This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Bloomberg reported Monday that Roche revised its payment rules and now requires some hospitals in Spain and Portugal with the worst arrears to settle their debts before the company will supply them with more drugs on credit. Company spokesperson Silvia Dobry said Roche is also considering implementing a similar policy change for "a limited number" of Italian hospitals that have not paid off their debts for two to three years.
Dobry noted that "several hospitals...have not paid their bills for more than two years," adding that some clinics are given credit again if they pay down their old debts to reach a certain level. The drugmaker, which last year suspended supplying medications to certain Greek hospitals for non-payment of debt, changed its policy in February with regard to Portugal, and last year in Spain, with more Spanish hospitals included on the list in March and April, Dobry said.
She indicated that the policy, which applies to all types of medications, affects a dozen Spanish hospitals, and according to a report in El Pais newspaper, Roche will not supply drugs to those that are more than 700 days behind on payments. Meanwhile, the change will impact 23 hospitals in Portugal, which account for about one quarter of the hospitals in that country, though Dobry specified that no cancer clinics are affected. According to Roche, some Portuguese hospitals are more than 1000 days late on payments.
In Greece, Roche offers an emergency access programme that permits hospitals with outstanding debts to pay on delivery to obtain certain drugs for HIV, organ transplants and other life-threatening diseases.
Genome Institute of Singapore scientists, in collaboration with the industry, unravels mechanism that causes liver cancer
May 28
Scientists at the Genome Institute of Singapore (GIS) have unraveled the mechanism that causes liver cancer (hepatocellular carcinoma, HCC), one of the most common solid tumors worldwide. This genome-wide research was done in collaboration with colleagues from the National University of Singapore (NUS), University of Hong Kong, Eli Lilly & Co. USA, Merck Research Laboratories USA, Pfizer Oncology USA and Beijing Genomics Institute China.
The discovery was published in the prestigious scientific journal, Nature Genetics, on 27 May 2012. The GIS is a research institute under the umbrella of the Agency for Science, Technology and Research (A*STAR).
One major cause of liver cancer, or HCC, is high exposure to the hepatitis B virus (HBV), resulting in the integration of HBV into the victim’s genes. Individuals who carry the HBV have a greater than 100-fold increased relative risk of developing HCC, considered to be a serious global health problem by the World Health Organization (WHO).
Due to technology and sample limitations in the past, only restricted results were found. In this study, the scientists leveraged on massively parallel sequencing technology to survey the HBV integrations on paired tumor and adjacent non-tumor tissues from 88 Chinese HCC patients.
Their analyses revealed that the incidences of HBV integrations were high – 76 of the 88 patients had HBV integration. Specifically, they discovered that the HBV will integrate into genes CCNE1, SENP5 and ROCK1, causing an increase in the expression levels in these genes, and subsequently enhancing the tumor growth. This discovery is in addition to the previously reported integration into the TERT and MLL4 genes.
The scientists also observed that HBV integration induced chromosome instability, resulting in the scrambling of the genome.
First author Dr Ken SUNG Wing Kin, Senior Group Leader of Computational and Systems Biology at the GIS, said: “Very importantly, we showed that HBV integration affects the patient’s overall survival. This work improves our understanding of HBV integration in HCC, which may lead us to develop better therapies for this highly malignant disease.”
“A lot of researchers have tried to study the importance of HBV integration sites, but with limited success,” said Prof Stephen TSUI, Professor at the School of Biomedical Sciences, and Director at the Centre for Microbial Genomics and Proteomics, The Chinese University of Hong Kong. “Thanks to the recent advance in sequencing technology and the continuing efforts of the team, I am so excited to see the light from the end of the tunnel finally. The findings in this article have important implications on the relationship between hepatitis B virus and hepatocellular carcinoma.”
Acting Executive Director of GIS Prof NG Huck Hui remarked: "Computational biology is a critical part of post-genome research. Ken, a Senior Group Leader at the GIS, has elegantly demonstrated the importance of informatics in deciphering the complex sequence datasets and discovered the sites which the hepatitis B virus invades the human genome."
The study was funded by the Asian Cancer Research Group (ACRG), a not-for-profit organization formed by Eli Lilly, Merck and Pfizer.
Notes to the Editor:
Research publication:
The research findings described in the press release can be found in the 27 May 2012 advance online issue of Nature Genetics under the title “Genome-wide survey of recurrent HBV integration in hepatocellular carcinoma”. Authors:Wing-Kin Sung1–4,16, Hancheng Zheng5,16, Shuyu Li6,16, Ronghua Chen7,16, Xiao Liu5,16, Yingrui Li5, Nikki P Lee1, Wah H Lee4, Pramila N Ariyaratne4, Chandana Tennakoon2,3, Fabianus H Mulawadi4, Kwong F Wong1,8–10, Angela M Liu1,8–10, Ronnie T Poon1, Sheung Tat Fan1, Kwong L Chan1, Zhuolin Gong5, Yujie Hu5, Zhao Lin5, Guan Wang5, Qinghui Zhang5, Thomas D Barber6, Wen-Chi Chou6, Amit Aggarwal6, Ke Hao7, Wei Zhou7, Chunsheng Zhang7, James Hardwick7,11, Carolyn Buser7, Jiangchun Xu12, Zhengyan Kan12, Hongyue Dai7, Mao Mao11,12, Christoph Reinhard6, Jun Wang5,13,14 & John M Luk1,8–10,15
1. Department of Surgery, University of Hong Kong, Hong Kong.
2. School of Computing, National University of Singapore (NUS), Singapore.
3. NUS Graduate School for Integrative Sciences & Engineering, National University of Singapore, Singapore.
4. Department of Computational & Systems Biology, Genome Institute of Singapore, Singapore.
5. Beijing Genomics Institute, Shenzhen, China.
6. Eli Lilly & Co., Indianapolis, Indiana, USA.
7. Merck Research Laboratories, Boston, Massachusetts, USA.
8. Department of Pharmacology, NUS, Singapore.
9. Department of Surgery, NUS, Singapore.
10. Cancer Science Institute, NUS, Singapore.
11. Asian Cancer Research Group, Inc., Wilmington, Delaware, USA.
12. Pfizer Oncology, San Diego, California, USA.
13. Department of Biology, University of Copenhagen, Copenhagen, Denmark.
14. The Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.
15. Present address: Department of Oncology, Roche R&D Center (China) Ltd., Shanghai, China.
16. These authors contributed equally to this work.
The Genome Institute of Singapore (GIS) is an institute of the Agency for Science, Technology and Research (A*STAR). It has a global vision that seeks to use genomic sciences to improve public health and public prosperity. Established in 2001 as a centre for genomic discovery, the GIS will pursue the integration of technology, genetics and biology towards the goal of individualized medicine.
The key research areas at the GIS include Systems Biology, Stem Cell & Developmental Biology, Cancer Biology & Pharmacology, Human Genetics, Infectious Diseases, Genomic Technologies, and Computational & Mathematical Biology. The genomics infrastructure at the GIS is utilized to train new scientific talent, to function as a bridge for academic and industrial research, and to explore scientific questions of high impact. www.gis.a-star.edu.sg
About the Agency for Science, Technology and Research (A*STAR)
The Agency for Science, Technology and Research (A*STAR) is the lead agency for fostering world-class scientific research and talent for a vibrant knowledge-based and innovation-driven Singapore. A*STAR oversees 14 biomedical sciences and physical sciences and engineering research institutes, and six consortia & centres, located in Biopolis and Fusionopolis as well as their immediate vicinity.
A*STAR supports Singapore's key economic clusters by providing intellectual, human and industrial capital to its partners in industry. It also supports extramural research in the universities, and with other local and international partners. www.a-star.edu.sg
MSD offers new treatment for hepatitis C Dubai: 33 minutes ago
MSD, a global healthcare leader, today launched a new hepatitis C treatment that could provide a life line to thousands of UAE citizens.
Up to 2 per cent of the UAE population suffers from hepatitis C, with many of them failing to be successfully treated by the current standard therapy of peginterferon alfa and ribivan, said a statement from the company.
Specifically designed to address this portion of the UAE population, Victrelis is the first in a new class of medications that focus on the treatment of chronic hepatitis C and is specifically indicated in adult patients who have compensated liver disease, who have not received treatment for the disease previously or who have not achieved success in previous treatment therapies, the statement said.
Talking about the important impact that Victrelis will have on the prevalence of hepatitis C in the UAE, Andrew Miles, managing director, MSD Gulf region, said: "Every year over 800,000 people in the Eastern Mediterranean region are newly diagnosed with hepatitis C. In the UAE estimates suggest that as many as 14 out of every 100,000 suffers from hepatitis C, with rates at their highest in Abu Dhabi, where incidence could be as much as 23 out of every 100,000 people. One of the greatest dangers of hepatitis C and the reasons that many UAE citizens may find that their condition is chronic by the time they are diagnosed, is that the disease is often very difficult to detect, particularly because many people are asymptomatic in the early stages.
“Today, it is estimated that as many as 69,000 UAE citizens may suffer from chronic hepatitis, Victrelis will have a significant impact on addressing the medical needs of this sector of society,” he said.
Dr Salim Awadh Sabih Al Khathiry, consultant gastroenterologist and hepatologist at Al Jazeira Hospital and Mafraq Hospital in Abu Dhabi, said: “Hepatitis C places a substantial financial burden upon patients, local communities and the UAE economy at large. Estimates suggest that to treat just one UAE patient with current standard treatment of peginterferon alfa and ribavirin could cost as much as Dh80,000 per year, with an additional Dh100,000 being added to treat chronic liver disease and the complications it results in.
“Victrelis which works through hepatitis C protease inhibitors, is the first of its kind in the UAE market and clinical trials have shown that when used in combination with peginterferon alfa and ribavirin in patients who were previously untreated or who had failed previous treatment therapies, Victrelis had a significantly higher chance of achieving a virological cure, than current standard therapies; a fact that could significantly reduce the overall financial burden, that patients face,” he said. – TradeArabia News Service
Ronald Spann, 53, had hepatitis C for decades without knowing it. His first symptoms arose in 1995. He had a liver transplant in 2000. The virus is attacking that liver. He got out of the hospital Wednesday and showed some of his medicines on Thursday, May 24, 2012, at his Portsmouth home. (Hyunsoo Leo Kim | The Virginian-Pilot)
How Ronald Spann contracted hepatitis C may always be a mystery.
What the virus has done to his 53-year-old body, however, is not.
By the time his first symptom arose in 1995, hepatitis C had been quietly lurking for decades, damaging his liver so badly he needed a transplant.
The liver the Portsmouth man received five years later improved his health for a while, until the virus began destroying that one, too.
Greg Whitley, 41, found out he had hepatitis C in 2007. He had not shown significant symptoms, and he agreed to participate in a clinical drug trial of a new hepatitis C drug. His blood is now clear of the virus, and his liver is healing. He posed near his home in the Sandbridge area of Virginia Beach on Thursday, May 24, 2012. (Hyunsoo Leo Kim | The Virginian-Pilot)
Greg Whitley, 41, of Virginia Beach was diagnosed more than a decade after Spann, but, unlike him, it was before he noticed any symptoms.
In 2011, he enrolled in a clinical trial of a drug that has since cleared his body of the virus and put his liver on the path toward healing.
"It's given me peace of mind," Whitley said.
These two faces of "hep C" illustrate why doctors are pushing for more people to be tested for the disease; an estimated 75 percent of victims don't even know they have it.
The federal Centers for Disease Control and Prevention proposed earlier this month that all baby boomers be tested. Currently, the agency only recommends that those at high risk be screened.
The shortcoming of that approach, according to Dr. David Trump, a state health department epidemiologist, is that even people who don't think they're in high-risk groups often find themselves fighting the virus. That was true for both Spann and Whitley.
Hep C is a contagious liver disease that is spread primarily through contact with the blood of an infected person. It ranges in severity from a mild illness to scarring of the liver that can lead to cirrhosis or liver cancer.
From 1999 to 2007, the number of people in the United States dying from hep C-related ailments almost doubled, and in 2007, the number of deaths surpassed those who die from HIV.
The virus - most often spread by injection drug use, sex, and blood transfusions before 1992 - is now the leading cause of liver transplants. Other people at high risk are health workers who are exposed to blood, children born to women with hep C infection, and people who received piercings and tattoos in unclean places with unsterilized equipment. Long-term dialysis patients also are at high risk.
Baby boomers, those born between 1945 and 1965, account for 2 million of the 3.2 million people infected with the virus. They're now reaching the age when the disease, often contracted in their youth, starts having an impact on their livers.
Dr. Michael Ryan, a Norfolk liver disease specialist who treated both Spann and Whitley, said his practice, Digestive and Liver Disease Specialists of Norfolk, treats about 600 people with hep C. Fortunately, new treatments have been developed that can rid the body of the virus.
"There's a tremendous amount of research going on," said Ryan, who is a clinical professor of medicine at Eastern Virginia Medical School. "The problem is, there are still a lot of people with advanced cases who already have cirrhosis."
Spann is one of them. His first clue that he had hepatitis C came in 1995 when he had what he thought was a case of the flu: body aches, fever, fatigue.
A fourth symptom, vomiting blood, led to tests that showed he had hep C.
He was referred to Ryan, who told him he probably contracted the virus decades ago. Spann says he thinks he may have picked it up through a job where he cleaned hospital linens, in which he occasionally was pricked by medical needles.
By the time he was diagnosed, the virus had led to cirrhosis, a condition in which healthy tissue in the liver is replaced by fibrous tissue and scarlike hardening.
For the next several years, he suffered such severe fatigue he had to stop working. High ammonia levels caused memory loss and confusion. His wife worked two jobs to support the couple and their three children.
Spann received a liver transplant in Northern Virginia in 2000, and, for a while, his condition improved.
But in 2003, he started having problems again.
"Everyone thinks if you get a liver transplant, it gets rid of the disease," Spann said. "But it doesn't."
The virus attacked his second liver, and he now needs another. But he's a poor candidate because second transplants are less successful.
Ryan said the virus can attack a transplanted liver even faster because patients are on immune-suppressive medications to ward off organ rejection.
The need for livers is far greater than the number available, and the demand has grown the past two decades. According to the United Network for Organ Sharing, there were 91 liver transplants in Virginia in 2011, and 624 Virginians are on the waiting list. In 1989, the year the hepatitis C virus was identified, there were 35 transplants in the state and 233 people awaiting a liver.
Besides hep C cases, other diseases are increasing the transplant waiting list. Nonalcoholic steatohepatitis is a disease in which there is too much fat in the liver, which can also lead to cirrhosis. The nation's obesity epidemic is fueling that disease.
Obesity and diabetes also worsen hep C cases, so a growing number of people are reaching the point of needing a transplant.
Ryan is hopeful that some of the new medications in the pipeline will be able to rid transplant patients of hep C to keep second livers from damage. In the meantime, health advocates are pounding a drumbeat of awareness so people will get screened and into treatment sooner.
Spann wishes he had known about his disease earlier. Not only did it wreak havoc on his body, but it delivered a stigma that's hard to overcome.
"People have the idea if you have liver disease, you're an alcoholic. That's the first thing out of their mouth. 'How much do you drink?' "
A letter from a life insurance company may have saved Greg Whitley from the same path.
He's a Virginia Beach native who was living in Oregon when his insurance company asked him to have a blood test to renew a life insurance policy in 2008.
The blood test showed he had hep C.
Whitley, the father of three children, couldn't believe it.
He felt fine. He wasn't a drug user, and he hadn't had blood transfusions during the time period that would have put him at high risk. The only thing he could think of was he had helped out on some emergency situations at work where he might have been exposed to blood.
He also has a tattoo, another possible venue for the virus.
"It's a disease that's 'out of sight, out of mind.' It's not like losing a limb or not being able to see. It's something inside your body, so you don't know what it's doing," Whitley said.
On his doctor's advice, he cut back on alcohol, and medications like painkillers: "I wanted to take the load off my liver."
He moved back to Virginia Beach, where Ryan told him about several new treatments that were in the works.
During the past few years, enormous progress has been made in hep C treatment. Two drugs approved by the Food and Drug Administration last year improved the cure rate to 79 percent of those diagnosed. At one time, only 30 percent were cured.
The treatments are expensive - $48,000 to $70,000, depending on how long they're needed - but they're far less costly than a transplant.
Ryan enrolled Whitley in a clinical trial that involved a cocktail of medications that Whitley injected into himself every week for 24 weeks. The injections made him feel nauseated, achy and tired. But he would time them so he immediately went to bed.
By the next morning he was well enough to work at his job as a manager of a steel building company.
The virus was cleared from his body within weeks. He's still being monitored.
Ryan expects the drug in the clinical trial to be approved by the FDA.
In the meantime, there are dozens of other clinical trials under way for hep C treatments: some that could help people who've had a transplant avoid damaging a second liver; others that would have fewer side effects; and still others that would shorten the treatment time.
Other research projects are under way to improve blood screening for the disease.
Whitley feels fortunate to have received the letter from the life insurance company at the time he did.
"If you catch it early, it can be fixed," he said. "But there's so many people walking around not knowing they have it."
More info-For more information about hepatitis C, visit the federal Centers for Disease Control and Prevention: www.cdc.gov/hepatitis/C/index.htm
May 18-2012 U.S. health officials want all baby boomers to get tested for hepatitis C.
The Centers for Disease Control and Prevention on Friday released draft recommendations calling for all baby boomers to get a one-time blood test for the liver disease. That's everyone born from 1945 to 1965.
CDC - Draft Recommendations
Find Hepatitis Testing Year Round Near You
Locate organizations offering Hepatitis testing and additional services vaccines and treatment in the NPIN Organizations Database.
SUPPORT
A new national toll-free helpline has been launched for people affected by hepatitis C: 877-HELP-4-HEP (877-435-7443).
This new consumer-run helpline is staffed by specially trained peer counselors Monday through Friday, 9am to 7pm EST to provide emotional support, health information, and referrals.
HELP-4-HEP is a partnership among several well-known and nationally recognized nonprofits with a combined 90+ years’ experience in hepatitis C education, support and patient advocacy.
Stem cells have assumed near-mythical status in the popular imagination as a possible cure for every disease under the sun. But while public attention has focused on their potential in regenerative medicine, stem cells have quietly gained a foothold in drug development — a move that may hail a huge but unheralded shake-up of the biological sciences.
“I think there are tremendous parallels to the early days of recombinant DNA in this field,” says James Thomson, director of regenerative biology at the Morgridge Institute for Research in Madison, Wisconsin, and one of the founders of Cellular Dynamics International, also in Madison. “I don’t think people appreciated what a broad-ranging tool recombinant DNA was in the middle '70s." At the same time, he says, they underestimated the difficulty of using it in treatments.
Now stem cells are in a similar situation, he says, and although therapeutic use is likely to come to fruition eventually, “people underappreciate how broadly enabling a research tool it is”, he says.
Drug companies began dipping a tentative toe into the stem-cell waters about two years ago (see 'Testing time for stem cells'). Now, the pharmaceutical industry is increasingly adopting stem cells for testing the toxicity of drugs and identifying potential new therapies, say those in the field.
Cellular Dynamics sells human heart cells called cardiomyocytes, which are derived from induced pluripotent stem (iPS) cells. Thomson says that “essentially all the major pharma companies” have bought some. The company also produces brain cells and cells that line blood vessels, and is about to release a line of human liver cells.
Yet Cellular Dynamics is just one of the companies in the field. Three years ago, stem-cell biologist Stephen Minger left his job in UK academia to head GE Healthcare’s push into stem cells (see 'Top scientist's industry move heralds stem-cell shift').
The medical-technology company, headquartered in Chalfont St. Giles, UK, has been selling human heart cells made from embryonic stem (ES) cells for well over a year, and is due to start selling liver cells soon.
Testing toxicity
Minger and his team at GE Healthcare assessed the heart cells in a blind trial against a set of unnamed drug compounds to see if the cells would reveal which compounds were toxic. When the compounds were unmasked, Minger says, they found that the cells had been affected by the known toxic compounds. But, crucially, in a number of cases, the cells identified a problem that had only been discovered after the drugs had reached the market — and after they had been approved by agencies such as the US Food and Drug Administration (FDA).
“These are compounds which went all the way through animal testing, then went through phase I, II, III and then were licensed in many cases by the FDA,” says Minger.
In addition to the obvious health benefits, using stem cells to weed out drugs with dangerous side effects before they reach the market could save the industry millions of dollars in wasted development costs. They could also be valuable tools for the discovery of new drugs, an application for which both Cellular Dynamics and GE Healthcare market their cells.
“Many of the animal models out there are poor, demonstrating great efficacy in the mouse, but not repeating in man during late-stage clinical trials. Therefore having an in vitro model years before, which can actually recapitulate human disease, would be a huge advantage,” says Adam Rosenthal, senior director for strategic and corporate development at iPierian, a biopharmaceutical company based in San Francisco, California.
Rather than selling its product to other drug companies, iPierian is using them in house to develop treatments for neurodegenerative diseases such as Alzheimer’s. Earlier this week, the company announced that it would be pushing forward with developing monoclonal antibodies that target the tau proteins thought to be important in Alzhiemer’s disease, as well as investigating another set of proteins implicated in neurodegeneration. The decision was based on insights from stem-cell work, says the company.
A way to go
There are still a number of unknowns in the nascent field. Lee Rubin, co-founder of iPierian and director of translational medicine at the Harvard Stem Cell Institute in Cambridge, Massachusetts, says that there is debate over whether stem cells can be used to study certain types of disease, particularly non-genetic or late-onset disorders and those that are linked to interactions between different tissues.
In his research, Rubin uses stem cells as a model of spinal muscular atrophy, a group of early onset genetic disorders. He points out that the only way to really prove that using stem cells for drug discovery is a better system is to find a drug and show that it works in people.
“That’s a long term project,” Rubin says. “That’s the ultimate test.”
But stem cells are likely to find even wider uses than drug-development work, says Thomson.
“What human ES cells and iPS cells now do is give you access to the basic building blocks of the human body, just for basic study,” says Thomson. “We will understand the human body at a much greater detail because of these cells.” Exactly how the cells will be used are not clear, he says, adding, “But I do think it will profoundly change human medicine.”
I.D. Hep C Campaign
I.D. Hep C is a campaign developed by the AGA to educate people, especially baby boomers, about hepatitis C and encourage people to initiate conversations about the disease and getting tested with their health-care provider. Learn more about the campaign
Pledge Today To Educate Yourself and Others About Hepatitis C
Hepatitis C is a potentially serious, often misunderstood liver disease affecting nearly 5 million Americans, 75 percent of whom don’t know they have it. Findings from a recent survey of baby boomers, released by the AGA, show a lack of knowledge about hepatitis C among baby boomers, a population that represents the majority of those infected. That’s why we are asking people to pledge their commitment to educating themselves and others about hep C and testing. Take the I.D. Hep C pledge today and encourage others to do the same. Take the Pledge!
National Hepatitis C Survey
What do baby boomers, who make up the majority of people infected, know about hepatitis C? We set out to test people’s knowledge about the disease. Check out the results of our national survey and see how your knowledge stacks up. National hepatitis C survey results
Know the Hepatitis C Basics
Did you know that 82 percent of people with hepatitis C are baby boomers (those born between 1945 and 1965)? Hepatitis C is a serious public health threat. Nearly 5 million people in the U.S. have hepatitis C – five times the number of people with HIV– and 75 percent don’t even know it. How much do you know about hepatitis C? Find out what you need to know about hepatitis C
Do You Know If You Have Hep C?
Did you know that screening for hepatitis C is not currently part of routine blood tests? You may think you have been tested, but chances are you haven’t. It’s a simple test.
To get tested and know your status, talk to your health-care provider about being tested for hepatitis C at your next appointment or visit our testing page to find a site near you where you can get tested. Learn about getting tested for hepatitis C
Most weekends this blog offers up a few substantial links to relevant HCV information, click here for previous "Weekend Reading" articles. Hepatitis C New Drug Research And Liver Health has an article database which includes full-text and abstracts on hepatitis C. View the RSS feed for this weekend of updates.
Adding telaprevir (Incivek) to pegylated interferon and ribavirin cured all hepatitis C patients with the favorable IL28B gene pattern, researchers reported at the 47th International Liver Congress (EASL 2012) last month in Barcelona. Another study found that adding the experimental HCV protease inhibitor VX-222 raised cure rates even for those with unfavorable IL28B patterns.
DDW, the annual meeting of the American Gastroenterological Association (AGA) Institute, is jointly sponsored by the American Association for the Study of Liver Diseases, the AGA, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract.
Increased mortality observed in patients with HCV and diabetes
May 23, 2012
Those with both hepatitis C and diabetes had a higher mortality rate when compared with those who had either condition alone, according to research presented during Digestive Disease Week 2012.
When we observed the rates for patients who had both hepatitis C and diabetes, we saw that the mortality rate was significantly increased — at least three times the amount of patients died in the group with both hepatitis C and diabetes compared with patients who had neither condition,”
Meira Abramowitz, MD, of the division of internal medicine at SUNY Downstate Medical Center in Brooklyn, N.Y., told Infectious Disease News.
Abramowitz and colleagues conducted a retrospective chart review of patients treated at the VA New York Harbor Healthcare System from 2002 to 2003. Mortality data were collected from 2011.
Patients with HCV were identified from a registry of more than 6,000 patients with HCV. These patients were age-matched with other patients without HCV from the VA system, some of whom had diabetes.
The final cohort included 1,846 patients, of whom 18.8% had neither HCV nor diabetes and 12.8% had both. Of the 579 patients with diabetes, 31.3% died vs. 20.6% of the 1,213 patients without diabetes. Of the 1,141 patients with HCV, 24.5% died vs. 24.1% of the 692 patients without HCV.
Of the 237 patients with both HCV and diabetes, 36.3% died vs. 20.8% of the 867 patients with HCV alone, 27.8% of the 342 patients with diabetes alone and 20.2% of the 346 patients with neither disease. The OR for mortality in patients with diabetes vs. patients without diabetes was 1.7 (95% CI, 1.3-2.24). This increased to 1.89 when the researchers compared patients with both HCV and diabetes to patients with neither disease (95% CI, 1.45-2.46).
“We are not entirely sure why this mortality increase took place because both of these conditions have their own individual complications,” Abramowitz said. “Hepatitis C can develop into hepatocellular carcinoma and hepatic encephalopathy, while diabetes can progress into diabetic nephropathy and diabetic neuropathy with accompanying cardiovascular complications.”
References:
Abramowitz M. #MO1905. Presented at: Digestive Disease Week 2012 Annual Meeting; May 19-22; San Diego.
Disclosures:
Dr. Abramowitz reports no relevant financial disclosures.
Update on the Diagnosis and Treatment of Hepatitis C
by Arun B. Jesudian, MD and Ira M. Jacobson, MD
Hepatitis C virus (HCV) infection is a national and global public health concern, affecting up to 4 million individuals in the United States and 200 million individuals worldwide. Despite a declining incidence of new HCV infections in the United States, the prevalence of advanced liver disease secondary to chronic HCV infection, including cirrhosis and hepatocellular carcinoma, is expected to rise in the coming years.
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NICE Bites is a monthly bulletin which summarises key prescribing points from NICE guidance. This edition includes two topics; Anaphylaxis and Hepatis C – technology appraisals.
Like curry? New biological role identified for compound used in ancient medicine
CORVALLIS, Ore. – Scientists have just identified a new reason why some curry dishes, made with spices humans have used for thousands of years, might be good for you.
New research at Oregon State University has discovered that curcumin, a compound found in the cooking spice turmeric, can cause a modest but measurable increase in levels of a protein that's known to be important in the "innate" immune system, helping to prevent infection in humans and other animals.
This cathelicidin antimicrobial peptide, or CAMP, is part of what helps our immune system fight off various bacteria, viruses or fungi even though they hadn't been encountered before.
Prior to this, it was known that CAMP levels were increased by vitamin D. Discovery of an alternative mechanism to influence or raise CAMP levels is of scientific interest and could open new research avenues in nutrition and pharmacology, scientists said.
Turmeric is a flavorful, orange-yellow spice and an important ingredient in many curries, commonly found in Indian, South Asian and Middle Eastern cuisine. It has also been used for 2,500 years as a medicinal compound in the Ayurvedic system of medicine in India – not to mention being part of some religious and wedding ceremonies. In India, turmeric is treated with reverence.
The newest findings were made by researchers in the Linus Pauling Institute at OSU and published today in the Journal of Nutritional Biochemistry, in collaboration with scientists from the University of Copenhagen in Denmark. The work was supported by the National Institutes of Health.
"This research points to a new avenue for regulating CAMP gene expression," said Adrian Gombart, an associate professor of biochemistry and biophysics in the Linus Pauling Institute. "It's interesting and somewhat surprising that curcumin can do that, and could provide another tool to develop medical therapies."
The impact of curcumin in this role is not nearly as potent as that of vitamin D, Gombart said, but could nonetheless have physiologic value. Curcumin has also been studied for its anti-inflammatory and antioxidant properties.
"Curcumin, as part of turmeric, is generally consumed in the diet at fairly low levels," Gombart said. "However, it's possible that sustained consumption over time may be healthy and help protect against infection, especially in the stomach and intestinal tract."
In this study, Chunxiao Guo, a graduate student, and Gombart looked at the potential of both curcumin and omega-3 fatty acids to increase expression of the CAMP gene. They found no particular value with the omega-3 fatty acids for this purpose, but curcumin did have a clear effect. It caused levels of CAMP to almost triple.
There has been intense scientific interest in the vitamin D receptor in recent years because of potential therapeutic benefits in treating infection, cancer, psoriasis and other diseases, the researchers noted in their report. An alternative way to elicit a related biological response could be significant and merits additional research, they said.
The CAMP peptide is the only known antimicrobial peptide of its type in humans, researchers said. It appears to have the ability to kill a broad range of bacteria, including those that cause tuberculosis and protect against the development of sepsis.
Q: Is coffee good for the liver?
A: Research suggests that regular, moderate coffee consumption can lower people’s risk of developing a range of liver diseases – including cancer, fibrosis (scar tissue that builds up within the liver) and cirrhosis (the result of a long-term build up of scar tissue within the liver).
Q: How many cups of coffee do I need to drink to see a benefit?
A: It is too early to make specific recommendations concerning the levels of coffee intake that may be beneficial for liver function. Research suggests that regular, moderate coffee consumption may be beneficial
1,2. However certain patients with specific conditions may need to limit their caffeine consumption. For example, pregnant women are advised to limit their caffeine intake to 200-300mg per day – the equivalent amount found in 2-3 regular cups of coffee.
Q: Are the benefits of coffee down to caffeine?
A: While research has suggested that caffeine may slow down the progression of liver fibrosis, alcoholic cirrhosis and liver cancer
3,4,5, the extent to which caffeine is implicated in the reduced risk of developing these diseases remains unclear. Research also suggests that other coffee constituents, including cafestol and kahweol6 (naturally occurring compounds found in the oily part of coffee), and antioxidants may have a beneficial effect on liver function.
Q: Is decaffeinated coffee as good as regular coffee?
A: Research suggests that caffeine might play a role in the relationship between coffee drinking and lower risk of liver disease; however, currently there are no published studies specifically investigating the effects of decaffeinated coffee on liver function.
Q: If I’m a coffee drinker, can I drink more alcohol without increasing my risk of liver disease?
A: No. All medical advice makes clear that excessive alcohol consumption is detrimental to health. Adults, who choose to consume alcohol, should be aware of the recommended advice for safe consumption. While scientific research suggests that coffee drinking may have a beneficial effect on liver function, the risks associated with excessive alcohol consumption are not counter balanced by coffee consumption.
Q: I’ve heard that the effects of alcohol on the liver can be different for women than for men. Is the same true for coffee?
A: Generally, the effect of coffee drinking does not differ between the sexes; however, some groups, such as pregnant women, smokers, or women taking hormone replacement therapy do metabolise caffeine at a different rate to those in the general population. Pregnant women are advised to limit their caffeine intake to 200-300mg per day – the equivalent amount found in 2-3 regular cups of coffee.
Q: Do all types of coffee have the same effect?
A: Studies investigating the relationship between coffee and liver function have demonstrated beneficial effects in various types of coffee preparation, including filtered, instant and espresso coffee.
Q: Is it safe for individuals with liver disease to drink coffee?
A: Yes, there is no evidence to suggest that moderate coffee drinking poses any dangers for individuals with liver disease. In fact, some studies suggest coffee may slow down the progression of liver disease in some patients.
Q: Does coffee have any benefits for individuals with liver disease?
A: Research has shown that individuals with liver disease who regularly drink moderate amounts of coffee tend to display a milder progression of the disease7,8.
Source and References
Think you eat a nutritious diet but still find yourself battling sugar cravings, feeling fatigued and struggling to lose weight? Then carve out time today to watch this talk by Stanford internist Nicole Peoples, DO. In this video lecture, she explains what happens once food enters your system, how your body responds to it and why the food choices you’re making could be contributing to these and other symptoms.
NEW YORK (Reuters Health) – Single-agent sorafenib improves outcomes for select patients with advanced hepatocellular carcinoma (HCC) and underlying Child-Pugh B liver cirrhosis, researchers from Hong Kong report in the April 19th online issue of Cancer.
“I would only recommend prescribing sorafenib to patients with score 7 instead of 8-9, as most benefits are seen in score 7 patients,” Dr. Thomas Yau from Queen Mary Hospital, Hong Kong, China told Reuters Health in an email.
Although sorafenib is FDA-approved as first-line treatment for advanced HCC, its efficacy and tolerability remain largely unknown for patients with suboptimal liver function.
Dr. Yau and colleagues explored that question in a retrospective study of three groups of patients with advanced HCC: 108 with Child-Pugh A cirrhosis (CPA), 37 with Child-Pugh B disease and a score of 7 (CPB7), and 27 with scores of Child-Pugh B and scores of 8-9 (CPB8-9).
Patients in Child-Pugh class A have well compensated disease. Child-Pugh B indicates significant functional compromise. (Child-Pugh class C patients, not included here, have decompensated liver disease.)
The overall clinical benefit rates (complete response + partial response + stable disease) did not differ significantly between patients with CPA, CPB7, or CPB8-9 (23.3%, 32.4%, and 14.8%; p=0.23).
Median progression-free survival was also similar — 3.2 months for CPA, 3.2 months for CPB7, and 2.3 months for CPB8-9 — but median overall survival was significantly greater for CPA and CPB7 than for CPB8-9 (6.1 and 5.4 vs 2.7 months; p=0.02).
Rates of most nonhematological and hematological adverse events were comparable in the three groups. There were, however, significantly more GI bleeding events and hepatic encephalopathy in CPB patients than CPA patients.
More CPB than CPA patients had drug termination due to adverse events, primarily related to more cirrhotic complications in CPB (15.6%) than CPA (5.6%) patients during sorafenib treatment.
“Therefore,” the researchers suggest, “when sorafenib is routinely used to treat advanced HCC patients with CPB cirrhosis, more vigilant surveillance and follow-up is advisable.”
“The on-going GIDEON (Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib) study will certainly provide us more information about the efficacy and safety of sorafenib use in patients with Child Pugh B cirrhosis,” Dr. Yau said. “We are planning to explore the potential benefits and safety of using sorafenib in other advanced HCC subgroups, such as patients with ECOG 3/4.”
The study was supported by the University of Hong Kong hepatocellular carcinoma research fund.
