Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015

Dateline City: KENILWORTH, N.J. Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During First Half of 2015 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1879Justin Holko, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Source: Merck.com - Corporate News - Category: Pharmaceuticals Tags: Hepatitis C Newsroom Corporate News Latest News Source Type: news

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Abstract Hepatitis C virus (HCV) infection is a silent killer that leads to rapid progression of liver cirrhosis and hepatocellular carcinoma (HCC). High prevalence of HCV infection has been reported in Taiwan, especially in high-risk populations including people who inject drugs (PWID) and patients requiring dialysis. Besides, certain populations merit special considerations due to suboptimal outcome, potential drug-drug interaction, or possible side effect. Therefore, in the second part of this 2-part consensus, the Taiwan Association for the Study of the Liver (TASL) proposes the treatment recommendations for t...
Source: J Formos Med Assoc - Category: General Medicine Authors: Tags: J Formos Med Assoc Source Type: research
ConclusionElbasvir/grazoprevir was highly effective in individuals with HCV genotype 1b infection in a large national Veterans Affairs clinical setting.
Source: Infectious Diseases and Therapy - Category: Infectious Diseases Source Type: research
ConclusionOur study showed excellent efficacy with the safety profile of this drug combination in end-stage renal disease patients. However, larger prospective studies and multicenter randomized controlled trials are needed for further confirmation.
Source: Journal of Clinical and Experimental Hepatology - Category: Gastroenterology Source Type: research
ConclusionOur study showed excellent efficacy with the safety profile of this drug combination in End Stage Renal Disease patients. However, larger prospective studies and multicenter randomized controlled trials are needed for further confirmation.
Source: Journal of Clinical and Experimental Hepatology - Category: Gastroenterology Source Type: research
Hepatitis C virus (HCV) infection is a global health challenge with an estimated 71 million individuals infected worldwide.[1] The disease burden of HCV infection is due to progression of chronic liver disease, which can lead to cirrhosis, liver failure, hepatocellular carcinoma, and death. Chronic HCV infection is also independently associated with the development of renal impairment referred to as chronic kidney disease (CKD) and has been shown to be more prevalent in patients with renal disease.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Source Type: research
Hepatitis C virus (HCV) infection is a global health challenge with an estimated 71 million individuals infected worldwide.1 The disease burden of HCV infection is due to progression of chronic liver disease, which can lead to cirrhosis, liver failure, hepatocellular carcinoma, and death. Chronic HCV infection is also independently associated with the development of renal impairment referred to as chronic kidney disease (CKD) and has been shown to be more prevalent in patients with renal disease.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Tags: Research Article Source Type: research
Conclusions: While there is a certain overlap between the results of the current study and published transcriptomic profiles of non-transplanted livers with steatosis, we have identified discrete characteristics of the non-alcoholic fatty liver disease in liver grafts potentially utilizable for the establishment of predictive signature. Introduction Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in industrialized countries, its prevalence being estimated at 19–31.3% (1). It encompasses a range of conditions that are thought to arise from fatty liver (simple steatosis) throu...
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
Authors: Borgia G, Scotto R, Buonomo AR Abstract INTRODUCTION: Pangenotypic drugs against HCV infections led to high rates of virologic response with very limited adverse events. Moreover, they are easy to administer among all HCV genotypes with minimal changes in treatment schedule. For this reason, the demand for new antivirals is greatly lowered. Areas covered. We discuss results from trials assessing safety and efficacy of Ravidasvir, which is the only direct-acting antiviral currently in clinical development. Expert opinion. The currently available pangenotypic drug combinations are very effective in HCV eradi...
Source: Expert Opinion on Investigational Drugs - Category: Drugs & Pharmacology Tags: Expert Opin Investig Drugs Source Type: research
Kidney transplantation is the best treatment for patients with end-stage renal disease (ESRD) because of a significant survival benefit conferred compared to patients who remain on haemodialysis.1 Although the prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection in patients with ESRD has significantly declined over time, it remains at least 4-times higher than in the general population.2,3 Chronic HCV or HBV infection can result in chronic liver disease, cirrhosis, and hepatocellular carcinoma4 –6 and increase the risk of chronic kidney disease (CKD).
Source: Journal of Hepatology - Category: Gastroenterology Authors: Tags: Research Article Source Type: research
CONCLUSIONS: Pangenotypic DAAs result in very high rates of sustained virologic responses and are well tolerated. However, they are contraindicated in patients with decompensated cirrhosis or advanced chronic kidney disease who failed previous DDA-based treatment. Further research is required to customize treatment, to "unpackage" current DAA combinations and to develop generic drugs against HCV. PMID: 30848211 [PubMed - as supplied by publisher]
Source: Reviews on Recent Clinical Trials - Category: Cancer & Oncology Authors: Tags: Rev Recent Clin Trials Source Type: research
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