scholarly journals Hepatitis C Virus (HCV) diagnosis, epidemiology and access to treatment in a UK cohort

2017 ◽  
Author(s):  
Emily Adland ◽  
Gerald Jesuthasan ◽  
Louise Downs ◽  
Victoria Wharton ◽  
Gemma Wilde ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Clinical Care ◽  
Virologic Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Direct Acting Antiviral

ABSTRACTBackgroundAs direct acting antiviral (DAA) therapy is progressively rolled out for patients with hepatitis C virus (HCV) infection, careful scrutiny of HCV epidemiology, diagnostic testing, and access to care is crucial to underpin improvements in delivery of treatment.MethodsWe performed a retrospective study of HCV infection in a UK teaching hospital to evaluate the performance of different diagnostic laboratory tests, to describe the population with active HCV infection, and to determine the proportion of these individuals who access clinical care.ResultsOver a total time period of 33 months between 2013 and 2016, we tested 38,510 individuals for HCV infection and confirmed a new diagnosis of active HCV infection (HCV-Ag+ and/or HCV RNA+) in 359 (positive rate 0.9%). Our in-house HCV-Ab test had a positive predictive value of 87% when compared to repeat HCV-Ab testing in a regional reference laboratory, highlighting the potential for false positives to arise based on a single round of antibody-based screening. Of those confirmed Ab-positive, 70% were HCV RNA positive. HCV-Ag screening performed well, with 100% positive predictive value compared to detection of HCV RNA. There was a strong correlation between quantitative HCV-Ag and HCV RNA viral load (p<0.0001). Among the 359 cases of infection, the median age was 37 years, 85% were male, and 36% were in prison. Among 250 infections for which genotype was available, HCV genotype-1 (n=110) and genotype-3 (n=111) accounted for the majority. 117/359 (33%) attended a clinic appointment and 48 (13%) had curative treatment defined as sustained virologic response at 12 weeks (SVR12).ConclusionsHCV-Ab tests should be interpreted with caution as an indicator of population prevalence of HCV infection, both as a result of the detection of individuals who have cleared infection and due to false positive test results. We demonstrate that active HCV infection is over-represented among men and in the prison population. A minority of patients with a diagnosis of HCV infection access clinical care and therapy; enhanced efforts are required to target diagnosis and providing linkage to clinical care within high risk populations.ABBREVIATIONSDAADirect Acting AntiviralELISAEnzyme linked immunosorbent assayHCVHepatitis C VirusHCV-AbIgG antibody to Hepatitis C virusHCV-AgHepatitis C virus core antigenHCV RNAHepatitis C ribonucleic acid (viral load)MSMmen who have sex with menNATnucleic acid testingPCRpolymerase chain reaction (test for viral load)PPVpositive predictive valuePWIDpeople who inject drugsSDGSustainable Development GoalsSVRsustained virologic responseWHOWorld Health Organisation

scholarly journals Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir Regimen in Haemodialysis Patients With Hepatitis C Virus Infection

2020 ◽  
Vol 39 (1) ◽  
pp. 23-27
Author(s):  
Antonija Verhaz ◽  
Tatjana Roganović ◽  
Ljiljana Pašić ◽  
Olja Čuković ◽  
Tanja Macanović-Kostić
Keyword(s):  
Liver Cirrhosis ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Events ◽  
Concomitant Medication ◽  
Demographic Data ◽  
Virologic Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Stage Renal Disease

Background: Hepatitis C virus (HCV) infection is common among patients on haemodialysis (HD) therapy and is an important cause of morbidity and mortality. In patients with chronic kidney disease (CKD), the risks for negative outcomes are significantly higher in HCV-infected patients than in those without HCV infection, including progression to cirrhosis, hepatocellular carcinoma and liver-related mortality. Ombitasvir (OBV), paritaprevir (PTV), ritonavir (r), and dasabuvir (DSV) are all hepatically metabolized and, therefore, require no dose adjustment in patients with any degree of renal impairment. Aims: We studied the safety and efficacy of OBV/PTV/r + DSV in a small group of HCV infected patients on haemodialysis therapy. Methods: Treatment course with ombitasvir/paritaprevir/ritonavir and dasabuvir; (3-DAA regimen of OBV/PTV/r+DSV±RBV) was analysed. Pre-treatment evaluation of HCV infection included HCV RNA, genotype, and liver fibrosis assed by transient fibroelastography (FibroScan). The stage 5 CKD was defined as an eGFR of &lt;15 mL/min/1.73 m2, respectively; those on haemodialysis were considered to have stage 5 CKD or end-stage renal disease (ESRD). Demographic data and concomitant medication were retrieved from patients’ records. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12). We collected data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Results: Among 7 treated patients, 6 were male and 1 female, all were infected with genotype 1 (5 GT1b, 2 GT1a). Patient had compensated liver cirrhosis and six patients did not have liver cirrhosis, none were liver transplant recipients. All of seven patients completed 12 weeks of treatment and achieved SVR12. Concomitant medication had to be modified with the treatment initiation in 5 out of 7 patients. One of the patients presented with a significant decrease in haemoglobin level, white blood cell and platelet count during the treatment period. The most frequent adverse events were nausea, diarrhoea. Adverse events were primarily mild, and no patient discontinued treatment due to an AE. Conclusions: Treatment with OBV/PTV/r +DSV ± RBV was well-tolerated and resulted in high rates of SVR12 (100%) for patients with HCV GT1b/1a on haemodialysis.

Detection of Occult Hepatitis C Virus Infection in Patients Who Achieved a Sustained Virologic Response to Direct-Acting Antiviral Agents

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Tarek Mohamed Yousef ◽  
Maha Mohsen Mohamed Kamal El Din ◽  
Tari Magdy Aziz George ◽  
Amr Adel Elzohary Mohamed
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Virologic Response ◽  
Hcv Rna ◽  
Occult Hepatitis ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Occult Hepatitis C ◽  
Direct Acting Antiviral Agents

Abstract Background Occult infection with hepatitis C virus (HCV) is defined as the presence of the HCV genome in either liver tissue or peripheral blood monocytes, despite constant negative results from tests for HCV RNA in serum. Objectives The aim of the study to detect the prevalence of occult hepatitis C Virus infection in patients who achieved a sustained virologic response (SVR) to direct-acting antiviral agents and to outline predictors of OCI. Patients and Methods This study included 100 patients with chronic HCV infection without liver cirrhosis attending to hepatitis C clinics at Ain Shams University Hospital, Ahmed Maher Teaching hospital and Elgomhorya Teaching Hospital.who received sofosbuvir (400mg) plus daclatasvir (60mg) daily for 12 weeks with or without ribavirin according to National committee to combat viral hepatitis (NCCVH) protocol. Results We tested peripheral blood for HCV RNA in PBMCs to detect OCI. Occult HCV was found positive in 12% of the studied cases. Occult HCV was positive more in male cases. Positive cases had significantly lower age, and higher total bilirubin, direct bilirubin, AST and ALT levels. Age had significant moderate diagnostic performance in predicting occult HCV, while direct bilirubin has significant low diagnostic performance in predicting occult HCV. Conclusion OCI following direct antiviral therapy may be present in some cases, and this may require further testing of patients with SVR particularly in younger male patients with persistantly high liver enzymes.

scholarly journals Significant Improvement in Diagnosis of Hepatitis C Virus Infection by a One-Step Strategy in a Central Laboratory: an Optimal Tool for Hepatitis C Elimination?

2019 ◽  
Vol 58 (1) ◽  
Author(s):  
Rosa López-Martínez ◽  
Andrea Arias-García ◽  
Francisco Rodríguez-Algarra ◽  
Laura Castellote-Bellés ◽  
Ariadna Rando-Segura ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Global Strategy ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Central Laboratory ◽  
Antiviral Therapies ◽  
One Step ◽  
Reflex Testing

ABSTRACT The remarkable effectivity of current antiviral therapies has led to consider the elimination of hepatitis C virus (HCV) infection. However, HCV infection is highly underdiagnosed; therefore, a global strategy for eliminating it requires improving the effectiveness of HCV diagnosis to identify hidden cases. In this study, we assessed the effectiveness of a protocol for HCV diagnosis based on viral load reflex testing of anti-HCV antibody-positive patients (known as one-step diagnosis) by analyzing all diagnostic tests performed by a central laboratory covering an area of 1.5 million inhabitants in Barcelona, Spain, before (83,786 cases) and after (45,935 cases) the implementation of the reflex testing protocol. After its implementation, the percentage of anti-HCV-positive patients with omitted HCV RNA determination remarkably decreased in most settings, particularly in drug treatment centers and primary care settings, where omitted HCV RNA analyses had absolute reductions of 76.4 and 20.2%, respectively. In these two settings, the percentage of HCV RNA-positive patients identified as a result of reflex testing accounted for 55 and 61% of all anti-HCV-positive patients. HCV RNA results were provided in a mean of 2 days. The presence of HCV RNA and age of ≥65 years were significantly associated with advanced fibrosis, assessed using the serological FIB-4 index (odds ratio [OR], 5.92; 95% confidence interval [CI], 3.4 to 10.4). The implementation of viral load reflex testing in a central laboratory is feasible and significantly increases the diagnostic effectiveness of HCV infections, while allowing the identification of underdiagnosed cases.

Acute hepatitis C virus infection and direct-acting antiviral drugs: Perfect combination to eliminate the epidemic?

2021 ◽  
pp. 095646242110337
Author(s):  
Cristina Gómez-Ayerbe ◽  
Rosario Palacios ◽  
Maria J Ríos ◽  
Francisco Téllez ◽  
Carmen Sayago ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Median Time ◽  
Sustained Viral Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Acute Hepatitis C ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Incident Cases

Early diagnosis and treatment of incident cases of hepatitis C virus (HCV) infection is fundamental to eliminate HCV in HIV-positive patients. From January 2016 to December 2019, we attended 40 episodes of acute HCV infection (AHC) in 35 subjects (9 reinfections) who were coinfected with HIV. The patients were treated with direct-acting antiviral agents (DAAs) in seven hospitals in Andalusia, Spain. All were men who have sex with men (MSM), mean age was 42.9 (±8.3) years and median time of HIV infection was 46.6 months (IQR: 20.4–67.2). All received antiretroviral therapy and had undetectable HIV viral load (except 2 with 65 and 68 copies/mL); median CD4 count was 632 cells/mm3 (IQR: 553–896). Over half (74.3%) also had another concomitant sexually transmitted infection, syphilis (48.6%) being the most common. AHC was asymptomatic in 32 cases (80%). Genotypeic distribution was G1a 65%, G4 32.5% and G1b 3%. Median time to DAA was 6 weeks (IQR: 4.3–18.3) and median baseline HCV RNA was 6.1 Log (IQR: 5.6–6.5). DAA regimens were SOF/LDV (19 episodes), SOF/VEL (14), ELB/GZV (5) and GLP/PIB (2). All presented sustained viral response and none discontinued due to adverse effects. In conclusion, early treatment with DAA in AHC patients proved effective and safe. It could be an excellent strategy to eliminate HCV infection in HIV-coinfected MSM.

scholarly journals A machine-learning algorithm to identify hepatitis C in health insurance claims data

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Mohammed A. Khan ◽  
Jae Eui Soh ◽  
Matthew Maenner ◽  
William W. Thompson ◽  
Noele P. Nelson
Keyword(s):  
Health Insurance ◽  
Hepatitis C ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Insurance Claims ◽  
Chronic Hcv Infection ◽  
Chronic Hcv ◽  
Sensitivity Specificity

ObjectiveWe developed a machine learning-based algorithm to identify patients with chronic hepatitis C infection in health insurance claims data.IntroductionHepatitis C virus (HCV) infection is a leading cause of liver disease-related morbidity and mortality in the United States. Monitoring the burden of chronic HCV infection requires robust methods to identify patients with infection. Insurance claims data are a potentially rich source of information about disease burden, but often lack the laboratory results necessary to define chronic HCV infection. We developed a machine learning-based algorithm to identify patients with chronic HCV infection using health insurance claims alone and compared it a previously developed ICD-9 code-based algorithm.MethodsWe obtained insurance claims, demographics, enrollment information, and hepatitis C laboratory results from the IBM MarketScan® Commercial Claims and Encounters databases. We defined chronic HCV infection cases as a patient with one or more positive HCV RNA result and required controls to have a negative HCV antibody result and no positive HCV RNA or antibody results. Patients were required to be continuously enrolled in a health insurance plan during the six months before and after the first positive or negative test result (index date). Outpatient and inpatient insurance claims for the six months before and after the index date were included in the analyses. The study period spanned from 2011 to 2014.Subjects were randomly divided into a training sample (80%) and test (20%) sample. We trained a random forest classifier using age, sex, region, Charlson comorbidity index, and variables defining the presence and frequency of 67 ICD-9 diagnosis codes and CPT procedure codes related to HCV and liver disease. We up-weighted cases to account for the low prevalence of infection in our sample. We generated forests of 1,000 trees for all models. The initial model included all variables. Permutation-based variable importance scores from this initial model were used to select variables for the final model. The previously developed algorithm defined chronic HCV infection as either two claims with codes for chronic hepatitis infection > 60 days apart after an HCV RNA test claim or three claims with codes for chronic HCV infection on different dates after an HCV RNA test claim. We compared the predicted classification to HCV laboratory result-defined classification and calculated percent agreement, Kappa, sensitivity, specificity, positive predictive value, and negative predictive value. We then applied the final classifier to all individuals continuously enrolled in commercial and/or Medicare supplemental insurance to estimate the prevalence of chronic HCV infection in this population in 2014. Analyses were performed in SAS version 9.4.ResultsWe identified 5,780 (5.6%) cases with chronic HCV infection and 97,831 controls with negative HCV test results. The training dataset consisted of 82,888 individuals with approximately six million inpatient and outpatient claims. The final model included 23 variables related to hepatitis C (e.g., number of HCV RNA test claims), liver disease (e.g., cirrhosis diagnosis code), and comorbidities. In the training dataset, percent agreement, Kappa, sensitivity, specificity, positive predictive value, and negative predictive value were 99.2%, 0.92, 92.3%, 99.6%, 93.2%, and 99.5%, respectively. The presence of a CPT code for HCV RNA testing had the highest variable importance score. The test dataset included 20,723 individuals with approximately 1.5 million inpatient and outpatient claims. In the test dataset, percent agreement, Kappa, sensitivity, specificity, positive predictive value, and negative predictive value for the final classifier were 98.9%, 0.89, 89.9%, 99.4%, 89.0%, and 99.4%, respectively. Percent agreement, Kappa, sensitivity, specificity, positive predictive value, and negative predictive value for the previously developed algorithm were 96.3%, 0.50, 35.0%, 99.9%, 96.7%, 96.3%, respectively. Among the 35.6 million individuals with continuous commercial and/or Medicare supplemental insurance in 2014, 317,932 (0.9%) were classified as having chronic HCV infection.ConclusionsOur machine learning-based algorithm was able to identify chronic hepatitis C cases in commercial health insurance claims data with relatively high estimates for percent agreement, Kappa, sensitivity, specificity, positive predictive value, and negative predictive. Future analyses and models will explore the ability of the algorithm to estimate the prevalence of HCV infection in different populations covered by different health plan types (e.g., commercial, Medicaid, Medicare, or no insurance) and for populations where laboratory testing data is not available or collected.  

scholarly journals Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older

2019 ◽  
Vol 5 ◽  
pp. 233372141881739 ◽  
Author(s):  
Steven Flamm ◽  
Cheng-Yuan Peng ◽  
Oren Shibolet ◽  
Ronald Nahass ◽  
Peggy Hwang ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Adverse Events ◽  
Virologic Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Efficacy And Safety ◽  
Limit Of Quantification ◽  
Serious Adverse Events ◽  
Infected People

Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. Methods: This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Results: Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. Conclusion: The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years.

scholarly journals Higher levels of hepatitis C virus RNA found in blood donors co-infected with HIV as compared to HCV mono-infected donors

2014 ◽  
Vol 8 (08) ◽  
pp. 1068-1071 ◽  
Author(s):  
Enagnon Kazali Alidjinou ◽  
Donatien Moukassa ◽  
Eben Ebatetou-Ataboho ◽  
Gael Honal Mahoungou ◽  
Jean-Paul Pambou ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Blood Donors ◽  
Hiv Infections ◽  
High Viral Load ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Infected People ◽  
Sub Saharan

Introduction: Hepatitis C virus (HCV) infection and human immunodeficiency virus (HIV) infections are public health problems in sub-Saharan countries such as the Republic of Congo. HIV infection could impact the characteristics of HCV infection in co-infected people. We investigated HCV-HIV co-infection among blood donors in Congo. Methodology: Ninety-nine HIV-positive and/or HCV-seropositive blood donors were selected during screening and subsequently tested for aminotransferases and HCV RNA. Results: A total of 29 donors were found positive for HCV RNA (HCV-infected individuals), including 19/60 (31.66%) HIV donors (co-infected) and 10/39 (25.64%) non-HIV donors (mono-infected). Most of the co-infected donors (17/19) displayed a high viral load (> 5 log). The median HCV RNA level was at least 2 logs higher in co-infected people. The levels of alanine aminotransferase (ALT) were also slightly higher in co-infected donors than in HCV mono-infected donors. Conclusion: This study reports HCV-HIV co-infection among blood donors in Congo and shows that HCV viral load is higher in HIV donors.

scholarly journals Direct acting anti-hepatitis C virus drugs: Clinical pharmacology and future direction

2017 ◽  
Vol 5 (1) ◽  
pp. 8-17 ◽  
Author(s):  
Ayman Geddawy ◽  
Yasmine F. Ibrahim ◽  
Nabil M. Elbahie ◽  
Mohammad A. Ibrahim
Keyword(s):  
Clinical Pharmacology ◽  
Drug Interaction ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Antiviral Agents ◽  
Virologic Response ◽  
Hcv Infection ◽  
Major Advance ◽  
Direct Acting Antiviral ◽  
Direct Acting

Abstract Chronic hepatitis C virus (HCV) infection is a leading cause of chronic liver disease. The introduction of direct acting antiviral agents (DAAs) for its treatment represents a major advance in terms of sustained virologic response (SVR) rates and adverse effect profiles. Mechanistically, DAAs inhibit specific HCV non-structural proteins (NS) that are vital for its replication. Boceprevir, telaprevir, simeprevir, asunaprevir, grazoprevir and paritaprevir are NS3/4A inhibitors. Ombitasvir, ledipasvir, daclatasvir, elbasvir and velpatasvir are NS5A inhibitors. Sofosbuvir and dasabuvir are NS5B inhibitors. Currently, a combination of two or more DAAs is the corner stone for the treatment of HCV infection. However, the success of DAA therapy is facing several challenges, including the potential of drug-drug interactions and resistant variance. Moreover, the shortage of relevant clinical pharmacological data and drug interaction regarding DAA is a clinical concern. The present review discusses the clinical pharmacology of DAAs with special emphasis on drug-drug interaction.

scholarly journals Rate of Sustained Virologic Response in Relation to Baseline Hepatitis C Virus (HCV) RNA Level and Rapid Virologic Clearance in Persons with Acute HCV Infection

2009 ◽  
Vol 200 (6) ◽  
pp. 877-881 ◽  
Author(s):  
Barbara H. McGovern ◽  
Ellen H. Nagami ◽  
Christopher E. Birch ◽  
Melinda J. Bowen ◽  
Laura L. Reyor ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Acute Hcv ◽  
Acute Hcv Infection
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