Overview

The field of HCV therapeutics continues to evolve rapidly and, since the World Health Organization (WHO) issued its first Guidelines for the screening, care and treatment of persons with hepatitis C infection in 2014, several new medicines have been approved by at least one stringent regulatory authority. These medicines, called direct-acting antivirals (DAAs), are transforming the treatment of HCV, enabling regimens that can be administered orally, are of shorter duration (as short as eight weeks), result in cure rates higher than 90%, and are associated with fewer serious adverse events than the previous interferon- containing regimens. WHO is updating its hepatitis C treatment guidelines to provide recommendations for the use of these new medicines.

The objectives of these WHO guidelines are to provide updated evidence- based recommendations for the treatment of persons with hepatitis C infection using, where possible, all DAA-only combinations. The guidelines also provide recommendations on the preferred regimens based on a patient’s HCV genotype and clinical history, and assess the appropriateness of continued use of certain medicines. This document also includes existing recommendations on screening for HCV infection and care of persons infected with HCV that were first issued in 2014.

Contents

• ACKNOWLEDGEMENTS
• ABBREVIATIONS AND ACRONYMS
• GLOSSARY OF TERMS
• EXECUTIVE SUMMARY
• 1. SCOPE AND OBJECTIVES
  • 1.1 Target audience
  • 1.2 Scope of the guidelines
  • 1.3 Related guidelines
• 2. BACKGROUND
  • 2.1 Epidemiology
  • 2.2 Screening for HCV infection
  • 2.3 Care of patients with HCV infection
  • 2.4 Treatment of HCV infection
  • 2.5 Access to and price of direct-acting antivirals
• 3. GUIDING PRINCIPLES
  • 3.1 Human rights
  • 3.2 Access to health care
  • 3.3 Service provision
  • 3.4 Integrated health care
  • 3.5 Public health approach
• 4. METHODS
  • 4.1 Updating the existing guidelines
  • 4.2 WHO guideline development process
  • 4.3 Formulation of recommendations
  • 4.4 Roles
  • 4.5 Declarations of interest
  • 4.6 Evidence that informed the recommendations
• 5. RECOMMENDATIONS ON SCREENING
  • 5.1 Screening to identify persons with HCV infection
  • 5.2 When to confirm a diagnosis of chronic HCV infection
• 6. RECOMMENDATIONS ON CARE OF PEOPLE INFECTED WITH HCV
  • 6.1 Screening for alcohol use and counselling to reduce moderate and high levels of alcohol intake
  • 6.2 Assessing the degree of liver fibrosis and cirrhosis
• 7. RECOMMENDATIONS ON TREATMENT
  • 7.1 Assessment for HCV treatment
  • 7.2 Treatment with direct-acting antiviral agents
  • 7.3 Removal of recommendation for treatment with telaprevir or boceprevir
  • 7.4 Preferred and alternative regimens for the treatment of persons with chronic hepatitis C virus infection
  • 7.5 Treatment with pegylated interferon and ribavirin
• 8. CLINICAL CONSIDERATIONS
  • 8.1 Clinical assessment of patients prior to treatment
  • 8.2 Monitoring for adverse events
  • 8.3 Drug–drug interactions
  • 8.4 Monitoring for treatment response
• 9. SPECIAL CONSIDERATIONS FOR SPECIFIC POPULATIONS
  • 9.1 People who inject drugs
  • 9.2 Persons with HIV/HCV coinfection
  • 9.3 Children and adolescents
  • 9.4 Persons with cirrhosis
  • 9.5 Persons with chronic kidney disease
  • 9.6 Persons with HBV/HCV coinfection
  • 9.7 Persons with TB/HCV coinfection
• 10. OPERATIONAL AND IMPLEMENTATION ISSUES
  • 10.1 Factors to be considered in prioritizing who receives treatment
  • 10.2 Service planning
  • 10.3 Service delivery
  • 10.4 Concerns of infringement of patient rights due to implementation of anti-diversion measures
• 11. DISSEMINATION AND UPDATING OF THE GUIDELINES
• REFERENCES
• Web Appendices, 2016
  • Appendix 1 PICO questions
  • Appendix 2 Systematic review and network meta-analysis to support the development of the WHO guidelines for the screening, care and treatment of persons with chronic hepatitis C infection
  • Appendix 3 Budget impact analysis to support the development of WHO guidelines for the screening, care and treatment of persons with chronic hepatitis C infection
  • Appendix 4 Values and preferences for treatment attributes of hepatitis C virus infection
  • Appendix 5 Decision-making tables
  • Appendix 6 Summary of declared interests
  • Appendix 7 Data from observational cohorts
• Web Appendices, 2014
  • Appendix 1 PICO questions
  • Appendix 2 Example of GRADE decision-making table
  • Appendix 3 Systematic reviews and evidence summaries
  • Appendix 4 Decision-making tables
  • Appendix 5 Technical report on monitoring during treatment
  • Appendix 6 Summary of declared interests

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