Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
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Nationwide hepatitis C serosurvey and progress towards HCV elimination in the country of Georgia, 2021
Gamkrelidze A , Shadaker S , Tsereteli M , Alkhazashvili M , Chitadze N , Tskhomelidze I , Gvinjilia L , Khetsuriani N , Handanagic S , Averhoff F , Cloherty G , Chakhunashvili G , Drobeniuc J , Imnadze P , Zakhashvili K , Armstrong PA . J Infect Dis 2023 228 (6) 684-693 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. |
Toward reaching hepatitis B goals: hepatitis B epidemiology and the impact of two decades of vaccination, Georgia, 2021
Khetsuriani N , Gamkrelidze A , Shadaker S , Tsereteli M , Alkhazashvili M , Chitadze N , Tskhomelidze I , Gvinjilia L , Averhoff F , Cloherty G , An Q , Chakhunashvili G , Drobeniuc J , Imnadze P , Zakhashvili K , Armstrong PA . Euro Surveill 2023 28 (30) 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. |
Interim impact evaluation of the hepatitis C virus elimination program in Georgia (preprint)
Walker JG , Fraser H , Lim AG , Gvinjilia L , Hagan L , Kuchuloria T , Martin NK , Nasrullah M , Shadaker S , Aladashvili M , Asatiani A , Baliashvili D , Butsashvili M , Chikovani I , Khonelidze I , Kirtadze I , Kuniholm MH , Otiashvili D , Stvilia K , Tsertsvadze T , Hickman M , Morgan J , Gamkrelidze A , Kvaratskhelia V , Averhoff F , Vickerman P . bioRxiv 2018 270579 Background and Aims Georgia has one of the highest hepatitis C virus (HCV) prevalence rates in the world, with >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. |
Hepatitis C care cascade among patients with and without tuberculosis: findings from nationwide programs in the country of Georgia, 2015-2020 (preprint)
Baliashvili D , Blumberg HM , Gandhi NR , Averhoff F , Benkeser D , Shadaker S , Gvinjilia L , Turdziladze A , Tukvadze N , Chincharauli M , Butsashvili M , Sharvadze L , Tsertsvadze T , Zarkua J , Kempker RR . medRxiv 2022 13 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. |
Hepatitis C care cascade among patients with and without tuberculosis: Nationwide observational cohort study in the country of Georgia, 2015-2020
Baliashvili D , Blumberg HM , Gandhi NR , Averhoff F , Benkeser D , Shadaker S , Gvinjilia L , Turdziladze A , Tukvadze N , Chincharauli M , Butsashvili M , Sharvadze L , Tsertsvadze T , Zarkua J , Kempker RR . PLoS Med 2023 20 (5) e1004121 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 HCV infection and treatment on mortality in the country of Georgia, 2015-2020
Gvinjilia L , Baliashvili D , Shadaker S , Averhoff F , Kandelaki L , Kereselidze M , Tsertsvadze T , Chkhartishvili N , Butsashvili M , Metreveli D , Gamkrelidze A , Armstrong PA . Clin Infect Dis 2023 77 (3) 405-413 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. |
COVID-19 SeroHub, an online repository of SARS-CoV-2 seroprevalence studies in the United States.
Freedman ND , Brown L , Newman LM , Jones JM , Benoit TJ , Averhoff F , Bu X , Bayrak K , Lu A , Coffey B , Jackson L , Chanock SJ , Kerlavage AR . Sci Data 2022 9 (1) 727 Seroprevalence studies provide useful information about the proportion of the population either vaccinated against SARS-CoV-2, previously infected with the virus, or both. Numerous studies have been conducted in the United States, but differ substantially by dates of enrollment, target population, geographic location, age distribution, and assays used. This can make it challenging to identify and synthesize available seroprevalence data by geographic region or to compare infection-induced versus combined infection- and vaccination-induced seroprevalence. To facilitate public access and understanding, the National Institutes of Health and the Centers for Disease Control and Prevention developed the COVID-19 Seroprevalence Studies Hub (COVID-19 SeroHub, https://covid19serohub.nih.gov/ ), a data repository in which seroprevalence studies are systematically identified, extracted using a standard format, and summarized through an interactive interface. Within COVID-19 SeroHub, users can explore and download data from 178 studies as of September 1, 2022. Tools allow users to filter results and visualize trends over time, geography, population, age, and antigen target. Because COVID-19 remains an ongoing pandemic, we will continue to identify and include future studies. |
Hepatitis B Prevalence and Risk Factors in Punjab, India: A Population-Based Serosurvey.
Shadaker S , Sood A , Averhoff F , Suryaprasad A , Kanchi S , Midha V , Kamili S , Nasrullah M , Trickey A , Garg R , Mittal P , Sharma SK , Vickerman P , Armstrong PA . J Clin Exp Hepatol 2022 12 (5) 1310-1319 ![]() 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. |
Association of treated and untreated chronic hepatitis C with the incidence of active tuberculosis disease: a population-based cohort study.
Baliashvili D , Blumberg HM , Benkeser D , Kempker RR , Shadaker S , Averhoff F , Gvinjilia L , Adamashvili N , Magee M , Kamkamidze G , Zakalashvili M , Tsertsvadze T , Sharvadze L , Chincharauli M , Tukvadze N , Gandhi NR . Clin Infect Dis 2022 76 (2) 245-251 ![]() 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. |
Economic evaluation of the hepatitis C virus elimination program in the country of Georgia, 2015 to 2017
Tskhomelidze I , Shadaker S , Kuchuloria T , Gvinjilia L , Butsashvili M , Nasrullah M , Gabunia T , Gamkrelidze A , Getia V , Sharvadze L , Tsertsvadze T , Zarqua J , Tsanava S , Handanagic S , Armstrong PA , Averhoff F , Vickerman P , Walker JG . Liver Int 2022 43 (3) 558-568 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. |
Barriers of linkage to HCV viremia testing among people who inject drugs in Georgia
Butsashvili M , Abzianidze T , Kamkamidze G , Gulbiani L , Gvinjilia L , Kuchuloria T , Tskhomelidze I , Gogia M , Tsereteli M , Miollany V , Kikvidze T , Shadaker S , Nasrullah M , Averhoff F . Subst Abuse Treat Prev Policy 2022 17 (1) 23 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. |
Door-to-door hepatitis C screening in Georgia: An innovative model to increase testing and linkage to care
Butsashvili M , Zurashvili T , Kamkamidze G , Kajaia M , Gulbiani L , Gamezardashvili A , Gvinjilia L , Kuchuloria T , Gamkrelidze A , Shadaker S , Nasrullah M , Averhoff F , Armstrong PA . J Med Screen 2022 29 (2) 9691413221086497 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. |
Risk factors and genotype distribution of hepatitis C virus in Georgia: A nationwide population-based survey.
Baliashvili D , Averhoff F , Kasradze A , Salyer SJ , Kuchukhidze G , Gamkrelidze A , Imnadze P , Alkhazashvili M , Chanturia G , Chitadze N , Sukhiashvili R , Blanton C , Drobeniuc J , Morgan J , Hagan LM . PLoS One 2022 17 (1) e0262935 ![]() 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. |
SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.
Gundlapalli AV , Salerno RM , Brooks JT , Averhoff F , Petersen LR , McDonald LC , Iademarco MF . Open Forum Infect Dis 2021 8 (1) ofaa555 BACKGROUND: There is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response. METHODS: Literature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results. RESULTS: Quantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses. CONCLUSIONS: Lack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public-private partnerships could facilitate realization of these advances in the United States and worldwide. |
Progress toward hepatitis B and hepatitis C elimination using a catalytic funding model - Tashkent, Uzbekistan, December 6, 2019-March 15, 2020
Dunn R , Musabaev E , Razavi H , Sadirova S , Bakieva S , Razavi-Shearer K , Brigida K , Kamili S , Averhoff F , Nasrullah M . MMWR Morb Mortal Wkly Rep 2020 69 (34) 1161-1165 In 2016, the World Health Organization (WHO) set hepatitis elimination targets of 90% reduction in incidence and 65% reduction in mortality worldwide by 2030 (1). Hepatitis B virus (HBV) and hepatitis C virus (HCV) infection prevalences are high in Uzbekistan, which lacks funding for meeting WHO's targets. In the absence of large financial donor programs for eliminating HBV and HCV infections, insufficient funding is an important barrier to achieving those targets in Uzbekistan and other low- and middle-income countries. A pilot program using a catalytic funding model, including simplified test-and-treat strategies, was launched in Tashkent, Uzbekistan, in December 2019. Catalytic funding is a mechanism by which the total cost of a program is paid for by multiple funding sources but is begun with upfront capital that is considerably less than the total program cost. Ongoing costs, including those for testing and treatment, are covered by payments from 80% of the enrolled patients, who purchase medications at a small premium that subsidizes the 20% who cannot afford treatment and therefore receive free medication. The 1-year pilot program set a target of testing 250,000 adults for HBV and HCV infection and treating all patients who have active infection, including those who had a positive test result for hepatitis B surface antigen (HBsAg) and those who had a positive test result for HCV core antigen. During the first 3 months of the program, 24,821 persons were tested for HBV and HCV infections. Among those tested, 1,084 (4.4%) had positive test results for HBsAg, and 1,075 (4.3%) had positive test results for HCV antibody (anti-HCV). Among those infected, 275 (25.4%) initiated treatment for HBV, and 163 (15.2%) initiated treatment for HCV, of whom 86.5% paid for medications and 13.5% received medications at no cost. Early results demonstrate willingness of patients to pay for treatment if costs are low, which can offset elimination costs. However, improvements across the continuum of care are needed to recover the upfront investment. Lessons learned from this program, including the effectiveness of using simplified test-and-treat guidelines, general practitioners in lieu of specialist physicians, and innovative financing to reduce costs, can guide similar initiatives in other countries and help curb the global epidemic of viral hepatitis, especially among low- and middle-income countries. |
The burden and epidemiology of hepatitis B and hepatitis D in Georgia: findings from the national seroprevalence survey
Kasradze A , Shadaker S , Kuchuloria T , Gamkrelidze A , Nasrullah M , Gvinjilia L , Baliashvili D , Chitadze N , Kodani M , Tejada-Strop A , Drobeniuc J , Hagan L , Morgan J , Imnadze P , Averhoff F . Public Health 2020 185 341-347 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. |
Integration of hepatitis C treatment at harm reduction centers in Georgia - findings from a patient satisfaction survey
Butsashvili M , Kamkamidze G , Kajaia M , Gvinjilia L , Kuchuloria T , Khonelidze I , Gogia M , Dolmazashvili E , Kerashvili V , Zakalashvili M , Shadaker S , Nasrullah M , Sonjelle S , Japaridze M , Averhoff F . Int J Drug Policy 2020 84 102893 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.
Butsashvili M , Gvinjilia L , Kamkamidze G , Metreveli D , Dvali S , Rukhadze T , Gamkrelidze A , Nasrullah M , Shadaker S , Morgan J , Averhoff F . BMC Res Notes 2020 13 (1) 332 ![]() 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
Bloch EM , Kipiani E , Shadaker S , Alkhazashvili M , Gvinjilia L , Kuchuloria T , Chitadze N , Keating SM , Gamkrelidze A , Turdziladze A , Getia V , Nasrullah M , Averhoff F , Izoria M , Skaggs B . Transfusion 2020 60 (6) 1243-1252 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. |
Screening and linkage to care for hepatitis C among inpatients in Georgia's national hospital screening program
Shadaker S , Nasrullah M , Gamkrelidze A , Ray J , Gvinjilia L , Kuchuloria T , Butsashvili M , Getia V , Metreveli D , Tsereteli M , Tsertsvadze T , Link-Gelles R , Millman AJ , Turdziladze A , Averhoff F . Prev Med 2020 138 106153 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. |
Effects and cost of different strategies to eliminate hepatitis C virus transmission in Pakistan: a modelling analysis
Lim AG , Walker JG , Mafirakureva N , Khalid GG , Qureshi H , Mahmood H , Trickey A , Fraser H , Aslam K , Falq G , Fortas C , Zahid H , Naveed A , Auat R , Saeed Q , Davies CF , Mukandavire C , Glass N , Maman D , Martin NK , Hickman M , May MT , Hamid S , Loarec A , Averhoff F , Vickerman P . Lancet Glob Health 2020 8 (3) e440-e450 BACKGROUND: The WHO elimination strategy for hepatitis C virus advocates scaling up screening and treatment to reduce global hepatitis C incidence by 80% by 2030, but little is known about how this reduction could be achieved and the costs of doing so. We aimed to evaluate the effects and cost of different strategies to scale up screening and treatment of hepatitis C in Pakistan and determine what is required to meet WHO elimination targets for incidence. METHODS: We adapted a previous model of hepatitis C virus transmission, treatment, and disease progression for Pakistan, calibrating using available data to incorporate a detailed cascade of care for hepatitis C with cost data on diagnostics and hepatitis C treatment. We modelled the effect on various outcomes and costs of alternative scenarios for scaling up screening and hepatitis C treatment in 2018-30. We calibrated the model to country-level demographic data for 1960-2015 (including population growth) and to hepatitis C seroprevalence data from a national survey in 2007-08, surveys among people who inject drugs (PWID), and hepatitis C seroprevalence trends among blood donors. The cascade of care in our model begins with diagnosis of hepatitis C infection through antibody screening and RNA confirmation. Diagnosed individuals are then referred to care and started on treatment, which can result in a sustained virological response (effective cure). We report the median and 95% uncertainty interval (UI) from 1151 modelled runs. FINDINGS: One-time screening of 90% of the 2018 population by 2030, with 80% referral to treatment, was projected to lead to 13.8 million (95% UI 13.4-14.1) individuals being screened and 350 000 (315 000-385 000) treatments started annually, decreasing hepatitis C incidence by 26.5% (22.5-30.7) over 2018-30. Prioritised screening of high prevalence groups (PWID and adults aged >/=30 years) and rescreening (annually for PWID, otherwise every 10 years) are likely to increase the number screened and treated by 46.8% and decrease incidence by 50.8% (95% UI 46.1-55.0). Decreasing hepatitis C incidence by 80% is estimated to require a doubling of the primary screening rate, increasing referral to 90%, rescreening the general population every 5 years, and re-engaging those lost to follow-up every 5 years. This approach could cost US$8.1 billion, reducing to $3.9 billion with lowest costs for diagnostic tests and drugs, including health-care savings, and implementing a simplified treatment algorithm. INTERPRETATION: Pakistan will need to invest about 9.0% of its yearly health expenditure to enable sufficient scale up in screening and treatment to achieve the WHO hepatitis C elimination target of an 80% reduction in incidence by 2030. FUNDING: UNITAID. |
Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia
Tsertsvadze T , Gamkrelidze A , Nasrullah M , Sharvadze L , Morgan J , Shadaker S , Gvinjilia L , Butsashvili M , Metreveli D , Kerashvili V , Ezugbaia M , Chkhartishvili N , Abutidze A , Kvaratskhelia V , Averhoff F . BMC Infect Dis 2020 20 (1) 30 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. |
Interim effect evaluation of the hepatitis C elimination programme in Georgia: a modelling study
Walker JG , Kuchuloria T , Sergeenko D , Fraser H , Lim AG , Shadaker S , Hagan L , Gamkrelidze A , Kvaratskhelia V , Gvinjilia L , Aladashvili M , Asatiani A , Baliashvili D , Butsashvili M , Chikovani I , Khonelidze I , Kirtadze I , Kuniholm MH , Otiashvili D , Sharvadze L , Stvilia K , Tsertsvadze T , Zakalashvili M , Hickman M , Martin NK , Morgan J , Nasrullah M , Averhoff F , Vickerman P . Lancet Glob Health 2019 8 (2) e244-e253 BACKGROUND: Georgia has a high prevalence of hepatitis C, with 5.4% of adults chronically infected. On April 28, 2015, Georgia launched a national programme to eliminate hepatitis C by 2020 (90% reduction in prevalence) through scaled-up treatment and prevention interventions. We evaluated the interim effect of the programme and feasibility of achieving the elimination goal. METHODS: We developed a transmission model to capture the hepatitis C epidemic in Georgia, calibrated to data from biobehavioural surveys of people who inject drugs (PWID; 1998-2015) and a national survey (2015). We projected the effect of the administration of direct-acting antiviral treatments until Feb 28, 2019, and the effect of continuing current treatment rates until the end of 2020. Effect was estimated in terms of the relative decrease in hepatitis C incidence, prevalence, and mortality relative to 2015 and of the deaths and infections averted compared with a counterfactual of no treatment over the study period. We also estimated treatment rates needed to reach Georgia's elimination target. FINDINGS: From May 1, 2015, to Feb 28, 2019, 54 313 patients were treated, with approximately 1000 patients treated per month since mid 2017. Compared with 2015, our model projects that these treatments have reduced the prevalence of adult chronic hepatitis C by a median 37% (95% credible interval 30-44), the incidence of chronic hepatitis C by 37% (29-44), and chronic hepatitis C mortality by 14% (3-30) and have prevented 3516 (1842-6250) new infections and averted 252 (134-389) deaths related to chronic hepatitis C. Continuing treatment of 1000 patients per month is predicted to reduce prevalence by 51% (42-61) and incidence by 51% (40-62), by the end of 2020. To reach a 90% reduction by 2020, treatment rates must increase to 4144 (2963-5322) patients initiating treatment per month. INTERPRETATION: Georgia's hepatitis C elimination programme has achieved substantial treatment scale-up, which has reduced the burden of chronic hepatitis C. However, the country is unlikely to meet its 2020 elimination target unless treatment scales up considerably. FUNDING: CDC Foundation, National Institute for Health Research, National Institutes of Health. |
Progress and challenges in a pioneering hepatitis C elimination program in the country of Georgia, 2015-2018
Averhoff F , Shadaker S , Gamkrelidze A , Kuchuloria T , Gvinjilia L , Getia V , Sergeenko D , Butsashvili M , Tsertsvadze T , Sharvadze L , Zarkua J , Skaggs B , Nasrullah M . J Hepatol 2019 72 (4) 680-687 BACKGROUND & AIMS: Georgia, with a high prevalence of hepatitis C virus (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 persons 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, 78,484 (79.7%) received viremia testing, of these, 66,916 persons (85.3%) tested positive for active HCV infection. A total of 52,576 persons with active HCV infection initiated treatment, 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 among persons screening positive for anti-HCV by 97.5%, however, rates of treatment initiation decreased by 60.7% among diagnosed viremic patients. CONCLUSIONS: Over one-third of persons living with HCV in Georgia have been detected and linked to care and treatment, however, identification and linkage to care of the remaining persons 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. |
Clustering of hepatitis C virus antibody positivity within households and communities in Punjab, India
Trickey A , Sood A , Midha V , Thompson W , Vellozzi C , Shadaker S , Surlikar V , Kanchi S , Vickerman P , May MT , Averhoff F . Epidemiol Infect 2019 147 e283 To better understand hepatitis C virus (HCV) epidemiology in Punjab state, India, we estimated the distribution of HCV antibody positivity (anti-HCV+) using a 2013-2014 HCV household seroprevalence survey. Household anti-HCV+ clustering was investigated (a) by individual-level multivariable logistic regression, and (b) comparing the observed frequency of households with multiple anti-HCV+ persons against the expected, simulated frequency assuming anti-HCV+ persons are randomly distributed. Village/ward-level clustering was investigated similarly. We estimated household-level associations between exposures and the number of anti-HCV+ members in a household (N = 1593 households) using multivariable ordered logistic regression. Anti-HCV+ prevalence was 3.6% (95% confidence interval 3.0-4.2%). Individual-level regression (N = 5543 participants) found an odds ratio of 3.19 (2.25-4.50) for someone being anti-HCV+ if another household member was anti-HCV+. Thirty households surveyed had 2 anti-HCV+ members, whereas 0/1000 (P < 0.001) simulations had 30 such households. Excess village-level clustering was evident: 10 villages had 6 anti-HCV+ members, occurring in 31/1000 simulations (P = 0.031). The household-level model indicated the number of household members, living in southern Punjab, lower socio-economic score, and a higher proportion having ever used opium/bhuki were associated with a household's number of anti-HCV+ members. Anti-HCV+ clusters within households and villages in Punjab, India. These data should be used to inform screening efforts. |
Three years of progress towards achieving hepatitis C elimination in the country of Georgia, April 2015 - March 2018
Tsertsvadze T , Gamkrelidze A , Chkhartishvili N , Abutidze A , Sharvadze L , Kerashvili V , Butsashvili M , Metreveli D , Gvinjilia L , Shadaker S , Nasrullah M , Adamia E , Zeuzem S , Afdhal N , Arora S , Thornton K , Skaggs B , Kuchuloria T , Lagvilava M , Sergeenko D , Averhoff F . Clin Infect Dis 2019 71 (5) 1263-1268 BACKGROUND: In April 2015, in collaboration with U.S. CDC and Gilead Sciences, Georgia embarked on the world's first hepatitis C elimination program. We aimed to assess progress towards elimination targets after three years since the beginning of the elimination program. METHODS: We constructed an HCV care cascade for adults in Georgia, based on the estimated 150,000 persons age >/= 18 years with active HCV infection. All patients who were screened or entered the treatment program during April 2015 - March 2018 were included in the analysis. Data on the number of persons screened for HCV was extracted from the national HCV screening database. For treatment component we utilized data from the Georgia National HCV treatment program database. Available treatment options included sofosbuvir (SOF) and ledipasvir/sofosbuvir (LDV/SOF) based regimens. RESULTS: Since April 2015, a cumulative 974,817 adults were screened for HCV antibodies, 86,624 persons tested positive, of which 61,925 underwent HCV confirmatory testing. Among estimated 150,000 adults living with chronic hepatitis C in Georgia, 52,856 (35.1%) were diagnosed, 45,334 (30.2%) initiated treatment with DAA, and 29,090 (19.4%) achieved sustained virologic response (SVR). Overall 37,256 persons were eligible for SVR assessment, of these only 29,620 (79.5%) returned for evaluation. In the per-protocol analysis, SVR rate achieved was 98.2% (29,090/29,620), and 78.1% (29,090/37,256) in the intent-to-treat analysis. CONCLUSIONS: Georgia has made substantial progress in the path towards eliminating hepatitis C. Scaling-up testing and diagnosis, along with effective linkage to treatment services are needed to achieve the goal of elimination. |
Excellence in viral hepatitis elimination - lessons from Georgia
Averhoff F , Lazarus JV , Sergeenko D , Colombo M , Gamkrelidze A , Tsertsvadze T , Butsashvili M , Metreveli D , Sharvadze L , Hellard M , Gnes S , Gabunia T , Nasrullah M . J Hepatol 2019 71 (4) 645-647 Globally, there are more than 70 million people living with chronic hepatitis C virus (HCV) infection, and an estimated 257 million people are living with hepatitis B virus (HBV) infection, both of which cause significant morbidity and mortality primarily as consequences of chronic infection, including hepatocellular carcinoma and liver failure.1 Georgia, a small country in the South Caucasus, has a high prevalence of HCV infection with an estimated 150,000 adults living with hepatitis C, representing 5.4% of the adult population.2 Georgia was the first country in the world to undertake the challenge of hepatitis C elimination. A serosurvey in 2015 laid the foundation for the elimination program; the survey not only defined the burden of hepatitis C in the country, but also identified the major risk factors for transmission (injection drug use and receipt of blood products) and the demographic profile of those infected, thus allowing for clear characterization of the epidemic including identifying the most at-risk populations.2 The cost of treatment in 2015 was prohibitive, so a key partnership was established with Gilead Sciences, who agreed to support the elimination program by providing free-of-charge treatment directly to the country because of the government's commitment to hepatitis C elimination nationwide. |
Progress in testing for and treatment of hepatitis C virus infection among persons who inject drugs - Georgia, 2018
Stvilia K , Spradling PR , Asatiani A , Gogia M , Kutateladze K , Butsashvili M , Zarkua J , Tsertsvadze T , Sharvadze L , Japaridze M , Kuchuloria T , Gvinjilia L , Tskhomelidze I , Gamkrelidze A , Khonelidze I , Sergeenko D , Shadaker S , Averhoff F , Nasrullah M . MMWR Morb Mortal Wkly Rep 2019 68 (29) 637-641 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
Hagan LM , Kasradze A , Salyer SJ , Gamkrelidze A , Alkhazashvili M , Chanturia G , Chitadze N , Sukhiashvili R , Shakhnazarova M , Russell S , Blanton C , Kuchukhidze G , Baliashvili D , Hariri S , Ko S , Imnadze P , Drobeniuc J , Morgan J , Averhoff F . BMC Public Health 2019 19 480 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. |
An evaluation of the hepatitis C testing, care and treatment program in the country of Georgia's corrections system, December 2013 - April 2015
Harris AM , Chokoshvili O , Biddle J , Turashvili K , Japaridze M , Burjanadze I , Tsertsvadze T , Sharvadze L , Karchava M , Talakvadze A , Chakhnashvili K , Demurishvili T , Sabelashvili P , Foster M , Hagan L , Butsashvili M , Morgan J , Averhoff F . BMC Public Health 2019 19 466 Background: The country of Georgia has a high burden of chronic hepatitis C virus (HCV) infection, and prisoners are disproportionately affected. During 2013, a novel program offering no cost screening and treatment of HCV infection for eligible prisoners was launched. Methods: The HCV treatment program implemented a voluntary opt-in anti-HCV testing policy to all prisoners. Anti-HCV positive persons received HCV RNA and genotype testing. Transient elastography was also performed on prisoners with positive HCV RNA results. Prisoners with chronic HCV infection who had ≥F2 Metavir stage for liver fibrosis and a prison sentence ≥ 6 months were eligible for interferon-based treatment, which was the standard treatment prior to 2015. We conducted an evaluation of the HCV treatment program among prisoners from the program's inception in December 2013 through April 2015 by combining data from personal interviews with corrections staff, prisoner data in the corrections database, and HCV-specific laboratory information. Results: Of an estimated 30,000 prisoners who were incarcerated at some time during the evaluation period, an estimated 13,500 (45%) received anti-HCV screening, of whom 5175 (38%) tested positive. Of these, 3840 (74%) received HCV RNA testing, 2730 (71%) tested positive, and 880 (32%) met treatment eligibility. Of these, 585 (66%) enrolled; 405 (69%) completed treatment, and 202 (50%) achieved a sustained virologic response at least 12 weeks after treatment completion. Conclusions: HCV infection prevalence among Georgian prisoners was high. Despite challenges, we determined HCV treatment within Georgian Ministry of Correction facilities was feasible. Efforts to address HCV infection among prison population is one important component of HCV elimination in Georgia. |
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