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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 29^th, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here

This Issue:

• Take ACTion

• Help-atitis B!

• Peregrine Pharmaceuticals Evaluating Therapeutic Opportunities for Tarvacin(TM) Against Influenza Viruses Including Avian Flu

• Three Rivers Has FDA Approval of Drug

• Chile Begins Program of Free Hepatitis C Treatment

• Human Genome Sciences Completes Patient Enrollment in a Phase 2b Clinical Trial of Albuferon(TM) in Combination With Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

• Regimen Revolution: Experimental Drugs for the Most Common Strain of Hepatitis C Could Head Off a Health Crisis

• MDs Must Report Their Blood-Borne Infections

• Harmony For Hep - Working Together to Raise Awareness of Hepatitis C

• Hepatitis C packs Cruel Punch

• Hepatitis C Leadership Summit, October 29-30, Seeks to Elevate the Current Response to the Hepatitis C Epidemic

• Portal-Systemic Shunts High in Hepatic Encephalopathy

• Viral Evolution of Hepatitis C in Injection Drug Users

• Hepatitis C Complicated by Morphine Withdrawal

• Defense Attorneys to Seek New Trial in Hepatitis C Case

• Tissue Implants in Canada May Have Come from Bodies Taken from Funeral Homes

CONSIDERING it's the second most common cause of cancer after tobacco, chronic hepatitis B ranks disappointingly low in public consciousness.

Scientists and treating specialists lament the lack of awareness among the public and even among some physicians themselves.

Now, 18 experts from 14 countries in the Asia-Pacific region have come together under the ACT-HBV (Advancing the Clinical Treatment of Hepatitis B Virus) Asia-Pacific Initiative to fight the hepatitis B threat in Asia.

These 18 clinicians, including some of the world's leading experts in hepatitis B, make up the Steering Committee that leads the Asia-Pacific initiative in its efforts to increase public awareness and promote professional education on hepatitis B.

Through this initiative, experts will discuss key issues, new and emerging clinical trial results, issues and advances in recommendations and treatment guidelines, and diagnostic and treatment advances in HBV.

Local country-specific chapters of the initiative, including Malaysia, will roll out programmes for medical specialists involved in the management of hepatitis B, as well as the public. The initiative was launched at the 15th Conference of the Asian Pacific Association for the Study of the Liver held in Bali, Indonesia, in August.

“There is an unmet need for greater public awareness to address hepatitis B-related issues. The ACT-HBV campaign will be an ongoing effort,” says Prof Liaw Yun-Fan, chairman of the steering committee. In Malaysia, the local ACT-HBV chapter will provide another avenue for increasing hepatitis B awareness, besides the existing efforts of the Ministry of Health and Malaysian Liver Foundation.

According to consultant physician and hepatologist Dr Lakshumanan Sanker, representing Malaysia’s Health DG Datuk Dr Ismail Merican in Bali, there will be a lot of focus on education for healthcare professionals. There are plans to produce teaching slides, with different sets tailored for different groups.

The local committee is also planning activities to raise public awareness, including a hepatitis B video to be played in doctors' clinics and hospital waiting rooms. “It is important to recognise that hepatitis B is prevalent in Malaysia,” he stresses.

ACT-HBV is supported by an independent educational grant from Bristol-Myers Squibb Company.

Five things to do

1. Get tested for hepatitis B. Just once in your lifetime, preferably after adolescence, is enough.

2. Get a vaccination shot if you haven't been vaccinated, especially if you have a job that involves contact with blood.

3. If you have been infected with the virus, or are a carrier, comply with therapy as advised by your doctor.

4. Avoid infecting others by not having unprotected sex, sharing personal items like toothbrushes or shaving razors, or sharing non-sterile needles.

5. Go for regular checkups.

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Help-atitis B!
http://thestar.com.my/health

Many experts agree that though there is treatment for chronic hepatitis B, there is reluctance by some physicians to prescribe treatment because of the dilemmas regarding resistance, misunderstanding of the benefits of treatment strategies and the lack of consensus in treatment guidelines.

THERE are two billion people worldwide with hepatitis B; 10-30 million are infected each year; 400 million have chronic hepatitis B; almost one million deaths from liver cancer – these are the stark stats of hepatitis B.

“Approximately 25-40% (of the chronically infected) will eventually succumb to the disease due to the long-term consequences of cirrhosis and its complications, or liver cancer,” says Prof Dr Rosmawati Mohamed, consultant hepatologist and gastroenterologist in Universiti Malaysia Medical Centre, speaking at the Time to Act in Hepatitis B symposium at the 15th Conference of the Asian Pacific Association for the Study of the Liver held in Bali, Indonesia, in August.

To talk about hepatitis B is to play the numbers game. But there’s no fun in this game, and no winners either. If an individual progresses to the level of liver damage or liver cancer, it’s most likely going to be “game over”.

B-aware

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). A quick lesson on this disease involves the alphabets. There are at least six different types of viral hepatitis: A, B, C, D, E and G.

Some of these viruses cause acute or short-term infection, with some progressing to chronic infection.

“Chronic (hepatitis) occurs when the virus persists longer than six months in the body, due to the immune system not being able to clear the virus,” explains Prof Rosmawati.

The hepatitis B and C viruses are two culprits of chronic hepatitis. However, of the two, hepatitis B is more prevalent, making it one of the common infectious diseases in the world.

Although the hepatitis B virus is 100 times more infectious than the HIV virus, it is a sneaky little bug that causes no symptoms in about half of patients infected. Those who do have symptoms often mistake hepatitis B infection for the flu – fever, fatigue, nausea, muscle aches and appetite loss are common complaints. Jaundice (yellowed discolouration of skin and eyes) may sometimes occur.

Fortunately, says Prof Rosmawati, more than 95% of people with acute hepatitis B will be able to get rid of the virus on their own.

But for the remaining five to 10% who develop chronic infection, the possibility of long-term complications, including cirrhosis (liver scarring) and liver cancer, should not be dismissed.

China has the greatest burden of hepatitis B and liver cancer in the world. Almost 10% of its population have chronic hepatitis B, and a whopping 120 million to 130 million people in the country are hepatitis B carriers.

Malaysia can count itself slightly more fortunate, if at all, with approximately 5.24% of our population chronically infected. Since 1984, a mass vaccination programme has been implemented in all hospitals, and our infant coverage rate is more than 90%.

However, Prof Rosmawati cautions that our disease burden will remain high for at least the next 30 to 50 years, as those infected with the virus before 1984 will take that amount of time to develop complications, if any.

During this intermediate period, it is absolutely imperative that some form of treatment be instituted to interfere with the natural course of the disease.

With no treatment, warns Prof Rosmawati, the disease will progress to liver failure or liver cancer, ending up with the patient needing a liver transplant, or worse, death.

Protect the liver

“Of course, what we want to do is completely cure the patient of hepatitis B,” Prof Rosmawati admits.

Unfortunately, the treatment currently available is not able to eliminate the virus completely from the body. “At best, we hope to achieve permanent suppression of the virus” to prevent cirrhosis, liver decompensation and liver cancer, she says.

Still, things are looking up. “Therapy has advanced dramatically with the introduction of new drugs with proven safety, efficacy and resistance profiles.”

The first form of therapy introduced in 1992, the injection-based interferon, has since evolved into oral therapy that is better tolerated, including lamivudine and adefovir.

“Each of these agents have several advantages and disadvantages,” cautions Prof Rosmawati. For instance, lamivudine is associated with a high risk of resistance, particularly with long-term therapy. Adefovir is inferior as a virus suppression agent and carries the risk of renal toxicity in certain patients.

The newest anti-viral agent on the block is entecavir, regarded as a much more potent agent that inhibits replication of the hepatitis B virus.

“We are actually at a very good time where therapy of hepatitis B is concerned,” says Prof Rosmawati.

In Malaysia, lamivudine, adefovir and interferon, including pegylated interferon, are all available. Approval for entecavir is still pending (Indonesia is the only country in Asia-Pacific to have approved it).

But Prof Rosmawati is unhappy that many patients with chronic hepatitis B still go on to develop liver complications, despite the availability of drugs to prevent this very occurrence.

“In reality, very few patients with chronic hepatitis B are treated. Less than 4% of those diagnosed receive treatment,” she reveals.

There are many reasons for this, most to do with a lack of awareness among patients and physicians.

She also mentions that there is reluctance by some general physicians to prescribe treatment, “because of the dilemmas regarding resistance, misunderstanding of the benefits of treatment strategies, and the lack of consensus in treatment guidelines.”

Asian countries face an added challenge: traditional and herbal medicines are widely used by the public, even though most of these therapies are not backed by scientific evidence.

Many times throughout her presentation and interview with journalists, Prof Rosmawati alludes to several issues that concern the international liver community. Her comments have been compiled into a wish list of sorts here.

There is a need for:

An ideal therapy that is safe, effective, well-tolerated, and easy to use without resistance issues.
Increased consensus on hepatitis B testing, treatment and monitoring.
Early treatment to stop viral replication and slow down the progression of liver disease.
Awareness that certain groups of patients, such as those with active viral replication and active liver disease, need treatment.
Ensuring that patients with e-antigen negative disease, and patients who have developed drug-resistant infection, receive treatment.
Standardisation of the definition of treatment response in order to ensure that the treatment is durable once the patient stops therapy.
Routine follow-up of the patient,not just in terms of treatment, but also in monitoring complications,like liver cancer.

It is clear that access to treatment needs to be stepped up, and a main strategy to achieve this is through public and professional education.

“Hepatitis B is a silent killer,” says Prof Masao Omata, chairman of the gastroenterology department in the University of Tokyo. Prof Omata’s own mother was a victim of hepatitis B, eventually dying of liver failure. “(But) we should not be silent. We should be advocates.”

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Peregrine Pharmaceuticals Evaluating Therapeutic Opportunities for Tarvacin(TM) Against Influenza Viruses Including Avian Flu
http://www.peregrineinc.com

Peregrine Pharmaceuticals (PPHM)Therapeutic Opportunities for Tarvacin(TM) Against Influenza Viruses Including Avian Flu

- Company Provides Review of Tarvacin Anti-Viral Program for Influenza, Including Collaborations with Federal Agencies, Academic Research Centers and Private Research Organizations -

TUSTIN, Calif., Oct 24, 2005 -- Peregrine Pharmaceuticals, Inc. (PPHM) today will provide a review of its ongoing programs to evaluate its unique anti-phospholipid agent Tarvacin(TM) Anti-Viral for the treatment of influenza including Bird Flu. Peregrine is actively collaborating with the National Institutes of Allergy and Infectious Diseases (NIAID) to assess Tarvacin Anti-Viral in preclinical flu models, and the company is also working directly with academic research centers and private research organizations to evaluate Tarvacin as a stand-alone agent and in combination with existing influenza therapies. In addition, Peregrine has entered into discussions with other federal officials to evaluate the potential of Tarvacin to treat influenza, including avian flu. Tarvacin Anti-Viral is currently in a Phase I clinical trial for the treatment of chronic hepatitis C virus infections.

Tarvacin Anti-Viral has been shown to protect animals from lethal infections in two preclinical models of enveloped viruses -- cytomegalovirus and pichinde virus, a model for the deadly Lassa hemorrhagic fever. Peregrine has previously reported that Tarvacin Anti-Viral binds to members of six different virus families, including influenza A and B, HIV 1 and 2, measles, respiratory syncytial virus and pichinde virus. Recent studies confirmed that Tarvacin Anti-Viral binds to human cells infected with influenza A.

"Evaluating Tarvacin Anti-Viral as a potential treatment for influenza, including deadly new strains such as avian flu, is a high priority for the company," said Steven King, president and CEO of Peregrine. "Given current global concerns about the possibility of an avian flu pandemic, we are rapidly identifying and assessing a number of opportunities to ramp up our existing collaborations with public and private sector partners to further accelerate these studies."

Unlike drugs that target an attribute of the virus, Tarvacin's host-derived phospholipid target is expected to be LESS SUSCEPTIBLE to the development of DRUG RESISTANCE, since the virus cannot simply mutate to avoid Tarvacin's anti-viral effects.

"The unique mechanism of action and stable nature of the target could make Tarvacin Anti-Viral a particularly attractive clinical candidate for the treatment of influenza, either as a stand-alone agent or in combination with existing therapies," said Joseph Shan, senior director of clinical and regulatory affairs at Peregrine. "We are accelerating our joint efforts with a number of public and private organizations to more fully evaluate the anti-influenza potential of Tarvacin Anti-Viral. If these preclinical studies produce positive results, we plan to expand our activities to expedite the initiation of human clinical trials."

CONTACT : BARBARA LINDHEIEM INVESTOR RELATIONS 212-918-4650

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Three Rivers Has FDA Approval of Drug
http://www.bizjournals.com

The U.S. Food and Drug Administration gave tentative approval to a Hepatitis C treatment from Three Rivers Pharmaceuticals Inc.

Three Rivers said it will market 200 mg, 400 mg and 600 mg tablets of ribasphere, the generic form of Roche Pharmaceutical's Copegus, which has annual U.S. sales of about $200 million.

Final approval is expected upon the expiration of the brand exclusivity in December.

The Cranberry Township, Pa., company said it would launch Ribasphere in conjunction with its marketing partner, PAR Pharmaceuticals Inc. (NYSE:PRX), of Spring Valley, N.Y.

Privately held Three Rivers Pharmaceuticals filed its first application with the FDA in July 2001 but had to overcome patent infringement lawsuits and certain regulatory issues to reach this stage.

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October 25th, 2005

Chile Begins Program of Free Hepatitis C Treatment
SourceURL:http://english.ohmynews.com/
Pedro Pablo Cortes (ppcortes)

The program will benefit about 200 patients in metropolitan Santiago

The director of the Chilean National Health Fund (FONASA), Dr Alvaro Erazo, and the directors of Metropolitan Health Services, signed on to a trial program to provide free treatment for about 200 patients infected with hepatitis C.

There is no vaccine to prevent hepatitis C and almost 100 percent of infected people lack any knowledge of their situation. Also, 80 percent of patients don't show any signs or symptoms, which include jaundice (yellow skin), fatigue, dark urine, abdominal pains, nausea and a loss of appetite.

The disease is caused by the hepatitis C virus (HCV) which is transmitted by blood transfusions, sharing needles or from an infected mother to her baby. The virus causes chronic liver disease, non-alcoholic cirrhosis and liver cancer.

Because hepatitis C is a stealthy disease, the treatment and prevention of it from spreading are fundamental. The work begins with doctors searching for possible infected patients in their medical files. In the past, when a blood bank detected an infected sample, they didn't tell the person because there wasn't a treatment, but now they will contact and apply a treatment in order to prevent the spread and eliminate the virus.

How the Program Works

During 2005, FONASA invested about US$1 million and for 2006 this will be increased by half. At the start, the program will attend to patients over 18 who suffer from non-alcoholic cirrhosis, or other urgent cases. The diagnosis includes basics tests like biochemical profiles to determine the viral load and genotype. The program then includes a liver biopsy, abdominal ecotomography and gastric endoscopy.

When a patient is detected, the treatment begins and its duration is about 24 to 48 weeks, depending on the genotype.

Drugs Included in the Treatment

According to World Health Organization (WHO), the treatment includes antiviral drugs such as interferon alone or in combination with ribavirin. The high cost of these drugs make the access this program provides a great success for people.

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Human Genome Sciences Completes Patient Enrollment in a Phase 2b Clinical Trial of Albuferon(TM) in Combination With Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
http://www.prnewswire.com

ROCKVILLE, Md., Oct. 25 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that it has completed enrollment, randomization and initial dosing in a Phase 2b clinical trial of Albuferon(TM) (albumin-interferon alpha) in combination with ribavirin in patients with chronic hepatitis C virus (HCV) genotype 1 who are naive to interferon alpha-based treatment regimens. Genotype 1 accounts for nearly 70% of all HCV infections in North America and is generally regarded as the most difficult HCV genotype to treat.

The trial is a randomized, open-label, multi-center, active-controlled, dose-ranging study conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania.(1) A total of 458 patients with chronic hepatitis C genotype 1 have received initial treatment in the Phase 2b study. Patients have been randomized into four treatment groups, three of which receive subcutaneously administered Albuferon (900 mcg at 14-day intervals, 1200 mcg at 14-day intervals, and 1200 mcg at 28-day intervals(2)). The fourth treatment group serves as the active control group and receives weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa-2a).

All patients receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses. The primary objectives of the Phase 2b study are to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon alpha-naive patients with chronic hepatitis C genotype 1. The primary efficacy endpoint is sustained virologic response, defined as undetectable virus at 24 weeks after completion of 48 weeks of treatment.

John McHutchison, M.D., Coordinating Center Principal Investigator for the Phase 2b study, and Professor of Medicine and Director, GI/Hepatology Research, Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, said, "The Phase 2b study of Albuferon in combination with ribavirin in treatment-naive patients will build upon preclinical and clinical results to date, which support the continued evaluation of Albuferon in larger populations to define its appropriate therapeutic role in the treatment of chronic hepatitis C. The current standard of care for the treatment of chronic hepatitis C is a combination of pegylated interferon alpha and ribavirin. This combination produces cures in approximately 42-46 percent of all genotype 1 HCV patients completing therapy, leaving more than 50 percent who relapse or do not respond. Clearly, chronic hepatitis C represents a significant unmet medical need. This unmet medical need perhaps explains the rapid enrollment of the Phase 2b study of Albuferon with ribavirin, which exceeded all our expectations."(3-12)

David C. Stump, M.D., Executive Vice President, Drug Development, said, "The current Phase 2b study is the largest Albuferon trial to date. We plan to take our first look at comparative data from the Phase 2b trial in Spring 2006, after the last patient has completed 12 weeks of treatment. In April 2005, we reported that the results of an earlier Phase 2 study of Albuferon monotherapy in treatment-naive patients with genotype 1 hepatitis C demonstrated that Albuferon was well tolerated, had a prolonged half-life and showed robust antiviral activity, with durable dose-dependent reductions in HCV viral load.(13-14) These data also enabled our identification of the range of active doses that we are evaluating in the current Phase 2b trial. An additional Phase 2 clinical trial of Albuferon in combination with ribavirin is ongoing in patients who have failed to respond to previous interferon alpha-based treatment regimens.(15) We look forward to presentation of interim results from this study in treatment-experienced patients at the annual meeting of the American Association for the Study of Liver Disease (AASLD) in November 2005. Based on the preclinical and clinical results that have emerged thus far(16-22), we believe that Albuferon has the potential to become an important therapeutic option for the treatment of chronic hepatitis C."

The results of a Phase 2 clinical trial of Albuferon monotherapy in interferon alpha-naive patients with genotype 1 chronic hepatitis C were presented at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL).(13-14) Data presented on 56 patients demonstrated that Albuferon exhibited robust antiviral activity in genotype 1 HCV. A mean reduction in HCV viral load of 3.2 log at Day 28 was observed in the combined 900 mcg and 1200 mcg dose cohorts, with 69% of patients (18/26) in these cohorts showing a >2-log reduction in HCV viral load at Day 28. Undetectable viral load was observed at Day 42 (28 days after the second injection) in 23% of patients (6/26) in the combined 900 mcg and 1200 mcg dose cohorts. Robust dose-dependent viral kinetics were observed, with the majority of patients in the 900 mcg and 1200 mcg cohorts exhibiting a second-phase decline in viral load of >0.3 log per week, which has previously been shown to be predictive of sustained virologic response (SVR) in treatment with the pegylated interferons.(23) Reductions in viral load of equal to or greater than 2 log are reported in approximately 42% of genotype 1 HCV patients treated with pegylated interferon alpha products in combination with ribavirin.(24) The results presented at EASL demonstrate that Albuferon remained in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha. Albuferon exhibited a median half-life of 148 hours, supporting dosing at intervals of 2-4 weeks. This compares with a reported mean (range) elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.(25-26) Albuferon was well tolerated with adverse events that were transient and mostly mild to moderate in severity. There were no discontinuations due to reductions in hematologic cell counts. No subjects developed newly emergent antibodies to alpha interferon.

Albuferon is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company's proprietary albumin fusion technology.

Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.

Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

For more information about Albuferon, see http://www.hgsi.com/products/albuferon.html. Health professionals interested in more information about trials involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the company's web site, http://www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.

HGS, Human Genome Sciences and Albuferon are trademarks of Human Genome Sciences, Inc.

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Footnotes:

1. (HGSI Press Release) Human Genome Sciences Initiates Phase 2b Clinical Trial of Albuferon in Combination with Ribavirin in Treatment-Naïve Patients with Chronic Hepatitis C. June 1, 2005.

2. It is important to note that the method of measurement for dose determination in the Phase 2b study of Albuferon in combination with ribavirin in treatment-naive patients (as well as in other Phase 2 studies of the compound) is different from the method of measurement in the Phase 1/2 study of Albuferon. Accordingly, the 900-mcg dose in the current study is equivalent to a 680-mcg dose in the Phase I / II study, and the 1200-mcg dose is equivalent to 900 mcg in the Phase I / II study.

3. Manns MP, McHutchison JG, Gordon S, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa 2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial. The Lancet 2001; 358:958-65.

4. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. New England Journal of Medicine 2002; 347:975-982.

5. Carithers RL, Zeuzem S, Manns MP, et al. Multicenter, randomized controlled trial comparing high dose daily induction interferon plus ribavirin versus standard interferon alfa-2b plus ribavirin. Hepatology 2000; 32:3317A (abstr).

6. Zeuzem S. Heterogeneous virologic response rates to interferon-based therapy in patients with chronic hepatitis C: who responds less well? Ann Intern Med 2004; 140:370-381.

7. Alter MJ. Epidemiology of hepatitis C in the West. Semin. Liver Disease. 1995;15:5-14.

8. Strader DB, Wright T, Thomas DL, and Seeff, LB. AASLD Practice Guideline: Diagnosis, Management, and Treatment of Hepatitis C. Hepatology 2004 April; 39 (4): 1147-1171.

9. Hadziyannis SJ, Sette H, Morgan TR, et al. Peginterferon alfa 2a and ribavirin combination therapy in chronic hepatitis C. Ann Intern Med 2004; 140:346-355.

10. Shiffman ML, Di Bisceglie AM, Lindsay KL, et al. Peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004; 126:1015-1023.

11. Zeng N, Cohen CK, Schwartz P, Rai R. Treatment of HCV infected patients, including non-responders to PEG-IFN alfa-2b/RBV, with PEG-IFN alfa-2a/RBV: the Johns Hopkins experience. Digestive Disease Week 2004 Internet Conference Report. Abstract #1233.

12. Management of Hepatitis C: 2002. National Institutes of Health Consensus Development Conference.

13. Bain V, et al. A Phase 2 study to assess antiviral response, safety, and pharmacokinetics of Albuferon in IFN alpha-naive subjects with genotype 1 chronic hepatitis C. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. Oral presentation. Abstract #18.

14. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 2 Clinical Trial of Albuferon in Treatment-Naive Patients with Chronic Hepatitis C. April 14, 2005.

15. (HGSI Press Release) Human Genome Sciences Initiates Phase 2 Clinical Trial of Albuferon in Combination with Ribavirin in Treatment-Experienced Hepatitis C Patients. November 30, 2004.

16. Balan V, et al. Albuferon(TM) -- A Novel Therapeutic Agent for Hepatitis C: Results of a Phase 1/2 Study in Treatment Experienced Subjects with Chronic Hepatitis C. 55th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 2, 2004. Oral presentation Abstract #265.

17. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 1/2 Clinical Trial of Albuferon(TM) in Chronic Hepatitis C. November 2, 2004.

18. Liu C, Zhu H, Xu Y, Nelson DR, et al. Albuferon(TM) exhibits efficient anti-HCV activity in cell culture. Digestive Disease Week (DDW) 2005, Chicago. Abstract #S920.

19. (HGSI Press Release) Human Genome Sciences Reports Results of Preclinical Study Comparing Anti-Viral Activity of Albuferon and Three Other Forms of Interferon Alpha Used to Treat Hepatitis C. May 17, 2005.

20. Balan V, et al. Molecular profiles of drug response in HCV infected patients during the first four weeks of therapy for chronic hepatitis C virus with pegylated interferon containing regimens or Albuferon. 54th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. October 25, 2003.

21. Moore P, Balan V, et al. Modulation of interferon specific gene expression by Albuferon in subjects with chronic hepatitis C and correlation with anti-viral response. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. Abstract #447.

22. Osborn B, Olsen H, Nardelli B, et al. Pharmacokinetic and pharmacodynamic studies of a human serum albumin-interferon-a fusion protein in cynomolgus monkeys. J Pharmacol Exp Ther 2002: Nov; 303: 540-548.

23. Neumann AU et al. The second phase HCV decline slope is the best predictor of sustained viral response during treatment of chronic HCV genotype 1 patients with peg-interferon-a-2b and ribavirin. 53rd Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 1-5, 2002. Abstract #778. Hepatology 2002: 36 (4), Pt 2 of 2.

24. Di Bisceglie AM, Rustgi VK, Thuluvath P, et al. Pharmacokinetics and pharmacodynamics of pegylated interferon alfa-2a or alfa-2b with ribavirin in treatment naive patients with genotype 1 chronic hepatitis C. Hepatology 2004;40,4;734a, abstract LB18.

25. PEGASYS(R) Physicians Desk Reference. (Last updated December 2003).

26. PEG-INTRON(R) Physicians Desk Reference. (Last updated February 2005).

SOURCE Human Genome Sciences, Inc.

Web Site: http://www.hgsi.com

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Regimen Revolution: Experimental Drugs for the Most Common Strain of Hepatitis C Could Head Off a Health Crisis
SourceURL:http://www.latimes.com
By Linda Marsa, Special to The Times

HEPATITIS C is a silent killer. Because the incubation period for the virus is 20 years or more, many people are unaware they're infected until irreparable liver damage has occurred.

Even with early diagnosis, treatment options are limited, and up to half of sufferers don't respond to standard drug therapy. Side effects — flu-like symptoms, depression, fatigue — can be so severe that some patients stop treatment.

FOR THE RECORD:

Hepatitis C - An article in Monday's Health section about experimental hepatitis C treatments said that, in a trial, the drug Valopicitabine reduced virus levels by up to 90% after 12 weeks of treatment. In fact, it took two weeks to reduce viral levels by more than 90%.

About 10,000 Americans die each year from chronic hepatitis C infection, but death rates are expected to triple over the next decade and far surpass those of AIDS.

Experimental medications in the research pipeline may avert this looming public health crisis. More than two dozen hepatitis C drugs are in development, and at least three drugs potentially could stop the lethal virus in its tracks by preventing it from reproducing.

"These drugs are more potent and have much less side effects, so the hope is that more people will come forward to be treated," says Dr. Eugene R. Schiff, director of the Center for Liver Diseases at the University of Miami in Florida.

The current treatment combines a synthetic version of pegylated interferon, a protein that bolsters the immune system, and ribavirin, which slows viral replication. However, fewer than half of people infected with the most common strain of hepatitis C respond to injections of that regimen.

The new antiviral therapies seem to effectively combat this strain, genotype 1, without those side effects. They also come as pills instead of shots.

Valopicitabine, made by Idenix Pharmaceuticals, is furthest along in its development. It works by blocking the action of RNA polymerase, an enzyme crucial to reproduction of the hepatitis C virus. A 2004 test of 79 patients revealed that the once-a-day pill reduced viral levels by up to 90% after 12 weeks of treatment - even though previous drugs hadn't worked for 87% of those patients.

Preliminary results from a recent Idenix test of Valopicitabine combined with pegylated interferon also show significant reduction of viral replication. The interim results of this trial, which used 190 patients unresponsive to conventional therapies, will be released next month.

Like the drug cocktails that transformed AIDS treatment, Valopicitabine will probably be part of a combination regimen, said Dr. Nathaniel Brown, chief medical officer at Cambridge, Mass.-based Idenix. "But we're in a race against time because the number of people with advanced disease is steadily increasing."

Two other experimental drugs have just completed early stage tests: SCH-503034, made by Schering-Plough in Kenilworth, N.J., and VX-950, made by Vertex in Cambridge.

Both disable a different enzyme, protease, thus preventing the virus from making copies of itself. Schering tested its drug - alone and in combination with pegylated interferon -on genotype 1 patients who didn't respond to standard treatments. Results of those trials will be released in November, and Janice K. Albrecht, a liver expert with Schering-Plough, says the reduction in viral levels was "significant."

A 2005 study of VX-950 using 34 volunteers was even more promising. After two weeks of treatment, the oral medication proved 250 times as potent as standard therapy in reducing viral levels.

Additional studies for both drugs are being planned.

"This data is profoundly encouraging," says Dr. John Alam, senior vice president for drug evaluation and approval at Vertex. "Within the next three to five years, a new generation of hepatitis C treatments could be available that can clear the virus in most patients."

Hepatitis C at a glance

Hepatitis C is spread through contact with infected blood. Before the virus was identified in 1989, people got it by receiving blood or organs from infected donors.

The blood supply is now screened, but IV drug users are still at risk.

About 4 million Americans are hepatitis C carriers, and 2.7 million of them have an active infection. Because there is no effective treatment for the majority of patients, hepatitis C infection accounts for 40% of terminal cirrhosis, 60% of liver cancers, and is the leading cause of liver transplants in the United States.

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Mds Must Report Their Blood-Borne Infections
SourceURL:http://www.medicalpost.com
By Barbara Kermode-Scott

EDMONTON | The council of the College of Physicians and Surgeons of Alberta (CPSA) has approved a new bylaw mandating self-reporting by physicians who have blood-borne infections such as HIV or hepatitis B or C.

Self-reporting will protect patients, physicians and the reputation of the medical profession, according to the college.

The new bylaw is not really something new, it simply fills a gap, suggested CPSA registrar Dr. Trevor Theman.

In the past physicians with blood-borne infections were reported to the college because hepatitis B and C and HIV are reportable diseases. Alberta's Medical Officers of Health have to report affected individuals and so physicians who were diagnosed while practising in Alberta would be identified and referred to the provincial expert review panel. The college was responsible for their followup and monitoring.

On registration form

"Really, the only piece of this that's new is that we are now going to ask every new physician on their registration form if they have been diagnosed with a communicable disease," explained Dr. Theman. "It's only going to make a difference to physicians who move into the province who may have been diagnosed previously."

Any new registrants who say they have been diagnosed with a blood-borne infection will be referred to Alberta's expert review panel.

The panel will then look at the type of their practice and their condition and make recommendations regarding any conditions or restrictions necessary to protect the public.

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October 26th, 2005

Harmony For Hep - Working Together to Raise Awareness of Hepatitis C
SourceURL:http://www.emediawire.com

HepCAware.org and The Arizona Hepatitis C Coalition host a concert to raise awareness of Hepatitis C. $10 donation gets you music, food and lots of info about Hepatitis C.

(PRWEB) October 26, 2005 -- HepCAware.org and The Arizona Hepatitis C Coalition host a concert to raise awareness of Hepatitis C. $10 donation gets you music, food and lots of info about Hepatitis C.

Two organizations working together to make a difference is not always done in the nonprofit world. But Kelly Zirbes and Christina Hurst want to change that in the Hepatitis C Community. Christina, who works for the Arizona Department of Health for Hepatitis C and volunteers for the Arizona Hepatitis C Coalition, discovered Kelly and her organization, Hepatitis C Awareness, Inc., after reading about their national campaign of using music to raise awareness of this silent epidemic. Wanting to bring more attention to hep c in Arizona, Christina asked Kelly to help her put together an awareness concert. They spoke on the phone, a date was set and a partnership was born.

"It's really important for organizations to team up when they have the same message. And the more voices you have the louder the message will be," says Kelly Zirbes. "I hope other hep c nonprofits can find inspiration from this and create other partnerships."

Hurst named the event "Harmony For Hep" to celebrate the joining of the two organizations. The concert takes place on Saturday November 5th at Flicka's Baja Cantina in Scotsdale, located at 2003 N. Scotsdale Rd. The event starts at 4 p.m. and will go till 9 p.m. Music will be provided by SoulCatcher and Kelly's Lot. A donation of $10 or more will get you dinner, music and lots of info about Hepatitis C. Sponsors include Flicka's Baja Cantina, Apothecary Shop, Walgreen’s Specialty Pharmacy, Pueblo Family Physicians, Audio Video Resources, Xango, The Biting Edge Family Dentistry.

Harmony For Hep Working Together To Raise Awareness of Hepatitis C

Saturday November 5, 4-9 p.m.

$10 Includes Dinner

@ Flicka's Baja Cantina

2003 Scottsdale Rd

Scottsdale, AZ

Featuring Blues/Rock from SoulCatcher and Kelly's Lot

Benefiting HepCAware.org and The Arizona Hepatitis C Coalition

The proceeds from the concert will go to HepCAware.org and The Arizona Hepatitis C Coalition.

Did You Know That:

- AZ Governor Janet Napolitano has declared November Hepatitis C Awareness Month

- Total reported cases to AZ Dept of Health is 55,910 as of 1998 when it became reportable.

- Hepatitis is #1 blood-borne disease in the state of AZ (HIV cases are at 14,650 when it became reportable in 1985)

- The Arizona Hepatitis C Coalition's (AZHCC) priorities are Harm Reduction, Screening and a Resource center

Hepatitis C is a systemic blood-borne virus that primarily attacks the liver. It is spread by blood to blood contact. One in 50 Americans have HCV - two out of three do not know it. There is no vaccine for Hepatitis C.

Have you:

Received blood, blood products, or an organ transplant prior to 1992?
Ever shared drug paraphernalia? injecting or snorting?
Ever been stuck by a used blood needle?
Been on kidney dialysis?
Had a tattoo or body piercing?
Had sexual activity that involves contact with blood?
Shared personal care items(razors, toothbrushes, etc.) with other people?
Been incarcerated?
War veteran (especially Vietnam)

If you answered YES to any of these questions, you may have been exposed to the Hepatitis C virus. Get tested.

Contact:
Kelly Zirbes
(818)769-2701
www.HepCAware.org

Christina Hurst
602 690-2810

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October 27th, 2005

Hepatitis C packs Cruel Punch
SourceURL:http://www.daytondailynews.com
By Laura A. Bischoff
Dayton Daily News

Former official gives testimony about disease

COLUMBUS | Despite seven years and four courses of expensive treatment, hepatitis C virus still ravages Craig Zimmers' liver and that's a fate he wants other Ohioans to avoid.

In 2000, Zimmers quit his job as Montgomery County Clerk of Courts so that he could focus on his health and he is now director of Ohio Hepatitis C Association.

Zimmers testified Wednesday before a joint meeting of the House and Senate health committees about hepatitis C, a disease that affects 200,000 Ohioans and 4 million Americans.

Hepatitis C is a liver disease, contracted through blood to blood contact such as transfusions, shared needles and personal items, or sex. It starts damaging the liver within weeks of infection but patients often live decades without knowing they have it.

Treatment is expensive, lengthy, difficult and often not effective. The cure rate is less than 50 percent, said Dr. Kenneth Cowens, an internist in Youngstown who has treated more than 50 patients with hepatitis C.

The drugs are costly -- about $30,000 a year -- and must be administered multiple times a week for six to 18 months. The treatment has harsh side effects -- flu-like symptoms, fatigue, hair loss and other problems.

Untreated, hepatitis C can lead to cirrhosis and liver cancer. Cowens said a liver transplant costs about $340,000.

The Ohio Department of Rehabilitation and Correction screens all inmates for hepatitis C and tests those at high risk. Dr. Scott Savage, the department's assistant medical director, said there are 3,547 inmates with hepatitis C and 19 are undergoing treatment. The prison system has spent about $900,000 on hepatitis C treatment in the past year, he said.

Information on how much hepatitis C costs the Ohio Medicaid system was not available Wednesday.

Contact Laura A. Bischoff at (614) 224-1624.

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Hepatitis C Leadership Summit, October 29-30, Seeks to Elevate the Current Response to the Hepatitis C Epidemic
SourceURL:http://www.genengnews.com

The Healthcare Advocacy and Research Collaboration Project (HARCP), a non-profit organization, and The Bruckner Group, are pleased to announce the Hepatitis C Leadership Summit (HCVLS), a private meeting taking place October 29-30 in Boston.

With 4 million hepatitis C (HCV) infections in the U.S. and 3 million chronic infections, HCV is a serious public health crisis for which the current response is vastly inadequate. The HCVLS, a new initiative, is bringing together stakeholder leaders in hepatitis C for a series of discussions aimed at elevating the response to the epidemic. The HCVLS will specifically explore opportunities to increase the number of patients tested and treated for hepatitis C using currently-available resources.

While there are many worthwhile areas for discussion, the HCVLS is focusing on these three specific areas:

1. Hepatitis C and the Insurance Industry: A discussion of the private and public insurance issues around the identification and treatment of hepatitis C patients.

2. Care options for HCV patients, with a focus on best practices that maximize patient outcomes.

3. Partnering with community faith organizations to expand HCV awareness and patient support.

Attendees at the HCVLS include the majority of the State Hepatitis C coordinators, leading managed care payers, state Medicaid organizations, the CDC, leading clinicians, advocates, and manufacturers.

"The HARCP and The Bruckner Group are pleased to bring together this distinguished group of stakeholder participants to discuss how we can collectively do better in the fight against HCV," said Michael J. Russo, President of The Bruckner Group. "The need and the urgency for action could not be clearer. I'm heartened by the unusually strong buy-in to this process. We'd like to especially commend the State Hepatitis C coordinators, as well as public and private insurance industry stakeholders, for their enthusiastic participation. We expect actionable items to emerge from the HCVLS."

The HCVLS will commence with a video welcome from Senator Edward M. Kennedy (MA). Senator Kennedy has for years demonstrated tireless leadership in the congressional fight for greater visibility and resources in efforts to combat HCV. His unstinting efforts deserve the widest possible recognition, and the HCVLS is honored by his participation.

The HCVLS, initiated and organized by the HARCP and The Bruckner Group, is sponsored by Roche Pharmaceuticals and The Bruckner Group, with additional support from Schering-Plough Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals.

The Healthcare Advocacy and Research Collaboration Project is a non-profit organization dedicated to improving access to, quality of, and delivery of healthcare services, particularly in under-served disease areas and patient populations. The HARCP conducts research studies and projects, develops and disseminates information, and demonstrates leadership in activities and efforts to fight disease. Current HARCP initiatives include activities in hepatitis C, hemophilia, and autoimmune disorders.

The Bruckner Group are strategy and research consultants in the pharmaceutical and biotechnology industries. BGI are the leading experts in value strategy, helping clients define, prove, and leverage the healthcare value of their therapeutics to build successful product launch strategies and post-launch brand strategies. BGI's strategies emerge from an understanding of the intersection of therapeutic outcomes, healthcare value at the standard of care, and a determination of unmet market needs of payers, physicians, and patients. BGI's unique and systematic approach creates market success by maximally addressing the healthcare value needs in therapeutic markets.

CONTACT:

The Bruckner Group, Inc. David Balekdjian, 781-245-4454, x222

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October 28th, 2005

Portal-Systemic Shunts High in Hepatic Encephalopathy
SourceURL:http://www.gastrohep.com

A study in the latest issue of Hepatology suggests that large spontaneous shunts may often sustain the chronicity of hepatic encephalopathy in cirrhosis, and the presence of large shunts should be sought in these patients.

Large spontaneous portal-systemic shunts have been occasionally described in patients with cirrhosis.

Dr Oliviero Riggio and colleagues from Italy assessed the prevalence of portal-systemic shunts in patients with cirrhosis.

The research team evaluated 14 patients with recurrent or persistent hepatic encephalopathy vs 14 with cirrhosis but without hepatic encephalopathy.

The team matched patients for age and studied the degree of liver failure.

Each patient underwent neurological assessment and cerebral magnetic resonance imaging to exclude organic neurological pathological conditions.

Hepatic encephalopathy evaluation included psychometric performance, and electroencephalogram.

Portal-systemic shunts occurred in 10 patients with hepatic encephalopathy vs 2 without – Hepatology

The researchers also assessed mental status examination and grading, arterial, venous, and partial pressure of ammonia determination.

The presence of portal-systemic shunts was assessed by portal venous phase multidetector-row spiral computed tomography.

Large spontaneous portal-systemic shunts were detected in 10 patients with hepatic encephalopathy and in only 2 patients without hepatic encephalopathy.

The researchers observed that patients with hepatic encephalopathy presented with ascites less frequently than the control group.

In addition, the team noted that patients with hepatic encephalopathy presented with medium/large esophageal varices less frequently than the control group.

Dr Riggio's team concludes, "Our study suggests that large spontaneous shunts may often sustain the chronicity of hepatic encephalopathy."

"The presence of large shunts should be sought in patients with cirrhosis with recurrent or persistent hepatic encephalopathy."

Hepatol 2005: 42(5): 1158-65

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Viral Evolution of Hepatitis C in Injection Drug Users
SourceURL:http://www.gastrohep.com

November's issue of the Journal of Viral Hepatitis shows that patients with ongoing or prior hep C develop immunity that protects against further infection with hep C despite repeated exposure.

Injection drug users represent the largest cohort of patients with established hepatitis C virus infection.

The group is also at highest risk for new infections.

Most published studies have focused on the clinical consequences of established hepatitis C infection and have not examined the consequences of new infection.

Dr Dove and colleagues measured the virological consequences of hepatitis C in patients with ongoing injection drug use.

The researchers assessed whether the virological consequences might pose a risk for new and/or for superinfection with additional strains of hepatitis C.

The research team examined 3 groups.

None of 6 patients with resolved infection had detectable hepatitis C RNA at 1 year – Journal of Viral Hepatitis

Group 1 included those with resolved hepatitis C infection with ongoing injection drug use and Group 2 were those with chronic infection who continued to inject.

The team included those with chronic infection who no longer injected in Group 3.

The researchers' study demonstrated a spectrum of responses.

The team found that the majority of patients appeared to be 'protected' from new infection.

None of 6 patients with resolved infection had detectable hepatitis C RNA by quantitative or qualitative polymerase chain reaction when followed for 1 year.

Similarly, the researchers noted that despite ongoing injection drug use, no patient with persistent infection had a 'switch' in hepatitis C genotype.

There was no indication of possible superinfection.

Virological analysis of hepatitis C quasispecies was undertaken to detect possible infection with new variants of hepatitis C in patients with 'stable' infection.

The research team showed that these analyses indicated divergence of virus over time, divergence that was unrelated to injection drug behaviour.

Dr Dove's team commented, "Patients with ongoing or prior hepatitis C infection appear to develop immunity that protects against further infection with hepatitis C despite repeated exposure."

J Vir Hep 2005: 12(6): 574

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Hepatitis C Complicated by Morphine Withdrawal
SourceURL:http://www.eurekalert.org

Philadelphia, PA -- Researchers at the University of Pennsylvania have demonstrated that morphine withdrawal complicates hepatitis C by suppressing IFN-alpha-mediated immunity and enhancing virus replication. The paper by Wang et al., "Morphine withdrawal enhances hepatitis C virus (HCV) replicon expression," appears in the November issue of The American Journal of Pathology and is accompanied by a commentary.

Hepatitis C virus (HCV) is common among intravenous drug users, with 70 to 80% of abusers infected in the United States. This high association has peaked interest in determining the effects of drug abuse, specifically opiates, on progression of the disease. The discovery of such an association would impact treatment of both HCV infection and drug abuse.

Dr. Wen-Zhe Ho has been interested in such interplay for some time. His laboratory has previously shown using cell culture that morphine enhances virus replication and inhibits IFN-alpha (a natural anti-viral factor produced by immune, as well as host cells, and the only one approved in recombinant form for treating HCV infection). To further these results, his lab has used a cell model system to determine the consequences of morphine withdrawal, which is a common recurring event in opioid users.

Chuan-Qing Wang and colleagues examined the effects of morphine withdrawal (MW) on HCV-infected cultured liver cells by exposing cells to the drug for four days followed by its removal. They also assessed the effects of using naloxone, to block the opioid receptors, in conjunction with drug removal, i.e. precipitated morphine withdrawal (PW). To measure HCV replication, they used a virus-like "replicon" that mimics the events that occur in liver cells and expression of viral RNA and proteins that HCV uses. Although the replicon does not produce the infectious virus, the HCV replicon system represents the best available system for examining the impact of opiates on HCV at the time of their research study.

Similar to their previous results, the authors found that MW and PW increased levels of HCV replicon RNA and protein expression. In addition, both withdrawal scenarios inhibited IFN-alpha expression in liver cells in the presence or absence of HCV replicon. Since IFN-alpha is a critical self-defense mechanism utilized by liver cells to fight off viral infection, including HIV, this study suggests that morphine withdrawal weakens host cell immunity and provides a favorable environment for HCV growth in the liver.

The authors extended their study by examining the mechanism behind these observations. MW and PW inactivated the IFN-alpha promoter (the switch for making IFN-alpha) by directly inhibiting its activator, interferon regulatory factor-7 (IRF-7), and this effect was more pronounced in HCV replicon-containing cells. Finally, the ability of IFN-alpha treatment to block HCV replicon expression (85%) fell following MW (60%) and PW (50%). This finding, in conjunction with the earlier report by the same group, provides an explanation to the question of why so many HCV-infected patients fail to respond to IFN-alpha treatment.

Although the clinical relevance of this study remains to be determined, these data showing that withdrawal promotes HCV expression by suppressing anti-HCV factor (IFN-alpha) production by liver cells suggests that "opioid abuse may contribute to the chronicity of HCV infection and promote HCV disease progression."The study also underscores the necessity of future clinical and epidemiological studies to define the role of opiate abuse in promoting HCV disease.

These results suggest that opioid abusers experiencing periods of drug abuse, followed by periods of withdrawal (due to lack of supplies) may lead to immunocompromised liver. These findings further support the need for methadone maintenance treatment as an additional benefit for opioid abusers.

Research was supported by National Institute on Drug Abuse, National Institutes of Health.

This work involved collaborators at Joseph Stokes, Jr. Research Institute at The Children's Hospital of Philadelphia; The Center for Studies of Addiction, University of Pennsylvania School of Medicine; and The Children’s Hospital of Fudan University, Shanghai, China.

1. Wang C-Q, Li Y, Douglas SD, Wang X, Metzger DS, Zhang T, Ho W-Z: Morphine withdrawal enhances hepatitis C virus (HCV) replicon expression. Am J Pathol 2005, 167:1333-1340

2. Commentary: Moore K and Dusheiko G: Opiate abuse and viral replication in hepatitis C. Am J Pathol 2005, 167:1189-1191

For press copies of the articles, please contact Audra Cox at 301-634-7409 or the Journal Editorial Office at 301-634-7959.

The American Journal of Pathology, the official journal of the American Society for Investigative Pathology (ASIP), seeks to publish high-quality original papers on the cellular and molecular mechanisms of disease. The editors accept manuscripts which report important findings on disease pathogenesis or basic biological mechanisms that relate to disease, without preference for a specific method of analysis. High priority is given to studies on human disease and relevant experimental models using cellular, molecular, biological, animal, chemical and immunological approaches in conjunction with morphology.

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Defense Attorneys to Seek New Trial in Hepatitis C Case
SourceURL:http://www.journalstar.com
By The Associated Press

FREMONT -- Defense attorneys for a doctor and nurse accused of causing a major hepatitis C outbreak have filed for a new trial in the civil case.

Greg Thomas, representing nurse Linda Prochaska, filed a motion for a new trial. Earlier this month, a jury awarded $685,000 to Robert and Verena Ridder, of Fremont, who filed the civil suit.

Robert Ridder, 61, was one of 99 patients who were infected with hepatitis C while undergoing chemotherapy at the Fremont Cancer Center and among 92 people to file civil suits in Dodge County District Court as a result.

The couple sued Dr. Tahir Javed, a former Fremont physician, and Prochaska, his former head nurse.

Javed was accused of using unsanitary practices that caused 99 people, including one who died, to contract the disease at his Fremont Cancer Clinic between March 2000 and December 2001.

The majority of the civil lawsuits related to the outbreak have been settled out of court for undisclosed amounts.

Ridder initially went to the clinic for chemotherapy for non-Hodgkins lymphoma in 2001.

The Ridders were seeking $10 million.

Both Javed and Prochaska have admitted some negligence in Ridder's case, according to court documents.

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Tissue Implants in Canada May Have Come from Bodies Taken from Funeral Homes
SourceURL:http://news.yahoo.com
SHERYL UBELACKER

TORONTO (CP) - Some Canadians who received transplants of bone, skin or tendons need to be tested for infectious diseases like HIV and hepatitis after it was discovered the U.S. supplier of the products may have illegally procured them from corpses at funeral homes.

About 300 human tissue products from Biomedical Tissue Services Ltd. were exported to several Canadian companies, which supply tissue to hospitals and health professionals across the country for grafting during dental and orthopedic procedures.

This week, a Health Canada advisory said distributors that purchased human tissue from Biomedical have recalled the products.

The Fort Lee, N.J., company is under investigation for allegedly obtaining bones and other tissues from bodies trafficked from New York-area funeral homes.

U.S. law prohibits the sale of body parts for profit, but the probe by the Brooklyn district attorney's office alleges that relatives' consent forms were forged and cause of death records altered to make the donations to tissue-processing companies acceptable.

Health Canada has asked importers to advise hospitals, physicians and dentists to contact patients who received the products and arrange for them to be tested for HIV, hepatitis B and C, human T-cell lymphotrophic virus (HTLV 1 and II) and syphilis.

"One of the things that even (Health Canada) has pointed out was they feel there is a low risk of any chance of disease, but the risk is still there," Bert Kelly, a spokesman for Medtronic Inc., said from Memphis, Tenn.

Kelly said Medtronic buys and distributes tissue products from Regeneration Technology Inc. (RTI) of Florida. His division sells bone products to Canadian hospitals and health professionals through Medtronic's branch in Mississauga, Ont. The products are used for such procedures as fracture repair and spinal fusion surgery.

Even though RTI goes through a rigorous screening and sterilization process of donor tissue, the company "felt the best thing to do would be to recall any tissue that came from this BTS company to alleviate the concerns of patients and everybody involved," Kelly said.

"The documentation could not be confirmed as to how patients died . . . and certainly if a patient had died of a disease like HIV or hepatitis, they would have been disqualified from donating," he said.

"So not knowing what the real cause of death was, that's absolutely of major concern for RTI and for us."

Medtronic first began purchasing the questionable tissues from Biomedical Tissue Services (BTS) in May 2002 and began recalling them in the United States and Canada earlier this month.

But the first recall came Sept. 30 after LifeCell Inc., a Branchburg, N.J., company that produces skin graft products, found discrepancies in donor documents from BTS. It notified the U.S. Federal Drug Administration, which issued a recall warning to all companies dealing with the products.

"While no adverse events have been reported, we took this prudent and precautionary measure because LifeCell is committed to patient safety and quality," CEO Paul Thomas said of the recall in a release.

"If the allegations . . . are proven true, we are sickened and outraged by BTS's activities," said Thomas.

Sharon Mullin, an assistant manager of compliance with the Health Products and Food Branch, Inspectorate, said Health Canada hasn't yet determined how many of the 300 tissue products actually ended up in Canadians' bodies.

"It's too early to say how many were transplanted and how many were on the shelf," Mullin said Thursday from Ottawa.

No cases of disease or death related to these tissue products have been reported in Canada or the United States, Mullin said. "The risk continues to be low."

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