Health systems requirements for viral hepatitis elimination: Are we 'Flying Blind' in our efforts?

Transcription

1 Health systems requirements for viral hepatitis elimination: Are we 'Flying Blind' in our efforts? Prof Jeffrey V. Lazarus CHIP, Rigshospitalet, University of Copenhagen, WHO Collaborating Centre on HIV and Viral Hepatitis Associate Researcher, ISGlobal, Hospital Clínic, University of Barcelona 1 - Ljubljana, Hep-CORE 2017

2 Disclosures Grants and personal fees from AbbVie, Gilead Sciences, MSD not for today s event Research grants from non-governmental organisations including the European Liver Patients Association and the World Hepatitis Alliance Previously employed by international agencies: Global Fund, World Health Organization 2 - Ljubljana, Hep-CORE 2017

3 A question to ponder Translating good biomedical tools into good health outcomes for people who inject drugs living with hepatitis C what will it take? 3 - Ljubljana, Hep-CORE 2017

4 Meeting two types of challenges to eliminate HCV Biomedical Public health Hepatitis DAA breakthrough: 2013 Access Coverage Quality Safety Achieving a sustained virologic response requires much greater attention to health systems challenges, to resolve the public health issues. 4 - Ljubljana, Hep-CORE 2017

5 New global political will to eliminate HCV World Health Assembly resolution (2014) Hepatitis C Elimination in Europe (2016) Our vision for a Hepatitis C-free Europe First World Hepatitis Summit (2015) 84 countries represented Sources: World Hepatitis Summit 2015 meeting report. Available at: Elimination manifesto. Available at: (both accessed January 2017) 5 - Ljubljana, Hep-CORE 2017

6 WHO Global Health Sector Strategy on Viral Hepatitis May 2016: The first of its kind, WHO publishes a global strategy aiming for elimination of viral hepatitis as a public health threat by 2030 Source: WHO Global Health Sector Strategy on viral hepatitis. Available at: (Accessed August 2016) 6 - Ljubljana, Hep-CORE 2017

7 Global Health Sector Strategy HCV targets at a glance Incidence targets 30% reduction in new HCV infections by % reduction in new HCV infections by 2030 Mortality targets 10% reduction in mortality by % reduction in mortality by 2030 Harm reduction Increase in sterile needle and syringes provided per PWID/year from 20 in 2015 to: 200 by by 2030 Testing targets 90% of people aware of HCV infection by 2030 Treatment targets 80% of people treated by 2030 Source: WHO GHSS. (Accessed August 2016). 7 - Ljubljana, Hep-CORE 2017

8 The continuum of viral hepatitis services and the retention cascade Source: WHO Global Hepatitis Report, Available at (accessed May 2017). 8 - Ljubljana, Hep-CORE 2017

9 The global cascade of care for chronic HCV infection in 2015 Adapted by Macmillan Publishers Ltd, part of Springer Nature with permission, from Global Hepatitis Report, 2017, World Health Organization, page 30, figure 8, Source: Lazarus JV. et al. Many European countries flying blind in their efforts to eliminate viral hepatitis. Nat. Rev. Gastroenterol. Hepatol. doi: /nrgastro Ljubljana, Hep-CORE 2017

10 The Six Building Blocks of the Health System A health system consists of all organisations, people and actions whose primary intent is to promote, restore or maintain health 10 Source: WHO Ljubljana, Hep-CORE 2017

11 A paradigm change: The central role of people and communication Source: Lazarus and France. A new era for the WHO health system building blocks? Ljubljana, Hep-CORE 2017

12 People-centred health systems See: Ljubljana, Hep-CORE 2017

13 A people-centred health system for hepatitis elimination Effective surveillance/monitoring of loss to follow up? National strategy/plan incl stakeholder input eg patients, PWID, clinicians? Strategies for engaging eg PWID (former/active)? Workforce needed to achieve elimination? Capacity to monitor disease progression? Budget for provision of testing & treatment? 13 - Ljubljana, Hep-CORE 2017

14 Eliminating HCV requires national strategies/plans The viral hepatitis resolution approved by the World Health Assembly in 2014 called on all countries to develop and implement national strategies for preventing, diagnosing and treating viral hepatitis.? 14 - Ljubljana, Hep-CORE 2017

15 Many countries have developed national hepatitis plans 15 - Ljubljana, Hep-CORE 2017

16 National HCV strategy Does your country have a written national HBV and/or HCV strategy? Yes = 11 NORWAY SWEDEN FINLAND No = 14 ESTONIA Unknown / Unavailable IRELAND DENMARK LITHUANIA LATVIA RUSSIA KAZAKHSTAN UK NETHERLANDS BELARUS POLAND BELGIUM GERMANY LUXEMBOURG CZECH REPUBIC UKRAINE FRANCE SWITZERLAND AUSTRIA SLOVAKIAY HUNGARY MOLDOVA ANDORRA ITALY SLOVENIA CROATIA BOSNIA AND HERZEGOVINA SERBIA ROMANIA BULGARIA GEORGIA AZERBAIJAN PORTUGAL MACEDONIA SPAIN ALBANIA GREECE TURKEY Source: Lazarus et al. The 2016 Hep-CORE Report: CORE_full_report_21Dec2016_Final%5B2%5D.pdf 16 - Ljubljana, Hep-CORE 2017 CYPRUS

17 Every country needs a bespoke strategy to reduce disease burden and eliminate HCV Public health threat 2. Treat high incidence Prevent new infections, contain the epidemic 3. Non-PWID screening and treatment Elimination Burden of disease threat 1. Treat F3/F4 patients Prevent mortality and morbidity High incidence population Slow progression population Advanced population Risk of onward transmission Risk of mortality and morbidity F0 F1 F2 F3 F4 One approach does not fit all Context matters! 17 - Ljubljana, Hep-CORE 2017

18 Minimum fibrosis stage required for reimbursement of interferon-free DAA treatment naïve patients with HCV infection in Europe 31% (n=11) of countries required evidence of F2 17% (n=6) of countries required evidence of F3 a Fibrosis stage restrictions based on HCV genotype b Fibrosis stage is included in a point system for prioritisation of DAA therapy c Fibrosis stage restrictions based on HCV genotype and IL28B polymorphism d Fibrosis stage restrictions based on HCV therapy Source: Marshall, AD et al. Restrictions for reimbursement of interferon-free direct acting antiviral therapies for HCV infection in Europe. Lancet GastroHep, in press Ljubljana, Hep-CORE 2017

19 Eliminate late presentation Source: Mauss et al. BMC Med, Ljubljana, Hep-CORE 2017

20 Reimbursement of interferon-free DAAs for HCV infection in Europe HCV DAA Therapy All European countries/jurisdictions reimbursed DAAs (n=35) Most common DAA reimbursed was PrOD ± RBV (94%; n=33) Source: Marshall, AD et al. Restrictions for reimbursement of interferon-free direct acting antiviral therapies for HCV infection in Europe. Lancet GastroHep, in press Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark England Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands N. Ireland Norway Poland Portugal Romania Scotland Slovakia Slovenia Spain Sweden Switzerland Wales SOF + RBV SOF/LED ± RBV SOF/VEL ± RBV PrOD ± RBV EBR-GZR ± RBV SOF + DCV ± RBV 20 - Ljubljana, Hep-CORE 2017

21 Prescriber-type restrictions for reimbursement of interferon-free DAAs for patients with HCV infection in Europe 94% (n=33) of countries required specialists to prescribe DAA therapy Source: Marshall, AD et al. Restrictions for reimbursement of interferon-free direct acting antiviral therapies for HCV infection in Europe. Lancet GastroHep, in press Ljubljana, Hep-CORE 2017

22 Expanding prescriber base In countries without prescriber restrictions, such as Australia, general practitioners and non-specialists have greater access to reach patients in need of treatment 5-15% of individuals initiating DAAs had treatment prescribed by a GP Figure 5: Prescriber distribution in each month for individuals initiating DAA treatment during March to September 2016 in Australia Supervised Medical Officers included interns, temporary resident doctors, and nonvocationally registered doctors Source: Hajarizadeh B, Grebely J, Matthews GV, Martinello M, Dore GJ. The path towards hepatitis C elimination in Australia following universal access to interferon-free treatments. Poster to be presented at: International Liver Congress. 2017; Amsterdam, Netherlands Ljubljana, Hep-CORE 2017

23 Treatment of HCV patients in nonhospital settings Do HCV patients in your country have the option of being treated in non-hospital settings? Yes =5 (20%) NORWAY SWEDEN FINLAND No =20 (80%) ESTONIA Unknown / Unavailable IRELAND DENMARK LITHUANIA LATVIA RUSSIA KAZAKHSTAN 80% (n=25) of patient groups surveyed reported that HCV treatment is not available outside of a hospital setting PORTUGAL SPAIN UK FRANCE ANDORRA BELGIUM NETHERLANDS LUXEMBOURG SWITZERLAND GERMANY ITALY CZECH REPUBIC AUSTRIA POLAND SLOVENIA CROATIA HUNGARY BOSNIA AND HERZEGOVINA SLOVAKIAY ALBANIA SERBIA MACEDONI A GREECE BELARUS ROMANIA BULGARIA MOLDOVA UKRAINE TURKEY GEORGIA AZERBAIJAN Source: Lazarus et al.the 2016 Hep-CORE Report: Ljubljana, Hep-CORE 2017 CYPRUS

24 SACC: Borgernær shared care 24 - Ljubljana, Hep-CORE 2017 Source:

25 Harm reduction services for PWID Needle and Syringe Programmes (NSP) All parts of the country = 10 Some parts of the country = 10 NORWAY SWEDEN FINLAND ESTONIA Unknown / Unavailable IRELAND DENMARK LITHUANIA LATVIA RUSSIA KAZAKHSTAN UK NETHERLANDS BELARUS POLAND BELGIUM GERMANY LUXEMBOURG CZECH REPUBIC UKRAINE FRANCE SWITZERLAND AUSTRIA SLOVAKIAY HUNGARY MOLDOVA SLOVENIA CROATIA ROMANIA GEORGIA ANDORRA ITALY BOSNIA AND HERZEGOVINA SERBIA BULGARIA AZERBAIJAN PORTUGAL MACEDONIA SPAIN ALBANIA GREECE TURKEY CYPRUS 25 - Ljubljana, Hep-CORE 2017

26 Harm reduction services for PWID Opioid Substitution Therapy (OST) All parts of the country = 22 Some parts of the country = 1 NORWAY SWEDEN FINLAND ESTONIA Unknown / Unavailable IRELAND DENMARK LITHUANIA LATVIA RUSSIA KAZAKHSTAN UK NETHERLANDS BELARUS POLAND BELGIUM GERMANY LUXEMBOURG CZECH REPUBIC UKRAINE FRANCE SWITZERLAND AUSTRIA SLOVAKIAY HUNGARY MOLDOVA SLOVENIA CROATIA ROMANIA GEORGIA ANDORRA ITALY BOSNIA AND HERZEGOVINA SERBIA BULGARIA AZERBAIJAN PORTUGAL MACEDONIA SPAIN ALBANIA GREECE TURKEY CYPRUS 26 - Ljubljana, Hep-CORE 2017

27 Testing & screening outside of hospitals Does your country have any HCV testing/screening sites outside of hospitals for high-risk populations? Yes = 16 NORWAY SWEDEN FINLAND No = 8 ESTONIA Unknown / Unavailable IRELAND DENMARK LITHUANIA LATVIA RUSSIA KAZAKHSTAN UK NETHERLANDS BELARUS POLAND BELGIUM GERMANY LUXEMBOURG CZECH REPUBIC UKRAINE FRANCE SWITZERLAND AUSTRIA SLOVAKIAY HUNGARY MOLDOVA SLOVENIA CROATIA ROMANIA GEORGIA ANDORRA ITALY BOSNIA AND HERZEGOVINA SERBIA BULGARIA AZERBAIJAN PORTUGAL SPAIN ALBANIA MACEDONIA GREECE TURKEY CYPRUS 27 - Ljubljana, Hep-CORE 2017

28 Available HCV treatment in prisons Is HCV treatment provided in prisons in your country? Yes 68% (n=25) of patient No groups surveyed reported Unknown / Unavailable that HCV treatment is not available in prisons Percentage of prisons providing HCV treatment: NORWAY SWEDEN FINLAND ESTONIA AT: 10-19% DK: 40-49% FR: 0-9% DE: 0-9% IRELAND UK BELGIUM DENMARK NETHERLANDS LUXEMBOURG GERMANY CZECH REPUBIC POLAND LITHUANIA LATVIA BELARUS UKRAINE RUSSIA KAZAKHSTAN HU: 20-29% PT: 0-9% FRANCE SWITZERLAND AUSTRIA SLOVENIA CROATIA SLOVAKIAY HUNGARY ROMANIA MOLDOVA GEORGIA SK: 100% ANDORRA ITALY BOSNIA AND HERZEGOVINA SERBIA BULGARIA AZERBAIJAN SV: 100% All other countries responding affirmatively were unable to specify percentages of prisons. PORTUGAL SPAIN ALBANIA MACEDONI A GREECE TURKEY CYPRUS 28 - Ljubljana, Hep-CORE 2017

29 HCV (micro-) elimination in certain populations is also feasible in the shortto-medium term Decompensated cirrhotics Veterans Patients with haemophilia Transplant patients PWID, prisoners HIV/HCV co-infected Source: Lazarus JV, Wiktor SZ, Colombo M, Thursz M. Micro-elimination a path to global elimination of hepatitis C. Journal of Hepatology, July Ljubljana, Hep-CORE 2017

30 Some countries may achieve the WHO targets by or even before 2030 Iceland Georgia Australia National plan to treat all HCV patients according to Icelandic guidelines over 3 years Prioritisation of active PWID and patients with moderate-to-severe fibrosis Jan to Dec 2016, 1/3 of the HCV population were treated Georgia HCV Elimination Program Prioritisation of patients with advanced liver disease April 2015 to April 2016, 8448 people treated, a 400% increase in the number patients treated over the previous 4 years Public health policy 2016, 15% (33,560 patients) of the HCV population were treated No disease stage restrictions No drug or alcohol use restrictions GPs can prescribe Sources: Gottfredsson F, et al. HIV and Hepatitis Nordic Conference 2016; Abstract #O5; Gvinjilia L, et al. MMWR 2016;65:1132 5; Monitoring hepatitis C treatment uptake in Australia. Issue #5, September Available at: (accessed Aug 2017) 30 - Ljubljana, Hep-CORE 2017

31 11th Central and Easter European Meeting on Viral Hepatitis and Co-infection with HIV 2025 Est September 2017 Price BREAKING NEWS-- Georgia? Slovenia? - the first in central and eastern Europe to eliminate hepatitis C 31 - Ljubljana, Hep-CORE 2017

32 Putting it all together A people-centred health systems approach to HCV elimination in central and eastern Europe Policy leaders Academia Industry Health care providers Other stakeholders Civil society 32 - Ljubljana, Hep-CORE 2017

33 Acknowledgements All authors of all cited studies in particular: Alison Marshall, Jason Grebely, Stine Nielsen, Evan Cunningham and Samya R. Stumo, Kelly Safreed- Harmon from the Hep-CORE team Hep-CORE study countries / ELPA members Austria Belgium Bosnia & Herzegovina Bulgaria Croatia Denmark Egypt Finland France Germany Greece Hungary Israel Italy Macedonia Netherlands Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Turkey Ukraine United Kingdom Hep-CORE study group Charles Gore (World Hepatitis Alliance) Hande Harmanci (WHO) Magdalena Harris (LSHTM) Greet Hendrickx (Viral Hepatitis Prevention Board) Marie Jauffret-Roustide (Paris Descartes University) Achim Kautz (ELPA) Mojca Matičič (University Medical Centre Ljubljana) Luís Mendão (Grupo de Ativistas em Tratamentos (GAT)) Antons Mozalevskis (WHO Euro) Raquel Peck (World Hepatitis Alliance) Tatjana Reic (ELPA) Eberhard Schatz (Correlation Network) Kaarlo Simojoki (A-Clinic Foundation, Finland) Joan Tallada (European AIDS Treatment Group) Contact: Jeffrey.Lazarus@isglobal.org 33 - Ljubljana, Hep-CORE 2017 Hep-CORE funding to ELPA was provided by AbbVie, Gilead Sciences, MSD.