CDC/IDSA guidelines, pages 5-6

14. Doses Per Week Continuation Phase
Therapy should be administered once daily
7-days-a-week and 5-days-a-week are both considered “daily” dosing
3-days-a-week is acceptable in uncomplicated cases
Do not use 3-days-a-week
HIV-positive patients
Patients with cavitary disease
ATS/CDC/IDSA guidelines, pages 4,6

15. Question 5
A 5-year-old child has hilar adenopathy, cough, and fever. Three sputum smears are negative; cultures are pending. The child’s mother is culture-positive; DST results are pending. Which of the following is the best regimen for this child?
Isoniazid, rifampin
Isoniazid, rifampin, pyridoxine
Isoniazid, rifampin, ethambutol, pyrazinamide
Isoniazid, rifampin, pyrazinamide, moxifloxacin
Rifampin, streptomycin, ethambutol

16. Ethambutol Now acceptable to give children ethambutol
American Academy of Pediatrics and most experts include ethambutol in intensive phase
Monitor for ocular toxicity
ATS/CDC/IDSA guidelines, page 6

17. Question 6
A 54-year-old woman with a cavity on CXR has pansusceptible TB. After 2 months of treatment, she is culture-positive. DST should be repeated.
True
False

18. DST During Therapy
Repeat DST if patient remains culture-positive after 3 months of therapy
ATS/CDC/IDSA guidelines, page 7

19. Question 7
For this 54-year-old woman with cavitary disease and who was culture-positive after 2 months of treatment, how long should the continuation phase be extended?
1 month
2 months
3 months
4 months
6 months
ATS/CDC/IDSA guidelines, page 7

20. Question 8
A 72-year-old man with pansusceptible TB received 2 weeks of treatment and then left your clinic to receive treatment by his regular physician. He changes his mind and returns after 3 weeks; there are no treatment records for his time away. What should you do?
Restart regimen from the beginning
Resume therapy and add 3 weeks to the initiation phase
Make applicant wait 1 year after treatment would end
Refer patient back to his regular physician

21. Treatment Interruptions
ATS/CDC/IDSA guidelines, page 8

22. Question 9
You are treating a 21-year-old patient who is HIV-positive. He has a normal CXR, and his isolate is pansusceptible. He is receiving antiretroviral therapy (ART). How long should his continuation phase last?
4 months
6 months
7 months
9 months

23. HIV and ART ART should be started Patient is receiving ART
Continuation phase of isoniazid and rifampin can last 4 months
Patient is not receiving ART
Continuation phase of isoniazid and rifampin should last 7 months
ART should be started
Within 2 weeks if CD4 count <50 cells/µL
Within 8-12 weeks if CD4 count ≥ 50 cells/µL
ATS/CDC/IDSA guidelines, pages 9, 11

24. Question 10
A 33-year-old male with a discrete linear opacity on CXR has TB symptoms. You begin treatment. After 8 weeks of treatment, the cultures are negative. What should you do?
Stop treatment
Finish a 6-month regimen
Finish a 4-month regimen
Re-evaluate
Switch patient to a regimen that treats latent Mycobacterium tuberculosis infection (LTBI)

25. Culture-negative Tuberculosis
Perform clinical and radiographic follow-up after 2-3 months of therapy
If clinical or radiographic improvement and no other etiology is identified, continue treatment
4-month regimen adequate for smear-negative, culture-negative pulmonary tuberculosis
If concern about adequacy of workup or accuracy of microbiologic evaluations
6-month regimen
ATS/CDC/IDSA guidelines, page 12

26. Summary Become familiar with new ATS/CDC/IDSA Treatment Guidelines
In the actual guidelines
Many other topics covered
Topics in this session are presented in greater depth
Always use clinical judgment!
When unsure of course of action
Use clinical consultation system managed by Regional Training and Medical Consultation Centers (RTMCC)

27. Directly Observed Therapy

28. Question 11
A receiving health department looks at the treatment record for an applicant you treated for TB disease. What features are they looking for in the DOT record?
Summary
Dates of treatment
Signature for each dose of medication
Laboratory results
CXR findings

29. True DOT Every dose is administered by a trained staff member
No self-administered therapy
No family-administered therapy
Each administration is documented

30. DOT Record Patient information Drug regimen
Signature for administration on each calendar day
Side effects

31. Question 12
A woman with pansusceptible tuberculosis has taken TB treatment for exactly 4 weeks. She received DOT in the clinic 5 days a week. This clinic also provided doses for the patient to self-administer on weekends. How many doses are counted for this patient? 16 20 28 30

32. Counting Doses Only doses that are delivered as DOT are counted
Must deliver the minimum number of doses of the recommended regimen as DOT

33. Refusal of Treatment
Patients must be informed of DGMQ-approved treatment options
Patients who refuse treatment at a DGMQ-approved DOT site
Repeat medical examination 1 year after treatment would have ended
Sputum specimens need to be collected at that time regardless of CXR findings

34. DOT Case Studies

35. Thank you cdcQAP@cdc.gov http://www.cdc.gov/panelphysicians
For more information, please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA
Telephone: CDC-INFO ( )/TTY:
Visit: | Contact CDC at: CDC-INFO or
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
National Center for Emerging and Zoonotic Infectious Diseases
Division of Global Migration and Quarantine

36. Answers B D C A