1. Use of 12 weekly doses of isoniazid and rifapentine for the treatment of latent tuberculosis − Connecticut ,
Kelley Bemis, MPH
CDC/CSTE Applied Epidemiology Fellow
Connecticut Department of Public Health
CSTE Annual Conference June 11, 2013

2. Current Standard Isoniazid (INH) Monotherapy
9 months treatment
Self-administered daily
<60% completion rate in most settings

3. New Alternative Isoniazid and Rifapentine (INH-RPT)
12 weeks of treatment
Administered once a week by directly observed therapy (DOT)
Evidence based on three randomized clinical trials

4. Results of a comparative study*
7,731 participants
Close contacts
Recent TST converters
Old, healed TB on chest x-ray
HIV-infected not on ART
Similar efficacy
Completion rates
82% for INH-RPT
69% for INH monotherapy
*Sterling TR, Villarino ME, Borisov AS, et al. Three months of once-weekly rifapentine and isoniazid for M. tuberculosis infection. N Engl J Med 2011;365:2155–66.

5. National Implementation
December 2011: CDC issues guidelines for a new treatment for LTBI
*Centers for Disease Control and Prevention. Recommendations for use of an isoniazid-rifapentine regimen with direct observation to treat Mycobacterium tuberculosis infection. MMWR 2011, 60 (48),

6. CDC Recommendations
Otherwise healthy persons ≥12 years old with at least one risk factor for progression to TB disease
Can be considered for other groups on a case-by-case basis
Leaves door open to treat groups not included in clinical trials

7. Implementation in Connecticut
Provider guidelines issued in February 2012
INH-RPT provided free-of-charge though TB Control Program beginning in March 2012

8. Objectives
Describe population being treated with INH-RPT in Connecticut
Monitor for adverse events
Measure treatment completion

9. Methods
Active follow up of all prescriptions for INH-RPT filled by the TB Control Program
Providers asked to complete two data collection tools
Monthly TB Control Program Follow Up Form
DOT Log

10. Data Collection Procedures
Provider letter sent with prescription
Follow up phone calls for forms not received in a timely manner

11. Monthly Follow Up Form

12. DOT Log

13. Analysis
Descriptive analysis performed on all patients started between March 2012 and May 2013

14. Results

15. Current Treatment Status
92 patients have a confirmed start date for treatment
22 are currently receiving treatment
70 have finished

16. Patient Demographics Characteristic N (%)* Gender Male 49 (53.3)
Female
43 (46.7)
Median Age (years) 41
Foreign Born
53 (66.3)
Race/Ethnicity
Hispanic
35 (37.6)
White, non-Hispanic
18 (19.4)
Black, non-Hispanic
17 (18.3)
Asian, non-Hispanic
14 (15.1)
Unknown
9 (9.7)
* Total N varies due to missing responses

17. Patient Demographics, cont.
Characteristic
N (%)*
Occupation
Student
23 (25.3)
Healthcare worker
12 (13.2)
Unemployed
16 (17.6)
Other
21 (23.1)
Unknown
19 (20.9)
Provider Type
Private
57 (62.0)
Public
24 (26.1)
School
11 (12.0)
* Total N varies due to missing responses

18. Risk Factors for Progression to Disease
Characteristic N
Recent arrival in the U.S.* 14
Contact to a case 9
TST converter 1
HIV infected
Homeless 5
Injectable drug use 4
Non-injectable drug use 3
* < 2 years prior to treatment start

19. Treatment Completion
61 of 70 patients who started treatment completed successfully
87% treatment completion rate
9 patients did not complete treatment
8 patients due to adverse events
1 patient due to pregnancy

20. Reasons for Stopping Therapy
# of Patients
# of Doses
Elevated liver enzymes 2
5, 9
Fever, chills, dizziness 1 3
Light-headed, itchy, jittery
Nausea / vomiting
Rash / hives
Methadone withdrawal symptoms 10
Fever/ headache*
* Patient was hospitalized and discharged after two days with complete resolution of symptoms

21. Side Effects
29 (45%) of 64 patients with available data reported side effects
Commonly reported symptoms
Abdominal pain
Dark urine
Fatigue
Nausea
Dizziness

22. Limitations
Only included patients receiving INH-RPT from the TB Control Program
Could not compare results to patients receiving other LTBI regimens in Connecticut

23. Conclusions INH-RPT has a high completion rate in Connecticut
Side effects are common but few result in stopping treatment
Private providers are willing to do DOT
Outcomes and safety should continue to be monitored

24. Acknowledgments Connecticut providers using INH-RPT Dr. Mark Lobato
Dr. Lynn Sosa
The Connecticut TB Control Program