Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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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. |
Treatment of hepatitis C in primary health care in the country of Georgia
Dolmazashvili E , Sharvadze L , Abutidze A , Chkhartishvili N , Todua M , Adamia E , Gabunia T , Shadaker S , Gvinjilia L , Arora S , Thornton K , Armstrong PA , Tsertsvadze T . Clin Liver Dis (Hoboken) 2022 20 (5) 175-178 Content available: Audio Recording. |
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. |
Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.
Morgan JR , Marsh E , Savinkina A , Shilton S , Shadaker S , Tsertsvadze T , Kamkamidze G , Alkhazashvili M , Morgan T , Belperio P , Backus L , Doss W , Esmat G , Hassany M , Elsharkawy A , Elakel W , Mehrez M , Foster GR , Wose K , Chew KW , Chasela CS , Sanne IM , Thanung YM , Loarec A , Aslam K , Balkan S , Easterbrook PJ , Linas BP . J Viral Hepat 2022 29 (6) 474-486 Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12-weeks post-treatment (SVR12). We assembled a global dataset of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique), and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90(th) , 95th, 97th, and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5,973 cases of detectable viremia at SVR12 from the combined dataset. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95(th) percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viremia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR=1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure. |
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. |
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. |
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. |
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. |
The role of screening and treatment in national progress toward hepatitis C elimination - Georgia, 2015-2016
Nasrullah M , Sergeenko D , Gvinjilia L , Gamkrelidze A , Tsertsvadze T , Butsashvili M , Metreveli D , Sharvadze L , Alkhazashvili M , Shadaker S , Ward JW , Morgan J , Averhoff F . MMWR Morb Mortal Wkly Rep 2017 66 (29) 773-776 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. |
Prevalence and diversity of Bartonella species in rodents from Georgia (Caucasus)
Malania L , Bai Y , Osikowicz LM , Tsertsvadze N , Katsitadze G , Imnadze P , Kosoy M . Am J Trop Med Hyg 2016 95 (2) 466-471 Bartonella infections are widespread and highly prevalent in rodents. Several rodent-associated Bartonella species have been related to human diseases. Recently, Bartonella species was reported as the etiology of a human case in the country of Georgia (Caucasus). However, information on Bartonella in rodents in Georgia is absent. Rodent hearts were collected from Georgia to investigate the presence and diversity of Bartonella species. Bartonella bacteria were cultured from 37.2% (16/43) of rodents examined, while Bartonella DNA was detected in 41.2% (28/68) of rodents by polymerase chain reaction targeting citrate synthase (gltA) gene. Sequences of gltA showed that rodents in this region harbored multiple Bartonella strains, including Bartonella elizabethae, Bartonella tribocorum, Bartonella grahamii, and an unknown genogroup. The first three Bartonella species, known to be rat-associated and human cases linked, were commonly observed in wood mice (Apodemus [Sylvaemus] uralensis) (5/8 positive with B. elizabethae and B. tribocorum) and social voles (Microtus socialis) (4/6 positive with B. grahamii and B. elizabethae) in this study. The frequent distribution of these Bartonella species suggests that they may contribute to unidentified clinical infections. The unknown genogroup was observed in 24 Bartonella isolates and/or DNA extracts from heart tissues, all of which were obtained from Libyan jirds (Meriones libycus). Further characterization of the bacterial cultures based on sequence analysis of four additional genes (ftsZ, nuoG, rpoB, and ssrA) supported that the jird-associated Bartonella strains comprise a distinct monophyletic clade. The impact of this bacterium on wildlife and human health needs to be determined. |
Launch of a nationwide hepatitis C elimination program - Georgia, April 2015
Mitruka K , Tsertsvadze T , Butsashvili M , Gamkrelidze A , Sabelashvili P , Adamia E , Chokheli M , Drobeniuc J , Hagan L , Harris AM , Jiqia T , Kasradze A , Ko S , Qerashvili V , Sharvadze L , Tskhomelidze I , Kvaratskhelia V , Morgan J , Ward JW , Averhoff F . MMWR Morb Mortal Wkly Rep 2015 64 (28) 753-7 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. |
Investigation of an outbreak of bloody diarrhea complicated with hemolytic uremic syndrome
Chokoshvili O , Lomashvili K , Malakmadze N , Geleishvil M , Brant J , Imnadze P , Chitadze N , Tevzadze L , Chanturia G , Tevdoradze T , Tsertsvadze T , Talkington D , Mody RK , Strockbine N , Gerber RA , Maes E , Rush T . J Epidemiol Glob Health 2014 4 (4) 249-59 In July-August 2009, eight patients with bloody diarrhea complicated by hemolytic uremic syndrome (HUS) were admitted to hospitals in Tbilisi, Georgia. We started active surveillance in two regions for bloody diarrhea and post-diarrheal HUS. Of 25 case-patients who developed HUS, including the initial 8 cases, half were 15years old, 67% were female and seven (28%) died. No common exposures were identified. Among 20 HUS case-patients tested, Shiga toxin was detected in the stools of 2 patients (one with elevated serum IgG titers to several Escherichia coli serogroups, including O111 and O104). Among 56 persons with only bloody diarrhea, we isolated Shiga toxin-producing E. coli (STEC) O104:H4 from 2 and Shigella from 10; 2 had serologic evidence of E. coli O26 infection. These cases may indicate a previously unrecognized burden of HUS in Georgia. We recommend national reporting of HUS and improving STEC detection capacity. |
Etiologic agents of central nervous system infections among febrile hospitalized patients in the country of Georgia
Akhvlediani T , Bautista CT , Shakarishvili R , Tsertsvadze T , Imnadze P , Tatishvili N , Davitashvili T , Samkharadze T , Chlikadze R , Dvali N , Dzigua L , Karchava M , Gatserelia L , Macharashvili N , Kvirkvelia N , Habashy EE , Farrell M , Rowlinson E , Sejvar J , Hepburn M , Pimentel G , Dueger E , House B , Rivard R . PLoS One 2014 9 (11) e111393 OBJECTIVES: There is a large spectrum of viral, bacterial, fungal, and prion pathogens that cause central nervous system (CNS) infections. As such, identification of the etiological agent requires multiple laboratory tests and accurate diagnosis requires clinical and epidemiological information. This hospital-based study aimed to determine the main causes of acute meningitis and encephalitis and enhance laboratory capacity for CNS infection diagnosis. METHODS: Children and adults patients clinically diagnosed with meningitis or encephalitis were enrolled at four reference health centers. Cerebrospinal fluid (CSF) was collected for bacterial culture, and in-house and multiplex RT-PCR testing was conducted for herpes simplex virus (HSV) types 1 and 2, mumps virus, enterovirus, varicella zoster virus (VZV), Streptococcus pneumoniae, HiB and Neisseria meningitidis. RESULTS: Out of 140 enrolled patients, the mean age was 23.9 years, and 58% were children. Bacterial or viral etiologies were determined in 51% of patients. Five Streptococcus pneumoniae cultures were isolated from CSF. Based on in-house PCR analysis, 25 patients were positive for S. pneumoniae, 6 for N. meningitidis, and 1 for H. influenzae. Viral multiplex PCR identified infections with enterovirus (n = 26), VZV (n = 4), and HSV-1 (n = 2). No patient was positive for mumps or HSV-2. CONCLUSIONS: Study findings indicate that S. pneumoniae and enteroviruses are the main etiologies in this patient cohort. The utility of molecular diagnostics for pathogen identification combined with the knowledge provided by the investigation may improve health outcomes of CNS infection cases in Georgia. |
Nosocomial infections in Tbilisi, Georgia: a retrospective study of microbiological data from 4 major tertiary care hospitals
Kandelaki G , Butsashvili M , Geleishvili M , Avaliani N , Macharashvili N , Topuridze M , Del Rio C , Blumberg HM , Tsertsvadze T . Infect Control Hosp Epidemiol 2011 32 (9) 933-4 The study aimed to evaluate epidemiology of nosocomial pathogens and their resistance patterns at four major tertiary care centers in Tbilisi, Georgia. Out of 3452 samples included in the study 1607 positive culture results were documented (46.6%). Study showed considerable burden of nosocomial infections on Georgian health care system. |
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