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Week Ending: August 6th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Roche Launches New Campaign to Educate Consumers About Hepatitis C
• Hepatitis Fighters
• Doctor at Centre of Tainted Blood Scandal Will Stand Trial
• IBTS Apologises for Withholding Hep C Test Results
• Get Tested
• Genelabs Drug Discovery Team Advances Compounds against the Hepatitis C Virus in Preclinical Development
• Bile Acids not Beneficial in Liver Transplant Patients
• Hepatic Iron Overload Reduces Liver Transplant Survival
• Treatment for Renal Dysfunction in Liver Transplants
• LOLA to Host NYC Hepatitis C 'March for Awareness'
• Ignorance Thwarts Hepatitis C Fight
July 26th, 2005
Roche Launches New Campaign to Educate Consumers About Hepatitis C
http://www.hepcfight.com/
Roche Launches New Campaign to Educate Consumers About Hepatitis C - Effort Encourages Patients to Speak with Physicians About Available Therapies
NUTLEY, New Jersey (July 26, 2005) – Roche announced today the launch of a major new campaign to motivate hepatitis C patients who have been diagnosed with the disease to take the critical step of discussing prescription treatment with a liver specialist or hepatitis C-treating physician.
Often called a “silent disease,” hepatitis C usually reveals no specific signs or symptoms and remains rarely diagnosed until its chronic stages when it has already caused severe liver isease. In fact, when left untreated, hepatitis C may lead to cirrhosis, liver cancer and even death. According to the Centers for Disease Control and Prevention (CDC), there are approximately four million Americans currently infected with hepatitis C, yet less than 30 percent, or about one million people, have actually been diagnosed with the disease. Additionally, almost 60 percent of those one million diagnosed patients have never been treated.
“It is critical for hepatitis C patients to be educated about the potential harmful effects of allowing the disease to go untreated,” said Dr. Paul Pockros, Scripps Clinic, San Diego, Calif. “Anyone who has been diagnosed with hepatitis C should speak to a physician to determine whether treatment is medically appropriate.”
The centerpiece of the campaign is a print advertisement featuring a man with a severely bruised face and a tagline that reads, “If Hep C was attacking your face instead of your liver, you’d do something about it.” The ad, which debuts in major national and local daily newspapers today, will begin to appear in national newsmagazines in August and in transit media in September. There are three versions of the ad, depicting a Caucasian, an African-American, and a Latino.
“As an advocate for those living with hepatitis C, I have seen firsthand the need for increased awareness of the disease. This campaign is an important addition to our own outreach efforts,” said Andi Thomas, Executive Director, Hep-C Alert. “Patients should know their options and be proactive in the management of their disease, and this campaign helps achieve those patient education objectives.”
The campaign directs consumers to a new Web site, www.hepCfight.com, and to a telephone information line (866-HepCSource), which both serve as patient resources for information about the disease.
“As the market leader in the treatment of hepatitis C, Roche is undertaking this new disease awareness campaign to communicate the potential harmful effects of hepatitis C on the liver in a way that consumers can easily recognize and understand,” said Gary Ziezula, Vice President, Commercial Operations, Roche. “Our hope is that the ad will motivate those diagnosed with hepatitis C to make an appointment and speak to their physicians to determine if treatment is the next best step.”
More About Chronic Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. An estimated 2.7 million Americans are chronically infected with the hepatitis C virus (HCV), with 35,000 to 180,000 new infections each year. The CDC estimates that hepatitis C is responsible for eight to ten thousand deaths per year and could increase to 38,000 by the year 2010, surpassing annual HIV/AIDS deaths.
Treatment of Hepatitis C
The combination therapy of pegylated interferon and ribavirin is the current standard of care for hepatitis C. Clinical trials have shown that this combination treatment makes the hepatitis C virus undetectable in more than half of the patients who are treated. Response to treatment may vary based on individual factors, genotype, viral load and race. There is no vaccine available for hepatitis C. Combination therapy results in better treatment responses than monotherapy, but the highest response rates have been achieved with pegylated interferon in combination with ribavirin. Currently, the best indicator of effective treatment is an SVR, defined by the absence of detectable HCV RNA in the serum as shown by a qualitative HCV RNA assay with lower limit of detection of 50 IU/mL or less at 24 weeks after the end of treatment.
The following are some of the most common side effects associated with pegylated interferon plus ribavirin therapy: flu-like symptoms, including fever, chills, and muscle aches; fatigue; upset stomach, nausea/vomiting; loss of appetite; difficulty in controlling blood sugar levels (which may lead to diabetes); skin reactions (such as rash, dry or itchy skin, temporary hair loss, or redness and swelling at the site of injection); temporary hair thinning; and trouble sleeping. Possible serious side effects include mental health problems such as depression, blood problems, infections, and problems with the lungs, eyes, immune system, and heart. Healthcare providers may treat these side effects, change the amount of medication, or stop treatment.
About Roche – More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world’s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche’s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche’s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: www.roche.com and U.S.: www.roche.us).
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August 3rd, 2005
Hepatitis Fighters
SourceURL:http://www.forbes.com
Peter Kang
In the stock market, the biotechnology sector is one of the more speculative places to put your money. Standard & Poor's reports that of the 340 biotech companies traded on U.S. exchanges, only 14 are consistently profitable.
But if you want to take a biotech gamble, try smaller companies focused on developing antiviral treatments, particularly cures for liver diseases. Why? Market opportunity.
One such family of ailments, hepatitis B (HBV) and hepatitis C (HCV), infects more than 5 million Americans, according to the Centers for Disease Control and Prevention. Hepatitis is the leading cause of chronic liver disease, the tenth major cause of death in the U.S. Some health experts predict that the death rate from the more deadly hepatitis C virus may surpass that of HIV/AIDS by 2015.
Idenix Pharmaceuticals (nasdaq: IDIX - news - people ) has promising drug candidates for both HBV and HCV. The company also boasts the support of Swiss drug giant Novartis (nyse: NVS - news - people ), which is co-developing a compound called Telbivudine for HBV.
According to Mark Schoenebaum, a biotech analyst with Bear Stearns, shares of Idenix, which carved out a new all-time high yesterday, could climb even higher if Novartis opts to take a stake in NM-283, an HCV treatment developed by Idenix.
"We believe NM-283 Phase IIb data in hepatitis C will be the most important event for Idenix this year," Schoenebaum said in a June 22 report. He expects positive data for NM-283 to be released by Idenix in September. He also thinks Idenix, which recently announced positive Phase III clinical trial data for Telbivudine, could see an upside spark in shares on a potential Novartis opt-in for NM-283.
While Idenix shows a lot of promise, security analysts reporting to Thomson First Call don't expect the company to deliver profits until 2007.
Vertex Pharmaceuticals (nasdaq: VRTX - news - people ), another company for which profits are still elusive, has a potential blockbuster drug in its HCV drug VX-950, currently in early-stage development. Vertex shares rose 20% on May 10 after the company's Phase I results showed that VX-950 was well tolerated by patients and demonstrated "potent antiviral activity," according to a Vertex release.
In a June 2 research report, Credit Suisse First Boston analyst Mark Augustine wrote that VX-950 "is the most exciting small-molecule HCV antiviral drug in the clinic," and estimates peak annual sales of more than $1 billion. Augustine said a recent alliance forged by Novartis and Anadys Pharmaceuticals (nasdaq: ANDS - news - people ) bodes well for Vertex. The deal, potentially worth $570 million (with an upfront payment of $20 million and milestone payments of up to $550 million), indicates a willingness on big pharma's part to invest in companies with early-stage hepatitis drugs, according to Augustine.
Investors might want to look at Valeant Pharmaceuticals (nyse: VRX - news - people ) (formerly known as ICN Pharmaceuticals), whose stock price has dropped 26% from a December high. In addition to tackling hepatitis, Valeant sells drugs for treating neurological and dermatological disorders and other infectious diseases. Its shares sell for 46 times their consensus 2006 forecast.
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August 4th, 2005
Doctor at Centre of Tainted Blood Scandal Will Stand Trial
www.cbc.ca
CBC News
A judge has ruled that Dr. Roger Perrault, the doctor at the centre of Canada's tainted blood scandal, will stand trial.
INDEPTH: Tainted blood
Perrault was the former national medical director with the Red Cross.
He faces several criminal charges for his alleged role in the tragedy that left thousands of Canadians infected with HIV or hepatitis C.
Last month Perrault's lawyer asked a Toronto court to drop the charges against him saying his client suffered from heart disease and the stress from the trial could kill him.
Perrault, 68, has had two heart attacks and open heart surgery. A cardiologist testified in court that in spite of the condition Perrault should be able to deal with the stress of even a long trial.
Perrault, the former director of blood transfusions, has been charged with four counts of criminal negligence causing bodily harm and one count of common nuisance endangering the public.
More than 1,000 Canadians were infected with HIV and up to 20,000 with hepatitis C after receiving tainted blood products from the charity in the 1980s and early 1990s. It was one of the worst public health disasters in Canada.
As of 1997, about 3,000 people had died.
The trial is scheduled to begin in November.
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IBTS Apologises for Withholding Hep C Test Results
SourceURL:http://breakingnews.iol.ie
The Irish Blood Transfusion Service has apologised to 33 blood donors who tested positive for Hepatitis C, but were not informed for several years.
The donors had tested positive for the illness in the early 1990s, but were not told by the IBTS until some years later.
The matter first came to light in 1996, at the time of the Finlay Tribunal into the infection of people with Hepatitis C through contaminated products supplied by the IBTS.
In a statement this morning, the service said it was deeply sorry for not informing the donors of that they had the illness as early as possible.
It said it would be contacting each donor individually over the coming week to pass on the apology.
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Get Tested
SourceURL:http://www.zwire.com/
By Susan Pagani
While Hep C infections climb dramatically, a downtown Hep C clinic struggles to find funding
The Metropolitan Health District estimates there are 20,000 cases of Hepatitis C in San Antonio, yet less than 25 percent know they're infected, and a clinic that could treat thousands of patients is understaffed and underfunded.
Hep C is a bloodborne virus that attacks the liver and, untreated, can cause liver disease, cancer, and failure. In Bexar County, about 4,000 new cases are reported annually.
The caseload overwhelmed gasteroenterology clinics at the University Health Center, prompting the need for a clinic devoted solely to treating Hep C. In 2000, it opened the Hepatitis Clinic, one of the few clinics that treats exclusively Hep C in South Texas, and the only one that treats low-income people and people without health insurance.
Prior to 1992, the most common way to contract Hep C was through blood transfusions. Today, that risk has virtually been eliminated with blood screening. Today people can contract Hep C through intravenous drug use and tattoos received with unsterile needles. People living with a Hep C-infected individuals should avoid sharing items such as razors, toothbrushes, and nail clippers to reduce the risk of exposure to infected blood.
Each month, the Hepatitis Clinic, staffed with two doctors - one full and one part-time - two physician assistants, and a clinic coordinator, sees 500-600 Medicare, Medicaid, and CareLink patients from all over the state (CareLink is Bexar County's insurance program for people who don't have health insurance and aren't eligible for Medicare or Medicaid).
Hep C treatments are expensive and intense, sometimes requiring patients to visit the clinic weekly, which is difficult, says Anastacio Hoyumpa, director of the Hepatitis Clinic, because the clinic is chronically underfunded and understaffed. In order to provide care for the high volume of patients it sees, the clinic relies on the tenuous goodwill of pharmaceutical companies and annual grants.
The clinic is working on outreach to get people at risk for Hep C to come in for testing. This year the clinic participated in National AIDS testing day, providing free Hep C rapid tests in conjunction with the San Antonio AIDS Foundation. "We don't talk about who has Hepatitis C, but who should be screened," says Hoyumpa. "In most cases, Hep C is discovered incidentally, when a patient comes in for some other procedure, such as a blood test."
The hard facts about Hepatitis C
Nationally
- More than 4 million people are infected with the disease, 2.7 million of them chronically
- 10,000 people die annually from complications of Hep C
- CDC projects the death rate will triple to 38,000 over the next 10 to 20 years
Locally
- 300,000 people are infected in Texas
- 20,000 are infected in San Antonio
- 3,000 new infections reported annually
- Hep C causes 80 deaths a year
- Hep C is detectable in antibody tests within 3 months of exposure.
Who should be tested?
Those who:
- Received a blood transfusion or organ transplant prior to 1992
- Used intravenous drugs
- Received long-term hemodialysis
- Received clotting factor prior to 1987
- Are health-care workers exposed to needles or sharps
- Were born to a Hep C-infected mother
- Have unprotected sex with multiple partners
- Received tattoos or body piercings with unsterile needles
- Have household exposure such as sharing a razor or toothbrushes with an infected person
NOTE: Hep C can only be contracted through exposure to blood. It can't be passed through saliva.
What does the liver do?
- Stores iron, vitamins, and minerals
- Produces bile to digest food
- Detoxifies air-born and ingested poisons (such as alcohol)
- Stores energy
- Manufactures proteins
- Regulates blood clotting
- Helps regulate the immune system
The American Liver Foundation 1-800-GO-LIVER
The Hepatitis Clinic, University Health Center 358-5832
Source: American Liver Foundation and the Center for Disease Control
According to the National Liver Foundation, at-risk groups for Hep C are diverse: from health-care workers exposed to Hep C-positive blood to people who received tattoos with unsterile needles to anyone who ever used intravenous drugs, even once. "It's a big mistake to think that this is a disease of drug users or a fringe element," says Bob Madison, a spokesman for the National Liver Association. "Soccer moms and CEOs are just as likely to have it as a rock 'n' roll freako with a tongue piercing and multiple tattoos."
Prior to 1996, it was common practice to vaccinate a group of soldiers using a jetgun without sterilizing it between patients. "The medics would move through a whole line of guys - by the time they got to guy 10, he was getting injected with the blood of nine guys," says Madison.
Once exposed, 85 percent of people infected will develop chronic Hep C. Untreated, a Hep C-infected person may take 10-40 years to develop cirrhosis depending on their general health and lifestyle. Cirrhosis, scarring or fibrosis of the liver, decreases liver function and increases the chance of liver failure and liver cancer. Yet, Hoyumpa says, "Even with cirrhosis, it's still not too late for treatment, as long as the person is not in liver failure."
The most successful treatment is a mixture of two drugs, pegylated interferon, an injection administered weekly, and ribavirin pills, which is generally prescribed for six months to a year. According to the National Liver Foundation, combination therapy costs $6,000-8,000 per patient, per year. While CareLink covers office visits and lab work, it does not pay for prescriptions; the Hepatitis Clinic works with three pharmaceutical companies that donate drugs. "The minute the drug companies say, We have given enough to the clinic," says Hoyumpa, "that will be the day that we close the clinic, because we can't treat any of those patients."
Follow-up visits comprise the bulk of the clinic's patient load. Patients are seen in the clinic once a week during the first two months of treatment. Even those who respond well experience difficult side effects: flu-like symptoms, fatigue, depression, and bouts of intense emotion. More severe side effects, which Hoyumpa says are "less common, but still our biggest fear, and something we have to monitor very closely," include suicidal thoughts and optic neuritis, inflammation of the optic nerve that causes vision loss and sometimes blindness.
Post-treatment patients must also be seen regularly to monitor liver function and cirrhosis, as must those who don't respond to or aren't qualified for treatment.
Patients with depression, diabetes, or heart and kidney disease, which can all be exacerbated by Hep C therapies, don't qualify for treatment. Similarly, people who use drugs, are obese, or drink alcohol - all of which contribute to liver disease - will not respond well to treatment. "I tell patients that drinking alcohol when you have Hep C is like pouring gasoline on a fire," says Hoyumpa, but he emphasizes that it's important for physicians to follow these patients. "In fact, greater effort should be exerted to make them a suitable patient."
The Hepatitis Clinic also offers a monthly support group, which provides yoga classes and emotional support, as well as lectures on issues such as social services and labor rights. "There are a lot of stigmas associated with Hep C," says Kashi. "Some people have lost their jobs jobs; they are fired because they are too sick to work during treatment. Some of our patients are shunned by their family members."
Today, the Hepatitis Clinic is funded through the University Physicians Group, which provides for the current staff level. Anything above that is funded through grants. According to Hoyumpa, who also works half-time at a similar clinic at the Veterans Administration Hospital, the clinic should have at least three physician assistants, but it recently lost one when a grant ended, which could result in patients waiting longer for appointments; at times the wait has been as long as six months. "We are looking for more grants," he says, "but the clinic sees so many patients that to be able to plan our programming and provide good care, we need stable salaries not dependent on grant money."
Hoyumpa has appealed to the city's elected officials for more funding. "We have approached the City Council and the county commissioners, but we haven't gotten anywhere. We have already saved the City millions in prevention, but the City would rather fund a soccer team."
Yet, if Hoyumpa is cynical about the future funding of the clinic, he is optimistic where the disease is concerned. "Ten to 15 years ago there were no treatments. Patients came to us with the feeling they were going to die," he says. "Today Hepatitis C is not a death sentence. There are effective treatments, and new drugs are coming on board. [Hep C treatments] are the subject of intense study. There is reason to hope."
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Genelabs Drug Discovery Team Advances Compounds against the Hepatitis C Virus in Preclinical Development
SourceURL:http://www.prnewswire.com
REDWOOD CITY, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB) today announced that a non-nucleoside compound from its internal Hepatitis C virus (HCV) drug discovery program has advanced into preclinical development. The compound, designated GL60667, is the second Genelabs non-nucleoside compound to advance into preclinical development. Genelabs also announced that the company has further advanced GL59728, its first non-nucleoside preclinical development candidate. Genelabs plans to initiate Good Laboratory Practices (GLP) preclinical studies on GL59728 which, if successful, would enable the company to file an Investigational New Drug Application (IND) for the compound. Genelabs retains all commercial rights to its non-nucleoside compounds.
Genelabs based its decision to advance compound GL60667 on rigorous pre-determined standards, including various measures of potency, metabolism, pharmacokinetics and toxicity. Genelabs believes that compounds meeting these criteria should hold a competitive advantage over other non-nucleoside HCV inhibitors described in the scientific literature. GL60667 has demonstrated the following properties in in vitro assays:
-- potency of approximately 40 nanomolar against an HCV replicon.
-- potency of approximately 20 nanomolar for inhibition of the HCV polymerase.
-- potency against the major genotypes of HCV, including genotype 1, the most common genotype in the United States and western Europe.
The concentration of GL60667 that is effective in reducing HCV replication is more than 100 times lower than the concentration that causes toxicity to various human cell lines, as demonstrated in a battery of tests conducted by Genelabs. Genelabs also has profiled the metabolic and pharmacokinetic properties of GL60667 in several different animal species. Extrapolating from this data, Genelabs believes the compound should be suitable for once-a-day dosing.
Separately, Genelabs advanced its first non-nucleoside preclinical candidate, GL59728, into IND-enabling studies based on favorable results from 1-day and 7-day toxicology studies in two animal species. Selection of a vendor for process development and large-scale synthesis is underway.
"The preclinical results generated to date from our hepatitis C virus drug discovery efforts demonstrate the depth and breadth of our research programs in this important and growing therapeutic area," stated James A.D. Smith, president and chief executive officer. "We know of only a handful of HCV drug discovery programs targeting the polymerase that have moved into preclinical development, and we believe ours has produced the most exciting results thus far. I am very pleased with the progress we have demonstrated towards our goal of developing best-in-class compounds targeting the hepatitis C virus."
In addition to its non-nucleoside HCV drug discovery program, Genelabs also has an HCV drug discovery program using nucleoside compounds under a September 2004 research collaboration and license agreement with Gilead Sciences, Inc.
Apart from the nucleoside and non-nucleoside HCV polymerase drug discovery programs, in 2004 Genelabs initiated a third HCV drug discovery program focusing on another target essential for HCV replication. This target is encoded by the region of the HCV genome known as NS5a. Genelabs believes compounds targeted at NS5a could lead to drugs that inhibit HCV by a novel mechanism. As such, these compounds may be particularly attractive for combination treatment regimens in HCV. In preliminary studies, Genelabs' small molecule compounds in this program can inhibit the HCV replicon with minimal toxicity to human cell lines. The company has generated initial lead compounds which are in the process of optimization.
About Hepatitis C
The Hepatitis C virus is an infectious and potentially fatal virus that can be contracted through blood and bodily fluid contact. The virus attacks the liver and can cause liver inflammation, liver scarring, liver failure and liver cancer. In most cases, the body is not able to fight off the infection and the infected individual becomes a chronic carrier of HCV. According to the World Health Organization, as many as 170 million people worldwide have chronic HCV infection. The United States Centers for Disease Control and Prevention estimates that approximately 2.7 million people in the United States are chronically infected with HCV and that each year there are approximately 25,000 new cases of HCV infection and approximately 8,000 to 10,000 deaths from hepatitis C complications. Liver failure resulting from chronic HCV infection is now recognized as the leading cause of liver transplantation in the United States. The current standard of care for treatment of HCV is a combination of pegylated interferon alpha and the nucleoside analogue ribavirin, typically given over a number of months, with interferon injected once weekly and ribavirin given orally once daily. This treatment regimen is effective only in approximately 50% of patients infected with HCV genotype 1, the genotype most prevalent in the United States. The interferon/ribavirin treatment has significant toxicities, most importantly severe anemia and psychiatric effects. There are no other drugs or biologics approved by the FDA for treatment of HCV. As a consequence, the pool of patients continues to grow.
About Genelabs
Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. Genelabs is currently concentrating its capabilities on developing a late-stage product for lupus, discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit http://www.genelabs.com.
NOTE: Genelabs(R) and the Genelabs logo are registered trademarks of Genelabs Technologies, Inc.
NOTE ON FORWARD LOOKING STATEMENTS AND RISKS:
Genelabs cautions that compounds in preclinical studies are at an early stage of development and there is no assurance that any of these compounds will successfully pass all the requirements necessary for studies in humans. This press release contains forward-looking statements including statements regarding the progress of Genelabs' hepatitis C virus research programs, the potency of compounds being developed by Genelabs and elsewhere, and the potential future properties of the compounds. These forward-looking statements are based on Genelabs' current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, failures or setbacks in our HCV research programs or in our collaboration with Gilead Sciences, Inc.; progress and announcements by competitors regarding their HCV programs; fluctuations in Genelabs' stock price; events which reduce Genelabs' future prospects; unexpected expenses and Genelabs' capital requirements and history of operating losses. Please see the information appearing in the Genelabs' filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions "Risk Factors" and "Forward-Looking Statements," for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward- looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.
Contact: Matthew M. Loar, Chief Financial Officer of Genelabs,
+1-650-562-1424.
SOURCE Genelabs Technologies, Inc.
Web Site: http://www.genelabs.com
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August 5th, 2005
Bile Acids not Beneficial in Liver Transplant Patients
SourceURL:http://www.gastrohep.com
Bile acids are well tolerated by liver transplant patients, but do not reduce all-cause mortality, retransplantation, or cellular rejection, however, do reduce chronic rejection in a fixed-effect model, reports the latest issue of the Cochrane Database of Systematic Reviews.
Liver transplantation has become a widely accepted form of treatment for numerous end-stage liver diseases.
Bile acids may decrease the degree of allograft rejection after liver transplantation.
This may occur by changing the expression of major histocompatibility complex class molecules in bile duct epithelium and central vein endothelium.
Dr Chen Gluud and colleagues assessed the beneficial and harmful effects of bile acids for liver-transplanted patients.
The research team performed searches of the Cochrane Hepato-Biliary Group Trials Register, CENTRAL, MEDLINE, and EMBASE to 2003.
The team also searched The Chinese Biomedical Database to 2002.
The researchers included all randomized clinical trials comparing any dose of bile acids or duration of treatment in liver-transplanted patients versus placebo.
Randomized clinical trials that compared bile treatment but had no intervention, or another intervention were also included.
The team included randomized clinical trials irrespective of blinding, language, and publication status.
6 out of 7 randomized trials identified evaluated ursodeoxycholic acid vs placebo – The Cochrane Database of Systematic Reviews
The researchers independently extracted and validated the data.
The methodological quality of the trials was evaluated from the method for generation of the allocation sequence, and allocation concealment.
The team also considered double blinding, and follow-up as part of the methodological quality assessment.
The team used intention-to-treat principle to perform meta-analyses.
The outcomes were presented as relative risk or weighted mean difference, both with 95% confidence intervals.
The research team identified 7 randomised trials, of which 6 evaluated ursodeoxycholic acid versus placebo or no intervention.
A further 1 of these trials evaluated tauro-ursodeoxycholic acid versus no intervention with a total of 335 liver-transplanted patients.
The team noted that the administration of bile acids began 1 day or more after liver transplantation.
All patients received the standard triple-drug immunosuppressive regimen of steroids, azathioprine, and cyclosporine or tacrolimus.
The triple-drug regimen was used to suppress the allograft rejection response after liver transplantation.
The team found that bile acids did not significantly reduce all-cause mortality, or mortality related to allograft rejection.
In addition, the team found that bile acids did not reduce retransplantation, acute cellular rejection, or number of patients with steroid-resistant rejection.
Bile acids significantly reduced the number of patients who had chronic rejection in a fixed-effect model but not in a random-effects model.
The researchers noted that bile acids were safe and well tolerated by liver-transplanted patients.
Dr Gluud's team concludes, “Bile acids do not seem to have significant beneficial effects in liver-transplanted patients.”
Cochrane 2005:3: Art. No.: CD005442. DOI: 10.1002/14651858.CD005442
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Hepatic Iron Overload Reduces Liver Transplant Survival
SourceURL:http://www.gastrohep.com
Research in August's issue of Gastroenterology has confirmed that 1- and 5-year survival after liver transplant is lower in patients with hepatic iron overload, presenting with or without HFE-associated hemochromatosis.
Previous uncontrolled studies have suggested that patients with hepatic iron overload have a poor outcome after liver transplantation.
Dr Kris Kowdley and colleagues examined the effect of HFE mutations on post-transplantation survival in patients with hepatic iron overload.
The researchers enrolled 260 patients with end-stage liver disease and hepatic iron overload from 12 liver transplantation centers.
The team recorded hepatic iron concentration, hepatic iron index, HFEmutation status, and survival after liver transplantation.
HFE-associated hemochromatosis was defined in 14 patients as homozygosity for the C282Y mutation.
In 11 patients, the team defined HFE-associated hemochromatosis as compound heterozygosity for the C282Y/H63D mutation.
The HFE-associated hemochromatosis mutations were identified in 13% of patients.
After age adjustment, HFE-associated hemochromatosis had a hazard ratio for death of 3 – Gastroenterology
The researchers found that survival post-liver transplantation was significantly lower among patients with HFE-associated hemochromatosis.
The 1-, 3-, and 5-year survival rates in these patients were 64%, 48%, 34%, respectively compared with simple heterozygotes or wild-type patients.
The researchers observed that patients with HFE-associated hemochromatosis had a hazard ratio for death of 3 after adjustment for age.
The hazard ratio for mortality remained the same after adjusting for United Network for Organ Sharing status, year of transplantation, and either elevated hepatic iron index or iron concentration.
The team noted that non-HFE-associated hemochromatosis patients with hepatic iron overload had decreased survival versus the overall population undergoing liver transplantation.
Dr Kowdley's team concludes, "1- and 5-year survivals after liver transplantation are significantly lower among patients with HFE-associated hemochromatosis."
“Our data also suggest that hepatic iron overload may be associated with decreased survival after liver transplantation, even in patients without HFE-associated hemochromatosis.”
“Early diagnosis of hepatic iron overload using HFE-associated hemochromatosis gene testing and iron depletion prior to liver transplantation may improve post-transplantation survival, particularly among patients with HFE-associated hemochromatosis.”
Gastroenterol 2005: 129(2): 494-503
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Treatment for Renal Dysfunction in Liver Transplants
SourceURL:http://www.gastrohep.com
The latest Transplantation issue shows that in liver transplantation recipients with renal dysfunction, mycophenolate mofetil allows nephrotoxic calcineurin inhibitors dose reduction, and stabilizes glomerular filtration rate in most patients.
Liver transplantation recipients with renal dysfunction may benefit from mycophenolate mofetil and reduction or discontinuation of nephrotoxic calcineurin inhibitors.
Dr David Reich and colleagues report the first randomized, multicenter pilot studies of this approach, 1 in cyclosporine and 1 for those on tacrolimus.
The investigative team included patients 3 to 27 months post-liver transplantation with greater than 20% reduced renal function since the operation.
The patients also had creatinine 1.8 to 4.0 mg/dL, creatinine clearance 20 to 60 mL/min, or both.
Patients were randomized to discontinuation in Group 1 or to a 50% reduction of nephrotoxic calcineurin inhibitors dose, with mycophenolate mofetil 1.5 g twice daily and prednisone in Group 2.
The team included endpoints that measured glomerular filtration rate 52 weeks after study entry and biopsy-proven rejection.
In the cyclosporine and tacrolimus trials, 15 and 12 patients, respectively, completed the 52-week follow-up.
The mean glomerular filtration rate in the cyclosporine trial changed from 35 to 58 mL/min at week 52 – Transplantation
In the cyclosporine trial, the team found that the mean glomerular filtration rate at baseline and week 52 were 35 and 58 mL/min for Group 1.
The investigators noted that the mean glomerular filtration rate at baseline and week 52 for Group 2 were 46 and 64 mL/min.
In the tacrolimus trial, glomerular filtration rates were 55 and 56 mL/min for Group 1 vs 46, and 60 mL/min for Group 2, at baseline and week 52, respectively.
The investigators noted that mild or moderate rejection occurred in 38% and 9% of patients in Groups 1 and 2 of the cyclosporine trial.
Mild or moderate rejection in the tacrolimus trial occurred in 14% of each group of the patients.
Dr Reich's team concludes, “These pilot studies show that in liver transplantation recipients with renal dysfunction, mycophenolate mofetil allows nephrotoxic calcineurin inhibitors dose reduction or discontinuation.”
“It also improves or stabilizes glomerular filtration rate in most patients.”
Transplant 2005: 80(1):18-25
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LOLA to Host NYC Hepatitis C 'March for Awareness'
SourceURL:http://biz.yahoo.com
City Council Majority Leader Joel Rivera to Lead Entire City Council in Welcoming LOLA Supporters and Hepatitis C Advocacy Community to the Steps of City Hall
NEW YORK, Aug. 5 /PRNewswire/ --
WHO:
* Debbie Delgado Vega, Founder & CEO, Latino Organization for Liver Awareness (LOLA)
* The Hon. Joel Rivera, Majority Leader of the New York City Council
WHAT:
Will lead hundreds of concerned New Yorkers in a march to City Hall to raise awareness about the importance of getting tested and treated for the Hepatitis C virus (HCV). The number one epidemic in the world, Hepatitis C is a blood-borne virus that has infected nearly 200,000 to 300,000 New York City residents, of whom 40% are Latino. It is a silent killer, which has become the leading cause of liver transplants in the United States.
LOLA CEO Debbie Delgado-Vega, herself a liver transplant recipient, will lead the march from Battery Park to City Hall, along with the family of the young man whose liver she received. They will be joined by elected officials, doctors, leading HCV and public health advocates, substance abuse treatment providers, and private citizens who either live with the disease or know someone who suffers from the Hepatitis C virus.
The march will kick off LOLA's 2nd Bilingual Hepatitis Public Education Get Tested, Get Treated campaign. Since 1998, LOLA has raised over $1.5 million in private funds to provide Hepatitis C prevention, education and treatment referral services that have helped thousands of New Yorkers fight this deadly disease. The first bilingual/bicultural organization in the nation, LOLA is committed to reaching as many New Yorkers as possible over the next year, particularly underserved populations suffering from liver disease and/or are in need of a liver transplant.
WHEN:
August 9, 2005, Pre-event festivities 11:00; March: 12 Noon (Sharp)
WHERE:
Battery Park, opposite 17 State Street in Manhattan
CONTACT:
Sarah R. Bisconte/Experti/914-948-8144, ext. 232/914-310-0467 (cell)
Cecilia Santana/Experti/914 948-8144, ext. 233/646-326-7956 (cell)
Source: Latino Organization for Liver Awareness (LOLA)
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August 6th, 2005
Ignorance Thwarts Hepatitis C Fight
SourceURL:http://health.dailynewscentral.com
'There's nothing that hits you like a ton of bricks. You put a lot of it -- tiredness, intolerance to alcohol -- down to the effects of aging. I thought maybe I just [needed my cholesterol checked].' Carriers of hepatitis C are going undiagnosed and missing new treatments because of ignorance and stigma, says a medical researcher. Dr. Ian Sheerin, of the Christchurch School of Medicine and Health Sciences, said general practitioners did not actively offer testing, and some patients preferred not to know.
"There seems to be an old view that there's nothing you can do about it, but there are some very good treatments now," he said.
Last year, Pharmac began funding a new combination therapy medication for hepatitis C, called pegylated interferon. Treatment had a success rate as high as 80 percent for some types of hepatitis C infection.
Contact with Infected Blood
As many as 30,000 New Zealanders are thought to have the disease, spread by contact with infected blood.
It is known as the "silent epidemic" because some never develop symptoms and it is thought fewer than 30 percent have been diagnosed.
Sheerin said there was a need for specialized GP clinics to test people and provide follow-up education, support and ongoing laboratory testing for liver function. He cited a successful example in Wellington that ran in conjunction with the needle-exchange program.
Because up to 80 percent of infections were associated with injecting-drug use, many affected people felt marginalized from society and did not like to go to a regular GP, he said.
Hepatitis Foundation chief executive John Hornell said all GPs should offer testing, so infected people could be monitored and treated.
Some people would have forgotten about illicit drug use in their past, he said.
Treatment Cleared Virus
"A lot of professional people did it in the 1970s when heroin came in, and I know of people who've got hep C who only injected once."
Bill Jang, 50, had hepatitis C for 25 years before he was diagnosed. His symptoms were "subtle and non-specific."
"There's nothing that hits you like a ton of bricks. You put a lot of it -- tiredness, intolerance to alcohol -- down to the effects of aging. I thought maybe I just [needed my cholesterol checked]."
Jang said he had injected drugs as a teenager. Although clean now, his condition was worsened by heavy drinking in his 20s and 30s.
After two courses of treatment in his 40s, he was clear of the virus.
Can Go Undiagnosed for Decades
Jang, who is manager of the Hepatitis C Resource Center in central Christchurch, said people needed to realize the infection was more of a problem than many thought.
"A lot of people my age have almost forgotten they put themselves at risk in the '70s and '80s," he said.
"We also need to upskill doctors a lot better so they can learn to monitor it."
Jang said the resource center needed more resources to employ paid educators.
About 4,000 people are affected by hepatitis C in Christchurch. The city has the most injecting-drug users per capita in the country.
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