HCV RNA Quantification Research Articles

Microfluidic-based fluorescence enhancement of silica-embedded carbon dots for direct detection and quantification of unamplified HCV RNA in clinical samples

Microfluidic-based fluorescence enhancement of silica-embedded carbon dots for direct detection and quantification of unamplified HCV RNA in clinical samples

Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA

Quantification of hepatitis C virus (HCV)-RNA in serum or plasma samples is an essential parameter in HCV diagnostics. Here, the NeuMoDx™Molecular System (Qiagen) was tested for the most common HCV genotypes and compared to the cobas c6800 system (Roche).HCV-RNA from 131 plasma/serum samples from chronically infected patients was determined in parallel on the NeuMoDx and c6800 systems. Linearity was analysed using the four most common HCV genotypes (1−4) in our cohort. The coefficient of variation (CV) within (intra-assay) and between (inter-assay) runs was calculated based on HCV-RNA concentration. Quantitative HCV-RNA results were highly correlated on both test systems (R2 = 0.7947; y = 0.94 x + 0.37). On average, the NeuMoDx and c6800 HCV RNA levels showed a mean difference of only 0.05 log10 IU/mL but with a broad distribution (±1.2 2 x SD). The NeuMoDx demonstrated very good linearity across all HCV genotypes tested at concentrations between 1.7 and 6.2 log10 IU/mL (R2 range: 0.9257–0.9991) with the highest mean coefficient of determination for genotype 1 (R2 = 0.9909). The mean intra- and inter-assay CV for both serum and plasma samples was <5 %. The NeuMoDx HCV-RNA Assay demonstrates high subtype-independent comparability, linearity, and reproducibility for the quantification of HCV-RNA in serum and plasma samples from chronically infected patients.

Distribution and genotyping of hepatitis C virus (HCV) infection in Gansu province, China.

The distribution of common subtypes of hepatitis C virus (HCV) in Gansu province were analyzed. This information provided a theoretical basis for the selection of appropriate antiviral treatment regimens. We collected data on HCV antibody screening tests from 421,802 outpatients and inpatients at the Second Clinical Hospital of Lanzhou University from January 2018 to June 2022. Ribonucleic acid (RNA) viral load, HCV genotypes, and HCV quantification were analyzed retrospectively. The results of HCV positive detection rate, copy number, and genotype distribution were statistically analysed using SPSS 26.0. A total of 421,802 HCV antibody screenings were performed resulting in 4,558 positive cases (1.081%). In addition, 2,345 cases (1.302%) were positive with quantitative HCV antibodies in 180,157 outpatients and inpatients. Quantitative HCV virus RNA was further measured in 2592 outpatients and inpatients. There were 825 positive cases for HCV, with a positivity rate of 31.83%. High-sensitivity quantification of HCV-RNA was performed in 6538 patients, among which 1336 were HCV-RNA positive infections (positivity rate of 20.43%). Among the 1484 genotype tests, 4 genotypes and 10 subtypes were detected, including 4a, 1b, 2a, 2b, 3a, 3b, 6a, 6n, 1b/2a, and 2a/6a, with the majority of results from 2a (51.89%) and 1b (42.72%). The most prevalent genetic subtype in HCV-positive patients in Gansu was 2a, followed by 1b. In addition, 8 genotype subtypes appeared: 1a, 2b, 3a, 3b, 6a, 6n, 1b/2a and 2a/6a. Understanding the distribution of HCV genes in Gansu province is of significance for the optimization of virus treatment.

HCV RNA Quantification by a Domestic Commercial Assay: A Case Study among People Who Inject Drugs in Vietnam.

The desired performance of nucleic acid testing (NAT) may vary if used for disease diagnosis or for the evaluation of the therapeutic efficacy of a treatment, although in most cases, the same assay is used. However, these tests may not be affordable in many situations including in low/middle income countries that in response have developed domestic assays. Given the example of HCV NAT among people who inject drugs in Vietnam, we aimed at evaluating a domestic assay versus an FDA- and CE-approved assay. This cross-evaluation revealed that (i) the domestic assay had a poorer sensitivity with a threshold of detection above 104 IU/mL, and (ii) the FDA-approved assay had a percentage of false negative results close to 1%. Together, in the present study, the domestic assay had a performance compatible with diagnosis purposes (given that this population was 70% HCV seropositive) but not compatible with HCV treatment monitoring (given that treatment failures are rare and the observed viremia frequently below the threshold of detection). This study highlights the need for a proper evaluation of HCV RNA domestic assays in order to efficiently contribute to the WHO HCV elimination target by 2030.

Performance of algorithms for identifying patients with chronic hepatitis B or C infection in the french health insurance claims databases using the ANRS CO22 HEPATHER cohort.

The validity of algorithms for identifying patients with chronic hepatitis B or C virus (HBV or HCV) infection in claims databases has been little explored. The performance of 15 algorithms was evaluated. Data from HBV- or HCV-infected patients enrolled between August 2012 and December 2015 in French hepatology centres (ANRS CO22 HEPATHER cohort) were individually linked to the French national health insurance system (SNDS). The SNDS covers 99% of the French population and contains healthcare reimbursement data. Performance metrics were calculated by comparing the viral status established by clinicians with those obtained with the algorithms identifying chronic HBV- and HCV-infected patients. A total of 14 751 patients (29% with chronic HBV and 63% with chronic HCV infection) followed-up until December 2018 were selected. Despite good specificity, the algorithms relying on ICD-10 codes performed poorly. By contrast, the multi-criteria algorithms combining ICD-10 codes, antiviral dispensing, laboratory diagnostic tests (HBV DNA or HCV RNA detection and quantification, HCV genotyping), examinations for the assessment of liver fibrosis and long-term disease registrations were the most effective (sensitivity 0.92, 95% CI, 0.91-0.93 and specificity 0.96, 95% CI, 0.95-0.96 for identifying chronic HBV-infected patients; sensitivity 0.94, 95% CI, 0.94-0.94 and specificity 0.85, 95% CI, 0.84-0.86 for identifying chronic HCV-infected patients). In conclusion, the multi-criteria algorithms perform well in identifying patients with chronic hepatitis B or C infection and can be used to estimate the magnitude of the public health burden associated with hepatitis B and C in France.

17β-Oestradiol Protects from Hepatitis C Virus Infection through Induction of Type I Interferon.

Background and Aims: Sex hormones are widely recognised to act as protective factors against several viral infections. Specifically, females infected by the hepatitis C virus display higher clearance rates and reduced disease progression than those found in males. Through modulation of particle release and spread, 17β-oestradiol controls HCV’s life cycle. We investigated the mechanism(s) behind oestrogen’s antiviral effect. Methods: We used cell culture-derived hepatitis C virus in in vitro assays to evaluate the effect of 17β-oestradiol on the innate immune response. Host immune responses were evaluated by enumerating gene transcripts via RT-qPCR in cells exposed to oestrogen in the presence or absence of viral infection. Antiviral effects were determined by focus-forming unit assay or HCV RNA quantification. Results: Stimulation of 17β-oestradiol triggers a pre-activated antiviral state in hepatocytes, which can be maintained for several hours after the hormone is removed. This induction results in the elevation of several innate immune genes, such as interferon alpha and beta, tumour necrosis factor, toll-like receptor 3 and interferon regulatory factor 5. We demonstrated that this pre-activation of immune response signalling is not affected by a viral presence, and the antiviral state can be ablated using an interferon-alpha/beta receptor alpha inhibitor. Finally, we proved that the oestrogen-induced stimulation is essential to generate an antiviral microenvironment mediated by activation of type I interferons. Conclusion: Resulting in viral control and suppression, 17β-oestradiol induces an interferon-mediated antiviral state in hepatocytes. Oestrogen-stimulated cells modulate the immune response through secretion of type I interferon, which can be countered by blocking interferon-alpha/beta receptor alpha signalling.

Optimization of a real time PCR methodology for HCV RNA quantification in saliva samples

Saliva may be an alternative biological specimen to expand HCV detection. This study aims to evaluate an in-house quantitative RT-PCR for HCV RNA quantification in saliva. A total of 80 individuals (56 anti-HCV/HCV RNA + and 24 negative controls) donated serum and saliva, that were tested using an in-house quantitative PCR for HCV RNA. The median viral load was 4.77 log10 copies/mL (1.04–7.0 log10 copies/mL) in serum and 2.31 log10 copies/mL (1.0–3.84 log10 copies/mL) in saliva. A sensitivity of 80 % and specificity of 100 % were observed for HCV detection in saliva, which demonstrates the usefulness of in-house real-time PCR to quantify HCV RNA in saliva samples, which might increase the access of molecular diagnosis of HCV in laboratories that lack complex infrastructures for molecular testing and in individuals with poor venous access.

Effect of Interleukin 28B SNP rs12979860 Genotype on Viral Load in Hepatitis C Virus in Kolar Population, Karnataka, India

Introduction: The natural course of Hepatitis C Virus (HCV) infection is influenced by a number of host and viral variables. Interleukin 28B (IL28B) is a kind of interleukin. A Single Nucleotide Polymorphism (SNP) designated as rs12979860 was reported to predict viral clearance with and without treatment. Subjects with the GG (favourable) IL28B rs12979860 genotype were more likely to clear the infection spontaneously and respond well to therapy. These findings imply that people who have the “favourable” GG genotype have a lower viral burden than those who have the “unfavourable” AA genotype. Aim: To determine the effect of IL28B SNP rs12979860 genotype on HCV viral load in Kolar population, Karnataka, India. Materials and Methods: The present study was a case-control study which was carried out in Department of Microbiology, Sri Devaraj Urs Medical College, Kolar, Karnataka, India. Subjects were enrolled from Department of Medicine of R. L. Jalapa Hospital and Research centre, teaching hospital of Sri Devaraj Urs Medical College between November 2020 to March 2021. A total of 248 were taken of which 124 were HCV antibody-positive and 124 were controls. The effect of IL28B rs12979860 SNP on HCV viral load and clearance among HCV-infected patients were examined. Detection and quantification of HCV-RNA was determined by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). IL28B rs12979860 genotyping was performed using PCR and Restriction Fragment Length Polymorphism (RFLP) technique and specific primers. Statistical analysis was done by using open epi tool. The frequency, percentage and Chi-square test were used to analyse categorical variable. A p-value &lt;0.05 was considered as significant. Results: In this study the frequency of G/G genotype was considerably high 83 (67%) compared to G/A 17 (13.7%) and A/A 24 (19.3%) and in group 2 the frequency of G/G genotype 84 (67.7%), G/A genotype 34 (27.4%) and A/A genotype 6 (4.9%). There was a statistically significant difference in both the HCV infected and healthy controls groups (p=0.002). The average (±SEM) HCV viral load was 4.6±3.6×107 , 9.4±7.7×107 and 5.5±5.2×107 IU/mL in patients with the IL28B rs12979860 GG, GA and AA respectively. Also there was a significance between the viral load and IL28B rs 12979860 (p-value &lt;0.05). Conclusion: Thus, present study results indicate that the IL28B rs12979860 genotype has an effect on viral load in untreated HCV patients. These findings highlight the importance of viralhost interactions in influencing the outcome of HCV infection.

IMPACT OF RISK FACTORS IN THE SCRUTINY AND DIAGNOSIS OF HEPATITIS C

Chronic hepatitis C is considered a public health problem. Risk factors for infection traditionally identified as blood transfusion, major surgeries, organ donation, hemodialysis, vertical transmission have undergone an epidemiological transition. Other risk factors have become the main causes of new infections, such as intravenous drug use, sexual intercourse, prison, and tattoos. To describe the risk factors associated with the positivity of Hepatitis C by analyzing the epidemiological profile of populations at high risk for Hepatitis C. A cross-sectional study was carried out in the Mexican population as part of an HCV 2-years screening program implemented from December 2017 to December 2019. People were invited to participate in the program mainly in public health institutions, or through special campaigns in state and federal social rehabilitation centers and prisons. Adults (> 18 years) with informed consent were included for the study. Participants received a multiple-choice questionnaire to identify sociodemographic variables and the existence of any risk factor for HCV. A rapid test for HCV was performed and those participants whose results were reactive were applied a PCR test to determine quantification of HCV RNA. For the statistical analysis, the population was classified according to risk, as a general population with at least one risk factor and a high-risk population. A logistic regression model adjusted for sociodemographic variables and risk factors for the general population was developed to analyze the factors that may be associated with HCV positivity. This national cross-sectional cohort included 297,397 eligible subjects with a rapid test performed. Of the total number of rapid tests carried out, 13,085 subjects were reactive (4.4%) and 9,426 subjects (3.2% of the total population) were confirmed as positive by PCR test. The prevalence of viremia in the general population was 2.5%, while in the population with HIV was 3.1% and in persons deprived of their liberty (CERESO) was 18.5%. (Table) The median age in the total population was 43 years. Jalisco (10.1%) and Colima (7.7%) were the states with the highest percentage of positive results, followed by Baja California (7.4%). The percentage of people with viremia increases with age, going from 1.1% in the group of 18-29 years to more than 4.7% in those older than 60 years. In this cohort, the most common risk factors were history of acupuncture/ tattooing/piercings (21%), intravenous drug use (15%), and high-risk sexual practices (12%). From the logistic regression by risk population, we found that having at least one risk factor increased the odds of being HCV positive by 62% (OR = 1.62, IC 95% 1.54-1.69), compared with the population without risk factors. When conducted the analysis by type of specific population, the results showed that incarcerated people were 55 times more likely to be positive for Hepatitis C and 14 times more likely to be positive to HCV, compared to the HIV positive population. In this cross-sectional study with different high-risk populations for detecting hepatitis C, we identified 3.2% of viremic patients who were linearly related to older age and the existence of risk factors. Based on the results for this analysis, screening and diagnosis in high-risk populations, even those that are routinely marginalized, could be more effective. The authors declare that there is no conflict of interest.

The Molecular Profiling and HCV RNA Quantification to Study the Distribution of Different HCV Genotypes in Accordance to Geographical Condition

The Molecular Profiling and HCV RNA Quantification to Study the Distribution of Different HCV Genotypes in Accordance to Geographical Condition

Performances of NeuMoDx™, a random-access system for hepatitis B virus DNA and hepatitis C virus RNA quantification

ObjectiveMonitoring of viral loads (VL) for hepatitis B and C viruses (HBV; HCV) is essential to evaluate disease progression and treatment response. Automated, random-access rapid systems are becoming standard to provide clinicians with reliable VL. The aim of this study was to evaluate the analytical performances of the recently launched NeuMoDx™ for HBV-DNA and HCV-RNA quantification. MethodsClinical samples routinely quantified on the Beckman–Veris system were either retrospectively (frozen samples; HBV n = 178, HCV n = 249), or in parallel (fresh primary tubes; HBV n = 103, HCV n = 117) tested using NeuMoDx™. Linearity range was assessed on serial dilutions of high-titre plasmas containing different genotypes for HBV (A–E, n = 9) and HCV (1a,1b,2–5, n = 12). ResultsOverall test failure, mostly internal control amplification failure, was 2.3% and was not influenced by matrix types (fresh or frozen). For HBV VL, κ agreement was 74%, with 27 (12.6%) discrepancies. Correlation between HBV assays on 72 quantified samples by both methods was excellent (r = 0.963) with a mean bias (NeuMoDx™–Veris) of 0.21 log IU/mL. For HCV VL, κ agreement reached 94%, with 9 (2.8%) discrepancies. The r correlation factor between assays on 104 samples was 0.960 with a mean bias of –0.14 log IU/mL (NeuMoDx™–Veris). Serial dilutions confirmed the claimed linear ranges for all analysed HBV and HCV genotypes. The mean turnaround time was 72 minutes (range 55–101 minutes) for HBV and 96 minutes (range 78–133 minutes) for HCV. ConclusionResults obtained on the NeuMoDx™ confirmed the overall good functionality of the system with a short turn-around-time, full traceability and easy handling. These results on HBV and HCV VL look promising and should be challenged with further comparisons.

Cost-effectiveness and budget impact analysis of facility-based screening and treatment of hepatitis C in Punjab state of India

ObjectiveDespite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted...

Evaluation of GeneXpert for Quantification Viral Load Hepatitis C Virus

Background: GeneXpert has been used for Mycobacterium tuberculosis testing, but is currently available for HCV RNA testing. GeneXpert assay is expected to be more accurate, efficient, and cost-effective for HCV viral load quantification. This study intended to evaluate the new method quantification of plasma HCV RNA by the GeneXpert in comparison to the Roche Cobas TaqMan 96 as standard diagnostic tools.Method: A total of 54 HCV-infected plasma samples with anti-HCV positive were examined by GeneXpert assay, followed with Cobas TaqMan 96 for quantification of HCV RNA. Correlation was performed by Pearson test (in log10) and diagnostic test by Chi-square test. Sensitivity and specificity of the GeneXpert assay measured by calculating 2x2 contingency table. Bland-Altman plot were generated to assess the mean difference between the two assays.Results: GeneXpert has strong correlation to the Roche Cobas TaqMan 96 (R=0.993; P value 0.001). GeneXpert has sensitivity of 100% (95% CI: 90–100%) and specificity of 90% (95% CI: 54.1–99.5%). The Bland Altmand plot showed that one sampel has 1 log difference with the Roche Cobas TaqMan 96 measurement result.Conclusion: There was a strong correlation in the measurement of HCV RNA by GeneXpert and moreover its assay also has an excellent overall performance compared to Cobas TaqMan 96. Thus, it can be considered as a reliable tools for HCV virological response monitoring.

Detection and Quantification of HCV-RNA by RT-PCR among Anti-HCV Positive Patients

Introduction: The most common contemporary strategy to diagnose chronic hepatitis C virus (HCV) infection consists of initial screening with an HCV enzyme immunoassay (EIA) antibody test followed by supplemental testing of positive screening tests with a quantitative HCV RNA assay to confirm the positive EIA and to determine whether they have active or resolved hepatitis C infection.&#x0D; Objectives: To detect and quantify HCV-RNA by real-time polymerase chain reaction (real-time PCR) among anti-HCV positive patients and to identify the socio demographic factors among these patients.&#x0D; Materials and Methods: This was a descriptive type of cross-sectional study which was conducted in Combined Military Hospital and Armed Forces Institute of Pathology, Dhaka cantonment. A total of 108 anti-HCV positive patients by enzyme-linked immunosorbent assay (ELISA), who were clinically suspected and advised for anti-HCV test, were selected randomly for the study and subjected to do HCV-RNA analysis during the period of October 2016 to September 2017.&#x0D; Results: Out of 108 anti-HCV positive patients by ELISA, HCV-RNA was detected in 72 (66.7%) cases with mean value of HCV RNA quantification was 2013323.95±2695207.41 (IU/ ml). Majority of anti-HCV positive patients (29.6%) belonged to 51-60 years age group with male predominance (58.33%). It was observed that 43.52% patients came from middle income group family, 31.48% came from poor and 25.0% came from high income group family. Risk factor for HCV infected population was found maximum in dialysis patients (47.37%), followed by blood transfusion (13.89%), Injecting drug User (IDUs) (12.04%), surgery &amp; intervention (9.26%) and sexual transmission (1.85%). Mean alanine aminotransferase (ALT) was found 67.30±44.99 U/L among HCV-RNA detected patients (p&lt; 0.05).&#x0D; Conclusion: The quantification of HCV RNA by RT-PCR will be helpful to rationalize the treatment, enhance antiviral responses and mitigate mortalities of HCV infected patients.&#x0D; Journal of Armed Forces Medical College Bangladesh Vol.15 (1) 2019: 84-86

Multicenter clinical evaluation of alinity m HCV assay performance.

Nucleic acid testing is essential for the detection and quantification of HCV RNA in the diagnosis of HCV infection and treatment monitoring. The Alinity m HCV assay was recently developed by Abbott Molecular for rapid detection and quantification of HCV RNA on the fully automated, continuous, random-access Alinity m analyzer. Our study assessed the performance of the new Alinity m HCV assay for detection and quantification of HCV RNA in a large series of patient samples of various genotypes. This international, multicentric study evaluated the linearity, precision, and reproducibility of the Alinity m HCV assay and its performance in comparison to three other HCV assays currently used in clinical practice. The Alinity m HCV assay demonstrated high linearity (correlation coefficient r = 1.00), precision (coefficients of variation [CV] 6.6-13.5 %) and reproducibility (CV 1.7-4.3 % across three control lots). At a concentration near the lower limit of detection, the Alinity m HCV assay exhibited >98 % detectability. The Alinity m HCV assay showed excellent correlation with comparator HCV assays in serum (n = 406) and plasma (n = 1401) samples (correlation coefficients ≥0.96, bias 0.01 to 0.14 Log10 IU/mL). More than 95 % of the quantified results with the Alinity m HCV assay were less than mean bias ± 1.96 SD different from those of the comparator assays. The newly developed Alinity m HCV assay is sensitive, reproducible, and accurately quantifies HCV RNA levels in serum and plasma samples from patients with chronic HCV infection, with no impact of HCV genotype on assay performance.

Time to Detection of Hepatitis C Virus Infection With the Xpert HCV Viral Load Fingerstick Point-of-Care Assay: Facilitating a More Rapid Time to Diagnosis.

Xpert HCV Viral Load Fingerstick assay (Xpert HCV VL FS) is a point-of-care test quantifying HCV RNA in <1 hour, enabling same-visit diagnosis and treatment. This study evaluated time to HCV RNA detection using the Xpert HCV VL FS assay. Fingerstick whole-blood samples were collected from participants in an observational cohort in Australia. In May 2018-2019, 1468 participants were enrolled, 1426 had Xpert HCV VL FS testing performed, and 1386 had a valid result. HCV RNA was detected in 23% (325/1386). Among people with undetectable HCV RNA (n = 1061), median time to result was 57 minutes. Among people with detectable HCV RNA (n = 325), median time to HCV RNA detection was 32 minutes and 80% (261/325) had a detectable HCV RNA result in ≤40 minutes. Median time to HCV RNA detection was dependent on HCV RNA level. A quicker HCV diagnosis could be achieved by monitoring the time when HCV RNA is first detected with the Xpert HCV VL FS test, rather than HCV RNA quantification, although the current platform does not allow for this. These findings could facilitate new strategies to reduce waiting times for an HCV diagnosis and improve linkage to treatment.

Detection and distribution of genotypes of Hepatitis C in a tertiary care hospital.

Hepatitis C virus (HCV) has emerged as a leading cause of chronic hepatitis and hepatocellular carcinoma. Thus, this study was undertaken for detection and to observe genotypic distribution of the virus in this geographical region.Aims and Objectives:The aim of the study was to quantitatively detect HCV RNA in Hepatitis C patients and to determine the distribution pattern of its genotypes by real time polymerase chain reaction.Materials and Methods:This is a retrospective study conducted in a tertiary care hospital. In seropositive Hepatitis C patients, quantification of HCV-RNA was done by real time PCR and in HCV-RNA positive samples, genotyping for HCV was conducted.Result:A total of 300 patients were recruited in the study, of which 165 were anti HCV positive and among them, 127 were HCV-RNA positive. These positive samples were further subjected to genotype determination using real time PCR. 98 samples were positive for genotype, where genotype 3 was seen in 90 patients, genotype 1, in 3 patients and genotype 4, in 5 patients.Conclusion:Knowledge of genotype is crucial for management of HCV infection and prediction of prognosis. Patients infected with HCV genotype 1 and 4 will have to receive IFN and ribavirin for a period of 48 weeks and show a poor sustained viral response. On the contrary, patients infected with HCV genotype 2 and 3 are reported to have better response to therapy.

Hepatitis C virus-microelimination program and patient trajectories after hepatitis C virus cure in an outpatient HIV clinical unit.

Treatment recommendations for hepatitis C now make no distinction between HIV/HCV-coinfected and HCV-monoinfected patients. The largest challenge remained lack of effective models to eliminate HCV in people living with HIV. We report the results of a microelimination program evaluating the possibility of eradicating HCV in an HIV-outpatient clinical unit within 12 months. This HCV-microelimination program began in February 2016 in an unit following approximately 1000 HIV-infected patients and combined screening and therapeutic components according to the French guideline. A nested cohort study evaluating the impact of HCV cure on different health outcomes was conducted through self-administered questionnaires and using generalized mixed models. Among 601 patients eligible for HCV serological testing, 445 were evaluated, and two HCV acute infections were diagnosed. Among the 151 patients eligible for HCV RNA quantification, 119 were evaluated, and one reinfection with HCV was diagnosed. Among the 110 patients eligible for direct-acting antiviral treatment, 51 (46.4%) initiated treatment within the 12 months program, and 35 (31.8%) after. Sustained virologic response (SVR) rate was 96.1%, and two treatments failed. At least one self-reported symptom was declared by 72.5% (n = 29) of patients. Positive impact of HCV cure was observed on various markers of physical and mental health as well as on health habits. Our program should be considered as a proof of concept, which confirmed the feasibility of a HCV-microelimination program at the scale of an HIV clinical unit. However, 12 months were not sufficient to achieve our objective despite the specific organization.

HCV Microelimination Program and Patient Trajectories After HCV Cure in an Outpatient HIV Clinical Unit

Background: Treatment recommendations for hepatitis C now make no distinction between HIV/HCV-coinfected and HCV-monoinfected patients. The largest challenge remained lack of effective models to eliminate HCV in people living with HIV. We report the results of a microelimination program evaluating the possibility of eradicating HCV infection in an HIV-outpatient clinical unit within 12 months. Methods: This HCV-microelimination program began in February 2016 in an unit following approximately 1000 HIV-infected patients and combined screening and therapeutic components according to the French guidelines for coinfection. A substudy evaluating the impact of HCV cure on different health outcomes was conducted through self-administered questionnaires and using generalized mixed models. Findings: Among 601 patients eligible for HCV serological testing, 445 (74%) were evaluated, and two cases of acute HCV infection were diagnosed. Among the 151 patients eligible for HCV RNA quantification, 119 (79%) were evaluated, and one case of reinfection with HCV was diagnosed. Among the 110 patients eligible for DAA treatment, 51 (46·4%) patients initiated treatment within the 12 months program, and 35 (31·8%) after. Sustained virologic response (SVR) rate was 96·1%, and two treatment failed. At least one self-reported symptom was declared by 72·5% (n=29) of patients. Positive impact of HCV cure was observed on various markers of physical and mental health as well as on health habits. Interpretation: Our program should be considered as a proof of concept, which confirmed the feasibility of a HCV-microelimination program at the scale of an HIV clinical unit. However, 12 months were not sufficient to achieve our objective despite the specific organization. Funding Statement: This study was conducted with a grant of Gilead sciences. The sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. Declaration of Interests: I Poizot-Martin: reports personal fees from Gilead Sciences, MSD, for consultancies, and support from Gilead sciences, ViiVhealthcare for travel/accommodation/meeting expenses, outside the submitted work. H Laroche: reports personal fees from GILEAD/VIIV/Pfizer for consultancies, and support from ViiV/Gilead/Pfizer/MSD for travel/accommodation/meeting expenses, outside the submitted work. S Bregigeon: reports personal fees from Janssen for consultancies, and support from MSD, ViiV for travel/accommodation/meeting expenses, outside the submitted work. C Solas: reports personal fees from Viiv, Abbvie, Gilead for consultancies, and support from MSD, Viiv, Gilead for travel/accommodation/meeting expenses, outside the submitted work. C Lions, O Zaegel-Faucher, E Ressiot, C Tamalet, MA Pieve, AS Ritleng, C Debreux, A Ivanova, Obry-Roguet, P Carrieri, P Geneau De Lamarliere: no conflicts of interest Ethics Approval Statement: This research program was approved by the Ethical Committee CCP-Sud-mediterranee-1 Marseille, France, number 2015-A01913-46.

Monitoring the Treatment of Hepatitis C Viral Infection by Molecular Techniques

The prevalence of Hepatitis C viral infection in Egypt is the highest rate in the world. It is a major public health problem in Egypt. The objective of this study was to detect the clearance of HCV-RNA in Egyptian patients who were recommended for combination therapy of pyglated interferon α 2a and ribavirin (PEG-interferon/Ribavirin). Ninety-five positive HCV-IgG cases were tested for HCV-RNA at baseline and at weeks 4, 12, 24, 48 and 72 of treatment with PEG-interferon α 2a/Ribavirin. The correlations between the viral parameters during and after treatment were evaluated. Patients recommended receiving PEG-interferon 2a/ribavirin combination therapy showed high response rate determined as 71.9% achieved Sustained Virological Response (SVR) from total patients, and 71.4% from patients who received 48 weeks therapy. In general, the employment of TMA provided us the accuracy of results with confidence in our work. There was a significant relation (p < 0.001) between results of Transcription mediated amplification (TMA) and response to therapy that indicate to positive correlation. The development of sensitive accurate assays for HCV-RNA detection and quantification is necessary to improve not only the assessment of the response to antiviral therapy but also our understanding of the mechanism underlying antiviral resistance.