Northern Ireland Regional Hepatitis B & C Managed Care Network Annual Update Event

1. Northern Ireland Regional Hepatitis B & C Managed Care NetworkAnnual Update Event Health Protection Scotland HCV Action Plan & Progress October 19, 2012 Professor David Goldberg

2. The Sexual Health and Blood Borne Virus Framework(Sexual Health, HIV, Hepatitis C and Hepatitis B)

3. Previous Policy • Sexual Health • Respect and Responsibility (end Mar 11) • HIV • HIV Action Plan (2009 – 2014) • Hepatitis C • Hepatitis C Action Plan Phase II (end Mar 11) • Hepatitis B • No existing policy other than vaccination • Acknowledged requirement to establish the landscape of Hep B in Scotland; consider and implement proposals to begin to address current and future disease burden

4. Framework Outcomes • Fewer newly acquired blood borne virus and sexually transmitted infections; fewer unintended pregnancies • A reduction in the health inequalities gap in sexual health and blood borne viruses • People affected by blood borne viruses lead longer, healthier lives • Sexual relationships are free from coercion and harm • A society whereby the attitudes of individuals, the public, professionals and the media in Scotland towards sexual health and blood borne viruses are positive, non-stigmatising and supportive

5. KEY AccountabilityAdvice, expertise, best practiceReporting/data provision to monitor outcomes & indicators Framework Governance Sexual Health and BBV FrameworkMinisterial Advisory Committee Sexual Health and BBV Framework Executive Leads Network (Governance Board) Scottish Government Sexual Health and BBV Team (encompassing National Coordinators) National Sexual Health and BBV Monitoring and Assurance Group (encompassing HPS/ISD co-Chairs) Scottish Government meetings/visits Lead Organisations Eg. NHS Boards, SPS, NES.. National Networks via Network chairs

6. Hepatitis C Action Plan for Scotland: Aims • To prevent the spread of Hepatitis C, • particularly among IDUs. • To diagnose Hepatitis C infected persons, • particularly those who would most benefit • from treatment. • To ensure that those infected receive • optimal treatment, care and support.

7. Hepatitis C Action Plan for Scotland • Phase I: Sept 2006-March 2008 (41 Actions) • Gathering evidence to inform Phase II • Actions • Generating Phase II Actions and the • Phase II Action Plan

8. Hepatitis C epidemiological landscape (estimates): Scotland 2006 People with chronic infection

9. HCV infection and disease trends New cases of HCV-related liver failure in Scotland Number of hospital bed-days associated with HCV-related liver failure in Scotland Annual number of deaths related to HCV and AIDS in Scotland HCV prevalence among IDUs <25 years in Glasgow

10. Modelled number of IDUs in Scotland developing liver failure each year with different uptake rates of HCV antiviral therapy, 2008-2030 150 100 Annual number of liver failures Uptake of HCV antiviral therapy: 225 IDUs per year 1,000 IDUs per year 2000 IDUs per year 50 0 2010 2015 2020 2025 2030 Increasing uptake of therapy to 2,000 per year (2008-2030) will prevent approx. 5,200 cirrhosis cases (including 2,700 liver failures)

11. Hepatitis C Action Plan for Scotland Phase II • Launched: May 2008 by Health Minister • 34 Actions • All Actions to develop/improve services: Prevention • Diagnosis • Treatment/Care

13. Hepatitis C Action Plan: Phase II 2008-2011Principles and Characteristics • The Plan : • is based on an extensive evidence base and • consultation process • is a high level one • embraces all service needs • adopts a multidisciplinary approach • covers all geographical areas and settings • is performance managed • addresses inequalities • is supported by serious investment

14. Scottish Hepatitis C Action Plan: Phase II 2008-2011Government Investment (£million)

15. Key Actions & Achievements as at 2011 Prevention Action : Major improvements in Injection Equipment provision for IDUs (esp. paraphernalia) Impact : Early signs that incidence of infection falling Diagnosis Action : Awareness raising initiatives Introduction of finger-prick sampling in non-clinical settings Impact : One-third increase in numbers diagnosed over 2-3 years Treatment/Care Action : Managed Care Networks Increase in clinical capacity Measures to support patients through clinical pathway National procurement of antiviral therapy Impact : Doubling numbers initiated onto treatment over 2 years

16. Prevention: Prevalence & incidence of HCV among IDUs surveyed in mainland Scotland during 2008/09 All IDUs N=2,516 HCV Ab+ve N=1,373 (55%) HCV Ab-ve N=1,143 (45%) Avidity testing underway HCV PCR+ve N= 21/1115 (2%) HCV prevalence  60% 50-59% 40-49% HCV incidence 10-15/100 pyrs 30-39% <30%

17. Trends in recent HCV infection among PWID in Scotland, 2008 – 2011 (B) HCV incidence per 100 person years* (among HCV Ab- PWID) (C) Number of new HCV infections per year* (among HCV Ab- PWID) (A) % PCR+ (among HCV Ab- PWID) 2,000 20 4% χ2 test for trend p=0.02 1,500 15 3% 1,000 10 2% 500 5 1% 0 0 0% 2008-9 2010 2011 2008-9 2010 2011 2008-9 (N=1140) 2010 (1319) 2011 (1027) * Assumes the number of PWID (N=24,000) remains stable * With 51 day pre-seroconversion window (Page-Shafer 2008)

18. Key Actions & Achievements as at 2011 Prevention Action : Major improvements in Injection Equipment provision for IDUs (esp paraphernalia) Impact : Early signs that incidence of infection falling Diagnosis Action : Awareness raising initiatives Introduction of finger-prick sampling in non-clinical settings Impact : One-third increase in numbers diagnosed over 2 years Treatment/Care Action : Managed Care Networks Increase in clinical capacity Measures to support patients through clinical pathway National procurement of antiviral therapy Impact : Doubling numbers initiated onto treatment over 2 years

19. Number of people diagnosed with HCV in Scotland, 1991-2011 • In 2011 • 2,147 new diagnoses • 19% diagnosed in specialist drug services (DBS testing introduced in 2009) • Total • 31,468 diagnosed by end 2011 • ~27,000 diagnosed and living by end of 2011 • ~50% of people living with HCV remain undiagnosed 30,000 2,000 1,500 20,000 Annual Cumulative 1,000 10,000 500 0 0 1991 1995 2000 2005 2010 Year of diagnosis

20. Key Actions & Achievements as at 2011 Prevention Action : Major improvements in Injection Equipment provision for IDUs (esp paraphernalia) Impact : Early signs that incidence of infection falling Diagnosis Action : Awareness raising initiatives Introduction of finger-prick sampling in non-clinical settings Impact : One-third increase in numbers diagnosed over 2 years Treatment/Care Action : Managed Care Networks Increase in clinical capacity Measures to support patients through clinical pathway National procurement of antiviral therapy Impact : Doubling numbers initiated onto treatment over 2 years

21. Annual number of people initiated on HCV antiviral therapy in Scotland Actual number (prison inmates) 468 (17) 2007/08 Scottish Government target 591 2008/09 500 904 2009/10 750 1049 (143) 2010/11 8-fold increase in the number of prison inmates treated between 2007/08 and 2010/11 1000 1002 2011/12 1100 0 500 1,000 Number of treatment initiations

22. Number of people initiated on HCV antiviral therapy, with a reported risk factor (data from 16/18 clinics) Treated and with a reported risk factor for infection* Treated and reported IDU Treated and reported IDU and aged <35 years N=1071 (100%) 1,000 (75%) N=714 (100%) 800 Number of treatment initiations (N) N=572 (100%) 600 (65%) N=358 (100%) (63%) N=249 (100%) 400 (26%) (61%) (58%) (21%) 200 (17%) (13%) (18%) 0 2000 & 2001 2002 & 2003 2004 & 2005 2006 & 2007 2008 & 2009 Calendar year of treatment initiation * Proportion with risk factor: 85% in 2000-01; 86% in 2002-03; 87% in 2004-05; 86% in 2006-07; and 81% in 2008-09.

23. SVR rates by genotype among patients from Scotland1 (initiated 2000-2007), and published RCTs2-4 Genotype 1 Genotype 2/3 80 80 72 70 70 67 SVR (%) 60 51 50 46 40 39 36 30 RCTs PWID (N=176) RCTs All (N=315) PWID <35 yrs* (N=39) PWID <35 yrs* (N=96) All (N=594) PWID (N=323) SCOTLAND SCOTLAND 1.Innes et al. Eur J Gastro Hep (in press) 2.Hadziyannis et al. Ann Intern Med, 2004. 3.Manns et al. Lancet, 2001. 4.Fried et al. NEJM, 2002. PWID: Ever-IDU * SVR rate among all patients aged <35yrs: genotype 1 was 54% (35/65); genotype 2/3 was 76% (121/159).

24. 53.2 50.0 26.8 Liver 10.5 10.0 5.9 Alcohol Excess risk* 7.4 5.0 4.5 2.0 1.3 1.0 0.5 Non-SVR (N=638) SVR (N=560) Non-cirrhotic SVR (N=503) Spontaneously resolved (N=3,690) Excess risk of a liver and an alcohol related hospital episode post treatment (in SVR & non-SVR patients) AND post diagnosis (in spontaneously resolved patients), compared to the general population * Age, sex & year standardised Innes et al. Hepatology, 2011.

25. Summary 1 • The foundations have been laid: coordination including networks. • Considerable progress on treatment front. • Positive signs that progress is being made in identifying infected persons. • Early indications that paraphernalia provision may be having a considerable impact.

26. Summary 2 • On reflection four key elements to securing the plan : Advocacy via patient representative groups : Epidemiological data : Clinical leadership : Therapeuticdevelopments • On reflection three key elements to sustaining the plan and making it successful : Strong governance : Programme Management approach : Adequate funding • Phase III including the incorporation of Hepatitis B underway.