Hepatitis C New Drugs Review
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Noninvasive Assessment of Fibrosis Regression in Hepatitis C Virus Sustained Virologic Responders

Noninvasive Assessment of Fibrosis Regression in Hepatitis C Virus Sustained Virologic Responders | Hepatitis C New Drugs Review | Scoop.it
The emergence of direct-acting antiviral (DAA) therapies and noninvasive measures of liver fibrosis has streamlined the management of patients with chronic hepatitis C virus (HCV) infection. DAA therapy is associated with a significantly higher rate o
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Hepatitis C New Drugs Review
FDA approved Incivek(telaprevir, Vertex) on Monday 23 May by its PDUFA deadline.A paradigm shift in the treatment of Hepatitis C virus infection. <a href="http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#"; rel="nofollow">http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#</a>;
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Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"

Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval" | Hepatitis C New Drugs Review | Scoop.it
Krishan Maggon published version 121 of a knol titled: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"...
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DAAs for HCV and risk of hepatocellular carcinoma: current standpoint

DAAs for HCV and risk of hepatocellular carcinoma: current standpoint | Hepatitis C New Drugs Review | Scoop.it
The advent of effective and safe direct-acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection, which are able to eradicate the virus even when patients have progressed to advanced cirrhosis, has raised hope not only that the risk of hepatic decompensation could be reduced, but also that the occurrence of new liver tumours could be prevented. However, in 2016, two articles 1 ,  2 reported that around 28% of patients treated with DAAs had hepatocellular carcinoma recurrence within a few months of achieving a sustained virological response (SVR), which was higher than expected. Additionally, one of the studies 2 reported an incidence of de-novo hepatocellular carcinoma of 3·1% at 1 year after achieving an SVR with DAAs, which was no lower than the previously reported incidence in patients with HCV infection that had progressed to cirrhosis. After 2 years of further research, some conclusions can be drawn about the effects of DAAs on the occurrence of hepatocellular carcinoma, but areas of uncertainty still exist.
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Pathways to ensure universal and affordable access to hepatitis C treatment | BMC Medicine | Full Text

Pathways to ensure universal and affordable access to hepatitis C treatment | BMC Medicine | Full Text | Hepatitis C New Drugs Review | Scoop.it
Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030.
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What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘Development and clinical validation of the genedrive point-of-care test for qualitative detection of he...

What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘Development and clinical validation of the genedrive point-of-care test for qualitative detection of he... | Hepatitis C New Drugs Review | Scoop.it
The major advances in hepatitis C virus (HCV) diagnosis and treatment now make hepatitis C infection a curable disease over a short period of time and thus, theoretically, an eliminable disease. In its viral hepatitis elimination plan, the WHO aims, by 2030, to scale-up HCV treatment coverage to...
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Review article: novel antivirals for hepatitis C—sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir - Pearlman - - Alimentary Pharmacology & Therapeutics - Wiley Online Library

Review article: novel antivirals for hepatitis C—sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir - Pearlman - - Alimentary Pharmacology & Therapeutics - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Summary
Background
In 2017, the hepatitis C treatment regimens sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and glecaprevir/pibrentasvir (G/P) received approval from the U.S. Food and Drug Administration. Although both SOF/VEL/VOX (NS5B polymerase inhibitor/NS5A inhibitor/NS3/4A protease inhibitor) and G/P (NS3/4A protease inhibitor/NS5A inhibitor) are pangenotypic regimens, they are indicated for distinct subsets of patients with hepatitis C.

Aim
To compare and contrast available safety and efficacy data for SOF/VEL/VOX and G/P and outline their clinical utility.

Methods
For each of the regimens, this review outlines the indications, safety information, and the major clinical studies in which SOF/VEL/VOX and G/P were evaluated.

Results
SOF/VEL/VOX is positioned as a salvage regimen for patients previously treated with NS5A inhibitors and for genotype 1a‐ and 3‐infected patients who had failed other sofosbuvir‐containing regimens. G/P is the first pangenotypic regimen with an 8‐week duration for treatment‐naïve, non‐cirrhotic patients, and it is indicated for patients with any genotype who have advanced kidney disease, including those on dialysis.

Conclusion
The addition of SOF/VEL/VOX and G/P to existing hepatitis C treatment options will expand the number of patients who are eligible for and responsive to treatment, thus increasing the possibility of eliminating hepatitis C as a public health issue.
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One hepatocyte, two malignant fates

One hepatocyte, two malignant fates | Hepatitis C New Drugs Review | Scoop.it
Hepatic microenvironment dictates lineage commitment of hepatocytes, which can form two completely distinct tumor types.
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HBV reactivation after hematopoietic stem cell transplantation and rituximab-containing chemotherapy: a 12-year experience at a single center

HBV reactivation after hematopoietic stem cell transplantation and rituximab-containing chemotherapy: a 12-year experience at a single center | Hepatitis C New Drugs Review | Scoop.it
Correspondence...
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IDWeek: Opioid-using youth could miss out on hepatitis C screening and treatment

IDWeek: Opioid-using youth could miss out on hepatitis C screening and treatment | Hepatitis C New Drugs Review | Scoop.it
Only one-third of youths diagnosed with opioid use disorder were tested for hepatitis C, according to the results of a large sample presented at IDWeek.
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Cureus | Hepatocellular Carcinoma Occurrence and Recurrence in Hepatitis C-infected Patients Treated with Direct-acting Antivirals

Cureus | Hepatocellular Carcinoma Occurrence and Recurrence in Hepatitis C-infected Patients Treated with Direct-acting Antivirals | Hepatitis C New Drugs Review | Scoop.it
From a total of 497 treated HCV-infected patients, 233 (46.88 %) had cirrhosis, out of which 16 (6.86%) were reported to develop HCC during or after DAA therapy was initiated. The remaining 217 (93.1%) cirrhotic patients did not develop HCC. As per our comparison, achieving SVR in cirrhotic patients should not preclude HCC screening, and more studies are needed to assess the risk of HCC in patients who achieve SVR but have a high FIB-4 score. In fact, patients who do not achieve SVR may be at a higher risk of eventually developing HCC and may be candidates for closer surveillance. 
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Allergan And Cenicriviroc In NASH Fibrosis: Revisiting FDA Guidelines For Conditional Approval - Allergan plc (NYSE:AGN)

Allergan And Cenicriviroc In NASH Fibrosis: Revisiting FDA Guidelines For Conditional Approval - Allergan plc (NYSE:AGN) | Hepatitis C New Drugs Review | Scoop.it
Allergan generates increasing revenues.Its NASH franchise is also progressing satisfactorily with the AURORA Phase 3 NASH trial interim data readout anticipate...
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The benefits of hepatitis C virus cure: Every rose has thorns - Salmon - 2018 - Journal of Viral Hepatitis - Wiley Online Library

The benefits of hepatitis C virus cure: Every rose has thorns - Salmon - 2018 - Journal of Viral Hepatitis - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
To examine mid‐term benefits on hepatic complications, extrahepatic clinical syndromes and quality of life associated with HCV cure; to review the few safety issues linked to oral direct‐acting antivirals (DAAs); and to discuss the potential population benefits of reducing the burden of HCV infection. DAAs cure HCV infection in more than 95% of patients. The halting of liver inflammation and fibrosis progression translates into both hepatic and extrahepatic benefits and reduces the need for liver transplantation. A reduction in the frequency of extrahepatic manifestations such as mixed cryoglobulinaemia and vasculitis and improvements in quality of life and fatigue have also been described. A few safety issues linked to DAAs such as the potential recurrence of aggressive HCC, the flares of hepatitis B virus in patients with overt or occult HBV infection are been discussed. Curing HCV infection also has a high potential to reduce the burden of HCV infection at the population level. With widespread scaling up of HCV treatment, several modeling studies suggest that major reductions in HCV prevalence and incidence are possible, and that elimination of viral hepatitis is an achievable target by 2030.
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The history of hepatitis C virus (HCV): Basic research reveals unique features in phylogeny, evolution and the viral life cycle with new perspectives for epidemic control

The history of hepatitis C virus (HCV): Basic research reveals unique features in phylogeny, evolution and the viral life cycle with new perspectives for epidemic control | Hepatitis C New Drugs Review | Scoop.it
The discovery of hepatitis C virus (HCV) in 1989 permitted basic research to unravel
critical components of a complex life cycle for this important human pathogen. HCV is a highly divergent group of viruses classified in 7 major genotypes and a great number of subtypes, and circulating in infected...
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Use of Ribavirin for Hepatitis C Treatment in the Modern Direct-acting Antiviral Era

Use of Ribavirin for Hepatitis C Treatment in the Modern Direct-acting Antiviral Era | Hepatitis C New Drugs Review | Scoop.it
Ribavirin, once a staple of hepatitis C treatment, has significant drawbacks, including treatment-limiting side effects, the requirement for intensive laboratory monitoring, the need for frequent dose adjustments, and teratogenicity.
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Neuralized E3 Ubiquitin Protein Ligase 3 Is an Inducible Antiviral Effector That Inhibits Hepatitis C Virus Assembly by Targeting Viral E1 Glycoprotein

Neuralized E3 Ubiquitin Protein Ligase 3 Is an Inducible Antiviral Effector That Inhibits Hepatitis C Virus Assembly by Targeting Viral E1 Glycoprotein | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C virus (HCV) infection is a major cause of chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. HCV can be sensed by host innate immunity to induce expression of interferons (IFNs) and a number of antiviral effectors.
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Hepatitis C virus cell culture models: an encomium on basic research paving the road to therapy development

Hepatitis C virus cell culture models: an encomium on basic research paving the road to therapy development | Hepatitis C New Drugs Review | Scoop.it
Chronic hepatitis C virus (HCV) infections affect 71 million people worldwide, often resulting in severe liver damage. Since 2014 highly efficient therapies based on directly acting antivirals (DAAs) are available, offering cure rates of almost 100%, if the infection is diagnosed in time. It took more than a decade to discover HCV in 1989 and another decade to establish a cell culture model. This review provides a personal view on the importance of HCV cell culture models, particularly the replicon system, in the process of therapy development, from drug screening to understanding of mode of action and resistance, with a special emphasis on the contributions of Ralf Bartenschlager’s group. It summarizes the tremendous efforts of scientists in academia and industry required to achieve efficient DAAs, focusing on the main targets, protease, polymerase and NS5A. It furthermore underpins the importance of strong basic research laying the ground for translational medicine.

Keywords
Hepatitis C virus HCV Hepatocyte DAA Therapy Antiviral Cell culture Replicon Genotype Bartenschlager Adaptation 
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Microbial translocation and T cell activation are modified by direct‐acting antiviral therapy in HCV‐infected patients - Lattanzi - - Alimentary Pharmacology & Therapeutics - Wiley Online Library

Microbial translocation and T cell activation are modified by direct‐acting antiviral therapy in HCV‐infected patients - Lattanzi - - Alimentary Pharmacology & Therapeutics - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it

Background

Microbial translocation from the gut lumen has been involved in the pathogenesis of liver damage in hepatitis C virus infection.

Aim

To investigate the impact of direct‐acting antiviral treatment on microbial translocation and T‐cell activation, in patients with hepatitis C‐related liver disease.

Methods

We enrolled two groups of HCV patients undergoing direct‐acting antiviral treatment: patients with fibrosis ≥F3 according to Metavir (Group ≥F3); patients with hepatitis C recurrence after liver transplantation and Metavir ≥F2 (Group Liver Transplantation + ≥F2). All patients were treated with direct‐acting antivirals based on ongoing guidelines. Surrogate biomarkers of microbial translocation (plasma concentrations of soluble‐CD14, lipopolysaccharide binding protein and intestinal fatty acid‐binding protein) were evaluated at baseline, at first month, at the end of treatment and 3 months later. T‐cell activation was measured by expression of CD38+ HLA‐DR at the same time points, only in Group ≥F3.

Results

There were 32 patients in Group ≥F3 and 13 in Group LT + ≥F2. At baseline, levels of soluble‐CD14 and lipopolysaccharide binding protein were significantly higher in both groups vs healthy controls. Baseline soluble‐CD14 correlated with glutamic‐oxalacetic transaminase (r = 0.384, P = 0.009) and glutamic‐pyruvic transaminase (r = 0.293, P = 0.05). A significant decrease in plasma levels of surrogate microbial translocation biomarkers was observed during and after treatment in the two groups although values were not normalised. In Group ≥F3, CD38+ HLADR+ T‐cell expression was significantly decreased by direct‐acting antiviral treatment. Relapsers (9%) showed higher soluble‐CD14 levels at baseline.

Conclusion

Surrogate microbial translocation markers and T cell activation are increased in hepatitis C patients with liver fibrosis and decrease during direct‐acting antiviral treatment.

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Molecular Mechanism of Resistance in a Clinically Significant Double-Mutant Variant of HCV NS3/4A Protease

Molecular Mechanism of Resistance in a Clinically Significant Double-Mutant Variant of HCV NS3/4A Protease | Hepatitis C New Drugs Review | Scoop.it
The molecular mechanism of resistance for HCV NS3/4A protease inhibitors (PIs) against
the clinically emerging Y56H/D168A variant is described by determining crystal structures
of this double mutant and Y56H variant. Substitution at the neighboring Y56 disrupted
critical stacking interactions with the catalytic His57, revealing a structural mechanism
that threatens cross-resistance.
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Exosomes from Hepatitis C Infected Patients Transmit HCV Infection and Contain Replication Competent Viral RNA in Complex with Ago2-miR122-HSP90

Exosomes from Hepatitis C Infected Patients Transmit HCV Infection and Contain Replication Competent Viral RNA in Complex with Ago2-miR122-HSP90 | Hepatitis C New Drugs Review | Scoop.it
Author Summary Since its first isolation and identification in 1989, Hepatitis C virus (HCV), has caused significant disease burden to humans worldwide. So far, there is no vaccine against HCV, and neutralizing antibody therapies to block receptor–mediated transmission of HCV to liver cells have...
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Current therapy for chronic hepatitis C: The role of direct-acting antivirals - ScienceDirect

Current therapy for chronic hepatitis C: The role of direct-acting antivirals - ScienceDirect | Hepatitis C New Drugs Review | Scoop.it
Highlights

HCV genotype-specific drugs evolve to pan-genotypic drugs.


Drug potency increases from moderate (∼60%) to high (>90%) levels of sustained virologic response.


Treatment durations are shortened from a 48-week to 12-week or 8-week period.


HCV therapies based upon multiple pills per day are simplified to a single pill per day.


HCV therapies are administered orally regardless of prior treatment history and cirrhotic status.
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Restoration of natural killer cell activity by interferon‐free direct‐acting antiviral combination therapy in chronic hepatitis C patients - Nakamura - 2018 - Hepatology Research - Wiley Online Lib...

Aim Interferon‐free direct‐acting antiviral (DAA) therapy is an effective treatment for chronic hepatitis C (CH(C)) patients. Activity of natural killer (NK) cells was reported to be impaired in patients with hepatitis C virus infection. The aim of this study was to examine whether DAA therapy could restore NK activity in patients with CH(C). Methods Direct‐acting antiviral therapy was given to 31 CH(C) patients as asunaprevir/daclatasvir (ASV/DCV) (n = 15), ledipasvir/sofosbuvir (n = 7), ombitasvir/paritaprevir/ritonavir (n = 6), or elbasvir/grazoprevir (n = 3). Prior to therapy (0M), at the completion of the therapy (EOT), and at 24 weeks after completion (AFTER), NK activity and the frequency of CD56dimNK and CD56brightNK cells in peripheral blood were estimated by Cr release assay and flow cytometry. Statistical analysis was carried out by anova and the Mann–Whitney U‐test. Results In one of the ASV/DCV‐treated patients, treatment was stopped 12 weeks after initiation of therapy because of viral breakthrough. The anova showed that NK activity significantly improved at EOT (vs. 0M, P < 0.01) and at AFTER (vs. 0M, P < 0.001) in 30 patients with sustained virologic response. It also showed that the frequency of CD56dimNK cells was significantly increased at EOT and at AFTER (vs. 0M, P < 0.05). In addition, the NK activity ratio (AFTER/0M) had no significant difference between patient groups with higher and lower Fibrosis‐4 scores. Conclusion Direct‐acting antiviral therapy in CH(C) patients could improve NK activity by increasing the frequency of CD56dimNK cells. Additionally, our results might imply that DAAs therapy could reduce the risk of hepatocarcinogenesis by restoring innate immune responses.
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The effects of direct‐acting antiviral agents on the frequency of myeloid‐derived suppressor cells and natural killer cells in patients with chronic hepatitis C - Li - - Journal of Medical Virology...

The effects of direct‐acting antiviral agents on the frequency of myeloid‐derived suppressor cells and natural killer cells in patients with chronic hepatitis C - Li - - Journal of Medical Virology... | Hepatitis C New Drugs Review | Scoop.it
Currently, hepatitis C antiviral therapy is entering a new era with the use of direct‐acting antiviral (DAA) agents. However, the precise immunological influences of DAA therapy in patients with chronic hepatitis C (CHC) are insufficiently understood. This study aimed to investigate the effects of DAA therapy on the frequency of myeloid‐derived suppressor cells (MDSCs), T lymphocytes, and natural killer (NK) cells in patients with CHC. Thirty‐two treatment‐naive CHC patients were treated with DAA therapy, and the frequency of immune cells was analyzed by flow cytometry at various time points during and after therapy. Sixteen healthy donors were recruited for comparison. DAA therapy decreased the frequency of MDSCs and monocytic MDSCs in patients with CHC to a normal level. DAA therapy also increased the CD8+ T and NK cell levels in patients with CHC. In addition, activation (NKp30 and NKp46) and inhibitory (NKG2A) receptors on NK cells were downregulated to yield an NK cell phenotype resembling that observed in the healthy controls. This study provides insight into the normalization of immune cell levels under DAA therapy and indicates that restoration of the immune system in patients with CHC strongly supports long‐term curative hepatitis C virus eradication.
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Outbreak of Nosocomial Hepatitis C Virus Infection Resolved by Genetic Analysis of HCV RNA

Outbreak of Nosocomial Hepatitis C Virus Infection Resolved by Genetic Analysis of HCV RNA | Hepatitis C New Drugs Review | Scoop.it
ABSTRACT
In July 2000, symptomatic acute hepatitis C was diagnosed in five patients who had attended the emergency room of a municipal hospital on the same day, about 6 weeks before. Investigation of the remaining 65 patients visited at the emergency room on that day disclosed that 8 patients had a positive anti-hepatitis C virus (anti-HCV) test and 4 of them had biochemical evidence of acute anicteric hepatitis. HCV RNA was detected in 12 of the 13 anti-HCV-positive patients. Phylogenetic analysis of the nonstructural 5A (NS5A) and E2 regions showed that 10 patients, including all 9 with acute hepatitis, were infected with a closely related HCV strain, while the remaining 2 patients harbored unrelated strains. Flushing of intravenous catheters with heparin retrieved from a multidose heparin solution in saline was carried out for all the patients involved in the hepatitis outbreak but in only 1 of 23 (4%) matched controls recruited among HCV-noninfected patients attending the emergency room on the same day, and this was the only significant difference concerning risk factors for HCV infection between patients and controls. Thus, accidental contamination of a multidose heparin solution with blood from an unrecognized HCV carrier was identified as the source of this nosocomial outbreak of hepatitis C.
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Protective effect of coffee consumption on all-cause mortality of French HIV-HCV co-infected patients

Protective effect of coffee consumption on all-cause mortality of French HIV-HCV co-infected patients | Hepatitis C New Drugs Review | Scoop.it
Patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are particularly vulnerable to developing liver disease due to immune activation/inflammation, exposure to antiretroviral therapy (ART) and evolution of HCV co-infection.1,2 In addition, HIV infection modifies...
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Hepatitis C Online

Hepatitis C Online | Hepatitis C New Drugs Review | Scoop.it
HCV Medications Medication Summaries Clinical Studies Slide Decks Learn about medications to treat HCV » Course Modules Browse the Online Course Materials Sign In and Track Your Progress Free Continuing Education Start the Online Course » Slide Lectures State-of-the-Art Expert Faculty Mini-Lectures Explore the Slide Lectures library » Core Concepts Concise Topic Reviews Up-to-Date Content Downloadable PDFs  See the extensive Core Concepts library » Clinical Calculators APRI, AUDIT-C; BMI, CAGE; CTP, MELD, SAAG, and more Discover the Clinical Calculators » 0 1 2 3 4 About Hepatitis C Online Hepatitis C Online is a free educational web site from the University of Washington.  The site is a comprehensive resource that addresses the diagnosis, monitoring, and management of hepatitis C virus infection.  Take the Free Online Course Browse or create an account and track your progress as you work through the course.  After registering, you can obtain free CME or CNE credit.
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HCV core antigen as an alternative to HCV RNA testing in the era of direct-acting antivirals: retrospective screening and diagnostic cohort studies

HCV core antigen as an alternative to HCV RNA testing in the era of direct-acting antivirals: retrospective screening and diagnostic cohort studies | Hepatitis C New Drugs Review | Scoop.it
These data support the use of HCV core antigen testing to document HCV viraemia in
a cost-saving diagnostic algorithm. In a treatment setting, HCV core antigen testing can be used instead of HCV RNA testing for diagnosis and documentation of treatment adherence, but it might not be adequate to...
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Hepatitis C mixed cryoglobulinemia with undetectable viral load: A case series

Hepatitis C mixed cryoglobulinemia with undetectable viral load: A case series | Hepatitis C New Drugs Review | Scoop.it
Mixed cryoglobulinemic vasculitis is caused by circulating cold-precipitable immunoglobulins,
or cryoglobulins, composed of monoclonal (type II) or polyclonal (type III) IgM directed
against a polyclonal IgG.
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