INTERNATIONAL STANDARDS FOR Tuberculosis Care DIAGNOSIS TREATMENT PUBLIC HEALTH 3RD EDITION, 2014 Developed by TB CARE I with funding by the United States Agency for International Development (USAID) TB CARE I Organizations Disclaimer: The Global Health Bureau, Office of Health, Infectious Disease and Nutrition (HIDN), US Agency for International Development, financially supports this publication through TB CARE I under the terms of Agreement No. AID-OAA-A-10-00020. This publication is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of TB CARE I and do not necessarily reflect the views of USAID or the United States Government. Suggested citation: TB CARE I. International Standards for Tuberculosis Care, Edition 3. TB CARE I, The Hague, 2014. Contact information: Philip C. Hopewell, MD Curry International Tuberculosis Center University of California, San Francisco San Francisco General Hospital San Francisco, CA 94110, USA Email: [email protected] Available at the following web sites: http://www.tbcare1.org/publications http://www.istcweb.org http://www.currytbcenter.ucsf.edu/international http://www.who.int/tb/publications To access a mobile version of ISTC, go to www.walimu.org/istc INTERNATIONAL STANDARDS FOR Tuberculosis Care DIAGNOSIS TREATMENT PUBLIC HEALTH 3RD EDITION, 2014 Table of Contents Acknowledgments . 1 List of Abbreviations . 2 Preface . 4 Summary . 8 Introduction . 14 Standards for Diagnosis . 20 Standards for Treatment . 34 Standards for Addressing HIV Infection and Other Co-morbid Conditions . 50 Standards for Public Health and Prevention . 57 References . 64 Annexes . 77 ISTC 3RD EDITION, 2014 TABLE OF CONTENTS Acknowledgments Development of the third edition of the International Standards for Tuberculosis Care was guided by a steering committee of World Health Organization Global Tuberculosis Pro- gramme staff and by an expert committee whose members were chosen to represent perspectives and areas of expertise relevant to tuberculosis care and control. Both com- mittees are listed below. The expert committees for editions 1 and 2 are in Annex 1. Steering Committee (WHO) • Haileyesus Getahun • Chris Gilpin • Malgosia Grzemska • Ernesto Jaramillo • Knut Lönnroth • Mario Raviglione • Mukund Uplekar • Diana Weil Expert Committee • RV Asokan, India • Knut Lönnroth, WHO • Erlina Burhan, Indonesia • G. B. Migliori, Italy • J.M. Chakaya, Kenya • Dyah Mustikawati, Indonesia • Gavin Churchyard, South Africa • Rick O’Brien, USA • Marcus Conde, Brazil • Madhukar Pai, Canada • Charles Daley, USA • Rose Pray, USA • Saidi Egwaga, Tanzania • Mario Raviglione, WHO • Elizabeth Fair, USA • Elizabeth Soares, Brazil • Paula Fujiwara, USA • Mukund Uplekar, WHO (Co-Chair) • Haileyesus Getahun, WHO • Marieke van der Werf, ECDC • Chris Gilpin, WHO • Dalene Von Delft, South Africa • Steve Graham, Australia • Jan Voskens, Netherlands • Malgosia Grzemska, WHO • Diana Weil, WHO • Philip Hopewell, USA (Co-chair) • Gini Williams, UK • Ernesto Jaramillo, WHO • Mohammed Yassin, GFATM • Aamir Khan, Pakistan • Charles Yu, Philippines Elizabeth Fair (University of California, San Francisco) in addition to being a member of the expert committee, provided scientific staffing and coordination. Fran Du Melle (American Thoracic Society) provided administrative coordination as well as guidance on dissemination and implementation. Cecily Miller and Baby Djojonegoro (University of California, San Francisco) provided assis- tance in organizing and preparing the document. In addition to the committees, many individuals have provided valuable input. All comments received were given serious consideration by the co-chairs, although not all were incorporated into the document. 1 ISTC 3RD EDITION, 2014 ACKNOWLEDGMENTS List of Abbreviations AFB Acid-fast bacilli AIDS Acquired immunodeficiency syndrome ART Antiretroviral therapy ATS American Thoracic Society BCG Bacille Calmette-Guérin CDC Centers for Disease Control and Prevention CI Confidence interval COPD Chronic obstructive pulmonary disease CPT Cotrimoxazole CRI Colorimetric redox-indicator DOT Directly observed treatment DOTS The internationally recommended strategy for tuberculosis control DR Drug-resistant DST Drug susceptibility testing EMB Ethambutol FDA Food and Drug Administration (US) FDC Fixed-dose combination FHI 360 Formerly Family Health International FM Fluorescence microscopy HAART Highly active antiretroviral therapy HIV Human immunodeficiency virus IDSA Infectious Diseases Society of America IGRA Interferon-gamma release assay INH Isoniazid IMAAI Integrated Management of Adolescent and Adult Illness IMCI Integrated Management of Childhood Illness IPT Isoniazid preventive therapy IRIS Immune reconstitution inflammatory syndrome ISTC International Standards for Tuberculosis Care IUATLD International Union Against Tuberculosis and Lung Disease (The Union) JATA Japan Anti-tuberculosis Association KNCV KNCV Tuberculosis Foundation LED Light emitting diode LPA Line probe assay LTBI Latent tuberculosis infection M&E Monitoring and Evaluation MDR Multidrug-resistant MIC Minimal inhibitory concentration 2 ISTC 3RD EDITION, 2014 LIST OF ABBREVIATIONS MODS Microscopic observation drug susceptibility MSH Management Sciences for Health NAAT Nucleic acid amplification test NALC N-acetyl L-cysteine NaOH Sodium hydroxide NIOSH National Institute for Occupational Services and Health NNRTI Non-nucleoside reverse transcriptase inhibitors NRA Nitrate reductase assay NTM Non-tuberculous mycobacteria NTP National tuberculosis control program PCTC Patients’ Charter for Tuberculosis Care PI Protease inhibitor PLHIV People living with HIV PPM Public-private mix PZA Pyrazinamide RIF Rifampicin RR Risk ratio STI Sexually transmitted infection TB Tuberculosis TBCTA Tuberculosis Coalition for Technical Assistance TNF Tumor necrosis factor TST Tuberculin skin test (Mantoux) USAID United States Agency for International Development WHO World Health Organization XDR Extensively drug-resistant ZN Ziehl-Neelsen staining 3 ISTC 3RD EDITION, 2014 LIST OF ABBREVIATIONS Preface to Edition 3 Development Process The standards in Development of the first edition of the International Standards for Tuberculosis Care (ISTC) the ISTC are all was funded by the United States Agency for International Development (USAID) via the Tuberculosis Coalition for Technical Assistance (TBCTA) and was guided by an expert supported by committee of 28 members from 14 countries representing relevant perspectives and existing WHO areas of expertise. The committee was co-chaired by Mario Raviglione of the World Health Organization (WHO) and Philip Hopewell of the American Thoracic Society (ATS). The guidelines and group first agreed on a content outline and then identified areas in which systematic policy statements, reviews were needed. Six reviews, largely related to approaches to diagnosis, were con- ducted and subsequently published in peer-reviewed publications. many of which had recently been Development of Edition 2 of the ISTC was also funded by USAID via its TB Control Assis- tance Program (TBCAP). A new expert committee of 56 persons from 15 countries, plus developed using WHO, chaired by Drs. Raviglione and Hopewell guided the process. Only one systematic rigorous review, related to contact investigation (subsequently published), was identified. methodology. Edition 3 was again funded by USAID via TB CARE I and was developed using essentially the same process. Development was led by Mukund Uplekar (WHO) and Philip Hopewell (ATS). A steering committee from the staff of the Global TB Programme at the WHO iden- tified areas in which revisions were needed. It was felt that no new systematic reviews were needed for this edition. The standards in the ISTC are all supported by existing WHO guidelines and policy statements, many of which had recently been developed using rig- orous methodology, including systematic reviews. The draft document was then reviewed by an expert committee of 27 members from 13 countries, co-chaired by Drs. Uplekar and Hopewell. Subsequent drafts were also reviewed and approved by the expert com- mittee. The final draft was reviewed and approved by the TB CARE I member organiza- tions (ATS, FHI 360, the Japan Antituberculosis Association [JATA], KNCV Tuberculosis Foundation [KNCV], Management Sciences for Health [MSH], the International Union against Tuberculosis and Lung Disease [The Union], and WHO). 4 ISTC 3RD EDITION, 2014 PREFACE TO EDITION 3 Key differences between ISTC Edition 2 and Edition 3 Edition 1 of the ISTC stated, “The Standards should be viewed as a living document that will be revised as technology, resources, and circumstances change.” It has now been five years since Edition 2 of the ISTC was published (2009); new information has emerged; new approaches are now feasible; and new guidelines have been written. These changes warrant an updating of the ISTC to be consistent with the concept of a “living document.” It was also stated in Edition 1 that, “As written, the Standards are presented within a con- text of what is generally considered to be feasible now or in the near future.” There is continued recognition that not all of the standards in this edition can be met in all places at this time. However, given the rapidity of technical advances and deployment of new technologies and approaches, it is anticipated that compliance with the standards will be possible in most