Hepatitis C Virus Ab Research Articles

A-268 Comparison of the Elecsys® HCV Duo Assay to Standard of Care Algorithmic Testing

Abstract Background Traditional hepatitis C virus (HCV) testing methods, though effective, may miss crucial diagnostic opportunities. The goal of this study was to assess the utility of Elecsys® HCV Duo antibody/antigen (Ab/Ag) assay as an alternative to traditional HCV algorithmic testing in the United States. Methods A prospective study was conducted at Barnes Jewish Hospital in St. Louis, Missouri. Patients with concurrent HCV Ab and molecular testing ordered within 48 h were enrolled. A total of 1,351 remnant serum and plasma-EDTA specimens were frozen following standard of care testing, which consisted of the Abbott Architect anti-HCV assay with reflex to cobas® HCV molecular assay. Patient demographics, risk factors, and results from both standard of care and HCV Duo testing were recorded. Results Among 1351 specimens, the HCV positivity rate as defined by algorithm was 19.9% (269/1351). Risk factors including homelessness and prior intravenous drug use were significantly associated with HCV diagnosis (P<0.0001). HCV Duo testing demonstrated a positivity rate of 19.6% (263/1345) based on Ab/Ag dual positivity. Comparing the HCV Duo Ab module to standard of care serology revealed a 95.1% PPA (95% CI, 93.1-96.5) and 98.8% NPA (95% CI, 97.7-99.4), while the HCV Duo Ag component exhibited a 72.3% PPA (95% CI, 66.7-77.3) and 99.6% NPA (95% CI, 99.1-99.9) when compared to molecular testing. In HCV-RNA+ patients, the Ag component was positively correlated to viral load with a Spearman r of 0.770 (95% CI, 0.715-0.815). The median viral load with for patients with Ag+ results was 6.27 log10 IU/mL (IQR, 5.90-6.69) and for patients with Ag- results was 5.08 log10 IU/mL (IQR, 4.47-5.61). Of HCV-RNA+ specimens , 266/271 (98.2%) were successfully detected on the Ab module. Among anti-HCV+/HCV-RNA+ cases, 99.2% (261/263) were detected as Ab+/Ag+ on the HCV Duo assay. These had a turnaround time (TAT) from serology to molecular results of 28.1 ± 23.5 h, which may have been significantly decreased if Ab/Ag dual positivity was solely used to establish a diagnosis (average TAT of 27 min). The remaining two discrepant specimens were from patients with a prior history of HCV infection, which may represent false negatives or seronegative chronic HCV infections. Notably, 5/8 (62.5%) anti-HCV-/HCV-RNA+ specimens were detected on the HCV Duo assay, which would have been missed by traditional algorithmic testing. These five patients had viral loads ranging from 323-41,400,000 IU/mL, compared to <15-5,400 IU/mL in the three undetected specimens. Of these five additional patient specimens captured on HCV Duo, two patients received an organ from an HCV+ donor, while the remaining three had no known history of HCV infection or transplant from an HCV+ donor. Conclusions The Elecsys® HCV Duo Ab/Ag assay, with its high sensitivity and specificity, drastically shortens the diagnostic window. Importantly, it successfully identified several anti-HCV-/HCV-RNA+ cases, a subgroup often undiagnosed by current algorithmic testing, demonstrating promise for improved diagnostic efficiency and accuracy in HCV detection. Further investigation is needed to determine whether improved diagnostic efficiency is due to enhanced antibody or antigen detection.

Comparison of a dual antibody and antigen HCV immunoassay to standard of care algorithmic testing.

The Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing, although effective, may miss crucial diagnostic opportunities. The goal of this study was to assess the utility of an antibody (Ab) and antigen (Ag) combination immunoassay as an alternative to traditional HCV screening. Remnant specimens from 1,341 patients with concurrent third-generation serologic (Roche anti-HCV-II) and nucleic acid amplification testing (NAAT) were assessed using the HCV Duo Ab/Ag immunoassay (Roche). Patient demographics, risk factors, and standard of care (SOC) laboratory results from the medical records were recorded. Overall, 99.0% (197/199) of the HCV Duo Ab+/Ag+specimens accurately identified active infections as confirmed by NAAT, and 99.9% (670/671) Ab-/Ag- samples corresponded to those without HCV infections. Individually, the HCV Duo Ab component demonstrated a 95.6% positive percent agreement (PPA) (95% CI = 93.8-96.9) and 99.1% negative percent agreement (NPA) (98.8-99.6) compared with SOC anti-HCV II Ab assay. The HCV Duo Ag had a 73.5% PPA (67.9-78.4) and 99.8% NPA (99.3-100) with NAAT. Among RNA+ specimens, 73.4% (197/267) were HCV Duo Ag+, and 265/267 (99.3%) were successfully detected on the HCV Duo Ab component. Notably, 5/7 (71.4%) Ab-/RNA +specimens were detected by HCV Duo, which would have been missed by traditional algorithmic testing. Fourth generation HCV Duo Ab/Ag assay demonstrated comparable performance to SOC testing and shortens the diagnostic window but does not eliminate the need for NAAT in all patients. Ab/Ag testing identified several Ab-/RNA+ cases, a subgroup often undiagnosed by current algorithmic testing, demonstrating promise for improved diagnostic efficiency and accuracy in HCV detection.IMPORTANCEThis study highlights the potential of a combined hepatitis C virus (HCV) Duo antibody (Ab) and antigen (Ag) immunoassay to improve early detection of HCV infections. Traditional Ab-only screening methods recommended by the Centers for Disease Control and Prevention may miss early-stage infections. The HCV Duo assay showed high accuracy, detecting nearly all active infections confirmed by nucleic acid amplification testing. Dual detection of HCV Ab and Ag shortens the diagnostic window, enabling intervention and treatment in a single visit, which is crucial for improving patient outcomes and reducing HCV transmission, especially in areas with limited access to confirmatory molecular testing.

Utilising integrated bio-behavioural surveillance (IBBS) to investigate declining hepatitis C antibody prevalence among people who inject drugs in the Australian Needle and Syringe Program Survey

BackgroundPrevalence of hepatitis C virus (HCV) antibody (Ab) on dried blood spot (DBS) samples in the Australian Needle and Syringe Program Survey (ANSPS) decreased nationally from 57 % in 2015 to 32 % in 2022. We aimed to investigate potential explanations for this decline. MethodsChanges in DBS HCV Ab prevalence were investigated by redefining positive cases as those with those with either a positive HCV Ab test result or a self-reported history of ever having HCV treatment (modified prevalence), examining HCV Ab prevalence by birth and age cohorts, and assessing trends in key risk behaviours. ResultsOverall prevalence of DBS HCV Ab declined rapidly and significantly from 57 % in 2015 to 32 % in 2022 (p < 0.001) however modified HCV Ab prevalence remained stable over time (85 % and 88 % in 2015 and 2022, respectively, p = 0.357). The proportion of participants with negative HCV Ab and self-reported HCV infection increased from 20 % in 1995 to 40 % in 2022 (p < 0.001) and the proportion with negative HCV Ab and lifetime HCV treatment increased from 3 % in 1999 to 67 % in 2022 (p < 0.001). We also observed a decreasing trend in DBS HCV Ab prevalence in all birth and age cohorts with a noticeable acceleration in the decline commensurate with the advent of HCV DAA treatment. A long-term decreasing trend was also observed for key risk behaviours (p < 0.001) however the short-term trend was not significant for recent receptive syringe sharing. ConclusionThe temporal decline in HCV Ab prevalence appears related to reduced sensitivity of DBS HCV Ab detection with viral clearance following treatment. Since 2016, HCV treatment uptake has increased markedly including among people who inject drugs. In this context, continuing to monitor HCV Ab prevalence by DBS testing is problematic, with a shift to surveillance of active infection the most relevant to guide policy and practice in this setting.

Publisher's Note

BackgroundPrevalence of hepatitis C virus (HCV) antibody (Ab) on dried blood spot (DBS) samples in the Australian Needle and Syringe Program Survey (ANSPS) decreased nationally from 57% in 2015 to 32% in 2022. We aimed to investigate potential explanations for this decline. MethodsChanges in DBS HCV Ab prevalence were investigated by redefining positive cases as those with those with either a positive HCV Ab test result or a self-reported history of ever having HCV treatment (modified prevalence), examining HCV Ab prevalence by birth and age cohorts, and assessing trends in key risk behaviours. ResultsOverall prevalence of DBS HCV Ab declined rapidly and significantly from 57% in 2015 to 32% in 2022 (p<0.001) however modified HCV Ab prevalence remained stable over time (85% and 88% in 2015 and 2022, respectively, p=0.357). The proportion of participants with negative HCV Ab and self-reported HCV infection increased from 20% in 1995 to 40% in 2022 (p<0.001) and the proportion with negative HCV Ab and lifetime HCV treatment increased from 3% in 1999 to 67% in 2022 (p<0.001). We also observed a decreasing trend in DBS HCV Ab prevalence in all birth and age cohorts with a noticeable acceleration in the decline commensurate with the advent of HCV DAA treatment. A long-term decreasing trend was also observed for key risk behaviours (p<0.001) however the short-term trend was not significant for recent receptive syringe sharing. ConclusionThe temporal decline in HCV Ab prevalence appears related to reduced sensitivity of DBS HCV Ab detection with viral clearance following treatment. Since 2016, HCV treatment uptake has increased markedly including among people who inject drugs. In this context, continuing to monitor HCV Ab prevalence by DBS testing is problematic, with a shift to surveillance of active infection the most relevant to guide policy and practice in this setting.

Decentralised same day test and treatment of hepatitis C levering existing peer support networks among men who inject drugs: feasibility and effectiveness

BackgroundPrevalence of hepatitis C virus (HCV) infection among people who inject drugs in the state of Manipur, India, is 43%; however, access to care is poor. We piloted a Community-led and comprehensive hepatitis care model that included same-day HCV treatment at drug treatment centres.MethodsScreening was conducted through venipuncture samples collected by community peer PWID, using HCV antibody (HCV Ab) rapid screening and hepatitis B virus (HBV) surface antigen (HBsAg) rapid diagnostic tests. Reactive HCV Ab samples were tested for HCV RNA using near point-of-care Truenat® HCV on Truelab® Quattro. Eligible HCV RNA-positive participants were treated on the same day using direct-acting antivirals and followed for sustained virologic response (SVR). HBsAg-negative participants received rapid HBV vaccination regimen while those positive for HBsAg were tested for DNA and referred for treatment.ResultsBetween November 2021 and August 2022, 643 individuals were approached and 503 consented and were screened. All screened were males with history of injection drug use, and a median age of 27 years (IQR 23–32). Of the 241 (47.9%) HCV Ab reactive all underwent RNA testing and 156 (64.7%) were RNA detectable. Of those with viraemia, 155 (99.4%) were initiated on treatment with 153 (98.1%) on same day, with 2 (1.2%) HBsAg positive and waiting for HBV DNA results. Among those 153, median time from HCV Ab screening to treatment was 6 h 38 min (IQR 5 h 42 min–8 h 23 min). In total 155 (100%) completed HCV treatment, of those 148 (95.5%) completed SVR testing and 130 (87.8%) achieved SVR12. 27 (5%) participants were HBsAg-positive, 3 (11.1%) were also living with HCV viraemia; 443 (97.6%) were eligible for vaccination and 436 (98.4%) received all 3 vaccine doses.ConclusionCommunity-led hepatitis care incorporating same day “test and treat” for HCV was feasible and effective. HBV screening identified a large proportion who were unvaccinated. Peer support extended resulted in ensuring compliance to care and treatment cascade and completing all the three doses of HBV vaccination. As the screening, diagnostics infrastructure and vaccine are available in most countries with national viral hepatitis programs also in place, our model can be adapted or replicated to progress towards global elimination targets.

Screening for hepatitis C virus at the time of mammography using rapid diagnostic tests in women aged between 50 and 74 years (Mamm'OC NCT05067374).

Chronic hepatitis C Virus (HCV) infection presents a global health challenge, with significant morbidity and mortality worldwide. Despite remarkable progress in treatment options, achieving elimination targets by 2030, as set by the World Health Organization, remains elusive. Our study aimed to address this gap by integrating HCV screening into a national breast cancer screening program. Between March 2022 and March 2023, a prospective cross-sectional multicenter study was conducted in four radiology centers in Montpellier, France. We proposed HCV screening to consecutive women undergoing mammography, targeting 1,500 participants aged 50-74 years. A rapid diagnostic test (RDT) for HCV antibodies (HCV Ab) was performed on capillary whole blood, with positive cases undergoing serological and RNA confirmation. Participants also completed a questionnaire on demographic data and risk factors. Acceptance rates, HCV prevalence, and linkage to care were assessed. The acceptance rate for this integrated screening approach was 82.4%. Notably, the seroprevalence of HCV was found to be 0.65%. Linkage to care was prompt, and the cascade of care demonstrated successful treatment outcomes. Importantly, the majority of detected infections were successfully resolved. These findings underscore the feasibility and acceptability of integrating HCV screening with breast cancer screening programs providing updated prevalence data and valuable insights for refining future screening strategies.

Distribution of ABO/Rhesus Blood Groups Among Hepatitis B and C Virus (HBV Ag, HCV Ab) Positive Patients in Anbar Providence, Iraq

This study aimed to retrospectively investigate the prevalence of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections among blood donors at Anbar Blood Bank in Iraq. The study also explored the correlation between ABO and Rh blood groups with Transfusion-Transmissible Infections (TTIs) and sociodemographic factors and cross-sectional retrospective study was conducted on 100 blood donors at Anbar Blood Bank from March 24, 2023, to June 21, 2023. Inclusion criteria encompassed HBV and HCV-positive patients who provided consent, while exclusion criteria included individuals without HBV and HCV infections. Blood samples (5 mL) were collected, and tests for TTI markers (HBV, HCV) and ABO and Rh blood grouping were performed using enzyme-linked immunosorbent assay (ELISA) and slide method, respectively. Sociodemographic data, TTI marker results, and ABO and Rh blood types were recorded for analysis. Descriptive analysis of sociodemographic data was performed, and a chi-square test was employed to assess the correlation between ABO and Rh blood groups with TTI markers and sociodemographic factors (Age, sex, and living area). Statistical significance was set at P&lt;0.05. The results revealed a male predominance (71%), with the majority aged between 20-30 years (39%) and residing in rural areas (52%). The most common blood group was O+ (39%), while AB- was the least prevalent (0%). In terms of viral infections, 80% of participants were found to be infected with HBs Ag, and 20% with HCV Ab. Notably, blood group O+ exhibited the highest infection rates for both HBs (28%) and HCV (11%), while blood group A- demonstrated the lowest HBs infection rate (3%) and no HCV infection. The study provides valuable insights into the prevalence of HBV and HCV infections among blood donors in Anbar, Iraq. Additionally, correlations between ABO and Rh blood groups, TTI markers, and sociodemographic factors were explored. The findings contribute to the understanding of transfusion safety and may inform blood screening and donor selection protocols.

The burden of HCV among prevalent hemodialysis patients after the National Egyptian HCV Eradication program

In the first phase of its treatment program, Egypt aimed to treat 250,000 people annually until 2020, thereby reducing the number of viremic patients and limiting hepatitis C virus (HCV) transmission. Egypt strives to eradicate HCV and HCV-associated morbidity by 2030. This study aimed to determine the prevalence of HCV infection among end-stage renal disease patients and the reasons for non-treatment among those offered free medication. This multi-center cross-sectional study was conducted during the period from November 2022 to April 2023. The study included 500 patients receiving hemodialysis (HD) sessions on a regular basis for more than three months in Dakahlia Governorate. According to patients` medical history, we found that 23.4% of patients had previous HCV infection. Of these, 12.6% received treatment, and 10.8% did not receive treatment due to a variety of reasons. For instance, some patients were unaware of the drug’s availability, five patients (1%) feared side effects, 43 patients (8.6%) did not require treatment, and five patients (1%) had other causes as contraindications of drugs, noncompliance and deterioration of health status. In addition, 20.4% of patients were reported to have fully recovered, while 0.8% had a recurrence. After investigations, 1% of patients had positive hepatitis B surface antigen (HbsAg), 23.4% positive HCV Ab, and 4.2% positive HCV by the polymerase chain reaction. In conclusion, the low prevalence of HCV among HD patients confirms that HCV infection is not currently a significant health concern among patients on maintenance HD.

Hepatitis C prevalence and cascade of care among patients in the decentralised opioid agonist therapy programme of the canton of St Gallen, Switzerland: a cross-sectional study.

To eliminate chronic hepatitis C virus (HCV) infection by 2030, 90% of those infected must be diagnosed and 80% treated. In Switzerland, >40% of the estimated 32,000 infected people are still undiagnosed. In the canton of St Gallen, HCV prevalence and cascade of care have only been studied in the centralised opioid agonist therapy (OAT) setting (institutions), although about 80% of OAT patients are treated decentrally (general practitioner [GP] or pharmacy). To describe HCV prevalence and cascade of care among patients in the decentralised OAT programme of the canton of St Gallen, Switzerland, and compare it to contemporaneous data from the centralised setting. For each patient receiving his/her OAT from a GP or pharmacy on 1 April 2021, the cantonal medical office sent a questionnaire to the prescribing GP. Patient characteristics, HCV antibody (Ab)/RNA screening uptake, HCV Ab/RNA prevalence and HCV treatment uptake were obtained and compared to those of patients of the Medizinisch-soziale Hilfsstelle 1 in St Gallen (centralised setting). Of the 563 OAT patients under the care of 127 GPs, 107 patients from 41 GPs could be analysed (median age: 48 years [IQR: 40-56]; ongoing intravenous drug use: 25%; OAT provider: 66% GP, 34% pharmacy). HCV Ab screening uptake was 68% (73/107) with an HCV Ab prevalence of 68% (50/73) among those tested. Of the HCV Ab-positive patients, 84% (42/50) were HCV RNA-tested, among whom 57% (24/42) were viraemic. HCV treatment uptake was 83% (20/24), with 95% (19/20) achieving a sustained virological response. Non-uptake of HCV screening and treatment tended to be higher among patients receiving OAT at the pharmacy vs at the GP's office: 37% vs 26% (p = 0.245) for screening and 30% vs 7% (p = 0.139) for treatment. The proportion never HCV Ab-tested and the proportion of HCV Ab-positives never HCV RNA-tested was significantly higher in the decentralised compared to the centralised setting: 32% vs 3% (p <0.001) never Ab-tested and 16% vs 0% (p = 0.002) never RNA-tested. In contrast, HCV treatment uptake (83% vs 78%), sustained virological response rate (95% vs 100%) and residual HCV RNA prevalence among the HCV Ab-positive (12% vs 14%) were comparable for both settings. In the decentralised OAT setting of the canton of St Gallen, HCV Ab prevalence is high. Since HCV Ab and RNA screening uptake are markedly lower than in the centralised setting, potentially >40% of patients with chronic HCV are not diagnosed yet. HCV screening in the decentralised setting needs improvement, e.g. by increasing awareness and simplifying testing. High HCV treatment uptake and cure rates are possible in centralised and decentralised settings.

Hepatitis C virus antibody seropositivity is associated with albuminuria but not peripheral artery disease in patients with type 2 diabetes

Hepatitis C virus (HCV) infection is prevalent in patients with type 2 diabetes mellitus (DM). We aimed to investigate whether HCV antibody (Ab) seropositivity is associated with diabetic micro- and macro-vascular diseases. In this hospital-based cross-sectional study, we retrospectively collected data from patients who participated in the diabetes pay-for-performance program and underwent HCV Ab screening in the annual comprehensive assessment between January 2021 and March 2022. We examined the relationships of HCV Ab seropositivity with the spot urinary albumin-to-creatinine ratio (UACR) and ankle-brachial index (ABI) in patients aged ≥ 50 years with type 2 DM. A total of 1758 patients were enrolled, and 85 (4.83%) of the enrolled patients had HCV Ab seropositivity. Multivariable regression analyses revealed that albuminuria showed a dose-dependent association with HCV Ab seropositivity (UACR [30–299 mg/g]: odds ratio [OR] = 1.463, 95% confidence interval [CI] 0.872‒2.456); UACR [≥ 300 mg/g]: OR = 2.300, 95% CI 1.160‒4.562; P for trend = 0.015) when compared with normal albuminuria (UACR < 30 mg/g). However, the proportion of patients with peripheral arterial disease, defined as an ABI ≤ 0.9, was not significantly different between the groups with and without HCV Ab seropositivity (3.5% vs. 3.9%, P = 0.999). In conclusion, severely increased albuminuria, but not the ABI, showed a significant association with HCV Ab seropositivity in patients aged ≥ 50 years with type 2 DM.

Birth cohort-specific consideration in an Emergency Department Hepatitis C Testing Programme: A description of age-related characteristics and outcomes.

The emergency department (ED) has increasingly become an important public health partner in non-targeted hepatitis C virus (HCV) testing and referral to care efforts. HCV has traditionally been an infection associated with the Baby Boomer generation; however, recent exacerbation of the opioid epidemic has resulted in a growing number of younger cohorts, namely Millennials, also impacted by HCV. Examination of this age-related demographic shift, including subsequent linkage success and linkage barriers, from the perspective of an ED-based testing and linkage programme may have implications for future population and health systems interventions. A retrospective descriptive chart review was performed, inclusive of data from August 2015 through December 2020. We compared the quantity of positive HCV screening antibody (Ab) and confirmatory (RNA) tests and further considered linkage rates and correlative demographics (e.g. gender, race). Patient barriers to HCV care linkage (e.g. substance misuse, lack of health insurance, homelessness) were also evaluated. The data set was disaggregated by birth cohort to include Silent Generation (SG) (1928-45), Baby Boomer (BB) (1946-64), Generation X (Gen X) (1965-80), Millennial (1981-96) and Generation Z (1997-2012). Descriptive statistics and chi-square analysis were performed. Overall, 83,817 patients were tested for HCV (50.6% of eligible); 6187 (7.4%) were HCV Ab positive, and 2665 were HCV RNA positive (3.2%). RNA-positive individuals were more likely to be white (70.4%) and male (67.7%); generational distribution was similar (BB 33.3%, Gen X 32.0% and Millennials 32.7%). Amongst Ab-positive patients, white (45.5%), male (47.2%) and Millennial (49.7%) individuals were most likely to be RNA-positive. Overall, 28.1% of the RNA-positive cohort successfully linked to care; linkage to care rates were significantly higher in older generations (38.1% in BB vs. 17.8% in Millennials) (p < .00001). Over 90% were identified as having at least one linkage to care barrier. Younger generations (Gen X and Millennials) were disproportionately impacted by linkage barriers, including incarceration, lack of health insurance, history of mental health and substance use disorders, as well as history of or active injection drug use (IDU) (p < .00001). Older generations (SG and BB) were more likely to be impacted by competing medical comorbidities (p < .00001). The ED population represents a particularly vulnerable, at-risk cohort with a high prevalence of HCV and linkage to care barriers. While past HCV-specific recommendations and interventions have focused on Baby Boomers, this data suggests that younger generations, including Gen X and Millennials, are increasingly affected by HCV and face disparate social risk and social need factors which impede definitive care linkage and treatment.

HepFREEPak: protocol for a multi-centre, prospective observational study examining efficacy and impact of current therapies for the treatment of hepatitis C in Pakistan and reporting resistance to antiviral drugs: study protocol

BackgroundPakistan has one of the highest burdens of Hepatitis C virus (HCV) infection globally. To achieve the World Health Organization’s goals for HCV elimination, there is a need for substantial scale-up in testing, treatment, and a reduction in new infections. Data on the population impact of scaling up treatment is not available in Pakistan, nor is there reliable data on the incidence of infection/reinfection. This project will fill this gap by providing important empirical data on the incidence of infection (primary and reinfection) in Pakistan. Then, by using this data in epidemic models, the study will determine whether response rates achieved with affordable therapies (sofosbuvir plus daclatasvir) will be sufficient to eliminate HCV in Pakistan.MethodsThis prospective multi-centre cohort study will screen 25,000 individuals for HCV antibody (Ab) and RNA (if Ab-positive) at various centers in Pakistan- Karachi (Sindh) and Punjab, providing estimates of the disease prevalence. HCV positive patients will be treated with sofosbuvir and daclatasvir for 12-weeks, (extended to 24-weeks in those with cirrhosis) and the proportion responding to this first-line treatment estimated. Patients who test HCV Ab negative will be recalled 12 months later to test for new HCV infections, providing estimates of the incidence rate. Patients diagnosed with HCV (~ 4,000) will be treated and tested for Sustained Virological Response (SVR). Questionnaires to assess risk factors, productivity, health care usage and quality of life will be completed at both the initial screening and at 12-month follow-up, allowing mathematical modelling and economic analysis to assess the current treatment strategies. Viral resistance will be analysed and patients who have successfully completed treatment will be retested 12 months later to estimate the rate of re-infection.ConclusionThe HepFREEPak study will provide evidence on the efficacy of available and widely used treatment options in Pakistan. It will also provide data on the incidence rate of primary infections and re-infections. Data on incidence risk factors will allow us to model and incorporate heterogeneity of risk and how that affects screening and treatment strategies. These data will identify any gaps in current test-and-treat programs to achieve HCV elimination in Pakistan.Study registrationThis study was registered on clinicaltrials.gov (NCT04943588) on June 29, 2021.

Prevalence of transfusion-transmissible infections among Blood Donors Attending the Regional Hospital Center of Franceville (Southern Gabon)

Background: Transfusion transmissible infections (TTI) constitute a worldwide threat to blood donation, especially in developing countries. Objective: To determine the prevalence of HIV, hepatitis C virus (HCV), hepatitis B virus (HBV), and Treponema palladium among prospective blood donors attending the Amissa Bongo Regional Hospital Center of Franceville (ABRH). Methods: CTKBiotech test strips were used to detected blood transmissible infections. Antibodies to HIV ½ (HIV), hepatitis C virus (HCV), Hepatitis B virus (HBV) and T.pallidium were detected using respectively OnSite HIV 1/2 Ab Plus Combo Rapid Test, the OnSite HCV Ab Plus Combo Rapid Test, the OnSite HBsAg Combo Rapid Test, the OnSite Syphilis Ab Rapid Test. Results: A total of 447 prospective blood donors attending the ABRH was included in this study. The age ranged between 18 and 50 with a median age of 30. Male and family donors made up more than 88% and 83% of the study population, respectively. HBV was the most prevalent TTI with 2.68%, follow by HIV, HCV, and Syphilis, with respectively 2.23%, 1.56%, and 0.89%.Among the examined blood transmissible pathogens, only HIV was significantly associated with unemployment. Females were 3.47, 1.3, and 2.62 times more prone to test positive to respectively HIV, HCV, T.pallidium compared to males. None of the risk factors considered in this study was significantly associated with any transfusion transmissible infection. Conclusion: The present results confirm the declined of syphilis among blood donors in Gabon. Co-infection cases reported here raises concerns as they are known to complicate the patient care.

2502. Best Practice Alert for Hepatitis C Virus Screening Demonstrates Importance of Reminders during Disruptive Times (COVID-19)

Abstract Background In 2015, a Best Practice Alert (BPA) was implemented into our electronic health record that prompts ordering of Hepatitis C Virus (HCV) antibody (Ab) screens for unscreened patients born between 1945-1965 (baby boomers: BB). The BPA begins the first step of the three-step care cascade, after which follow-up is needed for RNA testing if Ab-positive and HCV clinic visit if RNA-positive (figure 1). Prior studies found a 3.5-fold increase in HCV Ab screening after BPA implementation. We sought to understand the BPA’s role in cascade navigation during the COVID-19 pandemic. Initial BPA is triggered, which leads to subsequent steps including HCV antibody testing, HCV RNA testing, and ending with a clinic visit for treatment initiation. Methods This retrospective study included BB receiving their first BPA between 7/1/18-12/31/19 (pre-pandemic: PP) and 1/1/20-7/1/21, (intra-pandemic: IP), excluding patients with a death date ≤ 180 days after their BPA. Patients were followed for 180 days for each step and were marked unsuccessful if it was not completed. Successful navigation (SN) was defined as completing all steps or testing negative at any step. Hazard ratios for completion of each step were calculated via Cox Proportional Model. Clinical and demographic predictors of SN were examined via multivariable logistic regression in each cohort. Results Overall, 14,236 unscreened BB had a BPA (8,090 PP, 6,146 IP) fire during the study periods. The cohorts were similar, except for an increase in share with county financial assistance and those cared for by advanced practice providers in the IP cohort (table 1). An increase in HCV Ab screening (aHR 1.31 [95% CI: 1.25, 1.38]) and decreases in HCV RNA testing (aHR 0.79 [0.65, 0.96]) and clinic visits (aHR 0.43 [0.28, 0.66]) were seen in the IP cohort (figures 2A, B, and C). Hispanic patients had increased odds (aOR: 1.25 [1.02, 1.54]) of SN in the IP cohort (figures 3A and B). Compared to family medicine, those cared for in geriatric clinics had lower odds (aOR 0.75 [0.62, 0.91]) of SN in the IP cohort. Lower odds were also seen for those with Charlson Index ≥ 2 (aOR 0.85 [0.74, 0.98]) compared to 0.Table 1.Cohort Demographics.Baseline demographic, comorbidity, and provider factors for the pre-pandemic and intra-pandemic cohorts. Figure 2. Survival-Time Analysis of the HCV Care Cascade. Kaplan-Meier curves with 95% confidence intervals depicting time to completion by day after step initiation in each cohort. Data for the HCV antibody screening (A), HCV RNA testing (B), and liver clinic visit (C) steps are each shown separately. Log-rank test p-values are shown. Figure 3. Logistic Regression Forest Plots Forest plots showing the adjusted odds ratios and 95% confidence intervals for successful cascade navigation in the pre-pandemic (A) and intra-pandemic (B) cohorts. Odds ratio less than 1 indicates lower odds of successful navigation during that period. Odds ratio greater than 1 indicates higher odds of successful navigation. Conclusion The BPA increased the durability of HCV Ab screening rates during the pandemic compared to other steps in the cascade. Disparities in completing all steps of the cascade persisted and likely worsened in some groups during the pandemic. Overall, electronic reminders lessen impacts of disruptions in healthcare services. Disclosures Mamta K. Jain, MD, MPH, Gilead Sciences: Grant/Research Support|Laurent: Grant/Research Support

Hepatitis C infection seroprevalence in pregnant women worldwide: a systematic review and meta-analysis

Monitoring progress towards the WHO global target to eliminate hepatitis C virus (HCV) infection by 2030, entails reliable prevalence estimates for HCV infection in different populations. Little is known about the global burden of HCV infection in pregnant women. Here, for the first time to our knowledge, we estimated the global and regional seroprevalence of HCV antibody (Ab) and determinants in pregnant women. In this systematic review and meta-analysis study, we searched PubMed/MEDLINE, Web of Science, Embase, Scopus, and SciELO databases for peer-reviewed observational studies between January 1, 2000 and April 1, 2023, without language or geographical restrictions. Pooled global seroprevalence (and 95% confidence interval, CI) were estimated using random-effects meta-analysis and seroprevalences were categorised according to World Health Organization regions and subregions, publishing year, countries' income and human development index (HDI) levels. We used sensitivity analysis to assess the effect of four large sample size studies on pooled global prevalence through the "leave-one-out" method. We also investigated the association of potential risk factors with HCV seropositivity in pregnant women by subgroup and meta-regression analyses. The Protocol was registered in PROSPERO CRD42023423259. We included 192 eligible studies (208 datasets), with data for 148,509,760 pregnant women from 53 countries. The global seroprevalence of HCV Ab in pregnant women was 1.80% (95% CI, 1.72-1.89%) and 3.29% (3.01-3.57%) in overall and sensitivity analyses, respectively. The seroprevalence was highest in the Eastern Mediterranean region (6.21%, 4.39-8.29%) and lowest in the Western Pacific region (0.75%, 0.38-1.22%). Subgroup analysis indicated that the seroprevalence of HCV Ab among pregnant women was significantly higher for those with opioid use disorder (51.94%, 95% CI: 37.32-66.39) and HIV infection (4.34%, 95% CI: 2.21-7.06%) than for the general population of pregnant women (1.08%, 95% CI: 1.02-1.15%), as confirmed by multivariable meta-regression (p<0.001). A significant decreasing trend was observed with increasing human development index levels. Other important risk factors for HCV seropositivity included older age, lower educational levels, poly sexual activity, history of blood transfusion, hospitalization, surgery, abortion and sexual transmitted diseases, having scarification/tattoo or piercing, and testing hepatitis B positive. This meta-analysis showed relatively high burden of exposure to HCV infection (2.2-5.3 million) in pregnant women globally. However, due to substantial heterogeneity between studies, our estimates might be different than the true seroprevalence. Our findings highlighted the need to expand HCV screening for women of reproductive age or during pregnancy, particularly in countries with high prevalence; as well as for more studies that assess safety of existing therapeutic drugs during pregnancy or potentially support development of drugs for pregnant women. There was no funding source for this study.

Incidence of Reactivation of Hepatitis B in Co-Infected HB V/HCV Patients Treated with Regiments of Sofosbuvir and Daclatasvir with or without Ribavirin

Abstract Background HCV management was dramatically changed by the recent advent of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection, where DAA regimens are associated with a sustained virological response (SVR) rate of &amp;gt; 90–95% and are considered safe; nevertheless, a few complications have been reported including reactivation of hepatitis B virus (HBV). Aim of the Work To evaluate the incidence of re activation of HBV among patients treated by sof/dac with or without RBV Patients and Methods This study was held in out in centers for treatment of HCV in –Ain- Shams University Hospital and Aswan Fever Hospital from May 2019 to October 2020., All patients were subjected to history taking, clinical examination, abdominal ultrasound, laboratory investigations (CBC, liver function, HCV Ab, HBsAg, HBV eAg PCR for HCV RNAand PCR for HBV DNA. All patients were positive for HCVAb, HCV PCR, HBVsAg with HBV DNA less than 2000IU/ML and negative for HBVeAg. This study was conducted on 90 patients who were selected according to National Committee for Control of Viral Hepatitis (NCCVH) protocol were divided according to treatment protocol into two groups. Results In our study, 57% of cases aged &amp;lt; 50 years, 33% aged &amp;gt; 50 years, and 61% were males and 39% were females; In the present study, there were 23 patients were smokers,16 patients were diabetics and 21 patients were hypertensives. All treated patients were negative PCR for HCV RNA at week 12 with 100% (SVR12)response in all treated patients which is still negative till end of treatment and 12 week after end of treatment (SVR 24), AS regard HBV DNA, no statistically significant difference was found at the beginning, at the end of 12 weeks, and at the end of 24 week of treatment by DAAs (p-value &amp;gt; 0.05), except for one patient who was treated with SOF/DAC/RBV. This patient, with compensated cirrhosis at baseline, developed fatigue and anorexia at week 12, with HBV reactivation (HBV DNA levels increased from245 IU/mL at baseline to 532000IU/mL), after which entecavir was added to the SOF/RBV regimen. This patient did not show significant increase in ALT level. Conclusion Our study confirmed the importance of screening for HBV in patients undergoing DAA therapy and importance of follow. For those for positive HBsAg, to avoid HBV reactivation and particularly HBV-related hepatitis. Our study limits the benefit of systematic nucleoside analogue prophylaxis for all HBsAg-positive patients. In our Egyptian cohort, for example, if we had followed the EASL recommendation (ie, starting nucleos(t)ide analogue prophylaxis for all 90 HBsAg-positive patients irrespective of their HBV DNA levels at baseline), this could have prevented 1 case of HBV-related reactivation during the course of DAAs, but resulted in overtreatment in the rest of patients

Hepatitis C virus care cascade among people who inject drugs in Puerto Rico: Minimal HCV treatment and substantial barriers to HCV care

BackgroundPeople who inject drugs (PWID) in Puerto Rico are disproportionately affected by the hepatitis C virus (HCV) epidemic. However, there is a scarcity of data on the HCV care cascade among PWID in Puerto Rico. This study aims to describe the HCV cascade of care among PWID in Puerto Rico, identify gaps, and explore barriers to HCV care. MethodsParticipants were recruited using respondent-driven sampling and tested for both HCV antibodies (Ab) and RNA (ribonucleic acid) using rapid testing and dried blood spot samples (DBS). The cascade of care was estimated based on the DBS HCV Ab and RNA results, as well as self-reported data on HCV screening, linkage to care, treatment uptake and sustained virologic response collected through a questionnaire. The cascade was constructed sequentially, with each step using the number of people from the preceding step as the base denominator. The survey also assessed participants' perceived barriers to HCV care. ResultsOut of 150 participants, 126 (84%) had previously been HCV screened, 87% (109/126) were HCV Ab positive, 72% (79/109) were RNA positive,48% (38/79) were linked to care, 32% (12/38) initiated treatment, 58% (7/12) finished treatment, and 71% (5/7) achieved SVR. Barriers to HCV care included concerns about drug abstinence requirements, access to transportation, stigma in healthcare settings, and lack of knowledge about HCV treatment sites. ConclusionThis study provides insights into the HCV cascade of care among PWID in Puerto Rico for the first time and highlights limited diagnosis, treatment uptake, and barriers to care.

High Prevalence of Occult Hepatitis B Virus Infection among Iranian Hemodialysis Patients.

Considering the potential risks associated with occult hepatitis B virus (HBV) infection, this study was designed to investigate the magnitude and genotypic pattern of occult HBV infection among hemodialysis patients. All patients on regular hemodialysis attending the dialysis centers located in southern Iran and 277 nonhemodialysis controls were invited to participate in this study. Serum samples were tested for detection of hepatitis B core antibody (HBcAb) and hepatitis B surface antigen (HBsAg) by competitive enzyme immunoassay and sandwich ELISA, respectively. The molecular evaluation of HBV infection was conducted by two nested polymerase chain reaction (PCR) assays, targeting S, X, and precore regions of HBV genome, and sequencing by Sanger dideoxy sequencing technology. Moreover, HBV viremic samples were tested for hepatitis C virus (HCV) coinfection by HCV Ab ELISA and seminested reverse transcriptase PCR. Of 279 hemodialysis patients, five (1.8%) were positive for HBsAg, 66 (23.7%) were positive for HBcAb, and 32 (11.5%) had HBV viremia with HBV genotype D, sub-genotype D3 and subtype ayw2. Moreover, 90.6% of the hemodialysis patients with HBV viremia had occult HBV infection. Hemodialysis patients (11.5%) had significantly higher prevalence of HBV viremia than nonhemodialysis controls (1.08%; P = 0.0001). The prevalence of HBV viremia among hemodialysis patients was not statistically associated with duration of hemodialysis, age and gender distribution. In contrast, HBV viremia was significantly associated with place of residency and ethnicity, with residents of Dashtestan and Arab having had significantly higher prevalence of HBV viremia compared with the residents of other cities and Fars patients. Notably, 27.6% and 6.9% of hemodialysis patients infected with occult HBV infection were also positive for anti-HCV antibodies and HCV viremia, respectively. High prevalence of occult HBV infection was detected in hemodialysis patients, whereas 62% of patients with occult HBV infection were negative for HBcAb. Therefore, screening of all hemodialysis patients by sensitive molecular tests, regardless of the pattern of HBV serological markers, is recommended to increase the diagnosis rate of HBV infection.

Toxoplasma gondii, HBV, and HCV co-infection and their correlation with CD4 cells among Iranian HIV-positive patients.

Human immunodeficiency virus (HIV/AIDS) infected patients have a higher risk of opportunistic infections (OIs) depending on their immunological status, especially CD4 + cell count. Toxoplasma gondii, hepatitis C virus (HCV), and hepatitis B virus (HBV) are important OIs among Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) patients. However, little is known about co-infection of these pathogens among HIV-infected individuals and their correlation with the patient's CD4 + cell count. Hence, this study aimed to investigate the serological and molecular status of T. gondii infection among HIV-infected individuals who had co-infection with HBV and HCV infections. A total of 100 HIV/AIDS patients in two cities in the southwest of Iran was tested for T. gondii Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies as well as DNA detection by polymerase chain reaction (PCR) targeting the RE gene. HBV and HCV were detected by hepatitis B surface antigen (HBsAg) test, hepatitis C antibody (HCV Ab) test, and Real-Time PCR. The number of CD4 + cell counts was determined by Flow cytometry. Anti-T. gondii IgG was positive in 22% of the patients, but anti-T. gondii IgM and PCR were negative in all samples. HBV and HCV were positive in 8% and 33% of the patients, respectively. Co-infections were as followed: HIV + HCV (16%), HIV + HCV + T. gondii (11%), HIV + T. gondii (5%), HIV + HBV (1%), HIV + HBV + T. gondii (1%), HIV + HBV + HCV (1%), and HIV + HBV + HCV + T. gondii (5%). A significant decline in CD4 + cell counts was found in such co-infection groups (HIV + T. gondii, HIV + HCV + T. gondii, and HIV + HBV + HCV + T. gondii) compared with the HIV mono-infection group. Our study showed that co-infections of T. gondii, HCV, and HBV were common among HIV-infected patients and co-infections had a negative correlation with CD4 + cell counts of the patients.

Relationship of hepatitis C risk to hepatitis C test acceptance among adult patients participating in an ED hepatitis C screening programme

BackgroundIt is possible that adult ED patients consider their hepatitis C virus (HCV) risk factor history when deciding whether to accept HCV screening. To help address this question, we examined...