1. Evaluation of Hepatitis B surveillance system in Armenia, 2014 AUTHORS Karine Gevorgyan Lusine Paronyan Shushan Sargsyan Artavazd Vanyan NCDC, Armenia Funded by the European Union The LOGO of your institute and/ or the funders of the Investigation (if any)

2. Burden of Hepatitis B and C diseases Infections are causes of acute and chronic hepatitis worldwide Health and social problem due to limited access to treatment and absence of robust data Significant burden to healthcare system due to high morbidity and mortality Diagnosis of HCC and cirrhosis are posthumously without defining hepatitis as the reason Funded by the European Union The LOGO of your Institute

3. Background - ARMENIA Intermediate endemic region of HBV. Genotype D of hepatitis B virus is circulating in 96% of all cases More than 20% of patients with HBV cirrosis had revealed HDV positive markers Data-morbidity rates in 2014 (HIV - 11.6): - HBV - 4.9 - HCV - 5.7 - hepatocellular carcinoma -9.9 Funded by the European Union The LOGO of your Institute

4. The goal and objectives of the study To evaluate the surveillance system of Hepatitis B in Armenia To make recommendations on improving surveillance system, to enhance it’s effectiveness and usefulness Funded by the European Union The LOGO of your Institute

5. Methods The updated guidelines of the CDC(2001) were used Population-based surveillance data including monthly and annual recording and reporting forms were analyzed Funded by the European Union The LOGO of your Institute

6. Information flow Data collected in NCDC branches Integrated Epid. surveillance and risk menegment department NCDC Non infectious and nosocomial diseases epidemiology department NCDC MOH RA M F Laboratory in regions M F Laboratory in Yerevan 6

7. Case definition of hepatitis B Acute HBV infection Positive HBs-Ag and IgM antibody to the core antigen (HBc-Ag) if done. In initial phase of infection seropositive for antigen (HBe-Ag), marker of high level of replication of the virus Chronic HBV infection Positive HBs-Ag or HBe-Ag for at least 6 months Hepatitis B virus nucleic acid testing, HBV NAT (including genotype) result does not require an acute clinical presentation to meet the surveillance case definition Funded by the European Union The LOGO of your Institute

8. Distribution of Hepatitis cases, Armenia, 2014 Funded by the European Union The LOGO of your Institute

9. Results: simplicity System is passive, case-based, not simple - for the diagnosis at least 2 tests are needed (HBs-Ag and IgM Anti-HB core) Reporting system is different for acute and chronic cases Analysis of the data occurs at the central level (without feedback) Funded by the European Union The LOGO of your Institute

10. Results: flexibility The system is not flexible - reporting forms consist data on: a. Acute Hepatitis total b. Hepatitis A c. Hepatitis B acute Other viral Hepatitis and co-infections are presented in additional reporting form only Funded by the European Union The LOGO of your Institute

11. Acute and Chronic Hepatitis B reporting forms Monthly reporting form Hepatitis total Hepatitis A (B15) Hepatitis B (B16) acute Annual reporting form Hepatitis total Hepatitis A (B15) Hepatitis B (B16) acute Hepatitis B (B18.0-B18.1)chronic Hepatitis C (B17.1) acute Hepatitis C (B18.2) chronic Hepatitis E (B17.2) acute Hepatitis (B19)uncertain etiology Co-infections (B+C), (B+HIV), (C+HIV), (B+TBC), (C+TBC)

12. Results: Timeliness and Representativeness The system is timely for acute diseases, reporting every month, reporting of chronic cases – annually The system is partially representative (reported from 14 branches, covering all population) Private hospitals and laboratories do not always inform Few data screening, not all professional groups and patients included in the mandatory screening program In 2014 only 1066 HIV-patients examined on Hepatitis B Funded by the European Union The LOGO of your Institute

13. Results: Acceptability System is not acceptable – though notification forms with 19 variables filled out 89%, no data on epidemiological links No demographic data on patients in risk group with co-infection (positive result - 6 from 1066 with HIV), these cases were not included in database Case definition is acceptable only in areas with laboratory capacities for both: HBs-Ag and anti-HB- core detection Funded by the European Union The LOGO of your Institute

14. Results: Acceptability Laboratory capacities in regions and Yerevan/ Incidence Rate Funded by the European Union The LOGO of your Institute

15. Results: Predictive positive value Laboratory confirmed 52% of all suspected cases But data of PPV by regions are different: - Shirak region - 26% - Syunik region - 95% For all HBs-Ag positive cases /chromatographic immunoassay/ 86% of results were positive also on the ELISA Funded by the European Union The LOGO of your Institute

16. Results: Sensitivity Evaluation of sensitivity requires additional information from other sources (statistics of cancer, hepatocellular carcinoma and cirrhosis ) The system usually detects Hepatitis B cases with clinical manifestation (30-50% of all cases) Data of screening in risk groups aren't included in database Funded by the European Union The LOGO of your Institute

17. Results: Sensitivity Funded by the European Union The LOGO of your Institute 52% of all Hepatitis B cases initially reported as a chronic (64 from 122) HCV - 78% of all Hepatitis C cases initially reported as a chronic (164 from 210)

18. Results: Sensitivity The case definition is not consistently applied Standard operating protocols for case definition and interpretation of laboratory data are not always available Often the test is performed only on the HBs-Ag, but chronic Hepatitis B with low viral replication shows the negative result Funded by the European Union The LOGO of your Institute

19. Interpretation of laboratory results HBs Ag Anti-HBs Anti-HBc ______ “B”Hepatitis negative HBs Ag Anti-HBc Anti-HBs -++ -++ Immunity, after disease HBs Ag Anti-HBc Anti-HBs --+--+ Immunity, after vaccination HBs Ag Anti-HBc Anti-HBc Ig M Anti-HBs HBV DNA +++-++++-+ Acute viral hepatitis Chronic hepatitis active phase HBs Ag Anti-HBc Anti-HBs HBV DNA -+-+-+-+ Unclear interpretation Or- а) early recovery of acute ”B’’ b) false- positive PCR c) low -level chronic B HBs Ag Anti-HBc Anti-HBs HBV DNA -+---+-- Recovery Funded by the European Union The LOGO of your Institute

20. Usefullness of surveillance system Since 1999 in Armenia– vaccination of children and some professional groups Funded by the European Union The LOGO of your Institute

21. Recommendations: Implement of research projects in risk groups Obtain data from private laboratories Mandatory standard case definitions for all Medical facilities Improve laboratory capacities in regions Implement education programs for medical personnel Funded by the European Union The LOGO of your Institute

22. Acknowledgments NCDC, Armenia SC/FLTEP, Georgia MediPIET Funded by the European Union The LOGO of your Institute