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. Food and Drug Administration (FDA) for the treatment of patients with chronic HCV genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis. 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: Corporate News Latest News Source Type: news

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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
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
Conclusion The PROD regimen was very effective and safe for treatment in patients with HCV and CKD who were in stages 4 and 5.
Source: European Journal of Gastroenterology and Hepatology - Category: Gastroenterology Tags: Original Articles: Hepatology Source Type: research
CONCLUSION: We observed that the treatment with 3D regimen in hemodialysis patients infected with genotype 1 hepatitis C is highly effective and well tolerated. PMID: 30666967 [PubMed - as supplied by publisher]
Source: The Turkish Journal of Gastroenterology - Category: Gastroenterology Authors: Tags: Turk J Gastroenterol Source Type: research
AbstractChronic hepatitis C virus (HCV) infection is common among patients with chronic kidney disease (CKD) and those on hemodialysis due to nosocomial infections and past blood transfusions. While a majority of HCV-infected patients with end-stage renal disease are asymptomatic, some may ultimately experience decompensated liver diseases and hepatocellular carcinoma. Administration of a combination of elbasvir/grazoprevir for 12  weeks leads to high sustained virologic response (SVR) rates in patients with HCV genotypes (GTs) 1a, 1b or 4 and stage 4 or 5 CKD. Furthermore, a combination of glecaprevir/pibrentasvir fo...
Source: Hepatology International - Category: Infectious Diseases Source Type: research
This study assesses elbasvir (EBR) plus grazoprevir (GZR) for patients with HCV genotype 1 infection in the clinical setting, focusing on CKD stage 3-5D. This multicenter, real-world cohort study consisted of 282 Japanese patients who were treated with EBR (50 mg) plus GZR (100 mg) for a fixed 12-week duration. We evaluated the sustained viral response rate 12 weeks after the end of treatment (SVR12), longitudinal liver and renal parameters, and adverse effects according to the cirrhosis and CKD status. Of those enrolled, 89 (31.6%) were CKD stage 3–5 and 21 (7.4%) were CKD stage 5D (hemodialysis-dependent). The ...
Source: Antiviral Therapy - Category: Virology Source Type: research
This study assesses elbasvir (EBR) plus grazoprevir (GZR) for patients with HCV genotype 1 infection in the clinical setting, focusing on CKD stage 3-5D. This multicenter, real-world cohort study consisted of 282 Japanese patients who were treated with EBR (50 mg) plus GZR (100 mg) for a fixed 12-week duration. We evaluated the sustained viral response rate 12 weeks after the end of treatment (SVR12), longitudinal liver and renal parameters, and adverse effects according to the cirrhosis and CKD status. Of those enrolled, 89 (31.6%) were CKD stage 3-5 and 21 (7.4%) were CKD stage 5D (hemodialysis-dependent). The overal...
Source: Antiviral Research - Category: Virology Authors: Tags: Antiviral Res Source Type: research
Abstract Limited data has shown high efficacy of co‐formulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in the treatment of hepatitis C virus (HCV) genotype (GT)‐4, and combined with dasabuvir (DSV) in GT1 patients, with chronic kidney disease (CKD) stage 4‐5 (
Source: Liver International - Category: Gastroenterology Authors: Tags: Original Article Source Type: research
CONCLUSION: Elbasvir-grazoprevir achieves a high cure rate in the treatment of patients with chronic HCV with a once-daily oral regimen and without serious adverse effects; however, it requires close monitoring of liver function values. It is an effective option for patients with HCV genotype 1a, 1b, or 4 with or without compensated cirrhosis and is a particularly attractive option in patients with chronic kidney disease receiving hemodialysis and in patients with HIV coinfection. PMID: 28947524 [PubMed - in process]
Source: American Journal of Health-System Pharmacy : AJHP - Category: Drugs & Pharmacology Authors: Tags: Am J Health Syst Pharm Source Type: research
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