CSTE Annual Conference June 11, 2013

1. Use of 12 weekly doses of isoniazid and rifapentine for the treatment of latent tuberculosis − Connecticut , 2012-13 CSTE Annual Conference June 11, 2013 Kelley Bemis, MPH CDC/CSTE Applied Epidemiology Fellow Connecticut Department of Public Health

2. Current StandardIsoniazid (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), 1650-1653.

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 * Total N varies due to missing responses

17. Patient Demographics, cont. * Total N varies due to missing responses

18. Risk Factors for Progression to Disease * < 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 * 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