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

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

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

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.

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.

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

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

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

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

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

Monthly Follow Up Form

DOT Log

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

Results

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

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

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

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

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

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

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

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

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

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