Patients with HCV may deliberately skip early treatment doses when feeling well
Medication nonadherence during the first 24 weeks of treatment for chronic hepatitis C was often deliberate and attributed to feeling well, as opposed to forgetfulness or other factors, in a recent study.
Researchers evaluated adherence to treatment in a cohort of 401 patients with chronic HCV genotype 1. All participants had been enrolled in the Virahep-C study and received therapy with pegylated interferon (PEG) and ribavirin (RBV) for 24 weeks, with responders receiving an additional 24 weeks (n=242). Adherence was measured using the Medication Event Monitoring System, which recorded when the medication container was opened via a computer chip in the cap.
Full Story »
Monday, March 25, 2013
Better long-term outcomes with low hep C viral load
Better long-term outcomes with low hep C viral load
(HealthDay)—In patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC), low HCV viral load predicts better long-term surgical outcomes, regardless of the serologic eradication of HCV, according to research published in the Feb. 20 issue of the Journal of Clinical Oncology.
Junichi Shindoh, M.D., Ph.D., of the University of Tokyo, and colleagues conducted a study involving 370 patients with HCV-related HCC to determine whether HCV viral load impacts the long-term outcomes of HCC after curative surgical resection.
The researchers found that patients with low viral load had a 23.7 percent higher five-year recurrence-free survival rate than those with a high HCV viral load (36.1 versus 12.4 percent). Low viral load was also associated with an 18.9 percent higher five-year overall survival (76.6 versus 57.7 percent).
Patients with a high viral load were 87 percent more likely to develop tumor recurrence compared with low viral load patients. The favorable results obtained in low viral load patients were not dependent on serologic eradication of HCV.
"In conclusion, a low viral load may predict lower recurrence and better survival in patients undergoing hepatic resection for HCV-related HCC irrespective of the serologic eradication of HCV," the authors write. "Postoperative antiviral therapy with individually adjusted intensity and incorporation of direct antiviral agents may warrant prospective study to characterize safety and impact on recurrence risk in patients undergoing surgical resection for HCV-associated HCC.
" More information: Abstract Full Text (subscription or payment may be required)
Journal reference: Journal of Clinical Oncology
Health News Copyright © 2013 HealthDay. All rights reserved.
Read more at: http://medicalxpress.com/news/2013-03-long-term-outcomes-hep-viral.html#jCp
(HealthDay)—In patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC), low HCV viral load predicts better long-term surgical outcomes, regardless of the serologic eradication of HCV, according to research published in the Feb. 20 issue of the Journal of Clinical Oncology.
Junichi Shindoh, M.D., Ph.D., of the University of Tokyo, and colleagues conducted a study involving 370 patients with HCV-related HCC to determine whether HCV viral load impacts the long-term outcomes of HCC after curative surgical resection.
The researchers found that patients with low viral load had a 23.7 percent higher five-year recurrence-free survival rate than those with a high HCV viral load (36.1 versus 12.4 percent). Low viral load was also associated with an 18.9 percent higher five-year overall survival (76.6 versus 57.7 percent).
Patients with a high viral load were 87 percent more likely to develop tumor recurrence compared with low viral load patients. The favorable results obtained in low viral load patients were not dependent on serologic eradication of HCV.
"In conclusion, a low viral load may predict lower recurrence and better survival in patients undergoing hepatic resection for HCV-related HCC irrespective of the serologic eradication of HCV," the authors write. "Postoperative antiviral therapy with individually adjusted intensity and incorporation of direct antiviral agents may warrant prospective study to characterize safety and impact on recurrence risk in patients undergoing surgical resection for HCV-associated HCC.
" More information: Abstract Full Text (subscription or payment may be required)
Journal reference: Journal of Clinical Oncology
Health News Copyright © 2013 HealthDay. All rights reserved.
Read more at: http://medicalxpress.com/news/2013-03-long-term-outcomes-hep-viral.html#jCp
Thursday, March 21, 2013
Entering the new era of hepatitis C
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Statins tied to lowered liver cancer risk with hepatitis C
Statins tied to lowered liver cancer risk with hepatitis C
By Genevra Pittman
NEW YORK (Reuters Health) - People infected with chronic hepatitis C are less likely to develop liver cancer if they are taking cholesterol-lowering drugs, new research from Taiwan suggests.
The report doesn't prove statins ward off cancer, and one researcher not involved in the study says it's not reason enough to recommend using the popular medications solely for liver cancer prevention.
Previous studies have come to ambiguous and conflicting conclusions on the question of statins' cancer-preventing abilities, researchers noted.
"Observational studies do suggest a significant, modest reduction in the risk of (liver cancer) among patients with chronic liver disease who take statins," said Dr. Hashem El-Serag, a liver disease researcher from the Baylor College of Medicine and Michael E. DeBakey VA Medical Center in Houston.
Those trials, which follow different groups of patients to see who develops cancer over time, can't prove cause-and-effect.
"The downside to the observational studies, including this study, is because they are non-randomized, the decision to give statins to a patient with hepatitis C may or not may depend on factors that have a lot to do with severity of liver disease," El-Serag told Reuters Health.
For their study, Dr. Pau-Chung Chen from the National Taiwan University College of Public Health in Taipei and his colleagues used nationwide data to track about 261,000 people with hepatitis C from 1999 through 2010.
During that span, about 13 percent of them filled a prescription for statins.
A total of 28,000 people were diagnosed with liver cancer by 2011 - or about one percent of those with hepatitis C each year. After the researchers accounted for patients' age, gender and other diseases, they found those who took statins were about half as likely to get cancer as non-statin users.
Higher doses of statins, as well as longer-term use, were linked to a further drop in cancer risk, according to the findings published this week in the Journal of Clinical Oncology.
The researchers said statins may prevent the hepatitis C virus from replicating or slow the growth of malignant cells. But they can't prove the drugs stopped people from getting cancer.
One limitation, they noted, is that they weren't able to measure other health and lifestyle factors that influence people's risk of liver cancer, including their weight and whether they smoked or drank heavily.
Chen said a large study in which people with hepatitis C are assigned to take statins or not, known as a randomized clinical trial, is needed to clarify the drugs' effects in those patients.
In the United States, about 3.2 million people are chronically infected with hepatitis C, which is spread through blood. Having hepatitis C increases a person's chance of liver cancer up to 20-fold, Chen's team wrote.
The National Cancer Institute estimates 30,640 Americans will be diagnosed with liver cancer in 2013 and 21,670 will die of the disease.
The researchers did not find a link between statins and any serious complications.
"We feel more confident that statins do not cause harm in patients with liver disease," Chen told Reuters Health in an email.
Until recently, El-Serag said, many doctors feared prescribing statins to people with liver disease, believing they might cause liver-related complications. He agreed that the new study should allay those concerns.
"Do not avoid statins because of underlying liver disease, because you may help the statin-related indication, such as cholesterol and heart disease, but you may still get additional benefit for reducing the risk of liver cancer," he advised.
Still, El-Serag said, "I would stop shy of recommending it just to (prevent) liver cancer."
SOURCE: http://bit.ly/Ze6jf8 Journal of Clinical Oncology, online March 18, 2013.
By Genevra Pittman
NEW YORK (Reuters Health) - People infected with chronic hepatitis C are less likely to develop liver cancer if they are taking cholesterol-lowering drugs, new research from Taiwan suggests.
The report doesn't prove statins ward off cancer, and one researcher not involved in the study says it's not reason enough to recommend using the popular medications solely for liver cancer prevention.
Previous studies have come to ambiguous and conflicting conclusions on the question of statins' cancer-preventing abilities, researchers noted.
"Observational studies do suggest a significant, modest reduction in the risk of (liver cancer) among patients with chronic liver disease who take statins," said Dr. Hashem El-Serag, a liver disease researcher from the Baylor College of Medicine and Michael E. DeBakey VA Medical Center in Houston.
Those trials, which follow different groups of patients to see who develops cancer over time, can't prove cause-and-effect.
"The downside to the observational studies, including this study, is because they are non-randomized, the decision to give statins to a patient with hepatitis C may or not may depend on factors that have a lot to do with severity of liver disease," El-Serag told Reuters Health.
For their study, Dr. Pau-Chung Chen from the National Taiwan University College of Public Health in Taipei and his colleagues used nationwide data to track about 261,000 people with hepatitis C from 1999 through 2010.
During that span, about 13 percent of them filled a prescription for statins.
A total of 28,000 people were diagnosed with liver cancer by 2011 - or about one percent of those with hepatitis C each year. After the researchers accounted for patients' age, gender and other diseases, they found those who took statins were about half as likely to get cancer as non-statin users.
Higher doses of statins, as well as longer-term use, were linked to a further drop in cancer risk, according to the findings published this week in the Journal of Clinical Oncology.
The researchers said statins may prevent the hepatitis C virus from replicating or slow the growth of malignant cells. But they can't prove the drugs stopped people from getting cancer.
One limitation, they noted, is that they weren't able to measure other health and lifestyle factors that influence people's risk of liver cancer, including their weight and whether they smoked or drank heavily.
Chen said a large study in which people with hepatitis C are assigned to take statins or not, known as a randomized clinical trial, is needed to clarify the drugs' effects in those patients.
In the United States, about 3.2 million people are chronically infected with hepatitis C, which is spread through blood. Having hepatitis C increases a person's chance of liver cancer up to 20-fold, Chen's team wrote.
The National Cancer Institute estimates 30,640 Americans will be diagnosed with liver cancer in 2013 and 21,670 will die of the disease.
The researchers did not find a link between statins and any serious complications.
"We feel more confident that statins do not cause harm in patients with liver disease," Chen told Reuters Health in an email.
Until recently, El-Serag said, many doctors feared prescribing statins to people with liver disease, believing they might cause liver-related complications. He agreed that the new study should allay those concerns.
"Do not avoid statins because of underlying liver disease, because you may help the statin-related indication, such as cholesterol and heart disease, but you may still get additional benefit for reducing the risk of liver cancer," he advised.
Still, El-Serag said, "I would stop shy of recommending it just to (prevent) liver cancer."
SOURCE: http://bit.ly/Ze6jf8 Journal of Clinical Oncology, online March 18, 2013.
Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial
March 21, 2013, 7:00 p.m. EDT
Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial
SYDNEY and DURHAM, N.C., March 21, 2013 /PRNewswire via COMTEX/ -- RNAi-based therapeutics company Benitec Biopharma Limited (asx code:BLT) today announced the selection of the Duke Clinical Research Unit, the early phase unit of the Duke Clinical Research Institute (DCRI), Durham, North Carolina, USA as a site for its upcoming phase I/II first-in-man trial for TT-034 in Hepatitis C. TT-034 is being developed as a potential "one-shot-cure" for Hepatitis C (HCV).
"We are very excited to be working with Duke, a world renowned research institution with significant experience in this area," said Peter French, Ph.D., Chief Executive Officer of Benitec. "The TT-034 trial marks the transition of Benitec to a clinical stage company. We expect that positive results from the trial will provide a value inflection point for the company, and also be a validation for our ddRNAi technology as an effective platform for therapeutics."
The phase I/II clinical trial is an open-label dose escalation study to evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts. Additional consolidation cohorts may be added during the study to confirm the results of the trial. The primary safety endpoints are dose limiting adverse events. The primary activity end points are serum viral load reduction and degree of hepatocyte transduction (measured through liver biopsies). There is a pre-specified interim read on safety and activity within months of trial commencement. The clinical trial is expected to begin enrolling patients during the second half of 2013.
Duke's principal investigator for the study will be Keyur Patel, M.D. Dr Patel has previous experience with oligonucleotide therapeutics in HCV, is a recipient of the prestigious American Association for the Study of Liver Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and has over 100 citations in peer-reviewed publications.
"TT-034 is a potentially transformative new treatment," Dr. Patel commented. "A therapeutic that could cure an HCV patient with a single injection would obviously be a big step forward compared to even the best treatments that are currently on the horizon, as they all involve comparatively lengthy regimens with a combination of several drugs."
About TT-034
TT-034 is a potentially transformative therapeutic that is intended to provide a "one-shot-cure" for Hepatitis C with a single injection. TT-034 works through RNA interference (RNAi), which is a naturally occurring regulatory process in cells that acts to "silence" genes after they have been transcribed from DNA into messenger RNA. Benitec's proprietary ddRNAi approach involves the introduction of a DNA vector that produces short hairpin RNAs (shRNAs) that are processed by the cell into siRNAs. This approach emulates the cell's own gene silencing mechanism and provides long term activity (months). Moreover, the virus vector used to deliver the TT-034 construct, an engineered non-replicating adeno-associated virus (AAV8), targets almost exclusively liver cells (where HCV replicates). TT-034 is further designed to prevent viral escape through mutations (a major problem for most HCV drugs) by using three different shRNAs to simultaneously target three separate highly conserved regions in the HCV genome. In mice and monkeys, TT0-034 has been shown to transduce 100% of hepatocytes in the liver and provide high shRNA activity for 180 days (the duration of the studies), without adverse effects.
About the Duke Clinical Research Unit:
The Duke Clinical Research Unit (DCRU) is a state-of-the-art research facility located within the Duke Medicine campus that provides infrastructure support to sponsors and investigators who are testing new drug candidates and other cutting-edge therapies, or seeking to identify and validate novel biomarkers. The DCRU has more than 20 years of early-phase clinical trial experience and has successfully conducted more than 150 early-phase studies, including 80 phase 1 studies. The experience, support systems and infrastructure of the DCRU enable provision of the highest level of program management and services for early-phase clinical trials, including quality processes, accurate reporting, and regulatory expertise. The DCRU combines the clinical expertise and scientific leadership of one of the most prestigious academic medical centres in the world with the operational capabilities of a full-service contract research organization. The DCRU is part of the Duke Clinical Research Institute. The DCRI is a comprehensive academic research organization and the only one of its kind that can offer all the services of a commercial contract research organization with the academic credibility and expertise of an academic medical center.
About Benitec Biopharma Limited:
Benitec Biopharma Limited (asx code:BLT), based in Sydney, Australia, has a pipeline of in-house and partnered therapeutic programs based on its patented gene-silencing technology, ddRNAi. Benitec is developing treatments for chronic and life-threatening human conditions. Its most advanced program is TT-034 for the treatment of chronic HCV infection. Benitec has licensed ddRNAi technology to other biopharmaceutical companies who are advancing their programs toward the clinic for applications including HIV/AIDS, retinitis pigmentosa and Huntington's disease. For more information on Benitec refer to the Company's website at www.benitec.com.
For more information please contact:
For Duke Clinical Research Unit:Barry Mangum, PharmD | Director Clinical Pharmacology Phone: 919 210 8099 | Barry.Mangum@duke.edu | www.dcru.org
For Benitec:Dr Peter French | Chief Executive Officer Phone: +61 (02) 9555 6986 | pfrench@benitec.com | www.benitec.com
SOURCE Benitec Biopharma Limited
Copyright (C) 2013 PR Newswire. All rights reserved
Benitec Selects the Duke Clinical Research Unit as a Site for Hepatitis C Phase I/II Clinical Trial
SYDNEY and DURHAM, N.C., March 21, 2013 /PRNewswire via COMTEX/ -- RNAi-based therapeutics company Benitec Biopharma Limited (asx code:BLT) today announced the selection of the Duke Clinical Research Unit, the early phase unit of the Duke Clinical Research Institute (DCRI), Durham, North Carolina, USA as a site for its upcoming phase I/II first-in-man trial for TT-034 in Hepatitis C. TT-034 is being developed as a potential "one-shot-cure" for Hepatitis C (HCV).
"We are very excited to be working with Duke, a world renowned research institution with significant experience in this area," said Peter French, Ph.D., Chief Executive Officer of Benitec. "The TT-034 trial marks the transition of Benitec to a clinical stage company. We expect that positive results from the trial will provide a value inflection point for the company, and also be a validation for our ddRNAi technology as an effective platform for therapeutics."
The phase I/II clinical trial is an open-label dose escalation study to evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts. Additional consolidation cohorts may be added during the study to confirm the results of the trial. The primary safety endpoints are dose limiting adverse events. The primary activity end points are serum viral load reduction and degree of hepatocyte transduction (measured through liver biopsies). There is a pre-specified interim read on safety and activity within months of trial commencement. The clinical trial is expected to begin enrolling patients during the second half of 2013.
Duke's principal investigator for the study will be Keyur Patel, M.D. Dr Patel has previous experience with oligonucleotide therapeutics in HCV, is a recipient of the prestigious American Association for the Study of Liver Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and has over 100 citations in peer-reviewed publications.
"TT-034 is a potentially transformative new treatment," Dr. Patel commented. "A therapeutic that could cure an HCV patient with a single injection would obviously be a big step forward compared to even the best treatments that are currently on the horizon, as they all involve comparatively lengthy regimens with a combination of several drugs."
About TT-034
TT-034 is a potentially transformative therapeutic that is intended to provide a "one-shot-cure" for Hepatitis C with a single injection. TT-034 works through RNA interference (RNAi), which is a naturally occurring regulatory process in cells that acts to "silence" genes after they have been transcribed from DNA into messenger RNA. Benitec's proprietary ddRNAi approach involves the introduction of a DNA vector that produces short hairpin RNAs (shRNAs) that are processed by the cell into siRNAs. This approach emulates the cell's own gene silencing mechanism and provides long term activity (months). Moreover, the virus vector used to deliver the TT-034 construct, an engineered non-replicating adeno-associated virus (AAV8), targets almost exclusively liver cells (where HCV replicates). TT-034 is further designed to prevent viral escape through mutations (a major problem for most HCV drugs) by using three different shRNAs to simultaneously target three separate highly conserved regions in the HCV genome. In mice and monkeys, TT0-034 has been shown to transduce 100% of hepatocytes in the liver and provide high shRNA activity for 180 days (the duration of the studies), without adverse effects.
About the Duke Clinical Research Unit:
The Duke Clinical Research Unit (DCRU) is a state-of-the-art research facility located within the Duke Medicine campus that provides infrastructure support to sponsors and investigators who are testing new drug candidates and other cutting-edge therapies, or seeking to identify and validate novel biomarkers. The DCRU has more than 20 years of early-phase clinical trial experience and has successfully conducted more than 150 early-phase studies, including 80 phase 1 studies. The experience, support systems and infrastructure of the DCRU enable provision of the highest level of program management and services for early-phase clinical trials, including quality processes, accurate reporting, and regulatory expertise. The DCRU combines the clinical expertise and scientific leadership of one of the most prestigious academic medical centres in the world with the operational capabilities of a full-service contract research organization. The DCRU is part of the Duke Clinical Research Institute. The DCRI is a comprehensive academic research organization and the only one of its kind that can offer all the services of a commercial contract research organization with the academic credibility and expertise of an academic medical center.
About Benitec Biopharma Limited:
Benitec Biopharma Limited (asx code:BLT), based in Sydney, Australia, has a pipeline of in-house and partnered therapeutic programs based on its patented gene-silencing technology, ddRNAi. Benitec is developing treatments for chronic and life-threatening human conditions. Its most advanced program is TT-034 for the treatment of chronic HCV infection. Benitec has licensed ddRNAi technology to other biopharmaceutical companies who are advancing their programs toward the clinic for applications including HIV/AIDS, retinitis pigmentosa and Huntington's disease. For more information on Benitec refer to the Company's website at www.benitec.com.
For more information please contact:
For Duke Clinical Research Unit:Barry Mangum, PharmD | Director Clinical Pharmacology Phone: 919 210 8099 | Barry.Mangum@duke.edu | www.dcru.org
For Benitec:Dr Peter French | Chief Executive Officer Phone: +61 (02) 9555 6986 | pfrench@benitec.com | www.benitec.com
SOURCE Benitec Biopharma Limited
Copyright (C) 2013 PR Newswire. All rights reserved
Gilead And Its Competitors In The Hepatitis C Race
Investment Commentary
Gilead And Its Competitors In The Hepatitis C Race
Peter Geschek @ Seeking Alpha
Read more @ Seeking Alpha
Gilead And Its Competitors In The Hepatitis C Race
Peter Geschek @ Seeking Alpha
The major challenge to development of an all-oral, interferon-free treatment for hep C is drug resistance.
Hep C circulates as a mixture of viruses with various sequences. It has been estimated that pre-existing drug resistance variants with one, two, three and even four mutations may be present in most hep C-infected patients and account for the rapid development of drug resistance on exposure to direct-acting antiviral drugs ((DAAs)).
For a successful interferon-free treatment maybe necessary to use several DAAs concurrently, and each of these should have potent antiviral activity, possess nonoverlapping resistance profiles, and have limited or manageable drug interactions and minimal adverse effects.
It means that there may be room in the market for a range of combos, which would explain the presence of so many combo studies going on at the same time.
Monday, March 18, 2013
Mortality risk greater among patients with HCV who drank alcohol moderately, heavily
Mortality risk greater among patients with HCV who drank alcohol moderately, heavily
Younossi ZM. Aliment Pharmacol Ther. 2013;37:703-709.
March 18, 2013
Patients with chronic hepatitis C who drank a moderate amount of alcohol or more were at greater risk for death than controls and patients with HCV who did not drink in a recent study.
Researchers evaluated data on the average daily alcohol consumption of 8,985 adult participants collected from the Third National Health and Nutrition Examination Survey (NHANES III), along with the NHANES III Linked Mortality File. The cohort included 218 patients with chronic hepatitis C (CHC), with follow-up conducted for a mean of 178.27 months among controls and 162.95 months among patients.
Read More http://www.healio.com/hepatology/chronic-hepatitis/news/online/%7B90930740-D69C-4944-A56A-973BDC7AAE86%7D/Mortality-risk-greater-among-patients-with-HCV-who-drank-alcohol-moderately-heavily
Even moderate drinking may be risky with hepatitis C
Published March 18, 2013
Reuters
For people with the chronic liver infection hepatitis C, heavy drinking is an obvious no-no, but a new study links even modest alcohol consumption with an increased risk of death - and not just from liver disease.
"What this study shows is... truly, even what might be considered a moderate and safe amount of alcohol use in people without hepatitis C is dangerous to your health if you have hepatitis C," said Rae Jean Proeschold-Bell, a hepatitis C researcher at Duke University in Durham, North Carolina, who was not involved in the study.
The findings support what liver specialists typically recommend - that people with hepatitis C should limit their alcohol use, said Dr. Zobair Younossi, the study's lead author and chair of medicine at Inova Fairfax Hospital in Falls Church, VA.
"Patients with hepatitis C should not really drink," he said.
But the reality is that people with hepatitis C have higher rates of alcohol use than people without the liver disease, said Proeschold-Bell, who studies interventions to reduce drinking among people with the disease.
Doctors have known that excessive drinking can exacerbate liver disease caused by hepatitis C, but there's some debate about whether less frequent drinking would have a similar effect.
Younossi and his colleagues looked to a large national survey on health and lifestyle that tracked people for several years.
They compared 8,767 people without hepatitis C to 218 people with the disease.
Hepatitis C is a virus spread through blood. Some 3.2 million people in the U.S. have a chronic hepatitis C infection, according to the Centers for Disease Control and Prevention.
The disease can cause serious liver damage, and while some people are treated with medications, others will go on to require a liver transplant.
The survey tracked the participants for 13 to 14 years. During that period, 19 percent of those with hepatitis C and 11 percent of those without the infection died.
Younossi's team found that people with hepatitis C who drank excessively - three or more drinks a day - were five times more likely to die than heavy drinkers who were not infected.
That result was not surprising, "We've known heavy drinking is particularly bad if you have hepatitis C," Proeschold-Bell told Reuters Health.
But people infected with hepatitis C who had up to two drinks a day were also twice as likely to die during the study than those with similar drinking habits who were not infected.
For the purposes of the study, a drink was equivalent to 10 grams of alcohol, which is roughly the amount in four ounces of wine, 12 ounces of beer or one ounce of hard liquor.
Younossi said the increased risk of death from liver disease is driving the numbers.
"What is incredibly striking is liver-related death in patients with hepatitis C who even drink moderately," said Younossi.
For instance, the risk of liver-related death among people with hepatitis C who averaged two or fewer drinks a day was 74 times that of similar people without hepatitis C.
Those moderate drinkers with the virus were also nearly three times more likely to die of "all causes," the researchers report in the medical journal Alimentary Pharmacology & Therapeutics.
"A drink a day is not OK," Younossi told Reuters Health. "Even a moderate amount of alcohol use in the setting of hepatitis C can increase the risk of death and liver-related mortality specifically."
Proeschold-Bell said there is a great opportunity for intervening with people's alcohol use given that they are already interacting with the medical system if they have a chronic hepatitis C infection.
"This is potentially very powerful, because if the person with hepatitis C is already going in for medical care, they have some relationship with that clinic. They have some degree of trust, so (perhaps) you can provide alcohol treatment right then and there," she said.
Younossi said there's some evidence that if heavy drinkers without hepatitis C abstain from alcohol, their liver disease can improve.
He said he suspects the same might be true for patients with the infection, but that future studies will have to confirm that hunch.
Read more: http://www.foxnews.com/health/2013/03/18/even-moderate-drinking-may-be-risky-with-hepatitis-c/#ixzz2NufYzkw9
Roche's Pegasys gets EU backing for chronic hepatitis C in children aged five years and older
The European Medicines Agency has expanded the approval of Swiss drug major Roche’s (ROG: SIX) Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic hepatitis C virus (HCV) to include children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus.
Pegasys in combination with the antiviral ribavirin is the foundation of treatment for chronic HCV in adults. The drug was first approved in the European Union over 10 years ago.
“Hepatitis C can ultimately lead to the development of advanced liver disease if left untreated. This approval provides doctors and parents of children as young as five with a treatment combination for this infection,” said Hal Barron, Roche’s head of global product development and chief medical officer.
Mother-to-child transmission of HCV is the most common route of acquiring the infection in children, with approximately 65,000 children estimated to live with chronic HCV in Europe. While the minority of children (4%-10%) born to infected mothers become infected, 80% of these children will develop chronic disease. Most children infected with chronic HCV do not have any symptoms, but the disease is progressive and can lead to advanced liver damage (cirrhosis), liver cancer and end-stage liver disease. The approval of Pegasys plus ribavirin provides an important additional treatment option for these children.
Clinical backing
The expanded EMA approval is based on a randomized controlled trial involving 114 children between the ages of five and 17 years with chronic HCV. The study assessed the efficacy of Pegasys in combination with ribavirin, as compared to treatment with Pegasys alone. The study showed that treatment with Pegasys plus ribavirin achieved sustained viral response (undetectable HCV ribonucleic acid [RNA] in the blood 24 weeks after completion of treatment) in over half of the children treated (53%), compared with 21% of children who received Pegasys alone. The majority of patients were infected with HCV genotype 1, a difficult-to-treat genotype. These results in children and adolescents are consistent with the pattern of response rates seen in adults infected with HCV genotype 1 treated with this combination of medicines
Source
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