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HCV ADVOCATE WEEKLY NEWS REVIEW: A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: June 19^th, 2004

Alan Franciscus
Editor-in-Chief

In This Issue:

• Hepatitis C in a Los Angeles public hepatitis clinic
•Conservatives promise to compensate all hepatitis C victims
•MEDICAL REDRESS: Shaking off 'shame'
•Long-term benefit of interferon alpha in chronic hepatitis D
•Preliminary Results Presented at American Transplant Congress on Largest Ever Hepatitis C Trial Conducted in Liver Transplant Recipients
•Liver transplantation from donors aged 80 years and over
•Hepatitis C victims may get apology but no cash



June 7th, 2004

Hepatitis C in a Los Angeles public hepatitis clinic
www.gastrohep.com

Physicians, in the June issue of Clinical Gastroenterology and Hepatology, find that hepatitis C risk factors, sex distribution, and coinfection with hepatitis B vary with ethnicity.

In this study, physicians from California, USA, assessed possible racial-ethnic differences in hepatitis C presentation in an urban hepatitis clinic.

The team surveyed the clinic summary cards of patients with antibodies to hepatitis C virus seen between 1993 and 2000.

They evaluated a total of 1271 patients from 4 major racial-ethnic groups. Of the 1271 patients, 95 were Asian, 232 African American, 323 Caucasian, and 621 Latino.

The physicians found that Latino patients had higher serum alanine transaminase, aspartate transaminase, and bilirubin levels, compared to other patient groups. They also had lower serum albumin levels.

Asian patients were more likely to be coinfected with hepatitis B virus.
Clinical Gastroenterology and Hepatology

In addition, the team determined that Latino patients had the lowest rate of hepatitis B coinfection. They were significantly less likely to have normal serum ALT levels.

The physicians found that Asian patients were 10 years older than patients in other groups. They were also significantly more likely to be coinfected with hepatitis B virus.

Asian patients had an equal distribution of infected men and women whereas all other groups showed a male predominance.

The physicians established that injection drug use was a negligible cause of hepatitis C in Asian patients. However, this was a prevalent cause in Caucasian patients of both sexes and in African American and Latino men.

Dr Anne Celona and colleagues concluded, "Hepatitis C risk factors, sex distribution, and coinfection with hepatitis B vary by race-ethnicity".

"Latino patients showed statistically significant biochemical differences in alanine transaminase, aspartate transaminase, bilirubin, and albumin levels compared with all other racial-ethnic groups".

"Further studies are required to determine the possible causes for these biochemical differences".

Clinical Gastroenterology and Hepatology 2004; 2(6)

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June 13th, 2004

Conservatives promise to compensate all hepatitis C victims
www.cbc.ca

OTTAWA - Canadians who contacted hepatitis C through tainted blood but didn't qualify for government compensation would be helped financially by a Conservative government, a party spokesperson said Sunday.

In 1998, the Chrétien government decided that only Canadians who had been infected between 1986 and 1990 would be eligible to file a claim, an estimated 20,000 people.
The estimated 22,000 Canadians who contacted hepatitis C outside that four-year window are not eligible for government compensation.

The Liberal government's decision angered victims' groups, who said that discriminating based on a date was morally indefensible.
David Harvey, a lawyer who works with hepatitis C victims, welcomed the Conservative announcement, saying compensation would greatly help people who are having difficulty paying for living expenses and costly drugs.

Compensating all victims will not be done at the expense of taxpayers, says Grant Hill, an advisor to Conservative Leader Stephen Harper. Only $371 million from the $1.2 billion compensation package has been given to victims and their families to date.

"It's very obvious that the number of patients that [the Liberals] calculated were far in excess of those really in existence," said Hill. "It's very obvious that there's plenty of money for helping everyone."

"The money that was set aside for victims within the (1986-1990) window period is plenty sufficient to pay those outside the window," said Hill.

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MEDICAL REDRESS: Shaking off 'shame'
TOMOKO OTAKE, Staff writer
www.japantimes.co.jp

In a civilized society, people should not be scared to talk about their ailments -- especially when the illness may have been contracted from medical product infected with a potentially fatal virus. Yet in Japan, between 1980 and 2001, an estimated 10,000 people may have been infected with the hepatitis C virus (HCV) after being injected with a tainted blood coagulant during labor or surgery -- but most choose to keep their condition secret.

In fact, only 72 have braved the stigma (HCV is often associated with drug addicts and alcoholics) to join group lawsuits now taking their course. And of those 72 plaintiffs, who are suing the government and the makers of the coagulant called fibrinogen, only eight have decided to make their names public.

One of those unafraid to reveal her plight is Michiko Yamaguchi, a 48-year-old part-time schoolteacher and mother of two sons. When she became the first plaintiff to go public in April 2003, she was firm about her decision: "I've done nothing wrong," she said. "So, why can't I have everything out in the open?"

While many people would say they fear losing their jobs, voiding insurance policies or forfeiting close relationships, Yamaguchi has been able to persuade some fellow plaintiffs to defy Japan's culture of shame and speak out.

Compared to the high-profile post-transfusion HIV suits involving hemophiliacs in the early to mid-1990s, the HCV plaintiffs' campaign has been relatively low-key. This is partly because HCV does not have an image of being immediately life-threatening. While untreated hepatitis can lead to liver cancer, it usually takes 15 to 20 years before visible symptoms of HCV appear.

However, for Yamaguchi, an elegant and unassuming woman from Fukuoka, there is a sense of urgency. In a recent interview with The Japan Times, she recounted what she has been through -- and still goes through every day.

Even as a child, she said, her dream was to become an elementary school teacher, and she worked hard to realize that dream. Marrying at 25, she gave birth a son two years later. Life was good and fulfilling -- until the day in September 1987 when she checked into a local obstetrician's clinic to give birth to her second son.

As she went into labor, Yamaguchi said, she suffered a massive hemorrhage. She recalled that as she lay on an operating table, she heard a nurse calling out to someone else: "I'll give her a shot to stop the bleeding."

Yamaguchi had no idea that the coagulant in the syringe was tainted with HCV. She didn't know, either, that the blood coagulant was produced by the Osaka-based Green Cross Corp, a now-defunct pharmaceutical company. At that time, Green Cross was becoming embroiled in a scandal in which the firm was blamed for infecting hundreds of hemophiliacs with HIV.

A few days later, though, Yamaguchi was told she was infected with HCV. She spent the next six months hospitalized. Though she didn't appear to suffer adverse symptoms then, she said she was not allowed to cradle and breastfeed her new baby.

"I used to go up to the roof of my clinic every day, gazing at a nearby hospital building where my baby was being taken care of," she said sadly.

When she finally returned to teaching, she realized that something had changed. Plagued by anxiety over the life-threatening infection, Yamaguchi could no longer give 100 percent. On top of that, two years of outpatient treatment induced a range of side effects, including fever, diarrhea and fatigue. Climbing up stairs made her short of breath; she also lost three-quarters of her hair and had to wear a hairpiece.

Though Yamaguchi said her colleagues didn't openly discriminate against her, they really didn't support her or show much interest in her condition. She eventually quit her full-time job in March 2001.

After that, Yamaguchi said she might have lived a quiet life of shame forever -- had she not read a newspaper article in October 2002 about a lawsuit over allegedly HCV-tainted fibrinogen. The unnamed plaintiffs told the paper exactly the same story as Yamaguchi's -- hemorrhage during labor, a shot of fibrinogen and then becoming infected with HCV.

Anger swelled inside her. She immediately dialed the hotline number given in the article. A lawyer answered and suggested she confirm the facts with her obstetrician.

She hung up, then called the clinic right away. When the doctor answered the phone, she thanked him for "'saving her life" all those years ago. The doctor asked her how she was doing, to which Yamaguchi replied matter-of-factly that she had chronic hepatitis and takes a blood test every month.

Yamaguchi gradually moved on to the point of her call: "You know, I bled massively and had a blood transfusion." She didn't mention the word fibrinogen.

The doctor suddenly blurted out, "Back then, every obstetrician used fibrinogen."

"It was like, 'I did it!' " Yamaguchi recalled. Fifteen years of pent-up emotions and suffering finally found an outlet.
It has been a year since she revealed her name in the group lawsuits, which are pending before district courts across the nation and are likely to drag on for years.

But today, Yamaguchi feels she represents all Japan's faceless victims of tainted drugs. That includes those who haven't mustered the courage to come forward, and those who tried to join the suits but couldn't because their hospitals wouldn't cooperate in their search for evidence.

While a long road lies ahead, Yamaguchi's story is powerful testimony that, yes, we can have hope that the day will come when everyone in Japan will feel free to participate fully in their society.

Source: http://www.japantimes.co.jp/cgi-bin/getarticle.pl5?fl20040613x6.htm

June 14th, 2004

Long-term benefit of interferon alpha in chronic hepatitis D
www.gastrohep.com

High doses of interferon alpha-2a significantly improve the long-term outcome and survival of patients with chronic hepatitis D, find scientists in the June issue of Gastroenterology.

The long-term effects of interferon alpha on clinical outcome and survival of patients with chronic hepatitis D are unclear.

In this study, scientists from Europe evaluated 36 patients with chronic hepatitis D.

Patients were randomized to receive either a 48-week course of high doses of interferon alpha (9,000,000 units), a course of low doses (3,000,000 units), or no treatment.

Patients were followed for an additional 2 to 14 years. High dose patients had a dramatic improvement in liver histology.
Gastroenterology

The scientists found that long-term survival was significantly longer in the high-dose group than in either the low dose group or the controls. Long-term survival did not significantly differ between the low dose group and the control group.

After 12 years of follow-up, 7 of the 12 surviving patients in the high dose group had a biochemical response. A biochemical response was also found in 2 of the 4 surviving low dose patients.

The team found that long-term alanine aminotransferase normalization correlated with improved hepatic function and loss of IgM antibody to hepatitis delta antigen.

They determined that patients in the high-dose group had a sustained decrease in hepatitis D virus replication, leading to clearance of HDV RNA.

High dose patients also had a dramatic improvement in liver histology with respect to activity grade and fibrosis stage.

The team also found an absence of fibrosis in 4 patients with a long-term biochemical response and an initial diagnosis of active cirrhosis.

Dr Patrizia Farci and colleagues concluded, “High doses of interferon alpha-2a significantly improved the long-term clinical outcome and survival of patients with chronic hepatitis D, even though the majority had active cirrhosis before the onset of therapy”.

Gastroenterology 2004; 126(7)

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June 15th, 2004

Early Data Shows Steroid-Free Protocol May Be Safe with Low Rejection Rates

CINCINNATI, June 15 /PRNewswire/ -- CTI Clinical Trial and Consulting Services announced that Goran Klintmalm, M.D., Ph.D., chief of Baylor Regional Transplant Institute and principle investigator of a study comparing 3 immunosuppressant treatment regimens in liver transplant recipients with hepatitis C, presented preliminary data from the trial at the American Transplant Congress meeting last month in Boston and the International Liver Transplantation Society meeting last week in Kyoto, Japan. A total of 312 patients enrolled in this prospective, multicenter, randomized study at 18 leading U.S. transplant programs. Enrollment began in August 2002 and concluded in March 2004. All patients will be followed for 2 years. Hepatitis C is present in approximately 4 million Americans, and affects 50% of all patients receiving liver transplants. Hepatitis C frequently recurs following liver transplantation, leading to death or retransplantation.

Corticosteroids have been the cornerstone of immunosuppression in transplantation since the 1960s, however there is much controversy that corticosteroids may in fact increase recurrence of hepatitis C. In addition, the role and effect of mycophenolate mofetil, an immunosuppressant (non-steroid), in hepatitis C liver transplant patients is unclear.

"The purpose of this study is to determine the effect that the withdrawal of steroids, as an immunosuppressant, has on the recurrence of hepatitis C, as well as whether mycophenolate mofetil can reduce and slow down the development of hepatitis C as it recurs in the transplanted liver," said Dr. Klintmalm. "While definitive analysis and conclusions will have to await completion of the trial in approximately 2 years, the early results are very encouraging." Patients were randomized to one of the three treatment regimens at the time of transplantation and will be maintained on this regimen for two years.. Treatment regimen 1 includes conventional therapy (tacrolimus) and corticosteroids, but no mycophenolate mofetil; treatment regimen 2 includes tacrolimus, corticosteroids and mycophenolate mofetil; and treatment regimen 3 includes tacrolimus, mycophenolate mofetil and daclizumab (an antibody given to prevent early acute rejection), but no steroids. Liver biopsies will be performed at various times throughout the study to assess treatment failure. Data presented by Dr. Klintmalm on 261 patients enrolled through Dec. 31, 2003, focused on day 90 post transplant data.

The early data from this trial showed that the steroid-free protocol may be safe with low rejection rates. This preliminary analysis demonstrated that all three regimens had similar excellent early patient survival rates ranging between 95-100%, and graft survival rates ranging between 95-97%. In addition, protocol-defined acute rejection rates and hepatitis C recurrence rates were low in all three regimens. The complete avoidance of corticosteroids in regimen 3 had no negative impact on acute rejection incidence or recurrent hepatitis C. However, there appeared to be a decrease in diabetes and hypertension in this group of patients. Further, the use of mycophenolate mofetil in regimens 2 and 3 did not increase hepatitis C recurrence or severity at 90 days post transplant. Finally, in regimen 3, daclizumab appeared to be safe and did not increase early hepatitis C recurrence or severity.

"The data obtained from this study will provide important information to improve the management of hepatitis C patients after liver transplantation," Dr.. Klintmalm said. Baylor University Medical Center at Dallas initiated this trial and recruited the other 17 participating study sites. CTI, Clinical Trial and Consulting Services, is managing the trial on behalf of Baylor. Other participating members of the study include Emory University School of Medicine, Lahey Clinic, Mayo Clinic in Rochester, Mayo Clinic in Scottsdale, Medical University of South Carolina, New York Presbyterian Hospital, New York University School of Medicine, Northwestern University Feinberg School of Medicine, Oregon Health and Science University, University of Alabama at Birmingham School of Medicine, University of California - San Francisco Medical Center, University of Chicago Medical Center, University of Cincinnati Medical Center, University of Medicine and Dentistry in New Jersey, University of Southern California Keck School of Medicine, University of Texas Health Science Center at San Antonio, and University of Virginia Medical Center.

"It was particularly gratifying to work with this group of committed liver transplant programs on this study. Enrollment was completed early and participating investigators have been diligent about obtaining all protocol specified procedures," stated Lynn Fallon, senior vice president, CTI. For more information about this research, visit http://www.baylorhealth.com.

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services provides innovative clinical trial services and consulting solutions for the pharmaceutical industry in the specific areas of transplantation, infectious disease and end stage organ disease, including dialysis and liver function.

CTI's experience encompasses over 20 years of designing and implementing drug development programs. CTI's involvement spans the entire lifecycle of the product from drug development pathway design, clinical trial design, strategic marketing plan development, product management and sales. CTI is capable of managing all phases of the clinical trial process from pre-study planning and concept development to the preparation of the final trial manuscript. Combining market and industry expertise gives CTI the ability to evaluate information and drug compounds from every possible perspective, incorporating both clinical and market driven endpoints and interpretations.

SOURCE: CTI Clinical Trial and Consulting Services

CO: CTI Clinical Trial and Consulting Services; Baylor University Medical Center at Dallas; Baylor Regional Transplant Institute

ST: Ohio, Japan, Massachusetts

SU: SVY MAV

Web site: http://www.CTIFacts.com

http://www.prnewswire.com

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June 16th, 2004

Liver transplantation from donors aged 80 years and over
SourceURL: www.gastrohep.com

Hepatitis C recurrence is associated with a greater mortality in patients who receive octogenarian grafts, find researchers in the July issue of the American Journal of Transplantation.

Older donors make up a growing proportion of the total donor pool.

In this study, researchers from Italy compared 30 orthotopic liver transplantations (OLTs) with octogenarian donors with 60 OLTs performed with donors who were under 40 years.

The researchers found that refusal was greater with older compared to younger donors (48% versus 14%).

They found that cold ischemia was shorter in the older group.

They also found that recipients with hepatocellular carcinoma and older age received octogenarian grafts more frequently.

Long-term survival is lower in patients transplanted with octogenarian livers.
American Journal of Transplantation

However, there were no differences in post-operative complications, and 6-month graft and patient survival.

In the long-term, the team found that survival was lower in patients transplanted with octogenarian donors.

The researchers established that hepatitis C-related mortality was greater in patients with octogenarian donors.

Dr Bruno Nardo and colleagues concluded, "Octogenarian livers can be used safely but a careful donor evaluation and a short cold ischemia are required to prevent additional risk factors".

"However, hepatitis C recurrence is associated with a greater mortality in patients who received octogenarian grafts raising concerns whether to allocate these livers to HCV-positive recipients".

Am J Transplant 2004; 4(7): 1139-47


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June 18th, 2004

Hepatitis C victims may get apology but no cash
Chris Jones, national political reporter
thecouriermail.news.com.au/

THOUSANDS of Australians infected with hepatitis C through blood transfusions in the years before a test for the disease was developed in 1990 will be denied taxpayer-funded compensation.

Instead, the estimated 20,000 Australian victims of tainted blood are likely to receive access to a national fund established to help meet the cost of their medical needs that are not already covered by existing government services.

They also are likely to receive an official apology from governments and the Australian Red Cross Blood Service if recommendations of a parliamentary inquiry into the instances of hepatitis C in the nation's blood supply are adopted by government.

The Senate's community affairs references committee yesterday tabled its report examining the lack of safeguards in the blood supply system before 1990, and proposed ways to compensate victims of that apathy.

"The committee considers the most effective means of assisting people infected with hepatitis C through blood transfusion are improvements in services, including wider access to anti-viral drugs and financial assistance for (other) costs," the report said.

"The committee considers that extending the current compensation arrangements is not in the best interests of the people who have acquired hepatitis C through blood and blood products."

Committee chairwoman Jan McLucas (Labor, Queensland) told the Senate the key recommendation was the establishment of the fund to help victims pay for things such as allied health treatments, prescribed medication, and transport to general practitioners.

"We are recommending that a fund be established, funded by the states and Commonwealth ... and that fund will be able to be accessed by people who have hepatitis C contracted through the blood supply," Senator McLucas said.

"And we are saying 'If you think you got it through the blood supply and you know you had a transfusion, let's help you'.

"Let's not go down the legal path. Let's simply get you some support."

But Independent Blood Council president Charles MacKenzie said hepatitis C sufferers who caught the disease through blood transfusions were likely to now push for a royal commission because of the Senate committee's failure to compensate them.

Mr MacKenzie said hundreds of people debilitated by the disease would now be left to fend for themselves, and therefore would be forced to take legal action.

He said the failure to compensate victims was out of line with what other countries such as Canada, England, Ireland, Italy, Spain and Sweden had decided.

"The question is why is an Australian life worth so much less?" Mr MacKenzie said.

The Australian Red Cross Blood Service earlier this month apologised for the first time to victims of tainted blood, telling them that hepatitis C infections via transfusions were " a terrible fact" but that it would work to make things better.

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