Hepatitis C Virus Diagnosis Research Articles

Rapid detection of hepatitis C virus using recombinase polymerase amplification.

Over 71 million people are infected with hepatitis C virus (HCV) worldwide, and approximately 400,000 global deaths result from complications of untreated chronic HCV. Pan-genomic direct-acting antivirals (DAAs) have recently become widely available and feature high cure rates in less than 12 weeks of treatment. The rollout of DAAs is reliant on diagnostic tests for HCV RNA to identify eligible patients with viremic HCV infections. Current PCR-based HCV RNA assays are restricted to well-resourced central laboratories, and there remains a prevailing clinical need for expanded access to decentralized HCV RNA testing to provide rapid chronic HCV diagnosis and linkage to DAAs in outpatient clinics. This paper reports a rapid, highly accurate, and minimally instrumented assay for HCV RNA detection using reverse transcription recombinase polymerase amplification (RT-RPA). The assay detects all HCV genotypes with a limit of detection of 25 copies per reaction for genotype 1, the most prevalent in the United States and worldwide. The clinical sensitivity and specificity of the RT-RPA assay were both 100% when evaluated using 78 diverse clinical serum specimens. The accuracy, short runtime, and low heating demands of RT-RPA may enable implementation in a point-of-care HCV test to expand global access to effective treatment via rapid chronic HCV diagnosis.

Chronic hepatitis C infection is associated with higher incidence of extrahepatic cancers in a Canadian population based cohort.

IntroductionChronic infection with hepatitis C virus (HCV) is an established risk factor for liver cancer. Although several epidemiologic studies have evaluated the risk of extrahepatic malignancies among people living with HCV, due to various study limitations, results have been heterogeneous.MethodsWe used data from the British Columbia Hepatitis Testers Cohort (BC-HTC), which includes all individuals tested for HCV in the Province since 1990. We assessed hepatic and extrahepatic cancer incidence using data from BC Cancer Registry. Standardized incidence ratios (SIR) comparing to the general population of BC were calculated for each cancer site from 1990 to 2016.ResultsIn total, 56,823 and 1,207,357 individuals tested positive and negative for HCV, respectively. Median age at cancer diagnosis among people with and without HCV infection was 59 (interquartile range (IQR): 53-65) and 63 years (IQR: 54-74), respectively. As compared to people living without HCV, a greater proportion of people living with HCV-infection were men (66.7% vs. 44.7%, P-value <0.0001), had comorbidities (25.0% vs. 16.3%, P-value <0.0001) and were socially deprived (35.9% vs. 25.0%, P-value <0.0001). The SIRs for liver (SIR 33.09; 95% CI 29.80-36.39), anal (SIR: 2.57; 95% CI 1.52-3.63), oesophagus (SIR: 2.00; 95% CI 1.17-2.82), larynx (SIR: 3.24; 95% CI 1.21-5.27), lung (SIR: 2.20; 95% CI 1.82-2.58), and oral (SIR: 1.78; 95% CI 1.33-2.23) cancers were significantly higher among individuals living with HCV. The SIRs for bile duct and pancreatic cancers were significantly elevated among both individuals living with (SIR; 95% CI: 2.20; 1.27-3.14; 2.18; 1.57-2.79, respectively) and without HCV (SIR; 95% CI: 2.12; 1.88-2.36; 1.20; 1.11-1.28, respectively).Discussion/ConclusionIn this study, HCV infection was associated with increased incidence of several extrahepatic cancers. The elevated incidence of multiple cancers among negative HCV testers highlights the potential contributions of screening bias and increased cancer risks associated with factors driving acquisition of infection among this population compared to the general population. Early HCV diagnosis and treatment as well as public health prevention strategies are needed to reduce the risk of extrahepatic cancers among people living with HCV and potentially populations who are at higher risk of HCV infection.

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

In 2015, the country of Georgia launched an elimination program aiming to reduce the prevalence of Hepatitis C virus (HCV) infection by 90% from 5.4% prevalence (~150 000 people). During the first 2.5 years of the program, 770 832 people were screened, 48 575 were diagnosed with active HCV infection, and 41 483 patients were treated with direct-acting antiviral (DAA)-based regimens, with a >95% cure rate. We modelled the incremental cost-effectiveness ratio (ICER) of HCV screening, diagnosis and treatment between April 2015 and November 2017 compared to no treatment, in terms of cost per quality-adjusted life year (QALY) gained in 2017 US dollars, with a 3% discount rate over 25 years. We compared the ICER to willingness-to-pay (WTP) thresholds of US$4357 (GDP) and US$871 (opportunity cost) per QALY gained. The average cost of screening, HCV viremia testing, and treatment per patient treated was $386 to the provider, $225 to the patient and $1042 for generic DAAs. At 3% discount, 0.57 QALYs were gained per patient treated. The ICER from the perspective of the provider including generic DAAs was $2285 per QALY gained, which is cost-effective at the $4357 WTP threshold, while if patient costs are included, it is just above the threshold at $4398/QALY. All other scenarios examined in sensitivity analyses remain cost-effective except for assuming a shorter time horizon to the end of 2025 or including the list price DAA cost. Reducing or excluding DAA costs reduced the ICER below the opportunity-cost WTP threshold. 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.

Certification program of Addiction Centres for hepatitis C virus elimination in Spain. HepCelentes Project.

Microelimination strategies for the hepatitis C virus (HCV) in vulnerable populations, such as users of Addiction Centres (AC), are key for the elimination of hepatitis C. The aim of the HepCelentes project was to design a certification program for AC from the generation of a guide with the criteria to favour the prevention, diagnosis, control, and treatment of HCV in Spain. The project was structured in 4 phases: normalisation, implementation, certification, and communication. In the first phase, developed between July and December 2020, a Steering Committee was created (formed by representatives of scientific societies, healthcare professionals from AC, primary care centres and hospital units, and patient associations) that, from of an exhaustive bibliographic review, generated by consensus an accreditation guide for AC. The guide consists of 22 criteria (15 mandatory and 7 recommended) structured based on the requirements to be met by AC, justification for the selection, level of action (management, prevention, diagnosis and treatment/follow-up), measurement of the indicator, objective level to be achieved, evidence of compliance, clarifications to improve understanding, and mandatory / recommendation (depending on their relevance to achieve HCV elimination and its feasibility for implementation in real practice). The development of a certification system for the AC, based on consensus and coordination of multidisciplinary teams, is intended to favour the management of hepatitis C and its elimination in AC users, supporting the international, national, and regional elimination strategies.

FREQUENCY OF HEPATITIS C VIRUS INFECTION AMONG BETA-THALASSEMIA PATIENTS IN BAGHDAD CITY, IRAQ

Patients with thalassemia major are at high risk of Hepatitis C virus (HCV) due to the blood transfusion from donors infected by HCV. The purpose of this study was to study the correlation between some hematological parameters and liver function tests with viral hepatitis and to evaluate the ELISA and RT- PCR techniques for the diagnosis of HCV in thalassaemic patients. Blood samples from eighty patients with ß-thalassemia were subjected to the following tests: PCV, Hb concentration, liver function tests (GPT, GOT, Alkaline phosphatase). Serum samples from all patients were tested for antibodies to hepatitis C virus using ELISA test and for HCV RNA by the real time polymerase chain reaction (RT-PCR). It was shown that 67.5% of study patients were detected with a range of PCV 15-20%, whereas 100% of patients were detected with a range of Hb (5-9 g/dL). In addition, 98.8% of patients were detected with elevated liver enzymes. It was shown that 100% of patients revealed with positive ELISA anti-HCV antibodies in their serum specimens. Positive RT-PCR assay was detected in 86% of study patients. ELISA test was revealed with 14% false positive results. Thalassemia patients should be aware of the risks of viral infection during their blood transfusions, and those with chronic infections should beware of transmitting the infection to uninfected individuals.Thalassemia

Real-life validation of a sample pooling strategy for screening of hepatitis C

ObjectivesTo test a real-life sample pooling screening strategy which contributes to increasing the diagnostic capacity of clinical laboratories and expanding access to massive screening of hepatitis C. MethodsAfter evaluating the sensitivity of the pooling strategy for seven different commercial assays which are used to determine the concentration of hepatitis C virus (HCV)-RNA in the plasma or serum, consecutive samples submitted for HCV diagnosis during the first 3 weeks of November 2021 were tested for HCV antibodies and, in parallel and in a blinded way, were pooled into 100 samples and tested for HCV-RNA. When the result was positive, a strategy to un-mask the positive(s) pool(s), which needed up to 15 total HCV-RNA tests, was used. ResultsAll platforms were able to detect the presence of HCV-RNA in a single sample from a patient with viremic HCV present in pools of up to at least 10 000 HCV-RNA-free samples. A total of 1700 samples (17 pools) were analysed, with an overall prevalence of anti-HCV and HCV-RNA of 0.24%. After pooling, we could detect all samples previously detected using standard diagnosis tests (reflex testing) with a specificity and sensitivity of 100% (CI, 99.78–100%). Given the median current prices of anti-HCV and HCV-RNA on the market in Spain as well as personnel costs, testing using the pooling strategy would have resulted in a save of 3320€. ConclusionsHere, we demonstrated that by improving cost effectiveness, with no loss of sensitivity and specificity, the strategy of pooling samples may serve as an appropriate tool for use in large-scale screening of HCV.

Late hepatitis C virus diagnosis among patients with newly diagnosed hepatocellular carcinoma: a case–control study

BackgroundNew direct-acting antiviral therapies have revolutionized hepatitis C virus (HCV) infection therapy. Nonetheless, once liver cirrhosis is established, the risk of hepatocellular carcinoma (HCC) still exists despite virus eradication. Late HCV diagnosis hinders timely access to HCV treatment. Thus, we determined trends and risk factors associated with late HCV among patients with a diagnosis of HCC in Taiwan.MethodsWe conducted a population-based unmatched case–control study. 2008–2018 Claims data were derived from the Taiwan National Health Insurance Research Database. Individuals with an initial occurrence of liver cancer between 2012 and 2018 were included. The late HCV group were referred as individuals who were diagnosed with HCC within 3 years after HCV diagnosis. The control group were referred as individuals who were diagnosed more than 3 years after the index date. We used multivariable logistic models to explore individual- and provider-level risk factors associated with a late HCV diagnosis.ResultsA decreasing trend was observed in the prevalence of late HCV-related HCC diagnosis between 2012 and 2018 in Taiwan. On an individual level, male, elderly patients, patients with diabetes mellitus (DM), and patients with alcohol-related disease had significantly higher risks of late HCV-related HCC diagnosis. On a provider level, patients who were mainly cared for by male physicians, internists and family medicine physicians had a significantly lower risk of late diagnosis.ConclusionsElderly and patients who have DM and alcohol related disease should receive early HCV screening. In addition to comorbidities, physician factors also matter. HCV screening strategies shall take these higher risk patients and physician factors into consideration to avoid missing opportunities for early intervention.

The Hepatitis C Care Cascade During the Direct-Acting Antiviral Era in a United States Commercially Insured Population.

BackgroundPeriodic surveillance of the hepatitis C virus (HCV) care cascade is important for tracking progress toward HCV elimination goals, identifying gaps in care, and prioritizing resource allocation. In the pre-direct-acting antiviral (DAA) era, it was estimated that 50% of HCV-infected individuals were diagnosed and that 16% had been prescribed interferon-based therapy. Since then, few studies utilizing nationally representative data from the DAA era have been conducted in the United States.MethodsWe performed a cross-sectional study to describe the HCV care cascade in the United States using the Optum de-identified Clinformatics® Data Mart Database to identify a nationally representative sample of commercially insured beneficiaries between January 1, 2014 and December 31, 2019. We estimated the number of HCV-viremic individuals in Optum based on national HCV prevalence estimates and determined the proportion who had: (1) recorded diagnosis of HCV infection, (2) recorded HCV diagnosis and underwent HCV RNA testing, (3) DAA treatment dispensed, and (4) assessment for cure.ResultsAmong 120,311 individuals estimated to have HCV viremia in Optum during the study period, 109,233 (90.8%; 95% CI, 90.6%–91.0%) had a recorded diagnosis of HCV infection, 75,549 (62.8%; 95% CI, 62.5%–63.1%) had a recorded diagnosis of HCV infection and underwent HCV RNA testing, 41,102 (34.2%; 95% CI, 33.9%–34.4%) were dispensed DAA treatment, and 25,760 (21.4%; 95% CI, 21.2%–21.6%) were assessed for cure.ConclusionsGaps remain between the delivery of HCV-related care and national treatment goals among commercially insured adults. Efforts are needed to increase HCV treatment among people diagnosed with chronic HCV infection to achieve national elimination goals.

Treatment of Hepatitis C Virus Prior to Posterior Lumbar Fusion: No Difference in Medical Outcomes or Reoperation.

Retrospective cohort. To analyze and confirm the rates of postoperative complications of patients with hepatitis C virus (HCV) undergoing primary posterior lumbar fusion (PLF) and assess whether treatment of HCV before surgery reduces complications. HCV causes chronic disease, leading to increased risk of cirrhosis and chronic illness. Currently, there is a lack of research regarding whether the patient's HCV is a modifiable risk factor for postoperative complications after spinal procedures. The Mariner database was utilized to find patients from 2010 to 2018 undergoing PLF with active follow-up for a year. Cases involving same-day revision procedures and patients with a history of spine, infection, trauma, human immunodeficiency virus, hepatitis B, or neoplasm were excluded. Patients with a history of HCV diagnosis were identified and further stratified whether they had prior treatment using the national drug codes for antiviral, interferons, or ribavirin. Patients with HCV were matched with those without respect to age, sex, and comorbidity of burden. Outcome measured included 90-day medical complications, infection, readmission, and 1-year reoperation. There were 2,129 patients with HCV and 10,544 patients in the matched control group who underwent primary PLF. Out of the 2,129 patients, 469 (22.0.%) were treated with HCV medications before surgery. Patients with prior history of HCV had a significantly increased risk of wound complications (4.4% vs. 3.2%, odds ratio 1.56, 95% confidence interval 1.24-1.96, P =0.009), and infection (7.7% vs. 5.7%, odds ratio 1.26, 95% confidence interval 1.07-1.53, P =0.009) within 90 days of surgery. Patients treated before surgery did not have a difference in major ( P =0.205) or minor medical complications ( P =0.681) after surgery. Patients with prior history of HCV are at increased risk for many complications after surgery; however, this risk factor does not seem to be modifiable as the treatment group did not experience any improvement in postoperative outcomes. Level III.

Effect of COVID-19 on hepatitis B and C virus countermeasures: Hepatologist responses from nationwide survey in Japan.

AimAchieving hepatitis B virus (HBV) and hepatitis C virus (HCV) elimination requires continuous and sustained high volumes of diagnosis and treatment which have been affected by the ongoing COVID‐19 pandemic. This study assessed COVID‐19 effect on hepatitis‐related services in Japan and compare Japan’s situation with global survey.MethodsWe conducted an online cross‐sectional questionnaire survey of hepatologist of the Japan Society of Hepatology from August to October 2021 by using the same questionnaire from which a survey was conducted globally to address the COVID‐19 effect on hepatitis‐related services. Hepatologists responded based on own impression of their affiliated institutions.ResultsA total of 196 hepatologists participated from 35 prefectures including 49.5% were in managerial positions. Around 40% survey participants reported a 1‐25% decline in HBV and HCV screening and confirmatory testing. In addition, 53.6% and 45.4% reported no decline in HBV and HCV treatment initiation, respectively. Comparing any level of decrease, less decline was observed in Japan for screening (HBV: 51% vs 56.3%, HCV: 51% vs 70.9%) and treatment initiation (HBV: 32.7% vs 52.4%, HCV: 41.8% vs 66%) from global survey. However, Patient anxiety/fear (67.4%), and loss of staff due to COVID‐19 response (49.0%) were reported as challenges to resume services to pre‐COVID‐19 levels.ConclusionAlthough in Japan all‐inclusive decline in HBV and HCV related services were lower than in other countries, a greater decline was observed in HBV and HCV screening and diagnosis than in treatment initiation. Prolonged anxiety/fear among patients, loss of staffs and facilities on COVID‐19 responses must be addressed to achieve the hepatitis elimination by 2030.This article is protected by copyright. All rights reserved.

Effect of HCV or HIV infection on mortality among hospitalized persons who used opioids, 2000–2010

Mortality due to opioid misuse and overdose has increased substantially in the United States over the past two decades. The study objective was to describe the causes of death among persons with opioid-related hospitalizations and examine survival by Hepatitis C virus (HCV) or HIV. Opioid-related hospitalization records in Pennsylvania from 2000 to 2010 were linked to death registry files to assess cause of death, and survival from first hospital discharge date to death date, or December 31, 2010. Accelerated failure time models were used to compare survival between persons with and without HCV or HIV diagnoses. Among the 136,416 individuals with an opioid-related hospitalization, 13.0% died over a median of 56 months of follow-up; the most common causes of death were circulatory diseases (26.4%) and drug overdose (23.5%). There were 27,122 (19.9%) and 3662 (2.7%) persons who had an HCV and HIV diagnosis, respectively. Among patients aged ≥20 years, those with HCV had shorter survival time compared to those without HCV, with discrepancies more pronounced at older ages. Patients with HIV also had shorter survival time (time ratio: 0.29 [95% CI: 0.26, 0.34]) compared to without HIV. These findings show that in a cohort of patients with opioid-related hospitalizations, those with HCV or HIV diagnoses have shorter survival. This has public health implications, providing further evidence that medical providers should educate patients who use opioids about the risks of HCV and HIV infection and focus prevention and treatment to decrease mortality among patients hospitalized for opioid use.

Characterization of Patients Seeking Care at a Sexual Health Clinic Who Report Engaging in Exchange Sex.

People who exchange sex (PWES) for money or drugs are at increased risk for poor health outcomes and may be reluctant to engage in health services. We conducted a cross-sectional analysis of patients seen for new problem visits at the Public Health-Seattle and King County Sexual Health Clinic between October 2010 and March 2020 who reported exchanging sex for drugs or money in a computer assisted self-interview. We analyzed demographics; sexually transmitted infections (STIs), human immunodeficiency virus (HIV), and hepatitis C virus (HCV) history; and HIV preexposure prophylaxis (PrEP) use, stratified by gender. We compared characteristics of people who ever versus never exchanged sex using χ 2 tests and analyzed the visit reason and outcomes among PWES. Among 30,327 patients, 1611 (5%) reported ever exchanging sex: 981 (61%) cisgender men, 545 (34%) cisgender women, and 85 (5%) transgender and gender diverse persons. Compared with people who never exchanged sex, PWES were more likely to report homelessness (29% vs 7%, P &lt; 0.001), injection drug use (39% vs 4%, P &lt; 0.001), prior STIs (36% vs 19%, P &lt; 0.001), prior HIV diagnosis (13% vs 5%, P &lt; 0.001), and prior HCV diagnosis (13% vs 2%, P &lt; 0.001). People who exchange sex came to the clinic seeking STI tests (60%), HIV tests (45%), and care for STI symptoms (38%). Overall, 320 (20%) PWES were diagnosed with STIs, 15 (1%) were newly diagnosed with HIV, and 12 (1%) initiated PrEP at the visit. People who exchange sex have complex barriers to care, and sexual health clinic visits present an opportunity to improve health services for this population.

Integrating hepatitis C treatment into multidrug-resistant TB care.

Direct-acting antivirals (DAAs) are not widely used for patients with chronic hepatitis C virus (HCV) infection and multidrug- or rifampicin-resistant TB (MDR/RR-TB). We describe the implementation aspects of a new integrated model of care in Armenia and the perceptions of the healthcare staff and patients. We used qualitative methods, including a desktop review and semi-structured individual interviews with healthcare staff and with patients receiving HCV and MDR/RR-TB treatment. The new integrated model resulted in simplified management of HCV and MDR/RR-TB at public TB facilities. Training on HCV was provided for TB clinic staff. All MDR/RR-TB patients were systematically offered HCV testing and those diagnosed with HCV, offered treatment with DAAs. Treatment monitoring was performed by TB staff in coordination with a hepatologist. The staff interviewed had a positive opinion of the new model. They suggested that additional training should be provided. Most patients were fully satisfied with the care received. Some were concerned about the increased pill burden. Integrating HCV treatment into MDR/ RR-TB care was feasible and appreciated by patients and staff. This new model facilitated HCV diagnosis and treatment among people with MDR/RR-TB. Our results encourage piloting this model in other settings.

Hepatitis C Co-infection in People Living With HIV-Epidemiologic Differences Between Men Who Have Sex With Men MSM and Non-MSM.

People living with human immunodeficiency virus (PLHIV) constitute a unique group at higher risk of hepatitis C virus (HCV) co-infection. In light of the diverse profiles of PLHIV, we differentiated between men who have sex with men (MSM) and non-MSM in the characterization of the epidemiologic features of HIV/HCV co-infection. Clinical data of HCV co-infection patients from the HIV specialist clinic in Hong Kong were retrospectively collected in conjunction with their HIV subtypes and HCV genotypes. Logistic regression models were used to identify factors associated with HIV/HCV co-infection in MSM. Survival analysis was performed to compare the time lag between HIV and HCV diagnoses between two groups. Latent class analysis was conducted to describe the features of different classes of co-infections. Four classes of HIV/HCV co-infections were identified: local MSM acquiring HCV after HIV diagnosis, local MSM with HIV/HCV co-diagnoses, local non-MSM, and non-local non-MSM. Accounting for over half of the co-infections, MSM were more likely to be younger, local residents, and associated with HCV genotype 3, compared to genotypes 1 and 6 in non-MSM. Overall, MSM had higher odds of achieving HIV viral suppression and co-diagnosing with a sexually transmitted infection at HCV diagnosis, and having a longer time lag between HIV and HCV diagnoses. Drug injection accounted for a majority of non-MSM HCV infection. There were distinctive epidemiologic differences between MSM and non-MSM co-infected with HIV and HCV, the characteristics of which could inform intervention strategies for achieving HCV micro-elimination.

Surface-enhanced Raman spectroscopic analysis of centrifugally filtered blood serum samples of hepatitis C patients

BackgroundRaman spectroscopy is able to analyze non-invasively, disease related to body fluids. ObjectivesFor the qualitative and quantitative analysis of HCV serum samples surface-enhanced Raman spectroscopy (SERS) based method is developed. MethodSurface-enhanced Raman spectroscopy (SERS) technique is employed for analysis of filtrate portions of blood serum samples of hepatitis C virus (HCV) infected patients and healthy ones by using 50 kDa centrifugal filter device. The filtrate portions of the serum obtained in this way contain proteins smaller than 50 kDa and removal of bigger size protein which allows to acquire SERS spectral features of smaller proteins more effectively which are probably associated with Hepatitis C infection. Moreover, SERS spectral features of the filtrates of different level of viral load including low, medium and high viral loads are compared with SERS spectral features of the filtrate portions of healthy/control serum samples. SERS spectral data sets of different samples are further analyzed by using multivariate data analysis techniques such as principal component analysis (PCA) and partial least square regression (PLSR). Some SERS spectral features are solely observed in the filtrate portions of the serum samples of hepatitis C and their intensities are increased as the level of viral load increases and might be used for HCV diagnosis. ResultsPCA was found helpful for differentiation of SERS spectral data sets of filtrate portions of the serum samples of hepatitis C and healthy persons. The PLSR model helped for the quantification of viral loads in the unknown serum samples with 99% accuracy.

Prescreening with a Rapid Diagnostic Test Followed by a Confirmatory Qualitative Nucleic Acid Test Can Simplify Hepatitis C Diagnosis.

Asymptomatic hepatitis C virus (HCV) infection without treatment is associated with chronic liver diseases including hepatocellular carcinoma. A major obstacle to hepatitis C diagnosis leading to antiviral treatment in some developing countries is the complicated HCV testing required before treatment. To simplify an HCV test-to-treat strategy, which could lead to timely diagnosis and treatment at the point-of-care, we evaluated the performance of four anti-HCV rapid diagnostic tests (RDTs) (Abon, Blue Cross, Healgen, and SD Bioline). They yielded comparable sensitivity (80-83%), specificity (99-100%), and accuracy (90-91.5%). When we field-tested Abon in 4,769 residents of an HCV-endemic province in Thailand, 306 seropositive individuals (6.4%) were identified. In comparison, laboratory test using an automated commercial chemiluminescent microparticle immunoassay (Abbott ARCHITECT) identified slightly more seropositives (327% or 6.9%). Field implementation suggests that Abon was sensitive (88.7%), specific (99.6%), and accurate (98.9%). Furthermore, 82% (250/306) of Abon-positive samples had detectable HCV RNA as determined by nucleic acid test (Roche cobas). The same 250 samples out of 327 reactive in Abbott immunoassay also had detectable HCV RNA (mean RNA level: log 6.28 IU/mL, range: log 3.06- 7.78 IU/mL). The use of RDT followed by qualitative nucleic acid test can cost-effectively identify the majority of HCV seropositive individuals with active infection, which will obviate the need for expensive viral load quantification tests when simplifying HCV diagnosis for the test-to-treat program at the point-of-care.

Feasibility of hepatitis C virus testing and linkage in community supervision offices: Great potential but persistent challenges.

Persons involved with the justice system have an elevated risk of hepatitis C virus (HCV) yet remain marginalized from treatment. Efforts to eliminate HCV will require targeted interventions within the justice system effective at providing diagnosis and treatment. We implemented a novel HCV screening and treatment intervention for persons under community supervision in Rhode Island, USA during April 2018--March 2020. Participants received rapid point-of-care HCV antibody testing onsite and referral to community laboratory and treatment services as indicated. We assessed the HCV care cascade to identify areas for improvement. Overall, 483 individuals were screened for HCV antibody; 85 (18%) were positive. A minority of participants with positive HCV antibody tests (n=25/85, 29%) presented to community laboratories for confirmatory testing. Among participants that received HCV viral load results and linked to a treatment provider (n=12), four initiated treatment, three had record of completing treatment, and two were confirmed to have achieved cure. Linkage to HCV viral load testing and treatment was challenging in this community supervision population, with substantial loss to follow-up at each step of the HCV cascade. Community supervision remains an important venue for case identification but substantial barriers to accessing HCV treatment exist. Innovative HCV diagnosis and treatment strategies are needed for community supervision populations.

Impact of a Targeted Intervention on Hepatitis C Care Among African Americans With Serious Mental Illness.

This study aimed to update findings on the continuum of care for hepatitis C virus (HCV) infection with follow-up data for individuals with serious mental illness and to identify predictors of decisions to decline vaccination. The screening, testing, immunization, risk reduction, and referral (STIRR) intervention has been shown to increase testing and immunization rates. Prevalence of HCV diagnoses, HCV continuum of care, and hepatitis A (HAV) and B (HBV) vaccination were evaluated with laboratory results and chart review. The prevalence of HCV was 15% (N=40 of 270 African Americans receiving the STIRR intervention). Of the 40 individuals identified as having HCV, 75% (N=30) accepted referral to treatment, of whom 47% (N=14) achieved sustained virologic response. Nearly 68% (N=155) of those eligible received at least partial HAV/HBV vaccination. The STIRR intervention facilitated access to treatment for HCV and high acceptance of hepatitis vaccination. Avoidance proved to be a significant factor in decisions to decline vaccination.

An on-site community-based model for hepatitis C screening, diagnosis, and treatment among people who inject drugs in Kerman, Iran: The Rostam study.

People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection and its complications in many countries, including Iran. This pilot study aimed to evaluate the effect of a community-based HCV model of care on HCV testing and treatment initiation among PWID in Kerman, Iran. This study is part of the Rostam study and is a non-randomized trial evaluating the effect of on-site HCV- antibody rapid testing, venipuncture for HCV RNA testing, and treatment eligibility assessment on HCV testing and treatment initiation among PWID. Recruitment, interviews, and HCV screening, diagnosis, and treatment were all conducted at a community-based drop-in center (DIC) serving PWID clients. A total of 171 PWID (median age of 39 years and 89.5% male) were recruited between July 2018 and May 2019. Of 62 individuals who were HCV antibody positive, 47 (75.8%) were HCV RNA positive. Of RNA-positive individuals, 36 (76.6%) returned for treatment eligibility assessment. Of all the 36 participants eligible for treatment, 34 (94.4%) initiated HCV antiviral therapy. A sustained virologic response at 12 weeks post-treatment was 76.5% (26/34) in the intention-to-treat (ITT group) analysis and 100% (23/23) in the per-protocol (PP group) analysis. Our integrated on-site community-based HCV care model within a DIC setting suggested that HCV care including HCV testing and treatment uptake can be successfully delivered outside of hospitals or specialized clinics; a model which is more likely to reach PWID and can provide significant progress towards HCV elimination among this population.

The Korean Hepatitis C Virus Care Cascade in a Tertiary Institution: Current Status and Changes in Testing, Link to Care, and Treatment.

The care cascade for hepatitis C virus (HCV) infection is impeded by multiple barriers, including suboptimal anti-HCV testing, link to care, and diagnosis. We explored the changes in the care cascade of HCV for the past 20 years and its current status in a large cohort from a tertiary referral center. We analyzed 1,144,468 patients who had anti-HCV testing between January 2001 and June 2020. Metrics related to the care cascade of HCV infection and the long-term prognosis of patients were explored. The seroprevalence of anti-HCV positivity was 1.8%, with a recent decreasing trend. In all, 69.9% of anti-HCV positive patients performed HCV RNA testing, with a 65.7% positivity. Patients who did not have HCV RNA testing were older and more likely to have a non-hepatocellular carcinoma malignancy, normal alanine aminotransferase level, and good liver function. Linkage times for HCV RNA testing from the anti-HCV positivity and for antiviral treatment from HCV diagnosis decreased, notably after 2015, when highly efficacious oral antiviral treatment was introduced to Korea. The average treatment uptake rate was 35.4%, which increased to 38.9% after 2015. Of the 5,302 patients analyzed for long-term prognosis, the annual incidences of hepatocellular carcinoma were 1.02 or 2.14 per 100 person-years in patients with or without a sustained virological response, respectively. The care cascade of HCV infection has been suboptimal for the past 20 years, despite the recent changes. More effort should be made to increase HCV RNA testing and treatment uptake.