In draft guidance published today NICE recommends peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.. Hepatitis C is a blood-borne virus that infects the liver. Children and young people get the disease primarily from their mothers at birth. If the virus is not cleared from the body, either naturally or through drugs to treat it, an acute infection (defined as the first six months following initial infection) can progress to chronic hepatitis C (long term infection, lasting more than six months). Chronic hepatitis C infection increases the risk of scarring of the liver (fibrosis and cirrhosis), liver failure and liver cancer. Peginterferon alfa-2a (Pegasys, Roche Products) and peginterferon alfa-2b (ViraferonPeg, Merck Sharp and Dohme (MSD)), in combination with ribavirin are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents.. Professor Carole Longson, ...
Published: Nov 11, 2014 8:02 a.m. ET. - High Cure Rates in Nearly 800 HCV Patients with Advanced Liver Disease - BOSTON, Nov 11, 2014 (BUSINESS WIRE) -- Gilead Sciences, Inc. GILD, +0.55% today announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting2014) in Boston. "Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options," said Norbert Bischofberger, PhD, Executive Vice President ...
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni(R) (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2014) in Boston. "Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. "The data presented this week demonstrate that Harvoni provides high cure ...
TY - JOUR. T1 - Daclatasvir for the treatment of chronic hepatitis C virus infection. AU - Temesgen, Zelalem. AU - Rizza, Stacey. PY - 2015/5/1. Y1 - 2015/5/1. N2 - Daclatasvir is a nonstructural protein 5A (NS5A) replication complex inhibitor that has shown potent in vitro activity against multiple hepatitis C virus (HCV) genotypes (GT). It is currently in advanced clinical development as a component of combination treatment regimens in a variety of HCV-infected patient populations. In studies conducted thus far, it has been generally well tolerated. It has been approved for the treatment of HCV GTs 1-4 in the European Union. The combination of daclatasvir and asunaprevir (an HCV NS3/4A protease inhibitor) has been approved in Japan for the treatment of patients with GT1 HCV infection. Here we review the available literature on daclatasvir, including its information on its discovery, mechanism of action, pharmacology, preclinical and clinical activity, resistance and safety.. AB - Daclatasvir ...
New treatments for genotype 1 chronic hepatitis C – focus on simeprevir Tatsuo Kanda, Shingo Nakamoto, Shuang Wu, Osamu Yokosuka Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan Abstract: Chronic hepatitis C virus (HCV) infection causes end-stage liver diseases and hepatocellular carcinoma. In the USA, Canada, and Japan, simeprevir – one of the second-generation HCV NS3/4A protease inhibitors – in combination with peginterferon α-2a or 2b plus ribavirin has recently been approved for HCV genotype 1-infected patients and is now used in daily clinical practice. This review summarizes the mechanism of action of simeprevir and the results of clinical trials of simeprevir and peginterferon plus ribavirin for HCV genotype 1 patients. In general, the simeprevir and peginterferon plus ribavirin treatment is highly effective and its adverse events are similar to those of peginterferon plus ribavirin only, the exception being
Inclusion criteria:. 1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection. 1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load ,= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or ...
It has been reported that inosine triphosphatase (ITPA) gene variants protect against ribavirin-induced anemia in patients treated for chronic hepatitis C. IL28B variants also influence the treatment response of peginterferon plus ribavirin treatment in these patients. In the present study, we examined how ITPA and IL28B genotypes have clinical impacts on treatment-induced hematotoxicities and treatment response in HCV-infected patients treated with peginterferon plus ribavirin. ITPA genotypes (rs1127354 and rs6051702) and IL28B genotype (rs8099917) were determined by TaqMan SNP assay. We compared clinical background, treatment course and treatment response in terms of these genotypes. Only IL28B rs8099917 major type could predict sustained virological response. ITPA rs1127354 major type leads to significantly greater ribavirin-induced anemia than ITPA rs1127354 minor type between days 0 and 84. We noticed that IL28B rs8099917 minor genotype was associated with higher reduction of neutrophils and
Management of chronic hepatitis C virus infection in patients with end-stage renal disease: a review Jonathan Aguirre Valadez,1 Ignacio García Juárez,1 Rodolfo Rincón Pedrero,2 Aldo Torre11Department of Gastroenterology, 2Department of Nephrology, National Institute of Medical Sciences and Nutrition Salvador Zubirán, Mexico City, Mexico Abstract: Infection with hepatitis C virus (HCV) is highly prevalent in chronic kidney disease (CKD) patients, mainly in those on hemodialysis (HD). The seroprevalence of HCV in developing countries ranges between 7% and 40%. Risk factors for this infection in the CKD population include the number of blood transfusions, duration of end-stage renal disease (ESRD), and prevalence of HCV in HD. Chronic HCV infection in patients with ESRD is associated with an increase in morbidity and mortality in the pre and post kidney transplant periods. The increase in mortality is directly associated with liver complications and an elevated cardiovascular
79036 avhandlingar från svenska högskolor och universitet. Avhandling: Development of vaccines and mouse models for chronic hepatitis C virus infection.
Roches new investigational drug for hepatitis C has been shown to have a strong antiviral effect. The drug, which is known as R1626, has achieved clinically significant reductions in viral load in chronic hepatitis C patients infected with the difficult-to-cure genotype 1 virus.[i] Furthermore, the drop in hepatitis C viral load achieved in patients receiving R1626 is the largest seen for this class of antiviral treatments called polymerase inhibitors. These findings were announced today at the annual meeting for the 57th American Association for the Study of the Liver (AASLD) in Boston ...
Background: Chronic hepatitis C (CHC) patients achieving rapid virological response (RVR) on PEG-IFN/ribavirin (P/R) therapy have high chance of sustained virological response (SVR). To analyze host immunological factors associated with RVR, viral kinetics, phenotype distribution and Th1/Th2 cytokine production by peripheral blood mononuclear cells (PBMC) were studied prior to and during P/R therapy. Methods: TNF-α, IFN-γ, IL-2, IL-6, IL-4 and IL-10 production by PBMC were measured after Toll-like receptor 4 (TLR-4) or phorbol myristate acetate/Ionomycin stimulation in 20 healthy controls and in 50 CHC patients before receiving and during P/R therapy. RVR was achieved by 14, complete early virological response (cEVR) by 19 patients and 17 patients were null-responders (NR). Results: Patients with RVR showed an increased baseline TNF-α and IL-6 production by TLR-4 activated monocytes and increased IFN-γ, decreased IL-4 and IL-10 production by lymphocytes compared to non-RVR patients. SVR was ...
Background Hepatitis C virus is mainly transmitted by contact to infected blood. Chronic hepatitis C infection affects around 3% of the world population and progresses slowly. Most patients present without symptoms, or with symptoms like fatigue or liver-related morbidity. Frequently, the disease is discovered by coincidence because of abnormal laboratory results. Around 5% to 40% of all infected patients will develop severe liver damage which can cause severe liver-related morbidities and eventually death. Current treatment consists of pegylated interferon-alpha plus ribavirin and in some subgroups of patients these agents are combined with telaprevir or boceprevir, or other direct acting antivirals. In about 70% of patients with chronic hepatitis C, it is possible to eradicate the virus from the blood, but the clinical effects are not known. Aminoadamantanes (another group of antiviral drugs), mostly amantadine, have been tested in several clinical trials. The authors have previously ...
TY - JOUR. T1 - Functional B-cell response in intrahepatic lymphoid follicles in chronic hepatitis C. AU - Murakami, Jun. AU - Shimizu, Yukihiro. AU - Kashi, Yoshiro. AU - Kato, Tsutomu. AU - Minemura, Masami. AU - Okada, Kazuhiko. AU - Nambu, Shuji. AU - Takahara, Terumi. AU - Higuchi, Kiyohiro. AU - Maeda, Yoshinobu. AU - Kumada, Tokimasa. AU - Watanabe, Akiharu. PY - 1999/7/8. Y1 - 1999/7/8. N2 - Intrahepatic lymphoid follicle (ILF) formation is one of the most characteristic and commonly observed histological features in patients with chronic hepatitis C. However, little is known regarding whether follicles in the liver belong to functional lymphoid tissues, where B cells are activated, differentiated, and proliferated, or if the lymphocytes are merely infiltrated after recruitment from the secondary lymphoid organs. To ascertain this possibility, we examined the expression of markers for B-cell activation, differentiation, and proliferation in ILFs in patients with chronic hepatitis C using ...
BACKGROUND: Hepatocellular carcinoma (HCC) is one of the most common cancers in the world. The geographical prevalence varies considerably in different countries and Scotland is regarded as an area of low risk for the disease. AIMS: To assess the association between chronic hepatitis C infection (HCV) and HCC in a population of patients presenting to a single hospital. PATIENTS: One hundred and fourteen cases of histologically confirmed liver cancer presenting to the Royal Infirmary of Edinburgh between 1985 and 1994 were examined. METHODS: Of 114 cases of HCC, 80 samples of stored sera were available. Samples positive for HCV Ab were genotyped by restriction fragment length polymorphism analysis of HCV c-DNA. A population of 29 cirrhotic patients (diagnosed between 1985 and 1994) with chronic HCV infection was also genotyped. RESULTS: Chronic HCV infection was a major risk factor (30% of tested HCC patients) identified. HCV genotype 1b was predominant (16 of 20 patients). The time from HCV ...
The primary objectives of this study are to evaluate safety, efficacy and tolerability of treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).. ...
Patients with chronic hepatitis C and low serum and hepatic iron stores may have an improved response to interferon (IFN). We tested whether iron reduction before and during IFN therapy would lead to an improved sustained biochemical and virological response compared with IFN alone. Eighty-two previously untreated patients with chronic hepatitis C were randomized to either: group A IFN-α2b 3 MU 3 times per week for 6 months, or group B iron reduction before and during IFN-α2b 3 MU 3 times per week for 6 months. Group B patients had lower mean serum alanine transaminase (ALT) levels than group A patients during treatment and follow-up. Group B patients had significantly lower mean hepatitis C virus (HCV)-RNA levels at treatment weeks 4 and 12 (P , .05). Serum HCV RNA was undetectable at the end of treatment in 15 group B patients compared with 7 group A patients (P = .03); 7 group B patients and 3 group A patients had persistently undetectable serum HCV RNA 24 weeks after the end of therapy (P ...
Hospital and four different private clinics in Bahawalpur during 2002 to 2003 Material and Methods: 1. The case record files of 100 patients with chronic hepatitis C vs.100 with chronic hepatitis B were reviewed and the laboratory and demographic data were extracted.2. Anti-HCV and HBsAg were determined for 100 type 2 diabetes patients and 100 healthy adults by ELISA. The diagnosis of diabetes was based on the new WHO criteria. Pearson`s correlation coefficient was calculated and tested for significance Results: 1. The occurrence of diabetes in patients with chronic hepatitis C was 19%, higher than 8% in patients with chronic hepatitis B [ ...
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment ...
PubMed journal article Pilot study of pegylated interferon-alpha 2a in dialysis patients with chronic hepatitis C virus infectio were found in PRIME PubMed. Download Prime PubMed App to iPhone or iPad.
TY - JOUR. T1 - Intrahepatic levels of CXCR3-associated chemokines correlate with liver inflammation and fibrosis in chronic hepatitis C. AU - Zeremski, Marija. AU - Petrovic, Lydia M.. AU - Chiriboga, Luis. AU - Brown, Queenie B.. AU - Yee, Herman T.. AU - Kinkhabwala, Milan. AU - Jacobson, Ira M.. AU - Dimova, Rositsa. AU - Markatou, Marianthi. AU - Talal, Andrew H.. PY - 2008/11/1. Y1 - 2008/11/1. N2 - Chemokines, chemotactic cytokines, may promote hepatic inflammation in chronic hepatitis C virus (HCV) infection through the recruitment of lymphocytes to the liver parenchyma. We evaluated the association between inflammation and fibrosis and CXCR3-associated chemokines, interferon-γ (IFN-γ)-inducible protein 10 (IP-10/CXCL10), monokine induced by IFN-γ(Mig/CXCL9), and interferon-inducible T cell α chemoattractant (I-TAC/CXCL11), in HCV infection. Intrahepatic mRNA expression of these chemokines was analyzed in 106 chronic HCV-infected patients by real-time PCR. The intrahepatic ...
Although several researches have reported the connection between the transforming growth factor-beta 1 (TGF-β1) gene polymorphisms and chronic hepatitis C virus (HCV) infection, the conclusions of these studies were not always consistent. Here, this paper proposed a meta-analysis to evaluate whether the TGF-ß1 gene polymorphisms, −509C/T (rs1800469), codon 10 T/C (rs1982073) and codon 25G/C (rs1800471), were associated with chronic HCV infection. The summary odds ratios (ORs) of chronic HCV infected patients and controls with all SNPs were obtained by adaptive fixed or random effect model. A series of statistical tools were employed to guarantee the accuracy of related pooling ORs, including the Hardy-Weinberg equilibrium (HWE) test, sensitivity analysis and publication bias test. This paper analyzed 18 case-control studies in 17 articles which totally contains 2718 chronic HCV infection cases corresponding to 1964 controls. The results of the meta-analysis indicated that the −509C/T polymorphism
U.S. Food and Drug Administration (FDA) has approved VoseviTM (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis ...
Many patients with chronic hepatitis C have been treated with interferon (IFN) therapy in Japan, especially after the introduction of subsidies for medical expenses in 2008. However, its performance and outcome have never been evaluated. Therefore, a nationwide, mail-based, retrospective cohort study was conducted. Regional disparities in the demographic features, treatment performance, and virological response were evaluated using an intent-to-treat design. The participating prefectures were classified into nine regions from north to south (Hokkaido/Tohoku, Kanto, Shin-etsu, Hokuriku, Tokai, Kinki, Chugoku, Shikoku, and Kyushu). Multivariate logistic regression analysis was performed to select predictive factors for treatment performance and outcome. From December 2009 to May 2013, 16,854 patients with chronic hepatitis C were registered from 37 prefectures in Japan (median age: 60 years; 50.4 % male; 74.8 % IFN-naïve; HCV genotype [1 or 2]/viral load [high (≥5 log IU/mL) or low (|5 log IU/mL)]: 1
Hepatitis C viral infection can be associated with other infectious diseases including viral and bacterial infections such as tuberculosis. Mycobacterium tuberculosis infection may be latent for many years and revealed during an immunodeficiency state. The responsibility of antiviral treatment in the reactivation of tuberculosis is controversial. We report two cases of tuberculous reactivation during bitherapy with pegylated interferon and ribavirin for chronic hepatitis C. A rapid viral response was obtained in both cases. Tuberculous reactivation occurred at 12 and 13 weeks of antiviral treatment, respectively. Tuberculosis involved urinary tract in one patient and lymph nodes in the other. Antituberculous treatment was given and antiviral treatment maintained. The outcome of tuberculosis was favourable and a sustained viral response was obtained for both patients.
Background & Aims Individuals at risk of (H1N1) influenza A infection are recommended to receive vaccination. Chronic hepatitis C (CHC) patients receiving treatment might be at a higher risk of respiratory bacterial infections after influenza infection. However, there are no observational studies evaluating the immunogenicity, tolerance and acceptance of 2009 influenza A vaccine in CHC patients. Methods We evaluated the immunogenicity of influenza A vaccine (Pandemrix®) by using the hemagglutination inhibition (HI) titers method in a well defined cohort of CHC patients receiving or not receiving pegylated-interferon and ribavirin, and compared it with healthy subjects (controls). A group of patients with inflammatory bowel disease (IBD) under immunosuppression, thought to have a lower immune response to seasonal influenza vaccine, were also included as a negative control group. In addition, tolerance to injection site reactions and acceptance was assessed by a validated questionnaire (Vaccinees
The prognosis of chronic hepatitis C virus HCV infection is still ill-defined. The present study prospectively evaluated mortality and complications in a large cohort of patients with chronic hepatitis C. The study included 838 anti-HCV and HCV-RNA-positive patients who were followed for 50.2 26.9 months mean SD ; range, 6-122 months in a...
This study shows a clear relationship between daily tobacco consumption and the severity of histological activity in patients with chronic hepatitis C. Indeed, the proportion of patients with moderate and marked activity (A2-A3) increased gradually from 62.0% in patients who did not smoke to 81.7% in patients who smoked more than 15 cig/day (p,0.009). As confounding factors, namely alcohol intake, could explain this relationship, a multivariate analysis was performed. It showed that, in addition to two previously identified factors (that is, age over 50 years and alcohol intake exceeding 20 g/day), tobacco consumption higher than 15 cig/day within the six months before biopsy was associated with the severity of histological activity. Thus independent of alcohol intake, tobacco consumption higher than 15 cig/day was associated with aggravation of histological activity in patients with chronic hepatitis C. In our study, both univariate and multivariate analyses showed the relationship between ...
TY - JOUR. T1 - A Decade of Trials of Interferon-Alpha for Chronic Hepatitis C. A Meta-Regression Analysis. AU - Attanasio, Massimo. AU - Tinè, Fabio. AU - Russo, Francesco. PY - 2005. Y1 - 2005. N2 - The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in active versus control group versus usual clinical variables as IFN regimens, cirrhosis, genotype and versus less frequently addressed variables as funding, methodological quality or location of principal author. Meta-analysis estimates of global treatment effect varied according to trial design: group 1=IFN versus placebo/no treatment, 32 RCTs, 2499 pts, OR 9.5 (6.3-14.2); group 2a=comparison of IFN schedules, 43 RCTs, 7454 pts, OR 1.6 (1.4-1.9); group 2b=IFN+other drugs versus standard ...
Hepatitis C virus (HCV) infection remains a major global health burden. Hepatitis C causes significant liver-related morbidity and mortality due to hepatic decompensation and development of hepatocellular carcinoma. In addition, extra-hepatic manifestations of hepatitis C are frequent. There is a very large interindividual variability in the natural history of both acute and chronic hepatitis C which can be explained in part by a combination of various host, viral and environmental factors. Successful antiviral treatment can prevent short- and long-term complications of HCV infection in many patients. Still, the relative contribution of distinct risk factors for disease progression in different phases of HCV infection needs to be better defined. Personalized treatment approaches for HCV infection should consider individual risk profiles to avoid both under- and over-treatment - which will remain important also in upcoming era of interferon-free treatment of hepatitis C.
Purpose: Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs. Methods: Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting. Results: Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (,5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (,1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early ...
CD209, a c-type lectin expressed by dendritic cells (DCs) acts as a pathogen recognition receptor. A single nucleotide polymorphism (SNP) in the promoter region of CD209 (-336 A/G; rs4804803) affects transcription and is associated with the severity of Tuberculosis and Dengue fever. As CD209 binds Hepatitis C Virus (HCV) glycoprotein-E2, we investigated this SNP in the context of chronic HCV infection. 131 Irish women who had received HCV contaminated Anti-D immunoglobulin and 79 healthy controls were genotyped. We found no association between rs4804803 and the risk of HCV chronicity. However, of those with chronic infection, possession of at least one g-allele was associated with more advanced liver disease, with significantly higher liver fibrosis scores and levels of alanine transaminase (ALT) observed. We conclude that rs4804803, a SNP in the CD209 promoter contributes to the severity of liver disease in chronic HCV infection ...
Weiland O, Danielsson A, Loof L. Infektionskliniken, Huddinge sjukhus.. The article consists in a brief review of pre-treatment evaluation and antiviral treatment of chronic Hepatitis C (HCV) infection. Patients with viraemia (i.e. HCV RNA seropositive with the PCR technique) should be evaluated historically if they lack contraindications for interferon alpha (IFN-alpha) treatment. Patients with depression, autoimmune and thyroid disorders, decompensated cirrhosis, or solid organ transplants, are ineligible for-IFN-alpha treatment. If the histological evaluation shows moderate to severe chronic hepatitis, and the HCV RNA level is , 3 million Eq/mL serum as measured by bDNA, naive (i.e. formerly untreated) patients should be given an initial 12-week course of IFN-alpha to evaluate treatment response. Those who become HCV-negative should continue the treatment for 48 weeks to increase the likelihood of sustained virological response after treatment cessation. Treatment should be discontinued in ...
Razavi, H., ElKhoury, A. C., Elbasha, E., Estes, C., Pasini, K., Poynard, T. and Kumar, R. (2013), Chronic hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology, 57: 2164-2170. doi: 10.1002/hep.26218 ...
The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia. Professor Lai Wei, the principal investigator of Sovaldis Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, "The approval of sofosbuvir in China provides ...
Background: Regulatory T cells (Tregs) have been involved in impaired immunity and may have a pivotal role in persistence of viral infections. Objective: To develop a simple and reliable in-house three color flow cytometery of peripheral blood to understand the role of HCV infection in the increase of Tregs. Methods: The level of naturally occurring CD4+CD25+FoxP3+ regulatory T cells (nTregs) in 20 chronically infected with hepatitis C virus (HCV) patients was compared to those of 15 healthy individuals by flowcytometry. In a different approach we performed permeabilization and intracellular staining before surface staining which allows the preservation of the surface molecules in the combined detection process and results in the normal frequency of nTregs in blood. Results: Using the optimized method, it was shown that a significantly higher proportion of nTregs in the total CD4+ T cell population was seen in the peripheral blood of chronic HCV patients (0.83 ± 0.21%, p=0.05) as compared to controls
Guidelines for the screening, care and treatment of persons with chronic hepatitis C infectionMedEducation - Your Gate for Public Health , Epidemiology and Infection Control
BACKGROUND: It remains unclear how we can shorten the treatment duration of antiviral combination therapy with peginterferon and ribavirin for patients with chronic hepatitis C virus (HCV) genotype 2 infection who achieved a rapid virological respons
ClinicalTrials.gov summary of Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)
Bruce R. Bacon, M.D., professor of internal medicine at Saint Louis University School of Medicine and co-principal investigator of the HCV RESPOND-2 study, studied the protease inhibitor, boceprevir, and found that it significantly increased the number of patients whose blood had undetectable levels of the virus.. "These findings are especially significant for patients who dont respond to initial treatment," said Bacon. "When the hepatitis C virus is not eliminated, debilitating fatigue and more serious problems can follow.". Hepatitis C is caused by a virus that is transmitted by contact with blood. The infection may initially be asymptomatic, but for patients who develop chronic hepatitis C infection, inflammation of the liver may develop, leading to fibrosis and cirrhosis (scarring of the liver), as well as other complications including liver cancer and death.. The prognosis varies for patients with chronic hepatitis C. With the current standard therapy, about half fully recover after an ...
Remarkable progress has been made in the fight against hepatitis C infection, and Merck is enormously proud of the role we have had in that fight over the past 30 years," Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories said in the release. "We will continue to study Zepatier to understand even more about its role in treating chronic hepatitis C infection and will continue to work with others to help bring Zepatier to appropriate patients with chronic hepatitis C genotype 1 or 4 infection, the genotypes which make up the majority of patients with chronic hepatitis C infection ...
All-oral, direct-acting antivirals have significantly improved the efficacy and safety of chronic hepatitis C treatment but their effectiveness and safety among patients with chronic kidney disease remains poorly understood.. Open Article!. ...
Conclusion Early diagnosis of asymptomatic chronic hepatitis C is essential to prevent or delay end stage chronic parenchymal liver disease. 1H MRS may be a potential noninvasive helpful diagnostic tool in the assessment of staging and fibrosis of asymptomatic chronic hepatitis C. The increase in metabolites were correlated with histopathological changes. DW-MRI can be considered as an effective p...
Abstract. Objectives: To determine whether the soluble programmed cell death ligand 1 (sPD-L1) levels in patients with chronic hepatitis C (CHC) are associated with the clinical features of the disease and the efficacy of treatment, including interferon (IFN)-α.. Methods: We investigated the sPD-L1 levels in the sera of 80 genotype 1b Japanese patients with CHC who underwent 12 weeks of telaprevir (TVR)- or simeprevir (SMV)-based triple therapy followed by 12 weeks of dual therapy with pegylated IFN-α plus ribavirin. Serum was also obtained from 22 patients with chronic hepatitis B (CHB) and from 10 healthy donors (HC). The sPD-L1 levels were measured using an ELISA kit. In addition, we examined the PD-L1 expression on the cell surface of immortalized hepatocytes (HPT1) after incubation with cytokines, including IFN-γ.. Results: The pretreatment serum sPD-L1 levels were significantly increased in patients with CHC (median 109.3 pg/ml, range 23.1-402.3) compared with patients with CHB (69.2 ...
Treatment of chronic hepatitis C. Davis, Gary L // BMJ: British Medical Journal (International Edition);11/17/2001, Vol. 323 Issue 7322, p1141 Editorial. Focuses on treatment of chronic infection with hepatitis C virus. Reduction in the number of new hepatitis C infections as a result of improved blood screening and changes in injected drug use; Risk of death from chronic infections which lead to chronic liver disease; Initial... ...
This course explains the indications, risks, and histologic assessment for liver biopsy in persons with chronic hepatitis C infection. Also discussed will be non-invasive tests of liver fibrosis and the potential clinical utility of these tests. ...
Diagnostic tests for hepatitis C virus (HCV) can be divided into two broad categories:Serologic assays that detect antibodies to hepatitis CMolecular assays that detect or quantify HCV RNAOther investigations such as genotype testing, serum fibrosis
CD4+ T lymphocyte responses are thought to play a major role in control of the hepatitis C virus (HCV). Few, however, have been mapped down to the level of peptide and HLA restriction. Furthermore, the ability of such T cells to respond to viruses which differ in genotype has not been addressed in detail. In most cases of persistent infection with HCV, CD4 proliferative responses are weak or absent. From a large cohort of persistently infected patients, we identified an individual with unusually robust and persistent responses in the face of chronic infection. We firstly mapped two peptide epitopes to regions of the nonstructural protein NS4 (aa1686-1705 and aa 1746-1765). However, in contrast to the genotype 1a derived antigens used for mapping, the infecting virus was identified as genotype 3a. Strikingly, the patients CD4 response to these epitopes were specific only for the genotype 1a sequence, and did not recognize genotype 3a synthetic peptides. Serologic assays indicated that prior ...
1353 patients were included into the GECCO cohort until December 2015 and 1287 had complete datasets for this analysis: 337 (26.2%) fulfilled the criteria for an 8-week treatment as per package insert, but only 193 (57.2%) were eventually treated for 8 weeks. An additional 52 patients who did not fulfill the criteria for SL8 but were treated for 8 weeks. SL8 was generally well tolerated. The overall sustained virologic response rates 12 weeks after the end of treatment (SVR12) was 93.5% (186/199). The on-treatment response rate was 99.4% (159/160) in HCV-monoinfected patients and 96.4% (27/28) in HIV-HCV coinfected patients. Ten patients were lost-to-follow-up.. CONCLUSION ...
Merck presented the final results of its investigational chronic hepatitis C therapy clinical trial concerning grazoprevir and elbasvir combinations at the International Liver Congress 2015 in Vienna, Austria, last week.
U.S. Food and Drug Administration (FDA) has approved VoseviTM (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis ...