Prevalence of anti-HCV antibodies in the population of young women and general medicine patients

BACKGROUND: Comparison of the estimated prevalence of HCV infection and number of detected chronic hepatitis C (CHC) cases shows that most infections in Polish population remain undetected. Until now we have probably diagnosed and treated only approximately 20% of the whole HCV-infected population in Poland. METHODS: We performed anti-HCV antibodies testing in the groups of patients with arterial hypertension or diabetes mellitus and compared proportions of positive results with rates obtained in the group of young, healthy women aged < 35 years. All patients had positive history of at least one hospitalisation. RESULTS: The analysis of patient subgroups according to study inclusion criteria revealed the highest ratio of positive anti-HCV results in the group of young women aged < 35 years with positive history of at least one hospitalisation (5/91, 5.5%). Among patients with arterial hypertension and diabetes 6/505 (1.2%) and 1/94 (1.06%) positive anti-HCV results were detected, respectively. The difference in the proportion of positive anti-HCV results between the group of young women and subgroups of patients with arterial hypertension and diabetes was statistically significant (p=0.00327). CONCLUSION: In view of obtained results it seems reasonable to look for new risk groups of HCV infection in order to increase efficacy of screening tests.

Hepatitis C Virus Genotype Analyses in Chronic Hepatitis C Patients and Individuals With Spontaneous Virus Clearance Using a Newly Developed Serotyping Assay.

BACKGROUND: We developed a novel HCV serotyping assay and detected the genotypes in chronic hepatitis C (CHC) patients and individuals with spontaneous viral clearance (SVC). METHODS: Nine hundred and ninety-seven patients were enrolled in a previous study; their samples were genotyped originally using the molecular assays. Among them, 190 patients achieved sustained virological response; the post-treatment samples were also serotyped. Moreover, 326 samples from follow-up cohorts were serotyped, among whom 66 were from SVC individuals, and 260 from CHC patients. RESULTS: Nine hundred and fifty-eight out of 997 samples were available for serotyping, among which 29 samples generated indeterminate serotyping results. The consistency between the genotyping and serotyping assays was 91.50% (850/929). The specificity and sensitivity were 98.45% and 88.77% for genotype 1, 96.42% and 93.97% for genotype 2, and 94.15% and 80.52% for non-genotype 1 or 2. However, only 41 of 60 genotype-6 samples were correctly serotyped. Little difference was found in the 190 paired serotyping results. No difference existed in the genotype distribution between the SVC and CHC groups (P = 0.08). CONCLUSIONS: The assay provides an accurate alternative for determining HCV genotypes, whereas it is not recommended for detecting genotype 6. Furthermore, it facilitates identifying the genotypes in SVC individuals. HCV genotype has little impact on SVC.

Performance of rapid diagnostic tests for the detection of antibodies to hepatitis C virus in whole blood collected on dried blood spots.

Rapid diagnostic tests (RDTs) represent an attractive alternative to enzyme immunoassays. A total of 207 individuals, including 68 HCV-seronegative subjects, 10 patients with resolved infection and 129 patients with chronic HCV infection, were studied. The specificity of RDT detection of anti-HCV antibodies in whole blood was 100% with the four RDTs tested: OraQuick(®) HCV Rapid Antibody Test, First Response HCV Card Test, ASSURE HCV Rapid Test and MultiSure HCV Antibody Assay. Their diagnostic sensitivity varied between 98.6% and 100%. RDT detection of anti-HCV antibody in whole blood collected on dried blood spots appears to be a promising new tool for broadscale screening of HCV infection in high- to medium-risk populations.

High seroprevalence of HCV in the Abruzzo Region, Italy: results on a large sample from opt-out pre-surgical screening.

PURPOSE: Available estimates of the prevalence of chronic HCV infection in Italy are quite conflicting, varying from 1.5 to 22.5%, with an apparent north to south gradient. As Direct Acting Antivirals are expensive, both National and local governmental Agencies are in urgent need of detailed and reliable estimates of HCV patients to be treated, nationwide and in each district. We investigated the prevalence of anti-HCV antibodies in a large unselected sample of surgical patients providing consent to in-hospital opt-out pre-surgical HCV screening, at two hospitals from the Abruzzo Region, Italy. METHODS: Data were retrieved for 55,533 screened patients (4.1% of the total population in the Abruzzo Region), admitted in the Orthopedic and General Surgery wards of Pescara and Teramo Hospitals from 1999 to 2014. RESULTS: The prevalence of anti-HCV antibodies was 4.4% in the total sample. HCV-positive patients had a mean age of 63.8 ± 19.9 years; 49.2% were males. From 1999 to 2014, the prevalence of HCV antibodies decreased from 5.4% to 4.1%; at both sites, however, two age-related-peaks were evidenced, the first among patients aged 30-49 years, the second among those older than 70 years. Statistical analyses confirmed a significant trend to decrease over time and a higher prevalence in Pescara and among males (all p < 0.01). CONCLUSIONS: Data retrieved from opt-out pre-surgical screening programs may allow inexpensive and easy-to-perform estimates of HCV seroprevalence from large samples of unselected patients with a well-defined provenience, which may turn useful for future treatment resource allocation.

No association of oral lichen planus and hepatitis C virus infection in central Germany.

OBJECTIVES: Co-occurrence of oral lichen planus (OLP) and chronic hepatitis C virus (HCV) infection suggests a strong association, but the relation between mucocutaneus, autoimmune lichen planus and HCV infection remains unclear. In areas with higher prevalence of HCV infection in general population, like Japan and southern Europe, 20 to 40 % of patients with OLP test positive for anti-HCV antibodies, whereas in German populations, a co-occurrence of 4.2 to 16 % was reported. MATERIAL AND METHODS: We screened 143 patients with histopathologically proven OLP for prevalence of anti-HCV antibodies. Additionally, we examined 51 anti-HCV-positive subjects with current or past HCV infection for clinical symptoms of OLP. In all patients, confirmatory diagnosis was made by the detection of HCV RNA via reverse transcription-polymerase chain reaction (RT-PCR). A randomized control group comprised 109 blood sera samples of patients without any characteristics of OLP. RESULTS: The results of all patients showed no co-occurrence in either cohort. CONCLUSION: In conclusion, no association between oral lichen planus and chronic HCV infection in our study population was found. CLINICAL RELEVANCE: Anti-HCV antibody screening in patients with confirmed oral lichen planus is not indicated routinely in central Germany.

Hepatitis C seroprevalence in an at-risk population in the southwest Madrid region of Spain. / Seroprevalencia de hepatitis C en población con factores de riesgo del suroeste de la Comunidad de Madrid.

INTRODUCTION: The estimated seroprevalence of hepatitis C virus (HCV) in Spain is 1.7%, but is much higher in the at-risk population. The most efficient national screening strategy is unclear. AIMS: To estimate the prevalence of HCV among the at-risk population seen in primary care (PC), and to determine their epidemiological profile. MATERIALS AND METHODS: Cross-sectional descriptive prevalence study that included adult patients with risk factors for HCV infection seen in PC in the southwest Madrid region between 2010 and 2012. RESULTS: A total of 158 patients (men=51.3%), mean age 46 years (SD=16.6), were included. The most common risk factors were hypertransaminasaemia (44.3%) and major surgery (13.3%). Immigration, unsafe sexual practices, and tattoos or body piercing were more prevalent in patients younger than 45 years of age. Fifteen patients (9.5%) were positive for anti-HCV; 9 of these (5.7%) were HCV-ARN positive. Of the positive patients, 4 (44.4%) had significant fibrosis at diagnosis (F3-F4). Male patients had a higher rate of positive anti-HCV results (13.8 vs. 5.3%; P=.072), as did patients older than 45 years of age (12.8 vs. 6.3%; P=.167). Intravenous and intranasal drug use were associated with a higher rate of positive anti-HCV results (50 vs. 8.5%; P=.005 and 66.7 vs. 8.4%; P=.001, respectively). CONCLUSIONS: Patients with risk factors for HCV infection have high seroprevalence. Screening programmes must therefore be implemented to detect HCV infection in this population in PC.

Hepatitis C: Prevalence of serologic markers and risk factors in blood donors at a large blood centre in South-eastern Brazil (2007-2010).

This study aimed to evaluate the trends of HCV seropositivity rates in first time blood donors from a reference blood centre in Southeast Brazil. Data from the period of 2007-2010 were analysed according to anti-HCV antibodies, donor demographic characteristics and type of donation. There was a marked and continuous decline in prevalence in the analysed period, and in 93,534 first time donors, the prevalence of anti-HCV was 0.09%. Anti-HCV were associated with less education and older age (≥ 35 years). The rates of anti-HCV observed in the present study were lower than in Brazil, but considerably higher than developed countries.

HIV co-infection accelerates decay of humoral responses in spontaneous resolvers of HCV infection.

Acute hepatitis C virus (HCV) infection is primarily followed by chronic infection, while spontaneous recovery of HCV infection (SR-HCV) occurs in a minority of those infected. Identification of SR-HCV clinically depends on two combined indicators, persistently undetectable peripheral HCV RNA and positivity for anti-HCV. However, the characteristics of dynamic variation in anti-HCV antibodies in SR-HCV, especially in those patients co-infected with HIV, are still undefined. In this study, a cohort of patients infected with HCV through commercial blood collection practices was studied. We found that the annual decreasing rate of anti-HCV presented a gradually accelerated process in HCV resolvers. However, the variation in the decline of anti-HCV presented a slowly accelerated process within the early decrease stage and a gradually decelerated process within the latter decrease stage. In addition, we deduced that it expended approximately 16 years from natural HCV recovery to undetectable peripheral anti-HCV in HCV resolvers co-infected with HIV, while this time was estimated to be 20 years in SR-HCV without HIV co-infection. Our data indicated that the decay of anti-HCV was accelerated by HIV-related impairment of immune function. The prevalence of HCV infection may be severely underestimated in this large-scale retrospective epidemiologic investigation in an HIV-infected population.

Review: Occult hepatitis C virus infection: still remains a controversy.

Occult hepatitis C virus (HCV) infection is characterized by the presence of HCV RNA in the liver cells or peripheral blood mononuclear cells of the patients whose serum samples test negative for HCV RNA, with or without presence of HCV antibodies. The present study reviews the existing literature on the persistence of occult hepatitis C virus infection, with description of the clinical characteristics and methods for identification of occult hepatitis C. Occult hepatitis C virus infection was detected in patients with abnormal results of liver function tests of unknown origin, with HCV antibodies and HCV RNA negativity in serum, and also in patients with spontaneous or treatment-induced recovery from hepatitis C. The viral replication in the liver cells and/or peripheral blood mononuclear cells was present in all clinical presentations of occult hepatitis C. The peripheral blood mononuclear cells represent an extra-hepatic site of HCV replication. The reason why HCV RNA was not detectable in the serum of patients with occult hepatitis C, could be the low number of circulating viral particles not detectable by the diagnostic tests with low sensitivity. It is uncertain whether occult hepatitis C is a different clinical entity or just a form of chronic hepatitis C virus infection. Data accumulated over the last decade demonstrated that an effective approach to the diagnosis of HCV infection would be the implementation of more sensitive HCV RNA diagnostic assays, and also, examination of the presence of viral particles in the cells of the immune system.

Loss of anti-hepatitis C virus antibodies following therapeutic sustained virological response in a HIV co-infected patient.

No data are available for the kinetics of anti-Hepatitis C Virus (HCV) antibodies in HIV/HCV co-infected patients after sustained virological response (SVR). We present a case of a HIV/HCV co-infected patient, showing a significant anti-HCV antibodies decrease during therapy, who achieved a HCV seroreversion 3 years after SVR. Among them, antibodies to core protein, the most strongly antigenic protein showed significant decrease. Our results indicate an absence of antigenic stimulation suggesting a total clearance of HCV.

Microelimination of Hepatitis C in patients with substance use and dual disorders - a Portuguese study.

Chronic hepatitis C is a serious condition with relevant public health implications. In Portugal, the prevalence of detectable HCV antibodies is about 0,54%, with higher values in risk groups. Compared to the general population, the prevalence of HCV infection is higher in individuals with psychiatric disorders. There are no studies reporting the prevalence of HCV antibodies in Portuguese psychiatric patients, or in patients with substance use disorders.We carried an observational, prospective study during a period of one year, for patients followed at the Dual Pathology Outpatient and Inpatient Unity of the Coimbra Hospital and University Center, and patients were tested for HCV antibodies. Of 149 patients, 17.4% had positive HCV antibodies and 7.38% had detectable HCV RNA. Patients with confirmed CHC were mostly male inpatients, aged 50 to 59 years, and reported unprotected sex with more than one concurrent partner in the previous six months; their main psychiatric diagnosis was "Disorders due to use of multiple specified psychoactive substances, including medications".This study reports a very high prevalence of positive HCV antibodies and confirmed CHC in patients followed in the Dual Pathology Outpatient and Inpatient Unity. This prevalence is higher than in general Portuguese population.

Increasing Treatment Rates for Hepatitis C in Primary Care.

BACKGROUND: Despite antiviral agents that can cure the disease, many individuals with Hepatitis C Virus (HCV) remain untreated. Primary care clinicians can play an important role in HCV treatment but often feel they do not have the requisite skills. METHODS: We implemented a population-based improvement intervention over 10 months to support treatment of HCV in a primary care setting. The intervention included a decision-support tool, education for clinicians, enhanced interprofessional team supports, mentorship, and proactive patient outreach. We used process and outcome measures to understand the impact on the proportion of patients who initiated treatment and achieved Sustained Virologic Response (SVR). We used physician focus groups and pharmacist interviews to understand the context and mechanisms influencing the impact of the intervention. RESULTS: Between December 2018 and June 2020, the percentage of HCV RNA positive patients who started treatment rose from 66.0% (354/536) to 75.5% (401/531) with 92.5% (371/401) of those starting treatment achieving SVR. Qualitative findings highlighted that the intervention helped raise awareness and confidence among physicians for treating HCV in primary care. A collaborative team environment, education, mentorship, and a decision-support tool integrated into the electronic record were all enablers of success although patient psychosocial complexity remained a barrier to engagement in treatment. CONCLUSION: A multifaceted primary care improvement initiative increased clinician confidence and was associated with an increase in the proportion of HCV RNA positive patients who initiated curative treatment.

Comparison Of Hepatitis C Antibody Assays And Evaluation Of Agreement Between Hepatitis C Antigen And PCR Results.

BACKGROUND: Hepatitis C is associated with a wide range of health repercussions. Pakistan is one of the highly prevalent countries of Hepatitis C Virus (HCV) infection. The availability of cost-effective, robust, and reliable screening and diagnostic tests for hepatitis C is important to address the disease burden. Standardization of screening and diagnostic assays in clinical laboratories is crucial for achieving big goals. Objectives of this study are to correlate the results of two different HCV antibody (HCV Ab) assays and to examine the correlation of HCV core antigen (HCV c Ag) results with HCV PCR for HCV infection diagnosis. METHODS: This descriptive cross-sectional study was carried out from November to December 2020 at Dow University of Health Sciences. Total number of 40 HCV Ab samples were analysed by both chemiluminescence (CMIA) and electrochemiluminescence (ECLIA) immunoassays. Tests for HCV RNA PCR and HCV c Ag were performed on all samples. Results of screening and diagnostic assays were correlated and agreements were examined. Statistical analysis for agreement was carried out by using R software version 3.6.3 through AC1 Gwetz Statistic. The study was approved by the institutional ethical review committee. RESULTS: An agreement of 0.73 and 0.95 was found between two different HCV Ab immunoassays and HCV c Ag and HCV PCR, respectively. CONCLUSIONS: We found a good correlation between CMIA and ECLIA for HCV Ab. An excellent correlation was found between HCV c Ag and HCV PCR. Based on our study findings, HCV c Ag is a candidate test for the diagnosis of active HCV infection.

Prevalence of hepatitis C in the adult Mexican population: National Survey of Health and Nutrition 2018.

Background: Hepatitis C is a preventable and treatable disease that has been declared a public health problem. In 2012, the prevalence of HCV serum anti-bodies in the Mexican adult population aged 20 to 49 years was 0·30%. Methods: We randomly selected a probabilistic sub-sample of 12,389 adults (20+ years) from adults participating in the National Health and Nutrition Survey (ENSANUT) 2018 who provided a venous blood sample. Anti-HCV antibodies and HCV RNA were determined for this sub-sample. We estimated the national prevalence of anti-HCV antibodies and the proportion with viral RNA detection and evaluated their association with sociodemographic characteristics for all adults and with sexual behaviours in those aged 20 to 49 years using logistic regression. Findings: The national prevalence of anti-HCV antibodies in serum was 0·38% (95%CI 0·24, 0·59) in the population aged 20 years and older; 14·9% of them had viral RNA. In the population aged 20 to 49 years antibody prevalence was 0·23% (95%CI 0·11, 0·48), being higher for males and people living in urban areas. In the population aged 50 years and older, the prevalence was 0·59% (95%CI 0·34, 1·06). Interpretation: The prevalence of antibodies anti-HCV in people aged 20 to 49 years was similar in 2018 than in 2012, suggesting that the prevalence of HCV has remained stable. ENSANUT is a household study and could underestimate the prevalence of HCV. Further efforts must be made to identify cases in non-household populations. Funding: National Institute of Statistics and Geography and National Institute of Public Health of Mexico [CIEE/1807].

Laboratory Evaluation of Hepatitis C Virus Infection in Patients Undergoing Hemodialysis from North East India.

Introduction: Subjects undergoing hemodialysis have enhanced vulnerability to hepatitis C virus (HCV) infection due to invasive procedures and poor infection control practices. Early detection and treatment are essential to prevent cross-infection and mortality/morbidity. However, common use anti-HCV antibody tests lack the necessary accuracy, and alternative tests (e.g. core antigen detection kits) which are available need to be examined as a viable alternative. Method: A total of 270 continuous serum samples were collected from patients undergoing dialysis within 15 months of study period. Sequentially, multiple tests were performed - immunochromatography-based rapid test, third-generation ELISA i.e. (anti-HCV antibody detection), fourth-generation ELISA (HCV antigen-antibody combined detection assay), and HCV RNA quantitative real time polymerase chain reaction (qPCR) assay. Diagnostic parameters of serological kits were compared in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and so on. Statistical Package for the Social Sciences was used. Results: HCV-combined core antigen-antibody assays performed better than other serological assays in reference to the gold standard HCV RNA. This fourth-generation assay yielded a Kappa value of 0.947 compared with the value of 0.747 and 0.619 for anti-HCV ELISA and rapid detection test. Other parameters such as sensitivity, specificity, PPV, NPV, and so on were also better for fourth-generation ELISA compared with third-generation ELISA and other serological assays. HCV RNA was negative in 7.3% of anti-HCV-positive patients and was detected in 11.4% of anti-HCV ELISA-negative patients. In about 1.6% of HCV RNA-positive cases, fourth-generation ELISA was negative and had low HCV viral load (650 IU/ml and below). Fourth generation ELISA detected additional 7.4% HCV positive cases (compared to third generation kits) and upon cost effective analyis, additional cost to be bear for the better detection (by fourth generation kit) was found to be only INR 27 per 1% increased case detection. Conclusion: In resource scant setup, screening and follow-up of patients undergoing hemodialysis can be performed by fourth-generation HCV ELISA (antigen-antibody combined assay) instead of the current practice of anti-HCV antibody ELISA. Better yield in detection rate will compensate for slight addition to costs.

Early hepatocellular carcinoma developed within dysplastic nodule as nodule-within-nodule appearance: Case report with literature review.

Close follow-up of patients with liver cirrhosis has led to increased detection of hepatocellular carcinoma (HCC) at an early stage, especially with magnetic resonance imaging (MRI) innovations. We report the case of a 70-year-old man, with a recent history of liver cirrhosis due to chronic hepatitis C virus (HCV) complicated by hepatocellular carcinoma (HCC), and for whom trans-arterial chemoembolization (TACE) was planned, as the patient was assigned Child B7 at admission. Angiography performed during the first TACE cycle shows not only the "tumor blush" corresponding to previously detected HCC but also an additional small foci of HCC uptake seen within a large dysplastic nodule giving the appearance of "nodule-within-nodule." Early detection of hepatocellular carcinoma improves prognosis. Hence, it is essential to be aware of all early aspects of HCC, including the nodule-within-nodule appearance on cross-sectional imaging, and also in angiography, as in this case.

Incidence of hepatocellular carcinoma in a community-based Taiwanese population without chronic HBV/HCV infection.

BACKGROUND & AIMS: In addition to HBV/HCV causing hepatocellular carcinoma (HCC), other risk factors including obesity and alcohol drinking also increase risk. We describe the cumulative risk of HCC and mortality from liver-related disease by selected modifiable risk factors among a non-hepatitis virus-infected population. METHODS: For a community-based cohort, residents aged 30-65 years living in 7 townships in Taiwan were recruited, and have been followed up since 1991. A total of 18,541 individuals were seronegative for markers of chronic infection of HBV/HCV and with no history of HCC at baseline. New non-HBV/HCV HCC cases and liver-related deaths were ascertained through data linkage to the National Cancer Registry and Death Certification System from 1 January 1991 through 31 December 2017. RESULTS: There were 207 HCC cases and 215 liver-related deaths identified. The incidence rate of non-HBV/HCV HCC was 47.2 per 100,000 person-years. The mortality rate of liver-related death was 49.0 per 100,000 person-years. Baseline information on alcohol consumption, heart disease, diabetes, elevated aspartate aminotransferase, and alanine aminotransferase predicted higher risks of HCC, with hazard ratios (HRs) (95% CIs) of 1.7 (1.1-2.5), 2.2 (1.1-4.1), 1.9 (1.0-3.5), 1.7 (1.1-2.4), and 1.6 (1.0-2.4), respectively. The HRs (95% CIs) of liver-related death were 2.3 (1.6-3.2) for alcohol consumption, 1.4 (1.1-1.9) for BMI ≥25 kg/m2, 2.2 (1.4-3.3) for elevated aspartate aminotransferase, and 1.5 (1.0-2.4) for elevated alanine aminotransferase. The HR (95% CI) was 8.1 (3.6-18.5) for those with diabetes and elevated aspartate aminotransferase. CONCLUSIONS: Individuals with elevated liver enzymes are at high risk of liver disease. Prevention and treatment of diabetes and heart disease are critical for non-hepatitis B, non-hepatitis C (NonB/C)-HCC. LAY SUMMARY: We followed up individuals with no chronic HBV or HCV infection and described the risk of hepatocellular carcinoma (HCC, the most common form of primary liver cancer) and mortality from liver-related disease by modifiable risk factors. This study estimated the incidence rate of HCC by selected lifestyle risk factors and chronic diseases conditions. Alcohol consumption, heart disease, diabetes, and abnormal blood liver function tests showed a strong association with HCC risk and mortality.

Performance of rapid diagnostic tests for HCV infection in serum or plasma.

Aim: HCV diagnosis will become the bottleneck in eliminating hepatitis C. Simple, accurate and cost-effective testing strategies are urgently needed to improve hepatitis C screening and diagnosis. Materials & methods: Performance of seven rapid diagnostic tests (RDT) have been assessed in a large series (n = 498) of serum or plasma specimens collected in France and in Cameroon. Results: Specificity varied from 96.1 to 100%. The clinical sensitivity, compared with immunoassays as the reference, was high for all seven RDT (97.2-100%). The Multisure HCV antibody assay and OraQuick HCV rapid antibody test reached sensitivity ≥99%. Conclusion: A number of RDT may be suitable for WHO prequalification and may be implemented in the framework of large-scale low-cost treatment programs to achieve the WHO viral hepatitis objectives by 2030.

Lay abstract Diagnosis of hepatitis C infection is crucial in order to envisage elimination of hepatitis C virus (HCV). Diagnosis is usually based on the detection of antibodies in blood after phlebotomy in a centralized laboratory approach. New simpler testing strategies are urgently needed. We assessed the performance of several rapid tests for the detection of HCV antibodies. Rapid tests offer many advantages over classical tests because they are simple, easy-to-use, rapid and can perform close to the site of patient care. Most of the rapid tests included in our study showed satisfactory performance. They can confidently use to detect hepatitis C antibodies in clinical practice.

Performance of a new rapid diagnostic test for the detection of antibodies to hepatitis C virus.

Rapid diagnostic tests (RDTs) represent an attractive alternative to conventional diagnostic methods for hepatitis C virus (HCV) infection. The aim of the present study was to assess the clinical performance of the new CE-marked Advanced Quality™ Rapid Anti-HCV Test for the detection of HCV antibodies in various patient populations. A total of 396 individuals, including 178 patients with chronic HCV infection, 26 patients with resolved HCV infection, and 192 subjects not infected with HCV, were studied. The clinical sensitivity and specificity in serum samples of the Advanced Quality™ Rapid Anti-HCV Test were both 99%. The new CE-marked RDT Advanced Quality™ Rapid Anti-HCV Test fulfills the World Health Organization recommendations acceptance criteria for serological assays in terms of sensitivity and specificity and can thus be confidently used for the screening of HCV antibodies.

Estimating the Time to Diagnosis and the Chance of Spontaneous Clearance During Acute Hepatitis C in Human Immunodeficiency Virus-Infected Individuals.

BACKGROUND: Hepatitis C virus (HCV) infection is often asymptomatic, and the date of infection is almost impossible to determine. Furthermore, spontaneous clearance (SC) may occur, but little is known about its time of occurrence. METHODS: Data on human immunodeficiency virus (HIV)-HCV coinfected individuals were used to inform a stochastic simulation model of HCV viral load kinetics, alanine aminotransferase (ALT), and HCV antibodies during acute hepatitis C. The dates of diagnosis and potential SC were estimated through a Bayesian approach. Hepatitis C virus diagnosis was assumed to be based on an elevated ALT level detected during a control visit for HIV-infected individuals, which occurred every 3 months (scenario A) or every 6 months (scenario B). RESULTS: We found that HCV diagnosis occurred after a median of 115 days and 170 days of infection in scenarios A and B, respectively. Among spontaneous clearers, SC occurred after a median time of 184 days after infection. Seven percent (scenario B) to 10% (scenario A) of SCs appeared more than 6 months after diagnosis, and 3% (both scenarios) of SCs appeared more than 1 year after diagnosis. CONCLUSIONS: Acute hepatitis C diagnosis occurs late in HIV-HCV coinfected individuals. Screening for HCV in HIV-infected individuals should be performed frequently to reduce delays. Our findings about late occurrence of SC support "wait and see" strategies for treatment initiation from an individual basis. However, early treatment initiation may reduce HCV transmission.