Use of 12 weekly doses of isoniazid and rifapentine for
the treatment of latent tuberculosis − Connecticut ,
2012-13
CSTE Annual ConferenceJune 11, 2013
Kelley Bemis, MPHCDC/CSTE Applied Epidemiology Fellow
Connecticut Department of Public Health
Current StandardIsoniazid (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.
December 2011:CDC issues
guidelines for a new treatment
for LTBI
National Implementation
*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 DemographicsCharacteristic N (%)*Gender Male 49
(53.3) Female 43
(46.7)Median Age (years) 41Foreign 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 0 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, 9Fever, chills, dizziness 1 3Light-headed, itchy, jittery 1 1Nausea / vomiting 1 1Rash / hives 1 2Methadone withdrawal symptoms 1 10Fever/ headache* 1 3* 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