1. Global Hepatitis C Guidelines 2014: recommendations for a public health approach Gottfried Hirnschall

2. 2 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

3. 3 SVR (%) IFN 6 mos PegIFN/ RBV 12 mos IFN 12 mos IFN/RBV 12 mos PegIFN 12 mos 2001 1998 2012 Standard IFN RBV PegIFN 1991 DAAs PegIFN/ RBV/ DAA IFN/RBV 6 mos 6 16 34 42 39 55 70+ 0 20 40 60 80 100 1/2 or 3 DAA +/- RBV 90+ 2014+ Improved sustained virological response (cure rate) with newer HCV medicines

4. 4 How many persons need HCV treatment? ~185 million ~130-150 million ~26-30 million Persons with history of HCV infection Persons with chronic HCV infection Persons with F3-F4 stage fibrosis

5. 5 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

6. 6 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

7. 7 WHO hepatitis C treatment guidelines Recommendations across continuum of care (s creening, 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

8. 8 Topics for WHO hepatitis C screening, care and treatment guidelines AwarenessTestingReferral Disease- stage assessment TreatmentMonitoring Who should be tested for hepatitis C (antibodies)? When to confirm HCV infection (PCR)? What interventions to slow progression of liver disease? How to assess degree of liver fibrosis/cirrhosis? When to start treatment? What medicines to use? How to monitor for response to treatment and drug adverse reactions? ScreeningCareTreatment

9. 9 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 HCV guidelines recommendations (2014)

10. 10 WHO’s role in improving access to hepatitis therapy AwarenessTestingReferral Disease- stage assessment TreatmentMonitoring Advocacy; Improved prevalence estimates Prequalification of diagnostics Screening/ testing guidelines Treatment Guidelines Prequalification of generic medicines Essential Medicines List Technical assistance for improved treatment access Multi-stakeholder engagement ScreeningCareTreatment

11. 11 Treatment guidelines -- next steps Dissemination Regional and country adaptations Technical assistance (e.g., Egypt, Indonesia, Pakistan) Revise and update Towards Consolidated Hepatitis Guidelines

12. 12 Timeline of key hepatitis guidelines APRIL MAY JUNE HBV Guidelines Meeting June 2014 JULY AUGUST OCTOBER DECEMBER JANUARY HBV Guidelines launch Dec 2014 Consolidated Hepatitis Guidelines (2015) Consolidated Hepatitis Guidelines (2015) JUNE Launch of Hepatitis C Guidelines EASL Conference Launch of Hepatitis C Guidelines EASL Conference Hepatitis E Outbreak Response Manual launch June 2014 Hepatitis Surveillance Manual launch September 2014

13. 13 programmatic HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DO IT? Service delivery Diagnostics Drug supply HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation HOW TO DECIDE? Prioritization Equity and ethics Monitoring & Evaluation WHAT TO DO? Screening Who to treat Which regimen to use How to monitor WHAT TO DO? Screening Who to treat Which regimen to use How to monitor Operational WHO 2015 Consolidated Hepatitis Guidelines Simplification and consolidation across: - Continuum of hepatitis care (B,C) - Ages and populations - Clinical, operational and programmatic

14. 14 Acknowledgements Philippa Easterbrook Stefan Wiktor Nathan Ford Andrew Ball

15. 15 Thank you