Testing and Treatment of LTBI in the US: Practical Considerations

1. Testing and Treatment of LTBI in the US:Practical Considerations A Guide For Healthcare Providers(Companion Statement) Charles M. Crane, MD, MPH March 12, 2019

2. Sponsor • National Society of TB Clinicians (NSTC) • One of 3 Sections within NTCA

3. Authorship • Leadership • Charles M. Crane, Organizational Chair • Marcos Burgos, Chief Editor • Jennifer Kanouse, Copy Editor • Workgroup Lisa Armitige, Pennan Barry, Robert Belknap, Benita Cook, Thomas Dobbs. Diana Fortune, Juliana Ferreira, Jennifer Flood, David Griffith, Carol Dukes Hamilton, Deborah Isaacs, John Jereb, Ron Karpick, Quratulain Kizilbash, Julie Low, Brenda Montoya, Diana Nilsen, Margaret Oxtoby, Barbara Seaworth, Wendy Thanassi, Dean Tsukayama, Lisa Villarroel

4. Disclosures • None

5. Learning Objective • Participants will be able to describe the companion statement being developed by NSTC for the testing and treatment of LTBI in the US.

6. Outline • Background • Process • Content • Conclusions

7. Background - 1 • TB elimination requires more effective testing and treatment of LTBI in high risk groups • Revision of LTBI Guidelines in process • Limitations • Based on Highest Quality Evidence • GRADE criteria • RCTs limited by cost and time • Limited practical utility for providers • Expression of need for more practical document

8. Background - 2 • NTCA decision to sponsor Companion Statement • Assigned to NSTC, Clinicians Section of NTCA • Target Audience • Public Health TB Programs • Healthcare Providers

9. Process - 1 • Relationship with Guidelines Working Group • Parallel processes supported by NTCA • Hope of near simultaneous publication • Confidentiality Agreement • Workgroup Meetings • Scope of Statement • Writing Assignments • Sub-groups for each Section

10. Process - 3 • First Draft • Edits by Leadership Group • Revisions by Authors • Second Draft • Series of Meetings to Discuss Content • Further edits by Authors and Leaders • Final Draft • Publication and Distribution by NTCA and State/local TB Programs • Electronic version a living document

11. Content - 1 • Preface • List of Abbreviations • Section 1: Tests for LTBI • IGRAs • TST • Section 2: Whom to Test and Treat • General Considerations, principles • TB Risk Assessment based on CA model

12. Content - 2 • Section 3: Considerations before starting LTBI Treatment • Confirmation of diagnosis of untreated LTBI • Evaluation for active TB • Risk of progression • Risk of adverse reactions • Likelihood of completion of treatment • Patient education • Selection of a regimen

13. Content - 3 • Section 4: Treatment for LTBI (Regimens) • Rifapentine and isoniazid once weekly for 12 weeks (3HP) • Rifampin or rifabutin for 4 months (4R) • Isoniazid for 9 months (9H)

14. Content - 4 • Section 5: Monitoring for and Management of Adverse Reactions • Monitoring for adherence, adverse reactions • Management of nonadherence • Management of adverse reactions • Role of the Nurse Case Manager • Role of the Healthcare Provider

15. Content - 5 • Section 6: Considerations for Special Populations • Children • Pregnant, post-partem and breastfeeding women • Patients with co-morbidities • Patients with radiographic evidence of inactive TB (Class 4) • References

16. Content - 6 • Appendix 1: Documentation • Appendix 2: Drugs for LTBI • Appendix 3: Summary of Regimens • Appendix 4: Treatment by Private Providers • Education of private providers • Partnerships, MOUs, • Role of Health Department in monitoring treatment, DOT • Correctional Facilities, Drug Treatment Facilties, Renal Dialysis Facilities

17. Content - 7 • Appendix 5: Definitions • Test characteristics and interpretation (sensitivity, specificity, PPV, NPV) • Recent TB infection

18. Conclusions • Guidelines contain limitations based on their methodology • Companion Statement can be more effective for TB elimination • Current status • Next Steps • Discussion/questions?