Sharing the Care: Working Together on LTBI Treatment and Management Webinar. September 24, Curry International Tuberculosis Center

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1 TB Infection Diagnostics and Treatment Neha Shah MD MPH Field Medical Officer Tuberculosis Control Branch California Department of Public Health Centers for Disease Control and Prevention 1 Curry International Training Center Outline TB diagnostics TB Infection treatment Review of TBTC Trial 33 Experiences from the National Implementation Project Experiences from California Innovative ways to provide DOT 2 Testing 3 1

2 Testing Options Tuberculin Skin Test (TST) Interferon Gamma Release Assays (IGRAs) In vitro blood tests of cell mediated immune response Measure release of interferon gamma following stimulation by antigens unique to TB Both TST and IGRAs Are surrogate markers of LTBI Cannot distinguish between LTBI and active TB disease 4 TST and IGRAs 5 Sensitivity of IGRAs from low- and middle-income countries Metcalfe 6 J Z et al. J Infect Dis. 2011;204:S1120-S1129 2

3 TB Diagnostics Test Characteristics Specificity (95% CI) TST with BCG 59 (46 73) TST without BCG 97 (95 99) QFT GIT 96 (94 98) Menzies, Ann Intern Med, 2007 Pai, Ann Intern Med, IGRA vs. TST Advantages over TST Not affected by BCG vaccination No return visit needed for interpretation of test Not affected by most non tuberculous mycobacteria (NTM) Interpretation is more objective CDC, MMWR, Reading QFT GIT Results Source: Dr. Meza 9 3

4 TSTs and IGRAs 19% of all confirmed TB cases have a negative skin test 39% of HIV positive TB cases are TST negative Negative IGRA or TST does NOT rule out TB!!! CDC, National TB Surveillance System, Auld, BMC Infectious Disease, Sester, EurRespirJ, TBI Treatment 11 Options for treatment of TB infection Daily 9 months of INH Daily INH and rifampin for 3 4 months Daily Rifampin for 4 months Once weekly rifapentine and INH for 3 months (12 doses) 12 4

5 Isoniazid (INH) Can be used with any HAART regimen Adherence: Completion rates of 50% or less Hepatotoxicity: Incidence of hepatitis estimated at 1 per 1,000 Also rash and neuropathies Nolan, JAMA, 1999 Smieja, Cochrane Database Syst Rev, Menzies, Ann Int Med, 2008 Rifampin Can be given as 4 month daily Efficacy data limited but ongoing study comparing 4RIF to 9INH Recent network meta analysis suggests 4RIF efficacious compared to placebo Better completion rates and lower rates of hepatoxicity Menzies, 2011 IJMR Ziakas, CID Staff, Annals Internal Medicine 2014 Rifampin and INH Rifampin 600mg plus INH 300 mg daily for 3 4 months Limited data on efficacy but likely same as 6INH or 9INH Possible higher likelihood of side effects Menzies, 2011 IJMR Ziakas, CID Staff, Annals Internal Medicine

6 INH and Rifapentine 16 INH RPT INH No. of patients 3,986 3,745 Administration Directly observed therapy Self administered therapy Frequency Weekly Daily Duration 12 weeks 9 months Sterling, N Engl J Med, Prevent TB Study Results INH RPT INH P value Effectiveness 1.9 per 1, per 1,000 Non inferior Completion rate 82.1% 69.0% P<0.001 Hepatotoxicity 0.4% 2.7% P<0.001 Sterling, N Engl J Med,

7 National 3HP Implementation Project Purpose Detect adverse effects in non research settings Measure adherence and treatment completion Assess program impact Find and characterize breakthrough TB cases 19 Post Marketing Surveillance Project Sites 22 volunteer sites participated in study design 3 from California: Sacramento, Santa Clara, UCSD Patients treated from July 2011 December 2013 Some type of DOT was used at all sites 20 (dated 5/24/2013) Forms for Doses, Symptoms, and Outcomes Final Disposition: Completed INH RPT treatment Stopped INH RPT treatment Date / / Lost to follow up Died Other Adverse event Pending Completion of Alternate Regimen Slide adapted from Ho IAULTD

8 Form for Adverse Events Slide adapted from Ho IAULTD Data as of October started therapy 23 Excluded Active TB, TB 0, index case INH resistant 50 on treatment 2061 eligible to complete treatment 1745 (85%) completed 316 (15%) Discontinued Slide adapted from Ho IAULTD (57%) discontinued with symptoms 137 (43%) discontinued without symptoms * Side Effects # reported SE who had 1 dose Symptom N= 2143 % Any symptom Nausea/vomiting Fatigue Sore muscles/joints Fever/Chills Rash/hives Abdominal pain Dizziness/fainting Loss of Appetite 90 4 Numbness/tingling 90 4 Diarrhea 82 4 Other Slide adapted from Ho IAULTD

9 Severe Adverse Events Severe AE: any patient who was hospitalized or died while on therapy 17 reports of hospitalizations 6 on site CDC investigations complete 10in investigations in progress No deaths No serious or permanent medical sequelae California 3HP is being used in 21 CA jurisdictions Health department clinics only 8(38%) Private/community providers only 4(19%) Both health department clinics and community providers 7 (33%) Unspecified 2(10%) 27 9

10 Sacramento Methods Providing in clinic and field DOT Monthly lab monitoring Results: 95 patients started at time of data collection (now more than 200) 80% completed to date SE: malaise, gastric discomfort, headache, myalgia lasting 1 2 hours post dose, rare pruritis Medically managed side effects One discontinuation due to elevated liver function tests 28 University of California in San Diego Methods Several alternatives for providing DOT: video, phone, Results 37 students started therapy 92% completed to date 1 experienced flu like symptoms Side Effect # reporting event among Percent those completing therapy N=23 Nausea Fatigue Muscle aches Menstrual irregularities (females, n=20) Diarrhea Headache Other Santa Clara Corrections Methods DOT provided at the medication administration window Baseline and monthly liver function and complete blood count tests Results 91 patients started therapy 85% of these patients completed treatment 18% experienced a side effect 2 discontinued due to drug side effects Any adverse event 12 dose therapy (N=91) Hepatotoxicity* 1 (1.1) Dizziness 4 (4.4) Fever or chills 5 (5.5) 5) Rash/hives 4 (4.4) Abdominal pain 1 (1.1) Numbness or tingling 2 (2.2) Nausea 3 (3.3) 30 10

11 Alternative Directly Observed Therapy Options 31 Video DOT 32 Wireless DOT 33 11

12 Study 33 iadhere 34 Pharmacy based DOT 35 Community Resources 36 12

13 Summary 37 Summary IGRAs are good diagnostic tool but be aware of limitations Short course therapy for TB infection is being implemented nationally with good results and limited side effects California has had good experiences with using this new regimen New and improved ways to provide directly observed therapy TB elimination impossible without treating for TB infection 38 Questions 39 The findings and conclusions in this presentation are those of the presenter and do not necessarily represent the views of CDC. 13

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