cste annual conference june 11, 2013
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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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
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Current StandardIsoniazid (INH) Monotherapy
9 months treatment
Self-administered daily
<60% completion rate in most settings
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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
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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.
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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.
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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
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Implementation in Connecticut Provider
guidelines issued in February 2012
INH-RPT provided free-of-charge though TB Control Program beginning in March 2012
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Objectives
Describe population being treated with INH-RPT in Connecticut
Monitor for adverse events Measure treatment completion
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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
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Data Collection Procedures Provider
letter sent with prescription
Follow up phone calls for forms not received in a timely manner
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Monthly Follow Up Form
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DOT Log
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Analysis
Descriptive analysis performed on all patients started between March 2012 and May 2013
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Results
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Current Treatment Status 92 patients have a confirmed
start date for treatment 22 are currently receiving treatment 70 have finished
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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
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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
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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
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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
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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
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Side Effects 29 (45%) of 64 patients with
available data reported side effects
Commonly reported symptoms Abdominal pain Dark urine Fatigue Nausea Dizziness
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Limitations
Only included patients receiving INH-RPT from the TB Control Program
Could not compare results to patients receiving other LTBI regimens in Connecticut
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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
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Acknowledgments Connecticut providers using INH-
RPT Dr. Mark Lobato Dr. Lynn Sosa The Connecticut TB Control
Program