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

Week Ending: October 16th, 2004

Alan Franciscus
Editor-in-Chief

In This Issue:

• Caffeine Breath Test Measures Liver Function
• Higher Rates of Therapy Discontinuation than Expected with Combination Therapy for Hepatitis C
• Hepatitis C Victim Refuses Treatment
• MIGENIX Initiates Hepatitis C Phase II Clinical Study
• Hepatitis C Superinfection Is as Common as Infection in Recently Infected Drug Users
• Ottawa to Consider Compensating "Forgotten" Tainted-Blood Victims
• Ottawa to Consider Opening up the Coffers for Hepatitis C Victims
• California Blasted for Poor Prison Health Care
• Anadys Pharmaceuticals to Report New Clinical Data from Hepatitis C and Hepatitis B Programs at Upcoming AASLD Annual Meeting
• Prevalence of Alcohol-Induced Liver Disease and Hepatitis C in Tertiary Care
• Fresno Tries to Clean Up From IV Drug Use
• Hong Kong Issues Health Warning over Slimming Products

October 11th, 2004

Caffeine Breath Test Measures Liver Function
Source: www.reutershealth
by Marilyn Bitomsky

BRISBANE, Australia (Reuters Health) - Forget the liver biopsy. Now it's possible to detect advanced fibrosis—a complication of many liver diseases including hepatitis B, hepatitis C, fatty liver disease and hemochromatosis—by means of a simple breath test.

An Australian research team has developed the test, which involves drinking a small quantity of caffeine tagged with a short-lived isotope of carbon, and then blowing into a test tube one hour later.

The test can be conducted in an outpatient setting, so patients don't need to take time off work for a long procedure.

Describing the test at Australian Gastroenterology Week 2004, Dr. Gordon Park, a gastroenterologist at Concord Hospital in Sydney, said the test is "a promising method of assessing the severity of liver disease and monitoring a patient's response to treatment".

Caffeine was selected for the test because it is metabolized exclusively through the liver, he said. "An enzyme in the liver breaks it down, and the ability of that enzyme to break it down is intimately related to overall liver function."

The carbon isotope incorporated into the caffeine is eventually expelled in the breath as carbon dioxide. Because the isotope is slightly radioactive, the amount of it can be easily measured

"If the liver is not functioning well, metabolism of caffeine is impaired," Parks explained, and the amount of carbon isotope in the breath is reduced.

Cigarette smoking is a major confounder of the test in that it increases the activity of the liver enzyme, Park commented. Smokers generally have double the normal activity of nonsmokers.

"We can factor that into the analysis, and we have already done studies looking specifically at smokers," Park said. "We have now formulated a reference range for smokers and for nonsmokers."

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Higher Rates of Therapy Discontinuation than Expected with Combination Therapy for Hepatitis C
SourceURL: www.gastrohep.com

October's Alimentary Pharmacology and Therapeutics reports that combination therapy for Hep C does not alter sustained virological response and rate of therapy discontinuation is higher than anticipated.

Researchers from Texas, America compared the efficacy of high-dose induction with standard dose interferon therapy for the treatment of chronic hepatitis C virus at the Dallas Veterans Affairs Medical Center.

The research group randomly selected patients to receive 5 million units daily interferon-2b for 4-weeks.

The researchers followed this treatment up with 44-weeks of standard dose therapy (3 million units three times a week) for genotype 1 or 20 weeks for non-genotype 1.

Another group of patients received standard dose therapy for the whole of the treatment duration.

The researchers used daily weight-based ribavirin for the entire therapy interval.

In total, 45 patients were enrolled in the trial with genotype 1 comprising 76% of the sample.

The researchers noted that cirrhosis or bridging-fibrosis was present in 69% of the patients.

The group found that of the 29 liver biopsies available for Knodell scoring, 41% and 51% had scores of 6 to 10 and 11 to 15, respectively.

“Rate of sustained virological response was similar between the two treatment groups”— Alimentary Pharmacology and Therapeutics

The group's results showed that rates of sustained virological response did not differ significantly between the two treatment groups.

In addition, therapy type and/or early intervention for depression did not affect the rate of therapy discontinuation, which was 26.6%.

Dr Brown concluded, "The rate of sustained virological response was similar between the two treatment groups and higher than anticipated among patients with cirrhosis or bridging-fibrosis".

"The rate of therapy discontinuation was also higher than anticipated but was not attributable to therapy type or untreated depression".

Source: Alimentary Pharmacology & Therapeutics; 2004: 20 (6): 629

October 12th, 2004


Hepatitis C Victim Refuses Treatment
Source: www.eveningnews24.co.uk

A NORWICH man battling with a life-threatening illness is refusing his medical treatment in a last-ditch bid to force a public inquiry into his predicament.

Michael Colyer, a haemophiliac, was infected with Hepatitis C after receiving contaminated blood products through the NHS in the 1960s or 1970s.

The 53-year-old, of Colman Road, now wants a public inquiry held into why the dirty blood was ever used in the UK.

Despite writing scores of letters to the Department of Health asking to see 600 Government documents about the issue, none have yet been disclosed.

His attempt to get an answer from the Parliamentary Ombudsman last month has also reaped no rewards because he could not prove there had been maladministration by the Government.

Mr Colyer is now refusing a 48-week course of Pegylated therapy to force the Government to listen.

He has asked Charles Clarke, MP for Norwich South, to back his fight and push for the inquiry.

Mr Colyer, a married father-of-two, claims the Government imported blood products from the USA infected with Hepatitis V despite having blood being available in the UK.

He said the USA undertook a policy of paying drug addicts and prostitutes to donate blood and this is how their plasma pools became infected.

He said: "The Haemophilia Society has been pushing for an inquiry for 15 years and my protest is part of that.

"It's a personal protest between my me, my doctor and my medical records. If something happens to me because of this then at least it is stated in my records."

"I know am running a risk to of my liver being damaged by refusing treatment but I am trying to clobber that by keeping fit.

"I can't walk away from this issue because it has not been resolved. I want to know what caused the blood to be contaminated.

"I am not trying to be a hero. But I want to go as far as I can with this because this is the only weapon I have got to use—my health—as much as I am loathe to do it I am prepared to do it as it is all I can do."

Mr Colyer now works as postman in Bowthorpe after being made redundant from his role as senior sales executive in 1996 due to ill health.

He added a second reason for refusing treatment was that the side effects had previously made his ill and prevented him from working.

"You take 35 pills a week and you inject three times a week," he said.

"There are a whole draft of side effects and you are totally incapacitated from normal daily life," he said.

"But if the treatment is successful then the liver is a powerful organ and it can survive and there is a chance it can regenerate itself.

"By refusing treatment the virus is still attacking my liver. It is beavering away at my liver. "

October 13th, 2004


MIGENIX Initiates Hepatitis C Phase II Clinical Study
Source: http://biz.yahoo.com

VANCOUVER, BC, & SAN DIEGO, CA, Oct. 13 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI - News; OTC: MGIFF - News), a developer of drugs for infectious and degenerative diseases, has initiated enrollment in its MX-3253 Phase II Hepatitis C Virus (HCV) clinical efficacy study in chronic HCV patients.

Morris Sherman, M.D., FRCP, FRCPC, of the Toronto General Hospital and the University of Toronto, stated, "We are excited to be part of this study as MX-3253 could become an important new tool in our ongoing efforts to improve treatment outcomes for HCV patients who have no options when currently available treatments fail."

Jim DeMesa, M.D., President & CEO of MIGENIX commented, "Initiation of this study is significant for us since it represents a major step forward for this potential blockbuster product candidate. With results of the study expected in the second quarter of calendar 2005, we view this study as an important near-term value-creating opportunity."

About the Phase II Clinical Study
Approximately 60 treatment-naive or interferon-intolerant HCV patients (genotype I), divided into three dosing groups, will be treated for 12 weeks at 5 sites in Canada. The objective of this Phase IIa 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 MX-3253 in HCV patients. Since MX-3253 has shown additive and/or synergistic effects with currently marketed products in preclinical models, studies are also being planned to evaluate MX-3253 in combination with currently marketed products.

About MX-3253 and HCV
MX-3253 (celgosivir) is an orally-administered, unique antiviral agent exerting its effects through the inhibition of the mammalian cell enzyme, Alpha-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. MX-3253 has 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) Alpha-glucosidase I is important for successful HCV replication, (b) the hepatitis C virus is hypersensitive to Alpha-glucosidase inhibition, and (c) MX-3253 is additive and/or synergistic with the currently approved HCV therapies (ribavirin and interferon).

Chronic 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 MIGENIX
MIGENIX 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 broad clinical and preclinical stage pipeline of product candidates in the areas of infectious and degenerative diseases. MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.

"Jim DeMesa"
James DeMesa, M.D., MBA
President & CEO

CONTACTS:
Jonathan Burke
MIGENIX Inc.
Tel: (604) 221-9666 Extension 241
jburke@migenix.com

Gino de Jesus or Dian Griesel, Ph.D.
The Investor Relations Group
Tel: (212) 825-3210
Theproteam@aol.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: MIGENIX having results of the MX-3253 Phase IIa study by the second quarter of calendar 2005, and MIGENIX initiating combination studies of MX-3253. 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 MIGENIX 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.

Source: MIGENIX Inc.

A longitudinal study of 25 members of a cohort of intravenous drug users in San Francisco who were recently infected with hepatitis C (HCV) has found that during an average of 10 months' follow up, the incidence of superinfection with second strains of HCV was almost as high as incidence of new HCV infections in the group as a whole.

Altogether five cohort members were superinfected with second strains, representing an annual incidence of 20%, while the incidence for new infections among the whole cohort was estimated to be 25%.

The study authors comment that their findings cast doubt on the viability of a vaccine against HCV, a virus even more genetically diverse than HIV.

Eleven of the subjects were female and 14 male, and all were under 30. In the trial report they are identified with their cohort ID number.

Samples were taken at entry to the study and again after an average follow-up time of 316 days. Some intermediate samples were taken from three subjects suspected of superinfection.

A variety of genetic tests were taken to establish the genotype of subjects' virus and to detect any possible minority species at baseline, to eliminate possible dual infections. The HCV genome was sampled at two different points, one hypervariable and one less so, to establish accurate phylogenetic trees.

Subjects had on average been infected at the start of the study for no more than 160 days, and no subject for more than 388 days.

Two subjects were seronegative for HCV antibodies but positive for HCV RNA when they joined the study, indicating recent infection (< three months), and four previously uninfected members of the cohort became infected during the follow-up period and therefore joined the study.

HCV infections were of three genotypes: two widely-differing subtypes of genotype 1, labelled 1a and 1b (15 and one initial infections respectively) and genotype 3 (nine initial infections).

The genotyping was able to establish three probable "clusters" of infection between subjects, and the timing of their first positive HCV RNA sample was able to establish the direction of infection.

Subject 31 (a woman) infected subject 5 (a man) with a genotype 3 virus before the start of the study. Subject 2 (a man) infected subject 46 (a woman) with a genotype 1a virus at or around the start of the study.

Subject 23 infected subject 13 with a 1a virus. One of them then went on to superinfect subject 54, who at the start of the study was the only one carrying subtype 1b virus, at least 184 days into the follow-up period. All three were men.

The other superinfected subjects were subject 30, originally infected with a genotype 3 virus but found to also have a genotype 1a virus at the study's end; subject 32, originally infected with type 1a but superinfected at least 62 days into the follow-up period with a genotype 3 virus; and two subjects, 25 and 59, who were superinfected with a second genotype 1a virus, in the case of subject 59 at least 89 days into the follow-up period.

Superinfection in these two subjects was established when it was found that the genetic distance between different viruses carried by them was 13.9% and 18.4% respectively, compared with a difference on 1.75% in monoinfected subjects.

Superinfection did not appear to be associated with a change in viral load. Viral load in all subjects declined from a median of 5.9 logs (800,000) at the start of the study to a median of 4.8 logs (63,000) at the end.

The study authors comment: "The high frequency of HCV superinfections that we detected among young IDUs indicates the ease with which a new viral strain can surmount immune responses directed at the resident strain. "

"The result of this natural-history experiment in HCV challenge indicates that successful vaccination against this highly diverse virus may prove to be difficult."

Reference: Herring BL et al. Frequent hepatitis C virus superinfection in injection drug users. Journal of Infectious Diseases 190:1396-1402.

Ottawa to Consider Compensating "Forgotten" Tainted-Blood Victims
Source: Canadian Press

OTTAWA (CP) - In a major policy shift, the federal government says it will consider compensating thousands of people infected with hepatitis C through tainted blood before 1986 and after 1990.

Health Minister Ujjal Dosanjh said Wednesday that he is ready to reconsider the rules for access to a $1.1-billion compensation fund to include victims previously denied. When the fund was set up in 1998, Ottawa limited eligibility to people infected from 1986 to 1990.

People infected after 1990 were refused because the government said full measures to protect the blood supply were in place by then and it had no liability.

For pre-1986 victims, the government claimed there was nothing it could have done to protect the blood supply from the hep C virus.

That claim has been fiercely disputed over the last five years.

One reason for reconsidering the issue is that far fewer victims have come forward than expected, Dosanjh said.

"We need to make sure that the victims between '86 and '90 are taken care of and then, if there is an actuarial surplus that might survive over time – if we can take a look at that and examine that issue in terms of supporting victims pre-'86 and post '90 - I'm examining that issue," Dosanjh said.

"Obviously that has to be done in consultation with the plaintiffs, the plaintiffs' lawyers and the courts, because it's a fund that's in trust."

Activists say there is still more than $1 billion still in the fund and that it could be used to compensate excluded victims.

October 14th, 2004


Ottawa to Consider Opening up the Coffers for Hepatitis C Victims
Source: http://www.theglobeandmail.com
by BRIAN LAGHI

Aid would go to select group of sufferers

OTTAWA -- Ottawa will consider added financial help for a select group of tainted-blood victims suffering from hepatitis C amid new blasts of anger that a previous aid package was woefully inadequate.

Health Minister Ujjal Dosanjh said yesterday his department is looking at the possibility of releasing cash from a separate account that is currently used to compensate a different class of similarly afflicted people.

"We are re-examining that issue," he said. "It's obviously a very, very serious issue, dealing with serious injury to people."

The matter has been the subject of controversy in Ontario recently, where the governing provincial Liberals have been accused of misspending federal funds earmarked for the sick.

The issue has divided the federal Liberal caucus in the past, some of whose members have pressed cabinet to reopen the compensation package.

The extra money would flow to the so-called "forgotten victims" of the tainted-blood scandal, who contracted the disease from blood products before 1986 and after 1990. That group was the beneficiary of a help package of about $300-million announced in 1998, an amount many say has yet to reach them and others call inadequate.

Yesterday, Mr. Dosanjh said his government will look at whether it can redistribute money from another fund that is earmarked for victims who contracted the disease between 1986 and 1990, the years for which Ottawa admitted liability for the blood supply.

That federal-provincial fund is worth about $1.2-billion, but only about $200-million has been accessed. Mr. Dosanjh acknowledged yesterday that Ottawa overestimated the number of individuals who qualified for the money. Ottawa's share of the $1.2-billion kitty is $875-million.

Mr. Dosanjh said he didn't know when a decision would be made. Estimates originally put the number of people eligible for the larger fund at about 22,000, but experts now say that figure isn't likely to exceed 6,500.

Mike McCarthy, a former president of the Canadian Hemophilia Society who was infected by hepatitis C tainted-blood products, said hepatitis C sufferers have heard such promises before.

"People are tired, people are sick and people are dying," Mr. McCarthy said. "We can't wait any longer." He said he remains "cautiously optimistic" about an expanded aid package, which would allow patients to afford nursing care, specialists and enhanced treatment.

For Mr. McCarthy and others who can't get life insurance, the money would also provide financial security to their families.

"This is really important for blood victims so they have some closure in their lives," he said. "People really suffered, and we're looking for the government to show support and accountability for mistakes of the past."

Yesterday's remarks come as hepatitis C sufferers in Ontario complain that their government has not passed on any of the money from the smaller fund for the forgotten victims.

The New Democrats say the money was supposed to pay for health services not otherwise covered by the Ontario Health Insurance Plan.

However, Health Minister George Smitherman says he has met his obligations and suggested that the agreement with Ottawa is open to interpretation.

Mr. Smitherman wants to discuss the issue at a health ministers conference later this week.

California Blasted for Poor Prison Health Care
Source: www.npr.org

California spends $1 billion each year to provide medical services for inmates of the state's 32 prisons. But the quality of that care is being scrutinized. NPR's Mandalit del Barco reports on accusations of medical incompetence, lax staffing and outdated equipment, and the challenge of treating patients who often ignore their health until their illness is all but untreatable. (The audio for this program will be available at approximately 7:00PM ET, 4:00PM PT. Saturday, October 16, 2004)

Broderick Crawford, an inmate serving time for attempted murder at Corcoran State Prison, is typical of many prisoners who simply don't trust the quality of care behind bars. He's got a cracked tooth, but he's afraid to let the prison dentist fix it. He's willing to wait until his sentence is served—two years and counting—and get it fixed on the outside.

Many California prison doctors and medical staff have been hit with charges of incompetence and medical neglect. A recent case involving an inmate who died after having his wisdom tooth pulled has generated more negative headlines. There's also an ongoing class-action lawsuit against the California Department of Corrections( CDC).

"To put it very bluntly, the healthcare system at CDC is sick," says state Sen. Jackie Speier (D-San Mateo/San Francisco). "Twenty percent of the physicians that work at CDC have either a bad mark on their record or a series of malpractice lawsuits—a figure that is four to five times higher than the general population of physicians in California."

One inmate lawsuit recently labeled California's prison medical care as "cruel and unusual punishment."

But some prison doctors bristle at charges of incompetence. "We are as good as anybody out there doing medicine," says 73-year-old Dr. Juan Tur, who practices medicine at Chowchilla, the nation's largest women's prison. "I believe we're more scrutinized, to check our license completely."

Other prison doctors complain of outdated equipment and inadequate staffing. And the patients themselves can be a huge challenge to treat.

"When they were on the streets, health care was never a priority, says Dr. Joe Bick, who works at the California Medical Facility in Vacaville—the state's largest prison hospital. "So they've never seen a dentist, their teeth are rotting out, they've got terrible feet cause they've been living on the street, they've been shot, they've been stabbed, they've jumped out of buildings, they've had car crashes, they've got diabetes and hypertension.

"They're first diagnosed with HIV when their immune systems are shot. And now they have a moment of clarity, where they can focus on their medical care, and they want it all done now," Bick says.

Anadys Pharmaceuticals to Report New Clinical Data from Hepatitis C and Hepatitis B Programs at Upcoming AASLD Annual Meeting
SourceURL:http://biz.yahoo.com/

SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News), a biopharmaceutical company committed to the discovery, development and commercialization of novel medicines to treat chronic viral hepatitis and bacterial infections, announced today that it will be reporting new data from its clinical trials of isatoribine for the treatment of hepatitis C virus (HCV) infection and ANA380 for the treatment of hepatitis B virus (HBV) infection at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting, to be held in Boston from October 29 to November 2, 2004.

Prof. Ching-Lung Lai will present results of a completed Phase I/II clinical trial of ANA380, a compound that Anadys is co-developing with LG Life Sciences, Ltd. for the treatment of HBV infection. ANA380 is an orally available antiviral compound that has exhibited potent activity against HBV, including in vitro activity against HBV strains resistant to lamivudine. The podium presentation, entitled "Phase I/II Double-Blind, Randomized, Placebo- Controlled Study of the Novel Anti-HBV Agent LB80380/ANA380 in Patients with Chronic HBV Infection," will take place on Sunday, October 31, 2004 at 4:00 p.m.

Prof. Yves Horsmans will present new clinical data on isatoribine (ANA245), one of a new class of drugs being developed by Anadys to regulate innate immunity by interacting with Toll-Like Receptor 7. The podium presentation, entitled "Isatoribine, a Toll-Like Receptor 7 Agonist, Significantly Reduced Plasma Viral Load in a Clinical Proof-of-Concept Study in Patients with Chronic Hepatitis C Virus Infection," will take place on Tuesday, November 2, 2004 at 12:30 p.m.

Simon Fletcher, Ph.D., will also present new data on isatoribine in a poster session on Tuesday, November 2, 2004 at 10:00 a.m. The presentation is entitled "Examination of Interferon-Induced Gene Expression by Isatoribine, a Toll-Like Receptor 7 Agonist and Inducer of the Innate Immune Response."

Abstracts of all three presentations are now available on the AASLD web site at www.aasld.org.

About Anadys
Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule, anti-infective medicines for the treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial infections. Anadys is advancing its anti-infective portfolio through the development of its two clinical programs, the isatoribine family of compounds including the oral prodrug ANA975 for the treatment of HCV, and ANA380 for the treatment of HBV. In addition, Anadys' anti-infective therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the development programs of ANA380 and ANA245. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. In particular, the results of initial clinical trials may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will have favorable results in future clinical trials or receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, difficulties or delays in its clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. These and other factors that may cause actual results to differ are more fully discussed in the "Risk Factors" section of Anadys' Form 10-Q for the quarter ended June 30, 2004. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward- looking statements contained in this document as a result of new information, future events or otherwise.

Source: Anadys Pharmaceuticals, Inc.

October 15th, 2004


Prevalence of Alcohol-Induced Liver Disease and Hepatitis C in Tertiary Care
Source: www.gastrohep.com

Patients with alcoholic liver disease are driven to mortality from ongoing excessive alcohol use, irrespective of the underlying cause of the liver disease, reports October's Clinical Gastroenterology and Hepatology.

Dr Michael Lucy and colleagues, Wisconsin, USA examined the prevalence and clinical characteristics of alcohol-induced liver disease (ALD) in patients referred to a tertiary care center.

The researchers also examined the interaction between ALD and hepatitis C virus (HCV) in a longitudinal survival model.

The research team recruited a total of 1611 patients with chronic liver disease that had been referred to a tertiary care center between 1994 and 2001.

Researchers analyzed and compared the survival of ALD, HCV, and the combination of the 2 (ALD + HCV) in cirrhotic and precirrhotic patients, using Kaplan-Meier estimates.

Using a Cox proportional hazards model, the researchers were able to examine the independent effects of predictors on survival.

ALD comprised 31% of the cohort, ALD + HCV comprised 14%, HCV comprised 22%, and the rest comprised 33%.

“In patients with ALD, the addition of HCV does not change survival”—Clinical Gastroenterology and Hepatology

The researchers found that the survival of precirrhotic patients with HCV was significantly better than the survival of those with ALD over long-term and 1-year follow-up periods.

There was no difference in survival between patients with ALD and ALD + HCV.

In addition, the team found that in patients with cirrhosis, survival did not differ by cause, in fact, decompensated liver disease and continued alcohol abuse predicted worse survival in this group.

ALD with HCV remains a prevalent cause of chronic liver disease in patients referred to a U.S. tertiary care center.

Dr Lucy concluded, "In patients with ALD, the addition of HCV does not change survival, suggesting alcoholism is the driving force for mortality in patients coming to clinical attention. "

He added, "In patients with cirrhosis, ongoing excessive alcohol use and complications of end-stage liver disease drive mortality, irrespective of the underlying cause of chronic liver disease."

Clinical Gastroenterology and Hepatology; 2004: 2 (10): 928

Fresno Tries to Clean Up From IV Drug Use
Source: http://asia.news.yahoo.com

The nation's capital of intravenous drug use is not New York or Miami, not Chicago or Detroit—but Fresno. It is an unlikely distinction for a city of fewer than 500,000 people in the heart of one of the nation's richest agricultural regions.

The percentage of people shooting up heroin and other drugs in Fresno is nearly three times the national average, fueled by a boom in methamphetamine use, according to a study issued last month.

"This town is so full of meth," said Amy Wilson, 28, who was ordered into rehab after her daughter, now 3 1/2 months old, tested positive for methamphetamine at birth.

"My grasp on reality was gone," she said. She described drug use in California's Central Valley as "like a cancer."

Law enforcement agencies and treatment counselors say they are overwhelmed by the scope of the problem, which is compounded by HIV and hepatitis C infections that come from sharing needles.

The Fresno area has become home to Mexican drug cartels that operate in its rural expanses, where the farm chemicals used to make meth are readily available and the noxious fumes are less easily detected. According to a 2001 estimate by the Drug Enforcement Administration, 80 percent of the country's meth comes from the cartels.

Part of the problem in the Fresno area is also poverty, said Samuel Friedman, a research fellow at the National Development and Research Institutes in New York and primary author of the study in last month's Journal of Urban Health.

Fresno County, where farmworkers get paid rock-bottom, seasonal wages, is one of the poorest counties in the nation. More than 20 percent of its residents—an estimated 165,000 people—live in poverty, according to Census estimates, and the per capita income is just $15,495 a year.

In the study, Fresno was found to have 173 IV drug users for every 10,000 people; the national average is 60 per 10,000 people. Three other urban areas within 200 miles also made it into the top 10—San Francisco, Stockton-Lodi and Bakersfield.

It is a problem that has been costly for the government. Fresno County spends $20 million a year on drug treatment programs that served more than 9,000 people in 2002, and the programs are straining to keep up with demand.

"Now at least we have a waiting list," said Dennis Koch, administrator of Fresno County's Alcohol and Drug Program. "Before, we used to not have these programs. There was nothing to wait for."

Meanwhile, the number of addicts who shoot up with dirty needles has placed a heavy burden on public health. A recent Fresno County study found that 75 percent of the area's injection drug users had hepatitis C, compared with 2 percent of the general population. The county had 251 new HIV infections last year, a 17 percent increase from the previous year.

Last month, Gov. Arnold Schwarzenegger signed a law that makes it easier for drug addicts to buy clean needles. Currently, hypodermic needles can be sold without a prescription in only a few circumstances, such as to diabetics who need insulin.

"We can't stop all the drug use in this community," Koch said. "But there can be safer ways."

October 16th, 2004


Hong Kong Issues Health Warning over Slimming Products
Source: www.channelnewsasia.com

HONG KONG: Hong Kong's health department on Saturday urged the public against taking two slimming products after a 33-year-old woman suffered liver failure.

Laboratory tests had shown that "Supreme Quick Slim" and "Vital-plus Quick Slim" contained N-nitroso-fenfluramine, a chemical linked with liver-damage cases in Japan, Singapore and Britain, a statement said.

"Members of the public who have purchased the product are advised to stop using them, dispose of the product or surrender it to the Pharmaceutical Service of the Department of Health," the statement said.

"They are also advised to seek medical attention as soon as possible if they feel unwell after taking the products."

No further details of the 33-year-old woman's case were given.

The use of artificial slimming products is widespread among the former British territory's population of about seven million people. - AFP

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