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

Week Ending: March 3^rd , 2007

Alan Franciscus
Editor-in-Chief

To download pdf version click here

This Issue:

• Did State Fully Treat Inmate's Hepatitis?
• Anger as 'Hep C Widows' Left Out in the Cold
• Church Holds Program about HIV/AIDS, Hepatitis C
• The Valencia Hepatitis C Case is Ready for Sentencing
• Claim Filed against Alameda County Jail in Newark Man's Death
• Nautilus Biotech Announces IND Filing for Belerofon, Its Oral, Long-Lasting, Interferon-Alpha Drug
• Human Genome Sciences Announces Positive Interim Results of Phase 2b Trial of Albuferon(R) with Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C
• Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) with Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Genotypes 2 and 3
• Court: Inmates Must Be Told if They're Sick
• Key Protein for Hepatitis C Virus Entry Identified
• Pharmasset Initiates Multiple Ascending Dose Study of R7128 in Patients Chronically Infected With HCV Genotype 1
• P.E.I. Surgeon Tests Positive for Hep C
• Model for Predicting Survival in Liver Patients Has Many Applications but Could Be Refined Further
• Liver Health Begins at Home
• New Culture System Leads to Anti-Viral Treatments for Hepatitis C
• Dynavax Initiates Phase I Trial of Hepatitis B Therapy
• Hepatitis Foundation International: New Study Supports Effectiveness of Liver Wellness Education
• Hepatitis E Vaccine Called Highly Effective
• Idenix Announces Thirteen Data Presentations at the 2007 European Association fr the Study of the Liver

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February 25th , 2007


Did State Fully Treat Inmate's Hepatitis?
http://www.kansas.com

Alexis McCullough, an inmate at the Wichita Work Release Center, died in excruciating pain, screaming for an ambulance, last March.

Afterward, I started raising questions: Why did no one call an ambulance? Why was he allowed to suffer so?

Now, there may be a bigger question: Did the Kansas Department of Corrections contribute to his condition by failing to sufficiently treat McCullough's chronic hepatitis C?

Lawyer Randy Price leveled that charge at a civil service board hearing last week in Topeka. He represents William Del Gaudio, a shift supervisor appealing his firing in connection with the death.

Price noted that an autopsy showed McCullough died from hepatitis C and cirrhosis, which tends to develop from untreated hepatitis C.

"The bottom line is, you can knock this virus out," Price said, adding that the inmate's medical records offer no evidence that he had been treated for hepatitis C. "I don't find it anywhere, and they can't find it," Price said of state officials. "And if they could find it, they would have talked about it."

Hepatitis C is a liver disease commonly treated with a combination of interferon and ribavirin. This combination can chase the virus into remission in some patients.

McCullough apparently was diagnosed with hepatitis C nearly 15 years ago while a prisoner in Lansing, Price said. The level of treatment he has received since then is unclear.

Dr. Dean Rieger, corporate medical director of the department's health care provider, Correct Care Solutions, insists McCullough did receive treatment. He also said that the "monitoring" of a patient's condition could constitute treatment. He added he didn't have McCullough's file with him and couldn't recall whether the inmate had received supportive therapy -- medications -- along with monitoring.

Frances Breyne, a Department of Corrections spokeswoman, said Friday that McCullough was never given interferon.

Not every patient with hepatitis C is a good candidate for interferon treatment.

Rieger said hepatitis C treatment remains a complex undertaking. A patient with an active virus but only limited liver damage is the best candidate for treatment, he said. Doctors also would have to determine whether an inmate could tolerate the medicines and would remain in custody long enough to complete the full course of treatment.

"Treatment," he said, "is a broad term."

"It's not just medication treatment," Rieger said. "That also includes monitoring someone to see how affected their liver may be."

Dr. Tom Moore of the University of Kansas School of Medicineagreed that treatment hinged on many factors. But he questioned whether monitoring could constitute treatment.

"That's observation, not treatment," he said.

Moore considered hepatitis C treatable but cautioned that not everyone responds to treatment.

Bill Miskell, spokesman for the Department of Corrections, said the department pays Correct Care Solutions $42 million annually for health care and the University of Kansas Medical Center provides oversight.

CCS, through Miskell, sent me its extensive hepatitis C protocols that included its policy: "Correct Care Solutions will identify, treat, and monitor all inmates with risk factors for Hepatitis C within all Kansas Department of Corrections Facilities."

McCullough's daughter, Danielle Morris, said she didn't know what kind of treatment her father received, but said $42 million should get a patient more than monitoring.

"How could they expect anyone to get better by just watching them?" she asked. "That's stupid."

Reach Mark McCormick at 316-268-6549 or mmccormick@wichitaeagle.com.
http://www.kansas.com/mld/kansas/news
/politics/elections/

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Anger as 'Hep C Widows' Left Out in the Cold
http://politics.guardian.co.uk/
Lorna Martin
The Observer

Around 200 women living without financial aid

Widows whose husbands died after receiving contaminated NHS blood are urging the government to close a loophole which denies them access to financial assistance. Around 200 women in the UK, many of whom are pensioners and living in severe hardship, are excluded from the fund because their partners, who all suffered from haemophilia, died from hepatitis C complications before an official cut-off date to be considered for compensation. Had they died later or from an HIV-related illness, they would have been entitled to support.

The women are stepping up their campaign after the announcement on Monday that there is to be an independent public inquiry into the supply of tainted blood products to haemophiliacs in the UK.

For the past 15 years, The Observer has supported calls for an inquiry and adequate compensation for those affected in what the Labour peer Lord Robert Winston has described as the worst treatment disaster in the history of the NHS.

More than 4,800 haemophiliacs in Britain were infected with hepatitis C, and 1,200 of those also contracted HIV after being given contaminated blood products during the Eighties and early Nineties. More than 1,700 have since died, and many more are terminally ill. Campaigners say they have suffered extreme financial hardship because most of them are uninsurable, unemployable and unable to make adequate provision for their dependants.

Successive governments have ruled out inquiries but they have established two funds to help those affected - the Skipton Fund for those infected with hepatitis and the MacFarlane Trust for those who contracted HIV. All but the group of women known as 'hep C widows' have received or are entitled to some form of financial assistance from one of the funds.

The anomaly in the scheme is highlighted by the case of Maureen Murphy, a 69-year-old widow from Liverpool. Her husband, William, was one of three brothers with haemophilia who died after receiving contaminated blood. The widows and dependants of his two brothers, who contracted HIV, have received support.

However, because her husband contracted hepatitis C, which is now regarded as a more deadly disease in the western world than HIV, from the tainted blood and died before August 2003, Mrs Murphy is not entitled to any form of financial help. 'This is such an unjust and indefensible situation,' Mrs Murphy said. 'This is a dreadful thing to say but in the lottery of NHS blood infection, it would have been easier if my husband had got HIV rather than hepatitis C.'

Mrs Murphy gave up her work to become a full-time carer for her husband. Because of the problems surrounding haemophilia, they were unable to take out insurance policies or mortgage protection. Greg Murphy, her son, said the government had created a 'deplorable caveat'. 'Unlike widows of HIV victims, who were rightly compensated my mum has never received a penny. She has suffered the same pain at the loss of her husband. How can the government possibly decide that her suffering is less because he died from hepatitis rather than HIV?'

Harriet Bullock, who is in her seventies and who lost her husband, Ken, eight years ago, said the situation had devastated her family's life .'I feel so angry that there is a small group of us who are excluded simply because our husbands died before the government decided to create the fund. No one has ever said sorry. I can't yet begin to mourn Ken.'

Lord Morris of Manchester, president of the Haemophilia Society, who initiated the public inquiry after years of campaigning, said: 'It is a gross anomaly that widows of those infected with hepatitis C are excluded. It illustrates the piecemeal way this tragedy has been dealt with.'

A spokesman for the Department of Health said there were no plans to offer financial support to the widows, and stressed that the scheme was designed to make lump sum payments to those living with hepatitis C and not to compensate for bereavement.

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Church Holds Program about HIV/AIDS, Hepatitis C
http://www.sun-herald.com/
By CAROLYN QUINN
Staff Writer

Event focuses on disease prevention

PUNTA GORDA -- Dr. David Klein had a message for the 40 or so people gathered at First Macedonia Missionary Baptist Church for the sixth annual HIV/AIDS and hepatitis C awareness luncheon.

"We can make this disease go away in one generation," he said.

That point made an impact on Melody Washington, the church secretary.

"It's been an eye-opener," she said after the event Saturday. "I learned a lot."

Prevention and education were the themes of the program. The keynote speakers were Klein, who splits his time between volunteering at the Charlotte County Health Department's HIV/AIDS Clinic and an ophthalmology practice, and Dr. Mark Asperilla, an infectious disease specialist who works as director of medicine at the clinic.

The doctors said they spoke at the event to raise awareness of HIV/AIDS and hepatitis C infection. Those diseases, once associated with homosexuality, have become increasingly common among other population groups, the doctors said -- particularly black and Hispanic women, whom Asperilla said account for more than 50 percent of HIV/AIDS cases in the United States.

"We're in the right place, the right time and the right venue to preach prevention," Asperilla said.

To demonstrate the universality of the HIV/AIDS problem, Klein told those in attendance about one of his patients, a 78-year-old widow who had only had two sexual partners over her lifetime.

"I don't think anyone would stand there and say 'shame,'" he said.

The doctors also talked about hepatitis C, an infection that spreads in many of the same ways HIV/AIDS does -- through sex, needle-sharing and the transmission of bodily fluids. However, hepatitis C, which damages the liver over time, is four times more common than HIV/AIDS. Many people contract both.

"The worst thing is to treat the HIV but not the hep C," Klein said.

"They're dying from the hep C," Asperilla added.

In late March or April, the Hope Clinic of Charlotte County will begin treating 60 uninsured or underinsured patients per year who have chronic, active hepatitis C, Asperilla said. The clinic will be located at the county health department in Punta Gorda.

Speakers at Saturday's event also addressed the stigmatization of people with HIV/AIDS. Bo James, youth director at Sacred Heart Church, was one of several who spoke about the HIV/AIDS Pastoral Care Committee, which visits people with the disease.

"These people need to be touched," he said. "The Lord has no hands or feet on this earth. We are to be his hands or feet."

You can e-mail Carolyn Quinn at cquinn@sun-herald.com.

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February 26th, 2007


The Valencia Hepatitis C Case is Ready for Sentencing
http://www.typicallyspanish.com
By m.p.

Anaesthetist Juan Maeso, on trial for infecting 276 patients with Hepatitis C.

The anaesthetist Juan Maeso, the only person accused for the massive infection of 276 patients with the Hepatitis C virus in the Valencia Region in the late 1990s, has told the court that he is innocent and should be acquitted.

He is accused of infecting the patients during surgery at La Fe public hospital, and the private clinics Casa de Salud, Virgen del Consuelo and Clínica Quirón.

Maeso made his statement on the final day of his trial, which is now ready for sentencing. More than 350 people have been called to take the stand in the past 18 months, from the patients affected, to health staff and expert witnesses. 157 lawyers are involved in the case, along with 111 solicitors.

There are 32 separate volumes to the case summary.

Juan Maeso, a morphine addict, is charged with using the same needle on himself and his patients. He faces more than two thousand years in prison if found guilty.

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Claim Filed against Alameda County Jail in Newark Man's Death
http://www.fresnobee.com

The family of a Newark man has filed a $10 million claim against an Alameda County jail, alleging the staff ignored his calls for help as he slowly died from internal bleeding.

Michael Decoite, 42, suffocated last year as the bleeding blocked his ability to breath, according to the wrongful death and medical malpractice claim filed Thursday against the county's Santa Rita jail.

The claim also alleges Decoite, who suffered from hepatitis C and cirrhosis of the liver, was denied his medications while incarcerated at the jail.

Decoite died at Valley Care hospital in Pleasanton after he was found barely responsive in the jail's infirmary, according to an Alameda County Sheriff's Office report.

"We try to provide the best medical care we can," Sgt. J.D. Nelson, a spokesman for the sheriff's office.

Decoite was being held at the county's Santa Rita jail on suspicion of driving without a license, failing to obey inspection, driving under the influence and resisting arrest, according to court records.

Alameda County, the sheriff's department and the jail's private health care provider were also named as defendants in the claim, the first step in a likely lawsuit, said Larry K. Arguello, a lawyer for the family.

Information from: The Oakland Tribune, http://www.oaklandtribune.com

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February 27th, 2007


Nautilus Biotech Announces IND Filing for Belerofon, Its Oral, Long-Lasting, Interferon-Alpha Drug
http://www.pharmalive.com
 
PARIS, 27 February 2007 - Nautilus Biotech has announced that it has submitted an Investigational New Drug (IND) filing to the US Food and Drug Administration (FDA) for oral Belerofon(r), its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic Hepatitis C. The new drug will be administered orally - all currently marked interferon alpha drugs are administered by injection - resulting in improved safety and patient compliance. This IND filing for oral Belerofon follows Nautilus Biotech's recent IND filing for injectable Belerofon in October 2006.

Belerofon is a designed variant of IFN-alpha. It has a single point mutation for lower sensitivity to protease-mediated degradation, unchanged molecular weight and specific antiviral activity compared to non-pegylated IFNs. Following subcutaneous (SC) administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native-IFN alpha and pegylated derivatives. Nautilus Biotech has formulated lyophilized Belerofon together with inactive ingredients to produce enteric coated tablets. When administered orally, Belerofon shows blood levels comparable to SC administered native IFN-alpha, which is not orally bioavailable. Oral bioavailability of Belerofon is based on its low sensitivity to protease degradation in the intestine which renders the molecule available for absorption into the bloodstream.

Oral Belerofon is one of a number of proteins being developed by Nautilus Biotech for oral administration and has been designed and developed using the company's proprietary technology for protein engineering.

"We are developing a pipeline of therapeutic proteins aimed at improving the quality of life of patients through improved safety and compliance. The IND for oral Belerofon is a major milestone in our commitment to develop highly innovative, high value and orally available protein drugs", said Nautilus Biotech's CEO, Manuel Vega.

"The IND for oral Belerofon represents a significant advance in protein therapeutics. The shift from subcutaneous injection to oral administration marks an important step in the creation of next-generation products and has wide applicability across many therapeutic protein families", said Paul Martin, Nautilus Biotech's Vice President Strategy.

About Hepatitis C
Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV infection causes chronic inflammation in the liver that can lead to cirrhosis, liver failure, liver cancer or death. HCV infection represents a significant medical challenge worldwide. Currently, there is no vaccine that can prevent hepatitis C. According to the World Health Organization, more than 170 million people worldwide suffer from chronic HVC. With only half of all HCV patients benefiting from current therapy, there is considerable market potential for new medical solutions. The HCV market is expected to grow from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015 due to improved market penetration and improved diagnosis rates (source: Datamonitor).

About Nautilus Biotech
Nautilus Biotech is a drug discovery and development company with a pipeline of next-generation therapeutic proteins with superior pharmacological profiles that address unmet clinical needs. The company's protein engineering technology can significantly improve the pharmacological characteristics of important blockbuster protein drugs, offering improvements in drug stability and administration. The company is also creating proprietary 'third generation' therapeutic proteins which are, per se, suitable for oral administration.

The therapeutic proteins market is currently valued at over $35bn, and growing at a rate of 10-15% per annum. Nautilus Biotech has created a portfolio of next-generation therapeutic proteins with improved profiles, including long-lasting Interferon alpha (Belerofon), hGH (Vitatropin(r)), Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in collaboration with Wyeth Pharmaceuticals) and HMGB1 (in collaboration with Creabilis Therapeutics). Nautilus Biotech has established a strong intellectual property position covering enhanced versions of these multibillion dollar molecules and is rapidly moving these products into clinical development.

Nautilus Biotech is a private company with headquarters in Genopole(r) biopark, (Evry, France). For more information about Nautilus Biotech visit http://www.nautilusbiotech.com

Media Contact for Nautilus Biotech:
Lorna Watson, Account Director
or
Deborah Gaskell, Account Manager
Tel: +44 (0)20 268 3237

Email: nautilusbiotech@northbankcommunications.com

Kind regards

Deborah Gaskell Account Manager
Please note our new contact details

Direct line: +44 (0)20 7268 3237 Main tel: +44 (0)20 7268 3002 Fax: +44 (0)20 7268 3102 www.northbankcommunications.com

85 Tottenham Court Road,
London, W1T 4DU, UK

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Human Genome Sciences Announces Positive Interim Results of Phase 2b Trial of Albuferon(R) with Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C
http://www.redorbit.com/

ROCKVILLE, Md., Feb. 27 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced interim results at Week 12 following the completion of therapy in a Phase 2b clinical trial of Albuferon(R) (albinterferon alfa-2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment regimens. A presentation of the full interim data will take place on April 14, 2007, in Barcelona at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).

"The results suggest that Albuferon may offer comparable or improved efficacy versus Pegasys, with half the injections and the potential for less impairment of health-related quality of life," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "These data provide further support for the design of our recently initiated Albuferon Phase 3 development program."

The interim results of the Phase 2b trial at Week 12 following the completion of therapy include the following findings:

• The treatment group receiving Albuferon 900-mcg doses every two weeks achieved a higher rate of sustained virologic response at 12 weeks following completion of therapy (SVR12), and more favorable health- related quality-of-life scores, than the Pegasys treatment group.
• Among treatment-adherent patients, 73% of those in the groups receiving Albuferon every two weeks achieved SVR12, versus 63% for patients receiving Pegasys once a week.
• Lower relapse rates were observed among treatment-adherent patients for all Albuferon treatment groups than was observed in the Pegasys treatment group.
• In heavier patients (>75 kg) who were treatment-adherent, SVR12 was maintained in all Albuferon treatment groups, but declined in the Pegasys treatment group.
• The percentage of patients achieving SVR12 in the treatment group receiving 1200-mcg doses of Albuferon every four weeks was comparable to that observed in the group receiving Pegasys once a week, supporting further evaluation of Albuferon treatment with monthly administration.

"SVR12 rates were highest and quality-of-life scores were most favorable in the treatment group receiving 900 micrograms of Albuferon every two weeks," said Dr. Stump. "We note that among treatment-adherent patients, both doses of Albuferon administered every two weeks produced a higher rate of SVR12 than was observed in the Pegasys treatment group. Our recently initiated Albuferon Phase 3 program is evaluating both 900-microgram and 1200-microgram doses in a much larger patient population. In addition, the treatment group receiving 1200 micrograms of Albuferon every four weeks performed well, lending strong support to our plan for further evaluation of monthly dosing. We look forward to the initiation by Novartis of a Phase 2b study with this objective later this year."

An abstract of the complete presentation of interim results to be made at EASL in April -- entitled "Antiviral Response at Week 12 Following Completion of Treatment with Albinterferon Alfa-2b in Patients with Genotype 1, IFN- naive, Chronic Hepatitis C Infection" (Zeuzem S, Benhamou Y, Bain V, McHutchison J, et al) -- will soon be published on the website of the European Association for the Study of the Liver (EASL) at http://www.easl.ch/. Interim data are available through Week 12 following completion of 48 weeks of therapy for 458 patients who were enrolled in the randomized, open-label, multi- center, active-controlled, dose-ranging trial. The study was conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. Patients were randomized into four treatment groups, three of which received subcutaneously administered Albuferon (900 mcg every two weeks, 1200 mcg every two weeks, and 1200 mcg every four weeks). The fourth treatment group serves as the active control group and received 180-mcg doses of subcutaneously administered peginterferon alfa-2a (Pegasys) once a week. All patients received weight-based oral ribavirin daily. The primary efficacy endpoint is sustained virologic response (SVR), defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of therapy. Interim results at Week 12 following completion of therapy are regarded as highly predictive of SVR.

Of the four treatment groups in the Phase 2b study, based on an intention- to-treat analysis, the two treatment groups receiving Albuferon administered every two weeks had the highest percentage of subjects who were negative for hepatitis C RNA viral load at 12 weeks following the completion of therapy: 59.3% for 900-mcg Albuferon and 55.5% for 1200-mcg Albuferon, vs. 54.4% for Pegasys administered once a week, and 52.6% for 1200-mcg Albuferon administered once every four weeks. Among treatment-adherent patients (>80% adherent to therapy) in the groups receiving Albuferon every two weeks, 73.8% in the 900-mcg dose cohort and 72.0% in the 1200-mcg dose cohort achieved SVR12, versus 63.0% for patients receiving Pegasys once a week. Among heavier patients (>75 kg) who were treatment-adherent, SVR12 rates were generally maintained for all Albuferon treatment groups, while declining in the Pegasys group. Lower relapse rates among treatment-adherent patients were observed for all Albuferon treatment groups. The lowest rate of relapse among treatment-adherent patients was observed in the group receiving 900-mcg Albuferon every two weeks -- 13.0%, versus 29.7% for the Pegasys treatment group. The rate of discontinuations due to adverse events were: 9.3% in the group receiving 900-mcg Albuferon every two weeks; 19.1% in the group receiving 1200-mcg Albuferon every two weeks; 12.1% in the group receiving 1200-mcg Albuferon every four weeks; and 6.1% in the group receiving 180-mcg Pegasys once a week. Hematologic reductions were lowest in the group receiving 1200-mcg Albuferon every four weeks, and were comparable across other treatment groups. Health-related quality of life as measured by SF-36 was most favorable for the treatment group receiving 900-mcg Albuferon administered every two weeks.

"Of note, only 29% of the patients who discontinued due to adverse events in the treatment group receiving 1200 micrograms of Albuferon every two weeks had an attempt at dose reduction prior to discontinuation," said Dr. Stump. "In the Albuferon Phase 3 trials, we will strongly encourage dose titration to ensure tolerability and maximize the therapeutic benefit of the robust early antiviral response offered by the 1200-microgram dose on a two-week administration schedule."

About Albuferon
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for over twenty days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.

Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including a $45 million upfront payment and a $47.5 million payment received upon dosing of the first patient in a Phase 3 trial.

About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. 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. 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. The hepatitis C virus can cause serious liver disease in a significant proportion of infected individuals, leading to cirrhosis, primary liver cancer, and even death.

Conference Call
HGS management will hold a conference call to discuss this announcement, as well as the Company's fourth quarter and full-year 2006 results, today at 5:00 PM Eastern time. Investors may listen to the call by dialing 800-263-8506 or 719-457-2681, passcode 1549825, five to ten minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 1549825. Today's conference call also will be webcast and can be accessed at http://www.hgsi.com/. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.

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Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) with Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Genotypes 2 and 3

 - Enrollment of both Phase 3 trials of Albuferon to be completed in 2007

 - Global marketing applications planned in 2009

ROCKVILLE, Md., Feb. 27 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - News) today announced that it has initiated dosing in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon® (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotypes 2 and 3. ACHIEVE 2/3 is the second of two pivotal Phase 3 trials of Albuferon that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006.

"We believe that Albuferon could become the interferon of choice in treatment regimens for chronic hepatitis C, and we are pleased to announce that both Phase 3 trials of this potentially important compound are now underway," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for Albuferon in 2009."

Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. 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.

"Chronic hepatitis C represents a significant unmet medical need," said David Nelson, M.D., lead investigator of the ACHIEVE 2/3 trial, and Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section, University of Florida. "Albuferon requires half as many injections, and clinical results to date suggest it may offer efficacy at least comparable to pegylated interferon, with the potential for less impairment of health-related quality of life. We look forward to continuing the evaluation of Albuferon in larger populations in Phase 3 trials."

About the Albuferon Phase 3 Development Program
The Albuferon Phase 3 clinical development program includes two randomized, open-label, active-controlled, multi-center, non-inferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS (peginterferon alfa-2a) in combination with ribavirin. In December 2006, HGS initiated dosing in ACHIEVE 1, a Phase 3 trial of Albuferon in treatment-naive patients with chronic hepatitis C genotype 1. ACHIEVE 2/3 will be conducted in treatment-naive patients with chronic hepatitis C genotype 2 or 3.

"HGS designed ACHIEVE 1 and ACHIEVE 2/3 working closely with our development and commercialization partner, Novartis, and with leading international experts in the field of hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We also reviewed the pivotal trial designs with U.S. and key European regulatory authorities and received their positive feedback. Based on the response we have had from the clinical research community, we fully expect to attain our goal of completing the enrollment of both of our Phase 3 trials of Albuferon by the end of 2007."

Higher doses of Albuferon administered every 4 weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial to be conducted by Novartis, beginning in 2007.

About Albuferon
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for over twenty days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.

About the Collaboration with Novartis
Under an exclusive worldwide development and commercialization agreement entered into in June 2006, HGS and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including a $45 million upfront payment and $47.5 million received in January 2007 following dosing of the first patient in a Phase 3 trial.

Conference Call
HGS management will hold a conference call to discuss this announcement, as well as the Company's fourth quarter and full-year 2006 results, today at 5:00 PM Eastern time. Investors may listen to the call by dialing 800-263-8506 or 719-457-2681, passcode 1549825, five to ten minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 1549825. Today's conference call also will be webcast and can be accessed at http://www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.

About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company's primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon® for hepatitis C, and LymphoStat-B® for lupus. Phase 3 clinical trials of both compounds are now underway.

In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS drugs in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.

For more information about HGS, please visit the Company's web site at http://www.hgsi.com. For more information about Albuferon, visit http://www.hgsi.com/products/albuferon.html. Health professionals or patients interested in clinical trials of Albuferon or other studies involving HGS products may inquire via the Contact Us section of the company's web site, http://www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.

HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.

SafeHarbor Statement
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. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. 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.

Source: Human Genome Sciences, Inc.

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Court: Inmates Must Be Told if They're Sick
http://www.courierpostonline.com
By TOM BALDWIN
Gannett State Bureau

TRENTON -- A state prison inmate went for years without treatment for contagious Hepatitis C and was denied access to his medical records, while state officials and a private contractor pointed fingers trying to allay responsibility and deny the man was even ill.

The state Supreme Court ruled today the Department of Corrections must notify inmates if they're seriously sick, show them their records and - uniquely in this case - enable them to correct errors in their histories.

"Both of them were pointing at each other and nobody was taking care of the patient," said Roger Martindell, a Princeton lawyer who helped represent the inmate at New Jersey State Prison in Trenton who sued.

"Despite the serpentine history of this case," wrote Associate Justice Virginia Long in the unanimous decision, "during oral argument, DOC finally acknowledged that it, indeed, has a non-delegable duty to assure adequate medical care to inmates."

Even today, the Department of Corrections does not know if other inmates are in the same fix. "We would hope that that is not the case," spokesman Matt Schuman said today.

Martindell said the inmate in this case knew he suffered from Hepatitis C, having been tested in a Pennsylvania prison.

"When he was transferred to the state prison system in New Jersey, he told them he had tested positive for Hepatitis C in Pennsylvania. The state system here refused to test him, and they would not take his word for what he knew to be true," he said.

"So he went a significant amount of time, years, without any treatment," said Martindell.

Martindell said the New Jersey inmate finally got a test in 2001, but the notes entered into his medical record said it came up negative. "The patient knew the test was in error," Martindell said. "He asked to see the report."

But New Jersey prison officials refused to show the inmate his records, a move for which DOC spokesman Schuman said he had no explanation. Martindell said DOC had claimed the record was a legal document, so the inmate could not see it, until obtaining one with the help of a lawyer 18 months later.

"Finally he got a copy of his record, and it showed in fact that it (Hepatitis) was detected but the doctor misread the report," Martindell said. "First they did not test him, and then they misread the report."

Enter Correctional Medical Services of St. Louis, Mo., a private contractor which last year was paid $92.5 million to provide medical care for New Jersey inmates.

While the patient - unidentified in court documents beyond "J.D.A." - waited to have his record corrected, the state said CMS had to do the task while the contractor argued it was the state's responsibility. The records weren't fixed for 15 months.

"You had the contractor pointing at the DOC saying, 'Hey, it's your prisoner. ... And the DOC was pointing at the contractor saying, 'It's your problem,"' Martindell said.

"We will certainly work with the Department of Corrections to abide the court's ruling," said company spokesman Ken Fields. The contractor was not a party to the legal case.

"There is not much to comment. We'll abide by the court's decision," said Schuman. He refused to address how this had transpired: "The decision is giving the department stipulations on how these things should be handled, and that is how we will do it."

He refused to say if there had been prior protocols for keeping inmates' health records.

Hepatitis C is a potentially deadly virus spread by blood. The inmate was housed at New Jersey State Prison on Trenton's south end.

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Key Protein for Hepatitis C Virus Entry Identified
http://newswire.rockefeller.edu

New research shows that a protein called claudin-1, found primarily in liver cells, is required for the hepatitis C virus to gain entry into human cells.

For as many as 200 million people worldwide infected with hepatitis C, a leading cause of chronic liver disease, treatment options are only partially effective. But new research by Rockefeller University scientists points to a potential new target for better drugs: a key protein that resides in human liver cells that hepatitis C requires for entry.

Scientists have known that for HCV to infect human cells, at least two molecules — CD81 and SR-B1 — must be present on the surface of the cell. However, they suspected that at least one other molecule also has to be present, because in some cells that contained the known molecules HCV was still unable to gain entry.

Co-first authors Matthew Evans and Thomas von Hahn, postdoctoral associates in Rockefeller’s Laboratory of Virology and Infectious Disease led by Charlie Rice, set out to find the missing receptor. HCV is notorious for being too difficult to replicate in cell culture, so Evans and von Hahn used HCV “pseudoparticles,” HIV particles in which the HIV envelope proteins are replaced with those from HCV. This replacement tricks the host cell into allowing the engineered particle to enter in a manner identical to that of authentic HCV. Once inside the cell, however, the HIV replication machinery takes over.

In order to identify potential entry receptors, Evans and von Hahn teamed up with co-authors Theodora Hatziioannou and Paul Bieniasz, HIV researchers at Rockefeller and the Aaron Diamond AIDS Research Center who had developed a special multiple-round screening technique. The screen pointed them to claudin-1, a protein involved in the maintenance of cell structures called tight junctions that is found in several epithelial tissues in the body, and is most prevalent in the liver.

A series of experiments on various human cell lines confirmed that claudin-1 is a requirement for HCV entry, says von Hahn. The research showed that the HCV pseudoparticle was able to enter cells that contain claudin-1, as well as claudin-1-deficient cells that were made to artificially express the protein, but not other cells. “We did not see HCV enter any cell that did not have claudin-1,” says von Hahn.

Further experiments showed that claudin-1 only appears to come into play after the virus has bound to the cell, perhaps as a means for the virion to actually be taken up by the cell or facilitate fusion between the virus and cell membranes. The scientists reported their findings this week in an advance online publication in the journal Nature.

The researchers believe that there may be additional receptors – yet to be identified – that are necessary for HCV to infect cells, as some human cell lines contain all three receptors but still do not become infected. HCV also does not enter some human cells that express all three factors, nor can it infect mouse cells that have been engineered to express the three human receptors.

The identification of claudin-1, and the possible discovery of additional host cell receptors, offers the promise of new avenues for anti-HCV therapeutics, according to the authors.

“Anti-HCV drugs currently under development are directed against viral enzymes required for viral replication, to which the virus can readily evolve resistance,” says Evans. “HCV may be less able to develop resistance to drugs targeting receptors on the host cell.”

“We also foresee the potential for combination therapies, which would attack different stages of HCV infection, much like the HIV cocktail that has been so effective,” says Rice, who is the Maurice R. and Corinne P. Greenberg Professor and scientific director of the Center for the Study of Hepatitis C, a cooperative endeavor of Rockefeller, Weill Medical College of Cornell University and NewYork-Presbyterian Hospital.

Nature Online: February 25, 2007

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February 28th, 2007


Pharmasset Initiates Multiple Ascending Dose Study of R7128 in Patients Chronically Infected With HCV Genotype 1
http://www.prnewswire.com

PRINCETON, N.J., Feb. 28 /PRNewswire/ -- Pharmasset initiated the multiple ascending dose portion of an on-going Phase 1 clinical trial evaluating R7128 in up to 40 patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective of this part of the study, being conducted in collaboration with Roche, is to assess the safety, tolerability and pharmacokinetics of multiple doses of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy of R7128 by measuring the decrease in HCV viral load. As a result of the initiation of the multiple ascending dose portion of this study, Pharmasset triggered a $5.0 million milestone payment from Roche.

Pharmasset and Roche recently completed part 1 of this Phase 1 study in 38 healthy volunteers who received single ascending doses of R7128. The effect of food on R7128 was also assessed. Preliminary data from the single ascending dose portion of the study indicate:

• All doses of R7128 studied were generally well-tolerated.
• All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study.
• No hematological or laboratory abnormalities of clinical significance  were noted.

The preliminary safety and pharmacokinetic data from part 1 of the study supported progression of R7128 into part 2 of the study in patients chronically infected with HCV genotype 1.

About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated excellent potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.

R7128 Phase 1 Study Overview
The Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This study is comprised of two parts:

• Part 1 is a single ascending dose study being conducted in up to 38 healthy volunteers.  The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions.  The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.

• Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1.  The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by measuring the decrease in HCV viral load.

About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.

About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Contact:
Alan Roemer
Vice President, Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125

Statements in this company press release may constitute forward-looking Statements and are subject to numerous risks and uncertainties, including The failure of R7128 to perform as expected, the company's ability to Attract and retain qualified personnel to conduct the required clinical Trials of R7128 , the status of the company's hcv collaboration with Roche, The company's future capital needs to fund the R7128 development programs, The company's ability to obtain additional financing, the company's ability To obtain required regulatory approvals for R7128, the development of Competitive HCV products by others, the existence of third-party patent Rights, and other risks inherent in discovery and development stage Programs at a biotechnology company. The actual results for R7128 may Differ materially from those anticipated in this company press release. The Company disclaims any obligation to update the statements contained in this Company press release.

SOURCE Pharmasset, Inc.

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P.E.I. Surgeon Tests Positive for Hep C
http://www.cbc.ca
CBC News

An initial blood test indicates that P.E.I. surgeon Dr. David Ashby may have contracted hepatitis C.

Ashby has voluntarily stopped performing surgeries until the results of a second test come back, likely in the next four or five days.

'There would be a large number of patients and it's a huge procedure to get them all in for testing.' – Dr. Lamont Sweet, chief health officer

Chief health officer Dr. Lamont Sweet said if the diagnosis is confirmed, the chance of patients having contracted hepatitis during surgery is low, but a screening program will be set up.

"It will be a matter of reviewing the situation with consultants and experts in this area, and looking at setting up a screening program for patients who have had procedures done," Sweet said.

"It's most likely to go back for a few years first, like, two, three years first. Because there would be a large number of patients and it's a huge procedure to get them all in for testing."

Sweet said so far, officials in P.E.I. haven't found an incident in Canada of a surgeon contracting hepatitis C, although there have been similar situations in Europe.

The positive test result came from a routine physical exam. Ashby is feeling fine and will continue to see patients for consultations and follow-up visits, Sweet said.

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March 1st, 2007


Model for Predicting Survival in Liver Patients Has Many Applications but Could Be Refined Further
http://www.eurekalert.org

A review of the studies on the Model for End-Stage Liver Disease (MELD) found that it is an accurate predictor of survival of patients with a variety of liver diseases, is particularly useful in allocating organs for liver transplants, and can also be used to help determine the course of treatment in certain cases. However, it is possible to improve the accuracy of the model and efforts at refining will continue.

This review appears in the March 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/hepatology.

MELD uses three widely available laboratory tests in a mathematical formula to arrive at a score that predicts survival for patients with liver disease. It was initially created by researchers at the Mayo Clinic in Rochester, MN to predict survival following TIPS, a procedure to treat complications of liver disease that involves the placement of a shunt, but its use has been expanded. Most notably, for the past five years, MELD has become the standard for prioritizing patients awaiting liver transplants, replacing the previous system where patients who were on the list for the longest period of time received transplants first, regardless of how ill they were.

In the current review, Patrick S. Kamath, M.D. and W. Ray Kim, M.D. of the Mayo Clinic who were instrumental in creating and validating the model, reviewed how MELD is applied and assessed its strengths and limitations. They found that using MELD for organ allocation in liver transplants led to an immediate reduction in the number of patients awaiting a liver transplant (12 percent decrease in 2002) and also led to a reduction in mortality on the waiting list of almost 15 percent. However, MELD has not been shown to be useful in predicting mortality following a liver transplant, probably because other factors besides liver dysfunction play a role in transplant success. In addition, they found that use of healthcare resources has not increased since the implementation of MELD because the sickest patients, who were previously a drain on the healthcare system, are being transplanted earlier.

MELD, along with the traditional Child Turcotte Pugh (CTP) scoring system, predicts long-term survival in patients with late-stage cirrhosis, but MELD has other applications as well. In single center studies, it accurately predicts survival in patients with variceal (esophageal) bleeding and hepatitis B, and predicts mortality in patients with alcoholic hepatitis and infections leading to kidney failure. In addition, MELD can shed light on outcomes for liver cancer treatments and different types of surgery other than liver transplants.

Despite its accuracy, MELD has some limitations. For patients awaiting liver transplants, it should be used only after reversible complications, such as bacterial infections, have been treated. Also, the values used to determine the MELD score may be variable depending on how they are measured. In order to refine MELD, the authors conducted a study on how changing MELD scores affect mortality. They found that the current MELD score was the most important predictor of survivor, regardless of how it was reached.

"In conclusion, based on its ability to rank patients with cirrhosis according to their short term mortality, MELD has been recognized as a major contributor to the daily practice of hepatology," the authors state. "Successful implementation of MELD-based liver allocation in the U.S. has been followed by widespread adoption of the system globally, attesting to its validity." It is also a useful tool in a wide spectrum of disease severity and variety. However, since it is by no means a perfect system, the authors conclude, efforts to refine it must continue.

###
Article: "The Model for End-Stage Liver Disease (MELD)," Patrick S. Kamath, W. Ray Kim, Hepatology; March 2007 (DOI: 10.1002/hep.21563).

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Liver Health Begins at Home
http://www.newswire.ca

Canadian Liver Foundation releases Liver Healthy Home Checklist to encourage Canadians to make positive lifestyle choices

TORONTO, March 1 /CNW/ - Few Canadians realize that each day they makedecisions that affect their liver health. To kick off Liver Health Month, the Canadian Liver Foundation has prepared a Liver Healthy Home Checklist to demonstrate how everyday activities or common-place products can all have positive or negative effects on the liver.

"There is a misconception that only alcohol impacts the liver," says Gary Fagan, President, Canadian Liver Foundation, "but your choices of what to eat, how to treat an illness, or even your extracurricular activities can help or hurt your long-term liver health. The liver plays a critical role in nurturing and protecting your body so it only makes sense to learn what you can do to take care of it. Some of the most prevalent forms of liver disease – fatty liver disease, hepatitis A and B and toxic hepatitis - can often be prevented through lifestyle changes or simple precautions. The more you know, the better prepared you can be."

Liver Healthy Home Checklist
The Canadian Liver Foundation invites Canadians to tour their homes using the Liver Healthy Home Checklist to see how they can make their homes and daily routines liver healthy. The checklist, along with other resources and liver health information tips, is available on www.liver.ca

Kitchen

• Fill your cupboards and refrigerator with low fat, high fibre foods and keep salty and sugary snacks to a minimum. A healthy, well balanced diet can help keep your liver functioning at peak levels and you, in turn, will feel better and have more energy. On the other hand, an unhealthy diet can lead to obesity - a leading cause of fatty liver disease.

Living Room

• If you drink alcohol, do it in moderation. No more than one to two drinks at a time and never on a daily basis. Women process alcohol slower than men and therefore tend to be more susceptible to alcohol-related liver damage.
• If planning a trip, be sure to get immunized against hepatitis A and B. Hepatitis A can be contracted through contaminated food and water. Hepatitis B is spread through direct contact with blood or body fluids. You can be at risk of contracting these serious liver diseases both in Canada and abroad.

Bathroom

• Store medications and vitamins out of reach of children or in child-proof containers. Adult medications and supplements can do seriousharm to a child's liver if they are accidentally swallowed or are used inappropriately to treat an illness.
• Do not mix medications and/or herbal supplements without talking to your doctor or pharmacist. Prescription and non-prescription medications and herbal supplements can do damage to the liver if not taken as directed. Never mix medication with alcohol. Combining alcohol and acetaminophen, for instance, can lead to acute liver failure.
• Always wash your hands after going to the bathroom. Hepatitis A is a liver disease that can be spread when someone does not wash their hands properly after going to the bathroom and then touches something you eat.

Laundry Room/Garage

• When cleaning or painting, ensure the room is well-ventilated and/or wear a mask. Since the liver has to de-toxify everything you breathe in, exposure to airborne chemicals can damage your liver.

Backyard

• Take precautions to avoid exposure when using weed control chemicals or spraying for bugs. Another option is to investigate more organic methods for maintaining your lawn and gardens.
• Take every opportunity to get outside and enjoy some exercise. Exercise helps keep your body - and especially your liver – strong and better able to defend itself against viruses, disease and pollutants.

About Liver Health Month (March 2007)
March is Liver Health Month in Canada. Throughout the month, Canadian Liver Foundation chapters across Canada are encouraging Canadians to adopt lifestyles that may help prevent liver disease, which affects 1 in 10 Canadians.

About the Canadian Liver Foundation
Established in 1969, the Canadian Liver Foundation was the first organization worldwide to provide support for research and education into the causes, diagnosis, prevention and treatment of liver disease. Each year, the Foundation provides vital funding to Canadian researchers to ensure the search for treatments and cures continues. The Foundation serves patients, families, health care professionals and the general public through its volunteer chapters across Canada. For more information, visit www.liver.ca or call 1-800-563-5483.

For further information: Melanie Kearns, Canadian Liver Foundation,
Phone: (416) 491-3353 ext. 4923, Email: mkearns@liver.ca

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New Culture System Leads to Anti-Viral Treatments for Hepatitis C
http://www.innovations-report.de

A new way of growing viruses in the laboratory developed by Japanese researchers could spell hope for the 170 million people infected with hepatitis C, only half of whom currently respond to drug treatments, scientists announced today (Tuesday 27 March 2007) at the Society for General Microbiology’s 160th Meeting at the University of Manchester, UK, which will run from 26 – 29 March 2007.

 “Until now we have been unable to grow hepatitis C virus in the laboratory, which has delayed our development of new treatments. Now, thanks to the system from Japan, we can explore the full life-cycle of the virus”, says Dr Stephen Griffin from the University of Leeds, UK.

The scientists have identified a key protein which helps the viruses grow, called p7, by transporting molecules across membranes. A drug targeting a similar protein in the influenza virus was one of the first licensed anti-viral treatments. The Leeds research team has discovered that while the hepatitis viruses are growing, the same protein is crucial for stabilising new virus particles. This offers the hope that blocking its action could provide a new and effective way of combating hepatitis C.

Hepatitis C is now the leading cause of liver transplant surgery in developed countries. No vaccine is currently available to prevent the infection, and contamination through infected blood or other body fluids often happens without any obvious symptoms. This leaves many patients unaware that they have the disease until many years later when they develop liver disorders. Around one fifth of hepatitis C sufferers develop cirrhosis, and 5% will get liver cancer, leading to nearly 2 million deaths worldwide every year.

The current treatments are administered similarly to ones used for HIV, with doctors giving dual drug therapies to target different stages of the virus life-cycle in an attempt to overcome its natural drug resistance.

The new laboratory culture system will allow scientists to study the complete virus life-cycle, including how it builds new virus particles and how these in turn infect new cells.

“We have shown that the p7 protein can form seven sided pores in the cell membranes and alter acidity within the liver cells. We think this is crucial in forming new virus particles, so it is an ideal target for new types of drugs”, says Dr Stephen Griffin. “A drug called amantadine, which can be used successfully by doctors against influenza infections, specifically blocks the action of p7. Encouragingly, some clinical trials of amantadine used alongside current treatments have improved patients’ response. New drugs based on amantadine offer exciting possibilities for the future treatment of hepatitis C.

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Dynavax Initiates Phase I Trial of Hepatitis B Therapy
http://www.prnewswire.com

BERKELEY, Calif., March 1 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today announced that it had initiated a Phase 1 trial of its novel therapy for chronic hepatitis B virus (HBV) infection. The trial is being conducted in Hamburg, Germany and will enroll 20 healthy subjects to evaluate the safety of the therapy at two dosing schedules. The novel HBV therapy combines, for the first time, the surface and core antigen of HBV, manufactured at Dynavax Europe. Results are expected in the second half of 2007.

According to Dr. Eduardo Martins, VP, Clinical Development, "The trial represents the first evaluation of this therapeutic approach in humans. In addition to verifying safety, we will measure subjects' T-Cell responses to evaluate whether the vaccine demonstrates the same pharmacologic effects as those seen in animal models, namely the induction of virus-specific cellular immune responses."

Dnavax indicated that the hepatitis B therapy trial is the second of several trials slated to enter the clinic with funding from Symphony Dynamo, Inc. (SDI). In April, 2006, SDI committed $50 million to Dynavax to advance its cancer program and both its therapies for chronic hepatitis B and chronic hepatitis C into human clinical trials. Dynavax announced the initiation of its SDI-funded Phase I cancer program in metastatic colorectal cancer in late 2006.

More than 350 million people worldwide are chronically infected with hepatitis B. Approximately 25% of individuals with chronic hepatitis B infections die prematurely from cirrhosis or liver cancer. Current treatment for hepatitis B involves lengthy cycles of antiviral medication or injected interferon-alpha and rarely results in resolution of the infection.

About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our pipeline includes: HEPLISAV(TM), a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapeutic; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. NIH partially funds our preclinical work on a vaccine for influenza; Symphony Dynamo, Inc., funds our colorectal cancer and hepatitis B therapy trials and our preclinical hepatitis C therapeutic program. While the NIH and Symphony provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our hepatitis B therapy product candidate, clinical development plans and timelines and business plans. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

SOURCE Dynavax Technologies Corporation

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Hepatitis Foundation International: New Study Supports Effectiveness of Liver Wellness Education
http://www.genengnews.com

A new scientific study provides an imaginative educational intervention that has demonstrated success in having a significant impact on preventing viral hepatitis and other blood borne diseases related to participation in unhealthy behaviors. Results of a National Institute on Drug Abuse supported multi-site, randomized-control trial called, The Study to Reduce Intravenous Exposures (STRIVE), tested a behavioral intervention among a high-risk population of hepatitis C-infected injection drug users (IDUs) to identify new approaches to prevention of hepatitis and other blood borne pathogens. The intervention included messages about liver wellness and viewing the Hepatitis Foundation International's (HFI) video, The Silent Stalker.

The goal of the STRIVE study was to reduce the spread of hepatitis and HIV by providing information about the importance of the liver and how viruses can damage this vital organ essential to one's life.

The results of the study among 630 HCV IDUs indicated a 1.85 fold reduction in lending behaviors; and 2.1 fold reduction in the risk of injecting with used needles. At three months, those exposed to the intervention were 3 times more likely to have stopped injection drug use; at 6 months, they were 2 times more likely to have stopped injecting drugs.

The researchers concluded that these findings indicate an urgent need for HCV-related prevention interventions with IDUs and demonstrated the effectiveness of educating individuals about their liver and taking responsibility for their own healthcare.

"These encouraging results support efforts to provide liver wellness information to all individuals, young and old alike, to help them avoid the serious consequences of participating in liver damaging behaviors," said Thelma King Thiel, CEO of HFI.

HFI's video used in the study and others promoting liver health and prevention of substance abuse are being used in schools, colleges, STD and substance abuse clinics, health departments, correction facilities and HIV/AIDS organizations. They are available in several languages targeting various age groups and ethnicities.

HFI is a nonprofit organization dedicated to the eradication of viral hepatitis, a disease affecting over 500 million people worldwide. HFI conducts training programs promoting liver wellness as a means to motivate healthy lifestyle behaviors.

For more information about the study, HFI's video The Silent Stalker and Foundation for Decision Making training programs for counselors, social workers, and educators, call HFI's Education Department at 1-800-891-0707.

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Hepatitis E Vaccine Called Highly Effective
http://news.yahoo.com
By Serena Gordon
HealthDay Reporter

THURSDAY, March 1 (HealthDay News) -- A new vaccine may safely protect against hepatitis E, a virus prevalent in developing countries.

In a study of 2,000 healthy adults from Nepal, researchers found that the vaccine was 96 percent effective in preventing hepatitis E infection.

"This is the first new hepatitis vaccine strain for which efficacy has been shown since 1992, and it's very well tolerated. I would say this vaccine is a home run," said the study's lead author, Dr. Bruce Innis, vice president of clinical research and development for GlaxoSmithKline, the vaccine's manufacturer.

Results of the study are published in the March 1 issue of the New England Journal of Medicine. The study was funded by GlaxoSmithKline, U.S Army Medical Research and Material Command, and the National Institute of Allergy and Infectious Diseases.

Hepatitis E is an infectious disease that's generally spread through fecal contamination of food or water, according to the World Health Organization (WHO). It's often a self-limiting illness, and most people recover with no long-term consequences. However, women in their third trimester of pregnancy are particularly susceptible to hepatitis E and have a mortality rate as high as 20 percent from the infection.

The hepatitis E virus is relatively uncommon in the United States but is prevalent in other areas of the world. According to background information in the study, it's estimated that as many as one-third of the world's population has been infected with hepatitis E. And, in some countries, such as India, that rate may be as high as 60 percent.

Symptoms of hepatitis E develop from three to eight weeks after exposure, with an average incubation period of 40 days, according to WHO. Those most at risk include people between the ages of 15 and 40, pregnant women and people traveling to countries where hepatitis E is common, according to the U.S. Centers for Disease Control and Prevention. Symptoms of the disease include jaundice, abdominal pain, fatigue, loss of appetite, dark urine, nausea and vomiting.

To test the efficacy of the newly developed recombinant vaccine, 2,000 healthy adults -- 99.6 percent of them male -- from Nepal were randomly selected to receive either the vaccine or a placebo shot. All of the study volunteers were part of the Nepalese army.

The vaccine was administered in three doses, with the second dose given after a month and the third given at six months. The average follow-up time was 804 days. Innis said that political turmoil in Nepal added to the challenge of conducting a study in a country where there is little industrial development.

At the end of the study, complete follow-up data was available on 1,794 study volunteers -- 898 who received the vaccine and 896 from the placebo group.

Hepatitis E developed in 69 people during the study period. Sixty-six of those infected were from the placebo group.

The vaccine's efficacy was 95.5 percent, according to the study.

Innis said the researchers were surprised by the high rates of hepatitis E infection. "We knew that there was a good amount of hepatitis E in this population, but the incidence of disease in the placebo group was about twice as high as we anticipated it would be," he said. "By immunizing against hepatitis E -- an orphan disease -- we had a substantial impact on the well-being of those vaccinated. We do believe this is a product that could relieve a great deal of human suffering."

Liver specialist Dr. Tusar Desai, of William Beaumont Hospital in Royal Oak, Mich., said the study's findings are "exciting." He said he wasn't concerned that the study was done mostly with men, because men and women tend to react similarly to vaccines.

What is a concern, Desai said, is that the researchers conducted the study with soldiers, who tend to be thin. And, he said, there is a difference in the way thin and overweight people process immunizations -- vaccines aren't as effective in people who carry extra weight.

Still, Desai said, when this vaccine becomes available, he would recommend it to anyone in the United States who was traveling to an area of the world where hepatitis E is endemic.

It's still not clear when the vaccine might become available.

Innis said GlaxoSmithKline is looking for public or private partnerships to "share with us some of the risk of carrying the development of this vaccine forward."

More information
To learn more about hepatitis E infection, visit the World Health Organization.

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Idenix Announces Thirteen Data Presentations at the 2007 European Association fr the Study of the Liver
http://www.prnewswire.com

CAMBRIDGE, Mass., March 1 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, announced today that 13 abstracts have been accepted for presentation at the 42nd annual meeting of the European Association for the Study of the Liver (EASL), to be held in Barcelona, Spain, April 11-15, 2007. Full abstracts are available on the EASL web site (http://www.easl.ch/liver-meeting/).

Hepatitis C Abstracts

• Dr. Nezam Afdhal, Chief of Hepatology at Beth Israel Deaconess Medical Center in Boston and Associate Professor at Harvard Medical School, will present "Valopicitabine (NM283), Alone or With Peg-Interferon, Compared to Peg-Interferon/Ribavirin (Peg-IFN/RBV) Retreatment in Patients With HCV-1 Infection and Prior Non-Response to Peg-IFN/RBV: One-Year Results" in a general session on Thursday April 12, 2007 between 3:00 p.m. and 4:30 p.m. Central European Time (CET).
• Dr. Eric Lawitz of Alamo Medical Research in San Antonio will present "Clearance of HCV RNA With Valopicitabine (NM283) Plus Peg-Interferon in Treatment-Naïve Patients With HCV-1 Infection: Results at 24 and 48 Weeks" in a parallel session on Thursday, April 12, 2007 between 5:00 p.m. and 7:00 p.m. (CET).
• Vadim Bichko, Director, Biology at Idenix Pharmaceuticals, Inc., will present "Valopicitabine (NM283) Is Fully Active Against Known HCV Protease Resistance Mutations In Vitro" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.
• Dr. Robert Ralston, Senior Director, Virology, Schering-Plough Corporation, will present "Combination of Two Hepatitis C Virus Inhibitors, SCH 503034 and NM107, Provides Enhanced Anti-Replicon Activity and Suppresses Emergence of Resistant Replicons" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.

About Valopicitabine (NM283)
Valopicitabine is an investigational HCV RNA polymerase inhibitor being evaluated in ongoing clinical trials for the treatment of hepatitis C.

Hepatitis B Abstracts

• Dr. Thierry Poynard, Professor of Medicine at the University of Paris, Hopital Pitie-Salpetriere in Paris France, will present "Sustained Off- Treatment HBeAg Response in Telbivudine and Lamivudine Treated HBeAg-Positive Patients From The GLOBE Study" in a parallel session on Friday, April 13, 2007 between 4:00 p.m. and 6:00 p.m. CET.
• Dr. Antonio Riva of the UCL Institute of Hepatology, University College London, UK, will present "Effector/Memory Subsets and Functionality of CD4/CD8+ T-Cells During Potent Antiviral Therapy in Chronic Hepatitis B (CHB)" in a parallel session on Saturday, April 14 between 4:00 p.m. and 6:00 p.m. CET.
• Dr. Patrick Marcellin, Professor of Medicine and Head of the Viral Hepatitis Research Center at the University of Paris, Hopital Beaujon in Clichy, France, will present "76 Week Follow-up of HBeAg-Positive Chronic Hepatitis B Patients Treated with Telbivudine, Adefovir or Switched from Adefovir to Telbivudine" in a general session on Sunday, April 15, 2007 between 12:00 p.m. and 1:30 p.m. CET.
• Dr. Marcellin will also present "In Hepatitis B Patients Treated with Either Adefovir or Telbivudine, Maximal Early HBV Suppression at 24 Weeks Predicts Optimal One-Year Efficacy" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.
• Dr. Rifaat Safadi of the Division of Medicine at The Hebrew University in Jerusalem, Israel, will present "A Randomized Trial of Switching to Telbivudine Versus Continued Lamivudine In Adults With Chronic Hepatitis B: Results of the Primary Analysis at Week 24" in a poster session beginning on Thursday, April 12 at 7:00 p.m. CET.
• Dr. Jens Rasenack, Professor of Internal Medicine at Albert Ludwigs University, Freiburg, Germany, will present "Efficacy of Telbivudine vs Lamivudine at 2 Years In Patients With HBeAg-Positive Chronic Hepatitis B Who Are Eligible for Treatment Based on Guidelines" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.
• Dr. Ji-Dong Jia, Professor of Medicine and Director of the Hepatitis Research Center at Beijing Friendship Hospital, Beijing, China, will present "Two-Year Results of a Phase III Comparative Trial of Telbivudine vs Lamivudine in Chinese Patients" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.
• Dr. Edward Gane, Professor of Gastroenterology and Hepatology, Middlemore Hospital in Auckland, New Zealand, will present "Adefovir Salvage Therapy for Virologic Breakthrough in Telbivudine-Treated Patients from the GLOBE Study" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.
• Dr. John Wong, Professor of Medicine at Tufts University School of Medicine, Boston, will present "Cost-effectiveness of Telbivudine Versus Lamivudine for Chronic Hepatitis B" in a poster session beginning on Thursday, April 12, 2007 at 7:00 p.m. CET.

Important Information About Telbivudine
Telbivudine is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naive adult patients with HBeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease.

Important Safety Information about Telbivudine

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
• Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including telbivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
• Cases of myopathy have been reported with telbivudine use several weeks to months after starting therapy.  Myopathy has also been reported with some other drugs in this class. Physicians considering concomitant treatment with these or other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. Telbivudine therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed.
• Because telbivudine is eliminated primarily by renal excretion, co-administration of telbivudine with drugs that affect renal function may alter plasma concentrations of telbivudine and/or the coadministered drug. Dose interval adjustment is recommended in patients with creatinine clearance <50mL/min.
• The safety and efficacy of telbivudine in liver transplant recipients are unknown. If telbivudine treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with telbivudine.
• Patients should be advised that treatment with telbivudine has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
• Safety and effectiveness of telbivudine in pediatric patients under the age of 16 years have not been established.
• Frequently occurring adverse events (>5%) in clinical studies were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%).
• Creatine kinase (CK) elevations were more frequent among subjects on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of telbivudine-treated patients and 3% of lamivudine-treated patients.
• The optimal duration of treatment with TYZEKA has not been established. The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are unknown.

About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). For further information about Idenix, please refer to http://www.idenix.com.

Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements may be identified by implied discussions regarding clinical trial development of telbivudine or valopicitabine, any potential therapeutic benefits of telbivudine or valopicitabine or our clinical development programs in hepatitis B or C, or any potential pipeline candidates. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Idenix will successfully advance any clinical product candidate or other component of our potential pipeline. In particular, management's expectations could be affected by the unexpected regulatory actions or delays; uncertainties relating to results of clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its other product candidates and its discoveries. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2006 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.

All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Idenix Pharmaceuticals' Contacts:
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838

SOURCE Idenix Pharmaceuticals, Inc.
http://www.idenix.com
http://www.easl.ch/liver-meeting/

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