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Week Ending: March 12th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• First European Recommendations for the Treatment of Patients Co-Infected with HIV and Hepatitis B and C Viruses
• PM Approves Rs. 2.5b for Hepatitis Control
• Diabetes Mellitus, Hepatic Iron Staining, Ferritin and Fibrosis in Hep C
• Tattooist Blamed in Hepatitis C Cases
• Abbott Introduces Automated Hepatitis C Test for AxSYM System
• Hospital Vows Hepatitis C Clinic Will Stay Open
• Big Pharma Set to Move into HIV/Hepatitis Co-Infection Niche
• Laurel Woman Writes Cookbook for Hepatitis C Patients
• Transjugular Intrahepatic Portosystemic Shunt in Refractory Ascites
• Hepatitis C Virus Coinfection Does Not Lead to Faster HIV Disease Progression in US Women's Study
• Hepatitis Outbreaks Tied to Use of Test Devices
• Bristol-Myers Hepatitis Drug Effective - FDA Staff
• ViroPharma Halts Hepatitis C Drug Study on Side Effects
• Gps' College Issues Guidance on Hepatitis A and B Vaccination
• Blood Boss Calls Press Conference in Cork
March 6th, 2005
First European Recommendations for the Treatment of Patients Co-Infected with HIV and Hepatitis B and C Viruses
Source: European Consensus Conference on Coinfection (ECC) Press Release
Paris, March 3, 2005. The "1st European Consensus Conference on the Treatment of Chronic Hepatitis B and C in HIV Co-infected Patients" ended today with the adoption of recommendations that will enable physicians in all European countries to treat their patients using the best therapeutic protocols available.
The two-day conference brought together Europe and North America's leading specialists on AIDS and liver disease. They addressed the specific questions of the conference organizers and more than 950 participants. On the basis of their presentations and lively discussion and debate, a jury of ten physicians from eight European countries, presided by Professor Alfredo Alberti (Italy) and Professor Nathan Clumeck (Belgium), drew up the recommendations. "Our goal is to ensure that a consistent therapeutic approach is adopted at the European level, and to increase the number of patients who are diagnosed and treated," stated Professor Clumeck. "Today there is too much variation from one country to another. Our recommendations are adapted to the European context, both in terms of the patients and the health care systems."
Co-infection with the AIDS virus (HIV) and the hepatitis C virus (HCV) or B virus (HBV) is common: more than one fourth of HIV-positive individuals are infected with HCV and nearly 10% with HBV. The increased life expectancy of HIV-positive patients has brought the problem of hepatitis, a disease that progresses relatively slowly, to the fore. Cirrhoses and liver cancer due to hepatitis C have become the number one cause of mortality among AIDS patients. For these patients, hepatitis C develops into cirrhosis in five to ten years on average, compared to 30 or so years for the general population.
Such co-infections are especially common in certain high-risk groups, essentially IV drug users (in this group, 90% of HIV positive patients might be infected with HCV or HBV), and among immigrants, who are frequently carriers of HBV. Treatment of co-infections is therefore doubly complex: first, because treating two viruses simultaneously requires choosing the right combination of medicines, and second, because patients in the most widely affected groups need particular psychological and social support to help them adhere to the treatment regimen despite the side effects and the constraints of taking pills regularly.
The recommendations concern two main areas:
1. Overall patient care:
Routine treatment of the hepatitis C virus must be adopted since today there are drugs that can eliminate the virus in 15 to 60% of patients, depending, in particular, on the viral genotype. Treatment for HBV does not eradicate the virus, but can prevent progression toward liver disease. At the European level, only a small minority of patients are treated today for hepatitis viruses. Multidisciplinary teams composed of doctors, psychologists, social workers and patients' organizations must provide support for patients to ensure treatment adherence and observance.
A multidisciplinary approach is also necessary for alcoholic patients, since alcoholism aggravates hepatitis B and hepatitis C.
All patients infected with HIV but not HCV or HBV must be vaccinated against these viruses if they have not been immunized already. If their immune status is too weakened for vaccination to be effective, the vaccine should be given following the implementation of anti-retroviral treatment for HIV and once the immune defenses have been built up.
Prevention campaigns must be organized to stop the transmission of HCV and HBV, especially through vaccination and with programs specially targeting IV drug users (to avoid needle sharing, for example), since the prevalence of these viruses is on the rise.
2. Therapeutic protocols:
Protocols differ for HCV, which can be eliminated, and for HBV, since currently drugs can only slow or stop progression of the disease.
HIV/HCV: Treatment consists of a combination of pegylated interferon and ribavirin. The consensus meeting recommends increasing the dose of ribavirin among patients infected with genotype 1 HCV, which is more resistant to treatment than the other genotypes. After the first three months of treatment, efficacy can be assessed to determine whether or not to continue to the end of the treatment period (48 weeks).
HIV/HBV: Antiviral compounds are effective against both HIV and HBV, but they are complex to administer because both viruses may develop resistance to the drugs. The choice of which combinations to use must be made according to identifiable resistance and the specific biological parameters of each patient.
For patients whose immune system has been significantly depressed (low CD4 counts), antiretroviral treatment for HIV must first enable the CD4 count to rise, before treatment for HCV and HBV can begin.
There is a need for further studies to better understand the natural progression of co-infections and to determine exact treatment dosages and durations. Data about infection with HBV and HIV/HBV co-infection is especially lacking. One of the pressing questions that must be addressed is whether or not to continue HBV treatment, perhaps with reduced doses, when the viral response is not very satisfactory, in order to slow progression toward liver disease or the worsening of hepatitis B disease. The members of the jury also recommended that studies to evaluate new drugs currently under development be conducted at an earlier stage among patients co-infected with HIV and hepatitis B and C viruses.
All these recommendations are due to be published in the Journal of Hepatology in May 2005 and will thus become available to all physicians who treat HIV-positive patients.
Contacts:
Ruder Finn
Fanny Gaudry : 01 56 81 15 03 / 06 64 15 72 92 – fgaudry@ruderfinn.fr
Mai Tran : 01 56 81 15 05 / 06 64 74 70 80 – mtran@ruderfinn.fr
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PM Approves Rs. 2.5b for Hepatitis Control
SourceURL:http://www.pakistanlink.com/
ISLAMABAD, March 06 : Acceding to a proposal floated by the Ministry of Health, Prime Minister Shaukat Aziz has approved an amount of Rs. 2.5 billion for a comprehensive programme targeting prevention and control of hepatitis, making it the second major health programme of Pakistan after the National Programme for Family Planning and Primary Health Care.
Announcing this decision at the inaugural session of the annual symposium of Pakistan Institute of Medical Sciences (PIMS) here, the prime minister termed hepatitis as a disease that worries him most of all. Pakistan is feared to have over 10 million carriers of the deadly hepatitis virus.
The prime minister also disclosed that in line with the Fiscal Responsibility Law, the government has committed to double — by the year 2013 — its contribution to the health and education sectors as a percentage of the GDP because "an illiterate and unhealthy nation cannot progress in an age where change is the only constant."
Coming back to hepatitis, the prime minister said efforts are afoot to improve drinking water quality so that the threat of water-borne diseases can be warded off. The current allocation, which has been made in light of the National Strategy for Prevention and Control of Hepatitis formulated in compliance with a directive of the cabinet, will lead to implementation of a national programme that envisages measures for safe blood transfusion, use of sterilised medical equipment at government and private hospitals and prohibition of re-use of syringes.
The Ministry of Health is reported to have sought an amount of Rs. 1 billion for safe injections, invasive medical devices and proper waste management and an equal amount for management support. The remaining amount would be spent on hepatitis B vaccination (Rs.166 million), media-led awareness campaign (125 million), safety of blood (Rs. 20 million) and prevention and control of hepatitis A and E infections (Rs. 87 million).
According to official figures, the ratio of hepatitis B and C patients ranges between 3.1 and 6.6 percent of the total population, respectively. However, studies conducted by the Pakistan Society of Hepatology suggest that the country has around 8 million patients of hepatitis C, meaning 5 percent of the population.
Group-wise statistics show that 44.1 and 33.5 percent patients suffering from chronic liver diseases are affected by hepatitis C and B viruses, respectively. Among the general community, 3.1 percent victims are said to be suffering from hepatitis C and 3.4 percent from hepatitis B. As many as 5.2 percent pregnant women have hepatitis C and 3.8 percent have hepatitis B. Voluntary blood donors also carry the deadly virus; 3.6 and 2.4 percent of the blood donors are reported to be hepatitis C and B carriers, respectively.
Referring to other deficiencies, the prime minister said the Basic Health Units and the District Headquarters Hospitals should be energised in terms of availability of doctors, paramedical staff and equipment. He instructed government hospitals to purchase equipment from reputable suppliers who give warranty and service coverage.
On the question of availability of affordable but authentic medicines, the prime minister disclosed that he has already instructed the Ministry of Health to restructure the process governing the registration, approval and pricing of medicines. He said he was also awaiting a proposal visualising enhanced monetary compensation for nurses.
Earlier, Minister for Health Muhammad Nasir Khan said the Ministry of Health is in the process of tabling a draft bill for the introduction of a regulatory mechanism to prevent unethical practices in the area of human organ and tissue transplantation.
PIMS Executive Director Dr. Fazl-e-Hadi presented a recap of the major achievements of the institute. In the end, the prime minister presented gold medals and shields to professionals excelling in their respective fields of specialisation.
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March 7th, 2005
Diabetes Mellitus, Hepatic Iron Staining, Ferritin and Fibrosis in Hep C
SourceURL:http://www.gastrohep.com
Hep C virus infection may lead to elevated serum ferritin and/or iron deposition within the liver, especially in patients with diabetes, however, the former played no role in the progression of Hep C virus related liver injury, finds this month's Alimentary Pharmacology & Therapeutics
Chronic infection with the Hepatitis C virus affects over 170 million individuals worldwide and 20% of patients develop cirrhosis after 20 years.
Increased iron stores and hepatic iron content have been suggested to be important in fibrosis progression.
The increased prevalence of diabetes mellitus has been associated with increased iron deposits in patients with chronic Hepatitis C.
Dr D'Souza and colleagues assessed the potential relationship between serum ferritin and hepatic iron staining and liver fibrosis in patients with chronic Hepatitis C virus infection.
Serum ferritin and hepatic iron staining were unrelated to the degree of fibrosis but higher in diabetes – Alimentary Pharmacology & Therapeutics
The researchers wanted to determine whether these factors are increased in diabetic patients with Hepatitis C virus.
The team designed a cross-sectional, multi-centre study involving hospitals in the north-east of London between 1992 and 2003.
Patients were enrolled with chronic Hepatitis C followed by a liver biopsy.
The researchers collected data concerning age, sex, basal metabolic index, diabetes mellitus or impaired glucose tolerance, alcohol intake, serum ferritin level and ethnicity.
The investigators scored each biopsy for fibrosis and stained for hepatic iron.
The team enrolled 339 patients (200 Caucasian and 139 Asian) of which 53 patients had no fibrosis, 131 had mild fibrosis (stage 1 to 2 Modified Ishak), 68 moderate fibrosis (stage 3 to 4) and cirrhosis (stage 5 to 6).
4% of patients had elevations in serum ferritin, whilst 11% had increased hepatic iron staining.
The investigative team found that serum ferritin and hepatic iron staining were unrelated to the degree of fibrosis.
In addition, the researchers noted that serum ferritin was significantly higher in patients with diabetes or impaired glucose tolerance compared to non-diabetics.
No association was seen between diabetes and hepatic iron staining.
Dr D'Souza concludes that, "Many patients with chronic Hepatitis C virus infection may have elevated serum ferritin and/or iron deposition within the liver, however, both played no significant role in the progression of Hepatitis C virus related liver injury."
"The association between chronic Hepatitis C virus infection and type II diabetes mellitus exists, however the biological mechanism of this association still remains to be elucidated."
Alimentary Pharmacology & Therapeutics 2005: 21(5): 519
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Tattooist Blamed in Hepatitis C Cases
SourceURL:http://www.asahi.com/
The Asahi Shimbun
FUKUOKA-A teenager and an adult male contracted hepatitis C after receiving tattoos at a parlor here where the owner was already in trouble for his work on two minors, police said over the weekend.
The teen and man fell sick after being tattooed by Hiromi Sasahara, 26, presumably with needles contaminated with hepatitis C virus, police said.
Sasahara was arrested in February on suspicion of violating a prefectural ordinance to safeguard the development of minors by tattooing a 16-year-old boy and a 15-year-old girl.
Their tattooed designs were of a dragon and a sakurafubuki (storm of cherry blossoms), police added.
The man had frequented Sasahara's parlor in November. He brought along the teenager and urged him to be tattooed to “prove that you are a man,” police said.
The teenager visited the parlor seven times from November to December for tattoos on his back, police said.
In late January, the man began showing symptoms of acute hepatitis, including fevers and jaundice, and was diagnosed with hepatitis C, police said. The teenager collapsed at home after work in late February after developing jaundice.
He was taken to a hospital, where blood tests revealed the infection.
While the contamination route is not confirmed, police said the pair likely contracted the disease because the equipment used during the periods when they received their tattoos was never sterilized.
Officials at the Ministry of Health, Labor and Welfare warned the public and tattooing practitioners to be careful about spreading infections.
"When conducting any form of body piercing, ensure that the equipment used is sterilized and sanitary," said the health ministry.
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March 8th, 2005
Abbott Introduces Automated Hepatitis C Test for AxSYM System
SourceURL:http://biz.yahoo.com
Press Release Source: Abbott
- Sensitive and Efficient AxSYM(R) Anti-HCV Test Detects the Presence of Antibodies to the Hepatitis C Virus -
ABBOTT PARK, Ill., March 8 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT - News) announced the availability of a fully automated hepatitis C virus (HCV) test in the United States for its widely-used AxSYM® automated immunoassay instrument system. With results within 23 minutes, the AxSYM® Anti-HCV test provides laboratories with a quick and efficient test. The presence of antibodies to HCV indicate that an individual may have been infected with HCV in the past or have an ongoing infection.
"With more than 34 years of experience in hepatitis diagnostics, Abbott is a leader in this field, developing and introducing many of the world's first hepatitis assays," said William E. Brown, Ph.D., vice president, Diagnostic Assays and Systems Development, Abbott. "Not only is the AxSYM Anti-HCV test sensitive and specific, but also it has been designed and developed to detect the known genotypes of HCV."
Last year in the U.S., Abbott introduced two fully automated tests for the hepatitis A virus on the AxSYM system -- AxSYM® HAVAB-M(TM) 2.0 assay and AxSYM® HAVAB® 2.0. Abbott has also submitted an application to the U.S. Food and Drug Administration for its AxSYM hepatitis B tests, which are currently available outside of the United States. Abbott's hepatitis tests are used everyday for blood screening and diagnostic testing.
According to the Center for Disease Control and Prevention (CDC), an estimated 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected. Often called the "silent epidemic," many individuals infected with the virus have no signs or symptoms of the disease until chronic infection or chronic liver disease has developed. Additionally, there is no vaccine to prevent HCV.
A Microparticle Enzyme Immunoassay (MEIA) test, the AxSYM Anti-HCV test is designed for the qualitative detection of antibodies to HCV in human serum or plasma and is not intended for use in blood, plasma or tissue screening.
About AxSYM
The AxSYM immunoassay system can process up to 80 to 120 tests per hour. Test menus include assays for abused drugs, cancer, cardiac, endocrinology, fertility, hepatitis, infectious disease, metabolic/renal, therapeutic drug monitoring and toxicology.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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Hospital Vows Hepatitis C Clinic Will Stay Open
SourceURL:http://www.redlandsdailyfacts.com
By C.L. LOPEZ, Staff Writer
LOMA LINDA Officials at the Jerry L. Pettis Memorial VA Hospital addressed concerns the hospital's hepatitis C clinic was closing.
Patients visiting attending a Monday night support group were assured the hospital will continue caring for hepatitis C patients.
"The clinic will be open tomorrow and will be in full swing," said Chuck Maurer, the support group's vice president, said Monday night.
At the clinic, patients receive shots, get prescriptions and receive evaluations. The clinic was closed Monday when patients arrived expecting to get their daily shots. A sign was posted saying the hospital's monthly liver transplant support group would not meet until further notice.
Rumors took on a life of their own.
By mid-afternoon, the clinic's patients feared the clinic and support group would no longer be open.
The support group was, in fact never cancelled and met Monday night as usual amid concerns it would be the final meeting and that hospital officials would be making the announcement it would be the final meeting.
Hospital officials stepped in to assure patients the clinic was not closing and the support group would continue.
The group's president, vice president and secretary are all transplants recipients and volunteer their time.
"I never see that (the clinic closing) happening," said Maurer. "And it's never going to happen."
The support group is for patients who have had or will have liver transplants. Several of those in the group have Hepatitis C and will likely need liver transplants in the future.
Maurer said there is a high rate of veterans with hepatitis C because there were so many battlefield blood transfusions during the Vietnam War. The transfusions saved lives, but in some cases resulted in hepatitis C.
"This program is very important," said Annie Tuttle, the medical center's spokeswoman. "The care for the veterans will go on."
The clinic was closed Monday because it was understaffed, said Tuttle.
Two of the clinic's doctors were out of town, and the clinic's nurse practitioner is on leave until she completes her job certification.
There was a change in hospital policy in August, when the hospital required all of their nurse practitioners to be certified. At the time, there were only about 10 staff members who did not have the certification. Since then, eight of the employees completed the certification. When the final notification was made Friday, two employees did not have their certification one of whom was the clinic's practitioner. The absence of the clinic's nurse practitioner left the biggest void for patients who arrived at the clinic. She gives shots and writes prescriptions for the patients.
The clinic would have been staffed by one doctor, and it was decided that it was better to close the clinic for the day.
"We should have notified the patients," said Tuttle.
The clinic's nurse practitioner will be on paid leave until she completes her certification.
The test for certification takes 15 minutes online, and can be taken up to five times a month, but the paperwork that leads up to the test is what'stimely, said Tuttle. The two employees had the option of taking a leave of absence to complete their certification, working as registered nurses at the hospital until the were certified, or resigning.
"She does a great job," Tuttle said, and the plan is for her to return to the job once she has certification.
"We are very serious about our certification," said Tuttle.
The hospital will bring in an R.N. to assist the doctor at the clinic.
The clinic opened today and saw patients as scheduled, said Tuttle.
"It's unfortunate our patients received the wrong message," she said.
E-mail Staff Writer C.L. Lopez at clopez@redlandsdailyfacts.com
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March 10th, 2005
Big Pharma Set to Move into HIV/Hepatitis Co-Infection Niche
SourceURL:http://www.pharmaceutical-business-review.com
8 Mar 2005, 19:02 GMT - While the European Consensus Conference gained a consensus agreement for the treatment of HIV/HCV coinfection, the definition of best practice for the management of HIV/HBV remains clouded by the lack of data. However, this is certain to change with BMS' entecavir trial in HIV/HBV co-infected patients. Datamonitor's Brigitte de Lima reports.
The first European Consensus Conference on the Treatment of Chronic Hepatitis B and C in HIV Co-infected patients, held in Paris in early March 2005, was the first of its kind. The initiative brought together leading hepatitis and HIV specialists who drew up recommendations concerning the management of HIV/hepatitis co-infections. The goals to be achieved with these are, firstly, consistent therapeutic approaches across Europe and, secondly, increased diagnosis and treatment rates.
The delay of the onset of AIDS due to highly active antiretroviral therapy (HAART) has led to a significant increase in the life expectancy of patients infected with the human immunodeficiency virus (HIV). As a consequence, the management of concurrent illnesses, such as hepatitis B (HBV) and C (HCV), has been gaining increasing importance. Clinical experience has shown that concurrent HIV infection accelerates the progression of the underlying liver disease.
Concomitant with the AIDS epidemic, the absolute number of HIV/HBV and HIV/HCV co-infected patients has been rising steadily as a result of the common routes of transmission for these viruses. HIV is predominantly transmitted by sexual contact and intravenous drug use (IVDU). While the former is also the major route of HBV transmission, the latter predominates for HCV. Thus, depending on how HIV is acquired, simultaneous infection with either hepatitis virus is common. It is currently estimated that 10-15% of HIV patients also harbor a chronic HBV (CHB) infection, while the proportion chronically infected with HCV (CHC) might be as high as 30%.
The implications for the pharmaceutical industry are varied. First of all, with the establishment of pan-European guidelines, HIV/HBV and HIV/HCV co-infections can be regarded as new indications in their own, requiring existing and developmental drugs to be clinically tested in the co-infected populations. Key issues associated with clinical trials in co-infected patients are the possibility of pharmacokinetic interactions between antivirals to treat viral hepatitis and components of the HAART regime, and, importantly, the risk of viral resistance to both HIV and the hepatitis virus. Although viral resistance is currently only an issue for HBV therapy, it is anticipated that this will also become an issue in the context of HCV antivirals once developmental HCV polymerase and protease inhibitors reach the market.
Some pharmaceutical companies have already taken a step forward in this respect by trialing their hepatitis drugs in co-infected patients. Roche, for example, has recently received approval for the use of Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin) for the treatment of HCV in HIV co-infected patients following favorable results for the APRICOT study. This clearly gives it the lead in this patient sub-group, as supporting clinical data represent a significant driver in drug prescription choices.
In the context of HBV co-infection, the pharmaceutical sector has been slower to respond. While this might be due to the lower rate of HBV compared to HCV co-infected patients, 10-15% versus 30%, it is more likely to be a consequence of the very nature of CHB disease progression. While current HCV therapy is finite and can lead to virus eradication, HBV eradication, commonly defined as seroconversion from the presence of HBV surface antigen (HBsAg) to HBsAg loss and anti-HBsAg seroconversion, is rarely achieved with approved treatment options. Thus, it is not currently known whether treatment should be maintained in light of an unsatisfactory virological response.
HIV/HBV co-infection is currently managed using antivirals with dual activity against both viruses, such as Epivir (3TC/lamivudine), approved for both viral diseases - albeit at different doses - and Viread (tenofovir disoproxil), approved for HIV only. However, 3TC is associated with high rates of resistance for both viruses, limiting its usage in this population. In contrast, tenofovir has a favorable resistance profile, but apart from small independent trials, the drug has not officially been tested for either HBV monoinfection or HIV/HBV co-infection.
HIV/HCV and HIV/HBV co-infections clearly represent major clinical unmet needs. The development of new European guidelines, and the growth potential of the field, has set the foundation for more investment from the private sector. Bristol-Myers Squibb has already identified this niche market, with its lead HBV compound entecavir currently undergoing a Phase II clinical trial for HIV/HBV co-infection. Datamonitor expects others to follow this example to achieve greater drug differentiation.
Source: Datamonitor Expert View
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Laurel Woman Writes Cookbook for Hepatitis C Patients
SourceURL:http://www.laureloutlook.com
Hepatitis C is a potentially fatal virus that attacks the liver. According to the Centers for Disease Control, Hepatitis C has already infected an estimated four to five million Americans, and worldwide it may have infected as many as 200 million.
A Laurel woman, Heather Jeanne Holland, has written a cookbook targeted directly at the needs of Hepatitis C patients. Hepatitis C is not always fatal, and it can be fought successfully. For many people who suffer from the virus, eating properly can delay the end stages of the disease leading to cirrhosis of the liver. It also can diminish the uncomfortable symptoms of the disease.
Holland developed a person interest in the use of diet to treat Hepatitis C when she became the primary care provider for her father who has the disease. "I did the best I could and started to find out everything I could about how to treat the disease," said Holland, who uses the pen name Heather Jeanne. "Soon I found out by modifying his diet, his health improved and we moved to Montana from New York state where there is a more dry climate."
Two years ago, Holland decided to write about the use of diet to treat Hepatitis C . At first, she had several articles published. That inspired her to write The Hepatitis C Cookbook. She said she has always enjoyed writing and wrote for her school newspaper and yearbook when she was in high school.
Holland agrees with the estimate that more than five million people in the US have been diagnosed with Hepatitis C. Her father is now 57 years old and has lived with Hepatitis C for the past five years.
The Hepatitis C Cookbook has been prepared with the special dietary needs of people suffering from Hepatitis C in mind. Hepatitis C does not have to make eating a miserable experience, according to Holland.
By using medical guidelines, the cookbook provides a road map to healthy, tasty foods to eat and enjoy. Following these dietary changes can also make a significant difference in one's attitude as well as the variety, severity, and frequency of symptoms. All of these considerations can enhance the quality of life for anyone suffering from the disease.
Heather Jeanne has 12 years of experience in the restaurant field. Her recipes have been published in numerous magazines, such as Countyside, and she has won local prizes and awards for her great-tasting, creative foods. Her book is published by Cumberland House Publishing Company and it is available through Barnes and Noble and Amazon.com. It sells for $14.95 and is 150 pages.
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Transjugular Intrahepatic Portosystemic Shunt in Refractory Ascites
SourceURL:http://www.gastrohep.com/
Transjugular intrahepatic portosystemic shunt is a more effective treatment for refractory ascites than large volume paracentesis, however, also increases encephalopathy and does not improve survival, reports the latest issue of Liver International.
Transjugular intrahepatic portosystemic shunt is a more effective treatment for refractory ascites than large volume paracentesis.
However, the magnitude of its effect in terms of control of ascites, encephalopathy and survival has not been established.
Dr Deltenre and colleagues undertook a meta-analysis to compare transjugular intrahepatic portosystemic shunt to large volume paracentesis in terms of control of ascites at 4 and 12 months, encephalopathy and survival at 1 and 2 years.
The research team included 5 randomized controlled trials involving 330 patients.
The transjugular intrahepatic portosystemic shunt group achieved more control of ascites at 12 months than the controls - Liver International
In the transjugular intrahepatic portosystemic shunt group, control of ascites was more frequently achieved at 4 months (66% versus 24%) and 12 months (55% versus 19%), whereas encephalopathy was higher (55% versus 38%).
The investigators also reported that survival at 1 year (62% versus 57%) and 2 years (50% versus 43%) were not significantly different.
Dr Deltenre concluded that, "Transjugular intrahepatic portosystemic shunt is a more effective treatment for refractory ascites than large volume paracentesis."
"However, transjugular intrahepatic portosystemic shunt increases encephalopathy and does not improve survival.'
Liver International 2005
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Hepatitis C Virus Coinfection Does Not Lead to Faster HIV Disease Progression in US Women's Study
Source: www.aidsmap.com
Michael Carter
HIV-positive women coinfected with hepatitis C virus do not experience faster HIV disease progression, according to a US study published in the March 15th edition of Clinical Infectious Diseases.
The impact of hepatitis C coinfection on the course of HIV infection is controversial. Although some studies have suggested that coinfection with hepatitis C virus hastens damage to the immune system and the speed of progression to AIDS and death, this has not been the finding of all studies.
Investigators from the US Women and Infants Transmission Study (WITS) wished to address some of the outstanding questions regarding hepatitis C virus coinfection and the speed of HIV disease progression. Investigators prospectively examined the relationship between hepatitis C virus coinfection and CD4 cell percentage, HIV viral load, and progression to AIDS or death from any course. The investigators believed that they were well placed to answer such questions given that they had detailed information on the use of antiretroviral therapy and HAART, and data on illicit drug use, allowing them to adjust for any confounding variables that may result from HAART-related side-effects and hepatitis C virus coinfection.
A total of 652 pregnant women were enrolled to the WITS in several large US cities between 1989 and 1995 and provided a total of 1761 person-years of follow-up. Follow-up was provided until the end of 2003. Hepatitis C virus coinfection was present in 29% of women on enrollment. The mean age at enrollment was 27 years, 42% reported the use of hard drugs during pregnancy, the mean CD4 cell percentage at the study visit closest to delivery was 31% at which time the mean viral load was 63,000 copies/ml.
At the time of delivery hepatitis C virus coinfected women had comparable CD4 cell percentages and viral loads to women who were only infected with HIV. However, the women with hepatitis C virus were significantly older at the time of delivery (29 years versus 26 years, p < 0.001), were more likely to smoke, and have used hard drugs or alcohol (all p < 0.001).
HAART was used by a total of 19% of the study population including 13% of women coinfected with hepatitis C virus and 21% of women who were only infected with HIV.
In multivariate analysis, hepatitis C virus coinfected women had a CD4 cell percentage an average of 1.9% higher than women infected with HIV (p < 0.001). Hepatitis C virus coinfection was not associated with differences in HIV viral load over time.
A total of 48 women progressed to AIDS, 17 of whom subsequently died of an AIDS-related cause. In addition, 26 women died without an AIDS-related cause being attributed. In multivariate analysis, hepatitis C virus coinfected patients did not progress faster to AIDS or death.
The investigators acknowledge that a limitation of their study was that the duration of HIV infection in the women was unknown. In addition, the investigators did not have data on hepatitis C viral load or genotype allowing the stratification of their results by these variables.
“In this large cohort of HIV-infected women, we found no evidence that hepatitis C virus coinfection hastens progression of HIV disease” write the investigators. They add “hepatitis C virus infection was not associated with CD4 cell percentage trajectories, HIV RNA level trajectories, or progression to AIDS or death during follow-up.” They conclude “additional research is needed to understand the complex interactions between hepatitis C virus infection and antiretroviral therapy use and effectiveness in many settings worldwide.”
Reference
Hershow RC et al. Hepatitis C virus coinfection and HIV load, CD4+ cell percentage, and clinical progression to AIDS and death among HIV-infected women: Women and Infants Transmission Study. Clin Infect Dis 40: 859 67, 2005
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March 11th, 2005
Hepatitis Outbreaks Tied to Use of Test Devices
SourceURL:http://news.yahoo.com
Health - Reuters
By Paul Simao
ATLANTA (Reuters) - Improper use of blood sugar testing devices likely fueled a string of hepatitis B outbreaks in U.S. nursing homes that killed two diabetics and sent a number of others to hospital, federal and state health officials said on Thursday.
Their finding followed an investigation into about three dozen cases of the liver infection that surfaced in 2003 and 2004 in nursing homes in Mississippi and North Carolina and an assisted living center in California.
Between 70,000 and 80,000 Americans contract hepatitis B each year, but most of them are young adults who have had unprotected sex with an infected person or shared dirty needles while injecting drugs.
The cases in the extended care facilities raised eyebrows because they occurred largely among elderly diabetics, according to a report published on Thursday by the Atlanta-based Centers for Disease Control and Prevention (news - web sites).
Investigators soon discovered that some of the equipment used to monitor blood sugar, including parts of fingersticks and glucometers, were being shared by patients in the homes, allowing for the possibility of cross-contamination.
Some nursing staff also were not wearing gloves or disinfecting their hands when administering the tests.
Since 1990, the CDC and the Food and Drug Administration (news - web sites) have recommended that fingersticks, which draw a small trace of blood with a single prick, be restricted to a single use. The CDC also advises against sharing of glucometers.
Dr. Anthony Fiore, a CDC epidemiologist and one of the authors of the report, said he suspected other nursing homes across the nation were falling short of the federal guidelines, making them vulnerable to outbreaks of hepatitis B.
"These facilities looked perfectly nice and probably provided the same standard of care that many others provide," Fiore said. "I think it's a problem that could potentially exist elsewhere."
Fiore added that the three recent outbreaks were not identified or investigated in a timely manner, which complicated efforts to contain the spread of the virus, which is sometimes asymptomatic.
Those who do have symptoms of hepatitis B typically develop fatigue, fever, abdominal pain and jaundice. Most recover, although a small number go on to develop the chronic form of the disease.
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Bristol-Myers Hepatitis Drug Effective - FDA Staff
SourceURL:http://news.yahoo.com
Health - Reuters
By Susan Heavey
WASHINGTON (Reuters) - Bristol-Myers Squibb Co.'s. experimental drug for chronic hepatitis B infection is effective in treating the liver disease, but also raises questions about cancer risks, U.S. regulatory staff said in documents released on Thursday.
Food and Drug Administration reviewers also expressed concerns over possible long-term resistance to the drug.
The documents were released ahead of a panel meeting with outside experts on Friday to discuss whether the FDA (news - web sites) should approve the drug. The agency usually, but not always, takes its panelists' advice.
Clinical trials and related studies showed the drug, known by its chemical name entecavir, "effectively reduces the (hepatitis B) viral burden," the reviewers said.
Studies also showed a number of other benefits in patients taking the drug for 48 weeks, including few major interactions with other drugs and easily adjusted doses, they said.
But reviewers also expressed caution. "These positive findings ... must be weighed against findings that are less clearly understood."
The effect of the drug beyond 48 weeks was not clear, they said, warning that there may be a possibility of resistance. "This may have a significant impact on long-term dosing as the clinical trials continue," they said.
The company's studies also left lingering questions over whether the medicine could cause cancer, the reviewers said. They called for the experts to discuss the risk on Friday.
Hepatitis B, which is spread through contact with body fluids like blood, is an inflammation of the liver that can lead to scarring and even death. It can also cause liver cancer, making it difficult to discern whether the disease or a drug is the cause.
"To our knowledge, there has not been a public discussion of an acceptable level of carcinogenicity risk in relationship to chronic HBV treatment," the reviewers wrote.
Company officials could not immediately be reached for comment.
Shares of Bristol-Myers gained 12 cents at $24.84 in late morning trade on the New York Stock Exchange.
Industry analysts are eyeing the drug as one of three potential new products this year that could help the New York-based drugmaker rebound after an accounting scandal in 2002 and an ill-timed investment in ImClone Systems Inc. .
Along with new corporate strategy, entecavir's ultimate approval by the FDA could help offset sales declines when its cholesterol drug Pravachol and others lose patent protection over the next two years, industry experts have said.
Novartis and Idenix Pharmaceuticals Inc. are jointly developing a rival hepatitis drug called telbivudine.
Shares of Novartis were up 18 cents at $49 in late morning trade on the NYSE, while Idenix shares were up 4 cents at $20.19 on the Nasdaq.
About 1.25 million Americans suffer from chronic hepatitis B, according to the Centers for Disease Control and Prevention, and up to 30 percent of patients were infected during childhood.
Four other types of hepatitis viruses -- A, C, D, and E -- also cause similar liver problems.
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ViroPharma Halts Hepatitis C Drug Study on Side Effects
SourceURL:http://money.iwon.com
EXTON, Pa. -(Dow Jones)- ViroPharma Inc. (VPHM) said the results of a study doesn't support further development of HCV-086, a hepatitis C drug that was being co-developed with Wyeth Pharmaceuticals (WYE).
In a press release Thursday, the developmental-stage drug company said HCV- 086, which was in its phase 1b stage, induced "gastrointestinal adverse events" in several patients tested in the highest dose group during a 2-week study.
ViroPharma intends to expedite the development of its follow-on compound HCV- 796, which is from the same chemical series as HCV-086 with "the advantage of being more potent in vitro and, importantly, has demonstrated antiviral activity in an animal model of hepatitis C infection."
HCV-796 is currently in phase 1a safety study.
A ViroPharma spokesman said the company stopped the development of HCV-086 mainly because it didn't show the level of antiviral activity against Hepatitis C as the company had hoped for.
On safety issues, the official said the drug was, in general, well-tolerated with the exception of two patients in the highest dose group, who had to leave the trial due to upper-gastrointestinal side effects such as nausea.
The HCV-086 study involved 80 patients divided into five dose groups. Each group had 12 subjects taking HCV-086 and four taking placebos. The spokesman said the next-generation drug that is being pursued, HCV-796, is also co- developed with Wyeth.
Separately, ViroPharma posted fourth-quarter earnings of $5.8 million, or 22 cents a share, reversing a year-ago loss of $7.1 million, or 27 cents a share.
Fourth-quarter revenue rose sharply to $18.5 million from $1.1 million, led by Vancocin Pulvules, the only drug the company has on the market.
The company bought the rights to market the gastrointestinal drug from Eli Lilly & Co. (LLY) in October. According to ViroPharma, the antibiotic sold about $40 million in the U.S. last year.
The company expects that revenue from sales of Vancocin will enable it to be " at least cash flow neutral" in 2005.
After-hours, ViroPharma's stock gained 4.6% and recently changed hands at $ 2.96. The shares ended Thursday's regular trading session up 1.4% to $2.83.
-Judy Lam; Dow Jones Newswires; 201-938-5400; AskNewswires@dowjones.com
Order free Annual Report for ViroPharma Incorporated
Visit http://djnewswires.ar.wilink.com/?link=VPHM or call 1-888-301-0513
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Gps' College Issues Guidance on Hepatitis A and B Vaccination
SourceURL:http://bmj.bmjjournals.com
London: Robert Short
Injecting drug users should be vaccinated against hepatitis A, and all users of illegal drugs should be vaccinated against hepatitis B, the Royal College of General Practitioners recommended this week. The vaccinations should be carried out without waiting for prevaccination tests for hepatitis A or B.
One of the authors of the five page guidelines document, Dr David Young, clinical director of the drug and alcohol clinical management unit at Cheshire and Wirral Partnership Trust, emphasised that the guidance was for the whole of primary care and not just for people who specialised in treating drug users. He said the paper was the first defining guidance in England and Wales.
It is estimated that 21% of injecting drug users in England and Wales have evidence of past or current hepatitis B infection. Infection can be prevented by vaccination. Poor uptake of vaccination in drug users has led experts now to advise that vaccination is done before waiting for test results for hepatitis B.
Dr Clare Gerada, head of the Royal College of General Practitioners' substance misuse unit, said: "Prescreening can do more harm than good because a drug user may become infected before the next visit or, worse still, not return to see his or her GP."
All drug users should be vaccinated with hepatitis B vaccine because non-injectors often became injectors. The accelerated schedule for hepatitis B vaccination should be used, under which the vaccination is given at 0, 7, and 21 days.
All injecting drug users should be vaccinated against hepatitis A. The single A vaccine should be given in two doses, with the second dose preferably given after 6-12 months, although it can be delayed for up to three years. (The combined A and B vaccination is not recommended as it has only half the amount of hepatitis A antigen of the single component vaccine.)
Dr Young emphasised that the partners and children of drug users are also at risk of hepatitis B infection (through non-sexual or sexual intimate contact) and should be offered vaccination. This, he admitted, may be difficult: "Families may not be registered with the same practice as the drug user. Some drug users may be reluctant to disclose the risk to their partners." The guidance states that healthcare staff need to work with drug users to advise them of the risks and promote the routine offering of vaccination to partners and children.
Guidance for heptatitis A and B vaccination of drug users in primary care and Criteria for Audit is available at www.rcgp.org.uk/drug/
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Blood Boss Calls Press Conference in Cork
SourceURL:http://u.tv/newsroom
The Munster regional director of the Blood Transfusion Service has renewed calls for a public inquiry into the organisation.
Dr Joan Power was instrumental in revealing the infection of hundreds of people with Hepatitis C following blood transfusions.
The IBTSB is launching a separate inquiry into Dr Power`s conduct and the running of the Munster Centre.
The regional director has called a press conference in Cork this afternoon to highlight what she termed as profound problems within the IBTSB.
Minister for Health Mary Harney is to meet the chairperson of the Blood Transfusion Service following Doctor Power`s statement.
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