Overview

These are the first World Health Organization (WHO) guidelines for the prevention, care and treatment of persons living with chronic hepatitis B (CHB) infection, and complement similar recently published guidance by WHO on the prevention, care and treatment of infection due to the hepatitis C virus (HCV).

The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those with most advanced liver disease and at greatest risk of mortality; and recommend the preferred use of nucleos(t)ide analogues with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment. Recommendations for the treatment of HBV/HIV-coinfected persons are based on the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be updated in 2015.

These recommendations provide opportunities to save lives, improve clinical outcomes of persons living with CHB, reduce HBV incidence and transmission, and stigma due to disease, but they also pose practical challenges to policymakers and implementers in low- and middle-income countries.

Contents

• ACKNOWLEDGEMENTS
• ABBREVIATIONS AND ACRONYMS
• GLOSSARY OF TERMS
• EXECUTIVE SUMMARY
• 1. INTRODUCTION
  • 1.1. Goals and objectives
  • 1.2. Related WHO materials and guidelines
  • 1.3. Target audience
  • 1.4. Guiding principles
• 2. METHODOLOGY AND PROCESS OF DEVELOPING THE GUIDELINES
  • 2.1. WHO guideline development process
  • 2.2. Roles
  • 2.3. Management of conflicts of interest
  • 2.4. Disseminating and monitoring implementation of the guidelines
• 3. BACKGROUND
  • 3.1. Epidemiology and burden
  • 3.2. Virology
  • 3.3. Transmission
  • 3.4. Natural history of chronic hepatitis B
  • 3.5. Diagnosis and staging
  • 3.6. Screening
  • 3.7. Prevention through vaccination
  • 3.8. Antiviral therapy
  • 3.9. Special populations
• 4. RECOMMENDATIONS: NON-INVASIVE ASSESSMENT OF LIVER DISEASE STAGE AT BASELINE AND DURING FOLLOW UP
  • 4.1. Background
  • 4.2. Summary of the evidence
  • 4.3. Rationale for the recommendations
• 5. RECOMMENDATIONS: WHO TO TREAT AND WHO NOT TO TREAT IN PERSONS WITH CHRONIC HEPATITIS B
  • 5.1. Background
  • 5.2. Summary of the evidence
  • 5.3. Rationale for the recommendations
• 6. RECOMMENDATIONS: FIRST-LINE ANTIVIRAL THERAPIES FOR CHRONIC HEPATITIS B
  • 6.1. Background
  • 6.2. Summary of the evidence
  • 6.3. Rationale for the recommendations
• 7. RECOMMENDATIONS: SECOND-LINE ANTIVIRAL THERAPIES FOR MANAGEMENT OF TREATMENT FAILURE
  • 7.1. Background
  • 7.2. Summary of the evidence
  • 7.3. Rationale for the recommendations
• 8. RECOMMENDATIONS: WHEN TO STOP TREATMENT
  • 8.1. Background
  • 8.2. Summary of the evidence
  • 8.3. Rationale for the recommendations
• 9. RECOMMENDATIONS: MONITORING
  • 9.1. Monitoring for disease progression and treatment response in persons with CHB prior to, during and post-treatment
  • 9.2. Monitoring for tenofovir and entecavir toxicity
  • 9.3. Monitoring for hepatocellular carcinoma (HCC)
• 10. RECOMMENDATIONS FROM EXISTING WHO GUIDANCE: PREVENTION
  • 10.1. Infant and neonatal hepatitis B vaccination
  • 10.2. Prevention of mother-to-child HBV transmission using antiviral therapy
  • 10.3. Prevention of transmission of hepatitis B and measures to reduce disease progression in persons with chronic hepatitis B
  • 10.4. Prevention of hepatitis B and C transmission in health-care settings
  • 10.5. Prevention of hepatitis B and C and sexual transmission in persons who inject drugs
• 11. MANAGEMENT CONSIDERATIONS FOR SPECIFIC POPULATIONS
  • 11.1. Coinfections
  • 11.2. Decompensated cirrhosis and advanced liver disease
  • 11.3. Extrahepatic manifestations
  • 11.4. Acute hepatitis B
  • 11.5. Children and adolescents
  • 11.6. Pregnant women
  • 11.7. Persons who inject drugs (PWID)
  • 11.8. Dialysis and renal transplant patients
  • 11.9. Health-care workers
  • 11.10. Indigenous peoples
• 12. IMPLEMENTATION CONSIDERATIONS FOR NATIONAL PROGRAMMES
  • 12.1. Introduction
  • 12.2. Key principles
  • 12.3. Key considerations to support country planning and decision-making
• REFERENCES
• WEB APPENDICES
  • APPENDIX 1. PICO questions
  • APPENDIX 2. Systematic review (SR) reports and evidence summaries
  • APPENDIX 3. Summary of declared interests

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