Survival from five common cancers in Georgia, 2015-2019 (CONCORD).

BACKGROUND: Population-based cancer survival is a key metric of the effectiveness of health systems in managing cancer. Data from population-based cancer registries are essential for producing reliable and robust cancer survival estimates. Georgia established a national population-based cancer registry on 1 January 2015. This is the first analysis of population-based cancer survival from Georgia. METHODS: Data were available from the national cancer registry for 16,359 adults who were diagnosed with a cancer of the stomach, colon, rectum, breast (women) or cervix during 2015-2019. We estimated age-specific and age-standardised net survival at one, two and three years after diagnosis for each cancer, by sex. RESULTS: The data were of extremely high quality, with less than 2% of data excluded from each dataset. For the patients included in analyses, at least 80% of the tumours were microscopically verified. Age-standardised three-year survival from stomach cancer was 30.6%, similar in men and women. For colon cancer, three-year survival was 60.1%, with survival 4% higher for men than for women. Three-year survival from rectal cancer was similar for men and women, at 54.7%. For women diagnosed with breast cancer, three-year survival was 84.4%, but three-year survival from cervical cancer was only 67.2%. CONCLUSION: Establishment of a national cancer registry with obligatory cancer registration has enabled the first examination of population-based cancer survival in Georgia. Maintenance of the registry will facilitate continued surveillance of both cancer incidence and survival in the country.

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.

Risk factors and genotype distribution of hepatitis C virus in Georgia: A nationwide population-based survey.

In preparation for the National Hepatitis C Elimination Program in the country of Georgia, a nationwide household-based hepatitis C virus (HCV) seroprevalence survey was conducted in 2015. Data were used to estimate HCV genotype distribution and better understand potential sex-specific risk factors that contribute to HCV transmission. HCV genotype distribution by sex and reported risk factors were calculated. We used explanatory logistic regression models stratified by sex to identify behavioral and healthcare-related risk factors for HCV seropositivity, and predictive logistic regression models to identify additional variables that could help predict the presence of infection. Factors associated with HCV seropositivity in explanatory models included, among males, history of injection drug use (IDU) (aOR = 22.4, 95% CI = 12.7, 39.8) and receiving a blood transfusion (aOR = 3.6, 95% CI = 1.4, 8.8), and among females, history of receiving a blood transfusion (aOR = 4.0, 95% CI 2.1, 7.7), kidney dialysis (aOR = 7.3 95% CI 1.5, 35.3) and surgery (aOR = 1.9, 95% CI 1.1, 3.2). The male-specific predictive model additionally identified age, urban residence, and history of incarceration as factors predictive of seropositivity and were used to create a male-specific exposure index (Area under the curve [AUC] = 0.84). The female-specific predictive model had insufficient discriminatory performance to support creating an exposure index (AUC = 0.61). The most prevalent HCV genotype (GT) nationally was GT1b (40.5%), followed by GT3 (34.7%) and GT2 (23.6%). Risk factors for HCV seropositivity and distribution of HCV genotypes in Georgia vary substantially by sex. The HCV exposure index developed for males could be used to inform targeted testing programs.

A comparison of self-reported to cotinine-detected smoking status among adults in Georgia.

BACKGROUND: Self-reported measures of tobacco use may have limited validity, particularly among some populations. This study aims to validate self-reported smoking measures among Georgian adults participating in the 2016 STEPS survey using cotinine biomarker measurements, and to explore potential differences according to sociodemographic characteristics. Additionally, this paper examines how the estimated prevalence of smoking in the population varies according to measurement type. METHODS: Using the WHO standardized STEPS methodology, adults self-reported their smoking status. In a later stage of the survey, a subset of participants provided a urine sample, which was tested for cotinine. Using each participant's objective cotinine measurement and their self-reported smoking status, we calculated the sensitivity, specificity and positive predictive value of self-reported smoking. Next, we calculated the estimated prevalence of smokers according to the type of measurement. RESULTS: Results indicated high sensitivity (83.37%, 95% CI: 76.79-88.37%) among males and relatively low sensitivity (38.60% CI: 29.23-48.90%) among females. According to self-report, the prevalence of smokers was 26.44% (23.61-29.48%), while according to cotinine detection, the prevalence of smokers was 32.27% (29.16-35.55%). Among all subgroups, the self-reported prevalence of smoking was significantly lower than the cotinine-detected prevalence. CONCLUSIONS: To the best of our knowledge, this is the first time that the validity of the STEPS self-reported tobacco indicator has been tested. Self-reported measures of smoking status may lead to an under-estimation of smoking prevalence among Georgian adults, especially women. These findings suggest that integration of biochemical measures of smoking into tobacco use studies may be an important investment.

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.

Progress and challenges of a pioneering hepatitis C elimination program in the country of Georgia.

BACKGROUND & AIMS: Georgia, with a high prevalence of HCV infection, launched the world's first national hepatitis C elimination program in April 2015. A key strategy is the identification, treatment, and cure of the estimated 150,000 HCV-infected people living in the country. We report on progress and key challenges from Georgia's experience. METHODS: We constructed a care cascade by analyzing linked data from the national hepatitis C screening registry and treatment databases during 2015-2018. We assessed the impact of reflex hepatitis C core antigen (HCVcAg) testing on rates of viremia testing and treatment initiation (i.e. linkage to care). RESULTS: As of December 31, 2018, 1,101,530 adults (39.6% of the adult population) were screened for HCV antibody, of whom 98,430 (8.9%) tested positive. Of the individuals who tested positive, 78,484 (79.7%) received viremia testing, of whom 66,916 (85.3%) tested positive for active HCV infection. A total of 52,576 people with active HCV infection initiated treatment and 48,879 completed their course of treatment. Of the 35,035 who were tested for cure (i.e., sustained virologic response [SVR]), 34,513 (98.5%) achieved SVR. Reflex HCVcAg testing, implemented in March 2018, increased rates of monthly viremia testing by 97.5% among those who screened positive for anti-HCV, however, rates of treatment initiation decreased by 60.7% among diagnosed viremic patients. CONCLUSIONS: Over one-third of people living with HCV in Georgia have been detected and linked to care and treatment, however, identification and linkage to care of the remaining individuals with HCV infection is challenging. Novel interventions, such as reflex testing with HCVcAg, can improve rates of viremia testing, but may result in unintended consequences, such as decreased rates of treatment initiation. Linked data systems allow for regular review of the care cascade, allowing for identification of deficiencies and development of corrective actions. LAY SUMMARY: This report describes progress in Georgia's hepatitis C elimination program and highlights efforts to promote hepatitis C virus screening and treatment initiation on a national scale. Georgia has made progress towards eliminating hepatitis C, treating over 50,000 people, approximately one-third of the number infected, and achieving cure for 98.5% of those tested. However, identifying infected individuals and linking them to care remains challenging. Novel approaches to increase diagnostic testing can have unintended consequences further down the care cascade.

Examining smoke-free coalitions in Armenia and Georgia: baseline community capacity.

Local coalitions can advance public health initiative but have not been widely used or well-studied in low- and middle-income countries. This paper provides (i) an overview of an ongoing matched-pairs community-randomized controlled trial in 28 communities in Armenia and Georgia (N = 14/country) testing local coalitions to promote smoke-free policies/enforcement and (ii) characteristics of the communities involved. In July-August 2018, key informants (e.g. local public health center directors) were surveyed to compare their non-communicable disease (NCD) and tobacco-related activities across countries and across condition (intervention/control). More than half of the informants (50.0-57.1%) reported their communities had programs addressing hypertension, diabetes, cancer and human papilloma virus, with 85.7% involving community education and 32.1% patient education programs. Eleven communities (39.3%) addressed tobacco control, all of which were in Georgia. Of those, all included public/community education and the majority (72.7-81.8%) provided cessation counseling/classes, school/youth prevention programs, healthcare provider training or activities addressing smoke-free environments. Informants in Georgia versus Armenia perceived greater support for tobacco control from various sectors (e.g. government, community). No differences were found by condition assignment. This paper provides a foundation for presenting subsequent analyses of this ongoing trial. These analyses indicate wide variability regarding NCD-related activities and support across communities and countries.

Progress in Testing for and Treatment of Hepatitis C Virus Infection Among Persons Who Inject Drugs - Georgia, 2018.

In April 2015, the country of Georgia, with a high prevalence of hepatitis C virus (HCV) infection (5.4% of the adult population, approximately 150,000 persons), embarked on the world's first national elimination program (1,2). Nearly 40% of these infections are attributed to injection drug use, and an estimated 2% of the adult population currently inject drugs, among the highest prevalence of injection drug use in the world (3,4). Since 2006, needle and syringe programs (NSPs) have been offering HCV antibody testing to persons who inject drugs and, since 2015, referring clients with positive test results to the national treatment program. This report summarizes the results of these efforts. Following implementation of the elimination program, the number of HCV antibody tests conducted at NSPs increased from an average of 3,638 per year during 2006-2014 to an average of 21,551 during 2015-2018. In 2017, to enable tracking of clinical outcomes among persons who inject drugs, NSPs began encouraging clients to voluntarily provide their national identification number (NIN), which all citizens must use to access health care treatment services. During 2017-2018, a total of 2,780 NSP clients with positive test results for HCV antibody were identified in the treatment database by their NIN. Of 494 who completed treatment and were tested for HCV RNA ≥12 weeks after completing treatment, 482 (97.6%) were cured of HCV infection. Following the launch of the elimination program, Georgia has made much progress in hepatitis C screening among persons who inject drugs; recent data demonstrate high cure rates achieved in this population. Testing at NSPs is an effective strategy for identifying persons with HCV infection. Tracking clients referred from NSPs through treatment completion allows for monitoring the effectiveness of linkage to care and treatment outcomes in this population at high risk, a key to achieving hepatitis C elimination in Georgia. The program in Georgia might serve as a model for other countries.

Hepatitis C prevalence and risk factors in Georgia, 2015: setting a baseline for elimination.

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.

The Role of Screening and Treatment in National Progress Toward Hepatitis C Elimination - Georgia, 2015-2016.

Georgia, a country in the Caucasus region of Eurasia, has a high prevalence of hepatitis C virus (HCV) infection. In April 2015, with technical assistance from CDC, Georgia embarked on the world's first program to eliminate hepatitis C, defined as a 90% reduction in HCV prevalence by 2020 (1,2). The country committed to identifying infected persons and linking them to care and curative antiviral therapy, which was provided free of charge through a partnership with Gilead Sciences (1,2). From April 2015 through December 2016, a total of 27,595 persons initiated treatment for HCV infection, among whom 19,778 (71.7%) completed treatment. Among 6,366 persons tested for HCV RNA ≥12 weeks after completing treatment, 5,356 (84.1%) had no detectable virus in their blood, indicative of a sustained virologic response (SVR) and cure of HCV infection. The number of persons initiating treatment peaked in September 2016 at 4,595 and declined during October-December. Broader implementation of interventions that increase access to HCV testing, care, and treatment for persons living with HCV are needed for Georgia to reach national targets for the elimination of HCV.

Launch of a Nationwide Hepatitis C Elimination Program--Georgia, April 2015.

Hepatitis C virus (HCV) infects an estimated 130-150 million persons globally and results in an estimated 700,000 deaths annually from hepatocellular carcinoma or cirrhosis. Georgia, a middle-income Eurasian country, has one of the highest estimated HCV prevalences in the world. In 2011, Georgia began offering treatment to a limited number of HCV-infected persons. Beginning in 2013, when new oral medications that can cure >90% of HCV infections were licensed, Georgia engaged partners to develop a comprehensive HCV prevention and control plan, during which the concept of elimination of HCV transmission and disease emerged. To prepare for the launch of an HCV elimination program, Georgia requested CDC's assistance to describe HCV epidemiology, evaluate laboratory and health care capacity, and conduct program monitoring and evaluation. This report describes the activities undertaken to prepare for the program, launched in April 2015, and early results of its initial phase, focused on improving access to affordable diagnostics and free curative treatment for HCV-infected persons with severe liver disease. A national population-based serosurvey began in May 2015, and four clinical sites and their laboratories were selected as initial pilot sites; since June, three additional sites have been added. Through July 3, 2015, a total of 6,491 persons sought treatment, and 6,177 (95.2%) initiated diagnostic work-up. Among these, 1,519 (24.6%) completed work-up, 1,474 (97.0%) of whom initiated treatment. Georgia is scaling up capacity to meet the demand for HCV treatment and is collaborating with CDC and other partners on development of a comprehensive HCV elimination plan that includes specific goals and activities needed to achieve them.