Pub. Date:
World Health Organization
Guidelines for the Screening, Care and Treatment of Persons with Chronic Hepatitis C Infection, updated version April 2016: Guidelines

Guidelines for the Screening, Care and Treatment of Persons with Chronic Hepatitis C Infection, updated version April 2016: Guidelines

by World Health Organization


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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 interfere on 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.

The key audience for these guidelines are policy-makers in low- and middle-income countries who formulate country-specific treatment guidelines and who plan infectious disease treatment programs and services, in addition to those people responsible for delivering treatment. The guidelines are appropriate for all countries, including high-income countries.

Product Details

ISBN-13: 9789241549615
Publisher: World Health Organization
Publication date: 04/30/2016
Pages: 134
Product dimensions: 6.25(w) x 9.50(h) x (d)

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

Table of Contents

Acknowledgements 5

Abbreviations and Acronyms 8

Glossary of Terms 10

Executive Summary 11

1 Scope and Objectives 16

1.1 Target audience 16

1.2 Scope of the guidelines 17

1.3 Related guidelines 17

2 Background 18

2.1 Epidemiology 18

2.2 Screening for HCV infection 27

2.3 Care of patients with HCV infection 27

2.4 Treatment of HCV infection 27

2.5 Access to and price of direct-acting antivirals 30

3 Guiding Principles 32

3.1 Human rights 32

3.2 Access to health care 32

3.3 Service provision 32

3.4 Integrated health care 33

3.5 Public health approach 33

4 Methods 33

4.1 Updating the existing guidelines 34

4.2 WHO guideline development process 34

4.3 Formulation of recommendations 35

4.4 Roles 36

4.5 Declarations of interest 37

4.6 Evidence that informed the recommendations 37

5 Recommendations on Screening 43

5.1 Screening to identify persons with HCV infection 43

5.2 When to confirm a diagnosis of chronic HCV infection 47

6 Recommendations on Care of People Infected with HCV 50

6.1 Screening for alcohol use and counselling to reduce moderate and high levels of alcohol intake 50

6.2 Assessing the degree of liver fibrosis and cirrhosis 54

7 Recommendations on Treatment 59

7.1 Assessment for HCV treatment 59

7.2 Treatment with direct-acting antiviral agents 62

7.3 Removal of recommendation for treatment with telaprevir or boceprevir 69

7.4 Preferred and alternative regimens for the treatment of persons with chronic hepatitis C virus infection 71

7.5 Treatment with pegylated interferon and ribavirin 78

8 Clinical Considerations 81

8.1 Clinical assessment of patients prior to treatment 82

8.2 Monitoring for adverse events 84

8.3 Drug-drug interactions 88

8.4 Monitoring for treatment response 90

9 Special Considerations for Specific Populations 92

9.1 People who inject drugs 92

9.2 Persons with HIV/HCV coinfection 94

9.3 Children and adolescents 96

9.4 Persons with cirrhosis 97

9.5 Persons with chronic kidney disease 98

9.6 Persons with HBV/HCV coinfection 98

9.7 Persons with TB/HCV coinfection 99

10 Operational and Implementation Issues 100

10.1 Factors to be considered in prioritizing who receives treatment 101

10.2 Service planning 105

10.3 Service delivery 106

10.4 Concerns of infringement of patient rights due to implementation of anti-diversion measures 106

11 Dissemination and Updating of the Guidelines 108

References 109

Web Appendices, 2016

All appendices will be made available, on the WHO hepatitis website.

Appendix 1 PICO questions

Appendix 2 Network meta-analysis report

Appendix 3 Budget impact analysis

Appendix 4 Values and preferences

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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