Global Hepatitis C Guidelines 2014:

recommendations for a public health

approach

Gottfried Hirnschall
 Background

• HCV infection significant cause of morbidity and mortality:

– 130–150 million persons with chronic HCV infection
– 350,000–500,000 annual deaths

• Rapidly changing therapeutic environment

• Large geographical difference in standards of care

• Low levels of treatment coverage

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Improved sustained virological response
(cure rate) with newer HCV medicines

DAAs 2014+
100
2012 90+
PegIFN
80 RBV 2001
Standard 70+
IFN 1998
60 55
1991
42 39
40 34

20 16
6
0
IFN IFN IFN/RBV IFN/RBV PegIFN PegIFN/ PegIFN/ 1/2 or 3 DAA
6 mos 12 mos 6 mos 12 mos 12 mos RBV RBV/ +/- RBV
12 mos DAA

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How many persons need HCV treatment?

Persons with history

~185 million of HCV infection

~130-150 million Persons with chronic

HCV infection
~26-30
Persons with F3-F4
million stage fibrosis

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Some lessons from the HIV movement HIV HEP

 Impressive scale up is possible !!! 13 million people on Tx!!

 Strong voice of the community – advocacy and activism

 A global movement - need for multi-stakeholder engagement

 Strong government commitment – early champions show the

way, others follow suit

 Strategies to promote affordable and equitable access –

simplified guidance using a public health approach

 Major price reduction can be achieved

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 WHA Hepatitis Resolution (2014):
Access to treatment

• to facilitate equitable access to quality, effective,

affordable and safe hepatitis B and C treatments and
diagnostics

• to support Member States in access strategies, including

the use of TRIPS flexibilities

• to examine the feasibility of and strategies needed for the

elimination of hepatitis B and hepatitis C

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 WHO hepatitis C treatment guidelines

 Recommendations across
continuum of care (screening,
care, treatment)

 Aimed at health policy makers in

low- and middle-income
countries

 Public health approach

 Recommendations for all

approved hepatitis C drugs

 Launched in April 2014

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 Topics for WHO hepatitis C screening,
care and treatment guidelines
Screening Care Treatment

Who should be tested for

hepatitis C (antibodies)?
When to start treatment?
When to confirm HCV
infection (PCR)? What medicines to use?

Disease-
Awareness Testing Referral stage Treatment Monitoring
assessment

What interventions to slow How to monitor for

progression of liver response to treatment
disease? and drug adverse
reactions?
How to assess degree of
liver fibrosis/cirrhosis?

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HCV guidelines recommendations (2014)

1. HCV Ab testing offered to individuals of population with high HCV prevalence or

history of HCV-risk exposure / behaviour
2. RNA testing following positive HCV Ab test to establish diagnosis of active infection
and for treatment evaluation
3. Alcohol-intake assessment + offer of behavioural alcohol reduction intervention for
persons with moderate-high alcohol intake
4. Use non-invasive tests (APRI or FIB4) for assessment of liver fibrosis

5. Assessment of all adults and children with chronic HCV, including PWID for antiviral
treatment
6. PEG-IFN + Ribavirin rather than standard non PEG-IFN + Ribavirin
7. Telaprevir or boceprevir in genotype 1 infection

8. Sofosbuvir + Ribavirin ± PEG-IFN in genotypes 1, 2, 3 and 4 infection

9. Simeprevir + PEG-IFN + Ribavirin in genotype 1 infection

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 WHO’s role in improving access to
hepatitis therapy
Screening Care Treatment

Treatment Guidelines
Advocacy; Prequalification of generic medicines
Improved Essential Medicines List
prevalence estimates Technical assistance for improved treatment
access
Multi-stakeholder engagement

Disease-
Awareness Testing Referral stage Treatment Monitoring
assessment

Prequalification
of diagnostics
Screening/ testing
guidelines

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 Treatment guidelines -- next steps

• Dissemination

• Regional and country adaptations

• Technical assistance (e.g., Egypt, Indonesia, Pakistan)

• Revise and update

• Towards Consolidated Hepatitis Guidelines

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 Timeline of key hepatitis guidelines

Consolidated
Hepatitis
Launch of Hepatitis C Guidelines (2015)
Guidelines
EASL Conference HBV Guidelines
HBV Guidelines launch
Meeting Dec 2014
June 2014

DECEMBER

JANUARY
OCTOBER
AUGUST

JUNE
APRIL

JUNE
MAY

JULY

Hepatitis E Outbreak Hepatitis Surveillance

Response Manual Manual launch
launch September 2014
June 2014

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 WHO 2015 Consolidated Hepatitis Guidelines

HOW TO DO IT?
WHAT TO DO? •Service delivery
•Screening •Diagnostics
•Who to treat •Drug supply
•Which regimen to
use
•How to monitor
Clinical Operational
Simplification and consolidation
across:
programmatic
- Continuum of hepatitis care (B,C)
HOW TO DECIDE?
- Ages and populations
•Prioritization
- Clinical, operational and •Equity and ethics
•Monitoring &
programmatic Evaluation

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 Acknowledgements

• Philippa Easterbrook

• Stefan Wiktor

• Nathan Ford

• Andrew Ball

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 Thank you

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