Transcript Background

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
100
PegIFN
80
2014+
2012
90+
2001
RBV
Standard
IFN
DAAs
70+
1998
55
60
1991
42
40
34
39
16
20
6
0
IFN
6 mos
3
IFN
12 mos
IFN/RBV
6 mos
IFN/RBV
12 mos
PegIFN
12 mos
PegIFN/
RBV
12 mos
PegIFN/ 1/2 or 3 DAA
+/- RBV
RBV/
DAA
How many persons need HCV treatment?
~185 million
~130-150 million
~26-30
million
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Persons with history
of HCV infection
Persons with chronic
HCV infection
Persons with F3-F4
stage fibrosis
Some lessons from the HIV movement
HIV
 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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HEP
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)?
Awareness
Testing
What medicines to use?
Referral
Diseasestage
assessment
What interventions to slow
progression of liver
disease?
How to assess degree of
liver fibrosis/cirrhosis?
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Treatment
Monitoring
How to monitor for
response to treatment
and drug adverse
reactions?
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 Guidelines
Prequalification of generic medicines
Essential Medicines List
Technical assistance for improved treatment
access
Multi-stakeholder engagement
Advocacy;
Improved
prevalence estimates
Awareness
Testing
Prequalification
of diagnostics
Screening/ testing
guidelines
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Treatment
Referral
Diseasestage
assessment
Treatment
Monitoring
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
Hepatitis Surveillance
Manual launch
September 2014
JUNE
JANUARY
DECEMBER
OCTOBER
AUGUST
Hepatitis E Outbreak
Response Manual
launch
June 2014
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HBV Guidelines
launch
Dec 2014
HBV Guidelines
Meeting
June 2014
JULY
JUNE
MAY
APRIL
Launch of Hepatitis C
Guidelines
EASL Conference
Consolidated
Hepatitis
Guidelines (2015)
WHO 2015 Consolidated Hepatitis Guidelines
WHAT TO DO?
•Screening
•Who to treat
•Which regimen to
use
•How to monitor
HOW TO DO IT?
•Service delivery
•Diagnostics
•Drug supply
Clinical
Operational
Simplification and consolidation
across:
- Continuum of hepatitis care (B,C)
- Ages and populations
- Clinical, operational and
programmatic
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programmatic
HOW TO DECIDE?
•Prioritization
•Equity and ethics
•Monitoring &
Evaluation
Acknowledgements
• Philippa Easterbrook
• Stefan Wiktor
• Nathan Ford
• Andrew Ball
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Thank you
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