Lessons learned from global hepatitis C elimination programs.

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.

Toward reaching hepatitis B goals: hepatitis B epidemiology and the impact of two decades of vaccination, Georgia, 2021.

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.

Insights from a national survey in 2021 and from modelling on progress towards hepatitis C virus elimination in the country of Georgia since 2015.

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.

Hepatitis C care cascade among patients with and without tuberculosis: Nationwide observational cohort study in the country of Georgia, 2015-2020.

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 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.

Impact of Hepatitis C Virus Infection and Treatment on Mortality in the Country of Georgia, 2015-2020.

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 6 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 sustained virologic response (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% confidence interval [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 6-times higher hazard of death compared to treated groups with or without documented SVR (adjusted hazard ratio [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. CONCLUSIONS: 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.

Nationwide Hepatitis C Serosurvey and Progress Towards Hepatitis C Virus Elimination in the Country of Georgia, 2021.

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.

Advancing blood transfusion safety using molecular detection in the country of Georgia.

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.

Economic evaluation of the Hepatitis C virus elimination program in the country of Georgia, 2015 to 2017.

BACKGROUND AND AIMS: In 2015, the country of Georgia launched an elimination program aiming to reduce the 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 a >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 a 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% discount, 0.57 QALYs were gained per patient treated. The ICER from the perspective of the provider including generic DAAs was $2285 per QALY gained, which is cost-effective at the $4357 WTP threshold, while if patient costs are included, it is just above the threshold at $4398/QALY. All other scenarios examined in sensitivity analyses remain cost-effective except for assuming a shorter time horizon to the end of 2025 or including the 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.

Association of Treated and Untreated Chronic Hepatitis C With the Incidence of Active Tuberculosis Disease: A Population-Based Cohort Study.

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 2020) 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. A Cox proportional hazards model was used to calculate adjusted hazard ratios (aHRs). 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 3163 (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 infections were associated with a higher hazard of active TB, compared with 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.

Treatment of hepatitis C in primary health care in the country of Georgia.

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Hepatitis B Prevalence and Risk Factors in Punjab, India: A Population-Based Serosurvey.

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.

Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.

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 data set 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 90th, 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 5973 cases of detectable viraemia at SVR12 from the combined data set. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viraemia 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.

Barriers of linkage to HCV viremia testing among people who inject drugs in Georgia.

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 90 days 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.

Door-to-door hepatitis C screening in Georgia: An innovative model to increase testing and linkage to care.

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.

Feasibility and effectiveness of HCV viraemia testing at harm reduction sites in Georgia: A prospective three-arm study.

BACKGROUND AND AIMS: In 2015, Georgia began a hepatitis C virus (HCV) elimination programme. Although screening programmes have been decentralized 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 centralized 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.

Integration of hepatitis C treatment at harm reduction centers in Georgia-Findings from a patient satisfaction survey.

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.

High sustained viral response among HCV genotype 3 patients with advanced liver fibrosis: real-world data of HCV elimination program in Georgia.

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.

Blood transfusion safety in the country of Georgia: collateral benefit from a national hepatitis C elimination program.

BACKGROUND: In April 2015, the government of Georgia (country) initiated the world's 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.

Screening and linkage to care for hepatitis C among inpatients in Georgia's national hospital screening program.

The country of Georgia initiated an ambitious national hepatitis C elimination program. To facilitate elimination, a national hospital hepatitis C screening program was launched in November 2016, offering all inpatients screening for HCV infection. This analysis assesses the effectiveness of the first year of the screening program to identify HCV-infected persons and link them to care. Data from Georgia's electronic Health Management Information System and ELIMINATION-C treatment database were analyzed for patients aged ≥18 years hospitalized from November 1, 2016 to October 31, 2017. We described patient characteristics and screening results and compared linked-to-care patients to those not linked to care, defined as having a test for viremia following an HCV antibody (anti-HCV) positive hospital screening. Of 291,975 adult inpatients, 252,848 (86.6%) were screened. Of them, 4.9% tested positive, with a high of 17.4% among males aged 40-49. Overall, 19.8% of anti-HCV+ patients were linked to care, which differed by sex (20.6% for males vs. 18.4% for females; p = .019), age (23.9% for age 50-59 years vs. 10.7% for age ≥ 70 years; p < .0001), and length of hospitalization (21.8% among patients hospitalized for 1 day vs. 16.1% for those hospitalized 11+ days; p = .023). Redundant screening is a challenge; 15.6% of patients were screened multiple times and 27.6% of anti-HCV+ patients had a prior viremia test. This evaluation demonstrates that hospital-based screening programs can identify large numbers of anti-HCV+ persons, supporting hepatitis C elimination. However, low linkage-to-care rates underscore the need for screening programs to be coupled with effective linkage strategies.

Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia.

BACKGROUND: Georgia has one of the highest HCV prevalence in the world and launched the world's first national HCV elimination programs in 2015. Georgia set the ambitious target of diagnosing 90% of people living with HCV, treating 95% of those diagnosed and curing 95% of treated patients by 2020. We report outcomes of Sofosbuvir (SOF) based treatment regimens in patients with chronic HCV infection in Georgia. METHODS: Patients with cirrhosis, advanced liver fibrosis and severe extrahepatic manifestations were enrolled in the treatment program. Initial treatment consisted of SOF plus ribavirin (RBV) with or without pegylated interferon (INF). Sustained virologic response (SVR) was defined as undetectable HCV RNA at least 12 weeks after the end of treatment. SVR were calculated using both per-protocol and modified intent-to-treat (mITT) analysis. Results for patients who completed treatment through 31 October 2018 were analyzed. RESULTS: Of the 7342 patients who initiated treatment with SOF-based regimens, 5079 patients were tested for SVR. Total SVR rate was 82.1% in per-protocol analysis and 74.5% in mITT analysis. The lowest response rate was observed among genotype 1 patients (69.5%), intermediate response rate was achieved in genotype 2 patients (81.4%), while the highest response rate was among genotype 3 patients (91.8%). Overall, SOF/RBV regimens achieved lower response rates than IFN/SOF/RBV regimen (72.1% vs 91.3%, P < 0.0001). In multivariate analysis being infected with HCV genotype 2 (RR =1.10, CI [1.05-1.15]) and genotype 3 (RR = 1.14, CI [1.11-1.18]) were associated with higher SVR. Patients with cirrhosis (RR = 0.95, CI [0.93-0.98]), receiving treatment regimens of SOF/RBV 12 weeks, SOF/RBV 20 weeks, SOF/RBV 24 weeks and SOF/RBV 48 weeks (RR = 0.85, CI [0.81-0.91]; RR = 0.86, CI [0.82-0.92]; RR = 0.88, CI [0.85-0.91] and RR = 0.92, CI [0.87-0.98], respectively) were less likely to achieve SVR. CONCLUSIONS: Georgia's real world experience resulted in high overall response rates given that most patients had severe liver damage. Our results provide clear evidence that SOF plus IFN and RBV for 12 weeks can be considered a treatment option for eligible patients with all three HCV genotypes. With introduction of next generation DAAs, significantly improved response rates are expected, paving the way for Georgia to achieve HCV elimination goals.