Hepatitis C Burden in Romania Evaluation 2018 Challenges Prof. Adrian Streinu-Cercel MD, PhD, HC

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1 Hepatitis C Burden in Romania Evaluation 2018 Challenges Prof. Adrian Streinu-Cercel MD, PhD, HC Carol Davila University of Medicine and Pharmacy National Institute For Infectious Diseases, Prof. Dr. MATEI BALS. Bucharest, Romania

2 ROMANIA, HCV EPIDEMICS UPDATE Total population 20,121,641 persons (2011 Census) Prevalence: 3,3%, o 663,981 persons potentially infected with HCV 85% with potentially viral replication 99% from genotipe 1b infections (blood transfusion) o 563,406 potentially persons with active progressive disease Incidence: > 7,500 new cases of infection / year o 7,000-8,000 persons diagnosed with active disease / year Romania, top 20 worldwide regarding the number of HCV patients o 6,000 treated persons with DAA in 2016 (1.5%)

3 ROMANIA The prevalence of HBV, HCV and HIV infection in Romania - a nationwide screening program for surveillance of viral infections This study is part of the RO Project Strengthening the prevention and control of HIV/AIDS, HBV, HCV in Romania, financed by the Norway Financial Mechanism , Public Health Initiatives persons screened Median age 46 (IQR: 36, 57) years 62.7% females Oana Săndulescu /October nd Central and Eastern European Meeting on Viral Hepatitis and Co-Infection with HIV

4 Methods Nationwide screening program ( ) o HBsAg, anti-hcv, anti-hiv Confirmation and characterization of positive cases o HBV-DNA, HCV-RNA, HIV-RNA Risk factor assessment o Standardized paper-based questionnaire o Romanian population vs. international students Statistical analysis: IBM SPSS Statistics v.22 (Armonk, USA) A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

5 Romania... 4,9% 3,23% 4,4% Anuarul Statistic al României( Molnar G. Şi col., Bacteriologie, Virusologie, Parazitologie, epidemiologie 1994;30: Molnar G. Şi col., Bacteriologie, Virusologie, Parazitologie, epidemiologie 1994; 30: ; 2. Gheorghe L. şi col article in press 2009 Date obtinute din campaniile de testare , A Streinu-Cercel nepublicate

6 HCV testing Number of positive tests Total number of tests A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

7 HCV hotspots <2% 2-7% >=8% A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

8 Positive HCV tests 3.3% positive anti-hcv tests => 1.9% 60.7% of the positive tests had negative HCV-RNA 9 counties in Romania were HCV-free 14% 12% 12% 10% 10% 10% 9% 8% 8% 6% 7% 7% 7% 7% 7% 6% 6% 5% 5% 5% 4% 4% 4% 4% 3% 3% 4% 3% 3% 3% 3% 4% 3% 3% 2% 1% 1% 2% 2% 1% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

9 After screening in 2016 Vaccination decreased the incidence of HBV infection 21-fold persons screened o 7.7% positive HBsAg o 1.9% confirmed HCV infection o 0.4% positive HIV tests Targeted outreach programs in the identified hotspots A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

10 A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s Knowledge, attitudes and practices of the general population regarding HIV/AIDS, HBV&HCV Gender Age Average 46,5 y.o. Residence area Educational level Number of cases: 1005 Sample: general population

11 Disease awareness How can HCV/HBV be transmitted? 96,1% of respondents heard about hepatitis B 96,5% of respondents heard about hepatitis C 97% of respondents heard about HIV Number of cases: 1005/200 Sample: general population/idus A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

12 Have you ever went through screening for? 17,7% 37,4% of respondents were screened for hepatitis B/C of respondents were screened for HIV Hepatitis B/C HIV 85% of respondents were screened for hepatitis B/C 83% of respondents were screened for HIV Number of cases: 1005/200 Sample: general population/idus A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI s

13 Testing Campaign HCV Final Results -

14 OVERVIEW OF TESTING CAMPAIGN positive tested persons: 240 persons tested pozitive (2,0%) Testing campaigns in multiple locations: negative tested in HOSPITALS PERSONNEL (population at risk tested) (56%) Bacău, Bihor, București, Cluj, Constanța, Dolj, Galați, Iași, Mureș, Timiș tests on STREET Campaign (general population testing) (44%) Bihor, Botoșani, Brașov, București, Cluj, Constanța, Dolj, Galați, Iași, Mureș, Suceava STREET (general population) HOSPITALS (population at risk) Incidence > national average (3,3%) for general population 3,9% positive tests (202) during STREET Campaign 0,6% positive tests (38) during HOSPITAL PERSONNEL Campaign Source: INBIMB HOSPITALS (population at risk) STREET (general population)

15 2017 CAMPAIGN OVERVIEW tests 240 positive tests (2,0%) Total tests Positive Tests Satu Mare Salaj Bihor Cluj Maramures Bistrita Nasaud Botosani Suceava Iasi Neamt SUCEAVA ,0% BOTOȘANI ,1% BUCUREȘTI 4, ,9% CLUJ ,1% IAȘI 2, ,9% Timis Arad Hunedoara Alba Sibiu Mures Brasov Harghita Covasna Bacau Vrancea Vaslui Galati BIHOR ,9% CONSTANȚA ,0% Caras Severin Gorj Valcea Arges Prahova Dambovita Buzau Braila Tulcea MUREȘ ,0% TIMIȘ 1, ,7% Mehedinti Olt B Ialomita Calarasi DOLJ ,6% GALAȚI ,4% Dolj Teleorman Giurgiu Constanta BACĂU ,3% BRAȘOV ,0% Source: INBIMB > 2,0% > 1,0% <1,0%

16 male GENDER DISTRIBUTION tests => valid CNPs persons female (76%) persons male (24%) female female male female male HOSPITALS (population at risk) STREET (general population) Source: INBIMB

17 Source: INBIMB AGE DISTRIBUTION tests=> valid CNPs persons (64%) main segment (2.913 persons 28%) 46 years median age HOSPITALS (population at risk) STREET (general population)

18 2017 HOSPITALS PERSONNEL CAMPAIGN RESULTS tests Satu Mare Maramures Suceava Botosani 38 positive tests (0,6%) Total tests Positive results IAȘI ,1% TIMIȘ ,7% CONSTANȚA ,7% Timis Arad Bihor Salaj Cluj Alba Hunedoara Sibiu Bistrita Nasaud Mures Harghita Covasna Brasov Neamt Bacau Vrancea Iasi Vaslui Galati BIHOR ,5% GALAȚI ,4% CLUJ ,4% BUCUREȘTI ,4% BACĂU ,3% Caras Severin Gorj Mehedinti Dolj Valcea Olt Arges Prahova Dambovita B Giurgiu Teleorman Buzau Ialomita Calarasi Braila Tulcea Constanta MUREȘ ,0% DOLJ ,0% Source: INBIMB > 2,0% > 1,0% <1,0%

19 2017 STREET CAMPAIGN RESULTS tests 202 positive tests (3,9%) Total tests Positive results Satu Mare Salaj Bihor Cluj Maramures Bistrita Nasaud Botosani Suceava Iasi Neamt BIHOR ,1% DOLJ ,3% CONSTANȚA ,0% MUREȘ ,7% Timis Arad Hunedoara Alba Sibiu Mures Brasov Harghita Covasna Bacau Vrancea Vaslui Galati CLUJ ,5% SUCEAVA ,3% Caras Severin Gorj Valcea Arges Dambovita Prahova Buzau Braila Tulcea BUCUREȘTI ,3% Mehedinti B Ialomita BOTOȘANI ,2% IAȘI ,9% Dolj Olt Teleorman Giurgiu Calarasi Constanta GALAȚI ,0% BRAȘOV ,0% Source: INBIMB > 2,0% > 1,0% <1,0%

20 DAA Treated patients in Romania - More than patients treated with DAA - SVR obtained in 99%

21 UPDATE OF THE FRAMEWORK CONTRACT MOH & NATIONAL INSURANCE HOUSE HBsAg and HCV-ABs lab tests should be recommended by GPs for all listed patients

22 GENERAL PRACTITIONERS, A TURNING POINT IN HCV CONTROL General Practitioner Testing (HCV Ab and HBsAg testing) Patient referral to specialists for diagnosis confirmation and treatment initiation Patient management (including treatment adherence)

23 NATIONAL DISEASE REGISTRY, A KEY TOOL Customized menu for each user profile (levels access) Configurated alerts for each user profile/ level

24 CONCLUSIONS Development of National Testing Program o HCV testing in early phases of infection, o Eliminating HCV virus as a foundation of a cost-efficient approach Defining of National Prevention Standards o HCV and/or HBV infection can be 100% prevented o Action plan at GP and hospital level o General population education Development of a free access to treatment policy o o Elimination of access to treatment criteria Applying the principle first referral, first treated