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

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Hepatitis C Burden in Romania 2016-2017 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

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%)

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 19.02. Project Strengthening the prevention and control of HIV/AIDS, HBV, HCV in Romania, financed by the Norway Financial Mechanism 2009-2014, Public Health Initiatives. 12 000 persons screened Median age 46 (IQR: 36, 57) years 62.7% females Oana Săndulescu /October 2016 2nd Central and Eastern European Meeting on Viral Hepatitis and Co-Infection with HIV

Methods Nationwide screening program (2014-2016) 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 10.1186 s12879-016-1480-8

Romania... 4,9% 3,23% 4,4% Anuarul Statistic al României(http:// www.insse.ro/anuar%20200s/capitole/cap2.pdf Molnar G. Şi col., Bacteriologie, Virusologie, Parazitologie, epidemiologie 1994;30:141-149 Molnar G. Şi col., Bacteriologie, Virusologie, Parazitologie, epidemiologie 1994; 30:141-149; 2. Gheorghe L. şi col article in press 2009 Date obtinute din campaniile de testare 2014-2015, A Streinu-Cercel nepublicate

HCV testing Number of positive tests Total number of tests 178 71 28 914 5 6 56 183 0 8 42 3 10 734 6 199 69 2 25 0 38 0 190 3 26 410 43 633 1 50 23 24 2166 539 14 146 36 1120 29 450 0 36 13 385 7 129 62 6 106 3 62 2 46 3 29 0 9 200 1 45 3 33 4 105 0 65 34 663 6 81 0 57 30 2 30 111 0 4 17 1209 13 298 A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI 10.1186 s12879-016-1480-8

HCV hotspots <2% 2-7% >=8% A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI 10.1186 s12879-016-1480-8

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 10.1186 s12879-016-1480-8

After screening in 2016 Vaccination decreased the incidence of HBV infection 21-fold 12000 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 10.1186 s12879-016-1480-8

A Streinu-Cercel et all,bmc Infectious Diseases 2016, Volume 16 Suppl 3 DOI 10.1186 s12879-016-1480-8 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

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 10.1186 s12879-016-1480-8

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 10.1186 s12879-016-1480-8

Testing Campaign HCV 2017 - Final Results -

OVERVIEW OF TESTING CAMPAIGN positive 11.713 tested persons: 240 persons tested pozitive (2,0%) Testing campaigns in multiple locations: negative 6.556 tested in HOSPITALS PERSONNEL (population at risk tested) (56%) Bacău, Bihor, București, Cluj, Constanța, Dolj, Galați, Iași, Mureș, Timiș 5.157 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)

2017 CAMPAIGN OVERVIEW 11.713 tests 240 positive tests (2,0%) Total tests Positive Tests Satu Mare Salaj Bihor Cluj Maramures Bistrita Nasaud Botosani Suceava Iasi Neamt SUCEAVA 318 16 5,0% BOTOȘANI 96 3 3,1% BUCUREȘTI 4,907 140 2,9% CLUJ 331 7 2,1% IAȘI 2,636 49 1,9% Timis Arad Hunedoara Alba Sibiu Mures Brasov Harghita Covasna Bacau Vrancea Vaslui Galati BIHOR 216 4 1,9% CONSTANȚA 610 6 1,0% Caras Severin Gorj Valcea Arges Prahova Dambovita Buzau Braila Tulcea MUREȘ 209 2 1,0% TIMIȘ 1,000 7 0,7% Mehedinti Olt B Ialomita Calarasi DOLJ 512 3 0,6% GALAȚI 487 2 0,4% Dolj Teleorman Giurgiu Constanta BACĂU 318 1 0,3% BRAȘOV 73 0 0,0% Source: INBIMB > 2,0% > 1,0% <1,0%

male GENDER DISTRIBUTION 11.713 tests => 10.556 valid CNPs 8.028 persons female (76%) 2.528 persons male (24%) female female male female male HOSPITALS (population at risk) STREET (general population) Source: INBIMB

Source: INBIMB AGE DISTRIBUTION 11.713 tests=> 10.556 valid CNPs 6.708 persons 31-60 (64%) 41-50 main segment (2.913 persons 28%) 46 years median age HOSPITALS (population at risk) STREET (general population)

2017 HOSPITALS PERSONNEL CAMPAIGN RESULTS 6.556 tests Satu Mare Maramures Suceava Botosani 38 positive tests (0,6%) Total tests Positive results IAȘI 1.451 16 1,1% TIMIȘ 1.000 7 0,7% CONSTANȚA 588 4 0,7% Timis Arad Bihor Salaj Cluj Alba Hunedoara Sibiu Bistrita Nasaud Mures Harghita Covasna Brasov Neamt Bacau Vrancea Iasi Vaslui Galati BIHOR 200 1 0,5% GALAȚI 445 2 0,4% CLUJ 245 1 0,4% BUCUREȘTI 1.637 6 0,4% BACĂU 318 1 0,3% Caras Severin Gorj Mehedinti Dolj Valcea Olt Arges Prahova Dambovita B Giurgiu Teleorman Buzau Ialomita Calarasi Braila Tulcea Constanta MUREȘ 184 0 0,0% DOLJ 488 0 0,0% Source: INBIMB > 2,0% > 1,0% <1,0%

2017 STREET CAMPAIGN RESULTS 5.157 tests 202 positive tests (3,9%) Total tests Positive results Satu Mare Salaj Bihor Cluj Maramures Bistrita Nasaud Botosani Suceava Iasi Neamt BIHOR 16 3 23,1% DOLJ 24 3 14,3% CONSTANȚA 22 2 10,0% MUREȘ 25 2 8,7% Timis Arad Hunedoara Alba Sibiu Mures Brasov Harghita Covasna Bacau Vrancea Vaslui Galati CLUJ 86 6 7,5% SUCEAVA 318 16 5,3% Caras Severin Gorj Valcea Arges Dambovita Prahova Buzau Braila Tulcea BUCUREȘTI 3270 134 4,3% Mehedinti B Ialomita BOTOȘANI 96 3 3,2% IAȘI 1185 33 2,9% Dolj Olt Teleorman Giurgiu Calarasi Constanta GALAȚI 42 0 0,0% BRAȘOV 73 0 0,0% Source: INBIMB > 2,0% > 1,0% <1,0%

2016 2018 DAA Treated patients in Romania - More than 18 000 patients treated with DAA - SVR obtained in 99%

UPDATE OF THE FRAMEWORK CONTRACT 2018-2019 MOH & NATIONAL INSURANCE HOUSE HBsAg and HCV-ABs lab tests should be recommended by GPs for all listed patients

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)

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

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