(Press-News.org) April 24, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that a 12-week oral regimen of once-daily single tablet grazoprevir/elbasvir (GZR/EBR) is effective and well-tolerated in treatment-naive (TN) patients infected with chronic hepatitis C virus (HCV) genotypes (GT)-1, -4 or -6, including those with compensated cirrhosis.
Based on preliminary results from 316 GZR/EBR recipients in the immediate treatment arm, 299 patients (95%) achieved a sustained virologic response at 12 weeks (SVR12).
"These initial results show that once-daily grazoprevir/elbasvir offers significant advantages over older treatments, demonstrating the ideal combination of high efficacy with good tolerability and convenience in treatment-naive patients infected with chronic HCV," said Rajender Reddy, MD, FAASLD Professor of Medicine, Professor of Medicine in Surgery, Director of Hepatology, Medical Director of Liver Transplantation, University of Pennsylvania, USA.
Serious adverse events (AEs) occurred in 9 (3%) and 3 (3%) patients in the active (immediate treatment) and placebo (deferred treatment) arms, respectively.
"Newer antiviral regimens such as the combination of grazoprevir/elbasvir offer much hope to people living with hepatitis C. They have shown great efficacy and tolerability for the treatment of this chronic infection," said Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver.
C-EDGE TN is an international, randomised, blinded, placebo-controlled, parallel-group trial of an oral fixed-dosed combination of GZR 100 mg/EBR 50 mg once-daily in TN patients infected with HCV GT-1, -4 or -6, including cirrhotic and non-cirrhotic patients.
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About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.
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Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
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THE PHASE 3 C-EDGE TREATMENT-NAÏVE (TN) STUDY OF A 12-WEEK ORAL REGIMEN OF GRAZOPREVIR (GZR, MK-5172)/ELBASVIR (EBR, MK-8742) IN PATIENTS WITH CHRONIC HCV GENOTYPE (GT) 1, 4, OR 6 INFECTION
Stefan Zeuzem* 1, Reem Ghalib2, K. R. Reddy3, Paul J. Pockros4, Ziv B. Ari5, Yue Zhao6, Deborah Brown7, Mark DiNubile6, Michael Robertson6, Janice Wahl7, Eliav Barr6, Joan Butterton6
1Goethe University Hospital, Frankfurt, Germany, 2Texas Clinical Research Institute, Dallas, 3University of Pennsylvania, Philadelphia, 4Scripps Translational Science Institute, La Jolla, United States, 5Sheba Medical Center, Ramat Gan, Israel, 6Merck, 7Meck, Whitehouse Station, United States
Background and Aims: Safe, efficacious, and convenient antiviral regimens without interferon or ribavirin are being developed for chronic HCV infection. The C-EDGE TN study (P060) investigated the safety and efficacy of a once daily regimen of GZR (NS3/4A protease inhibitor) and EBR (NS5A inhibitor) for 12 weeks (wks) in TN patients (pts) with GT 1, 4, or 6 infection.
Methods: C-EDGE TN is an international, randomized, blinded, placebo-controlled, parallel-group trial of an oral fixed-dosed combination of GZR 100 mg/EBR 50 mg once daily in TN, HCV GT 1-, 4-, or 6-infected pts. Cirrhotic patients were eligible. Exclusion criteria included decompensated liver disease, HCC, HIV or HBV co-infection, platelets END
April 24, 2015, Vienna, Austria: A new study presented today at The International Liver Congress™ 2015 has demonstrated that ledipasvir (LDV) in combination with sofosbuvir (SOF) achieves sustained virologic response rates 12 weeks after treatment (SVR12; primary endpoint), of 93% and 95% in patients chronically infected with hepatitis C virus (HCV) genotypes 4 or 5, respectively.
In the study, LDV/SOF was administered in a once-daily, fixed-dose combination tablet for 12 weeks to treatment-naive and treatment-experienced patients with or without cirrhosis. A total ...
April 24, 2015, Vienna , Austria: Results announced today at The International Liver CongressTM 2015 show that cancer rates in patients with the hepatitis C virus (HCV) were significantly increased compared to the non-HCV cohort. The researchers suggest an extrahepatic manifestation of HCV may be an increased risk of cancer.
The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin's lymphoma, renal and prostate cancers, as well as liver ...
April 24, 2015, Vienna, Austria: Findings were presented today at The International Liver CongressTM 2015 on a novel therapeutic candidate for a genomically defined subset of hepatocellular carcinoma (HCC) patients with an aberrant fibroblast growth factor receptor 4 (FGFR4) pathway. BLU-554, a small molecule inhibitor of FGFR4, has been identified as a potential treatment option for up to 30% of HCC patients. In preclinical studies, the investigational drug was shown to be potent and 'exquisitely selective' for FGFR4 compared to other kinases targeting the FGFR family. ...
April 24, 2015, Vienna, Austria: Results from a large population-based cohort of almost a million people in the UK found that the chances of dying from non-alcoholic steatohepatitis (NASH), over a 14-year period, was approximately 50% higher than for those with non-alcoholic fatty liver disease (NAFLD).
Reported today at The International Liver CongressTM 2015, the large study analysed the overall burden of cardiovascular disease and all-cause mortality across the spectrum of NAFLD. The four stages of NAFLD are steatosis (or simple fatty liver), non-alcoholic steatohepatitis ...
Cincinnati, OH, April 24, 2015 -- Sleep-related deaths are the most common cause of death for infants 1-12 months of age. The American Academy of Pediatrics recommends that infants sleep on their back on a firm mattress, without loose bedding. However, many parents use sitting or carrying devices, such as car seats, swings, or bouncers, as alternative sleeping environments, which could lead to potential injury or death. In a new study scheduled for publication in The Journal of Pediatrics, researchers describe how the improper use of these items can lead to infant deaths.
Erich ...
Turmeric - the familiar yellow spice common in Indian and Asian cooking - may play a therapeutic role in oral cancers associated with human papillomavirus, according to new research published in ecancermedicalscience.
One of the herb's key active ingredients - an antioxidant called curcumin - appears to have a quelling effect on the activity of human papillomavirus (HPV).
HPV is a virus that promotes the development of cervical and oral cancer. There is no cure, but curcumin may offer a means of future control.
"Turmeric has established antiviral and anti-cancer properties," ...
SEATTLE - Today, Americans are more likely to be heavy drinkers and binge drinkers than in recent years due in large part to rising rates of drinking among women, according to a new analysis of county-level drinking patterns in the United States.
By contrast, the percentage of people who drink any alcohol has remained relatively unchanged over time, according to the latest research by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington.
Published in the American Journal of Public Health on April 23, the study "Drinking patterns in ...
SAN FRANCISCO - New ophthalmology research from the University of Miami shows that dry eye - the little understood culprit behind red, watery, gritty feeling eyes - strikes most often in spring, just as airborne allergens are surging. The study marks the first time that researchers have discovered a direct correlation between seasonal allergens and dry eye, with both pollen and dry eye cases reaching a yearly peak in the month of April. The paper was published online today in Ophthalmology, the journal of the American Academy of Ophthalmology.
Dry eye can significantly ...
GAINESVILLE, Fla.-- New genetic data suggest the red lionfish invasion in the Caribbean Basin and Western Atlantic started in multiple locations, not just one as previously believed, according to a new study led by the U.S. Geological Survey.
Florida has often been cited as the likely location of the introduction, but the new research suggests multiple introductions occurred, with some potentially coming from the more southern parts of the range. The Caribbean Basin stretches from parts of Florida's Gulf Coast through South America.
Genetically unraveling the progression ...
GAINESVILLE, Fla.--Many loggerhead sea turtles that nest in Dry Tortugas National Park head to rich feeding sites in the Bahamas after nesting, a discovery that may help those working to protect this threatened species.
Researchers from the U.S. Geological Survey used satellites to track the population of loggerheads that nest in the Dry Tortugas - the smallest subpopulation of loggerheads in the northwest Atlantic - and found the turtles actually spend a considerable portion of their lives in the Bahamas, returning to the Dry Tortugas to nest every two-to-five years. ...
