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Week Ending: May 28th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Needle Sharing Fuels Prison Hep C Epidemic
• Government to Subsidise Hepatitis Drug
• Hepatitis C Sufferers Urged to Access Treatment
• The ABC's of Viral Hepatitis
• Steroid-Free Regimen with Cellcept Found Comparable to Standard Therapy in Liver Transplantation
• Ministry Denies Shutting Out Foundation
• Indiana Nixes Transplant from Death Row Inmate
• Get Real about Hepatitis C, Pammy
• ViroPharma Announces Advancement of HCV-796 into Phase 1B Clinical Testing in Hepatitis C Patients
• Not All Hepatitis B Patients Show Symptoms of Disease
• Gravely Ill Doctor Left Waiting for New Liver
• Study Shows Using Expanded Criteria Donors Is Safe, University of Pittsburgh
• Model of End-Stage Liver Disease Predicts Hepatorenal Syndrome Prognosis
• Benitec to Present Preclinical Data on Its Hepatitis C Virus Program at the American Society for Gene Therapy Meeting
• Cluster of HCV and LGV Identified amongst Gay Men in the Netherlands
• Hepatitis C Has a High Cure Rate
• New Medication for Hepatitis C
• Hepatitis C Awareness Week
• Prison Staff Fear Sickly Inmates
• Talecris Biotherapeutics Becomes First Plasma Fractionator to Perform in-house HBV Screening Using FDA-Licensed Protocol
• Factors Affecting Long-Term Outcomes of Orthotopic Liver Transplants
• Health Officials Send Out Warning about Tattoo Parties
• Schering-Plough Announces Results of Chronic Hepatitis C Survey
May 23rd, 2005
Needle Sharing Fuels Prison Hep C Epidemic
SourceURL:http://www.theage.com.au/
By Misha Schubert
Political Correspondent, Canberra
Rampant needle sharing and a lack of funds for health treatment inside prisons are fuelling Australia's hepatitis C epidemic, posing a risk to the rest of the community.
The warning comes in a draft copy of the Howard Government's new hepatitis C strategy, obtained by The Age, which is due to be released mid-year.
Experts warned the Government two years ago that its last strategy had failed to bring the epidemic under control. About 250,000 Australians have the disease, and 16,000 are estimated to contract it each year.
Advocates have warned more money is needed to curb the disease's spread, and to cure many of those who already have it.
Despite Health Minister Tony Abbott's anti-drug views, the draft strategy endorses a "harm minimisation" approach. It warns that without a substantial increase in treatment, the number of people with hepatitis C-related cirrhosis may triple to 26,000 by 2020.
Citing a lack of needle exchanges and health care in prisons as a risk to the whole community, it says many prisoners admit to injecting themselves with used needles. As many as four in 10 prisoners have hepatitis C, according to the strategy and seven in 10 women prisoners.
A spokeswoman for Mr Abbott said yesterday the final report would be released by mid-year, but refused to say if any extra funds would be committed. This week is the first National Hepatitis C Awareness Week.
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Government to Subsidise Hepatitis Drug
SourceURL:http://www.nzherald.co.nz
A Government subsidy for a hepatitis B drug will mean an extra 200 people suffering from the disease will be eligible for treatment.
The state's drug-buying agency, Pharmac, says that from June 1, people with the liver infection who are undergoing chemotherapy will be able to have the drug lamivudine fully subsidised.
Pharmac medical director Peter Moodie said the funding decision recognised a need identified by clinicians.
"This decision meets a clinical need," Dr Moodie said.
"Our advice is that there is about a 20 to 50 per cent chance that chemotherapy will reactivate the hepatitis B virus in people who carry it.
"This decision will help avoid that occurring and the subsequent liver damage that can result."
Dr Moodie said extending funding of lamivudine to people in that group would see about 200 additional people treated each year, at a total cost over five years of about $800,000.
- NZPA
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Hepatitis C Sufferers Urged to Access Treatment
SourceURL:http://www.abc.net.au/
Treatment for people with hepatitis C has up to a 90 per cent success rate but just one in five Australians eligible for treatment are accessing it.
The blood-borne disease affects the liver, and about 5 per cent of people with hepatitis C develop liver cancer.
The Hepatitis Council warns that unless there is an increase in the number of people undertaking treatment, there will be 25,000 Australians with hepatitis C-related cirrhosis of the liver by 2020.
The council aims to use this week's national awareness week to educate GPs and the public about advances in treatment.
Chairman of the Ministerial Advisory Committee on Aids, Sexual Health and Hepatitis, Dr Michael Wooldridge, says hepatitis C is no longer necessarily a life-long illness.
"We now do know that for some people there's almost a 90 per cent chance of a cure and across the whole population of people with hepatitis C a 60 per cent chance of a cure," he said.
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The ABC's of Viral Hepatitis
SourceURL:http://www.manilatimes.net
By Jun R. Ruiz, M.D.
THE term "hepatitis" refers to a condition involving the inflammation of the liver. Most patients equate hepatitis with viral hepatitis, though viruses are not the only causes. The other common causes are alcohol, drugs and toxins.
Hepatitis can be spread by eating or drinking contaminated food or water.
Not all types of viral hepatitis are created equal. There are currently five known types of viral hepatitis. Hepatitis A is a self-limiting disease, while Hepatitis B and Hepatitis C can lead to cirrhosis (scarring of the liver) and liver cancer. The signs and symptoms of the different types of viral hepatitis may be similar, and only blood tests can establish the definitive diagnosis.
A: Hepatitis A is a liver disease caused by the Hepatitis A virus (HAV). HAV is found in the feces of persons with Hepatitis A. Thus, this disease is transmitted through the fecal-oral route. Patients with Hepatitis A can have yellowing of the skin and eyes (jaundice), abdominal pain, fatigue and loss of appetite.
Among the persons at risk for infection are household and sexual contact with infected persons, men who have sex with men, intravenous drug abusers, and persons traveling to countries where Hepatitis A is common.
Since Hepatitis A is a self-limiting disease, there is no chronic hepatitis condition. There is no progression to chronic hepatitis, cirrhosis, or liver cancer.
Good personal hygiene and proper sanitation can help prevent Hepatitis A. It is advisable to always wash your hands with soap and water after using the bathroom, changing a diaper, and before preparing and eating food. Vaccines are available for prevention of Hepatitis A virus infection.
B: Around 400 million people worldwide are affected with Hepatitis B infection, caused by the Hepatitis B virus (HBV). The virus is transmitted through unprotected sexual intercourse, intravenous drug use, blood transfusions, or during delivery from the mother to her child. The patient’s complaints are similar to Hepatitis A, though about 30 percent of patients do not have signs or symptoms at the time of infection.
Chronic infection can occur and is age-dependent. Ninety percent of infants affected at birth develop chronic Hepatitis B. On the other hand, only 6 percent of patients above 5 years of age develop chronic infection.
Among the high risk groups for Hepatitis B are: sex contacts of infected persons, persons with multiple sex partners, men who have sex with men, intravenous drug abusers, household contacts of chronically infected persons, infants born to infected mothers, health care and public safety workers, and hemodialysis patients.
Hepatitis B vaccine is the best protection against developing Hepatitis B. Consistent and proper use of condoms can reduce transmission of the virus. Pregnant women should undergo screening for Hepatitis B. Intravenous abuse of drugs and sharing of needles should be avoided. Infants born to HBV-infected mothers should be given immune globulin and vaccine after birth. If you have or had Hepatitis B, do not donate blood, organs, or tissue.
Some persons with chronic Hepatitis B benefit from treatment with medications like pegylated interferon, lamivudine and adefovir. However, sustained response to therapy is less than 30 percent.
C: Hepatitis C is caused by an infection of the Hepatitis C virus (HCV). An estimated 3 million Americans are chronically infected with HCV. Eighty percent have no symptoms, but symptomatic patients develop jaundice, fatigue, abdominal pain and nausea. The virus is transmitted during blood transfusion, sharing of needles, or from an infected mother to her baby during birth. Unlike Hepatitis B, 85 percent of patients with acute infection will develop chronic disease.
Persons at risk for this disease include intravenous drug abusers, recipients of blood transfusion or solid organ transplant before July 1992, recipients of clotting factors made before 1987, and those on long-term kidney dialysis.
There is no vaccine to prevent Hepatitis C. If one is a health care or public safety worker, always follow routine barrier precautions and safely handle needles and other sharps. Always consider the risks of intravenous drug use, sharing of needles, and getting a tattoo or body piercing. The Hepatitis C virus can be transmitted via sex, but this is rare.
The combination of pegylated interferon and ribavirin is the standard treatment in chronic hepatitis C.
D: Hepatitis D is a liver disease caused by the Hepatitis D virus (HDV). This virus is a defective virus that needs the HBV to exist. Hepatitis D is very uncommon in China and Southeast Asia. The symptoms of Hepatitis D are similar to the other viral hepatitis diseases. The mode of transmission is similar to Hepatitis B, though prenatal transmission is rare.
HDV can be acquired either as a co-infection (occurring simultaneously with acute Hepatitis B infection) or as a super-infection in persons with existing chronic HBV infection. HBV-HDV co-infection has more severe acute disease, while patients with HBV-HDV superinfection usually progress to chronic HDV infection and cirrhosis.
Vaccination with Hepatitis B vaccine can prevent Hepatitis D co-infection, since a person cannot get Hepatitis D without concomitant Hepatitis B infection. Reducing risk behavior in Hepatitis B patients will reduce risk for Hepatitis D superinfection.
E: Hepatitis E is a liver disease caused by the Hepatitis E virus (HEV) transmitted in much the same way as Hepatitis A virus (fecal-oral route), spread by eating or drinking contaminated food or water. Most outbreaks are associated with drinking contaminated water. Hepatitis E, however, has not been reported in our country, and more common in India. Symptoms include jaundice, abdominal pain, nausea and fatigue.
High-risk persons are usually between 15 to 40 years old, and travelers to endemic areas. Severe disease is usually found in pregnant women in their third trimester.
There is no chronic condition for Hepatitis E. Treatment is supportive. Proper hygiene and avoidance of contaminated food and water are strongly recommended.
Dr. Ruiz is a Diplomate in Gastroenterology and Internal Medicine of the American Board of Internal Medicine and a Diplomate in Internal Medicine of the Philippine College of Physicians. He is a consultant at the St. Luke's Medical Center and MTECH Medical Center and associate editor of the Philippine Journal of Internal Medicine. He has authored several book chapters and published medical articles in peer-reviewed international journals.
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Steroid-Free Regimen with Cellcept Found Comparable to Standard Therapy in Liver Transplantation
SourceURL:http://www.eurekalert.org
No increase found in hepatitis C recurrence
Researchers seeking to enhance transplant patient care with less toxic drug regimens presented early findings of a steroid-free treatment regimen in liver transplant recipients with hepatitis C. One-year data from an open label study reported Sunday at the American Transplant Congress (ATC) suggests that a steroid-free treatment regimen including CellCept® (mycophenolate mofetil) provided comparable efficacy and safety to a standard steroid-containing protocol. CellCept is approved for the prevention of organ rejection in combination with cyclosporine and corticosteroids in patients receiving kidney, heart and liver transplants.
Steroids have been a cornerstone of transplant therapy for the past 50 years. However, long-term steroid use has shown significant side effects, which can include bone and muscle problems, eye disease, delayed wound healing and decreased ability to fight infection. For patients with hepatitis C, steroids are widely recognized to have an adverse effect on virus replication, putting them at an increased risk for hepatitis C recurrence following liver transplantation.
"The question has always been: how do we achieve the right balance of immunosuppression to prevent acute rejection without over-suppressing the immune system, which would allow hepatitis C virus to rapidly replicate?" said Goran Klintmalm, M.D., principal investigator, who is Chief and Chairman of the Baylor Regional Transplant Institute, Baylor University Medical Center, Dallas. "In our study, the steroid-free CellCept regimen demonstrated comparable efficacy, without increasing the risk of hepatitis C recurrence. We are encouraged by these trends at one year."
Study Background and Results1
A total of 312 adult hepatitis C liver transplant patients participated in the open-label, prospective multicenter study. Patients were randomized to one of three treatment regimens: tacrolimus and prednisone (arm one); CellCept, tacrolimus and prednisone (arm two); or CellCept, tacrolimus, and three-dose Zenapax® (daclizumab) without steroids (arm three). Primary endpoints in the study were clinically significant differences in acute cellular rejection (ACR) and/or clinically significant differences in hepatitis C recurrence. Acute rejection rates were 16%, 9% and 5% in the three arms, respectively.
A total of 151 patients had one-year follow-up data available for the preliminary analysis presented at ATC. Study results found that hepatitis C recurrence was comparable across all arms. Additionally, the CellCept-based steroid-free regimen was comparable to the standard steroid-containing regimens in organ survival, patient survival and incidence of adverse events (infections, malignancies, hyperlipidemia and diabetes).
Additional Study Underway
"With transplant physicians around the world using CellCept for more than a decade to prevent organ rejection in their transplant patients, Roche is looking to the future," said Robert Gordon, M.D., senior medical director at Roche and a former transplant surgeon. "We're evaluating new, low-toxicity regimens with CellCept that we hope will further improve patient outcomes."
Roche recently initiated the Liver Spare the Nephron (STN) study, a prospective, open-label randomized trial to evaluate low toxicity regimens including CellCept. The study will take place in more than 35 transplant centers in the U.S. and Canada. The study, which will recruit 340 liver transplant recipients, is designed to evaluate the efficacy and safety of a regimen of CellCept with either sirolimus or standard calcineurin inhibitors (CNI). Investigators will evaluate the effect of these regimens on preservation of renal function and prevention of acute rejection, organ loss and patient survival.
CellCept – A Cornerstone of Treatment for 10 Years
CellCept is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants. Ten years after its approval by the FDA, CellCept is the most frequently used branded immunosuppressant in the United States with more than four million prescriptions filled. CellCept received FDA approval for the prevention of organ rejection in transplanted kidneys in 1995, in hearts in 1998 and in livers in 2000.
The FDA approved dosages for CellCept are: for adult kidney transplants, 2 g daily; for pediatric kidney transplants, oral suspension 600 mg/m2; for adult heart and liver, 3 g/day.
Additional CellCept Information
There are no adequate and well-controlled studies in pregnant women. As CellCept (mycophenolate mofetil) has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy.
Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information).
Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leukopenia , thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.
Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
Warning: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. For full prescribing information, visit www.rocheusa.com/products/cellcept/pi.html.
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 worldwide. For further information, please visit our worldwide and U.S. websites (Global: www.roche.com and U.S.: www.roche.us).
1 Fasola CG, Klintmalm GB, et al. Abstract #475: "Multicenter Randomized Hepatitis C (HCV) Three Trial Post-Liver Transplantation (OLT): A One-Year Follow-Up Report."
2 Patients should be monitored for neutropenia. Dosing should be interrupted or the dose reduced if neutropenia develops.
Contact: Adam Pawluk
adam.pawluk@ketchum.com
917-847-8488
Ketchum
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May 24th, 2005
Ministry Denies Shutting Out Foundation
SourceURL:http://home.nzcity.co.nz
Health Ministry insists it has not shut out the Haemophilia Foundation by leaving it out of bad blood working group
The Health Ministry denies shutting out the Haemophilia Foundation from the bad blood compensation claim process.
Around 170 haemophiliacs are demanding compensation after contracting Hepatitis C from untested blood.
Donor blood was not screened until after 1992.
The ministry has set up a working party to evaluate whether the people affected should be compensated after a submission by the Haemophilia Foundation.
However, the Foundation is not represented on the working group and is accusing the ministry of not taking the claim seriously. .
The ministry says it is an internal group, considering the factual aspects of the Foundation's submission.
The Crown Law Office will consider all the material before advising the Government.
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Indiana Nixes Transplant from Death Row Inmate
SourceURL:http://www.reutershealth.com
CHICAGO (Reuters) - Indiana officials recommended on Friday that a man facing execution next week should not get clemency, a decision that could end his attempt to donate part of his liver to his sister.
Gregory Johnson, 40, had asked for clemency for legal reasons, or a delay in his May 25 execution date so the transplant could take place.
A spokeswoman for the Indiana Parole Board said the panel's four members voted unanimously to recommend that Johnson be denied clemency. There was no separate vote on a stay, she said.
The final decision on clemency or a stay will be up to Gov. Mitch Daniels who has given the go-ahead to two other executions in the state since taking office earlier this year.
Johnson was sentenced to death for killing an 82-year-old woman during a home break-in in 1985. His 48-year-old sister, Deborah Otis, has said she would like a partial liver transplant from her brother.
Her organ is afflicted with nonalcoholic cirrhosis, though she is not currently on a transplant waiting list because of a temporary medical complication.
During a hearing before the parole board, Johnson's lawyer said blood tests found his liver would be compatible with his sister.
Johnson contended the lethal injection of chemicals used for executions would poison the organ, making a post-execution transplant impossible. There was disagreement among medical experts on whether that would be the case.
If Johnson donates part of his liver, it could take up to two months for him to recover enough to return to death row.
Transplant requests from death row prisoners in the United States have occurred before, though they are unusual, according to Richard Dieter, executive director of the Death Penalty Information Center.
In 1995, a condemned Delaware man donated a kidney to his mother, and returned to death row. In Alabama, a prisoner awaiting execution won permission for an organ donation, but he was not a correct match, Dieter said.
In a Florida case, an inmate was denied a request to donate a kidney to his brother. The condemned man was later exonerated and released from jail, but his brother died waiting for a transplant, Dieter said.
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Get Real about Hepatitis C, Pammy
SourceURL:http://www.abc.net.au
Presenter: Peter Eustace & Amelia Chappelow
Imagine checking your diet every day, and keeping secrets from your friends and work colleagues.
You have to think about the condition of your liver for the rest of your life.
For someone who lives with Hepatitis C the diagnosis can be life changing.
"Once people have Hepatitis C it means for many people that you have it for the rest of their life," says Helen McNeil, the Executive Officer with the Hepatitis C Council of Victoria.
But for many people, living with the condition can be very isolating, even more so for people with Hepatitis C in Gippsland.
"It's a highly stigmatised condition and often people can feel quite lonely and isolated when they are diagnosed," says Helen.
"It's not something they are comfortable talking to their family and friends about."
"We know that there's 63, 000 people in Victoria who are affected specifically by Hepatitis C," she says.
"In 2004 there were 132 people diagnosed with Hepatitis C in Gippsland alone, and that's quite a significant number."
"And if you compare that figure to HIV, where we've had 217 people newly diagnosed for the whole state in 2004, 132 people in an area like Gippsland is quite large."
While the condition is life altering in some ways, many people with Hepatitis C can live happy and healthy lives.
But reaching out for help is sometimes embarrassing.
"We hear that people are worried about accessing care and support because they have concerns about being discriminated against or they feel the stigma so strongly," says Helen.
"So it makes people feel isolated."
"Treatment isn't an easy path for people," she says, "but it's now available in the Gippsland area."
"Before people had to go to Melbourne to be considered for treatment," says Helen, but now there are high success rates for treatment so it's expanded to regional areas.
If you know someone who is affected with the condition or you are feeling unsteady about talking about your diagnosis with Hepatitis C there are people who can help at the Latrobe Community Health Service.
And we can all do our bit to ease the sensitivity.
"Hepatitis C is strongly associated with injecting drug use, and that means for a lot of people they don't like to talk about it," says Helen.
"I think we can help by encouraging people to feel ok to talk about it," she says, "Understanding more about the condition, finding out more about it, all helps misinformation."
"A lot of people think that it's really easily spread to other people in general situations like kissing or hugging," she says, but "you can't get Hepatitis C through cups or general household contact, there has to be blood present before you can actually get Hepatitis C."
"If you get that sort of information you will really help someone with Hepatitis C," says Helen.
An American celebrity who has spoken openly about her diagnosis with Hepatitis C has been Baywatch actor Pamela Anderson.
Helen McNeil says having a celebrity living with the condition has made people more aware of Hepatitis C, but she says, "It's been a bit of a mixed blessing with our friend Pamela."
"When talking about Pamela Anderson's condition the media has quite often reported that people will die within ten years because of the Hepatitis C, but deaths from the condition are actually a very small number," says Helen.
"We must remember that it's not just one particular group in our community as it's often stigmatised, it's right across the community."
"Before 1990 some people got Hepatitis C from the blood supply," says Helen, "so Hepatitis C is widespread and people need to realise that."
It's National Hepatitis C Awareness Week, and if you'd like to learn more about Hepatitis C you can contact either the Hepatitis C Council of Victoria on 1800 703 003 or dial up Latrobe Community Health Service.
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ViroPharma Announces Advancement of HCV-796 into Phase 1B Clinical Testing in Hepatitis C Patients
SourceURL:http://au.biz.yahoo.com
EXTON, Pa., May 24, 2005 (PRIMEZONE) -- ViroPharma Incorporated (Nasdaq:VPHM) today announced the commencement of a Phase 1b proof of concept clinical study in hepatitis C positive patients with HCV-796, a novel antiviral compound that the company is co-developing with Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE). HCV-796 is a potent orally dosed compound that has the potential to interfere with the replication of hepatitis C virus (HCV). Preclinical studies have shown that HCV-796 is the most potent of all anti-HCV compounds developed to date between the two companies.
"Throughout the history of our partnership, ViroPharma and Wyeth Pharmaceuticals together have identified a series of compounds targeting the hepatitis C virus. HCV-796 is by far the most potent, demonstrating nanomolar potency in replicon containing cells and significant activity in a mouse model of HCV infection," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "In our recently completed single dose study, escalating doses of HCV-796 were well tolerated with favorable pharmacokinetics, consistent with our experience of a predecessor molecule. With HCV-796, we also have the major advantage of at least a 22-fold increase in potency, based on replicon data. We are very encouraged as we expeditiously move forward with this compound, and expect to have data from this trial in the fourth quarter of 2005."
Preclinical Data
To date, HCV-796 has demonstrated potent efficacy in inhibiting viral replication in cell-based assay systems and in an animal model for hepatitis C. In these studies, HCV-796 antiviral activity was highly selective and significantly reduced HCV RNA levels in an in vitro replicon assay, a cell-based system in which the antiviral activity of a compound can be tested against HCV RNA replicating in a human cell line, with an EC50 (the effective concentration at which viral replication is reduced by 50 percent) of 5nM against genotype 1a and 9nM against genotype 1b. This represents a 128-fold and 22-fold increase in potency, respectively, compared to data generated for the predecessor molecule HCV-086.
In addition, HCV-796 has shown significant antiviral activity as a single agent in chimeric mice that support HCV infection, and appears to be additive with interferon alpha as a combined treatment.
Phase 1b Study Design
This clinical trial is a randomized, double blind, multiple ascending dose, placebo controlled study at a leading clinical research facility in the United States involving 96 patients naive to treatment with chronic HCV infection. In the study, patients will be given multiple ascending oral doses of HCV-796 for fourteen days. The study will assess the antiviral activity, safety, and pharmacokinetic profile of the drug compared to placebo.
ViroPharma and Wyeth have completed a single dose, placebo controlled, dose escalation Phase 1 trial with HCV-796, to assess the safety, tolerability and pharmacokinetics of the compound administered orally to healthy volunteers. Preliminary data from this single dose trial indicate that HCV-796 was well tolerated at all doses tested, with a favorable pharmacokinetic profile.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) Pulvules(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at www.viropharma.com.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development program as well as its ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. Also, there is no validated animal or other preclinical model for HCV, and thus preclinical results for HCV-796, including animal efficacy data, are not necessarily predictive of safety or efficacy in the humans. There can be no assurance that ViroPharma's HCV studies can be conducted within the timeframe that the company expects, that such studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-K for the year ended December 31, 2004 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
CONTACT:
ViroPharma Incorporated
Will Roberts, Director, Corporate Communications
(610) 321-6288
Source:ViroPharma Incorporated
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Not All Hepatitis B Patients Show Symptoms of Disease
SourceURL:http://www.floridatoday
ROSEMARY and TIMOTHY LAIRD
ASK THE DOCS
DEAR DOCS: Please provide information about hepatitis B. My husband's recent blood donation was rejected because tests revealed the disease. His doctor tested him and "found nothing." Is this a concern?
ANSWER: Your husband's blood may show evidence of past hepatitis B infection, making him ineligible for blood donation. He may not, however, have evidence of active liver damage, explaining the doctor's reassurance.
Hepatitis B is a viral infection acquired through bodily fluid contact (sex, IV drugs and transfusions). It can be a serious disease causing cirrhosis and liver cancer, or it can have no symptoms. Few treatments exist.
In 1981, a vaccine became available to prevent infection and now is part of childhood vaccinations.
Local physicians Rosemary and Timothy Laird answer readers' questions about medicine and health. Write to them at doctors@mail.flatoday.net or mail to "Ask the Docs," FLORIDA TODAY, Health section, 1 Gannett Plaza, Melbourne FL 32940. Include your name, daytime phone number and the city in which you reside in.
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Gravely Ill Doctor Left Waiting for New Liver SourceURL:http://www.northjersey.com
By BOB IVRY, STAFF WRITER
Dr. Michael Harris remembers the moment that changed his life - the moment he was infected with hepatitis C.
It was February 1986. He drew blood from a patient and looked around for one of those plastic medical waste boxes where he could throw away the needle. He couldn't find one in the hospital room. He went to another room, then another. No medical waste containers. So he tried to put the cap back on the needle.
And pricked his finger.
"Klutz that I am," Harris said.
The patient had hepatitis C, a virus that attacks the liver. Harris became infected.
For 19 years, Harris and his family kept his illness a secret. Harris, chief of pediatric oncology and director of the Tomorrows Children's Institute at Hackensack University Medical Center, said he made sure his patients were never in any danger.
Besides, there was nothing that could be done about the hepatitis C. It's incurable.
Harris, 61, can't keep it a secret any longer.
He's facing liver failure. He's on a waiting list for a liver transplant.
"It's been hell," said Freida Harris, his wife of 36 years.
The liver produces proteins that clot blood and regulate the fluid in the body. It filters toxins from the blood and metabolizes medications. Without a functioning liver, we die.
Today, 17,341 patients nationwide await a new liver; 197 live in New Jersey. Five years is the median waiting time, according to Annie Moore of the United Network for Organ Sharing.
"There are deaths on the waiting list every day," Moore said. Last year, she said, 1,781 patients died waiting for a liver transplant.
Donors don't have to be dead because the liver is the only organ able to regenerate. After transplant, a piece of a liver from a living donor can become a functioning organ. The practice is rare, however - only 323 liver transplants last year out of 6,169 were from living donors. New York state, where Harris is registered as a prospective liver recipient through the hospital where he's being treated, allows living donations only from the patient's family.
Freida Harris said she would be willing to donate. "I don't want to live without him," she said.
But doctors have said her husband's case is so severe he needs a liver from a younger donor. The Harrises have four adult children. Their two daughters are smaller than their father, so they wouldn't make good transplant candidates either. As for her sons, Freida said, "It would be very traumatic to put two people in a family at risk. I'm not sure I could take two people in the family going through that."
So he's waiting for someone with Type A blood to die.
One of Harris' friends, Dr. Joel Budin, urged him to go public with his infection in hopes it would increase his chances of getting a donor match.
"He was reluctant to do that," says Budin, a radiologist at the Hackensack hospital. "He's a very dedicated physician, really loved by his patients. He's had a very positive outlook, a very optimistic person. I've been amazed, seeing the problems he has to deal with, that he's maintained this optimistic attitude. It's a great service to his patients."
None of those patients knew Harris was infected with hepatitis C. That wasn't an issue with Hackensack University Medical Center, he said, which hired him knowing about the illness.
"Direct blood contact is the only way to get hepatitis C," Harris said.
Despite the infection, Harris kept a full calendar for years. He stopped seeing patients in March, he said, only when his fatigue got so bad he could hardly get out of bed. It's not walking his daughter down the aisle or seeing his son graduate from college that Harris lists as reasons to get better. It's his patients.
"His work is his passion," Freida Harris said. "He loves us, but he says he wants to get better so he can treat his patients. There's no downtime for him. He's always doing as much as he can."
In the spacious living room of their Englewood home Monday, the Harrises fielded phone call after phone call. The irony of a widely respected healer now seeking healing wasn't lost on the many well-wishers.
"I appreciate the outpouring of interest," Harris said.
Freida took a call while Michael sat back on the couch and detailed his recent turn for the worse. He has been hospitalized twice since February. He constantly feels nauseous and tired. At 6 feet 4 inches, he once weighed 185. Now he weighs 168. His skin is sallow and his eyelids are heavy.
An estimated 4 million to 5 million Americans have hepatitis C. Even a liver transplant, in 80 percent of the cases, won't get rid of the infection, though the disease doesn't seem to greatly damage the new liver in the majority of cases. The transplant success rate for hepatitis C sufferers is only slightly lower than for the rest of the population.
"After five years, the patient survival rate is close to 70 percent," said Baburao Koneru, chief of transplant surgery at University Hospital in Newark. "For liver transplant patients who don't have hepatitis C, the rate is about 10 to 15 percent higher."
As a doctor who treats children with cancer, Harris said, he has seen his share of tragedy.
"So I know what tragedy can do to a family. For me to have to wait for that tragedy in order to survive .... " Harris' voice trailed off. He cleared his throat. "I feel some ambivalence."
Then Freida came and hooked her arm under his, to help him up. The doctor had another phone call.
E-mail: ivry@northjersey.com
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May 25th, 2005
Study Shows Using Expanded Criteria Donors Is Safe, University of Pittsburgh
SourceURL:http://www.medicalnewstoday.com
Patients who had received livers from hepatitis B virus core antibody (HBcAb) positive (indicates prior exposure to hepatitis B) and/or hepatitis C virus (HCV) positive donors had similar graft and patient survival compared to patients who received HBcAb negative or HCV negative livers, according to a study by the University of Pittsburgh's Thomas E. Starzl Transplantation Institute. The results of their findings are being presented today at sixth annual American Transplant Congress, the joint scientific meeting of the American Society of Transplant Surgeons and the American Society of Transplantation at the Washington State Convention & Trade Center in Seattle.
To help alleviate the shortage of organs, there has been an increase in the transplantation of livers obtained from extended criteria donors, such as organs from HBcAb positive and HCV positive donors. In the Pitt study, the researchers conducted a seven-year review of liver transplant recipients who received HBV positive and HCV positive organs between 1997 and 2004. The patients were divided into three groups. Group one consisted of 28 patients that received both HBcAb positive and HCV positive livers; the second group consisted of 58 patients that received HBcAb positive livers; and the third group consisted of 34 patients that received HCV positive livers. Patient and graft survival and recurrence of the HBV and HCV infections were compared between the various groups of patients.
Treatment to prevent recurrent HBV infection consisted of hepatitis B immune globulin and/or lamivudine for groups one and two. The mean follow up for all patients was two years and there were no significant differences between recipients of all groups with respect to age, sex and MELD scores - a liver transplant scoring system which estimates a patient's risk of dying while waiting for the transplant.
Patient and graft survival were the following: Group one, 68 percent and 64 percent respectively; Group two, 76 percent and 65 percent respectively; Group three, 82 percent and 76 percent respectively. Overall, recurrent HBV post-transplantation occurred in four out of 86 patients and no grafts were lost to HBV recurrence. Of those patients who received HCV positive livers, 15 of 62 patients who received HCV positive grafts have died; two deaths were due to HCV graft failure and another two were HCV related. One patient has been re-transplanted for recurrent HCV cirrhosis. While HCV recurrence in groups one and three were universal, the severity of recurrence and response to interferon-based therapy was comparable to HCV patients who received HCV negative livers.
Michael E. de Vera, M.D., assistant professor of surgery at the University of Pittsburgh's Thomas E. Starzl Transplantation Institute and lead author of the study, concluded based on these research findings that the use of HBV and/or HCV positive livers for organ donation is safe. HBV recurrence is minimal with the use of HBV prophylaxis and HCV recurrence is similar to that of HCV patients who receive HCV negative livers.
"These findings substantiate the practice of transplanting HBcAb positive and/or HCV positive livers. When selected properly for transplantation, these organs are often of good quality, and so long as they are transplanted to the appropriate recipients, long-term results are comparable to patients who receive livers from HBV- or HCV-negative donors. The use of these livers significantly increases the number of organs available for transplantation," according to Amadeo Marcos, M.D., chief, clinical transplantation at the University of Pittsburgh's Thomas E. Starzl Transplantation Institute.
Collaborating with Drs. de Vera and Marcos from the University of Pittsburgh were Kusum Tom, M.D., Paulo Fontes, M.D., Wallish Marsh, M.D., Bijan Eghtesad, M.D. and Paul Lignoski, from the Center for Organ Recovery and Education.
NOTE TO EDITORS: "Abstract #1138, Liver Transplantation of HbcAb+ and HCV+ Allografts," is being presented at 3:30 P.M., ET, Tuesday, May 24. According to the American Transplant Congress (ATC) embargo policy, abstract presentations are embargoed until the start of the abstract presentation.
Contact: Maureen McGaffin or Frank Raczkiewicz
mcgaffinme@upmc.edu
412-647-3555
University of Pittsburgh Medical Center
http://www.upmc.edu
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Model of End-Stage Liver Disease Predicts Hepatorenal Syndrome Prognosis
SourceURL:http://www.gastrohep.com
Outcomes for patients with cirrhosis and hepatorenal syndrome can be estimated by hepatorenal syndrome type and model of end-stage liver disease score, variables particularly useful for liver transplant candidates, reports the latest Hepatology issue.
Important progress has been made recently regarding the pathogenesis and treatment of hepatorenal syndrome.
However, scant information exists about factors predicting outcome in patients with cirrhosis and hepatorenal syndrome.
Moreover, the prognostic value of the model of end-stage liver disease score has not been validated in the setting of hepatorenal syndrome.
The model of end-stage liver disease score in type 2 hepatorenal syndrome was 20 with 3 months median survival – Hepatology
Dr Mónica Guevara and colleagues from Spain designed a study to assess the prognostic factors and outcome of patients with cirrhosis and hepatorenal syndrome.
The research team included 105 consecutive patients with hepatorenal syndrome.
The team reported that 41 patients had type 1 hepatorenal syndrome, while 64 patients had type 2 hepatorenal syndrome.
The researchers noted that patients with type 1 hepatorenal syndrome had more severe liver and renal failure than type 2 patients.
Patients with type 1 hepatorenal syndrome also had greater impairment of circulatory function, as indicated by lower arterial pressure and higher activation of vasoconstrictor factors.
The investigators observed that in the whole series, the median survival was 3 months.
The investigative team conducted a multivariate analysis of survival, and found that only hepatorenal syndrome type and model of end-stage liver disease score were associated with an independent prognostic value.
The researchers noted that all patients with type 1 hepatorenal syndrome had a high model of end-stage liver disease score of 20 and showed an extremely poor outcome with a median survival of 1 month.
By contrast, the team found that survival of patients with type 2 hepatorenal syndrome was longer and dependent on model of end-stage liver disease score.
Patients with type 2 hepatorenal syndrome with a model of end-stage liver disease score of 20 had a median survival of 3 months and a score less than 20 showed a median survival of 11 months.
Dr Guevara concluded, "The outcome of patients with cirrhosis and hepatorenal syndrome can be estimated by using two easily available variables, hepatorenal syndrome type and model of end-stage liver disease score."
"These data can be useful in the management of patients with hepatorenal syndrome, particularly for patients who are candidates for liver transplantation."
Hepatol 2005: 41(6): 1282-9
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Benitec to Present Preclinical Data on Its Hepatitis C Virus Program at the American Society for Gene Therapy Meeting
SourceURL:http://biz.yahoo.com
MOUNTAIN VIEW, Calif., May 25 /PRNewswire-FirstCall/ -- Benitec Ltd. (ASX: BLT - News) announced today that it will present preclinical data on its RNA interference (RNAi)-based therapeutic against the hepatitis C virus (HCV) at the American Society for Gene Therapy (ASGT) meeting in St. Louis, Missouri, USA June 1-5, 2005.
Benitec scientists Sasha Kolykhalov Ph.D., David Suhy Ph.D., Mick Graham Ph.D., Linda Couto Ph.D. and Peter Roelvink Ph.D. will detail progress made to date on developing Benitec's HCV drug candidates in two oral and two poster presentations. Benitec recently announced the identification of highly potent clinical candidates against the hepatitis C virus.
Stanford Medical School Professor Dr. Mark Kay, Benitec's Strategic Consultant and President-elect of the ASGT, commented, "In just over a year, Benitec scientists have identified seven potent clinical candidates from a thorough analysis of 30 promising short list candidates. This is an impressive achievement and speaks to the depth of talent in their development team. Their presentations at the ASGT meeting should be well received."
Sara Cunningham, CEO of Benitec, stated, "We are happy to have four presentations accepted by the ASGT, a premier forum for molecular therapies. We are fortunate to have a dynamic group of scientists who have been executing successfully on our vision for creating a multi-targeted RNAi-based therapy for hepatitis C."
Cunningham added, "Given the fact that both the outgoing as well as incoming Presidents of the ASGT are scientific advisors to Benitec, I can think of no better meeting to present the highlights of our HCV program."
About Benitec
Benitec is an international biotechnology company focused on developing therapeutics to treat serious diseases using its proprietary RNAi technology. Benitec is listed on the Australian Stock Exchange and has its operations centered in the heart of Silicon Valley in Mountain View, California, USA. Its lead therapeutic programs are designed to create novel RNAi-based therapies for the Hepatitis C Virus (HCV) and the Human Immunodeficiency Virus (HIV). Benitec's RNA-based HIV therapeutic, co-developed with the Center for Biomedicine & Genetics at the City of Hope in Los Angeles, California, will enter Phase I clinical trials in 2006. For additional information, please visit http://www.benitec.com.
Forward-looking Statements
This press release contains forward-looking statements that reflect the Company's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
CONTACTS:
BENITEC
United States:
Laurie Reisinger
+650 564 9850 ext.1101
lreisinger@benitec.com
THE RUTH GROUP
Zack Kubow
+646 536 7020
zkubow@theruthgroup.com
Source: Benitec Ltd.
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Cluster of HCV and LGV Identified amongst Gay Men in the Netherlands
SourceURL:http://www.aidsmap.com
Sexual transmission of hepatitis C virus in a cluster of mainly HIV-positive gay men is reported in the June 10th edition of AIDS. Recent infection with the sexually transmitted infection lymphogranuloma venereum (LGV) and unprotected fisting were identified by investigators as risk factors for infection with hepatitis C virus during sex.
In early December 2003 hepatitis C virus infection was diagnosed in a 29-year-old HIV-positive gay man. In March 2003 he had suffered from proctitis, which was diagnosed as LGV in May of that year. His hepatitis C seroconversion was determined to have occurred between January and May 2003. The individual was part of a cluster of mainly HIV-positive gay men reported as having LGV to Dutch health authorities in late 2003.
Investigators hypothesised that infection with LGV might facilitate the sexual transmission of hepatitis C virus. They therefore initiated intensive contact tracing to identify the man's sexual partners. They also assessed the prevalence of hepatitis C virus infections amongst men diagnosed with LGV earlier in 2003.
Sexual contacts of the individual in the previous six months and four recent contacts were identified. Consent was also obtained from 14 men with known LGV infection for the testing of serum samples obtained at the time of LGV diagnosis for hepatitis C virus antibodies.
Identified individuals were asked to complete a questionnaire providing socio-demographic details, hepatitis C virus transmission risk activity, history of sexually transmitted infections, the number of sexual partners in the previous six months, sexual practices and drug use.
The index patient had had approximately 30 partners in Europe in the six months before his hepatitis C diagnosis. Nine of these individuals were identified as being part of the LGV cluster. He also reported four recent contacts at a sex party. Two of these men were found to have hepatitis C virus and one man had recent LGV infection.
Four cases of hepatitis C virus were identified in the cluster of 14 men with LGV. In three cases, hepatitis C virus seroconversion coincided with proctitis/LGV diagnosis. None of the men had a history of injecting drug use.
Infection with a sexually transmitted infection other than LGV was frequent, being present in two of the seven men with hepatitis C virus.
Investigators tried to determine which sexual practices were associated with hepatitis C virus transmission.
There was no difference in the number of hepatitis C virus-infected (86%) and hepatitis C virus uninfected (89%) gay men reporting unprotected insertive or receptive anal sex.
However, unprotected fisting was reported by all seven men with hepatitis C virus compared with only two men in the uninfected group (p = 0.003).
There was no significant difference in the number of sexual partners reported by the hepatitis C virus-infected and uninfected men. Use of non-injected recreational drugs was frequent and reported by all men, regardless of their hepatitis C virus infection status.
"Within this group of 11 [gay] men identified in cluster of mainly HIV-positive LGV cases, seven recent HCV infections were diagnosed, sexual behaviour techniques being the unique risk of transmission", note the investigators, who note that their findings are in line with recent reports of sexual transmission of hepatitis C amongst HIV-positive gay men from the UK and France.
However, although unprotected anal sex with ejaculation has been reported as a risk factor for hepatitis C virus transmission, the investigators "found no difference in reported unprotected anal intercourse between hepatitis C virus-infected an uninfected cases, and transmission by sperm is unlikely." They note that "this finding is supported by studies isolating hepatitis C virus RNA, in which minority of sperm samples were positive for hepatitis C virus RNA and positive samples were of low titre."
Unprotected fisting during group sex was more common among hepatitis C virus infected men. "One can imagine that fisting and the use of rectal enema may cause mucosal damage, thereby increasing the risk of transmission", they note.
In addition, the investigators suggest that rectal infection with LGV "probably facilitated transmission of hepatitis C virus."
Several hepatitis C genotypes were found within the cluster indicating "several entries for hepatitis C virus. Within this greatly anonymous network, still only the tip of the iceberg is traced."
The investigators note that HIV-positive gay men often select partners of the same HIV status, so called "serosorting." They note that unprotected anal sex and fisting at "serosorting parties provide ideal conditions for the spread of highly virulent sexually transmitted infections and blood-born diseases and form hazards for individuals and are reservoirs for infections in the community."
Reference
Gotz HM et al. A cluster of acute hepatitis C virus infection among men who have sex with men – results from contact tracing and public health implications. AIDS 19: 969 – 974, 2005.
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May 26th, 2005
Hepatitis C Has a High Cure Rate
SourceURL:http://www.sunherald.com
This is the second installment of a two-part column on hepatitis C.
Q: How is hepatitis C transmitted?
A: Any bodily fluids could potentially lead to the development of infection from an infected person. The most common source of contamination, as you know, is by way of needle sticks by IV drug use, occurring more than 60 percent of the time as far as we can tell.
About 15 percent of the time it appears to be related to sexual transmission although this is thought to be very uncommon, and it is extremely uncommon among persons with monogamous sexual relationships, but when there are multiple sexual contacts involved this has become not an uncommon source of contamination.
Blood transfusions, especially if the transfusion occurred before 1992, account for more than 10 percent of the implications and occupational hazards occur about 4 percent of the time. About 10 percent of the time we cannot identify the source.
Q: Can hepatitis C become a long-term disease?
A: Again, our fear is hepatitis C about 85 percent of the infected cases where the patient developed an acute infection will go on to develop a chronic disease and that is why we have 2.7 million people with the disease, most of whom are currently not identified.
The precautions that should be taken in dealing with people with the disease are do not share any drug paraphernalia such as needles, diluted water, cotton or the cookers often used.
The active drug users need to be enrolled in rehabilitation programs.
They should not donate blood or organs, tissue or semen. All these have been shown to carry the virus. In the home, you must avoid contact with toothbrushes and razors.
From the point of view of sexual activity, use of condoms is very effective especially with multiple sexual partners and is also helpful in monogamous sexual relationships to significantly lower any possible chances of contamination or transmission of disease.
Q: What other recommendations can a person with hepatitis C follow?
A: The other recommendations are for people who know they have hepatitis C to avoid alcohol since alcohol rapidly speeds up the damage to the liver and these people develop cirrhosis early.
They should also avoid the overuse of Tylenol, Acetaminophen, that is over 2 gms a day. Again the patient should clearly re-evaluate the possibility of treatments since the cure rate is between 50 and 85 percent.
I hope we have been able to answer your questions and maybe even enlightened you on the fact that hepatitis C is very common.
The disease, for the most part, has not been diagnosed in most of the patients who really need to be tested by their physician or some health care facility.
With the current cure rate of hepatitis C being between 50-85 percent, there is clearly a lot of hope for this disease.
Submit questions to Dr. Bharat Sangani at bsangani@encore.bz or 5601 Sound Bluff Road, Ocean Springs, MS 39564. Sangani also would like to hear from physicians interested in contributing to this column.
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New Medication for Hepatitis C
SourceURL:http://rdu.news14.com
By: Ivanhoe Newswire
It's a deadly disease that affects nearly four million Americans. Now, there is a new drug that offers new hope for Hepatitis C patients.
One drug could be the medical breakthrough patients have been waiting for.
Superstar Billy Graham took home the Worldwide Wrestling Federation title in 1977; but what happened in the ring brought him a challenge he never expected.
"We cut our foreheads to produce blood to make the match look more authentic," Graham said.
Graham thinks that may be how he contracted Hepatitis C. The disease is most commonly spread through blood.
"Hepatitis C is a virus that can infect the liver and cause cirrhosis if it is untreated," said liver specialist Dr. Vijayan Balan.
Dr. Balan is working on a new treatment.
"I think there is significant hope in conquering this disease."
Right now, patients must take medication once a week that can induce days of flu-like symptoms.
Now a new drug, Albuferon, is only taken once a month and causes fewer side effects.
Dr. Balan said, "They get the drug more continuously for a longer period of time."
Albuferon is a combination of interferon, which helps fight infection and albumin, which allows the medication to stay in the body longer.
"You don't have the peaks and valleys with this new drug," Dr. Balan said.
Studies show the drug is safe. Soon it will be tested in up to 1000 people across the country.
Graham says a drug that's easier to handle would have had him back in the gym sooner and able to focus on the good times.
The first phase of the study showed albuferon is safe and well tolerated by patients.
Right now, more than 100 people are taking the drug.
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Hepatitis C Awareness Week
SourceURL:http://www.ssonet.com.au
Sydney Star Observer, Issue 766
There are so many different health “weeks” and “days” now that you can be forgiven for not really paying much attention to them.
Although many of them are fundraisers, some are purely designed to draw attention to important health issues that often receive little attention.
An issue that is often forgotten in our community is hepatitis C.
The First National Hepatitis C Awareness Week is currently in full swing and is aimed at raising awareness of the recent significant improvements in hepatitis C pharmaceutical treatment.
The hepatitis C virus is passed on via blood-to-blood contact, with injecting drug use the main mode of transmission in Australia.
It is estimated that of the 240,000 Australians who have been exposed to hepatitis C, more than 30,000 are currently eligible for treatment under the pharmaceutical benefits scheme, yet fewer than 2,000 people access treatment each year.
Antiviral treatment has improved, with 50-80 percent of people on treatment (pegylated interferon and ribavirin) clearing the infection.
Importantly, there have also been improvements in the management of treatment side effects, with 80 percent of people on treatment managing the side effects and completing treatment.
Access to treatment has also improved. Not everyone with hepatitis C will need treatment and there are eligibility criteria for government-subsidised treatment to determine those most in need due to progressive liver damage.
People co-infected with HIV are also eligible for treatment and should speak to their doctor for more information.
People who are on methadone or currently using drugs are not restricted from accessing hepatitis C treatment.
However, compliance to the treatment regimen over a significant period of time (six to 12 months depending on genotype and/ or degree of liver damage) is important to gain the best chance of viral clearance, and people need to consider whether their drug and alcohol use is stable enough to support treatment compliance or whether they need to postpone treatment to a period of greater stability in their lives.
A trial for the treatment of newly acquired hepatitis C is also under way. This trial enables people who have recently become infected to access interferon treatment without the need for a liver biopsy.
Previous research has found that treating hepatitis C with interferon alone for six months in the early stages of infection can be very effective.
If you would like to know more about treatment options or any other information on hepatitis C, call the NSW Hep C Helpline on 9332 1599 (Sydney callers) or 1800 803 990 (other NSW callers), or visit www.hepatitisc.org.au
Alternatively, speak to your GP or other healthcare worker. If you would like more information on accessing treatment for newly acquired hepatitis C infection, contact Barbara Yeung on 9385 0900.
Remember: if you do not want any negative consequences, do not use drugs and, no matter how many times you have used a substance, never be blasé.
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Prison Staff Fear Sickly Inmates
SourceURL:http://www.nst.com.my
PUTRAJAYA
Prison inmates suffering from chronic diseases worry prison staff, who fear they may be infected.
Of the 35,000 inmates in the country's 47 prisons, 1,800 have HIV/AIDS, 132 tuberculosis, 200 have a mental illness, and eight have hepatitis B.
"Most prison staff are afraid to deal with prisoners having TB for fear of infection," Internal Security Ministry parliamentary secretary Datuk Abu Seman Yusop said yesterday.
"This is also a main reason why many people are not attracted to a career as a prison officer."
He said the Government spent some RM1.6 million last year to pay for escorts to accompany prisoners on their regular hospital visits.
"We cannot afford such expenditure any more, and the only way to trim it down is by having two hospitals built on prison grounds under the Ninth Malaysian Plan."
The Prisons Department has 10,287 staff, but it needs 11,752 for all prisons.
Abu Seman said there were 50 positions for medical staff for the prisons, of which only 27 had been filled: four doctors and 23 hospital assistants.
He said there were problems filling the other vacancies because of the unattractive work environment.
If the proposal to have two prison hospitals was approved, he said, the ministry would upgrade the facilities in two prisons in Kedah and Penang to turn them into hospitals.
This is because the two prisons are close to the general hospitals in Penang and Kedah.
He said the ministry had asked for about RM14 million to upgrade the two prisons; RM10 million of which was for renovating the buildings and the rest to buy medical equipment.
He said the hospitals would be equipped to provide all medical treatment except major surgery.
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Talecris Biotherapeutics Becomes First Plasma Fractionator to Perform in-house HBV Screening Using FDA-Licensed Protocol
SourceURL:http://biz.yahoo.com
Talecris Now Approved for In-House Testing of HIV, HCV, and HBV, Further Ensuring the Safety of Its Plasma-Derived Biological Therapies
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May 26, 2005-- Building on a tradition of leadership in pathogen safety of biological products, Talecris Biotherapeutics has become the first plasma fractionator to use an FDA-licensed test to perform in-house nucleic acid testing (NAT) of hepatitis B (HBV) for source plasma. Moreover, Talecris also is now the first plasma fractionator conducting in-house testing on source plasma for human immunodeficiency virus (HIV), hepatitis C (HCV), and HBV using FDA-approved tests. This provides Talecris with even greater control in confirming the safety of its plasma donations, above and beyond the strict standards and protocols already in place for the screening and donation process.
Talecris collaborated with Roche Diagnostics to provide the necessary data to the FDA for consideration of the HBV NAT test. Roche's FDA-approved Cobas AmpliScreen HBV Test allows for the detection of HBV in whole blood, blood components, and source plasma. Concurrent with Roche's application to the FDA, Talecris submitted a supplement to its Biologics License Application (BLA) to include Roche's Cobas AmpliScreen HBV Test for in-house testing of human-source plasma.
The Cobas AmpliScreen HBV Test is on par with other testing protocols conducted by commercial laboratories. The testing allows for rapid identification and detection of specific HBV-infected donations, resulting in faster notification to all parties, potentially earlier treatment of the infected donor, and prevention of further donations by that donor. By receiving approval for conducting this testing in-house using the Cobas AmpliScreen HBV Test, Talecris can more directly ensure the integrity of the testing process and the resulting safety of its plasma products.
"Approval of this additional test is further demonstration of Talecris' commitment to provide the safest, most reliable products to our patients," said Larry Stern, Executive Chairman of Talecris Biotherapeutics. "We are pleased to be an industry leader when it comes to the testing and safety of our plasma, and we will continue to set the standard for our industry."
Douglas C. Lee, Ph.D., Director of Nucleic Acid Technologies (NAT), led the Talecris effort resulting in FDA approval of this new screening protocol. "NAT testing is the state-of-the-art for pathogen detection. Through the use of Roche's innovative Cobas AmpliScreen Tests, Talecris now screens plasma for HIV, HCV, and HBV in our own laboratories using a state-of-the-art NAT method."
About Talecris Biotherapeutics
Talecris is a newly-formed company with the contributed assets and history of Bayer HealthCare Biological Products Division's plasma business. With global headquarters in Research Triangle Park, N.C., primary manufacturing facilities for Talecris products in Clayton, N.C., and additional fractionation and manufacturing facilities of Precision Pharma Services in Melville, N.Y., Talecris employs nearly 1,700 people.
Inheriting a legacy of more than 60 years of providing lifesaving and life-enhancing plasma-derived therapeutic proteins, Talecris is well positioned to become recognized as the global leader in developing and delivering premium protein products. Through its people, technology, and state-of-the-art facilities, Talecris will build on this long history of innovation through a focused, entrepreneurial approach to new product development, application of cutting-edge manufacturing technologies, and marketing and customer service. Talecris is talented industry professionals providing critical care treatments and services for patients, while maintaining a vision for the future of care.
Information about Talecris can be found at www.talecris.com.
Contact:
Talecris
Lacy McMahon, 919-316-6316
Fax: 919-316-6673
lacy.mcmahon@talecris.com
Source: Talecris Biotherapeutics
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May 27th, 2005
Factors Affecting Long-Term Outcomes of Orthotopic Liver Transplants
SourceURL:http://www.gastrohep.com/
Factors including the recipient, etiology of liver disease, operative variables, and surgical experience influence long-term survival outcomes of liver transplant with benefits greatest in pediatric and nonurgent patients, reports the latest Annals of Surgery.
Few studies have evaluated long-term outcomes after orthotopic liver transplantation.
Dr Busuttil and colleagues analyzed the experience of nearly 2 decades by the same team in outcomes of orthotopic liver transplantation and factors affecting survival.
The research team conducted a retrospective analysis of 3200 consecutive orthotopic liver transplantation that were performed at a single center between 1984 and 2001.
The researchers reported that of the 2662 recipients, 578 were pediatric, and 659 were urgent patients.
Recipient survival after 5 years in children with biliary atresia was 79% - Annals of Surgery
Overall, the team found that 1-, 5-, 10-, and 15-year patient and graft survival estimates were 81%, 72%, 68%, 64% and 73%, 64%, 59%, 55%, respectively.
The researchers observed that patient survival significantly improved in the second era of transplantation, between 1992 and 2001, versus Era I from 1984 to 1991.
The investigators found that graft survival was better in Era II of transplantation, however, biliary and infectious complications increased in Era II.
When the team considered orthotopic liver transplantation indications, best recipient survival was obtained in children with biliary atresia with 82%, 79%, and 78% at 1, 5, and 10 years, respectively.
The researchers noted that malignant disease in adult patients resulted in the worst outcomes of 68% and 43% at 1 and 5 years, post-orthotopic liver transplantation.
The investigators reported that patients less than 18 years and nonurgent recipients exhibited superior survival when compared with recipients older than 18 years or urgent patients.
The team concluded that of 13 donor and recipient variables, era of orthotopic liver transplantation, recipient age, urgent status, and donor age influenced patient survival.
In addition, donor length of hospital stay, etiology of liver disease, retransplantation, warm and cold ischemia, but not graft type (whole, split, living-donor), significantly impacted patient survival.
Dr Busuttil's team concluded, "Long-term benefits of orthotopic liver transplantation are greatest in pediatric and nonurgent patients."
"Multiple factors involving the recipient, etiology of liver disease, donor characteristics, operative variables, and surgical experience influence long-term survival outcomes."
"By balancing and matching these factors with a given recipient, optimum results can be achieved."
Ann Surg 2005: 241(6): 905
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Health Officials Send Out Warning about Tattoo Parties
SourceURL:http://www.whiotv.com/
Ohio health officials are sending out a warning about so-called tattoo parties.
Seven people in Northern Ohio have contracted serious infections after attending private parties where they got tattoos from unlicensed artists. Doctors say the needles used at the parties are probably not sterilized. That puts people at risk for serious bacterial and viral infections, including hepatitis and HIV.
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Schering-Plough Announces Results of Chronic Hepatitis C Survey SourceURL:http://www.japancorp.net
By Aki Tsukioka, JCNN
Tokyo (JCNN) - On May 17, Schering-plough announced the results of its latest survey of chronic hepatitis C. The company surveyed a total of 400 chronic hepatitis C patients (213 male and 187 female) nationwide via the Internet in February. Of the respondents, about 20% did not receive proper outpatient treatments since they noticed no subjective symptoms or had no hepatic dysfunction.
Further, many of the respondents misunderstood that the disease does not develop while the liver functions well so that there is no need for treatment. About 20% of the respondents knew the combination therapy of peginterferon and ribavirin, a new treatment highly effective for patients with genotype 1.
The company concludes that there is substantial needs for more educational activities on the disease and treatment, especially among those who did not consult with doctors.
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