MARYLAND GUIDELINES FOR PREVENTION AND TREATMENT OF TUBERCULOSIS 2019 3rd Edition Maryland Department of Health Prevention and Health Promotion Administration Center for TB Control and Prevention Development of this document was funded, in part, by the Maryland Tuberculosis Elimination and Laboratory CDC Cooperative Agreement 5 NU52PS004690-05-00 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 i The use of trade names in this document is for identification purposes only and does not imply endorsement by the U.S. Public Health Service, the U.S. Department of Health and Human Services, the U.S. Centers for Disease Control and Prevention (CDC) or the Maryland Department of Health. The services and facilities of the Maryland Department of Health (MDH) are operated on a non- discriminatory basis. This policy prohibits discrimination on the basis of race, religion, color, sex, or national origin and applies to the provisions of employment and granting of advantages, privileges and accommodations. The Department, in compliance with the Americans with Disabilities Act, ensures that qualified individuals with disabilities are given an opportunity to participate in and benefit from MDH services, programs, benefits, and employment opportunities. 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 ii Maryland Guidelines for Prevention and Treatment of Tuberculosis 2019 Table of Contents page I. INTRODUCTION 1 II. ROLE OF THE LOCAL HEALTH DEPARTMENT IN TUBERCULOSIS CONTROL 2 Reporting of Cases 2 Priorities of LHD TB Control Programs 2 Nurse Case Management 3 Directly Observed Therapy 6 Video DOT (VDOT) 6 Case Reviews 6 Program Evaluation and Cohort Review 7 Contact Investigations 7 Interjurisdictional Referrals 8 Airline Contacts 9 Travel Restrictions 9 Surveillance 9 TB Research 10 Partnering with Others 10 III. PATHOGENESIS OF TUBERCULOSIS 11 IV. TUBERCULOSIS TESTING 12 Administering and Reading TB Tests 12 Mantoux Tuberculin Skin Test (TST) 12 Interpreting TST Reactions 13 Booster Phenomenon and Two-Step TST 13 Two-Step Procedure 13 Interferon Gamma Release Assay 13 Interpreting IGRA test results 14 “Convertor” vs. “Reactor” 14 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 iii Special Situations (Testing) 14 Children 14 Live-Virus Vaccinations 15 Pregnancy 15 HIV Infection 15 Individuals Born Outside the US 15 Bacille Calmette-Guerin (BCG) Vaccination 18 Immunosuppressive Treatment 18 LTBI Reporting in Maryland 19 V. TREATMENT OF LATENT TUBERCULOSIS INFECTION 19 Medical Evaluation for a Positive TST/IGRA 19 Chest Radiographs 19 HIV Testing 20 Diabetes Screening and Testing 20 Pregnancy 20 Pregnancy/Post-Partum 20 Medication Regimens for TLTBI 20 Medication Interactions 21 Children 21 Breast Feeding 21 HIV Infection 21 Renal Insufficiency and End-Stage Renal Disease 21 Contacts to Active TB Cases 21 Persons with Fibrotic Lesions 22 Suspected TB Disease Ruled Out 22 Pyridoxine Supplement (Vitamin B6) 22 Monitoring LTBI Treatment 22 Laboratory Monitoring TLTBI 23 Managing Interruptions in LTBI Treatment 23 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 iv VI. DIAGNOSIS OF TUBERCULOSIS DISEASE 26 Pulmonary 26 Extrapulmonary 26 TB Meningitis 26 Disseminated (military) TB 26 Lymphatic TB 26 Skeletal TB (bones and joints) 26 Pleural TB 26 Abdominal TB 27 Ocular TB/ TB of Reproductive Organs 27 Chest X-ray Manifestations of TB 27 Diagnostic Specimens/Laboratory Testing 27 Sputum 27 Tissue 27 AFB Smear 27 Nucleic Acid Amplification Tests 28 AFB Culture 28 AFB Culture Identification 28 Drug Susceptibility Testing 28 Molecular Detection of Drug Resistance (MDDR) 29 Submission Criteria for MDDR 29 Genotyping 29 VII. TREATMENT OF TUBERCULOSIS DISEASE 32 General Principles 32 Promoting Adherence to Treatment 32 Nurse Case Management 32 Directly Observed Therapy (DOT) 33 Video/Electronic Directly Observed Therapy 33 Enablers and Incentives 33 CTBCP Patient Consultations 34 Case and Cohort Reviews 35 CDC Centers of Excellence 35 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 v Tuberculosis Treatment Regimens 35 Intensive Phase 35 7 day per week dosing and 2017 Maryland TB Expert Panel Recommendations 36 Continuation Phase 36 Follow-up Sputum Examination 36 Sputum Culture Conversion 36 Medication Administration 37 General Principles 37 Medication Interactions 37 Methadone 37 Hormone-based Contraceptives 37 Antiretroviral Medications (ARVs) 38 Other Medication Interactions 38 Laboratory Monitoring 38 Therapeutic Drug Monitoring (TDM) 38 Monitoring Treatment of TB Disease 38 Managing Adverse Reactions 39 Gastrointestinal (GI) 39 Rash 39 Hepatitis 39 Managing Interruptions in Treatment 39 Drug Resistance or Intolerance 40 Pyridoxine (B6) Supplementation 40 Treatment Duration 41 Treatment Completion 41 Special Situations (TB Treatment) 41 Cavitary TB with Positive M. tuberculosis Cultures at 60 Days 41 Extrapulmonary TB 41 Culture-Negative (abacillary) Pulmonary TB 41 Children 42 Pregnancy 42 Congenital TB 42 Breastfeeding 42 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 vi Renal Insufficiency/ End-Stage Renal Disease 43 HIV Co-infection and Dosing Schedules 43 Immune Reconstitution Inflammatory Syndrome (IRIS) 43 Medication Reference Tables for TB Treatment (Tables 9-14, pages 44-52) 43 VIII. LEGAL ASPECTS OF TB CONTROL 53 General Principles 53 Legal Steps 53 Tuberculosis Patient/Provider Agreement for Treatment (MDH Form 4511) 53 Health Officer Order for Appropriate TB Treatment and Medical Care 54 Secretary of MDH or Health Officer Order for Medical Isolation/Quarantine 55 Violation of Order for Quarantine 55 HIPAA (Health Insurance Portability and Accountability Act) 55 IX. CONTACT INVESTIGATIONS AND TREATMENT OF CONTACTS 56 Decision to Initiate a tuberculosis (TB) Contact Investigation 56 Prioritization 56 Planning the Investigation 56 Contact Investigation Procedures 57 Medical Evaluation of High and Medium Priority Contacts 57 Treatment of Contacts 58 Contacts 2-5 years of age 58 Contacts 6 Months to 2 years of age 58 Documented Prior Positive TST or IGRA 58 Contacts with Immunosuppression 58 Source Case Investigation 58 Confidentiality 59 Use of Social Media 61 X. INFECTION CONTROL 62 Discontinuation of Airborne Infection Isolation Precautions (AII) within Hospital 62 Multi-drug Resistant TB (MDR-TB) and Extensively-drug Resistant TB (XDR-TB) 62 Discharge from Hospital 62 Admission to Long Term Care (LTC), Rehabilitation or Hospice Facilities 63 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 vii Readmission to Long Term Care (LTC) Facilities 63 Return to Work or School 63 Infection Control Plans 63 Local Health Departments 63 Long Term Care Facilitates 64 Addictions Treatment Facilities 64 Hospitals 64 Other Types of Residential Facilities 64 Recommendations for Screening, Testing and Treatment of Health Care Personnel 64 XI. TB CONTROL IN CORRECTIONAL AND DETENTION FACILITIES 67 Importance 67 Facility Risk Assessment for TB 67 TB Testing and Facility Risk 67 HIV Testing 68 Reporting 68 Airborne Infection Isolation (AII) 68 Release of Inmates with TB 68 Undocumented Persons 68 Program Evaluation 69 Contact Investigations 69 XII. NATIONAL TUBERCULOSIS INDICATORS 69 NTIP National TB Program Objectives 69 TB Program Evaluation 70 XIII. IMMIGRANT AND REFUGEE SCREENING FOR TUBERCULOSIS 70 Overseas TB Screening 70 United States TB Screening 71 Adjustment of Status 72 B-Waivers 74 2019 Maryland Guidelines for the Prevention and Treatment of Tuberculosis _ Updated_November 2019 MDH, 201 W. Preston Street ∙ Baltimore, MD 21201 ∙ health.maryland.gov ∙ Toll Free: 1-877-463-3464 ∙ TTY: 1-800-735-2258 viii REFERENCES 76 FIGURES Figure 1. Pathogenesis of TB in Untreated Immune Competent Persons Exposed to TB 11 Figure 2. Decision to initiate a tuberculosis (TB) contact investigation 60 Figure 3. Flow Chart for Assessing Priority Status of Contacts 61 Figure 4. Diagnostic Evaluation Steps for All TB B-waiver individuals 75 except persons with B0 status TABLES Table 1. Priorities for Tuberculosis Control Resource Allocation 5 Table 2. TB Risk Factors 11 Table 3. Adult Risk Groups for Targeted Testing and Treatment of LTBI 16 Table 4. Pediatric Risk Groups for Targeted Testing and Treatment of LTBI 17 Table 5. TST Cut-Points by Age for Low-Risk Persons 17 Table 6. Regimens for Treatment of Latent TB Infection/ Recommended Monitoring 24 Table 7. Components of a Tuberculosis Diagnostic Work-Up 30 Table 8. Examples of Enablers and Incentives 33 Table 9. Approved Dosing Regimens