Global reform of blood transfusion services is underway in the country of Georgia. New legislation mandates exclusive collection of blood from non-remunerated blood donors in Georgia by July 2025. Retrospective data (2018-2023) from the National Blood Donor Registry were analyzed. The prevalence was calculated for human immunodeficiency virus (HIV) antigen/antibody (Ag/Ab), hepatitis C virus antibody (anti-HCV), hepatitis B surface antigen (HBsAg). Results were stratified by remuneration status and mode of donation. Descriptive analysis was performed to elucidate differences in positivity by year and donor type. During 2018-2023, there were a total of 548,530 donations from 221,492 blood donors in Georgia; 68.3 % of donors were male and the median age was 34 years (interquartile range: 2644). Overall, 17.0 % were paid, 24.9 % were replacement, 47.4 % were voluntary non-remunerated blood donors (VNRBD), and 10.7 % had ≥ 2 donations of varying remuneration type. Paid donors had an average of 2.5 donations per year, compared to 1.0 for replacement, and 1.1 for VNRBDs. During 2018-2023, the proportions of paid donors decreased (38.8-22.1 %); the proportions of replacement (19.1-26.0 %) and VNRBDs (38.7-48.3 %) increased. Among first-time donors, prevalence decreased during 2018-2023 for anti-HCV (2.0-0.9 %) but were stable for HBsAg (range: 1.9 %-2.1 %) and anti-HIV (range: 0.1 %-0.2 %). Among repeat donors, prevalence of anti-HCV decreased (from 0.3 % to 0.2 %) while rates were stable for anti-HIV (0.04 %-0.1 %), and HBsAg (0.1 % in all years). The findings underscore the importance of donor retention in concert with efforts to attain exclusive VNRBD.

Zanzibar, a low-resource semiautonomous region of Tanzania, has an estimated prevalence of hepatitis B virus (HBV) infections of 3.6%. To assess the feasibility of care and treatment, a 5-year hepatitis B demonstration project was implemented in Zanzibar during January 2017-December 2021, following the 2015 WHO HBV care and treatment guidelines. Participants included adults (aged ≥ 18 years) who tested positive for HBV surface antigen and tested negative for HIV and hepatitis C antibody. Participants were examined for clinical signs of liver disease and testing was conducted at baseline to assess treatment eligibility and every 6-12 months thereafter. Tenofovir disoproxil fumarate (TDF) was provided at no cost to treatment-eligible participants. Clinical and laboratory data were analysed to assess improvement in proximal disease outcomes. Among 596 participants enrolled, the median age was 32 years (IQR 26-39) and 365 (61%) were male. Of those enrolled, 268 (45%) returned for ≥ 1 follow-up visit, with a median of 511 days of follow-up. Overall, 58 patients initiated treatment: 15 met treatment criteria based on liver cirrhosis alone; 13 by APRI > 1.5; among those with HBV DNA results, six met criteria based on HBV DNA levels and ALT activity; 24 met ≥ 2 criteria. Significant decreases in ALT activities, APRI scores and HBV DNA levels were observed among those treated. This hepatitis B care and treatment programme was demonstrated to be feasible in a low-resource setting. Despite challenges, testing and linkage to care is critical to decrease the global burden of hepatitis B.

BACKGROUND AND OBJECTIVES: Blood donor cohorts are an underappreciated resource for surveillance and public health programming for infectious diseases. The incidence of hepatitis C virus (HCV) infection was evaluated in repeat blood donors in Georgia. MATERIALS AND METHODS: Using data from the national hepatitis C screening registry, we calculated overall hepatitis C incidence for 2017-2023 and annual incidence during 2017-2022 among adults who donated blood at least twice and had a nonreactive HCV antibody (anti-HCV) test result upon first screening and a subsequent anti-HCV test conducted in any location. Rates of anti-HCV seroconversion and current infection were calculated by year, sex, age group, and location of last HCV screening and expressed per 100,000 person-years (PY). RESULTS: Of 101,443 blood donors with ≥2 anti-HCV results,775 (0.8%) seroconverted to anti-HCV reactive, of whom 403 (52.0%) had current infection. Incidence of anti-HCV seroconversion decreased from 408 per 100,000 PY in 2017 to 218 per 100,000 PY in 2022 and incidence of infection decreased from 172 per 100,000 PY in 2017 to 118 per 100,000 PY in 2022. Males, persons aged 18-39 years, and people last tested for HCV in prisons had the highest incidence rates for anti-HCV seroconversion and HCV infection, while persons last screened in blood banks and during antenatal care had the lowest. CONCLUSION: Despite the observed decline, incidence of HCV infection among repeat blood donors remains high in specific subgroups. Hepatitis C prevention, screening and treatment interventions need to particularly focus on incarcerated populations and young adults in Georgia.

A nationwide serosurvey among adults in 2021 showed a 2.7% (95% confidence interval [CI]: 2.3%-3.4%) prevalence of hepatitis B. Our analysis evaluates knowledge, attitudes and practices (KAP) for hepatitis B virus (HBV) infection among primary healthcare physicians (PHPs) in Georgia. We randomly selected 550 PHPs from medical facilities in Georgia's six largest cities. Using bivariate ordinal regression, we assessed the association of socio-demographic factors with an ordinal knowledge score (low/middle/high). Multivariable logistic regression was performed to calculate adjusted odds ratios (aOR) and 95% CI to determine associations between HBV knowledge score and practices. Of 550 selected PHPs, 506 (92.0%) agreed to participate. Among them, 62.8% scored in the medium or high knowledge tertiles, 72.7% were confident in diagnosing HBV infection, 37.3% were confident in managing patients with hepatitis B; 47.4% reported being screened for and 26.2% reported being vaccinated against HBV infection. Compared to those with low knowledge scores, PHPs with a high score were less likely to recommend activities not supported by evidence, such as: the use of 'hepatoprotective' medications (aOR 0.43, 95% CI 0.25-0.73), caesarean sections (aOR 0.47, 95% CI 0.27-0.82) and withholding breastfeeding (aOR 0.57, 95% CI 0.34-0.96) to prevent HBV transmission. The majority of PHPs were confident in diagnosing HBV infection, but only one in three were confident in managing patients with hepatitis B. PHPs with higher HBV knowledge were less likely to provide inaccurate instructions to their patients. These findings will help to develop awareness and education campaigns supporting HBV elimination in Georgia.

BACKGROUND: Hepatitis C virus (HCV) infection can lead to a type of primary liver cancer called hepatocellular carcinoma (HCC). Georgia, a high HCV prevalence country, started an HCV elimination program in 2015. In addition to tracking incidence and mortality, surveillance for the HCV-attributable fraction of HCC is an important indicator of the program's impact. This study assesses HCV infection-attributable HCC in the Georgian population. METHODS: This case-control study utilized HCV programmatic and Georgian Cancer Registry data from 2015-2019. Bivariate logistic regression and age- and sex-stratified analyses assessed HCV and liver cancer association. HCV-attributable liver cancer proportions for the HCV-exposed and total population were calculated. A sub-analysis was performed for HCC cases specifically. RESULTS: The total study population was 3874 with 496 liver cancer cases and 3378 controls. The odds for HCV-infected individuals developing liver cancer was 20.1 (95% confidence interval [CI] 15.97-25.37), and the odds of developing HCC was 16.84 (95% CI 12.01-23.83) compared to the HCV-negative group. Odds ratios varied across strata, with HCV-infected older individuals and women having higher odds of developing both liver cancer and HCC. A large proportion of liver cancer and HCC can be attributed to HCV in HCV-infected individuals; however, in the general population, the burden of liver cancer and HCC cannot be explained by HCV alone. CONCLUSION: HCV was significantly associated with a higher risk of developing liver cancer and HCC in the Georgian population. In addition, given Georgia's high HCV burden, increased HCC monitoring in HCV-infected patients is needed.

Hepatitis B and hepatitis C are leading causes of cirrhosis and liver cancer and caused 1.3 million deaths worldwide in 2022. Hepatitis B is preventable with vaccination, and hepatitis C is curable with direct-acting antivirals. In 2015, in collaboration with CDC and other partners, Georgia, a country at the intersection of Europe and Asia, launched a hepatitis C elimination program to reduce the prevalence of chronic hepatitis C; at that time, the prevalence was 5.4%, more than five times the global average of 1.0%. In 2016, the World Health Assembly endorsed a goal for the elimination of viral hepatitis as a public health problem by 2030. In 2024, 89% of the Georgian adult population have received screening for hepatitis C, 83% of persons with current chronic HCV infection have received a diagnosis, and 86% of those with diagnosed hepatitis C have started treatment. During 2015-2023, vaccination coverage with the hepatitis B birth dose and with 3 doses of hepatitis B vaccine among infants exceeded 90% for most years. In 2021, the prevalence of hepatitis B surface antigen was 0.03% among children and adolescents aged 5-17 years and 2.7% among adults. Georgia has demonstrated substantial progress toward hepatitis B and hepatitis C elimination. Using lessons from the hepatitis C elimination program, scale-up of screening and treatment for hepatitis B among adults would prevent further viral hepatitis-associated morbidity and mortality in Georgia and would accelerate progress toward hepatitis B and hepatitis C elimination by 2030.

Background: Individuals receiving hemodialysis for end-stage kidney disease are at increased risk of infection with hepatitis C virus (HCV) and hepatitis B virus (HBV) due to regular and frequent receipt of invasive medical treatment in a shared space. Aim: This study assessed infection prevention and control practices in dialysis facilities, evaluated HCV and HBV testing practices, and estimated the number of cases of seroconversion for HCV and HBV infection in dialysis facilities in Georgia. Methods: We invited all 27 dialysis centers that provide maintenance dialysis in Georgia to participate in a facility-based survey during April–June 2021. Results: In total, 68.2% (n = 15/22) of facilities performed anti-HCV screening upon admission to the center. At the majority of facilities (n = 21/22, 95.5%), HBV screening was performed upon admission to the center. A total of 329 anti-HCV positive patients were reported from 20 of 22 facilities, 29.5% (n = 97/329) were HCV RNA positive, 18.2% (n = 60/329) were HCV RNA negative, and 52.3% (n = 172/329) were not tested or their result was missing. Overall, 200 HBsAg-positive patients were reported from the same 20 facilities. At 10 facilities: 39 patients from seven facilities seroconverted for HCV infection, and 31 patients from eight dialysis facilities seroconverted for HBV infection. Conclusions: We identified a high number of HBV and HCV seroconversions among dialysis patients in Georgia suggesting serious gaps in infection control practices. Strict adherence to infection prevention and control practices is essential to prevent transmission of HCV and HBV infections through contaminated equipment and surfaces. © The Author(s) 2024.

BACKGROUND: The country of Georgia initiated its hepatitis C virus (HCV) elimination program in 2015, at which point a serosurvey showed the adult prevalence of HCV antibody (anti-HCV) and HCV RNA to be 7.7% and 5.4%, respectively. This analysis reports hepatitis C results of a follow-up serosurvey conducted in 2021, and progress towards elimination. METHODS: The serosurvey used a stratified, multistage cluster design with systematic sampling to include adults and children (aged 5-17 years) providing consent (or assent with parental consent). Blood samples were tested for anti-HCV and if positive, HCV RNA. Weighted proportions and 95% confidence intervals (CI) were compared with 2015 age-adjusted estimates. RESULTS: Overall, 7237 adults and 1473 children were surveyed. Among adults, the prevalence of anti-HCV was 6.8% (95% CI, 5.9-7.7). The HCV RNA prevalence was 1.8% (95% CI, 1.3-2.4), representing a 67% reduction since 2015. HCV RNA prevalence decreased among those reporting risk factors of ever injecting drugs (51.1% to 17.8%), and ever receiving a blood transfusion (13.1% to 3.8%; both P < .001). No children tested positive for anti-HCV or HCV RNA. CONCLUSIONS: These results demonstrate substantial progress made in Georgia since 2015. These findings can inform strategies to meet HCV elimination targets.

In 2016, World Health Organization (WHO) introduced global targets for the care and management of hepatitis C virus (HCV) infection to eliminate hepatitis C as a public health threat by 2030. Despite significant improvements in testing and treatment, in 2020 only 23% of all persons infected with HCV globally were diagnosed. We explore examples from global hepatitis C programs in Georgia, Rwanda, and Nigeria that have used decentralized and integrated models to increase access to HCV testing. Georgia established the world's first national hepatitis C elimination program in 2015. In 2022, 2.6 million people (80% of the adults) have been screened for antibodies for HCV infection, and 80,000 persons with HCV virus detected were treated. To achieve these results, Georgia implemented HCV core antigen (HCVcAg) testing, utilization of point-of-care HCV RNA, and simplification of HCV viremia detection by qualitative HCV RNA. Rwanda was the first country in sub-Saharan Africa to commit to HCV elimination in 2018, and as of 2022 it has achieved its screening target of 7 million people and initiated approximately 60,000 patients on hepatitis C treatment by rapid decentralization and integration of HCV services. In Nigeria, the integrated near-point-of-care testing approach in Nasarawa state has been effective in expanding access to HCV viremia testing and enabling the possibility of same-day testing and treatment initiation. Examples of decentralization and integration of HCV testing and linkage to care in Georgia, Rwanda and Nigeria could help inform effective strategies to reach 2030 hepatitis C elimination goals in other countries.

BackgroundGeorgia has adopted the World Health Organization European Region's and global goals to eliminate viral hepatitis. A nationwide serosurvey among adults in 2015 showed 2.9% prevalence for hepatitis B virus (HBV) surface antigen (HBsAg) and 25.9% for antibodies against HBV core antigen (anti-HBc). HBV infection prevalence among children had previously not been assessed.AimWe aimed to assess HBV infection prevalence among children and update estimates for adults in Georgia.MethodsThis nationwide cross-sectional serosurvey conducted in 2021 among persons aged ≥ 5 years used multi-stage stratified cluster design. Participants aged 5-20 years were eligible for hepatitis B vaccination as infants. Blood samples were tested for anti-HBc and, if positive, for HBsAg. Weighted proportions and 95% confidence intervals (CI) were calculated for both markers.ResultsAmong 5-17 year-olds (n = 1,473), 0.03% (95% CI: 0-0.19) were HBsAg-positive and 0.7% (95% CI: 0.3-1.6) were anti-HBc-positive. Among adults (n = 7,237), 2.7% (95% CI: 2.3-3.4) were HBsAg-positive and 21.7% (95% CI: 20.4-23.2) anti-HBc-positive; HBsAg prevalence was lowest (0.2%; 95% CI: 0.0-1.5) among 18-23-year-olds and highest (8.6%; 95% CI: 6.1-12.1) among 35-39-year-olds.ConclusionsHepatitis B vaccination in Georgia had remarkable impact. In 2021, HBsAg prevalence among children was well below the 0.5% hepatitis B control target of the European Region and met the ≤ 0.1% HBsAg seroprevalence target for elimination of mother-to-child transmission of HBV. Chronic HBV infection remains a problem among adults born before vaccine introduction. Screening, treatment and preventive interventions among adults, and sustained high immunisation coverage among children, can help eliminate hepatitis B in Georgia by 2030.

BackgroundBetween May 2015 and February 2022, 77,168 hepatitis C virus (HCV)-infected people in Georgia have been treated through an HCV elimination programme. To project the programme's long-term impacts, an HCV infection model was initially developed, based on data from surveys among people who inject drugs and a national serosurvey in 2015.AimAccounting for follow-up surveys in 2021, we validate and update projections of HCV infection prevalence and incidence.MethodWe assessed the initial model projections' accuracy for overall prevalence, by age, sex, and among people who ever injected drugs, compared with 2021 serosurvey data. We used 2021 results to weight model fits and to recalculate the national programme's impact leading up to March 2022 on HCV infection incidence rates. Cases and deaths averted were estimated. The impact of reduced treatment rates during the COVID-19 pandemic was assessed.ResultsThe original model overpredicted adult (≥ 18 years old) chronic HCV infection prevalence for 2021 (2.7%; 95% credible interval (CrI): 1.9-3.5%) compared with a 2021 serosurvey (1.8%; 95% confidence interval (CI): 1.3-2.4%). Weighted model projections estimated a 60% decrease in HCV infection incidence by March 2022, with an absolute incidence of 66 (95% CrI: 34-131) per 100,000 person-years (overall population). Between May 2015 and March 2022, 9,186 (95% CrI: 5,396-16,720) infections and 842 (95% CrI: 489-1,324) deaths were averted. The COVID-19 pandemic resulted in 13,344 (95% CrI: 13,236-13,437) fewer treatments and 438 (95% CrI: 223-744) fewer averted infections by March 2022.ConclusionResults support the programme's high effectiveness. At current treatment rate (406/month), 90% reductions in prevalence and incidence in Georgia are achievable by 2030.

Background and Aims Georgia has one of the highest hepatitis C virus (HCV) prevalence rates in the world, with &gt;5% of the adult population (~150,000 people) chronically infected. In April 2015, the Georgian government, in collaboration with CDC and other partners, launched a national program to eliminate HCV through scaling up HCV treatment and prevention interventions, with the aim of achieving a 90% reduction in prevalence by 2020. We evaluate the interim impact of the HCV treatment program as of 31 October 2017, and assess the feasibility of achieving the elimination goal by 2020.Method We developed a dynamic HCV transmission model to capture the current and historical epidemic dynamics of HCV in Georgia, including the main drivers of transmission. Using the 2015 national sero-survey and prior surveys conducted among people who inject drugs (PWID) from 1997-2015, the model was calibrated to data on HCV prevalence by age, gender and PWID status, and the age distribution of PWID. We use the model to project the interim impact of treatment strategies currently being undertaken as part of the ongoing Georgia HCV elimination program, while accounting for treatment failure/loss to follow up, in order to determine whether they are on track to achieving their HCV elimination target by 2020, or whether strategies need to be modified to ensure success.Results A treatment rate of 2,050 patients/month was required from the beginning of the national program to achieve a 90% reduction in prevalence by the end of 2020, with equal treatment rates of PWID and the general population. From May 2015 to October 2017, 40,420 patients were treated, an average of ~1,350 per month; although the treatment rate has recently declined from a peak of 4,500/month in September 2016 to 2100/month in November-December 2016, and 1000/month in August-October 2017, with a sustained virological response rate (SVR) of 98% per-protocol or 78% intent to treat. The model projects that the treatments undertaken up to October 2017 have reduced adult chronic prevalence by 26% (18-35%) to 3.7% (2.9-5.1%), reduced total incidence by 25% (15-35%), and prevented 1845 (751-3969) new infections and 93 (31-177) HCV-related deaths. If the treatment rate of 1000 patients initiated per month continues, prevalence will have halved by 2020, and reduce by 90% by 2026. In order to reach a 90% reduction by 2020, the treatment rate must increase 3.5-fold to 4000/month.Conclusion The Georgia HCV elimination program has accomplished an impressive scale up of treatment, which has already impacted on prevalence and incidence, and averted deaths due to HCV. However, extensive scale up is needed to achieve a 90% reduction in prevalence by 2020.

Background: The Eastern European country of Georgia initiated a nationwide hepatitis C virus (HCV) elimination program in 2015 to address a high burden of infection. Screening for HCV infection through antibody testing was integrated into multiple existing programs, including the National Tuberculosis Program (NTP). We sought to evaluate loss to follow-up (LTFU) from the hepatitis C care cascade among persons diagnosed with active tuberculosis (TB) disease. Method(s): Using national ID numbers, we merged databases of the HCV elimination program, NTP, and national death registry from January 1, 2015, to September 30, 2020. We estimated the proportion of patients with and without TB who were LTFU at each step of the HCV care cascade and explored temporal changes. Result(s): Among 11,985 patients with active TB, 9,065 (76%) were tested for HCV antibodies, and 1,665 (18%) had a positive result; LTFU from hepatitis C care was common, with 20% of patients with a positive antibody test not undergoing viremia testing, and 43% of patients with viremia not starting treatment for hepatitis C. Overall, among persons with confirmed viremic HCV infection, only 28% of patients with TB had a documented cure from HCV infection, compared to 55% among patients without TB. LTFU after positive antibody testing substantially decreased in the last three years, from 32% among patients diagnosed with TB in 2017 to 12% among those diagnosed in 2019. Conclusion(s): LTFU from hepatitis C care after a positive antibody or viremia test was high and more common among patients with TB than in those without TB. Better integration of TB and hepatitis C care systems can potentially reduce LTFU and improve patient outcomes. Existing large-scale programs for both TB and hepatitis C in Georgia create a unique opportunity for such integration to contribute to hepatitis C elimination efforts. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.

BACKGROUND: The Eastern European country of Georgia initiated a nationwide hepatitis C virus (HCV) elimination program in 2015 to address a high burden of infection. Screening for HCV infection through antibody testing was integrated into multiple existing programs, including the National Tuberculosis Program (NTP). We sought to compare the hepatitis C care cascade among patients with and without tuberculosis (TB) diagnosis in Georgia between 2015 and 2019 and to identify factors associated with loss to follow-up (LTFU) in hepatitis C care among patients with TB. METHODS AND FINDINGS: Using national ID numbers, we merged databases of the HCV elimination program, NTP, and national death registry from January 1, 2015 to September 30, 2020. The study population included 11,985 adults (aged ≥18 years) diagnosed with active TB from January 1, 2015 through December 31, 2019, and 1,849,820 adults tested for HCV antibodies between January 1, 2015 and September 30, 2020, who were not diagnosed with TB during that time. We estimated the proportion of patients with and without TB who were LTFU at each step of the HCV care cascade and explored temporal changes. Among 11,985 patients with active TB, 9,065 (76%) patients without prior hepatitis C treatment were tested for HCV antibodies, of which 1,665 (18%) had a positive result; LTFU from hepatitis C care was common, with 316 of 1,557 (20%) patients with a positive antibody test not undergoing viremia testing and 443 of 1,025 (43%) patients with viremia not starting treatment for hepatitis C. Overall, among persons with confirmed viremic HCV infection, due to LTFU at various stages of the care cascade only 28% of patients with TB had a documented cure from HCV infection, compared to 55% among patients without TB. LTFU after positive antibody testing substantially decreased in the last 3 years, from 32% among patients diagnosed with TB in 2017 to 12% among those diagnosed in 2019. After a positive HCV antibody test, patients without TB had viremia testing sooner than patients with TB (hazards ratio [HR] = 1.46, 95% confidence intervals [CI] [1.39, 1.54], p < 0.001). After a positive viremia test, patients without TB started hepatitis C treatment sooner than patients with TB (HR = 2.05, 95% CI [1.87, 2.25], p < 0.001). In the risk factor analysis adjusted for age, sex, and case definition (new versus previously treated), multidrug-resistant (MDR) TB was associated with an increased risk of LTFU after a positive HCV antibody test (adjusted risk ratio [aRR] = 1.41, 95% CI [1.12, 1.76], p = 0.003). The main limitation of this study was that due to the reliance on existing electronic databases, we were unable to account for the impact of all confounding factors in some of the analyses. CONCLUSIONS: LTFU from hepatitis C care after a positive antibody or viremia test was high and more common among patients with TB than in those without TB. Better integration of TB and hepatitis C care systems can potentially reduce LTFU and improve patient outcomes both in Georgia and other countries that are initiating or scaling up their nationwide hepatitis C control efforts and striving to provide personalized TB treatment.

BACKGROUND: Mortality related to hepatitis C virus (HCV) infection is a key indicator for elimination. We assessed the impact of HCV infection and treatment on mortality in the country of Georgia during 2015-2020. METHODS: We conducted a population-based cohort study using data from Georgia's national HCV Elimination Program and death registry. We calculated all-cause mortality rates in six cohorts: 1) Negative for anti-HCV; 2) anti-HCV positive, unknown viremia status; 3) current HCV infection and untreated; 4) discontinued treatment; 5) completed treatment, no SVR assessment; 6) completed treatment and achieved SVR. Cox proportional hazards models were used to calculate adjusted hazards ratios and confidence intervals. We calculated the cause-specific mortality rates attributable to liver-related causes. RESULTS: After a median follow-up of 743 days, 100,371 (5.7%) of 1,764,324 study participants died. The highest mortality rate was observed among HCV infected patients who discontinued treatment (10.62 deaths per 100 PY, 95%CI: 9.65, 11.68), and untreated group (10.33 deaths per 100 PY, 95%CI: 9.96, 10.71). In adjusted Cox proportional hazards model, the untreated group had almost six-times higher hazard of death compared to treated groups with or without documented SVR (aHR=5.56, 95%CI: 4.89, 6.31). Those who achieved SVR had consistently lower liver-related mortality compared to cohorts with current or past exposure to HCV. CONCLUSION: This large population-based cohort study demonstrated the marked beneficial association between hepatitis C treatment and mortality. The high mortality rates observed among HCV infected and untreated persons highlights the need to prioritize linkage to care and treatment to achieve elimination goals.

BACKGROUND: In 2015, the country of Georgia initiated its hepatitis C virus (HCV) elimination program. Given a high background incidence of HCV infection, centralized nucleic acid testing (NAT) of blood donations was prioritized for implementation. STUDY DESIGN AND METHODS: Multiplex NAT screening for HIV, HCV and hepatitis B virus (HBV) was launched in January 2020. An analysis was conducted of serological and NAT donor/donation data for the first year of screening (through December 2020). RESULTS: A total of 54,116 donations representing 39,164 unique donors were evaluated. Overall, 671 donors (1.7%) tested positive for at least one infectious marker by serology or NAT, with the highest prevalence among donors aged 40-49 years (2.5%; n=200), male (1.9%; n=524), replacement (2.8%; n=153) and first time (2.1%; n=642) donors. Sixty donations were seronegative but NAT positive, and therefore would not have been found by traditional serology testing alone. These were more likely among female vs. male (adjusted odds ratio [aOR] 2.06; 95% confidence interval [95%CI]: 1.05-4.05), paid (aOR 10.15; 95%CI: 2.80-36.86) or voluntary (aOR 4.30; 95%CI: 1.27-14.56) vs replacement, and repeat vs. first time (aOR 13.98; 95%CI: 4.06-48.12) donors. On repeat serological testing (including HBV core antibody [HBcAb] testing), 6 HBV+ donations, 5 HCV+ donations and 1 HIV+ donations were deemed NAT yield (detected through the implementation of NAT, and would have otherwise been missed by serology screening alone). CONCLUSION: This analysis offers a regional model for NAT implementation, demonstrating the feasibility and clinical utility in a nationwide blood program.

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BACKGROUND: The prevalence of hepatitis B virus (HBV) infection in Punjab, India, is unknown. Understanding the statewide prevalence and epidemiology can help guide public health campaigns to reduce the burden of disease and promote elimination efforts. METHODS: A cross-sectional, population-based survey was conducted from October 2013 to April 2014 using a multistage stratified cluster sampling design. All members of selected households aged ≥5 years were eligible. Participants were surveyed for demographics and risk behaviors; serum samples were tested for total antibody to hepatitis B core (total anti-HBc), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (anti-HCV), and HCV RNA. HBsAg-positive specimens were tested for HBV genotype. RESULTS: A total of 5543 individuals participated in the survey and provided serum samples. The prevalence of total anti-HBc was 15.2% (95% confidence interval [95% CI]: 14.1-16.5) and HBsAg was 1.4% (95% CI: 1.0-1.9). Total anti-HBc positivity was associated with male sex (adjusted odds ratio [aOR] 1.46; 95% CI: 1.21-1.75), older age (aOR 3.31; 95% CI: 2.28-4.79 for ≥60 vs. 19-29 years), and living in a rural area (aOR 2.02; 95% CI: 1.62-2.51). Receipt of therapeutic injections in the past 6 months also increased risk (4-8 injections vs. none; aOR 1.39; 95% CI: 1.05-1.84). Among those positive for total anti-HBc, 10.4% (95% CI: 8.1-13.2) were also anti-HCV positive. CONCLUSION: Punjab has a substantial burden of HBV infection. Hepatitis B vaccination programs and interventions to minimize the use of therapeutic injections, particularly in rural areas, should be considered.

BACKGROUND: Hepatitis C virus (HCV) infection causes dysregulation and suppression of immune pathways involved in the control of tuberculosis (TB) infection. However, data on the role of chronic hepatitis C as a risk factor for active TB are lacking. We sought to evaluate the association between HCV infection and the development of active TB. METHODS: We conducted a cohort study in Georgia among adults tested for HCV antibodies (January 2015 - September 2o2o) and followed longitudinally for the development of newly diagnosed active TB. Data were obtained from the Georgian National programs of hepatitis C and TB. The exposures of interest were untreated and treated HCV infection. Cox proportional hazards model was used to calculate adjusted hazards ratios. RESULTS: A total of 1,828,808 adults were included (median follow-up time: 26 months, IQR: 13-39 months). Active TB was diagnosed in 3,163 (0.17%) individuals after a median of 6 months follow-up (IQR: 1-18 months). The incidence rate per 100,000 person-years was 296 among persons with untreated HCV infection, 109 among those with treated HCV infection, and 65 among HCV-negative persons. In multivariable analysis, both untreated (aHR=2.9, 95%CI: 2.4-3.4) and treated (aHR=1.6, 95%CI: 1.4-2.0) HCV infection were associated with a higher hazard of active TB, compared to HCV-negative persons. CONCLUSIONS: Adults with HCV infection, particularly untreated individuals, were at higher risk of developing active TB disease. Screening for latent TB infection and active TB disease should be part of clinical evaluation of people with HCV infection, especially in high TB burden areas.

BACKGROUND AND AIMS: In 2015, the country of Georgia launched an elimination program aiming to reduce prevalence of Hepatitis C virus (HCV) infection by 90% from 5.4% prevalence (~150,000 people). During the first 2.5 years of the program, 770,832 people were screened, 48,575 were diagnosed with active HCV infection, and 41,483 patients were treated with direct-acting antiviral (DAA) based regimens, with >95% cure rate. METHODS: We modelled the incremental cost-effectiveness ratio (ICER) of HCV screening, diagnosis, and treatment between April 2015 and November 2017 compared to no treatment, in terms of cost per quality-adjusted life year (QALY) gained in 2017 US dollars, with 3% discount rate over 25 years. We compared the ICER to willingness-to-pay (WTP) thresholds of US$4357 (GDP) and US$871 (opportunity-cost) per QALY gained. RESULTS: The average cost of screening, HCV viremia testing, and treatment per patient treated was $386 to the provider, $225 to the patient, and $1042 for generic DAAs. At 3% discounting, 0.57 QALYs were gained per patient treated. The ICER from the perspective of the provider including generic DAAs was $2,285 per QALY gained, which is cost-effective at the $4357 WTP threshold, while if patient costs are included it's just above the threshold at $4,398/QALY. All other scenarios examined in sensitivity analyses remain cost-effective except for assuming a shorter time horizon to end of 2025, or including list price DAA cost. Reducing or excluding DAA costs reduced the ICER below the opportunity-cost WTP threshold. CONCLUSIONS: The Georgian HCV elimination program provides valuable evidence that national programs for scaling up HCV screening and treatment for achieving HCV elimination can be cost-effective.

BACKGROUND: People who inject drugs (PWID) in Georgia have a high prevalence of hepatitis C virus antibody (anti-HCV). Access to care among PWID could be prioritized to meet the country's hepatitis C elimination goals. This study assesses barriers of linkage to HCV viremia testing among PWID in Georgia. METHODS: Study participants were enrolled from 13 harm reduction (HR) centers throughout Georgia. Anti-HCV positive PWID who were tested for viremia (complete diagnosis [CD]), were compared to those not tested for viremia within 90days of screening anti-HCV positive (not complete diagnosis [NCD]). Convenience samples of CD and NCD individuals recorded at HR centers using beneficiaries' national ID were drawn from the National HCV Elimination Program database. Participants were interviewed about potential barriers to seeking care. RESULTS: A total of 500 PWID were enrolled, 245 CD and 255 NCD. CD and NCD were similar with respect to gender, age, employment status, education, knowledge of anti-HCV status, and confidence/trust in the elimination program (p>0.05). More NCD (13.0%) than CD (7.4%) stated they were not sufficiently informed what to do after screening anti-HCV positive (p<0.05). In multivariate analysis, HCV viremia testing was associated with perceived affordability of the elimination program (adjusted prevalence ratio=8.53; 95% confidence interval: 4.14-17.62). CONCLUSIONS: Post testing counselling and making hepatitis C services affordable could help increase HCV viremia testing among PWID in Georgia.

OBJECTIVES: In 2015, the Republic of Georgia initiated a National Hepatitis C Elimination Program, with a goal of 90% reduction in prevalence of chronic hepatitis C virus (HCV) infections by 2020. In this article, we explore the impact of the COVID-19 pandemic on the 2020 hepatitis C cascade of care in Georgia. STUDY DESIGN: Retrospective analytic study. METHODS: We used a national screening registry that includes hospitals, blood banks, antenatal clinics, harm reduction sites, and other programs and services to collect data on hepatitis C screening. A separate national treatment database was used to collect data on viremia and diagnostic testing, treatment initiation, and outcome including testing for and achieving sustained virologic response (SVR). We used these databases to create hepatitis C care cascades for 2020 and 2019. Bivariate associations for demographic characteristics and screening locations per year and care cascade comparisons were assessed using a chi-squared test. RESULTS: In 2020 compared to 2019, the total number of persons screened for HCV antibodies decreased by 25% (from 975,416 to 726,735), 59% fewer people with viremic infection were treated for HCV infection (3188 vs. 7868), 46% fewer achieved SVR (1345 vs. 2495), a significantly smaller percentage of persons with viremic infection initiated treatment for HCV (59% vs. 62%), while the percentage of persons who achieved SVR (99.2% vs. 99.3%) remained stable. CONCLUSIONS: The COVID-19 pandemic had a negative impact on the hepatitis C elimination program in Georgia. To ensure Georgia reaches its elimination goals, mitigating unintended consequences of delayed diagnosis and treatment of hepatitis C due to the COVID-19 pandemic are paramount.

OBJECTIVES: Georgia has a high prevalence of hepatitis C virus (HCV) infection. In 2015 a national HCV elimination program was launched providing free access to screening and treatment. To achieve elimination, innovative approaches to increase screening coverage and linkage to care are needed. This study estimates feasibility, acceptability, and outcomes of the door-to-door pilot HCV testing program in three cities. METHODS: Households were approached by system random sampling and all members were invited for study participation. Researchers used a detailed guide for conducting door-to-door testing and served as case navigators to link anti-HCV-positive individuals to care. RESULTS: Testing acceptance rate was high. In total 4804 individuals were tested and 48 (1.0%) were HCV positive. Among the entire sample of newly and previously tested individuals, overall HCV antibody prevalence was 3.6%. Through case navigation, of 48 newly identified and 26 previously identified anti-HCV-positive individuals, 42 (87.5%) and 17 (65.4%), respectively, were successfully linked to care. CONCLUSIONS: Door-to-door HCV testing has potential to increase testing uptake. Such community-based approaches not only improve testing, but can also serve to increase linkage to care, which is important in achieving the goal of HCV elimination. The study provides a model for high prevalence countries aiming to eliminate hepatitis C.

Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12-weeks post-treatment (SVR12). We assembled a global dataset of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique), and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90(th) , 95th, 97th, and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5,973 cases of detectable viremia at SVR12 from the combined dataset. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95(th) percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viremia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR=1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure.

BACKGROUND AND AIMS: In 2015, Georgia began a hepatitis C virus (HCV) elimination programme. Although screening programmes have been decentralised for high-risk groups, viraemic testing remains a bottleneck for people who inject drugs. Here, we describe two models of viraemic testing that aimed to address this gap. METHODS: We assigned eight harm reduction sites (HRS) to one of three arms (2:1:1): Xpert HCV viral load testing on-site, blood draw on-site with centralised HCV core antigen testing (HCVcAg), or standard-of-care (SOC) referral with viremia testing performed at treatment centres. RESULTS: 1671 HCV-seropositive participants were enrolled (Xpert, 37·1%; HCVcAg, 29·1%; referral, 33·8%). Participants were predominantly male (95·4%), mean age (IQR) 43 (37, 50) years, and 1290 (77·2%) were currently injecting drugs. Significantly higher proportions of participants in the Xpert (100%) and HCVcAg (99·8%) arms received viraemia testing compared with the referral arm (91·3%) (Xpert vs referral, p<0·0001; HCVcAg vs referral, p<0·0001). Among viraemic participants, treatment uptake was similar (Xpert, 84·0%; HCVcAg, 79·5%; referral, 88·4%). The time between screening and sample collection for viraemia testing was significantly longer in the referral arm compared with both Xpert and HCVcAg arms (median 1 day compared with 0 days, respectively), and the overall time between screening to treatment initiation was longer for the referral arm (median 67 days) compared with both Xpert and HCVcAg arms (median 57 and 50 days, respectively). CONCLUSIONS: Point-of-care viraemia testing and blood drawn on-site for HCVcAg testing yielded more HCV-seropositive patients receiving viraemic testing within a shorter timeframe compared with referrals.

BACKGROUND: Georgia launched national HCV elimination program in 2015. PWID may experience barriers to accessing HCV care. To improve linkage to care among PWID, pilot program to integrate HCV treatment with HR services at opiate substitution therapy (OST) centers and needle syringe program (NSP) sites was initiated. Our study aimed to assess satisfaction of patients with integrated HCV treatment services at HR centers. METHODS: Survey was conducted among convenience sample of patients receiving HCV treatment at 5 integrated care sites and 4 specialized clinics not providing HR services. Simplified pre-treatment diagnostic algorithm and treatment monitoring procedure was introduced for HCV treatment programs at OST/NSP centers which includes fewer pre-treatment and monitoring tests compared to standard algorithm. RESULTS: In total, 358 patients participated in the survey - 48.6% receiving HCV treatment at the specialized clinics while 51.4% at HR site with integrated treatment. Similar proportions of surveyed patients at HR sites (88.0%) and clinics (84.5%) stated that they did not face any barriers to enrollment in the elimination program. Most patients from HR pilot sites and specialized clinics stated that they received comprehensive information about the treatment (98.4% vs 94.3%; p<0.010). 95% of respondents at both sites were confident that confidentiality was completely protected during treatment. Higher proportion of patients at pilot sites thought that HCV treatment services provided at facility were good compared to those from the specialized clinics (85.3% vs 81.0%). We found significant difference in the time to treatment, measured as average time from viremia testing to administration of first dose of HCV medication: 42.9% of patients at pilot sites vs 4.6% at specialized clinics received the first dose of medication within two weeks. CONCLUSION: Quality of services and perceived satisfaction of patients receiving treatment, suggests that integration of HCV treatment with HR services is feasible.

OBJECTIVES: The burden of hepatitis B virus (HBV) and hepatitis D virus (HDV) infections is unknown in Georgia. This analysis describes the prevalence of hepatitis B and coinfection with HDV and the demographic characteristics and risk factors for persons with HBV infection in Georgia. STUDY DESIGN: This is a cross-sectional seroprevalence study. METHODS: A cross-sectional, nationwide survey to assess hepatitis B prevalence among the general adult Georgian population (age ≥18 years) was conducted in 2015. Demographic and risk behavior data were collected. Blood specimens were screened for anti-hepatitis B core total antibody (anti-HBc). Anti-HBc-positive specimens were tested for hepatitis B surface antigen (HBsAg). HBsAg-positive specimens were tested for HBV and HDV nucleic acid. Nationally weighted prevalence estimates and adjusted odds ratios (aORs) for potential risk factors were determined for anti-HBc and HBsAg positivity. RESULTS: The national prevalence of anti-HBc and HBsAg positivity among adults were 25.9% and 2.9%, respectively. Persons aged ≥70 years had the highest anti-HBc positivity (32.7%), but the lowest HBsAg positivity prevalence (1.3%). Anti-HBc positivity was associated with injection drug use (aOR = 2.34; 95% confidence interval [CI] = 1.46-3.74), receipt of a blood transfusion (aOR = 1.68; 95% CI = 1.32-2.15), and sex with a commercial sex worker (aOR = 1.46; 95% CI = 1.06-2.01). HBsAg positivity was associated with receipt of a blood transfusion (aOR = 2.72; 95% CI = 1.54-4.80) and past incarceration (aOR = 2.72; 95% CI = 1.25-5.93). Among HBsAg-positive persons, 0.9% (95% CI = 0.0-2.0) were HDV coinfected. CONCLUSIONS: Georgia has an intermediate to high burden of hepatitis B, and the prevalence of HDV coinfection among HBV-infected persons is low. Existing infrastructure for hepatitis C elimination could be leveraged to promote hepatitis B elimination.

OBJECTIVE: In 2015, Georgia launched HCV elimination program. Initially, patients with advanced liver disease were treated with sofosbuvir-based regimen-the only DAA available for all genotypes. Purpose of the study was assessing real-world data of treatment outcome among patients with HCV GEN3 and advanced liver fibrosis with sofosbuvir-based regimens. RESULTS: Totally 1525 genotype 3 patients were eligible for analysis; most (72.6%) were aged > 45 years, majority were males (95.1%), and all (100%) had advanced liver disease (F3 or F4 by METAVIR score based on elastography). Of those who received sofosbuvir/ribavirin (SOF/RBV) for 24 weeks, 79.3% achieved SVR, while 96.5% who received sofosbuvir/pegylated interferon/ribavirin (SOF/PEG/RBV) for 12 weeks achieved SVR (p < 0.01). Among patients with liver cirrhosis (defined as F4) overall cure rate was 85.7% as opposed to 96.4% for those with F3. Females were more likely to be cured (98.7% vs 89.7%; OR = 8.54). Patients aged 31-45 years had higher likelihood of achieving SVR compared to patients aged 46-60 years (95.7% vs 87.4%; OR = 0.32,). Independent predictors of SVR were treatment with SOF/PEG/RBV (aOR = 6.72) and lower fibrosis stage (F3) (aOR = 4.18). Real-world experience among HCV GEN3 patients with advanced liver fibrosis and treated by sofosbuvir regimen w/o PEGIFN, demonstrated overall high SVR rate.

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.