Back to News Review
Week Ending: December 1st , 2007
Alan Franciscus
Editor-in-Chief
To download pdf version click
here
This Issue:
November 25th, 2007
Hepatitis scare stokes concerns about needles, syringes
http://www.newsday.com
BY KEITH HERBERT
keith.herbert@newsday.com
Last week, nurse Roseann Nitz got a question from a patient unlike any other she's fielded in two decades.
The patient asked Nitz, who works in an Amityville health clinic, to replace the needle and syringe that the nurse had just prepared in order to give an injection. The patient wanted to watch as a new needle and syringe were taken out of their packaging.
Nitz willingly complied, but said, "I was taken aback. It made me feel like she didn't trust me. I guess we're going to be getting more of that."
The recent alleged practices of Dr. Harvey Finkelstein, a Nassau County anesthesiologist, have spotlighted how essential it is for health care professionals to be scrupulous in procedure and practice.
Finkelstein, linked to the reuse of a syringe and contamination of multi-dose vials, is believed to have caused the infection of at least one of his patients with hepatitis C. State health officials have notified hundreds of Finkelstein's patients that they could be at risk for infectious diseases such as hepatitis B and C and the HIV virus.
Whenever blood is involved, whether a person is undergoing a medical procedure or getting a tattoo, there's the potential for transmission of diseases if instruments are not sterile.
Patients can cut the risk of such transmission by asking key questions before the first drop of medication is drawn, doctors and infectious-disease control specialists interviewed last week said.
"In the old days, you and I wouldn't think to ask those questions," said Dr. William Schaffer, an epidemiologist who works at Vanderbilt University and a board member of the Infectious Disease Society of America. "We would assume that every nurse or doctor is adhering to professional procedures."
Inquiries can be as simple as asking whether doctors or nurses washed their hands before injecting medications, or whether all medical staff members are wearing protective gloves, experts said.
When getting an injection of medication, any patient should ask the health-care professional whether he or she used needles and syringes only once. If the doctor or nurse says they reuse such instruments, "I'd be out of there fast," Schaffer said.
A more detailed question could be whether medication being drawn by a needle and syringe is coming from a single-dose vial -- a factor that in itself reduces the risk of blood-borne disease transmission.
Multi-dose vials of medication, which are at the center of the Finkelstein case, are routinely used in all types of medical care settings, and are safe when proper infection-control procedures are used, experts said.
But if procedures are sloppy, multi-dose vials can become a transmission source to patients who subsequently receive injections.
When multi-dose vials are used, one disease-transmission prevention technique that consumers should watch for is the use of germ-killing alcohol to swab a vial's rubber top before a needle is placed inside the vial.
Just as important as what to ask can be when to ask, said Jackie Rowles, president-elect of the American Association of Nurse Anesthetists and a certified registered nurse anesthetist in Indianapolis.
Rowles recommended getting concerns addressed as soon as possible, before medications are placed on the table.
An ideal time is when a patient is presented with a consent form. Often, as in the case of a flu vaccination, the consent form outlines the risks associated with the injection and possible side effects, and health care professionals expect questions from patients at that time, Rowles said.
Wait much later, and a patient -- especially a person receiving an injection for pain, such as an epidural -- could be lying on his or her stomach and unable to observe medications being drawn into needles and syringes.
Another safety protocol is standard procedure in some, but not all, physicians' practices: the presence of another person in the room when a doctor or other health care professional is preparing medication and an injection is given.
"There has to be someone else in the room to check the sterile technique," Rowles said. "Part of their job is to be a watchdog."
Back to top
November 26th, 2007
Family struggles against foreclosure
http://www.dailyherald.com/
By Anna Marie Kukec
Steven Fugate stood tall before the DuPage County judge, fighting the weight of owing $248,000 in mortgage and late fees on his Carol Stream home. Yet standing tall could not erase the reality that he and wife Melanie dreaded most: foreclosure.
The couple, who have five children, struggled to buy that raised ranch about 2½ years ago. Now they're struggling to avoid a foreclosure, the stigma, the heartache and the black mark on their credit. Despite frantic attempts to hold on to it, their home has been slipping out of their grasp.
Steven, a 48-year-old mechanic, has Hepatitis C, a liver disease that often leaves him too fatigued to work regularly. He's been denied disability, but has appealed, which could take up to a year. Yet Steven holds on to the hope that he'll become healthy enough to get a good job and pay off the debt.
Time is not on their side. The sheriff's auction of their home has been set for Jan. 8. It also places them in a Catch-22. In this tough real estate market, could they sell their home in a so-called short sale to get what they can before it lands on the auction block?
Melanie, 43, sat at the back of the courtroom and watched her husband talk to the judge. Steven's back remained straight, his jeans pressed. She couldn't hold back the emotion welling inside, so she stepped into the hallway. Tears flowed.
"We need to have something to start over," Melanie said later. "We need to keep a roof over our heads. That's the whole thing. We've worked for years and years and it's all being pulled out from under us. That's the hardest part."
Staggering numbers
The Fugates are not alone. Tens of thousands of other homeowners nationwide have been facing foreclosure in record numbers.
The foreclosure crisis is a perfect storm of sorts. It includes a mortgage industry in turmoil with years of risky loans coming to roost and with billions in losses for lenders who doled out sub-prime loans and the resulting rules that tightened borrowing. Then there are adjustable loans that quickly strangled homeowners when those rates reset at a soaring interest rate. Add to that a shaky economy, a depressed housing market, a volatile stock market, and the air let out of inflated housing prices.
Other reasons run the gamut. Job loss, sickness, hefty medical bills, out-of-control credit card debt and divorce. Couple these problems with those in the industry and the foreclosure crisis is expected to get worse, experts said.
All it takes for a warning notice or foreclosure complaint is for the homeowner to miss two or three payments.
Some people are able to work out a payment plan. Others cannot pay and have little option but to lose the house. Ignoring the complaint or subsequent notices or going into denial can be detrimental to their case.
"It's almost natural and universal for many people to go into denial," said Steven B. Bashaw, a Lisle attorney specializing in real estate and foreclosure cases. "Some come into this late because of their denial, and that's the worse thing you could do."
The Fugates are among 6,662 households in the Northwest and West suburbs that have received foreclosure notices just from January through September. That amount already has exceeded the full year of 2006, which had 6,428, according to data provided by Kaneville-based Record Information Services.
Throughout Illinois, 20,008 filings were made in the third quarter (July through September). That's one for every 257 households. Those filings involve 19,128 properties. That is about 12 percent higher than the previous quarter and 38 percent higher than the same period a year ago, according to foreclosure data service RealtyTrac Inc. in Irvine, Calif.
Nationwide, a total of 635,159 foreclosure filings -- including default notices, auction sale notices and bank repossessions -- were reported on 446,726 properties during the third quarter. That's a 30 percent increase from the previous quarter and a 100-percent increase from the same period last year, said RealtyTrac.
At that rate, it's one foreclosure filing for every 196 U.S. households. A single property often will have multiple filings against it.
The cycle hasn't peaked yet, some experts say. They expect foreclosures to escalate by this spring as ARM loans with initial low-interest rates balloon with much higher interest.
That could further flood the real estate market with homes, making it tougher to sell and reduce home values even more. And that could slow the nation's economy further, experts said.
"We have about 300 clients and we try to work with them and their mortgage lenders," said Helena Walls, a mortgage counselor with the Lake County Housing Authority, which helps low- and moderate-income people with housing opportunities.
"But if you have no income, none at all, then there's nothing we could do."
Despite the hurdles, both emotionally and financially, the Fugates remain hopeful.
"But we don't have time on our side," Melanie said.
How it started
Melanie and Steven owned a two-bedroom condo since 1998. Steven earned good money as an auto mechanic and later as a forklift mechanic. But he was starting to have various health problems and couldn't pinpoint the exact problem.
They scraped together a down payment for their first home, which cost $275,000. They obtained a 30-year fixed mortgage at 6 percent.
By January 2005, they moved in to the new home, which offered more space with three bedrooms and two baths.
Most of all, the home offered direction for their future, a sense of belonging to a community and a piece of the American dream.
By March 2006, Steven's health worsened, leading to a lot of time off. He lost his job and spent days in bed. Doctors diagnosed him with Hepatitis C, which had led to cirrhosis of the liver. He's worked on and off since.
Last May, Steven's condition worsened with internal bleeding. He started treatments to help eliminate the virus coursing through his veins.
Health insurance covered nearly all his bills. But without a steady job, only the most critical bills were paid first, so the utilities wouldn't be turned off.
"We looked to a lot of different agencies to help keep us from getting behind," Melanie said.
But they feel they have fallen through the cracks, not poor enough for free legal services or other programs, yet not wealthy enough to keep all of them with the basics while paying for utilities, food and other bills.
In April, they received their first foreclosure notice. They had only paid half of their monthly $1,800 mortgage bills for the last three months. The partial payments weren't accepted by the lender and were not credited to their account, Melanie said.
"My first reaction was sadness," said Melanie. "Then I was just utterly scared. Where do we go? What do we do? We couldn't afford an attorney."
Taking action
The Fugates started talking with their lender and agreed to a customized payment schedule to help them catch up on the mortgage.
They then contacted their credit card companies and arranged for set monthly payments with no interest. "They pretty much leave us alone," Melanie said.
They have no car payments or school loans.
Steven also sold some tools, a motorcycle, a ladder and other items, putting the cash toward bills.
But without regular employment, Steven couldn't help with the mortgage. Melanie, an independent researcher who works from home, makes a small wage. But that income couldn't stretch much further.
They also talked to lawyers but didn't qualify for pro bono services.
Their last resort was to put the home up for sale "by owner."
"The market's not good," Melanie said. "Nobody really was looking to buy."
Next, they hired a Realtor, The home lists for $279,900, but so far no one has made an offer. Even if they could sell the home before it hits the auction block on Jan. 8, where would they go?
"We can't afford to live in Illinois anymore," Melanie said. "We have some relatives out of state, but we don't want to do that because the kids are in school here and they like it, and my husband has family here. He needs their love and support."
Whatever happens, they have decided against filing for bankruptcy. "That only stalls the problem and doesn't make it go away. Not really," Melanie said.
They also attend every court date to make sure the judge knows they're sincere in their efforts, Steven said.
"We've always been sort of lucky. Something will work out," he said.
Still, the stress has exacerbated some of Steven's symptoms. He has accepted his physical limitations, such as the fatigue. He must also avoid contact with chemicals, which his liver can no longer process. That means he can no longer handle motor oils and grease, which often seep onto the hands and arms of a mechanic. So he's been looking for other work.
Melanie has been doing her best to care for the home, the kids, her husband and her job.
"We're losing our home," Melanie said. "It's the worse thing in the world, not knowing where to turn or what to do next. If it wasn't for my faith in God, I wouldn't have been able to get through any of this."
Back to top
Artificial liver offers sufferers new hope
http://news.scotsman.com
KATE FOSTER
kfoster@scotlandonsunday.com
SCOTTISH scientists are developing an artificial liver that could save the lives of hundreds of patients by avoiding the need for an organ transplant.
Researchers have created a 'bioartificial' liver using living cells in a machine that can filter blood and take over the functions of the natural organ.
They believe the artificial liver - which works outside the body in a way similar to kidney dialysis - could help patients suffering from acute liver disease such as hepatitis or those who have taken a paracetamol overdose, by giving their own liver the chance to 'rest' and heal itself.
They also say it could give a patient dying from chronic liver failure, such as cirrhosis, valuable extra time while they wait for an organ transplant. The team of University of Strathclyde researchers are at the forefront of the technology in the UK.
They have already created devices that replicate the functions of the liver and are now developing ways to allow the living cells used within the device to thrive better.
Deaths from liver disease are on the increase and researchers are trying to find alternatives to transplantation.
Each year in the UK, liver problems kill about 6,700 people but there are only about 650 transplants. Currently, 231,000 people have hepatitis C, which can lead to liver cancer and liver failure.
Over the past 30 years, deaths from chronic liver disease have increased eightfold in men aged between 35 and 44, and sevenfold in women.
Dr John Gaylor, from the Bioengineering Unit at the University of Strathclyde, has led the team responsible for developing the artificial liver.
He said patients could benefit from the treatment within a decade if sufficient funding is put into the research.
"We are looking at creating a device that would buy time for a patient with acute liver failure where the liver has the potential to regenerate.
"If you can buy time the patient can recover. This includes overdose of paracetamol as an attempted suicide and where they go into liver failure within days or weeks. Hepatitis is another big problem. We were also hoping to use the device as a bridge to transplantation where they have chronic liver failure, such as cirrhosis, and would buy time before transplantation. It is to provide some of the lost functions."
Gaylor and his team used live cells taken from rats' livers and placed them on plates in a specially constructed machine. They coated the inside of the plates with a special protein mixture that allowed them to stick and continue to thrive.
Animal blood was pumped into the bioartificial liver and it was shown to have been detoxified by the cells in a similar way to how the liver normally functions. The scientists then 'spiked' the blood with toxins usually found in the blood of patients suffering from liver disease and found this was successfully removed as well.
Gaylor and his team are now looking at how to make the liver cells work best.
In humans, blood would be taken from the patient directly into the bioartificial liver, allowing their own liver a rest from processing toxins. This could allow the patient's liver to heal itself. The treatment would take a number of weeks or months before the liver was repaired.
A spokeswoman for the British Liver Trust said of the developments: "This sounds particularly positive as there is currently nothing similar out there for liver patients. The benefits could be enormous.
"We would support anything that would benefit patients. Most people do not know they have liver disease until it is too late and the damage is done."
Back to top
Maxygen ends hepatitis drug development
http://biz.yahoo.com
Maxygen Inc. said Monday the development of hepatitis C and B drug MAXY-alpha was terminated.
Redwood City-based Maxygen (NASDAQ:MAXY - News) said in September a hold had been placed on clinical development of the program by its research partner, Swiss pharmaceutical giant Roche. At the time Roche said early observations in a first-phase trial shows it needs more study.
"While we are disappointed, we recognized and had advised earlier that termination of the program was one of the likely possibilities," said Russell Howard, Maxygen's chief executive. "Tremendous potential remains in Maxygen's portfolio and we look forward to 2008, a key year for our two lead programs, MAXY-G34 and MAXY-VII."
The MAXY-alpha program was fully funded by Roche, with no milestone payments expected in 2007 or 2008. Therefore Maxygen said it expects no near-term impact on its financials as a result of the termination. Upon termination of the agreement, all rights to Maxygen's interferon variant product candidates revert back to Maxygen.
In May 2003, Roche and Maxygen announced the partnership and said the deal could earn Maxygen $230 million.
Under the terms of the deal, Maxygen was to use its portfolio of interferon alpha and beta variants to develop candidates to treat the diseases, and Roche would have worldwide commercialization rights.
Back to top
Peregrine Announces Addition of The Johns Hopkins Hospital as Study Site for Bavituximab Trial in HCV Patients Co-Infected With HIV
http://money.cnn.com
--Addition of New Study Site at Leading Urban MedicalCenter Will Expand the Eligible Patient Pool for the Ongoing Bavituximab HCV/HIV Co-Infection Trial—
--Dr. Sulkowski, Principal Investigator of The Johns Hopkins Study Site, Has Expertise in Studying HCV Infection in HIV Patients--
TUSTIN, Calif., Nov. 26 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced the addition of The Johns Hopkins Hospital in Baltimore, Maryland to its ongoing clinical trial designed to evaluate the safety and pharmacokinetics of bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV). The trial will be conducted under the direction of Dr. Mark Sulkowski, associate professor of medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine. Patient dosing is continuing in the bavituximab HCV/HIV co-infection study at Saint Michael's Medical Center in Newark, New Jersey.
Dr. Sulkowski is a co-investigator for the Johns Hopkins University AIDS Clinical Trials Unit and has served as the principal investigator for numerous clinical trials related to the management of HCV in persons with and without HIV co-infection. Dr. Sulkowski has also co-authored several medical papers on HCV patients infected with HIV.
"We expect that this new study site for the bavituximab co-infection trial will be a valuable addition to our efforts to ensure that enrollment in the trial proceeds as planned," said Steven W. King, president and CEO of Peregrine. "We are pleased that this distinguished group from Johns Hopkins is supporting our efforts, and we look forward to working with all of our investigators in the coming year to generate clinical data enabling us to assess the potential of bavituximab as a possible new therapy for patients co-infected with HCV and HIV."
This open-label, dose escalation study is expected to enroll up to 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to eight weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.
In the United States alone, an estimated 300,000 individuals are co-infected with HCV and HIV, representing up to 30% of all HIV-infected patients. Co-infected patients have been shown to have a lower response to current HCV treatment regimens, and the adverse effects of these regimens can be especially problematic for some HIV patients.
About Bavituximab
Bavituximab is a monoclonal antibody in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses, including both HCV and HIV. Bavituximab helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Since bavituximab's PS target comes from the host and not the virus, bavituximab may be less susceptible to the development of anti-viral resistance. Peregrine has completed two bavituximab Phase I monotherapy clinical trials in patients with chronic HCV infection. In these trials, the drug appeared safe and well tolerated with encouraging signs of anti-viral activity. Bavituximab is also in Phase II trials for the treatment of solid cancers.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the results from the co-infected HCV/HIV clinical trial will not be consistent with the results from the company's prior HCV clinical trials or preclinical studies and the risk that bavituximab will not be as effective as the current standard of care for co-infected patients. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products, as all of our products are currently in development; preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2007 and quarterly report on Form 10-Q for the quarter ended July 31, 2007. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts:
GendeLLindheim
BioCom Partners
Investors
info@peregrineinc.com
(800) 987-8256
Media
Barbara Lindheim
(212) 918-4650
Source: Peregrine Pharmaceuticals, Inc.
Back to top
Mexican Americans Carrying Haplotype H6 Of The CYP2E1 Gene Have A Greater Risk Of Alcoholism
http://www.sciencedaily.com/
ScienceDaily (Nov. 26, 2007) — Mexican Americans make up 66 percent of the U.S. Hispanic population and, when compared to other ethnic groups, show high rates of heavy drinking and alcohol-related problems. First-of-its-kind research that examines haplotypes -- clusters of genetic polymorphisms -- of the CYP2E1 gene among a Mexican-American population has found that carrying haplotype H6 may enhance susceptibility to developing alcoholism.
"The prevalence rate of heavy drinking among male Mexican Americans is three times higher than that of non-Hispanic male populations," said Yu-Jui Yvonne Wan, professor of pharmacology and director of the Liver Center at the University of Kansas Medical Center. "Mexican Americans have also been found to have more alcohol-related problems -- such as withdrawal, tolerance, and accidents -- than Caucasians. Furthermore, Hispanics are more likely than Caucasians to continue their alcohol dependence once it begins."
Wan, who is the study's corresponding author, has been studying minority-health related issues for more than 15 years. She said that alcohol consumption by Hispanics also appears to lead to greater health-related complications.
"In comparison with Caucasians, Hispanics have a higher prevalence of hepatitis C, a serious infectious liver disease that greatly increases the risk for liver damage in heavy drinkers," she said. "Hispanics with alcoholic liver disease also appear to do significantly less well than those from other ethnic backgrounds."
Given the apparent susceptibility of Mexican Americans to alcohol-related problems, as well as previous inconsistent and inconclusive findings of the association between alcoholism and polymorphisms of the CYP2E1 gene, Wan designed her study to address both issues.
"Our study is the first to use a genetic haplotype approach to investigate an association of the four polymorphisms of the CYP2E1 gene -- CYP2E1*1D, *5B, *6, and *1B -- and alcoholism in the Mexican American population," she said. "A haplotype is the combination of marker alleles on a single chromosome. Haplotype analysis allows us to explore potential interactions among alleles and thus can be more informative than individual allele analysis."
Researchers recruited 699 Mexican Americans living within a 50-mile radius of Los Angeles for this study: 334 alcoholics and 365 non-alcoholics or "controls." All participants provided blood samples and clinical data for genotype, allele, and haplotype frequency comparisons. Haplotypes were also tested for associations with clinical phenotypes such as age of drinking onset, maximum number of drinks within a 24-hour period, and smoking status.
"Our data demonstrate that haplotype analysis is more informative than individual allele analysis," said Wan. "More specifically, subjects carrying haplotype H6, the combination of the four alleles -- 1C, c2, C and A2 -- appear to have increased susceptibility to developing alcoholism."
Results also indicate that H6 is associated with late-age onset of drinking as well as heavy drinking. In addition, the H1, H2 and H3 haplotypes were associated with alcohol consumption and smoking.
"Linkage disequilibrium (LD) is often termed 'allelic' association," explained Wan. “When alleles at two distinctive loci occur more frequently than expected given the known allele frequencies, the alleles are said to be in linkage disequilibrium. For instance, our study found that the CYP2E1 c2 allele is in linkage disequilibrium with the CYP2E1 C allele in Mexican Americans, which means the two alleles frequently coexist in one chromosome. Our data also showed that the c2 and C allele are linked with each other more tightly in alcoholics than in non-alcoholics. This suggests that an individual with both c2 and C alleles is more susceptible to alcoholism. These and other findings support the notion that LD is population specific, and the risk factor of alcoholism might be population specific as well.”
Wan recommended that future studies examine the "functional significance" of the H6 haplotype. "Whether H6 changes enzyme activity or alcohol-induced enzyme activity needs to be examined," she said. "Although only five percent of Mexican alcoholics have the H6 haplotype, it is important to use the same approach to study other ethnic groups, particularly Asians, who have high frequency of both c2 and C alleles. Furthermore, since elevated CYP2E1 causes oxidative stress, polymorphisms of this gene might also have an impact in other disease processes such as cancer."
Results are published in the December issue of Alcoholism: Clinical & Experimental Research.
The co-author of the ACER paper, "A Haplotype Analysis of CYP2E1 Polymorphisms in Relation to Alcoholic Phenotypes in Mexican Americans," was Min Yang of the Department of Pharmacology, Toxicology & Therapeutics at The University of Kansas Medical Center. The study was funded by the National Institute on Alcohol Abuse and Alcoholism.
Adapted from materials provided by Alcoholism: Clinical & Experimental Research.
Back to top
10 top tips - hepatitis C
http://www.pulsetoday.co.uk
GP Dr Clare Gerada gives her hints on managing hep C in primary care
1. Hepatitis C infection is common. It is estimated that about 200,000 to 400,000 people in the UK are infected. Between eight and 18 people are likely to be hep C positive in an average practice with a list of 1,800 – more in areas with a lot of substance misuse. Most of these cases will be unknown to the doctor and unknown to the patient.
2. Untreated, the cost to the NHS will be up to £8bn over the next 30 years. There will be increasing numbers of people with late complications such as cirrhosis, liver failure and liver cancers and increasing numbers needing liver transplants. Early treatment is often successful but only 1-2% of infected people in the UK receive NICE-approved treatments.
3. Think of hep C in any patient with even mildly deranged LFTs. Hep C causes slowly progressive, often asymptomatic liver disease. Most people who become infected are unaware of it at the time. Some people may briefly feel unwell, or may have nausea and vomiting and, rarely, jaundice. Many with chronic hep C infection will have no symptoms, while others will feel unwell to varying degrees. Most people will remain well and without symptoms for a number of years and this makes the infection difficult to recognise. Disease progression and severity is very variable and patients may not become symptomatic until their liver disease is advanced. Symptoms, though not common, may include muscle aches and a high temperature, mild to severe fatigue, nausea, loss of appetite, weight loss, depression or anxiety, pain or discomfort in the liver, jaundice, poor memory or concentration and alcohol intolerance.
4. About 25% of patients with hep C will naturally clear the virus with no treatment. Of the remaining 75%:
• some will remain asymptomatic for life
• many will develop symptomatic or asymptomatic mild or moderate liver damage
• most will progress to cirrhosis over 20 to 40 years
• about 5% per year will develop liver failure or hepatocellular carcinoma.
5. Hep C infection is curable. The chance of treatment completely clearing the virus is maximised by early diagnosis and early referral. So it is very important that doctors are able to identify and offer testing to anyone who could be considered at current or past risk – possibly during a new patient health check.
6. GPs can also help reduce further risks and improve the chances that treatment can be successful.
• Offer harm reduction advice – remember that injecting equipment includes needles, syringes, spoons, filters.
• Provide brief intervention for heavy drinkers and/or alcohol detoxification for dependent drinkers.
• Provide smoking cessation products – smoking is an independent risk factor for hep C inflammation in patients with chronic infection.
• Provide weight reduction advice – body mass index above 25 has been associated with more rapid disease progression.
7. Initial testing should include an antibody test and a test for current circulating virus.
Blood needs to be taken for an initial antibody blood test and this will indicate whether a person has ever been infected with hep C. About 15-20% of people who become infected will clear the virus at the acute stage but these will still have positive antibody results. A polymerase chain reaction (PCR) test will identify current circulating virus. More sophisticated PCR tests can then identify the viral load and genotype. As the mere act of taking blood may be difficult in many former and current drug misusers, some labs allow for two samples to be sent at the same time, the first asking for hep C test and the second requesting, if hep C positive, PCR and genotype testing.
8. Refer early. Patients who are antibody positive but PCR negative do not need specialist treatment but need counselling about lifestyle – either in primary or secondary care. All patients who are PCR positive need further assessment and investigation, which usually means specialist referral to a hepatologist, gastroenterologist or infectious disease specialist. NICE guidelines recommend early treatment.
9. Treatment can clear the virus in 40-80% of people. The current treatment is combination therapy with pegylated interferon and ribavirin. Primary care can continue to play an important role, offering support through the treatment process.
10. Offer practical help during treatment. Help can be given to manage side-effects – paracetamol for pyrexia, anti-emetics if nauseated and moisturisers and steroid cream for itchy skin. Also useful are harm-reduction information, support for drug dependency and monitoring of mental health, especially depression.
The RCGP has recently produced guidance for the prevention, testing, treatment and management of hep C in primary care (May 2007), available at: www.smmgp.org.uk and www.rcgp.org.uk
Dr Clare Gerada is a GP in south London and a member of the RCGP sex, drugs and HIV working group
Back to top
November 27th, 2007
Inovio Biomedical Partner Tripep Treats First Subject in Phase I/II Study of Novel Hepatitis C DNA Vaccine
http://www.finanznachrichten.de
Inovio Biomedical (Nachrichten) Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB of Sweden, treated the first subject in a Phase I/II clinical trial of a novel DNA vaccine designed to treat chronically infected hepatitis C virus (HCV) patients. The clinical trial is designed to test Tripep's proprietary DNA vaccine, ChronVac-C®, administered using Inovio's MedPulser® DNA Delivery System, in 12 subjects already infected with HCV. The trial is being conducted in Sweden at two Karolinska University Hospitals, the Center for Gastroenterology in Solana and at the Infections Clinic in Huddinge.
"The treatment of the first subject in this clinical study of a novel therapeutic vaccine for a significant chronic pathogen is another step in a paradigm shift toward DNA-based vaccines that may address a number of diseases that have not been controllable using conventional prophylactic vaccination,” stated Avtar Dhillon, MD, Inovio's president and CEO. “We look forward to the development of a number of important therapeutic vaccines using Inovio's proprietary delivery technology.”
“Current therapies for chronic infections caused by HCV type-1 strains are largely unsuccessful and represent a major unmet need for a therapeutic vaccine,” stated a scientific paper published in the Journal of Immunology, July 2007. In this peer-reviewed article, entitled “In Vivo Electroporation Enhances the Immunogenicity of Hepatitis C Virus Nonstructural 3/4A DNA by Increased Local DNA Uptake, Protein Expression, Inflammation, and Infiltration of CD3+ T Cells,” authors Gustaf Ahlen et al present their results using Inovio's electroporation platform to deliver Tripep's vaccine against HCV-1 in animal models for HCV. They conclude that the vaccine resulted in elimination of liver cells expressing the targeted hepatitis C virus proteins and that in vivo electroporation “greatly enhanced” DNA uptake (into muscle), protein expression levels, and the strength of the primed immune responses. The authors concluded that the ChronVac-C® vaccine against HCV can be effectively delivered using in vivo electroporation, resulting in the activation of a broad immune response that may assist a host in gaining control of a hepatitis C infection.
About Inovio's DNA Vaccine Technology
DNA vaccines have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical data has indicated the ability of Inovio's technologies to effectively deliver and significantly enhance the potency of such immunotherapies without the potential safety concerns of viral delivery systems.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and electroporation-based DNA delivery systems. DNA plasmids are designed to express (produce) antigens that can induce an immune response specific to a cancer or infectious disease-causing organism. These plasmids are created synthetically and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into muscle or tumor cells, production of the desired antigens may induce a preventive or therapeutic immune response against the intended disease. Inovio's advanced electroporation devices facilitate delivery and expression of DNA vaccines to produce the desired antigens. Primate and/or interim Phase I data has have shown significantly enhanced antibody and T-cell immune responses relative to plasmid DNA delivered by other methods, suggesting the potential to provide better preventive or therapeutic effects against complex infectious diseases and cancers.
Inovio is poised to deliver advanced DNA-based vaccines and immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions and re-use of inadequately sterilized needles and syringes. As many as 70% - 90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis). Globally, an estimated 170 million people are chronically infected with HCV, representing a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006).
HCV infections in the liver do not trigger an immune response very effectively. Certain antiviral therapies, while expensive, are somewhat effective in treating hepatitis C. There is no vaccine currently available to prevent hepatitis C. ChronVac-C(R) is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments demonstrated that ChronVac-C vaccination activated B-cells and T-cells (the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C) that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid will be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined antigens that may activate the body's immune system to attack all cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops and commercializes candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C(R), a therapeutic vaccine against hepatitis C; preclinical research focusing on the development of therapeutic and prophylactic vaccines against influenza A and HIV; and the RAS(R) technology platform. More information is available at www.tripep.se. Contact Jan Nilsson, CEO, at +46 8 449 8480 or jan.nilsson@tripep.se.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple DNA-based immunotherapies and commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Interim human data has shown that Inovio's DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. The SECTA therapy for locally treating solid tumors is designed to selectively kill cancerous cells and minimize cosmetic or functional detriments often caused by surgical removal of predominantly healthy tissue typically treated around a tumor. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com .
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the nine months ended September 30, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
Back to top
November 28th, 2007
Drug boosts platelets in hepatitis C patients
http://www.eurekalert.org
DURHAM, N.C. – It’s not a cure, but this may be some of the best news patients infected with the hepatitis C virus (HCV) have heard in a long time: A new drug, eltrombopag, appears to be effective in boosting low platelet counts, one of the major reasons why patients can’t endure antiviral treatments.
Other drugs that can restore normal platelet functions are infusions or injections; eltrombopag is a pill taken just once a day.
Researchers at Duke University Medical Center and other centers world-wide studied eltrombopag (marketed as Promacta in the U.S. and Revolade in Europe by GlaxoSmithKline) in 74 patients with low platelet counts and cirrhosis of the liver due to HCV infection. They found that it boosted platelet counts in a majority of patients at each of three dosage levels, enabling most of them to continue or start conventional antiviral treatment.
The findings appear in the current issue of the New England Journal of Medicine.
“We feel this is an important development for many people infected with the hepatitis C virus world-wide,” says Dr. John McHutchison, professor of medicine and associate director of the Duke Clinical Research Institute. “A significant number of patients with HCV infection will at some point develop platelet problems that will compromise their getting the best treatments we have. Anything we can do to prevent that from happening would improve their care.”
It’s estimated that 4 million people in the U.S. and 170 million world-wide carry the hepatitis C virus. The virus causes inflammation and scarring in the liver, and while it is curable in about half of those who have it, it can lead to significant liver damage, liver cancer and death in others. HCV infection is a common cause of cirrhosis and the most common reason for a liver transplant.
Platelets are cells made in the bone marrow that are important in clot formation, and serious bleeding can occur if platelet levels fall too low. Some diseases, like HCV infection, can cripple the body’s ability to manufacture platelets, but so can some medical treatments. Cancer patients, for example, can experience plummeting platelet levels when undergoing chemotherapy.
In the phase II, multi-center trial, participants were randomized to a control group or to receive 30, 50, or 75 milligrams of eltrombopag daily. The patients had platelet levels ranging from 20,000 to 70,000 (145,000 to 450,000 is normal).
A phase II trial is designed to test the safety and efficacy of a drug at different doses, and the Duke study found that eltrombopag worked in a dose-dependent manner, meaning that patients got a better response with increasing amounts of the drug. Seventy-four percent of those in the trial who took the lowest dose saw their platelet counts go up significantly, while 79 percent and 95 percent of the participants saw increases with the higher doses.
Eltrombopag does cause side effects. Some of the patients complained of headaches, dry mouth, abdominal pain and nausea.
“We are encouraged by these results and are already working on another multi-center, international, phase III trial where we hope these results will be confirmed,” says McHutchison.
Back to top
Commissioner Vows Changes After Needle Scare
http://www.1010wins.com/
MELVILLE, N.Y. (AP) -- The state health commissioner says he's taking steps to insure timely investigations after an outcry over the handling of a hepatitis and HIV scare traced to a Long Island doctor.
Commissioner Richard Daines says he wants to "improve the timeline'' for investigations and "improve public communication'' about them.
He says he has set up an internal team to make sure investigations move as quickly as possible and plans to appoint an expert group as advisers. He also hopes to boost the Health Department's power to obtain doctors' records.
Gov. Eliot Spitzer and others have blasted the agency for taking nearly three years to notify 600 patients of one Long Island anesthesiologist that they were at risk for hepatitis and the HIV virus. Health officials say the doctor's sloppy needle techniques infected at least one person with hepatitis. The doctor has said he has changed his technique.
Back to top
Alta. hospital patients test positive for Hep B, C
http://www.ctv.ca/
The Canadian Press
VEGREVILLE, Alta. -- Some former patients of an Alberta hospital that was cited for improperly sterilizing medical equipment have tested positive for Hepatitis B and C, health region officials announced Tuesday.
However, Dr. Gerhard Benade stressed it is not yet known whether the infections are linked to the sterilization scandal that rocked St. Joseph's Hospital in Vegreville.
"If you test people in the general population, you will find positive results," Benade said. "The numbers we have found so far are much lower than what you would expect in the general population."
Benade declined to say how many people have tested positive, explaining that each case is being reviewed by an independent specialist in Edmonton.
"There are a large number of risk factors which may contribute to people becoming positive or having been exposed to things," he said.
"We need to finish the process."
Benade said a final report on the investigation's findings will be submitted to the provincial government in February or March.
The hospital was closed to new patients last March after an outbreak of a super-bug.
Since then, 1,850 former patients out of 2,872 have come forward for testing, with many declining to be tested.
Benade said 98 per cent of patients affected have been contacted, but there are still some who haven't yet been tracked down.
"This is an enormous project. People are mobile and we have to track them down across the province, across Canada, and a significant amount of people out of country."
Health Minister Dave Hancock promised quick action last summer after the release of a government review on infection control following the Vegreville situation.
Hancock said the review looked at infection prevention policies in all the province's health regions and didn't find any threats to patient safety.
A separate review by the Health Quality Council of Alberta found it was unclear who ran the facility, and the result was confusion, testy relations and a culture that did not view patient safety as job one.
Back to top
Boat’s Battle
http://www.styleweekly.com
by Lisa Antonelli Bacon
Prickly longtime public defender John Boatwright runs into a different kind of enemy — hepatitis C.
John Boatwright III used to swagger into courtrooms like a lion entering a Roman arena: confident, brash and hungry. Whether it was in the heat of litigation or in the chilly brinkmanship of plea negotiations, his forthright manner often irked opponents. Some things change; others never do.
His walk is much slower. And whether he admits it or not, his softer side occasionally forces its way to the surface, only to be snatched back like a kid who shares his ice cream and immediately regrets it. In the old days, he could dish out a courtroom pummeling, and all it took to revive him was a cold beer and a cigarette. Now, there’s no beer, no smokes; just Boat, in a tiresome battle that won’t end.
There isn’t much to say about hepatitis C, other than there is no cure, and it is a miserable, life-altering disease. Cigarettes are verboten when you’re on the liver transplant list. And drinking, for Boat, ended in January ’06. “I’d had 54 years to slurp up all I could. I had my share and some for others,” he says. By that August, he could barely get out of bed. “Up to the summer of ’06, I felt fine.”
Now, barely more than a year later, he sits sock-footed in jeans and a flannel shirt in the living room of his home near Chippenham Medical Center, a dark red blotch from an iron transfusion swallowing his right forearm.
Boatwright is on short-term disability from his post as capital defender for Virginia’s central region. Since the office first opened its doors in 2002 — offering legal representation to those facing capital offenses — Boat has led it. Turnover has been a big issue, as it always is when the hours are long, the pay seems grossly inadequate, and the clients are people like Ricky Javon Gray (now facing the death penalty for murdering the Harvey family on Jan. 1, 2005).
He’s paler, smaller, but he’s lost none of his puckish bravado. His wife, Allison, a paralegal, comes home during her lunch break to check on him. “If you can think of it, I’ve had it,” he says. “It” includes iron transfusions, colonoscopies and laser surgery for internal bleeding, to name a few. When his liver got frighteningly sluggish, doctors added a shunt to bypass the liver. In the process, they found he had a 40 percent blockage in one artery, so he underwent another procedure to place a stent in the blocked artery.
One thing hasn’t changed: Boat’s insistence that all is fine, and he’s still in the lead, although that has become a relative issue. “Two days after they put that shunt in, I hadn’t felt that good in 20 years,” he says.
Although his hands shake a little and his voice isn’t as loud, it’s the same strident one that was easily recognizable on the third floor of the John Marshall Courthouse. In the 1980s, Boat made his bones in criminal court working for attorney Michael Morchower, known then as “Magic Mike” for his ability to get acquittals and lighter sentences for many clients who might have deserved much worse.
In 1987, Boatwright struck out on his own and formed Boatwright & Linka with attorney Bill Linka, a partnership that lasted until 2002 when Boatwright was named Virginia’s first capital public defender.
“You’ll find as many who love him as hate him,” says Linka, whose firm now practices under the name Richmond Criminal Law. “But regardless of what they think of him, he’s always well prepared.”
Although Boatwright has spent the last 25 years representing people who could’ve shared a myriad of diseases, from the common cold to HIV, he has no idea where he contracted hepatitis C. “The only way you can get it is through infected blood products,” he says.
It’s possible he got it through vaccinations while in basic training for the U.S. Army in 1972. “You lined up front to back, and you rolled up your sleeve. They came along with a [needle] gun and went ‘bam’ to you, ‘bam’ to the next guy, and the next guy. Some bled.” Because the disease can incubate over years, there is no scientific way to determine where or how he became infected.
“I don’t care how I got it,” Boatwright says. “I feel good. I’m fine.”
Back to top
HepaGamB(TM) In-Home Aftercare Access Program for Liver Transplant Patients Launched By Apotex and Centric Health Resources
http://www.pr-inside.com
- Apotex Corporation and Centric Health Resources today launched a new in-home aftercare program designed to help liver transplant patients transition from hospital to home with ease while enhancing desired outcomes and lowering overall costs. The new HepaGamB(TM) Aftercare Access Program(C) combines specialty pharmacy and home health management services with access to the FDA-approved HepaGamB therapy. HepaGamB (Hepatitis B Immune Globulin Intravenous (Human)) is the only medication approved by the FDA to prevent recurrence of post-liver transplant Hepatitis B.
Transition of post-liver transplant patients from hospital to home typically requires the patient to visit the transplant center frequently to receive their medications, update their compliance with therapy and monitor their health status. In addition, these patients and transplant centers must also seek reimbursement for the costs associated with these health care services and medications.
The new HepaGamB Aftercare Access Program allows patients to receive their medication and health management services in the convenient and lower-cost setting of their own homes, while also getting professional assistance in seeking reimbursement from their insurer. The program offers the following aftercare services:
- Patient intake
- Order fulfillment and overnight shipping of HepaGamB and related supplies to the patient's home;
- Training and education services for patients, physician offices and staff;
- Nursing services including infusion, monitoring and reporting of compliance with therapy, and improved lifestyle information and guidance;
- Payer education;
- Reimbursement services including verification of coverage, authorization of services, billing and collection from payer and patient, and claims support/appeal as needed;
- Around-the-clock on-call support;
"This program will significantly ease the transition for transplant centers and their liver transplant patients to aftercare in the home while helping to enhance the desired outcomes and lower overall costs," said Craig Kephart, President and CEO of Centric Health Resources. "With one phone call, a patient can be enrolled and begin receiving our comprehensive services, while also relieving the transplant center from dealing with patient discharge, cost reimbursement and therapy compliance."
Post-liver transplant patients typically can remain on aftercare from one year to the remainder of their lives. Recurrence of Hepatitis B is a major concern among this patient population, which is at risk for infection and rejection of certain medications.
"Our role in this program demonstrates our core competencies and shows the value of our patient-centered health management business model," Kephart, added. "We hope this program will help thousands of post-liver transplant patients, stay compliant with their medication and enjoy improved health outcomes and better lifestyles."
For more information on the HepaGamB Aftercare Access Program, call 866-588-6932.
Centric Health Resources is a nationwide organization serving the specialized needs of individuals with certain rare and chronic genetic disorders, along with their families, specialist physicians and healthcare payers. As a specialty pharmacy employing patient centered health management services, Centric Health Resources works with patient advocacy organizations, pharmaceutical companies, biotech firms and managed care organizations to deliver prescribed therapies and specialized health services. The company's comprehensive approach reduces health care spending and improves the quality of life for patients and their families. Centric Health Resources is currently the most experienced and successful provider of specialized pharmacy and patient centered health management services for persons affected by AAT Deficiency. Centric currently dispenses, Prolastin(R), IVIG products, hemophilia factor products and several therapies now undergoing clinical trials. For more information, visit www.centrichealthresources.com.
Apotex Corp. is the US Subsidiary of Apotex, Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida and operations center in Indianapolis, Apotex Corp, is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com.
Centric Health Resources
Craig Workman, 314-640-9033
Back to top
Graft Size May Affect Thrombocytopenia After Liver Transplant
http://www.medscape.com
Laurie Barclay, MD
November 19, 2007 — Portal venous pressure (PVP) and small graft size may indicate the need for simultaneous splenectomy during liver transplantation to avoid posttransplant thrombocytopenia, according to the results of a retrospective analysis published in the November issue of the Archives of Surgery.
"In living donor liver transplant (LDLT), the graft size is sometimes inadequate, causing elevated PVP and the small-for-size syndrome, which may result in thrombocytopenia," write Shigeru Marubashi, MD, PhD, from Osaka University Graduate School of Medicine in Osaka, Japan, and colleagues. "Splenectomy at the time of transplant is one of the definitive procedures for avoiding postoperative thrombocytopenia and the small-for-size syndrome in LDLT, although its protective mechanism has not been fully understood. In this study, we aimed to clarify the relationship between perioperative variables, including PVP, graft size, and thrombocytopenia, after LDLT."
At a university hospital, the investigators reviewed 45 adult patients with liver cirrhosis who underwent LDLT without splenectomy (n = 38) or with simultaneous splenectomy (n = 7). The primary endpoints were preoperative and postoperative platelet counts, recipient age, preoperative Model for End-Stage Liver Disease score, donor age, ratio of graft volume to standard liver volume, PVP, cold and warm ischemia times, blood loss, and surgical complications.
In the 38 recipients in whom splenectomy was not performed, PVP after transplant was strongly correlated with platelet counts at 14 days, 28 days, and 3 months. Factors associated with posttransplant thrombocytopenia were high PVP (>25 mm Hg) and small graft size. Regardless of graft volume, patients who underwent splenectomy at the time of transplant had sufficient platelet levels at each time point.
"Portal venous pressure and graft size were associated with posttransplant thrombocytopenia," the study authors write. "Splenectomy is an option in cases with a high PVP or a small graft, especially for patients receiving postoperative interferon therapy for hepatitis C virus."
The authors note that the incidence of infection, particularly with Streptococcus pneumoniae, may increase after splenectomy. They therefore recommend prophylaxis with preoperative vaccination and careful monitoring for infection after LDLT.
The authors have disclosed no relevant financial relationships.
In an invited critique, Steven D. Colquhoun, MD, from Cedars-Sinai Medical Center in Los Angeles, California, notes that the contribution of thrombocytopenia to an increased incidence of infection or other morbidity should be balanced against risks of the splenectomy itself, especially in the immunosuppressed patient.
"A logical proposition would be selective intervention based on measurements of posttransplant PVPs," Dr. Colquhoun writes. "If elevated beyond the 25–mm Hg threshold observed by
Marubashi and colleagues, then splenic artery ligation could easily be performed. If PVPs were persistently elevated, then a splenectomy would be more completely justified."
Dr. Colquhoun has disclosed no relevant financial relationships.
Arch Surg. 2007;142(11):1054–1058.
Back to top
Long-Term Liver Transplant Better in UK Than in US
www.reuters.com
By David Douglas
NEW YORK (Reuters Health) Nov 21 - Although patients undergoing liver transplantation in the US have better 90-day survival, many of those who undergo the procedure in the UK and Ireland seem to do better after the first year, UK researchers report in the November issue of Gut.
Dr. Muhammad F. Dawwas of Addenbrooke's Hospital, Cambridge and colleagues note that international comparisons of surgical results can be problematic and often fail to allow for long-term results.
However, they point out that the "standardised nature of liver transplantation practice makes it uniquely placed for undertaking reliable international comparisons of surgical outcome."
To investigate further, the researchers examined data for a 10-year period. This covered all 5925 transplants which took place in the UK and Ireland as well as all 41,866 transplants which had been conducted in the US during the same time interval.
In the UK group, at 90 days, risk-adjusted mortality was greater than in the US (hazard ratio, 1.17). This was true for patients with acute liver failure (hazard ratio, 1.27) and those who had had chronic liver disease (hazard ratio, 1.18).
There were no significant international group differences between 90 days and 1 year. However, after a year, those transplanted in the UK or Ireland because of chronic liver disease did better than US patients (hazard ratio, 0.88). An exception was for acute liver failure patients (hazard ratio, 1.02).
"These results highlight interesting differences between two health systems funded by entirely different mechanisms," Dr. Dawwas told Reuters Health. "A predominantly privately funded healthcare system, such as the one in the United States, was demonstrated to have better short-term outcome for liver transplantation, but a system of universal publicly funded healthcare, as in the UK, had a better outcome after the first post-transplant year."
"Our results therefore could have important implications for health policymakers in those countries and beyond," he concluded.
Gut 2007;56:1606-1613.
Back to top
November 30th, 2007
Ministry accepts blame for silence over hepatitis infection
http://www.japantimes.co.jp/
Kyodo News
The government accepted the blame Friday for taking no action after receiving reports that 418 people had been infected with hepatitis C via a tainted blood product.
"Due consideration should have been paid about notification to the patients" over the administration of the tainted fibrinogen blood product, and the government should reflect upon its inaction, the Ministry of Health, Labor and Welfare said in a report.
While denying legal responsibility, the ministry indicated its intention to punish the officials involved for what it called "lax" methods of storing and handling the reports.
A health ministry panel looked into why the ministry failed to take action after it received the reports in 2002 from Mitsubishi Pharma Corp., successor to Green Cross Corp., the maker of fibrinogen. Mitsubishi Pharma is now part of Mitsubishi Tanabe Pharma Corp.
The ministry interviewed 47 officials involved at that time, as well as doctors and patients, and found that the ministry did not consider informing patients because officials thought doctors would tell their patients.
In Friday's report, the ministry, however, denied that it is legally responsible for neglecting to inform the 418 people that they had received the tainted blood product.
The ministry said in the report that there was no obligation then to inform them because it had promoted campaigns urging patients to see their doctors and to undergo checkups, and it had disclosed all available documents.
But "the whole ministry should fully listen to the criticism against it" for lacking consideration for people who were suffering from hepatitis C, the report said.
In October, the health ministry announced it had found Mitsubishi Pharma's reports on the 418 people, filed between March and July of 2002, in its basement storage room.
The documents concern records on the 418 who were administered the tainted product between 1965 and 1993.
The ministry said at that time it had not informed the people who had received the tainted product.
The revelation drew strong criticism from plaintiffs in lawsuits filed against the government and drug makers over the hepatitis C infections.
The plaintiffs say some patients could have slowed the deterioration of their condition if they had been notified that they had contracted hepatitis C because of the blood product.
Of the 418, Mitsubishi Tanabe has so far identified 250, of whom 47 have died.
Meanwhile, the health ministry said it will shortly announce disciplinary action against officials over sloppy record-keeping.
Hepatitis C is a blood-borne, infectious viral disease.
Back to top
Back to News Review
|
