Background The country of Georgia launched the world’s first Hepatitis C Virus (HCV) Elimination Program in 2015 and set a 90% prevalence reduction goal for 2020. We conducted a nationally representative HCV seroprevalence survey to establish baseline prevalence to measure progress toward elimination over time. Methods A cross-sectional seroprevalence survey was conducted in 2015 among adults aged ≥18 years using a stratified, multi-stage cluster design ( n = 7000). Questionnaire variables included demographic, medical, and behavioral risk characteristics and HCV-related knowledge. Blood specimens were tested for antibodies to HCV (anti-HCV) and HCV RNA. Frequencies were computed for HCV prevalence, risk factors, and HCV-related knowledge. Associations between anti-HCV status and potential risk factors were calculated using logistic regression. Results National anti-HCV seroprevalence in Georgia was 7.7% (95% confidence interval (CI) = 6.7, 8.9); HCV RNA prevalence was 5.4% (95% CI = 4.6, 6.4). Testing anti-HCV+ was significantly associated with male sex, unemployment, urban residence, history of injection drug use (IDU), incarceration, blood transfusion, tattoos, frequent dental cleanings, medical injections, dialysis, and multiple lifetime sexual partners. History of IDU (adjusted odds ratio (AOR) = 21.4, 95% CI = 12.3, 37.4) and blood transfusion (AOR = 4.5, 95% CI = 2.8, 7.2) were independently, significantly associated with testing anti-HCV+ after controlling for sex, age, urban vs. rural residence, and history of incarceration. Among anti-HCV+ participants, 64.0% were unaware of their HCV status, and 46.7% did not report IDU or blood transfusion as a risk factor. Conclusions Georgia has a high HCV burden, and a majority of infected persons are unaware of their status. Ensuring a safe blood supply, implementing innovative screening strategies beyond a risk-based approach, and intensifying prevention efforts among persons who inject drugs are necessary steps to reach Georgia’s HCV elimination goal.

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Abstract Background Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies. Methods Two lots of 13 RDTs were evaluated at three laboratories using archived plasma samples from four countries (Nigeria, Georgia, Cambodia, Belgium). HCV status was determined using three reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV infected and HIV uninfected populations. Operational characteristics were also assessed. Results In total, 1,710 samples met inclusion criteria. In HIV uninfected samples (n=384), the majority of RDTs had sensitivity ≥98% in one or both lots and most RDTs had specificity ≥99%. In HIV infected samples (n=264), specificity remained high, but sensitivity was markedly lower than in HIV uninfected samples; only one RDT reached >95%. The majority of HIV infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Inter-reader variability, lot-to-lot variability and rate of invalid runs were low for all RDTs (<2%). Conclusion HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status.

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BACKGROUND In April 2015, the government of Georgia (country) initiated the worldʼs first national hepatitis C elimination program. An analysis of blood donor infectious screening data was conducted to inform a strategic plan to advance blood transfusion safety in Georgia. STUDY DESIGN AND METHODS Descriptive analysis of blood donation records (2015‐2017) was performed to elucidate differences in demographics, donor type, remuneration status, and seroprevalence for infectious markers (hepatitis C virus antibody [anti‐HCV], human immunodeficiency virus [HIV], hepatitis B virus surface antigen [HBsAg], and Treponema pallidum). For regression analysis, final models included all variables associated with the outcome in bivariate analysis (chi‐square) with a p value of less than 0.05. RESULTS During 2015 to 2017, there were 251,428 donations in Georgia, representing 112,093 unique donors; 68.5% were from male donors, and 51.2% of donors were paid or replacement (friends or family of intended recipient). The overall seroprevalence significantly declined from 2015 to 2017 for anti‐HCV (2.3%‐1.4%), HBsAg (1.5%‐1.1%), and T. pallidum (1.1%‐0.7%) [p < 0.0001]; the decline was not significant for HIV (0.2%‐0.1%). Only 41.0% of anti‐HCV seropositive donors underwent additional testing to confirm viremia. Infectious marker seroprevalence varied by age, sex, and geography. In multivariable analysis, first‐time and paid donor status were associated with seropositivity for all four infectious markers. CONCLUSION A decline during the study period in infectious markers suggests improvement in blood safety in Georgia. Areas that need further improvement are donor recruitment, standardization of screening and diagnostic follow‐up, quality assurance, and posttransfusion surveillance.