View clinical trials related to Hepatitis C.
Filter by:This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.
The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.
Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care (1-5). PR therapy offered limited performance and availability across the diverse spectrum of HCV disease and was fraught with excessive and often limiting side effects. The first direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could only be used only in combination with PR because of concerns for rapid PI viral resistance. Although the first generation PIs added increased efficacy to the PR regimen, they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes, disease stages, and special patient groups such as those co-infected with HIV. When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients yet can be given in a personalized regimen to maximize performance
The present study evaluates neurocognitive performance as well as measures of mood, quality of life, and fatigue in patients with chronic hepatitis C infection. In a prospective longitudinal study design, included patients are monitored before, during, and in the long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/- Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post therapy results of sustained virologic responders to corresponding pretreatment values as well as to historic interferon-treatment patients without virological response. It is expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at least in part - reversible by the successful application of modern IFN-free antiviral medication.
This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir. It will also measure the effectiveness of using a social network-based approach to reduce HCV incidence among PWID.
Acute or chronic HCV infection can lead to liver complications, including liver failure, cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical question remains the terms of treatment initiation. In Europe, new treatments are available since the approval of three direct acting antivirals. However with the high cost of these treatments, they are currently only available for critically ill patients. Other molecules are currently in advanced clinical development phases. The use of clinical predictors remains relevant for the selection of a suitable treatment for each patient, in particular to limit the adverse effects and reduce costs. Currently the quantification of viral load is a measure of response to treatment; with the recommendation to stop treatment in patients who fail to achieve an undetectable level of viral load. Genetic factors have also been identified as predictors of response to treatment, in particular polymorphisms of the IL-28B gene. Genotyping of this gene is currently performed using classical PCR amplification applied to DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to test a non-invasive method and rapid test for IL-28B genotype which could be used for point of caring testing, and ultimately better patient management. This is a monocenter, cross-sectional study among HCV chronic patients. The study will be conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris, France). Objectives The principal objective is to assess the accuracy of the newly developed Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as gold standard. The secondary objective is to assess the concordance between the genotype results of the Genedrive and the gold standard regarding the three genotypes CC, CT and TT.
Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.
This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014. The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection.
A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic subjects with chronic hepatitis C.
Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining adequate doses of both drugs throughout the treatment period, the emergence of hematological side effects is expected and requires intervention. The hematological adverse effects lead to a trade-off between continuing the treatment with optimal dosage, to clear the virus, exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia, reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus ribavirin in HCV patients will lead to better health outcomes and improvement in their quality of life (HRQOL).