Hepatitis C Virus RNA Testing Research Articles

Sustained virological response from interferon-based hepatitis C regimens is associated with reduced risk of extrahepatic manifestations

HCV infection is associated with several extrahepatic manifestations (EHMs). We evaluated the impact of sustained virological response (SVR) on the risk of 7 EHMs that contribute to the burden of extrahepatic disease: type 2 diabetes mellitus, chronic kidney disease or end-stage renal disease, stroke, ischemic heart disease, major adverse cardiac events, mood and anxiety disorders, and rheumatoid arthritis. A longitudinal cohort study was conducted using data from the British Columbia Hepatitis Testers Cohort, which included ~1.3 million individuals screened for HCV. We identified all HCV-infected individuals who were treated with interferon-based therapies between 1999 and 2014. SVR was defined as a negative HCV RNA test ≥24 weeks post-treatment or after end-of-treatment, if unavailable. We computed adjusted subdistribution hazard ratios (asHR) for the effect of SVR on each EHM using competing risk proportional hazard models. Subgroup analyses by birth cohort, sex, injection drug exposure and genotype were also performed. Overall, 10,264 HCV-infected individuals were treated with interferon, of whom 6,023 (59%) achieved SVR. Compared to those that failed treatment, EHM risk was significantly reduced among patients with SVR for type 2 diabetes mellitus (asHR 0.65; 95%CI 0.55-0.77), chronic kidney disease or end-stage renal disease (asHR 0.53; 95% CI 0.43-0.65), ischemic or hemorrhagic stroke (asHR 0.73; 95%CI 0.49-1.09), and mood and anxiety disorders (asHR 0.82; 95%CI 0.71-0.95), but not for ischemic heart disease (asHR 1.23; 95%CI 1.03-1.47), major adverse cardiac events (asHR 0.93; 95%CI 0.79-1.11) or rheumatoid arthritis (asHR 1.09; 95% CI 0.73-1.64). SVR was associated with a reduction in the risk of several EHMs. Increased uptake of antiviral therapy may reduce the growing burden of EHMs in this population. We estimated the rates of chronic comorbidities other than liver disease between those who were cured and those who failed treatment for hepatitis C virus (HCV) infection. Our findings showed that the rates of these non-liver diseases were largely reduced for those who were cured with interferon-based treatments. Early HCV treatments could provide many benefits in the prevention of various HCV complications beyond liver disease.

HCV reinfections after viral clearance among HIV-positive patients with recent HCV infection in Taiwan.

Higher rates of hepatitis C virus (HCV) reinfection after viral clearance have been well described among HIV-positive men who have sex with men (MSM) in Europe. The epidemiology of HCV reinfection, however, has rarely been investigated among HIV-positive patients in Asia-Pacific region. We retrospectively identified HIV-positive patients with recent HCV infection who had cleared their primary infection, either spontaneously or via treatment, between January 2011 and May 2018. All included patients were observed until 31 March 2019. HCV reinfection was defined as recurrent HCV viraemia after achieving viral clearance with anti-HCV treatment or after spontaneous clearance. During the study period, 219 HIV-positive patients (90.4% MSM) were diagnosed with recent HCV infection. Viral clearance with successful treatment was achieved in 108 patients (49.3%) and spontaneous clearance occurred in 20 (9.1%); of them, 18 (14.1%) acquired HCV reinfections, resulting in an incidence rate of 8.2 per 100 person-years of follow-up (95% CI 5.2-13.1). With the adjusted Cox proportional hazards model, we found a higher reinfection risk in patients with syphilis (adjusted hazard ratio 10.3, 95% CI 1.4-77.8, P=.023) compared to those without syphilis. HCV RNA testing, if performed only following syphilis and elevated aminotransferases, might miss 44.4% and 33.3% of HCV reinfections, respectively. Similar to the findings in Europe, we observed a high incidence of HCV reinfection among HIV-positive Taiwanese with recent HCV infection, which was significantly associated with syphilis. To identify HCV reinfections, annual HCV RNA testing should be instituted instead of testing driven by symptoms, syphilis or elevated aminotransferases.

Introducing hepatitis C virus healthcare pathways in addiction care in the Netherlands with a Breakthrough project: a mixed method study

BackgroundPeople who inject drugs (PWID) are disproportionally affected by the hepatitis C virus (HCV) infection. In the Netherlands, active HCV transmission in PWID has practically been halted but uptake of HCV testing and linkage to care remains insufficient in this risk group. A national HCV in Addiction Care (HAC) quality improvement project based on the Breakthrough methodology (i.e. Breakthrough project) aimed to secure proper linkage to care in PWID by introducing local HCV healthcare screening and treatment pathways in addiction care units.AimTo qualitatively appraise the local HCV healthcare pathways; to evaluate the yield in terms of number of PWID screened, diagnosed, referred, and treated; and to identify best practices and barriers to successful participation in the HAC Breakthrough project.MethodsBetween 2013 and 2016, 12 units of addiction care centers throughout the Netherlands participated in two series of a HAC Breakthrough project. Local multidisciplinary teams created HCV healthcare pathways. Quality assessment of HCV healthcare pathways was performed retrospectively and data on screening results was collected. In-depth interviews were conducted to elucidate best practices and essential elements for successful participation.ResultsIn total, six HCV healthcare pathways were submitted by ten teams of which 83% was judged to be of “good” or “sufficient” quality. Uptake of HCV-antibody screening was 40% (N = 487/1219) and uptake of HCV-RNA in HCV-antibody positives was 59% (N = 107/181). The project resulted in 76 (6%) newly detected cases of persistent HCV viremia. Of all HCV-RNA positives, 92% was referred to a hepatitis treatment center. In 39% (N = 27/70) of those referred, treatment initiation was documented and 82% (N = 22/27) achieved a sustained virological response. Teams identified several best practices including motivational counseling training, oral swabs for anti-HCV testing, facilitating complementary HCV RNA testing, and supervised hospital visits.ConclusionThe HAC Breakthrough project has brought about good quality HCV healthcare pathways in the majority of participating addiction care centers and has successfully linked PWID with ongoing HCV viremia to care. Uptake of HCV screening and treatment after referral were identified as the main gaps to be closed in the HCV cascade of care to achieve final HCV elimination in Dutch PWID (i.e. micro-elimination).

Achievement of hepatitis C cascade of care milestones: a population-level analysis in Alberta, Canada.

Despite highly effective directly acting antiviral (DAA) therapy for hepatitis C virus (HCV), many patients do not receive treatment. We characterized the achievement of cascade of care milestones within 2years of diagnosis among the Alberta population and evaluated variables associated with engagement at each stage. All Albertans with a first-time positive HCV antibody between 2009 and 2014 were included in this retrospective study. We determined which patients received follow-up testing (HCV RNA and HCV genotype), referral to hepatitis specialty care, and antiviral prescription, and achieved SVR within 2years of diagnosis. Factors associated with achieving cascade milestones were identified by multivariable logistic regression analysis. Of 6154 patients with HCV antibody and complete follow-up, 4238 (68.9%) had HCV RNA testing, 2360 (38.3%) had HCV genotyping, 2096 (34.1%) were assessed by a specialist, 711 (11.6%) were prescribed treatment and 207 (3.4%) achieved SVR within 2years of diagnosis. Independent variables associated with reduced likelihood of achieving cascade milestones were Indigenous heritage (adjusted odds ratio (AOR) 0.53 (0.41-0.68) for HCV RNA testing), unstable housing (AOR 0.50 (0.32-0.79) for specialist assessment) and alcohol misuse (AOR 0.61 (0.38-0.99) for antiviral prescription). Men, older patients, patients with a higher income and patients with more advanced liver disease were more likely to achieve cascade of care milestones. At each stage of patient engagement, opportunities for improvement were identified. Understanding the local cascade of care and factors associated with achieving cascade milestones will help prioritize initiatives to facilitate access to DAA therapy in Alberta.

Point-of-care hepatitis C testing from needle and syringe programs: An Australian feasibility study

BackgroundAchieving hepatitis C elimination requires novel approaches to engage people at highest risk of infection into care pathways. Point-of-care-tests may help to overcome some of the barriers preventing people who inject drugs (PWID) accessing testing and progressing to treatment for hepatitis C virus (HCV). We assessed the feasibility and acceptability of HCV point-of-care testing at needle and syringe exchange programs (NSPs) co-located in three community health clinics in Melbourne, Australia. MethodsNSP clients were offered an oral fluid point-of-care test for HCV antibody by NSP staff. Positive HCV antibody tests were followed by a point-of-care test for HCV RNA alongside standard-of-care laboratory testing for hepatitis C treatment work-up. Participants were offered same-day point-of-care results on site, via phone or text message, or upon return to the service. Participants were scheduled for follow-up review with the study nurse for assessment and linkage to treatment. ResultsA total of 174 participants completed HCV antibody point-of-care test; 150 (86%) had a reactive result. Of these, 140 (93%) underwent a HCV RNA point-of-care test and 76 (54%) tested positive; few participants (5%) waited on site for results delivery, but the majority of RNA positive (63%) attended a follow-up visit for treatment work-up (median time to follow-up visit = 11 days; IQR = 7–20 days). The majority of participants reported a preference for point-of-care tests (66%) and supported NSP staff involvement in testing (90%). ConclusionProvision of HCV point-of-care tests, follow-up and linkage to treatment services through NSPs was feasible and acceptable to PWID. Despite few participants waiting to receive same-day results, there was effective linkage to care, suggesting value in further evaluation of this approach.

Determination of HCV Genotypes and Viral Loads in Chronic Hepatic Sudanese infected Patients

Background. Knowledge of Hepatitis C virus (HCV) genotypes is significant for arranging treatment regimes. Quantitative HCV RNA testing provides prognostic data useful in monitoring the efficacy of antiviral therapy. Methods. A total of 1203 serum samples were collected from individuals attending out-patients units at Khartoum State and Gezera State. The study population comprises two groups. Blood donors study groups (n= 600) and chronic hepatic patients during the course of HCV infection (n= 603). Serum samples were screened using enzyme linked immune-sorbent assay (ELISA) (Biokit, A.S. Spain®).HCV positive samples (n=100) were quantified by HCV Real-TM Quant SC (Sacace Biotechnologies Italy®). Results: Hundred HCV seropositive samples were subjected to genotyping and quantitative analysis of these samples using RT- PCR, HCV genotype 4 was the predominant genotype (92%) followed by genotype 2 (4%), Genotype 1 (2%) and 3 (2%) in different groups. The average viral load of the patients infected with genotype 4 was higher than an average viral load of the patients infected with genotypes 1,2 and 3. Conclusions: The present study highlighted that genotype 4 is the predominant genotype in Sudanese hepatic patients followed by genotype 2. The severity of liver disease was more among genotype 4 patients as assessed by a higher viral load.

An evaluation of the hepatitis C testing, care and treatment program in the country of Georgia\u2019s corrections system, December 2013 \u2013 April 2015

BackgroundThe 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.MethodsThe 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.ResultsOf 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.ConclusionsHCV 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 effects of sustained virological response to direct-acting anti-viral therapy on the risk of extrahepatic manifestations of hepatitis C infection.

Direct-acting anti-viral (DAA) therapy may have a beneficial role in extrahepatic manifestations of hepatitis C virus (HCV) infection. However, the available data are limited. To examine the effects of DAA treatment on the risk of several extrahepatic manifestations of HCV. We conducted a retrospective cohort study of patients from the US Department of Veterans Affairs Corporate Data Warehouse who had a positive HCV RNA test and received first course of DAAs between 2012 and 2016. We calculated incidence rates by sustained virological response (SVR) status for six extrahepatic manifestations, and effect of SVR on these conditions was evaluated in adjusted Cox regression models. Of the 45260 patients treated with DAA with mean follow-up of 2.01years, 41711 (92.2%) experienced SVR. Incidence rates ranged from 0.17/1000 PY for porphyria cutanea tarda to 21.04/1000 PY for diabetes in the SVR group and 0.51/1000 PY for porphyria cutanea tarda to 23.11/1000 PY for diabetes in the no SVR group. The risk was reduced with SVR for mixed cryoglobulinaemia (adjusted HR (aHR)=0.23; 95% CI 0.10-0.56), glomerulonephritis (aHR=0.61; 95% CI 0.41-0.90) and lichen planus (aHR=0.46; 95% CI 0.30-0.70), but not for non-Hodgkin's lymphoma (aHR=0.86; 95% CI 0.52-1.43) or diabetes (aHR=0.98; 95% CI 0.81-1.19). Non significant risk reduction was seen for porphyria cutanea tarda (aHR=0.33; 95% CI 0.11-1.03). Successful DAA treatment resulting in SVR was associated with significant reductions in the risk of mixed cryoglobulinaemia, glomerulonephritis, lichen planus and possibly porphyria cutanea tarda, but not non-Hodgkin's lymphoma or diabetes.

Clinical practice guidelines for the provision of renal service in Hong Kong: Potential Kidney Transplant Recipient Wait-listing and Evaluation, Deceased Kidney Donor Evaluation, and Kidney Transplant Postoperative Care.

Clinical practice guidelines for the provision of renal service in Hong Kong: Potential Kidney Transplant Recipient Wait-listing and Evaluation, Deceased Kidney Donor Evaluation, and Kidney Transplant Postoperative Care.

An Automated Immunoblot Method for Detection of IgG Antibodies to Hepatitis C Virus: a Potential Supplemental Antibody Confirmatory Assay.

An estimated 41,200 people were newly infected with hepatitis C virus (HCV) in 2016 in the United States. Screening tests for antibodies to HCV may generate up to 32% false positivity in low-risk populations. Current Centers for Disease Control and Prevention (CDC) screening recommendations do not require confirmatory testing of a screening anti-HCV-positive test; however, confirmation is valuable for surveillance in the absence of HCV RNA testing. A recombinant immunoblot assay (RIBA) was used as a confirmatory assay for anti-HCV-reactive samples but was discontinued in 2013. Another anti-HCV confirmatory assay, INNO-LIA, is commercially available in Europe but is not approved by the Food and Drug Administration (FDA) in the United States. We report the development of an anti-HCV assay that was performed on an automated immunoblot platform using a fourth-generation HCV recombinant fusion protein. Based on testing of 70 well-characterized samples, of which 40 were HCV RNA and anti-HCV positive, 15 were HCV RNA positive/anti-HCV negative, and 15 were HCV RNA and anti-HCV negative, the specificity and sensitivity of the HCV-WES assay were 100% and 95%, respectively. Concordance between INNO-LIA and HCV-WES was determined by testing 205 HCV RNA-negative/anti-HCV-positive samples, of which 149 (72.7%) were positive by HCV-WES, while 146 (71.2%) were positive by INNO-LIA. We have shown proof of concept for the use of this test for confirmation of screened anti-HCV results. The HCV-WES assay has advantages over manual Western blot assays and INNO-LIA, including ease of use, lower cost, and reduced hands-on time.

Screening for hepatitis C in a general adult population in a low-prevalence area: the Troms\xf8 study

BackgroundChronic hepatitis C virus (HCV) infection can progress to cirrhosis and end-stage liver disease in a substantial proportion of patients. The infection is frequently asymptomatic, leaving many infected individuals unaware of the diagnosis until complications occur. This advocates the screening of healthy individuals. The aim of this study was to estimate the prevalence of HCV infection in the general adult population of the municipality of Tromsø, Norway, and to evaluate the efficiency of such an approach in a presumed low-prevalence area.MethodsThe study was part of the seventh survey of the Tromsø Study (Tromsø 7) in 2015–2016. Sera from 20,946 individuals aged 40 years and older were analysed for antibodies to HCV (anti-HCV). A positive anti-HCV test was followed up with a new blood test for HCV RNA, and the result of any previous laboratory HCV data were recorded. Samples positive for anti-HCV and negative for HCV RNA were tested with a recombinant immunoblot assay. All HCV RNA positive individuals were offered clinical evaluation.ResultsAmong 20,946 participants, HCV RNA was detected in 33 (0.2%; 95% CI: 0.1–0.3), of whom 13 (39.4%; 95% CI: 22.7–56.1) were unaware of their infection. The anti-HCV test was confirmed positive in 134 individuals (0.6%; 95% CI: 0.5–0.7) with the highest prevalence in the age group 50–59 years. Current or treatment-recovered chronic HCV-infection was found in 85 individuals (0.4%; 95% CI: 0.3–0.5) and was associated with an unfavorable psychosocial profile.ConclusionIn this population-based study, the prevalence of viraemic HCV infection was 0.2%. A substantial proportion (39%) of persons with viraemic disease was not aware of their infectious status, which suggests that the current screening strategy of individuals with high risk of infection may be an inadequate approach to identify chronic HCV infection hidden in the general population.

Occult hepatitis C virus infection in patients with beta-thalassemia major: Is it a neglected and unexplained phenomenon?

Occult hepatitis C virus (HCV) infection (OCI) is described as the presence of viral genome in both hepatocytes and peripheral blood mononuclear cells (PBMCs) despite constant negative results on serum HCV RNA tests. Beta-thalassemia major (BTM) describes a group of inherited blood diseases. Patients with BTM require repeated blood transfusions, increasing the risk of exposure to infectious agents. We aimed to assess the prevalence of OCI in Iranian BTM patients and to identify the role of host factors in OCI positivity. A total of 181 BTM patients with HCV negative markers were selected. HCV RNA was tested in PBMCs using nested polymerase chain reaction assay. The positive samples were then genotyped via restriction fragment-length polymorphism (RFLP) and 5'-untranslated region sequencing. Six (3.3%) out of 181 BTM patients had viral HCV genomes in PBMC samples. Three (50.0%), two (33.3%), and one (16.7%) out of these six patients were infected with HCV-1b, HCV-1a, and HCV-3a, respectively. OCI positivity was significantly associated with the serum level of uric acid (P = 0.045) and ABO blood group (P = 0.032). Also, OCI patients had unfavorable IFNL3 rs12979860 TT, IFNL3 rs8099917 GG, IFNL3 rs12980275 GG, and IFNL4 ss469415590 ∆G/∆G genotypes. In conclusion, we indicated the low frequency of OCI in BTM patients. Nevertheless, more attention is warranted considering the importance of this infection. Also, further studies are necessary to determine the actual prevalence of OCI among BTM patients in Iran.

Performance evaluation of the Hologic Aptima HCV Quant Dx assay for detection of HCV RNA from dried blood spots

BackgroundThe availability of effective direct-acting antiviral therapy for hepatitis C virus (HCV) has led to a need for simplified diagnostic pathways. Barriers to treatment uptake, specifically in people who inject drugs and in remote and resource limited settings, may be overcome by utilizing novel collection methods, such as dried blood spots (DBS). However, there are currently no registered assays for HCV RNA testing from DBS samples. ObjectivesTo evaluate the sensitivity and specificity of the Aptima HCV Dx Quant assay for HCV RNA detection in DBS samples Study design107 paired venepuncture and DBS samples from HCV antibody positive individuals were analyzed for HCV RNA on the Aptima HCV Dx Quant and Roche CAP/CTM (gold standard) HCV assays. Results78% (n=83) had detectable HCV RNA in plasma. Sensitivity of the Aptima assay for HCV RNA detection in DBS was 96.4% (95% CI 89.8–99.3%) and specificity was 95.8% (95% CI 78.8–99.9%). Sensitivity for HCV RNA detection in DBS using a quantitative threshold of ≥15 IU/mL in plasma was 95.1% (95% CI 88%–98.7%) and specificity was 96.0% (95% CI 79.7%–99.9%). The sensitivity of HCV RNA detection in DBS using a quantitative threshold of ≥1000 IU/mL (based on a clinically relevant threshold) was 100% (95% CI 95.3–100%) and specificity was 100% (95% CI 88.4–100%). ConclusionsOur data indicates that the Aptima HCV Dx Quant can detect active HCV infection from a DBS sample with good sensitivity and specificity, particularly when using a threshold of ≥1000 IU/mL.

Evaluation of Dried Blood Spots as a Feasible Alternative to Plasma for the Detection and Quantification of Hepatitis C Virus in a Tropical Setting: A Pilot Study

AbstractIntroduction: Confirmatory diagnosis of hepatitis C virus (HCV) infection (HCV RNA detection) is essential before start of the therapy. HCV RNA detection is not available in many parts of India. Shipment of plasma from distant places to referral laboratories may affect HCV RNA titres. Dried blood spots (DBS) provide an easy alternative for transporting samples to centres where HCV RNA testing is done. Aim: Evaluation of DBS as a feasible alternative to plasma for HCV diagnosis. Methods: In this cross-sectional study, 40 consecutive patients’ blood samples were collected from patients referred from the Liver Clinic. Whole blood was spotted onto two Whatman 903TM cards. One card was incubated at ≥37°C and other at 4°C for 15 days, after drying. DBS was eluted and run in Abbott RealTime HCV assay. HCV was also quantified using the Abbott ARCHITECT HCV core antigen assay for 29 of the study patients. Results were compared with normal plasma values. Results: The median log HCV RNA value (in log10 IU/mL) of plasma was 5.74, with normalised DBS it was 4.92 (≥37°C) and 4.66 (4°C); difference in plasma and DBS median log values was 0.82 (≥37°C) and 1.08 (4°C) logs, respectively. Interclass correlation values were 0.943, P < 0.0001 (≥37°C) and 0.950, P < 0.0001 (4°C), showing high agreement. The median HCV core antigen value (in fmol/L) for plasma was 325.35, whereas it was 4.77 (≥37°C) and 4.64 (4°C) for DBS samples. Conclusions: DBS can be used for sampling patients from distant resource-limited settings as an alternative to plasma for HCV RNA estimation. Larger studies are required to evaluate the feasibility of DBS in the Indian subcontinent, especially for HCV core antigen estimation.

Strategy and Efficacy of Generic and Pan-genotypic Sofosbuvir/Velpatasvir in Chronic Hepatitis C Virus: A Myanmar Experience

In resource-constrained areas, generic direct-acting antivirals (DAAs) have considerably reduced the cost of hepatitis C virus (HCV) therapy while there remain significant costs related to the baseline and follow-up virologic assays. The aim was to assess the efficacy and safety of HCV therapy in Myanmar with pan-genotypic generic DAA sofosbuvir/velpatasvir (SOF/VEL) and with and without the baseline genotype testing, while the duration of treatment and use of ribavirin (RBV) was dictated by cirrhosis and prior treatment failure. Between September 2016 and June 2017, data from the 359 participants who completed treatment with SOF/VEL (± RBV) for 12-24 weeks were analyzed. Two hundred one patients did not have the baseline HCV genotype tested. Regimens included SOF/VEL for 12 weeks (n= 43), SOF/VEL/RBV for 12 weeks (n= 275), or SOF/VEL/RBV for 24 weeks (n= 41). The mean age was 52 years, 44% were men (n= 159), 41 (11.4%) had a history of previous DAA therapy, 7 (1.9%) had a history of hepatocellular carcinoma, and 55 (15.3%) had cirrhosis. Overall, the sustained viral response (SVR)12 rate was 98.6% (354/359) and with a good adverse event profile. SVR rates were similar to those with and without baseline genotype testing and also across all genotypes in those who had genotype tested. In Myanmar, generic and pan-genotypic SOF/VEL±RBV is a highly effective and safe treatment for HCV, regardless of the HCV genotype, and therefore, the requirement for the baseline genotype can be eliminated. Future strategies should include elimination of treatment and end of treatment HCV RNA testing to enhance treatment uptake and further reduce cost.

932. Universal Hepatitis C Virus Screening in a Tennessee Tertiary Care Emergency Department

BackgroundDespite hepatitis C virus (HCV) age cohort and risk factor screening recommendations, many at-risk individuals remain undiagnosed. Current screening practices may not adequately capture those at high risk for infection, especially in regions with increasing injection drug use (IDU). Universal HCV screening in a Tennessee tertiary care emergency department (ED) was introduced to help define regional epidemiology and to improve diagnosis and linkage to care.MethodsThis screening program was implemented in the Vanderbilt University Medical Center ED. Adult patients who underwent phlebotomy for clinical purposes were offered HCV screening. Samples were initially tested for HCV antibodies; if positive, samples were reflexed for HCV RNA testing. Patients with positive HCV RNA tests (i.e., active HCV infection) were notified, counseled, and offered linkage to care.ResultsA total of 11,637 screening tests were performed between April 1, 2017 and March 31, 2018, with 1,008 (8.7%) HCV antibody positive and 488 (4.2%) RNA positive. Of note, 81 (0.7%) were HCV antibody positive but RNA testing could not be performed due to insufficient sample volume. Several notable populations had high rates of HCV (Table 1). Importantly, 3.9% of people not born between 1945 and 1965 were HCV RNA positive, and they were the majority (63.5%) of patients with active HCV (Table 2). A minority (31.6%) of those with active HCV had a known history of IDU (Table 2).ConclusionHCV is common among patients presenting for emergency care at a Tennessee tertiary care ED. Universal screening identified many infections that would have been missed using age cohort and risk factors alone. ED HCV screening may be a useful method to augment guideline-based testing and intervene among populations not consistently screened.Table 1:Notable Groups Screened for HCV (n = 11,537)DemographicsTotal ScreenedHCV Antibody + (%)HCV RNA + (%)People Born 1945–19653,670436 (11.9%)178 (4.9%)People Not Born 1945–19657,967572 (7.2%)310 (3.9%)Women Age 18–452,622156 (5.9%)77 (2.9%)Table 2:Demographics Among HCV RNA + (n = 488)Demographicsn (%)People Born 1945–1965178 (36.5%)People Not Born 1945–1965310 (63.5%)Women Age 18–4577 (15.8%)Known IDU154 (31.6%)People Not Born 1945–1965 With No Known IDU179 (36.7%)Disclosures C. A. Chastain, Gilead Sciences, Inc.: Grant Investigator and Research Contractor, Grant recipient and Research support. J. Johnson, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. K. Miller, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. J. H. Han, Gilead Sciences, Inc.: Grant Investigator, Grant recipient. W. H. Self, Gilead Sciences, Inc.: Grant Investigator, Grant recipient.

2202. The Hepatitis C Virus Cascade of Care at Stony Brook University Hospital: Risk Factors for Linkage to Care

BackgroundHuge efforts are being made to screen high-risk populations for Hepatitis C virus (HCV) infection, however linkage to care (LTC) rates remain low. The aim of this study was to assess the factors affecting LTC among HCV positives in a major tertiary academic medical center in eastern New York.MethodsA retrospective chart review was performed on all patients with ICD-9 or 10 diagnostic codes for HCV positive antibody over a period of 2 years (2016–2017) at Stony Brook Medicine. Data were collected for HCV RNA, LTC, demographics, type of insurance, employment status, psychiatric diagnosis, comorbidities, HIV or HBV coinfections, substance use disorder, and level of fibrosis. Univariate and multivariate analyses were performed to find associated factors with LTC.ResultsA total of 600 cases (62.6% male; 74% White; median age: 59 years) had a positive HCV antibody, 264 (44.4%) had a positive follow-up HCV RNA test and 138 (52.2%) were LTC. The average time for LTC was 1.5 months (50 days; interquartile range 21–121). In the univariate analysis, the following factors were significantly associated with LTC: older age (OR 1.022), having medicaid (OR 0.421), people who inject drugs (PWID) (OR 0.216), cocaine and marijuana use (OR 0.457), polysubstance use (OR 0.311), having a primary care provider (OR 2.290) and being a baby boomer (OR 1.718). The vast majority of patients came from three zip codes within south central Suffolk County, coinciding with the highest prevalence of heroin use.ConclusionIn this population insurance type, younger age and substance use (injection drugs, marijuana, cocaine, polysubstance) were associated with lower odds of LTC. Having a primary care provider and being a baby boomer were the only two independent risk factors associated with increased odds of LTC. Due to an increased number of HCV cases in younger populations, particularly PWID, further outreach efforts are urgently needed to spread HCV screening awareness and increase testing in high prevalence areas.Disclosures All authors: No reported disclosures.

Profile of the VERSANT HCV genotype 2.0 assay

ABSTRACTIntroduction: Hepatitis C virus (HCV) is divided into 7 genotypes and 67 subtypes. HCV genotype studies reflect the viral transmission patterns as well as human migration routes. In a clinical setting, HCV genotype is a baseline predictor for the sustained virological response (SVR) in chronic hepatitis C patients treated with peginterferon or some direct acting antivirals (DAAs). The Versant HCV genotype 2.0 assay has been globally used for HCV genotyping over a decade.Areas covered: The assay is based on reverse hybridization principle. It is evolved from its former versions, and the accuracy and successful genotyping/subtyping rate are substantially improved. It shows an accuracy of 99–100% for genotypes 1–6. It can also reliably identify subtypes 1a and 1b. However, the assay does not allow a high resolution for many other subtypes. Reasons for indeterminate or inaccurate genotyping/subtyping results are discussed.Expert commentary: Genotyping helps to find the most efficacious and cost-effective treatment regimen. The rapid development of anti-HCV treatment regimens, however, is greatly simplifying laboratory tests. In the near future, the need for HCV genotyping and frequent serial on-treatment HCV RNA tests will decrease along with the wide use of the more potent and pan-genotypic DAA regimens.

Hepatitis C Virus Diagnostics: The Road to Simplification.

Hepatitis C Virus Diagnostics: The Road to Simplification.

Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia

BackgroundUptake of hepatitis C virus (HCV) testing remains inadequate globally. Simplified point-of-care tests should enhance HCV diagnosis and elimination. We aimed to assess the acceptability of finger-stick and venepuncture HCV RNA testing among people who inject drugs (PWID). MethodsParticipants were enrolled in an observational cohort study with recruitment at 13 sites between June 2016 and February 2018. Capillary whole-blood collected by finger-stick and plasma collected by venepuncture were performed for Xpert® HCV viral load testing. Participants completed a questionnaire on acceptability of, and preferences for, blood collection methods. ResultsAmong 565 participants (mean age, 44 years; 69% male), 64% reported injecting drugs in the last month, and 63% were receiving opioid substitution treatment. Eighty three percent reported that finger-stick testing was very acceptable. Overall, 65% of participants preferred finger-stick over venepuncture testing, with 61% of these preferring to receive results in 60 min. The most common reason for preferring finger-stick over venepuncture testing was it was quick (62%) followed by venous access difficulties (21%). The main reasons for preferring venepuncture over finger-stick testing were that it was quick (61%) and accurate (29%). Females were more likely to prefer finger-stick testing than males (adjusted OR 1.96; 95% CI 1.30, 2.99; p = 0.002). Among people with recent (previous month) injecting drug use, Aboriginal and/or Torres Strait Islander people were less likely than non-Aboriginal people to prefer finger-stick testing (adjusted OR 0.57; 95% CI 0.34, 0.9; p = 0.033). ConclusionsFinger-stick whole-blood collection is acceptable to people who inject drugs, with males and Aboriginal and/or Torres Strait Islander people with recent injecting drug use less likely to prefer finger-stick testing. Further research is needed to evaluate interventions integrating simplified point-of-care HCV testing to engage people in care in a single-visit, thereby facilitating HCV treatment scale-up.