Hepatitis C Virus RNA Testing Research Articles

Hepatitis C virus core antigen: A potential alternative to HCV RNA testing among persons with substance use disorders

BackgroundThe hepatitis C virus (HCV) core antigen (HCVcAg) may be an alternative diagnostic method to HCV RNA especially in populations such as substance users, the homeless or in resource-limited settings. AimsTo evaluate performance of HCVcAg test in patients with opioid use disorder (OUD) on methadone in order to document its performance characteristics in the target population and to ensure that its specificity remains consistent across different populations. MethodsHCVcAg levels from 109 methadone-maintained patients were compared to HCV RNA levels. ResultsMean age was 53.8±7.8years, 59.6% were male, 68.8% African American, and 44% HCV-infected. HCVcAg was detectable in 47 of 48 HCV-infected, and undetectable in all HCV RNA negative patients. The HCVcAg assay had sensitivity of 97.9% and specificity of 100%. Correlation with HCV RNA levels was excellent (r=0.88, 95% CI 0.76; 0.95, p<0.01). ConclusionHCVcAg has excellent performance for the diagnosis of HCV infection in patients with OUD on methadone.

Low prevalence of hepatitis B and C infections among the healthcare workers despite low vaccination coverage for hepatitis B in Mumbai

&lt;p class="ABS"&gt;&lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Background&lt;/span&gt;&lt;span class="Bold"&gt;:&lt;/span&gt; The risk of acquiring hepatitis B virus (HBV) and hepatitis C virus (HCV) infections through exposure to blood or its products and contact with other body fluids is high amongst health care workers (HCWs). Despite potential risks, a proportion of HCWs never get vaccinated. This study aimed to investigate the vaccination practices and the prevalence of HBV infection in HCWs. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Aims:&lt;/span&gt; To determine the prevalence of HBV and HCV, their possible association with occupational and non-occupational risk factors. We also studied the prevalence of vaccination for hepatitis B in different subgroups of study population. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Materials and Methods:&lt;/span&gt; In this cross-sectional study, total 1347 hospital staffs were screened for hepatitis B and hepatitis C. HBV is detected by HBsAg testing, and HCV is detected by anti-HCV testing by ELISA method. Positive results were confirmed by HBV DNA testing (Qualitative) and HCV RNA testing (Qualitative). A questionnaire used to collect data from study participants was pre-designed by the authors. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Results:&lt;/span&gt; Out of total 1347 hospital staffs screened, 6 (0.4%) were HBsAg-positive and 2 (0.1%) were anti-HCV-positive. Only 54% had a history of complete vaccination, and 0.3% had incomplete vaccination. Vaccination coverage was highest in residents (76.7%), medical students (68.9%), nursing (66.1%), and teachers (61.4%) and lowest in servants (5.4%), office staff (6.6%), and lab technicians (24.3%). Awareness about the risk factor for transmission of HBV and HCV and complication related to them was 77.7%. It was highest in teachers (93.9%) and residents (97.8%), lowest in servants (16.3%). No statistically significant difference in the exposure to various risk factors among those who are HBsAg or anti-HCV-positive and HBsAg or anti-HCV-negative. &lt;span class="ABS_Bold-Italic" lang="en-GB"&gt;Conclusions:&lt;/span&gt; The prevalence of HBV and HCV infection is not high in hospital staff than general population. Hepatitis B vaccination coverage was below expectation in all the subgroups even in resident doctors and teachers.&lt;/p&gt;&lt;div&gt; &lt;/div&gt;

Interrelationship of hepatitis C virus genotypes with patient characteristics in Bahrain.

AimHepatitis C virus (HCV) shows genotype-based variation in prevalence across geographical regions. This study was conducted to understand the clinical interrelationship of HCV genotypes with patient characteristics.MethodsMedical records of 122 patients positive for HCV RNA test collected during 2013 and 2014 were included for analysis. Only adults were included in the study. HCV RNA extraction and genotyping was done as part of the routine diagnostic requirements. The association of continuous and categorical variables with genotypes was analyzed through analysis of variance and chi-square tests, respectively.ResultsOf the 122 patients selected, 103 were Bahrainis, 18 non-Bahrainis, and 1 was unregistered. Genotype 1 was the predominant (53%) one, followed by types 3 (23%) and 4 (20%). Classical symptoms, clinical signs, liver function test, and ultrasonographic results were recorded. Cirrhosis and ascites showed significant variation across genotypes. Although alanine transaminase, total bilirubin, and albumin levels were increased, gamma-glutamyltransferase and alkaline phosphatase levels were normal. About 12% of the subjects were alcohol users, 4% were positive for HIV infection and 2.4% were positive for hepatitis B virus infection. The circulating HCV RNA load was at medium-level in the study cohort and showed significant association with the HCV genotypes and subtypes. Patients with genotype 1a had 6 times more load than patients with type 4 (P<0.05).ConclusionThis study reconfirmed the incidence and distribution of different genotypes in Bahrain population, and delineated the relationship of HCV RNA viral load with the severity of liver disease in our cohort.

Primary Care Perspectives on Hepatitis C Virus Screening, Diagnosis and Linking Patients to Appropriate Care

Enormous progress has been made in recent years toward effectively treating and curing patients with chronic hepatitis C (CHC). However, at least half of the possible 7 million individuals infected with hepatitis C virus (HCV) in the US remain undiagnosed. The formidable task of increasing the number of patients diagnosed, and subsequently linked to appropriate care has fallen to primary care clinicians, who are mandated by some US States to offer screening to individuals born between 1945 and 1965 (the Baby Boomer Generation). This peer-reviewed video roundtable discussion http://hepcresource.amjmed.com/Content/jplayer/video_roundtable.html#video0 addresses the challenges encountered by primary care clinicians faced with the increasing societal need to screen for HCV, make appropriate diagnoses, and subsequently link infected patients to appropriate care. Discussion in this roundtable initially focuses on the offering of HCV screening to patients in primary care settings. Roundtable participants discuss the need for primary care clinicians to ask appropriate risk factor-based questions of their patients, especially if the ongoing HCV epidemic is to be curtailed. The participants note, however, that the majority of patients currently infected with HCV in the US are Baby Boomers, and USPTF guidelines require this population to be tested for HCV regardless of any past risk-taking behaviors. So while asking the right questions is important, the failure of a Baby Boomer to recall risk-taking behavior does not preclude HCV screening. In fact, clinicians should proactively screen all persons in this birth cohort, and be more sensitive and open to screening requests from these individuals. Roundtable participants also discuss how HCV screening results should be communicated to patients, and how physicians can keep patients engaged and not lost to follow-up after an initial positive HCV antibody test. Patients screened and found to be HCV antibody positive require a follow-up HCV RNA test, and every effort must be made to overcome the challenge of losing patients between these two steps. Good communication between the physician, the physician's office staff, and the patient is necessary. In addition, point-of-care tests and PCR reflex testing can alleviate the need for HCV antibody positive patients to arrange subsequent office visits to undergo confirmatory HCV RNA testing.Physician and patient perspectives are presented throughout this roundtable discussion to obtain a complete picture of the management barriers encountered prior to initiation of therapy. Physician perspectives are provided by Edward Lebovics, the Upham Professor of Gastroenterology and Director of the Sarah C. Upham Division of Gastroenterology and Hepatobiliary Diseases at New York Medical College and Westchester Medical Center in Valhalla, New York, and Richard Torres, Chief Medical Officer at Optimus Health Care and an Associate Professor of Medicine at Yale School of Medicine. Torres has been a primary care provider for 29 years, working at the largest federally qualified community health center in Southwestern CT, which provides over 240,000 patient visits annually primarily to populations that are underserved and suffering from healthcare disparities. Patient perspectives in this roundtable are provided by Lucinda K. Porter, RN, who is the author of two books for hepatitis C patients, and is a former hepatology nurse and hepatitis C patient. She has been advocating for others since 1997, and writes for the HCV Advocate. Lucinda is a contributing editor of HEP magazine, and she blogs at www.LucindaPorterRN.com.The overall goal of this video roundtable discussion is to demonstrate that when provided with appropriate clinical knowledge, and aided by supportive collaborations with appropriate specialists, primary care clinicians should be able to effectively screen, diagnose, and link patients with hepatitis C to appropriate care. While patients need to be educated on the possible outcomes of a positive HCV antibody test, the significance of a positive HCV RNA test, and how to prevent further transmission, they should also be assured that currently available therapies have dramatically increased the chances of being cured. Appropriate education and the availability of excellent treatment options will hopefully quell fears and increase the morale of patients as they navigate the process of HCV screening and diagnosis.

Real-world Outcomes of Hepatitis C Treatment during the Interferon-free Era at an Urban Safety-net Hospital.

Little is known about real-world outcomes for new interferon-free treatment for hepatitis C virus (HCV) among underserved and diverse communities. To identify predictors of treatment prescription and evaluate outcomes as measured by sustained virologic response (SVR) with HCV RNA testing three months after therapy completion. Retrospective cohort at a safety-net health care system. Patients with (1) at least one clinical visit between December 6, 2013, and December 31st 2014; and (2) at least three months follow-up. Predominantly non-White cohort (61%). Of 1,284 HCV-infected patients 121 prescribed sofosbuvir-based therapy. Severe liver fibrosis (OR 1.66, 95% CI 1.05, 2.64) independently associated with treatment prescription. In those with evaluable HCV RNA, SVR was 99%. Cure rates similar to clinical trial data can be achieved in diverse underserved communities.

Evaluation Of An Enzyme Immunoassay For Hepatitis C Virus Core Antigen As A Diagnostic Test For Detection Of Hepatitis C Virus Infection In Comparison To Real-Time RT-PCR

Hepatitis C virus (HCV) is a global public health care problem. Diagnosis of HCV infection was mainly based on the detection of anti-HCV antibodies as a screening test with serum samples and detection of HCV RNA by using RT-PCR, which considered as a golden standard test. In this study, we compared the HCV core antigen test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV core antigen test may be used as an alternative confirmatory test to the HCV RNA test and to assess the diagnostic values of the total HCV core antigen test by determining the diagnostic specificity and sensitivity rates compared with the HCV RNA test. Sera from 100 patients were analyzed for anti-HCV and HCV core antigen both with the ELISA and with the molecular HCV RNA assay consisting of a real time-PCR method as a confirmatory test. The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 76.1%, 86.2%, 80%, and 82.5%, respectively. The HCV core antigen levels showed a poor correlation with those from the HCV RNA quantification (r = 0.321, p= 0.079). In conclusion, the core antigen detection test can be more valuable in HCV diagnosis than anti-HCV antibodies but it cannot replace HCV RNA in confirmation of the diagnosis of HCV because the sensitivity of the HCV core antigen detection assay is significantly lower than that of PCR-based methods.

Racial/Ethnic and Socioeconomic Disparities in Initiation of Direct-Acting Antiviral Agents for Hepatitis C Virus in an Insured Population

Background The high cost of direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection may present a barrier to access, thus contributing to disparities in treatment. However, few real-world data exist on factors associated with DAA uptake.Methods We conducted an observational study of Kaiser Permanente Northern California members with HCV infection, defined as a positive HCV RNA test or an HCV genotype, during the recent DAA era (i.e., October 2014–December 2016). To evaluate factors independently associated with DAA initiation, an adjusted Poisson model included age, sex, race/ethnicity, census-based neighborhood deprivation index, HCV genotype, advanced fibrosis (i.e., Fibroscan ≥9.5 kPa, if available; else FIB-4 >3.25), prior HCV treatment, drug abuse diagnosis, smoking, alcoholic drinks per week, HIV infection, and hepatitis B virus infection.ResultsWe identified 18,140 HCV-infected individuals, of whom 6167 (34%) initiated DAA treatment. Treatment was less likely among Black (risk ratio [RR] 0.83, 95% confidence interval [CI]: 0.79-0.88) and Hispanic individuals (RR 0.92, 95% CI: 0.87-0.98) compared with White individuals, and among individuals with greater neighborhood-level economic disadvantage (quartile 3 vs. 1: RR 0.89, 95% CI: 0.85-0.94; quartile 4 vs. 1: RR 0.79, 95% CI: 0.75-0.83). Treatment was also less likely among those with a history of drug abuse (RR 0.87, 95% CI: 0.82-0.91), smoking (RR 0.84, 95% CI: 0.80-0.87), or more alcoholic drinks per week (1–7 vs. 0 drinks: RR 0.88, 95% CI: 0.82-0.93; 8-16 vs. 0 drinks: RR 0.72, 0.63-0.82); ≥17 vs. 0 drinks: RR 0.63, 95% CI: 0.49-0.80). There was a higher likelihood of treatment among individuals with advanced fibrosis (RR 1.39, 95% CI: 1.34-1.44), HCV genotype 1 (RR 1.97, 95% CI: 1.87-2.08), no prior HCV treatment (RR 1.44, 95% CI: 1.37-1.52), or HIV infection (RR 1.19, 95% CI: 1.08-1.30).Conclusion Although clinical factors appear to drive HCV treatment decisions, racial/ethnic and socioeconomic disparities exist in DAA uptake. Lifestyle factors, such as alcohol use and drug abuse, may also influence patient or provider decision-making regarding DAA initiation. Strategies are needed to ensure equitable access to DAAs, even in insured populations.Disclosures All authors: No reported disclosures.

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

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. We investigated whether patients who maintained a sustained virologic response 12 weeks after therapy (SVR12) with direct-acting antiviral (DAA) agents for recurrent HCV infection after liver transplantation had occult HCV infections. We performed a prospective study of 134 patients with recurrent HCV infection after liver transplantation who were treated with DAAs, with or without ribavirin, from 2014 through 2016 (129 patients achieved an SVR12). In >10% of the patients who achieved SVR12 (n= 14), serum levels of aminotransferases did not normalize during or after DAA therapy, or they normalized transiently but then increased sharply after DAA therapy. Of these 14 patients, 9 were assessed for occult HCV infection by reverse transcription quantitative polymerase chain reaction. This analysis revealed that 55% of these patients (n= 5) had an occult infection, with the detection of negative strand viral genome, indicating viral replication. These findings indicate the presence of occult HCV infection in some patients with abnormal levels of serum aminotransferases, despite SVR12 to DAAs for HCV infection after liver transplantation.

HEPATITIS C VIRUS (HCV) CORE ANTIGEN AS AN ALTERNATIVE TO PCR FOR HCV, RNA QUANTIFICATION TO EARLY DIAGNOSIS OF HCV INFECTION AMONG BLOOD DONORS

Background: Safety blood transfusion is based on reliable donor screening for transmissible infections such as the hepatitis C virus (HCV) infection. HCV-RNA by polymerase chain reaction (PCR) test is a gold standard test for HCV infection but with three major limitations: liability of RNA molecules, higher costs, and longer turnaround time as compared with HCV core antigen (HCVcAg) testing. Objective: To evaluate HCV core Ag as an alternative to PCR for HCV RNA to early diagnosis of HCV infection among blood donors. Patients and Methods: 4222 blood donors collected between March 2015 and July 2016 at Blood Bank Center of Najran Hospitals, Southwestern Saudia Arabia. Anti-HCV, HBsAg, syphilis and HIV were screened by third generation ELISA. Those reactive to HbsAg, syphilis and/or HIV were excluded. HCV core Ag and HCV RNA by RT-PCR were performed on 76 positive HCV-Ab sera. Results: Among total 4222 blood donors (3837 males (90.88%) and 385 females (9.12%)), 76 (1.8%) were positive for HCV-Ab (72 males; 94.74% and 4 females; 5.26%). HCV core Ag was ≥ 11 fmol/L in 65 cases (85.53%) of HCV Ab positive patients (61 males; 93.85% and 4 females; 6.15%), 3 cases with HCVcAg levels in grey zone (3-11 fmol/L) and 8 cases with HCVcAg ≤ 3 fmol/L all of both were males. HCV RNA was detected in 71/76 (93.42%) of donors with positive HCV-Ab and in 3 of 8 (37.5%) of those with positive HCV-ab and negative HCVcAg. HCVcAg has sensitivity, specificity, PPV and NPV of 97.14, 100, 100 and 99.76 values respectively at a cutoff 2.82 fmol/L compared to HCV RNA test. Conclusion: Higher sensitivity and specificity of HCVcAg with rapid turn around time of the results, and its lower price suggested that can be used alternatively to HCV RNA test in early diagnosis of HCV infection.

The Population Level Cascade of Care for Hepatitis C in British Columbia, Canada: The BC Hepatitis Testers Cohort (BC-HTC)

BackgroundPopulation-level monitoring of hepatitis C virus (HCV) infected people across the cascade of care identifies gaps in access and engagement in care and treatment. We characterized a population-level cascade of care for HCV in British Columbia (BC), Canada and identified factors associated with leakage at each stage. MethodsThe BC Hepatitis Testers Cohort (BC-HTC) includes 1.5million individuals tested for HCV, HIV, reported cases of hepatitis B, and active tuberculosis in BC from 1990 to 2013 linked to medical visits, hospitalizations, cancers, prescription drugs and mortality data. We defined six HCV cascade of care stages: 1) estimated population prevalence; 2) HCV diagnosed; 3) HCV RNA tested; 4) genotyped; 5) initiated treatment; and 6) achieved sustained virologic response (SVR). ResultsWe estimated that 73,203 people were HCV antibody positive in BC in 2012 (undiagnosed: 18,301, 25%; diagnosed: 54,902, 75%). Of these, 56%(40,656) had HCV RNA testing; 34%(26,300) were genotyped; 12%( 8532 ) had received interferon-based therapy and 7%(5197) had SVR. Males, older birth cohorts, and HBV coinfected were less likely to undergo HCV RNA testing. Among those with chronic HCV infection, 32% had received liver-related care. Retention in liver care was more likely in those with HIV, cirrhosis, and drug/alcohol use and less likely in males and HBV coinfected. ConclusionsAlthough there are gaps in HCV RNA testing and genotyping after HCV diagnosis, the major gap in the cascade of care was low treatment initiation. People with comorbidities progressed through the cascade of testing and care but few received treatment.

The end of the hepatitis C burden: Really?

The end of the hepatitis C burden: Really?

Cost-Effectiveness Analysis of Different Testing Strategies that Use Antibody Levels to Detect Chronic Hepatitis C in Blood Donors.

Aim. We conducted a cost-effectiveness analysis of seven hepatitis C virus (HCV) testing strategies in blood donors. Methods. Three of the seven strategies were based on HCV diagnosis and reporting guidelines in Mexico and four were from previous and current recommendations outlined by the CDC. The strategies that were evaluated determine antibody levels according to the signal-to-cut-off (S/CO) ratio and use reflex Immunoblot (IMB) or HCV RNA tests to confirm true positive (TP) cases of chronic HCV infection. Costs were calculated from the perspective of the Mexican Institute of Social Security (IMSS). A decision tree model was developed to estimate the expected number of true positive cases and costs for the base-case scenarios and for the sensitivity analyses. Results. Base-case findings indicate an extended dominance of the CDC-USA2 and CDC-USA4 options by the IMSS Mexico3 and IMSS-Mexico1 alternatives. The probabilistic sensitivity analyses results suggest that for a willingness-to-pay (WTP) range of $0–9,000 USD the IMSS-Mexico1 strategy is the most cost-effective of all strategies ($5,000 USD per TP). The IMSS-Mexico3, IMSS-Mexico2, and CDC-USA3 strategies are also cost-effective strategies that cost between $7,800 and $8,800 USD per TP case detected. The CDC-USA1 strategy was very expensive and not cost-effective. Conclusions. HCV antibody testing strategies based on the classification of two or three levels of the S/CO are cost-effective procedures to identify patients who require reflex IMB or HCV RNA testing to confirm chronic HCV infection.

Integrating Routine HCV Testing in Primary Care: Lessons Learned from Five Federally Qualified Health Centers in Philadelphia, Pennsylvania, 2012-2014.

An estimated 2.7-3.9 million Americans are infected with hepatitis C virus (HCV). Despite being the most common blood-borne virus in the United States, routine HCV testing is not commonly practiced. To address this gap, we measured the impact of integrated routine HCV testing on patient care. As part of CDC's Hepatitis Testing and Linkage to Care initiative, which promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites, National Nursing Centers Consortium integrated a routine opt-out HCV testing and linkage-to-care model at five federally qualified health centers in Philadelphia, Pennsylvania, from October 1, 2012, to June 30, 2014. The model included medical assistant-initiated testing, reflex laboratory-based HCV tests, and electronic health record modifications to prompt, track, and facilitate reimbursement for tests performed on uninsured patients. During the study period, 4,207 unique patients received HCV antibody (anti-HCV) testing, of whom 488 (11.6%) tested anti-HCV positive. Of those testing positive, 433 (88.7%) received a confirmatory HCV RNA test; of these 433 recipients, 313 (72.3%) were diagnosed with current infection (overall prevalence = 7.4%), of which 243 (77.6%) received their HCV RNA-positive results, 184 (58.8%) were referred to an HCV care provider, and 121 (38.7%) were linked to care. The highest rates of current infection were among non-Hispanic white patients (18.1%, 90/496); patients from the Public Health Management Corporation Care Clinic, which treats HIV and HCV patients on-site (14.3%, 200/1,394); and patients aged 50-69 years (10.7%, 189/1,767). Our model successfully integrated HCV testing and linkage to care into routine primary care. This study also identified potential successes and barriers that may be experienced by other primary care health centers that are integrating HCV testing.

Early Identification and Linkage to Care for People with Chronic HBV and HCV Infection: The HepTLC Initiative.

In 2012, CDC's Division of Viral Hepatitis launched a public health initiative to increase hepatitis B virus (HBV) and hepatitis C virus (HCV) infection testing for those at risk and to improve linkage to medical care for those infected. We describe testing outcomes of previously unidentified people at risk for HBV and HCV infection and the lessons learned while linking patients to care. CDC's Hepatitis Testing and Linkage to Care (HepTLC) initiative provided 34 financial awards to U.S. organizations that serve people at risk for viral hepatitis, 25 of which focused on HCV and nine of which focused on HBV. Grantees offered testing and test result notification to people at risk for HBV and/or HCV infection, as well as counseling, referral, and verification or notification of linkage to care for people with positive test results. We entered demographic data, self-reported risk factors, country of origin (for HBV), and testing outcomes into a confidential database. The 34 grantees tested 87,860 people at more than 260 sites in 17 states. Of the 23,144 people tested for HBV, 1,317 (6%) were positive. Of the 64,716 people tested for HCV, 57,570 (89%) received an HCV antibody (anti-HCV) test, of whom 7,580 (13%) tested anti-HCV positive. Of the 4,765 people who received an HCV RNA test, 3,449 (72%) tested positive. Of the 4,766 people who tested positive for either HBV or HCV infection, 2,116 (44%) were linked to care. Interventions targeting people at risk for HBV and HCV infection reached a substantial number of people for whom testing is recommended and identified a large proportion of those who had previously unrecognized infection. Patient navigation was critical for follow-up and linkage to care.

Streamlining Screening to Treatment: The Hepatitis C Cascade of Care at Kaiser Permanente Mid-Atlantic States

Hepatitis C virus (HCV) screening is recommended for patients at risk and/or born during 1945-1965, but screening gaps persist. This new program screens target populations and enhances care linkage for chronically HCV-infected patients. Kaiser Permanente Mid-Atlantic States created a comprehensive HCV screening pathway, supported by a HCV care coordinator. The testing pathway includes HCV antibody (Ab), automatic HCV RNA for Ab-positive patients, coinfection and liver health tests, vibration-controlled transient elastography (VCTE), and a physician referral. A total of 11 200 patients were screened; 3.25% were HCV Ab positive, and 100% of Ab-positive patients received HCV RNA testing. Of HCV Ab-positive patients, 75.9% had chronic HCV, of which 80.8% underwent VCTE. HCV diagnosis was communicated to 94% of patients, and 70.9% had HCV documented in the electronic health record. The pathway shows promise in closing gaps, including improving HCV RNA testing, communicating diagnoses, and assessing liver fibrosis. Improved testing and linkage could increase curative treatment access.

Public health clinic-based hepatitis C testing and linkage to care in Baltimore.

Testing and linkage to care are important determinants of hepatitis C virus (HCV) treatment effectiveness. Public health clinics serve populations at high risk of HCV. We investigated their potential to serve as sites for HCV testing, initiation of and linkage to HCV care. Cross-sectional study of patients accessing sexually transmitted infection (STI) care at the Baltimore City Health Department (BCHD) STI clinics, from June 2013 through April 2014 was conducted. Logistic regression was used to assess factors associated with HCV infection and specialist linkage to care. Between 24 June 2013 and 15 April 2014, 2681 patients were screened for HCV infection. Overall, 189 (7%) were anti-HCV positive, of whom 185 (98%) received follow-up HCV RNA testing, with 155 (84%) testing RNA positive. Of 155 RNA-positive individuals, 138 (89%) returned to the STI clinic for HCV RNA results and initial HCV care including counselling regarding transmission and harm reduction in alcohol, and 132 (85%) were referred to a specialist for HCV care. With provision of patient navigation services, 81 (52%) attended an offsite HCV specialist appointment. Alcohol use and lack of insurance coverage were associated with lower rates of specialist linkage (OR 0.4 [95% CI 0.1-0.9] and OR 0.4 [95% CI 0.1-0.9], respectively). We identified a high prevalence of HCV infection in BCHD STI clinics. With availability of patient navigation services, a large proportion of HCV-infected patients linked to off-site specialist care.

Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL). All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age. In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.

PREVALENCE AND RISK FACTORS OF HEPATITIS C VIRUS INFECTION IN HAEMODIALYSIS PATIENTS: TESTING ANTIBODIES, RNA AND GENOTYPES

Hepatitis C virus (HCV) infection is an important global public health problem affecting approximately 180 million people. Multiple risk factors are associated with HCV transmission among haemodialysis (HD) patients leading to an increased risk for liver-related mortality. Patients undergoing HD may show a decreased humoral and cellular immunity, which lowers the sensitivity of the HCV antibodies (Abs) test resulting in false negative antibody test, thus requiring HCV RNA testing. Our study is to determine the prevalence of HCV markers (antibody RNA and genotype) and risk factors of HCV infection among patients in HD unit in Baghdad. A sample of 54 patients were interviewed. HCV Abs (anti-HCV) was tested using third generation enzyme immunoassay (EIA-3) and immunoblot assay (Lia-Tek III) as screening and confirmatory test respectively. Sera of 46 patients (irrespective to anti-HCV results) were subjected to molecular analysis, using the most developed RT-PCR and DNA Enzyme immunoassay (DEIA) method. Seropositive rate of anti-HCV and HCV-RNA were (66.6%) and (60.9%) respectively. Anti-HCV seropositive rate was significantly higher in males (77.1%), and history of blood transfusion (85%). Blood transfusion acts as a significant risk for acquiring HCV (OR 44.2, 95% CI 7.6-256.9). Genotype 4 was the most prevalent (33.3%), followed by genotype 1a (25.9%) and genotype 1b (22.2%). We concluded that, the prevalence of HCV among the haemodialysis patients is high. It is significantly related to gender, duration of dialysis and number of blood transfusion. Blood transfusion acts as a significant risk factor. Molecular test for detection for HCV RNA is necessary and proper nosocomial prevention program should be implemented to prevent HCV transmission.

Eighteen- to 30-year-olds more likely to link to hepatitis C virus care: an opportunity to decrease transmission.

Hepatitis C virus (HCV) infection incidence among 18- to 30-year-olds is increasing and guidelines recommend treatment of active injection drug users to limit transmission. We aimed to : measure linkage to HCV care among 18- to 30-year-olds and identify factors associated with linkage; compare linkage among 18- to 30-year-olds to that of patients >30 years. We used the electronic medical record at an urban safety net hospital to create a retrospective cohort with reactive HCV antibody between 2005 and 2010. We report seroprevalence and demographics of seropositive patients, and used multivariable logistic regression to identify factors associated with linkage to HCV care. We defined linkage as having evidence of HCV RNA testing after reactive antibody. Thirty two thousand four hundred and eighteen individuals were tested, including 8873 between 18 and 30 years. The seropositivity rate among those ages 18-30 was 10%. In multivariate analysis, among those 18-30, diagnosis location (Outpatient vs Inpatient/ED) (OR 1.78, 95% CI 1.28-2.49) and number of visits after diagnosis (OR 5.30, 95% CI 3.91-7.19) were associated with higher odds of linking to care. When we compared linkage in patients ages 18-30 to that among those older than 30, patients in the 18-30 years age group were more likely to link to HCV care than those in the older cohort even when controlling for gender, ethnicity, socioeconomic status, birthplace, diagnosis location and duration of follow-up. Eighteen- to 30-year-olds are more likely to link to HCV care than their older counterparts. During the interferon-free treatment era, there is an opportunity to prevent further HCV transmission in this population.

Cost-effectiveness of strategies for testing current hepatitis C virus infection.

Six strategies for identifying hepatitis C virus (HCV) viremia, involving testing for HCV antibody (HCVAb) followed by a nucleic acid test (NAT) for HCV RNA when the antibody test is positive, are compared. Decision analysis was used to determine mean relative cost per person tested and outcomes of HCV viremia detection. Parameters included proportions of test population with HCVAb and viremia plus specificity, sensitivity, and cost of individual tests. For testing a population with an HCVAb seroprevalence of 3.25%, all strategies when adopting quantitative NAT vary little in cost (range, $29.50-$30.70) and are highly viremia specific (≥0.9997). Four of the strategies using venipuncture blood for HCVAb testing (whether laboratory conducted or employing a rapid, point-of-care assay) and for NAT (whether done by reflex or using separately drawn blood) achieve the highest viremia sensitivities (range, 0.9950-0.9954). Point-of-care HCVAb testing in fingerstick blood followed by NAT in venipuncture blood yields relatively lower viremia sensitivity (0.9301). The strategy that requires returning for NAT is even less viremia sensitive (<0.9000) because of follow-up loss. Strategies adopting qualitative rather than quantitative NAT are slightly cheaper (range, $28.90-$29.99), similarly viremia specific (≥0.9997), but less viremia sensitive (≤0.9456). Viremia sensitivity and specificity remain the same regardless of the proportion of HCVAb-seropositive persons in the cohort being tested. Strategies involving HCVAb testing in venipuncture blood, whether laboratory conducted or using a point-of-care assay, when followed by quantitative NAT done reflexively or in separately drawn blood, are comparably economical and suitably viremia sensitive. Less cost-effective is point-of-care HCVAb testing in fingerstick blood followed by NAT in venipuncture blood. Least cost-effective is the strategy requiring the tested person to return for NAT.