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

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

Authorship Leadership Workgroup 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

Disclosures None

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.

Outline Background Process Content Conclusions

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

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

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

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

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

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

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)

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

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

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

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

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