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

Week Ending: September 11th, 2004

Alan Franciscus
Editor-in-Chief

In This Issue:

• County Health Board Moves to Keep Needle Exchange
•Hepatitis B, Silent Killer, Puts 1 in 10 Filipinos at Great Risk
•Vertex Pharmaceuticals Reports Completion of Dosing in the Phase 1a Clinical Study of VX-950, an Oral HCV Protease Inhibitor for the Treatment of Hepatitis C
•Micrologix Receives Approval to Initiate Phase II Study of MBI-3253 (Celgosivir) in Hepatitis C Patients
•Long-Term Outcomes for Liver Transplantation Due to Hepatitis C
•More than 2,000 patients at a Redwood City hospital may have been exposed to hepatitis C and B
•Hepatitis C Recurrence after Liver Transplantation
•Southwestern Lab Selects Third Wave Reagents for Hepatitis Tests
•Safe Injection Activist Honoured


September 4th, 2004

LCounty Health Board Moves to Keep Needle Exchange
Anita Srikameswaran
Source: Pittsburgh Post-Gazette

The Allegheny County Board of Health has decided to draft a regulation to allow the continuation -- and ensure accountability -- of a local needle exchange program.

For the past two years, a private organization, Prevention Point Pittsburgh, has operated it as a pilot program, authorized by the health board's declaration of a "public health emergency."

The program aims to slow the spread of infections like HIV and hepatitis by providing intravenous drug users with clean needles.

The health department last month conducted three public hearings regarding the program. Most people who testified supported its continuation.

The yet-to-be-drafted regulation, discussed at Wednesday's health board meeting, would have to go through another public comment period and would have to be approved by County Council and Chief Executive Dan Onorato, said health department spokesman Guillermo Cole.

"I'm pretty optimistic that we're going to get support both from the board of health and County Council," said Renee Cox, executive director of Prevention Point. "It's kind of been a slow process, but we're trying to cooperate as best we can."

Tim Curges, the health department's acting chief of the sexually transmitted diseases program, told the board that 64 of 67 people, or 96 percent, who spoke or sent letters during the recent comment period supported continuation of the needle exchange program.

One dissenter said taxpayer dollars would be better spent on the flu vaccine program, noted Dr. Bruce Dixon, county health director.

"There's been a lot of confusion," he said. "The county does not fund or receive funding for needle exchange. There is no public money involved in this."

He said the health board's role would be to set up the rules under which the program would operate and ensure accountability.

Prevention Point operated underground for seven years before the health board authorized it as a pilot program in 2002. It provides services every Sunday at a site in Oakland with an annual budget of $180,000, Cox said.

In addition to exchanging needles, the program offers HIV and hepatitis testing, case management and treatment referrals. More than 2,000 people have registered to use the services and about 200 participate each week. About half of those tested have been infected with hepatitis C virus, Cox noted.

Some were frustrated that the program didn't acquire more permanent standing at Wednesday's meeting.

"I am sorry that there's at least another two-month delay," said Prevention Point board member Caroline Acker. "It's very difficult for us to raise funds when we don't have secure status, and yet we can only go to the private sector to support this lifesaving work."

"We're struggling to stay alive and to provide services," Cox said. "The demand has completely exceeded our resources."

One board member wondered whether the program would reduce infectious disease transmission at the cost of higher rates of drug use.

"That is an important question and it has been extremely well-studied," Acker said. "The research is clear that needle exchange does not increase drug use."

If anything, she said, it appears to get people into treatment.

In another matter, County Council President Rich Fitzgerald spoke to the board about broadening an ordinance that limits school bus idling to include other diesel-powered vehicles, like trucks.

September 6th, 2004


Hepatitis B, Silent Killer, Puts 1 in 10 Filipinos at Great Risk

By CHER JIMENEZ, TODAY Reporter
Source: www.abs-cbnnews.com

Around eight million Filipinos or 10 percent of the population are living a dangerous life that could have been prevented with only US$3.

The Philippine Cancer Society (PCS) said 10 percent of the population are afflicted with Hepatitis B, with one out of four of them dying of liver cancer. Liver cancer, described by experts as a “silent killer,” is the second most common type of cancer in the country.

Erlinda Valdellon, chairman of the Philippine Society on Gastroenterology, estimates that there will be 7,629 new liver cancer cases by next year. By 2005, it is also predicted that 7,477 Filipinos would die of liver cancer.

A study by the PCS showed that one out of 10 Filipinos is suffering from chronic Hepatitis B (CHB), while one out of four will die of cirrhosis and liver cancer.

Valdellon said the only way to stop the spread of Hepatitis B among Filipinos is to immunize newborn babies.

Samuel So, director of the Liver Cancer Program of the Asian Liver Center of Stanford University, said newborn babies should be immunized against Hepatitis B 12 hours after delivery to make them 95-percent protected from the virus.

The Hepatitis B virus is transmitted by blood and other bodily fluids. People who experience tiredness, loss of appetite, nausea, abdominal discomfort, dark urine, clay-colored feces, and yellowing of the skin and eyes have a possibility of being infected with the virus.

Pregnant mothers can transmit the virus to their unborn children, making immunization the best way to deter the disease.

So said it only costs $3 to immunize an infant with the required three rounds of vaccination, which should be done within six months after delivery. But So added that many countries in Asia, including the Philippines, do not have a “functional vaccination program.”

“With three dollars, which is the price of pirated DVDs [digital video discs], you can protect your child for life,” he said.

Jose Sollano Jr., chief of the gastroenterology department of the University of Santo Tomas, said only 15 percent of Filipinos with Hepatitis B are into treatment, while the rest are too poor to afford therapy.

In addition, the disease does not show symptoms immediately and can only develop to liver cancer after about 20 years, indicating that most patients do not know they have the virus, Sollano added.

“The drugs are available, but they are not effective because they are not affordable,” he said.

Treatment for Hepatitis B costs P12,500 weekly for medicines that are injected, while those that are to be taken orally cost P4,500, said Solano.

The Department of Health (DOH) admitted that immunization against the virus has not been a priority unlike measles and polio immunization, which are being done regularly among children. Health Secretary Manuel Dayrit admitted in an interview on Monday that no DOH hospital is offering free vaccines for infants being born there. The Dr. Jose Fabella Memorial Medical Center has the biggest number of infant deliveries among DOH-controlled hospitals.

Dayrit said the government made Hepatitis B immunization a policy during the Aquino administration but was able to cover only 25 percent of the target owing to lack of funds. Back then, the price of vaccine was still higher, according to him. “The issue is sustainability,” he told reporters.

Asked if the government does not see immunization as a priority, Dayrit said, “it’s urgent from the point of view of trying to prevent build-up. It’s less urgent because you got 30 to 40 years [to show] manifestation.”

Meanwhile, Sen. Pia Cayetano, whose father, former Sen. Rene Cayetano, died of liver cancer in 2003, pledged to give P50 million of her pork barrel for the purchase of Hepatitis B vaccines.

Cayetano, who gave up half of her P200 million pork barrel fund, said she has allotted P100 million for education and health.

September 7th, 2004


Vertex Pharmaceuticals Reports Completion of Dosing in the Phase 1a Clinical Study of VX-950, an Oral HCV Protease Inhibitor for the Treatment of Hepatitis C
Source: PRNewswire

CAMBRIDGE, Mass.-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced it has successfully completed the dosing portion of a Phase Ia clinical trial for VX-950, an investigational oral protease inhibitor for the treatment of hepatitis C virus (HCV) infection. The study, involving 35 healthy volunteers and conducted in Europe, was designed to assess safety, tolerability and pharmacokinetics in escalating, single doses of VX-950. Based on the results from this study and preclinical studies, the Company expects to begin a Phase 1b clinical study of VX-950 in HCV-infected patients by the end of the year.

"As an oral, direct antiviral therapy, VX-950 represents an exciting novel approach for the treatment of chronic hepatitis C infection," stated John J. Alam, M.D., Senior Vice President of Drug Evaluation and Approval at Vertex. "VX-950 is a key compound in our core HCV drug development portfolio, and the completion of the Phase I study represents another important step forward for this clinical development program."

In the Phase Ia study, single doses ranging from 25 mg to 1250 mg were administered. No dose-limiting toxicities were identified, and a maximum tolerated dose was not reached. However, blood concentrations of VX-950 were observed that exceeded the concentration known to demonstrate potent antiviral activity in preclinical laboratory experiments, and at certain dose levels these target concentrations were maintained for more than 12 hours. Analysis of combined clinical and preclinical pharmacokinetic results for VX-950 suggest that liver concentrations 10- to 30-fold above the replicon 50% inhibitory concentration ("IC50") are achievable in humans using practical doses and regimens. The liver is the target organ for antiviral therapies directed against hepatitis C infection.

"The data from the Phase I study met our expectations, and we look forward to the first evaluation of VX-950 in HCV-infected patients," stated Dr. Alam. "While extrapolations based on single dose studies must be made with caution, the concentrations of VX-950 we observed in the bloodstream of healthy volunteers are at levels which we would expect to be required to demonstrate antiviral activity when VX-950 is dosed in HCV-infected patients."

In the fourth quarter of 2004, Vertex expects to initiate a multi-dose, Phase Ib clinical study with VX-950. This placebo-controlled trial will be designed to evaluate the safety, tolerability, and pharmacokinetics of up to 14 days of dosing with VX-950 in both healthy volunteers and HCV-infected patients. The data from the Phase Ia study, together with data from nonclinical studies, are being compiled for submission to the appropriate regulatory authorities for review prior to initiation of the Phase Ib study.

About VX-950 and Hepatitis C
VX-950 is Vertex's lead oral HCV protease inhibitor and one of the most advanced of a new class of antivirals in development for HCV. Preclinical data have shown that VX-950 significantly reduces levels of HCV-RNA in both the replicon system and infectious virus assays within days. Preclinical pharmacokinetic studies completed to date have indicated that VX-950 is orally bioavailable and achieves excellent exposure in the liver, the target organ for HCV treatment.

Chronic hepatitis C virus infection is a serious public health concern affecting approximately 2.7 million people in the United States. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Worldwide, the disease strikes as many as 185 million people. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV.

Collaboration with Mitsubishi Pharma Corporation
In June 2004, Vertex and Mitsubishi Pharma Corporation signed an agreement to develop and commercialize VX-950 in Japan and certain Far East countries. Mitsubishi will make pre-commercial payments to Vertex to support clinical development of VX-950. Additionally, Mitsubishi will pay royalties to Vertex on commercial sales of VX-950 in Mitsubishi's territories. Vertex owns development and commercialization rights to VX-950 in the rest of the world, including North America and Europe.

About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical partners. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the new HIV protease inhibitor, Lexiva(R), with GlaxoSmithKline.

This press release may contain forward-looking statements, including statements that (i) preclinical and Phase I clinical results support the initiation of a Phase Ib clinical study in HCV-infected patients; (ii) a Phase Ib study is planned for the fourth quarter of 2004; and (iii) the concentrations of VX-950 observed in the bloodstream of healthy volunteers suggest that antiviral activity will be observed in HCV-infected patients. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. These risks and uncertainties include, among other things, the risks that clinical trials for VX-950 may not proceed as planned due to technical, scientific, supply or patient enrollment issues, that subsequent clinical studies of VX-950 will not reflect the results obtained in nonclinical and initial clinical testing, that clinical results may not demonstrate the value of VX-950, and other risks listed under Risk Factors in Vertex's form 10-K filed with the Securities and Exchange Commission on March 15, 2004.

Lexiva(R) is a registered trademark of the GlaxoSmithKline group of companies. Vertex's press releases are available at http://www.vrtx.com.

Vertex Contacts:
• Lynne Brum, Vice President, Corporate Communications and Financial Planning, (617) 444-6614
• Michael Partridge, Director, Corporate Communications, (617) 444-6108
• Jaren Irene Madden, Manager, Media Relations, (617) 444-6750

Micrologix Receives Approval to Initiate Phase II Study of MBI-3253 (Celgosivir) in Hepatitis C Patients
Source: PRNewswire

Results Expected Q2 Calendar 2005 from Multi-center, Monotherapy Study

VANCOUVER, BC, and SAN DIEGO, CA, - Micrologix Biotech Inc. (TSX: MBI - News; OTC: MGIXF - News) has received a Letter of Authorization for its clinical trial application (CTA) from Health Canada to begin a Phase IIa human clinical study with MBI-3253 (celgosivir), an oral first-in-class therapy in development for the treatment of chronic Hepatitis C Virus (HCV) infections. Study site selection has been completed, with the study expected to begin enrolling patients within the next few weeks and results expected in the second quarter of calendar 2005.

Lorne Tyrrell, MD, Ph.D., an internationally recognized hepatitis expert and Chair of the Micrologix Hepatitis C Clinical Advisory Board, stated, "Preclinical results to date indicate that MBI-3253 could be effective as monotherapy and in improving combination therapy with existing treatments for HCV infections. HCV-infected patients currently have few treatment options, and those options have limited effectiveness in treating the most common strain of HCV infection in North America (genotype I). If MBI-3253 can achieve evidence of viral load reduction as monotherapy and/or in combination therapy, it could be an important new product candidate to improve treatment outcomes for HCV patients."

MBI-3253, an a-glucosidase I inhibitor, has already demonstrated efficacy in a surrogate model of HCV infection and has been well tolerated in over 500 human subjects to date. Recent peer-reviewed publications have shown that (a) a-glucosidase is important for HCV replication, (b) the hepatitis C virus is hypersensitive to a-glucosidase inhibition, and (3) MBI-3253 is additive and/or synergistic with the currently approved HCV therapies (ribavirin and interferon).

Nancy Coulson, Senior VP of Product Development at Micrologix commented, "This approval represents a great step forward for MBI-3253 since a recognized regulatory agency has reviewed the clinical, preclinical, and manufacturing data available for the product. This confirms our assessment that the work done to date has been well done, and along with the information we have thus far, further increases our confidence in achieving clinical success".

Jim DeMesa, MD, President & CEO of Micrologix added, "Our team has once again executed rapidly to get this potential blockbuster product opportunity advancing through development in just a few months after its acquisition. This is important since starting this study as planned allows us to get clinical efficacy data in the near-term. Overall, clinical activity within our company is expected to be significant over the next 12 months as we initiate Phase II studies for MBI-3253 (HCV) and MITO-4509 (Alzheimer's disease) and continue Phase III trials with MBI-226 (catheter-related infections)."

About the Clinical Study
Approximately 60 treatment-naive or interferon-intolerant HCV patients will be treated for 12 weeks at 5 sites in Canada, divided into three dosing groups. The objective of this initial study is to evaluate HCV viral loads at various time points during the study and at 12 weeks. The study will also assess the safety of MBI-3253 in HCV patients. Since MBI-3253 has shown additive and/or synergistic effects with currently marketed products in preclinical models, combination studies are being planned to further evaluate efficacy.

About MBI-3253 and HCV
MBI-3253 (celgosivir) is an orally-administered, unique antiviral agent exerting its effects through the inhibition of the mammalian cell enzyme, a-glucosidase I. Alpha-glucosidase I inhibitors can inhibit the replication of a broad range of enveloped viruses (including HCV) by preventing the correct folding of their envelope glycoproteins.

Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 4.5 million people in the United States. Worldwide, the disease affects as many as 185 million people. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. Current therapies for HCV infection have only limited effectiveness, especially against genotype I, the most common strain of HCV in North America. It is predicted that deaths from HCV will surpass those of AIDS in the United States by 2010, at which time the global HCV market is forecasted to be approximately $6 billion.

About Micrologix
Micrologix is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs for the prevention and treatment of major medical diseases and certain conditions with unmet medical need. With its expertise and experience in product development, the Company is focused on advancing its pipeline of product candidates in the areas of infectious and degenerative diseases. Micrologix is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information about Micrologix is available at www.mbiotech.com.

Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward looking statements in this news release include, but are not limited to: Micrologix having results of the MBI-3253 Phase IIa study by the second quarter of calendar 2005, initiating combination studies of MBI- 3253, initiating a Phase II study with MITO-4509 (Alzheimer's disease) in the next 12 months and a Phase III study for MBI-226 (catheter-related infections) being initiated in the next 12 months. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: government regulation, dependence on and management of current and future corporate collaborations, early stage of development; technology and product development; future capital needs; uncertainty of additional funding; no assurance of market acceptance; dependence on proprietary technology and uncertainty of patent protection; manufacturing and market uncertainties; and intense competition. These and other factors are described in detail in the Company's Annual Information Form and Annual Report on Form 20-F, forthcoming news releases and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission. Forward-looking statements are based on our current expectations and Micrologix is not obligated to update such information to reflect later events or developments.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

September 8th, 2003


Long-Term Outcomes for Liver Transplantation Due to Hepatitis C
Source: www.medicalnewstoday.com

A new study on liver transplants necessitated by the hepatitis C virus (the most common indication for this type of transplant) found that long-term outcomes are similar to patients receiving transplants due to other diseases.

It was the first study to examine long-term transplantation results in hepatitis C patients and to identify risk factors that might lead to transplant failure or death. The results of this study appear in the September 2004 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at http://www.interscience.
wiley.com/ journal/livertransplantation.

Unlike other liver diseases, hepatitis C infection commonly recurs in transplant patients. Although previous studies had shown that short-term transplantation survival rates for hepatitis C patients were similar to patients undergoing transplants for other indications, a recent analysis of the United Network for Organ Sharing (UNOS) database suggested that five-year transplant outcomes may be poorer for hepatitis C patients. The current study utilized the Liver Transplantation Database, which was established in 1990 by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) to collect data on patients being evaluated for liver transplants.

Led by Michael Charlton, M.D. of the division of Gastroenterology & Hepatology at the Mayo Clinic in Rochester MN, researchers examined the records of 165 patients with hepatitis C who underwent liver transplants and were followed for up to 12 years post transplant. They found that these patients had 10-year outcomes similar to patients undergoing liver transplants for other reasons, that the most common cause of death or transplant failure in these patients was due to recurrence of hepatitis C, and that risk of transplant failure increased over time.

In addition, researchers examined a number of factors to see if they could be used to predict transplant success. These included recipient age, donor age, bilirubin, INR (a measure of blood-clotting capability), and viral load and the presence of cytomegalovirus (CMV) antibodies prior to transplant. Donor and recipient age were found to more strongly predict transplant failure or death, with absence of CMV antibodies and higher hepatitis C viral load also playing a role. The researchers hypothesize that all of these factors are indications of poor immunity, which would in turn lead to lower transplant success. Higher bilirubin and INR, which are associated with early death following transplant, may in turn indicate general debility in the patient. Using these factors, researchers were able to construct a model that identifies potential transplant hepatitis C patients who are at the greatest risk of early death or transplant failure.

Article: "Long-Term Results and Modeling to Predict Outcomes in Recipients With HCV Infection: Results of the NIDDK Liver Transplantation Database," Michael Charlton, Kris Ruppert, Steven H. Belle, Nathan Bass, Daniel Schafer, Russell H. Wiesner, Katherine Detre, Yuling Wei, and James Everhart, Liver Transplantation; September 2004; 10:9; pp. 1120-1130.

Contact: David Greenberg
dgreenbe@wiley.com
201-748-6484
John Wiley & Sons, Inc.

September 9th, 2004

More than 2,000 patients at a Redwood City hospital may have been exposed to hepatitis C and B during gastrointestinal examinations there, a hospital spokesman said Wednesday.

Patients at the Kaiser Permanente Redwood City Medical Center received certified letters this week from the hospital warning them of the possibility of exposure to hepatitis from instruments that had not been thoroughly cleaned during a six-month period, said Richard Drumn, a hospital spokesman.

Hospital officials stress that the risk of infection is minimal, though all patients who received letters are eligible for free screenings.

Patients who choose to be screened for exposure to hepatitis must wait about a week for their results, Drumn said. The hospital said it was too early to tell whether anyone had been infected. The letters were mailed Saturday to patients who underwent invasive gastrointestinal procedures, such as colonoscopies, from Oct. 30, 2003 to May 3, 2004. Both types of hepatitis are viruses that attack the liver.

Hospital administrators said they had learned of the problem two weeks ago when a hospital worker mentioned that he had fixed some malfunctioning machines in May.

During that routine maintenance check in early May, the hospital worker discovered that two of four automated machines that clean instruments used in the procedures were not working properly, Drumn said.

The instruments are first scrubbed and disinfected manually. They are then attached to the automated machines that soak the equipment with more disinfectant for 41 minutes.

But on two machines, two out of five ports that dispense the disinfectant were blocked, Drumn said. A maintenance worker fixed the problem at the time but did not notify hospital administration, Drumn said.

Before May, the machines were last tested in October 2003, and workers found no problems then, Drumn said.

The hospital now checks the machines daily to ensure they function properly.

This is the first instance of the possibility of contamination of gastrointestinal equipment at the Redwood City hospital. There have been cases elsewhere in the United States in which patients have been exposed to hepatitis during procedures such as colonoscopies.

Hepatitis C can cause chronic infections and chronic liver disease, according to the Centers for Disease Control and Prevention. There is no vaccine for the virus.

Symptoms include jaundice, dark urine, loss of appetite and nausea.

There is a vaccine for hepatitis B, though the virus is deadlier than other strains. It can lead to cirrhosis, liver cancer and liver failure. Symptoms are similar to those of hepatitis C.

E-mail Wyatt Buchanan at wbuchanan@sfchronicle.com.

Hepatitis C Recurrence after Liver Transplantation
SourceURL:http://www.eurekalert.org

Severe recurrence is more common in transplants from living donors

Hepatitis C recurs with severity more often in individuals who receive liver transplants from living donors compared with those who get transplants from cadavers, according to a new study published in the September 2004 issue of Hepatology.

Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD), published by John Wiley & Sons, Inc., is available online via Wiley InterScience at http://www.interscience.wiley.com
/journal/hepatology.

Hepatitis C recurs in all patients after liver transplantation, but certain factors, such as high viral load and increased donor age, have been associated with more severe recurrence. Some studies have also suggested that HCV recurs earlier and more severely in patients who receive liver transplants from living, as opposed to deceased, donors.

Researchers led by Xavier Forns of the Hospital Clinic in Barcelona, investigated the effect of donor life status on outcomes of HCV patients receiving liver transplants. They examined a cohort of 116 consecutive HCV-infected patients undergoing liver transplantation for end-stage cirrhosis or hepatocellular carcinoma between March 2000 and August 2003. Ninety-five of the patients received livers from cadavers while 22 received livers from living donors.

The researchers recorded 29 variables potentially associated with severe HCV recurrence, including recipient age and gender, HCV genotype, and pre-transplantation viral load. After transplantation, they followed up with patients clinically, performing liver biopsies when possible. They defined severe HCV recurrence as the presence of liver cirrhosis in a liver biopsy or the development of clinical decompensation secondary to liver disease with portal hypertension. The researchers then used statistical analyses to determine which variables were associated with severe recurrence.

After a median follow-up period of 22 months, 26 of the patients developed severe HCV recurrence. Of the 95 patients who had received cadaveric liver transplantation, 17 (18 percent) had severe recurrence. Of the 22 who had undergone living donor transplantation, 9 (41 percent) had severe recurrence. By univariate analysis, living donor transplant, as well as significant necroinflammation in an early liver biopsy and biliary complications after liver transplantation were predictive of severe HCV recurrence. The association between liver donor transplant and severe HCV recurrence remained significant even after the authors adjusted for confounding variables known to be associated with recurrent hepatitis C.

"Our data, though limited to a single center, show that living donor liver transplantation is a strong and independent predictor of severe HCV disease recurrence following transplantation," the authors report. "Accordingly, the 2-year probability of presenting severe recurrence was significantly higher in living donor liver transplantation compared to cadaveric liver transplantation."

The mechanisms that would explain the recurrence are unknown, though the authors theorized that either biliary complications or liver regeneration would accelerate liver fibrosis.

"In summary, our data indicate that living donor liver transplantation is a strong predictor of severe HCV disease recurrence after transplantation," the authors conclude. "Although the data need to be validated, the more aggressive course of HCV infection in living donor compared to cadaveric transplantation should be considered in LDLT programs, since it may ultimately compromise graft and patient survival."

An editorial by Mark W. Russo and Roshan Shrestha of the University of North Carolina, in the same issue of Hepatology lauds the study's design, but points out that its conclusions conflict with other similar studies, and suggests that the results may not apply to all populations.

"The benefits of living donor liver transplantation should not be overlooked," the editorialists say, and "must be considered before making a premature decision about the risk of recurrent hepatitis C with living donor liver transplantation."

References:

Article: "Hepatitis C Recurrence Is More Severe After Living Donor Compared to Cadaveric Liver Transplantation," by Montserrat Garcia-Retortillo, Xavier Forns, Josep M. Llovet, Miquel Navassa, Anna Feliu, Anna Massaguer, Miquel Bruguera, Josep Fuster, Juan Carlos Garcia-Valdecasas, and Antoni Rimola, Hepatology; September 2004; 40:3; pp 699-707 (DOI: 10.1002/hep.20357)

Editorial: "Is Severe Recurrent Hepatitis C More Common After Adult Living Donor Liver Transplantation?" by Mark W. Russo and Roshan Shrestha, Hepatology; September 2004; 40:3; pp. 524-526 (DOI: 10.1002/hep.20418)

Southwestern Lab Selects Third Wave Reagents for Hepatitis Tests
SourceURL:http://www.wistechnology.com

MADISON, Wis. -- Third Wave Technologies Inc. has announced that the southwestern laboratory network TriCore Reference Laboratories has adopted Third Wave's Invader Hepatitis C Virus genotyping reagents.

The reagents are part of tests that can identify all six types of the Hepatitis C virus, a blood-transmitted disease estimated to be chronic in 4 million Americans. As many as 80 percent of those infected do not know it, according to Third Wave's company statement.

"Third Wave is very pleased with TriCore's adoption of our Invader(R) HCV genotyping product," John Puisis, Third Wave's chief executive, said in a statement. "Customer response to our HCV genotyping product has been favorable, even in the relatively short time it has been on the market. We look forward to demonstrating additional, sustained traction in the market through the balance of 2004 and beyond."

TriCore has its headquarters in Albuquerque, N.M. The company provides laboratory services to clients across the Southwest United States, including New Mexico, Texas, Arizona, Colorado and Nevada.

Other diseases tested by Invader-based products include cystic fibrosis, a genetic disease that leads to potentially fatal lung infections, and a variety of other cardiovascular and blood-related conditions.

September 10th, 2004


Safe Injection Activist Honoured
Source: http://vancouver.cbc.ca/

VANCOUVER - The Vancouver nurse who set up an unauthorized safe injection site for IV drug users on the Downtown Eastside last year has won an international human rights award.

Megan Oleson Human Rights Watch and the Canadian HIV/AIDS Legal Network call 26-year-old Megan Olseson a "defender of human rights," giving her their Award for Action.

The award also goes to the Pivot Legal Society which worked with Olseon to set up the temporary injection site while Canada's first legal supervised injection site was still under construction nearby.

She says she and the others defied local officials because they couldn't wait any longer.

"It was exactly at a time where the Vancouver Police Department was cracking down on drug users and really placing a lot of people in jeopardy and making poor people's lives miserable, basically."

In the past, Human Rights Watch and the Legal Network have handed the "Award for Action on HIV/AIDS and Human Rights" to activists in China, Thailand and South Africa - all developing nations.

Ralf Jurgens of the Legal Network likens conditions in which Vancouver drug users live to those in the third world - not just because of the rate of HIV and Hepatitis C infection, but also because their treatment by the authorities.

Jurgens concedes life is now improving for IV drug users in the Downtown Eastside.

Oleson, meanwhile, is now trying to set up a supervised site where crack users can smoke without spreading disease.

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