Emerging epidemics: Will they derail progress? Eastern/Central Europe

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1 Emerging epidemics: Will they derail progress? Eastern/Central Europe Marieta Simonova, MD Clinic of Gastroenterology, Military Medical Academy Sofia, Bulgaria

2 Disclosures Speaker/Adviser for AbbVie, Gilead, Merck No relevant disclosures in regards of this presentation

3 Viral hepatitis infections global health problem WHO estimates, 2015: Chronic HBV infection million persons (3.5% of the world population) 2.7 million persons - coinfected HBV and HIV Chronic HCV infection - 71 million persons (1% of world population) 2.3 million persons - coinfected HIV and HCV Viral hepatitis - responsible for 1.34 million deaths and number of deaths due to viral hepatitis have been increasing over the time deaths due to cirrhosis deaths due to hepatocellular carcinoma Global Hepatitis Report Geneva: World Health Organization; 2017

4 Prevalence of HCV and HBV in Europe: general population European Centre for Disease Prevention and Control. Systematic review on hepatitis B and C prevalence in the EU/EEA. Stockholm: ECDC; 2016

Anti HCV Ab (%) positive Epidemiology of HCV in Central/Eastern Europe Prevalence of anti HCV in CE Europe - general population 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0.4 0.5 0.5 0.9 1.28 1.67 1.9 2 2.2 2.3 3 3.

5 Anti HCV Ab (%) positive Epidemiology of HCV in Central/Eastern Europe Prevalence of anti HCV in CE Europe - general population Duffell E, ECDC, ILC 2017, presentation; Hahne et al, BMC Infectious Disease, 2013, 13:181; Hope VD et al,epidemiol. Infect. (2014), 142, ; Lavanchy D, CMI, 2011, 17, ; Petrunov B al, J Hepatol, 2002, v 36, supp.1, Gheorghe L et al, J Gastroeintest Liver Dis, 2010, vol.19, 4: ; Cornberg M et al, Liver International, 2011: 30-60; Flisiak R et al, Eur J Gastroenterol Hepatol 2011; 23: ; Maticic M, Warsaw, 2015, presenation; Chlibek R, Prevalence of hepatitis C virus in adult population in the Czech Republic ± time for birth cohort screening. (2017) PLoS ONE 12(4): e Vilibic-Cavlek T et al. Epidemiology of hepatitis C in Croatia, WJG, 2015, 21 (32),

Epidemiology of HCV in Central/Eastern Europe Routs of transmission: - Injecting drug use - Nosocomial transmission (Romania) European Centre for Disease Prevention and Control.

6 Epidemiology of HCV in Central/Eastern Europe Routs of transmission: - Injecting drug use - Nosocomial transmission (Romania) European Centre for Disease Prevention and Control. Annual epidemiological report for 2015 Hepatitis C [Internet]. Stockholm: ECDC; 2017 Available from: Poland Contry Drug Report, EMCDDA

7 Anti HCV ab (%) positive Epidemiology of HCV in Central/Eastern Europe Prevalence of HCV among PWID in CE Europe EMCDDA, Country drug reports 2017 CZ, HR, SL, PL, LV, HU, SL, BG, RO, LT avalable at : UNODC, World Drug Report 2017, avalable at and UNOS

HBs Ag (%) positive Epidemiology of HBV in Central/Eastern Europe Prevalence of HBV in CE Europe - general population 10 9 9 8 7 6 5 4 3.87 4.4 3 2 1 0 0.4 0.6 0.6 0.7 1.1 1.2 1.3 1.5 2.

8 HBs Ag (%) positive Epidemiology of HBV in Central/Eastern Europe Prevalence of HBV in CE Europe - general population European Centre for Disease Prevention and Control. Systematic review on hepatitis B and C prevalence in the EU/EEA. Stockholm: ECDC; 2016 Hahne et al, BMC Infectious Disease, 2013, 13:181; Hope VD et al,epidemiol. Infect. (2014), 142, ; Petrunov B al, J Hepatol, 2002, v 36, supp.1, ; Gheorghe L et al, Europ J Gastroeterol and Hepatol, 2013, vol.25, 1: 56-64; Rybacki M, Int J Occup Med Environ Health, 2013, 26 (3);

9 Epidemiology of HBV in Central/Eastern Europe Downward trend continues in the rate of acute cases

10 HIV/ Viral hepatitis co-infections in CE Europe 2nd Central and Eastern European Meeting on Viral Hepatitis and Co-Infection with HIV, 6-7 Oct 2016, Bucharest, Romania Country Romania Czech Republic Slovak Republic HIV prevalence Prevalence co-infected HIV/HBV Prevalence co-infected HIV/HCV 0.07% 19.9% 5 1.8% (86.8% of IDUs) Source presenations: Săndulescu O, HIV/Hepatitis co-infection situation in Romania 0.026% 2.1% 10.9% Aster V, HIV/Hepatitis co-infection situation in Czech and Slovak Republics 0.015% 5% 5% Russian Federation % (among PWID) Rassohkin V, HIV and HCV situation in Russia Ukraine 0.6% % (50.9% IDUs) Skala P, Hepatitis and HIV co-infection situation in Ukraine Estonia 1.3% - 70% (89.3% - IDUs) Caplinskas S, HIV/Hepatitis co-infection situation in Baltic countries

11 Eastern/Central Europe measures taken against viral hepatitis infection spread and their consequences?

National plan or strategy on the prevention and control of viral hepatitis in CE Europe Written national strategy or plan that focuses exclusively on the prevention and control of viral

12 National plan or strategy on the prevention and control of viral hepatitis in CE Europe Written national strategy or plan that focuses exclusively on the prevention and control of viral hepatitis in CE European countries Czech Republic Republic of Moldova The Russian Federation Slovenia WHO, Global policy report on the prevention and control o f viral hepatitis in who member states, 2013

13 Viral hepatitis infections in CE Europe responses Core intervention areas: 01/ HepB vaccination 02/ Prevention of mother-to-child transmission of hepatitis B virus 03/ Injection safety measures and securing the safe supply of blood products 04/ Harm reduction for people who inject drugs 05/ Treatment for HCV and HBV WHO, Global hepatitis report 2017, World Health Organization 2017

14 Countries with Hepatitis B Birth dose (HepB-BD) vaccine in the national immunization programme ,700 3,400 Kilometers WHO/IVB Database as at 14 April 2017 and ECDC published data at WHO Member States Map production Immunization Vaccines and Biologicals (IVB), World Health Organization Date of slide: 14 April 2017 HepB-BD introduced to date (97 countries or 49%) HepB-BD only for infants born to HBsAG-positive mothers (22 countries or 11%) HepB in schedule but no HepB-BD (71 countries or 37%) HepB given only for risk groups or adolescents (4 countries or 2%) Not available Not applicable

15 Vaccination of at risk populations for HBV All countries reported activities in vaccinating at risk populations for HBV Health care workers Families of HBV infected persons; pts on hemodialysis; pts waiting for organ transplantation Different risk groups are covered in different counties: people living with HIV, PWID, prisoners, MSM, sex workers Data are not systematically reported

Viral hepatitis infections in CE Europe safe blood and safe injection practices All countries have national infection control policy for blood banks All blood donations are tested for HBsAg and

16 Viral hepatitis infections in CE Europe safe blood and safe injection practices All countries have national infection control policy for blood banks All blood donations are tested for HBsAg and anti-hcv in all reporting MSs of Council of Europe All countries have national policies on injection safety in healthcare settings The Collection, Testing and Use of Blood and Blood Components in Europe is published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe Global policy report on the prevention and control of viral hepatitis in WHO Member States; WHO; 2013

Viral hepatitis infections in CE Europe Harm reduction services Availability of NSPs and OST in community All countries have implemented NSPs and OST - The Russian Federation no OST available In

17 Viral hepatitis infections in CE Europe Harm reduction services Availability of NSPs and OST in community All countries have implemented NSPs and OST - The Russian Federation no OST available In majority of countries coverage of HRS is insufficient to the needs of affected population Reported data on HRS from the National Focal Points - not always complete The Global State of Harm Reduction 2016, Harm Reduction International European Monitoring Centre for Drugs and Drug Addiction (2017), European Drug Report 2017: Trends and Developments

18 Viral hepatitis infections in CE Europe Harm reduction services Coverage of OST (percentage of estimated high-risk opioid user receiving the intervention, 2015 European Monitoring Centre for Drugs and Drug Addiction (2017), European Drug Report 2017: Trends and Developments

19 Viral hepatitis infections in CE Europe Harm reduction services Number of syringes provided per estimated injecting drug user, 2015 European Monitoring Centre for Drugs and Drug Addiction (2017), European Drug Report 2017: Trends and Developments

20 Viral hepatitis infections in CE Europe Harm reduction services Lack acknowledgement and support for HR on political level Insufficient internal funding remain the key constrain for number HRS and scope of their activities In some non EU counties HRS still receive support by external funding/ internal funding very limited or no funding at all Low acceptance of HRS in some non EU countries

21 Viral hepatitis infections in CE Europe diagnostic and treatment National policies relating to screening and referral to care for HBV and HCV Belarus; Croatia; Czech Republic; Estonia; Montenegro; Poland; Republic of Moldova; The Russian Federation; Serbia; Slovenia; TFYR of Macedonia; Ukraine No national policies relating to screening and referral to care for HBV and HCV Albania; Bulgaria; Latvia; Lithuania; Slovakia Global policy report on the prevention and control of viral hepatitis in WHO Member States; WHO; 2013

22 Viral hepatitis infections in CE Europe - HCV diagnostic and treatment Number diagnosed and treated pts with HCV is still low

23 Viral hepatitis infections in CE Europe diagnostic and treatment Majority of the countries have national guidelines for diagnosis and treatment of viral hepatitis, few countries are using international guidelines In all counties antiviral treatment is prescribed and led by specialists (gastroenterologists or/and infectious disease specialists) Antiviral drugs are reimbursed by Public funds/ National Heath Insurance funds HBV drugs are reimbursement in all countries DAAs are reimbursed in all EU countries, but not in the majority of non-eu countries Marshall A. et all, Restrictions for reimbursement of interferon-free DAA antiviral therapies for HCV infection in Europe, J Hep, 2017, Supplement No. 1, Vol. 66, S95 (LBP -505) * European Liver Patients Association. The 2016 Hep-CORE Report. Brussels: ELPA, 2017

24 Availability of reimbursed antivirals for HBV treatment in CE Europe TDF ETV LAM LdT ADV PegIFN Bosnia &Herzegovina YES YES YES YES YES YES Bulgaria YES YES YES YES YES Croatia YES YES YES YES YES Hungary YES YES YES YES YES TFYR Macedonia Poland YES YES Romania YES YES YES YES YES Slovakia Slovenia YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES Serbia YES YES Ukraine YES YES YES YES YES YES European Liver Patients Association. The 2016 Hep-CORE Report. Brussels: ELPA, 2017

25 Availability of reimbursed DAAs for HCV treatment in CE Europe SOF + RBV SOF/LED ± RBV SOF/VEL ± RBV 3D ± RBV EBR/GZR ± RBV Bulgaria YES YES YES YES Croatia YES YES YES YES YES SOF/DCV ± RBV Czech Republic YES YES YES YES YES YES Estonia YES YES Hungary YES YES Latvia YES YES Lithuania YES YES Poland YES YES YES YES Romania YES YES Slovakia YES YES YES Slovenia YES YES YES YES YES Ukraine* YES YES YES Bosnia & Herzegovina* YES Marshall A. et all, Restrictions for reimbursement of interferon-free DAA antiviral therapies for HCV infection in Europe, J Hep, 2017, Supplement No. 1, Vol. 66, S95 (LBP -505) * European Liver Patients Association. The 2016 Hep-CORE Report. Brussels: ELPA, 2017

26 Restrictions for reimbursement of DAAs for HCV treatment in Europe Marshall A. et all, Restrictions for reimbursement of interferon-free DAA antiviral therapies for HCV infection in Europe, J Hep, 2017, Supplement No. 1, Vol. 66, S95 (LBP -505)

27 Conclusions Prevalence of viral hepatitis infections very substantially among countries in CE Europe, however national studies on viral hepatitis prevalence are lacking in the majority the countries National surveillance systems for viral hepatitis exist across CE European countries, but their activities should be improved Accurate, good quality epidemiological data are urgently needed in order to develop policies, programs and resource allocation for viral hepatitis elimination Only four countries currently have national plan for prevention and control of viral hepatitis

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