HBV and HCV Advocate Hepatitis Blog

Hepatitis A vaccination rates vary greatly from state to state

2012-01-31T10:37:00.000-08:00

A new survey on the hepatitis A vaccine recently released by the U.S. Centers for Disease Control and Prevention shows that vaccination rates vary greatly from state to state.

In two states, Alaska and Oklahoma, approximately 85 percent of children are fully vaccinated for hepatitis A, but overall, the average rate is 30 percent, according to Fox News.

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Cardiopulmonary Exercise Testing May Predict Post-Liver Transplantation Survival

2012-01-31T10:25:00.000-08:00

Large Scale Evaluation of CPET as Predictor of Survival Outcome is Needed

Researchers from the U.K. determined that preoperative cardiopulmonary exercise testing (CPET) is a specific predictor of 90-day survival following liver transplantation. Study results available in the February issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, shows that the CPET measurement—the anaerobic threshold or fitness level—significantly predicts mortality in patients post-transplantation.

CPET is a non-invasive measure of cardiorespiratory fitness and has been previously used as a predictor of morbidity and mortality following other types of major surgeries. “Liver transplantation carries a significant mortality risk in the early days following surgery,” explains Dr. James Prentis from Freeman Hospital in Newcastle upon Tyne in the U.K. “An accurate preoperative assessment like CPET could help minimize patient mortality and optimize limited donor organs.”

For the current study, researchers included CPET as part of the preoperative assessment in 182 patients undergoing liver transplantation at Freeman Hospital over a 3-year period. Of those in the study, 91% (165) successfully completed the CPET which the team defined as the ability to determine the anaerobic threshold. Following transplantation patients received follow-up to determine 90-day mortality, critical care and length of hospital stay.

Findings report that 60 patients (33%) received a liver transplant and of those 6 (10%) died following transplantation. The mean anaerobic threshold was significantly higher in survivors compared to non-survivors, with multivariate analysis showing cardiopulmonary reserve to be a significant predictor of mortality. Dr. Prentis concludes, “CPET is a non-invasive, sensitive and specific predictor of survival following liver transplantation. However, further evaluation of its predictive value in larger cohorts is necessary.”

In a related editorial also published in Liver Transplantation, Dr. James Findlay from the Mayo Clinic in Rochester, Minnesota writes, “While CPET is widely available there are similar preoperative assessments such as the six-minute walking test that could also be used. Liver transplantation specialists have a duty to provide candidates with an accurate risk-benefit assessment and ensure that scarce donor organs are used effectively. The findings of Prentis and colleagues are striking enough to merit further evaluation.” Dr. Findlay suggests large, multi-center investigations of CPET that include additional mortality indicators are necessary to develop an outcome model that could be widely used in evaluating candidates for liver transplantation.

This study is published in Liver Transplantation. Media wishing to receive a PDF of the article may contact healthnews@wiley.com. Full citations: “Submaximal Cardiopulmonary Exercise Testing Predicts 90-day Survival after Liver Transplantation.” JM Prentis, DMD Manas, MI Trenell, M Hudson, DJ Jones and CP Snowden. Liver Transplantation; (DOI: 10.1002/lt.22426) Published online: January 25, 2012; Print Issue Date: February 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.22426/abstract.
Editorial: “Exercise for All?” James Y. Findlay. Liver Transplantation; (DOI: 10.1002/lt.22482) Published online: January 25, 2012; Print Issue Date: February 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.22482/abstract.
Author Contact: Dr. Prentis can be reached at james.prentis@nuth.nhs.uk . To arrange and interview with Dr. Findlay, please contact Bryan Anderson with the Mayo Clinic at Anderson.Bryan@mayo.edu.
About the Journal
Liver Transplantation. is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation. delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation.
About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Cell Permeable Peptide Identified that Inhibits Hepititis C Replication

2012-01-30T16:39:00.000-08:00

Discovery Could Lead to a New Treatment for a Disease that Impacts up to 160 Million People Worldwide

(HealthNewsDigest.com) - Researchers from UCLA’s Jonsson Comprehensive Cancer Center have identified a cell-permeable peptide that inhibits a hepatitis C virus protein and blocks viral replication, which can lead to liver cancer and cirrhosis.

This finding by Dr. Samuel French, an assistant professor of pathology and senior author of the study, builds on previous work by the French laboratory that identified two cellular proteins that are important factors in hepatitis C virus infection.

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Stem cells may shed light on hepatitis, MIT researchers find

2012-01-30T16:37:00.000-08:00

Researchers at MIT and their colleagues said they have devised a way to produce liver-like cells from stem cells, a key step in studying why people respond differently to Hepatitis C.

An infectious disease that can cause inflammation and organ failure, Hepatitis C has different effects on different people, but no one is sure why, the researchers said in a press release from MIT. Some people are very susceptible to the infection, while others are resistant.

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Alcohol Treatment Boosts Hep C Cure Rates Among Drinkers

2012-01-30T16:35:00.000-08:00

People who drink—even heavily—can successfully undergo treatment for hepatitis C virus (HCV) if they’re provided with individualized, multidisciplinary care that also addresses their alcohol use, according to a study published in the February 2012 issue of Journal of Hepatology.

Caroline Le Lan, MD, and her colleagues in Brittany, France, treated 73 alcohol-dependent patients for both hepatitis C and addiction, between September 2002 and February 2008. Their treatment outcomes were compared to a matched group of non-drinkers. Although overall cure rates were similar (48 percent versus 49 percent for non-drinkers), people who drank excessively during HCV treatment—defined as 21 or more drinks per week for men, 14 or more drinks per week for women, or at least four drinks at a time, at least twice—were less likely to be cured than those who drank less or were abstinent.

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Syringe Exchange Program Ban Position Statement

2012-01-30T11:02:00.000-08:00

Sign the Position Statement

Position Statement on U.S. Congressional ban on the use of federal funds to support needle and syringe programs

Click here to sign

Cortland sees spike in Hepatitis C in drug users

2012-01-27T16:18:00.000-08:00

Cortland, N.Y. -- Public health officials are investigating a surge of Hepatitis C cases in Cortland County showing up mostly among people under 35 who shoot drugs.

Catherine Feuerherm, Cortland’s public health director, said the county has seen 30 cases of Hepatitis C in the last five months. She said Onondaga, Tompkins and other neighboring counties are not seeing similar increases.

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Statins May Stave Off Liver Cancer in People With Hepatitis B

2012-01-27T11:09:00.000-08:00

Study found lower risk of developing disease for people taking these cholesterol-cutting drugs

THURSDAY, Jan. 26 (HealthDay News) -- Popular cholesterol-lowering statins may also lower risk for liver cancer among people with hepatitis B, a new study shows. Hepatitis B, an inflammation of the liver due to the hepatitis B virus, is one of the main causes of liver cancer.

In the new study of more than 33,000 individuals with hepatitis B followed from 1997 to 2008, those who took a statin were less likely to develop liver cancer, when compared to participants who were not prescribed statins. What's more, the longer a person took statins, the greater the liver-cancer risk reduction. Study participants were prescribed the statins to treat high cholesterol levels. Overall, 1,021 people developed liver cancer during the study period.

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VIHA moves cautiously to step up efforts for harm reduction

2012-01-27T11:05:00.000-08:00

The Vancouver Island Health Authority is now expanding its harm-reduction program in the central Island, meaning Nanaimo addicts will soon have more places to get condoms, syringes, crack-pipe mouthpieces and other materials.

The goal is to reduce addicts' harm and to relieve life pressures that tend to feed the vicious cycle of addiction, while at the same time reducing the harm to society from increased crime, policing and health-care costs.

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Urgent Online Petition on Essential Health Benefits

2012-01-26T12:44:00.000-08:00

Click below to sign the online petition that urges Secretary Sebelius to ensure that the needs of people living with chronic conditions are met through the Essential Health Benefits package when health care reform is implemented. It would be great to have many signatures from the viral hepatitis community on this petition. Please consider signing and forwarding widely. Thanks!

Click Here to Sign

The sharp side: B.C. hospitals aim to safeguard health professionals from sharp instruments

2012-01-26T10:32:00.000-08:00

Five thousand health professionals, including hundreds of nurses and doctors in operating rooms, are stabbed by sharp medical instruments each year in B.C.

All stab wounds put health professionals at risk of contracting potentially deadly infections like HIV or hepatitis B and C from patients. About 30 other blood-borne diseases can also be contract

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Drop in effectiveness of HCV treatment in national VA practice

2012-01-26T10:17:00.000-08:00

The most recent issue of the Journal of Hepatology investigates gaps in the achievement of effectiveness of HCV treatment in national VA practice

Antiviral treatment for hepatitis C virus (HCV) has high efficacy rates for achieving sustained viral response in randomized controlled trials.

However, it can be lower in community-based practice settings.

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New NC Law Aims to Prevent Infectious Diseases

2012-01-25T11:48:00.000-08:00

WAYNE COUNTY, N.C. (WNCT) – Unsafe practices used in blood sugar monitoring led to a hepatitis outbreak that killed six people at a Wayne County nursing home. Now North Carolina legislators are hoping a new law will prevent something like this from happening again.

In late 2010 investigators discovered staff at GlenCare Assisted Living Center had been spreading infections by re-using fingersticks and other tools to test diabetes patients. At the time residents were still trying to make sense of it all.

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“B A Hero” PSA Video Contest Announced by Hep B Free Philadelphia and Hepatitis B Foundation

2012-01-25T11:46:00.000-08:00

PHILADELPHIA - Hep B Free Philadelphia, a citywide and community-owned education campaign led by the Hepatitis B Foundation to save lives and stop hepatitis B, is calling on the Greater Philadelphia community to participate in its "B A Hero" Public Service Announcement (PSA) Video Contest 2012. Interested participants are asked to create 30-second PSAs to raise awareness about hepatitis B.

There are three opportunities to submit PSAs about the subject of hepatitis B awareness in relation to the "B A Hero" theme. Deadlines are Feb. 17, 2012; Mar. 16, 2012; and Apr. 13, 2012 - no later than 11:59 p.m. EST. There will be three separate judging periods in which video submissions will be added to the Hep B Free Philadelphia Facebook page and Facebook users will have the opportunity vote on their favorite video. Three finalists will be identified and each will receive a prize of $100. The grand prize winner, selected by Hep B Free Philadelphia and Hepatitis B Foundation representatives, will receive an additional $150 and their PSA will be shown at the 2012 Philadelphia Asian American Film Festival and Hep B Free Philadelphia's annual media event.

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Genoscience, BioLineRx to develop and commercialize BL-8020 for HCV

2012-01-25T11:43:00.000-08:00

Jerusalem, Israel – January 24, 2012 – BioLineRx (NASDAQ: BLRX; TASE: BLRX), a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C.

BL-8020 has been developed for anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience. Prof. Halfon is a founder of several biotechnology companies and is world renowned for his work on HIV (AIDS virus), HPV (human papilloma virus causing cervical cancer) and Hepatitis.

BL-8020 acts via a unique mechanism of action, by inhibiting Hepatitis C virus (HCV)-induced autophagy, which differs from the mechanism of currently used anti- HCV agents. BL-8020's safety and efficacy were demonstrated in pre-clinical studies. These studies have shown that BL-8020, when combined with other anti-Hepatitis C virus (HCV) agents, has a synergistic effect. BL-8020's synergistic effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs, by enabling utilization of lower dosages. In addition BL-8020 may reduce therapy duration, which is currently up to 48 weeks. The use of two drugs acting by different mechanisms is also likely to be beneficial for patients who have developed resistance to current treatments and is an effective strategy used against other viruses such as HIV.

Dr. Kinneret Savitsky, CEO of BioLineRx said, "We are excited about entering the field of Hepatitis C therapeutics, which is a very important field in the pharmaceutical market today. The current global Hepatitis market is estimated at approximately $6.5 billion and is growing steadily. Current therapies are characterized by numerous severe side effects, long treatment duration and development of resistance. In these respects, BL-8020 has a demonstrated safety and efficacy profile, may shorten therapy duration and may combat resistance by acting as an add-on platform which can potentially be combined with other oral Hepatitis C therapies to increase their efficacy.”

"We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them for the further development of our product for the treatment of Hepatitis C," said Prof. Philippe Halfon, Co-Founder and President of Genoscience. "There is clearly a huge unmet medical need in finding a safe and effective treatment for the disease, and based on pre-clinical results, its unique mechanism of action and synergistic effect, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to bring remedy to millions worldwide."

Read complete release here

Pharmasset’s Hepatitis C Drug: How it Could Change Australia

2012-01-25T11:27:00.000-08:00

Finding cures for diseases is always a tall order to take up on, but to have a drug that can cure a disease without fail is almost too good to be true. That is why when the news that Pharmasset Inc. is working on a drug that can cure hepatitis C without fail, people started buzzing, and wondered how a sure fire drug could affect the world, but more importantly, Australia.

Hepatitis C is infamous world-wide for being a virus that can cause liver inflammation and liver disease. With more and more people getting the disease, especially in Australia, a cure for it would be a heaven sent. In response to this problem, a new drug is being developed.

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Hep C victim holds hope for others

2012-01-25T11:24:00.000-08:00

Maybe if she were the Grammy-winning singer Natalie Cole life would be completely different. However for a hepatitis C sufferer living in Minden Hills, barely surviving on the meagre income provided by Ontario Disability Support Program (ODSP), the reality is far more disturbing. This woman, who moved from British Columbia, simply wanted to spend what little time she had left to live in her home province.

Jane Smith (not her real name) contracted the hepatitis C virus (HCV) from a blood transfusion during a hysterectomy in 1981. Her first diagnosis of HCV was in 1997.

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Entry point for hepatitis C infection identified

2012-01-24T10:47:00.000-08:00

A molecule embedded in the membrane of human liver cells that aids in cholesterol absorption also allows the entry of hepatitis C virus, the first step in hepatitis C infection, according to research at the University of Illinois at Chicago College of Medicine.

The cholesterol receptor offers a promising new target for anti-viral therapy, for which an approved drug may already exist, say the researchers, whose findings were reported online in advance of publication in Nature Medicine.

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Vertex Vows to Fight On With Alios Drugs in High-Stakes Hepatitis C Race

2012-01-24T10:44:00.000-08:00

Vertex Pharmaceuticals went from king of the hill in the treatment of hepatitis C to yesterday’s news in about six wild months. But while many on Wall Street say Vertex’s big drug will soon become obsolete, Vertex and its small partner in South San Francisco have quietly put themselves in position to defend a big share of this future multi-billion dollar market.

Cambridge, MA-based Vertex (NASDAQ: VRTX), which has significant operations in San Diego, is running a series of small clinical trials this year that will mix and match combinations of antiviral medicines against hepatitis C. These trials will help determine whether Vertex and its partner, South San Francisco-based Alios Biopharma, have hit upon a combination of drugs that can raise the cure rate, and reduce side effects, for millions of patients with this liver-damaging virus.

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New National Hepatitis C Helpline Promises "One Call – Lots of Help"

2012-01-24T10:40:00.000-08:00

Fort Lauderdale, FL, January 24, 2012 --(PR.com)-- A new national helpline, 877-HELP-4-HEP, run by and for people affected by hepatitis C will formally launch February 1, 2012. This new consumer resource is the result of a year-long collaboration among five national nonprofits with a combined 90 years’ experience in phone-based peer counseling.

Being diagnosed with hepatitis C creates many emotional and social challenges. It is especially complicated by the lack of comprehensive medical, mental health, and community support services. People with hepatitis C report spending countless hours trying to find a reliable support and information. Resources are few and often transient based on available funding.

Judi, one of the 877-HELP-4-HEP counselors states, “People with hepatitis C just can’t seem to get the help they need. Sometimes, I’m the fourth or fifth person they have spoken to. As a peer counselor, I can share common experiences and talk about different coping strategies and resources. When I was diagnosed I had many of the concerns and questions that they are having and since then have spoken to people with similar experiences. I can really set their minds at ease with answers to their questions that contribute to a sense of well-being and hope.”

Unique to 877-HELP-4-HEP (877-435-7443) are specially trained peer counselors using a structured approach to help callers navigate through screening, diagnosis, medical evaluation, and treatment. Follow-up contact by the counselors keep callers engaged at each step of their journey and help them make and follow through with their hepatitis C related decisions.

Additional HELP-4-HEP assets include an up-to-date national database of 25,000 referral resources and a secure shared caller database for counseling continuity. Andi Thomas, the helpline’s managing partner, stated, “What sets us apart is our standardized health messaging and the follow-up call feature. HELP-4-HEP is designed to maintain contact with callers to improve health outcomes as well as document and measure the impact of our services.”

HELP-4-HEP is administered by The Support Partnership whose mission is to improve the well-being of people affected by viral hepatitis through collaborations that increase service quality, access, and impact. Founding partners are HealthPro (formerly Hep-C ALERT), FL; Hepatitis C Association, NJ; Hepatitis Education Project, WA; Hep C Connection, CO; and Project Inform, CA.

877-HELP-4-HEP (877-435-7443) operates Monday through Friday 9:00am to 7pm EST. To learn more, visit www.help4hep.org or email info@help4hep.org.

###

Contact Information

The Support Partnership
Andi Thomas
954-692-0450
Contact
www.help4hep.org
Denny Simon
908-812-2488

Community Health Center launches new video conferencing technology

2012-01-22T10:47:00.000-08:00

MIDDLETOWN — Community Health Center unveiled a new tool Friday that will allow it to lend the expertise of CHC HIV specialist to other CHC clinics that do not have such specialists.

Called Project ECHO Hepatitis C/HIV, is a state of the art video conferencing system that allows for multiple clinics in the CHC system to link together to share expertise and information to treat HIV and Hepatitis C patients.

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New law will slow spread of pathogens

2012-01-22T10:16:00.000-08:00

Last October, Gov. Brown signed into law Senate Bill 41, as part of statewide efforts to reduce the spread of HIV, hepatitis C, and other blood-borne pathogens.

The new law, which took effect on Jan. 1, expands legal access to hypodermic needles and syringes in an effort to reduce the sharing of contaminated injection equipment.

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Funding for needle exchange programs drying up

2012-01-21T11:15:00.000-08:00

Advocates say the public should consider the cost-effectiveness of the programs, which help to prevent the spread of diseases.

By GLENN ADAMS The Associated Press

AUGUSTA - Hypodermic needle exchange programs in Maine, which collected more than a quarter-million syringes in a recent 12-month period, are running into serious funding problems because of the poor economy, say officials who oversee the programs.

None of Maine's four exchange programs receives public funding, and private grants and other donations are drying up.

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A second chance at life

2012-01-21T11:12:00.000-08:00

National shortage spikes advocacy for organ donation

Nearly 12 years ago, Dr. Richard Darling was planning his own funeral. Ailing from liver cancer after a battle with Hepatitis C, he wasn’t eligible for a transplant and had no hope for survival. Darling and his wife decided to prepare for the dreaded future, pre-paying for funeral expenses.

That year, the federal government reversed its position on organ transplantation for liver cancer patients. The law saved Darling’s life. He was placed on a waiting list for a new liver and received a transplant. The transplanted organ failed, so Darling received a second liver.

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Common side-effects of hepatitis C protease inhibitors: clinical management advice published

2012-01-21T09:44:00.000-08:00

The addition of the protease inhibitors telaprevir or boceprevir to hepatitis C treatment regimens increases the risk of anaemia, according to a review article published in Liver International. The author also found that telaprevir treatment was associated with an increased risk of rash and itching as well as some anorectal symptoms.

However, these side-effects were generally mild and could be managed without the need to discontinue therapy.

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DOH receives $40k for hepatitis education efforts

2012-01-20T10:16:00.000-08:00

The Hawaii State Department of Health recently received a $40,350 grant from Kaiser Permanente Hawaii to help with the prevention, diagnosis and treatment of viral hepatitis.

“Hepatitis B and C are truly silent epidemics because most people don’t know that they have been infected with hepatitis. There may not be any symptoms for many years, and there is still limited awareness about hepatitis,” said Thaddeus Pham, DOH Adult Viral Hepatitis Prevention Coordinator. “This is especially true for foreign-born Asian and Pacific Islander communities who may not have access to culturally appropriate, in-language materials about viral hepatitis.”

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Many high-risk Americans don't get hepatitis B vaccine

2012-01-20T09:56:00.000-08:00

More than half, 51.4 percent, reported not being fully innoculated in 2007 survey

PROVIDENCE, R.I. [Brown University] — Although there is an effective vaccine for hepatitis B and public health officials have a strong sense of who is at highest risk for the infectious liver disease, tens of thousands of people in the United States contract the virus every year. According to a new study by researchers at Brown University, missed opportunities to administer the vaccine continue to be a reason why infections persist.

"This is a really simple thing that we could do and if somebody ends up getting the disease because we didn't make the effort then I think that's really a shame," said Brian Montague, assistant professor of medicine in the Warren Alpert Medical School of Brown University and a physician at The Miriam Hospital.

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Harm reduction programs threatened

2012-01-19T10:38:00.000-08:00

HEALTH / Activists say federal omnibus bill will put drug users, prisoners at greater risk

Local advocates for successful harm reduction programs are arguing that the Federal Omnibus C-10 Crime Bill places drug users at a higher risk of contracting diseases like HIV/AIDS and Hepatitis C.

They say the Bill, re-introduced last September by the Conservative Party, has more consequences than simply being “tough on crime.”

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Hepatitis C infection identified as leading risk factor for HCC

2012-01-19T10:34:00.000-08:00

Liver-scarring diseases such as cirrhosis from alcohol consumption continue to present a high risk for the development hepatocellular carcinoma, but hepatitis C infection has been identified as the leading risk factor, according study results published in Mayo Clinic Proceedings.

Researchers analyzed trends in incidence, etiology and treatment of liver cancer among residents in Olmsted County, Minn. Using medical records from a community-wide medical record linkage system, they identified 104 residents aged older than 20 years diagnosed with hepatocellular carcinoma (HCC) from 1976 to 2008.

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Hope for Hepatitis C

2012-01-19T10:28:00.000-08:00

Imagine, for a moment, that you recently received a brand new Time-O-Matic Time Machine as a gift. How far back would you have to set the dial to see that meaningful progress has been made in the treatment of hepatitis C?

First, let’s say you set the dial to January 2011 and –- Puff-kachunk! — you’re there. Standard treatment for chronic hepatitis C genotype 1 infection consisted of 48 weeks of pegylated interferon-alpha and ribavirin, an approach more likely to produce adverse effects than clearance of the virus.

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First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published

2012-01-19T10:25:00.000-08:00

--Study also Demonstrated 100% Sustained Virologic Response 12-Weeks Post Treatment with Quadruple Therapy

--Phase II Investigational Data Published Today in the New England Journal of Medicine

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced the full results, published in the New England Journal of Medicine, from a Phase II clinical trial in patients with hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin (‘null responders’1). The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible with a direct-acting antiviral (DAA)-only combination containing daclatasvir and asunaprevir (4/11 patients, including two of two patients infected with HCV genotype 1b). This study was the first study to demonstrate the possibility that hepatitis C can be cured (defined as sustained virologic response 48 weeks post-treatment or SVR48) without the use of interferon. The study also demonstrated that 100 percent (10/10) of these difficult-to-treat patients dosed with quadruple therapy containing daclatasvir and asunaprevir in combination with PEG-Interferon alfa and ribavirin achieved SVR12.

In this study there were no serious adverse events on treatment or discontinuations due to adverse events. Diarrhea was the most common adverse event in both groups (73% and 70%).

“Even with the recent approval of two protease inhibitors, treatment of hepatitis C patients who have not responded to PEG-interferon alfa and ribavirin has limited success. Because of this high unmet medical need, there is a necessity for new combination regimens that can increase response rates in null responders,” said lead investigator Anna Lok, MD, FRCP, director of clinical hepatology and professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor. “The data seen in this study with Bristol-Myers Squibb’s investigational DAAs daclatasvir and asunaprevir, either as DAA-only therapy or as part of quadruple therapy, are encouraging as we work to advance hepatitis C therapy for this difficult-to-treat patient population. This study also shows for the very first time that sustained viral responses can be achieved without the use of interferon and ribavirin.”

Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an investigational, oral, selective NS3 protease inhibitor.

Study Results

Viral Response: Dual DAA Therapy with daclatasvir and asunaprevir (Group A)

Eleven patients were randomized to receive dual DAA therapy for 24 weeks. Seven of the 11 patients (64%) in Group A achieved undetectable viral load by week four, and five patients remained undetectable at the end of treatment. Of these 11 patients, one patient relapsed at four (4) weeks post treatment while four patients (36%) had sustained virological response at 12 weeks post-treatment (SVR12). In follow-up to 48-weeks post treatment, no additional cases of viral relapses were observed.

Six patients, all with HCV genotype 1a, experienced viral breakthrough on dual DAA therapy, and analysis of HCV sequences following breakthrough confirmed resistance to both antivirals. With the addition of PEG-interferon alfa and ribavirin to their regimen (rescue therapy), four of the six patients achieved undetectable viral load. Two of these patients relapsed following the treatment period and two remained undetectable, one with 14 weeks and one with 42 weeks of post treatment follow-up. Two of the six patients did not achieve undetectable HCV RNA and treatment was discontinued.

Viral Response: Quadruple Therapy with daclatasvir, asunaprevir and PEG-Interferon alfa and ribavirin (Group B)

Ten patients were randomized to receive quadruple therapy for 24-weeks. Six of the 10 patients (60%) in Group B achieved undetectable HCV RNA by week four. Ten of the 10 patients (100%) were undetectable by the end of treatment, and all 10 achieved SVR12. No patients experienced viral relapse during 48 weeks of post-treatment observation.

Safety

In the study, there were no serious adverse events on treatment, no deaths, and no treatment discontinuations due to adverse events. Most adverse events were mild to moderate, and the most common AEs were diarrhea (group A: 8/11, 73%; group B: 7/10, 70%), fatigue (group A: 6/11, 55%; group B: 7/10, 70%), headache (group A: 5/11, 45%; group B: 5/10, 50%), and nausea (group A: 2/11, 18%; group B: 5/10, 50%).

Six patients (four from group A, including two receiving rescue therapy, and two from group B) experienced elevated liver enzymes [ALT >3x upper limit of normal (ULN)] which did not require treatment discontinuation or dose interruptions, and all patients stabilized or improved with continued therapy. Six patients, all of whom received PEG-interferon alfa and ribavirin, experienced Grade 3 or 4 neutropenia, a blood disorder characterized by an abnormally low number of white blood cells.

About the Study

This open-label, phase IIa study evaluated the antiviral activity and safety of the combination of daclatasvir and asunaprevir with and without PEG-Interferon alfa and ribavirin in 21 HCV genotype 1 null responders. Patients in the study were randomized to receive one of two treatment regimens for 24 weeks. The 11 patients in Group A received dual-DAA therapy with daclatasvir 60 mg once daily and asunaprevir 600 mg twice daily, both taken orally. The 10 patients in Group B received quadruple therapy with daclatasvir 60 mg once daily, asunaprevir 600 mg twice daily, PEG-interferon alfa 180 µg once weekly, and ribavirin 1000-1200 mg daily (according to body weight) in two divided doses. The primary study objective was to determine the proportion of patients achieving undetectable viral load (HCV RNA <10 IU/mL) 12 weeks post-treatment (SVR12). This dual-DAA combination is now in Phase III development.

About Bristol-Myers Squibb’s Commitment to Liver Disease

Bristol-Myers Squibb is advancing a portfolio of compounds that aims to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. The Company’s hepatitis C pipeline includes a portfolio of compounds with different mechanisms of action, pursuing both biologics as well as small molecule antivirals. These compounds are being studied as part of multiple novel treatment regimens with the goal of increasing SVR rates across diverse patient types and geographies. Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir, also known as BMS-790052, is the first NS5A replication complex inhibitor to be investigated in hepatitis C clinical trials and is currently in Phase III development. Asunaprevir, also known as BMS-650032, is an NS3 protease inhibitor in Phase III development for hepatitis C.

Read complete press release here

Scientists show brain vulnerable to Hepatitis C virus

2012-01-18T10:51:00.000-08:00

Scientists at the University of Birmingham have demonstrated for the first time that human brain cells can become infected with the Hepatitis C virus (HCV), it is reported today.

The team of virologists found that the endothelial cells in the brain possess the four main protein receptors necessary for the blood-brain barrier to be targeted by HCV.

The findings, which are published online today in Research Highlights in the journal Nature Reviews Gastroenterology and Hepatology, show that cells other than liver hepatocytes can be vulnerable to HCV infection.

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Israelis find vitamin D helps against liver diseases

2012-01-17T11:12:00.000-08:00

--Discovery of the weakening of the hepatitis C virus in the presence of the vitamin opens up a potential treatment for the infections

- Vitamin D fights liver cirrhosis

Two Israeli research teams have separately become the first to discover two different benefits from vitamin D against common liver diseases – hepatitis C and cirrhosis.

One involved the mechanism in human cells in the lab, while and the other proved itself on liver tissue in rats. The two discoveries have not yet been tested clinically.

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Kidney failure risk higher for liver transplant patients following allocation policy change

2012-01-16T20:08:00.000-08:00

Research from the University of Michigan Health System shows the risk for kidney failure among liver transplant recipients is higher following the implementation of Model of End Stage Liver Disease (MELD), a policy change in 2002 that altered how liver transplant allocation is decided.

The study, led by Pratima Sharma, M.D., M.S., an assistant professor in the Department of Internal Medicine, examined the effect of MELD score-based allocation on post-liver transplant kidney failure. MELD, which was introduced in 2002, is a scoring system that evaluates liver disease severity and has since become the basis for deciding which patients receive liver transplants.

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Researchers Discover Means for Blocking Hepatitis C Infection

2012-01-16T11:03:00.000-08:00

Researchers in Canada have discovered a new approach to blocking infection from the hepatitis C virus in the liver that could lead to new therapies.

HCV requires fat to replicate, and a team of scientists at the University of British Columbia have developed an inhibitor that decreases the size of host fat droplets in liver cells and stops the virus from multiplying and infecting other cells.

"Human Subtilase SKI-1/S1P Is a Master Regulator of the HCV Lifecycle and a Potential Host Cell Target for Developing Indirect-Acting Antiviral Agents."

Olmstead AD , Knecht W , Lazarov I , Dixit SB , Jean F , 2012 Human Subtilase SKI-1/S1P Is a Master Regulator of the HCV Lifecycle and a Potential Host Cell Target for Developing Indirect-Acting Antiviral Agents. PLoS Pathog 8(1): e1002468. doi:10.1371/journal.ppat.1002468

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FREE HIV and Hepatitis C testing coming to Guerneville Jan 18, 2012

2012-01-15T11:16:00.000-08:00

Testing Jan 18, 2012-- Russian River Empowerment Center parking lot on January 4 and January 18 from 3:30 P.M. until 6 P.M

The Drug Abuse Alternatives Center (DAAC), staffed by experienced and knowledgeable counselors and outreach workers, offers counseling and testing for HIV/AIDS and hepatitis C on a drop-in basis, and much more, and this coming January, their Big Blue Van will becoming to Guerneville.

The Drug Abuse Alternatives Center is dedicated to improving the lives of individuals and families, and their mission is “Turning Lives Around by Providing Healthy Alternatives to Alcohol and other Drug Use”. They have provided thousands of people with “the tools and guidance to live a healthy and sober life.”

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CDC Warns Against Sharing Insulin Pens

2012-01-14T11:38:00.000-08:00

Doing so exposes people with diabetes to blood-borne infection risk

FRIDAY, Jan. 13 (HealthDay News) -- Due to a growing number of reports about improper use of insulin pens, the U.S. Centers for Disease Control and Prevention has issued a reminder that the devices must never be used on more than one person.

Using insulin pens on more than one person puts people at risk for infection with blood-borne pathogens such as hepatitis viruses and HIV, which causes AIDS, the agency warns. Infection can occur even if an insulin pen's needle is changed.

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Hep C threat to health services

2012-01-13T11:10:00.000-08:00

The large number of people in Ireland with hepatitis C poses serious implications for the national health services in the future, the Health Protection Surveillance Centre (HPSC) has warned.

A recent study has estimated that between 20,000 and 50,000 people in Ireland are now chronically infected with hepatitis C.

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Merck Hepatitis C Drug May ‘Anchor' Future Worldwide Regimen

2012-01-10T16:38:00.000-08:00

If trials are successful for the drug, called MK-5172, the therapy may become the foundation medicine for future combination pill treatments, he said.

“What we have seen makes us quite optimistic that the drug could be an anchor,” he said.

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Alarming Incidence of Hepatitis C Virus Re-Infection After Treatment of Sexually Acquired Acute Hepatitis C Virus Infection in HIV-Infected MSM

2012-01-10T11:19:00.000-08:00

The seroprevalence of sexually transmitted HCV among men who have sex with men in Amsterdam is stabilizing, recent data show. Little is known, however, about the incidence of HCV re-infection in MSM who have cleared HCV. In the current study, the team assessed the incidence of HCV re-infection in HIV-positive MSM who were HCV RNA-negative following HCV treatment of acute primary infection.

The subjects of the Amsterdam-based study were HIV-infected MSM attending two large outpatient clinics; the men were previously diagnosed with a sexually transmitted acute HCV infection and tested HCV RNA-negative at the conclusion of treatment. "We defined HCV re-infection as detectable HCV RNA in individuals with an undetectable HCV RNA at the end of treatment accompanied by a switch in HCV genotype or clade," the authors wrote. Re-infection incidence was calculated using person-time methods.

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New Target and FDA-Approved Cholesterol-Lowering Drug Identified for HCV Therapy

2012-01-10T11:15:00.000-08:00

Scientists have identified what they claim is a new target for preventing HCV infection, and also demonstrated that an existing FDA-approved cholesterol-lowering drug may fit the bill as a therapeutic agent against the disease. Building on previous research implicating viral cholesterol as a key factor in facilitating the entry of HCV into host cells, a team led by researchers at the University of Illinois-Chicago identified the cellular Neimann-Pick C1-like 1 (NPC1L1) cholesterol uptake receptor as a key HCV entry factor that is amenable to therapeutic intervention. Their work in addition showed that the FDA-approved NPC1L1 antagonist ezetimibe not only inhibits infection by all major HCV genotypes in vitro, but also delays the establishment of HCV genotype 1b infection in mice with human liver grafts.

Susan L. Uprichard, M.D., and colleagues report their findings in Nature Medicine in a paper titled “Identification of the Niemann-Pick C1–like 1 cholesterol absorption receptor as a new hepatitis C virus entry factor.”

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No link yet between hepatitis B, C cases and Ottawa clinic

2012-01-10T11:12:00.000-08:00

In the interim report released Monday, the city's chief medical health officer, Dr. Isra Levy, says the agency has reached more than 90 per cent of the patients who were potentially affected by the lapse.
Levy says the agency conducted 4,353 tests. Of those:

8.5 per cent, or 369 patients, showed evidence of hepatitis B infection
0.9 per cent, or 39 patients, showed evidence of hepatitis C infection
none of the tests came up positive for HIV

"While new cases of hepatitis B and hepatitis C have been diagnosed through this testing, no cases to date have been linked with the clinic," the report said.

New Fibrosis Classification Improves Accuracy of Diagnosis in Hepatitis C

2012-01-10T10:45:00.000-08:00

More Precise Diagnostic Algorithm Reduces Need for Liver Biopsy

A new classification for diagnosing fibrosis in patients with chronic hepatitis C virus (HCV) has shown to be as accurate as currently used algorithms, but required no further liver biopsy. The study appearing in the January issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, details a method that synchronously combines two fibrosis tests, providing a non-invasive and more precise fibrosis diagnosis.

HCV affects up to 170,000 million individuals worldwide and is a leading cause of chronic liver disease and a primary indication for liver transplantation according to the World Health Organization (WHO). The Centers for Disease Control and Prevention (CDC) estimates that 2.7 to 3.9 million Americans are living with chronic HCV with roughly 12,000 deaths reported each year. WHO has reported up to 20% of HCV patients develop cirrhosis and 1% to 5% die from cirrhosis or liver cancer.

“Fibrosis progression can be highly unpredictable and accurate classification of the stage of fibrosis is extremely important,” said Dr. Jérôme Boursier from Centre Hospitalier Universitaire d’Angers in France. “A diagnostic algorithm that provides similar accuracy as successive classifications without the need of liver biopsy to determine the extent of fibrosis is highly beneficial to patients.”

Dr. Boursier and colleagues evaluated the Sequential Algorithm for Fibrosis Evaluation (SAFE) and Bordeaux algorithm (BA), compared to a more detailed classification for determining fibrosis severity. The team used data for 1785 patients with chronic HCV who were enrolled in 3 previous study populations (SNIFF, VINDIAG, and FIBROSTAR), representing a total of 31 centers throughout France. Data included liver biopsy, blood fibrosis test, and Fibroscan—an ultrasound technology used to assess liver fibrosis (stiffness).

The team found that successive SAFE diagnostic accuracy was 87%—significantly lower than the individual SAFE devoted for the diagnosis of significant fibrosis (F≥2) at 95% or for cirrhosis (F4) at 90%. The number of liver biopsies required with successive SAFE was significantly higher than individual SAFE for F≥2 or SAFE for F4 at 71% compared to 64% and 6%, respectively. Researchers also reported similar results with successive BA diagnostic accuracy at 85% compared to individual BA at 88% (F≥2) and 94% (F4). More biopsies were required for successive versus individual BA at 50% compared to 35% and 25%, respectively.

“Our findings show that SAFE and BA diagnostic testing are highly accurate in determining fibrosis or cirrhosis in patients with HCV,” said Dr. Boursier. However, a high percentage of patients also required liver biopsy to confirm the diagnosis. The authors creation of a new classification which synchronously combines two fibrosis tests (FibroMeter + Fibroscan) was as accurate as successive SAFE or BA at 87%, and did not require any liver biopsy. “The new non-invasive classification of fibrosis is as accurate as successive SAFE or BA, but is more precise with six fibrosis classes and entirely non-invasive with no liver biopsy required,” concludes Dr. Boursier.

Full Citation: “Comparison of 8 Diagnostic Algorithms for Liver Fibrosis in Hepatitis C: New Algorithms are More Precise and Entirely Non-invasive.” Jérôme Boursier, Victor de Ledinghen, Jean-Pierre Zarski, Isabelle Fouchard- Hubert, Yves Gallois, Frédéric Oberti, Paul Calès, and multicentric groups from SNIFF 32, VINDIAG 7, AND ANRS/HC/EP23 FIBROSTAR studies. Hepatology; Published Online: December 21, 2011 (DOI: 10.1002/hep.24654); Print Issue Date: January 2012. http://onlinelibrary.wiley.com/doi/10.1002/hep.24654/abstract.

Author Contact: To arrange an interview with Dr. Boursier, please contact ServiceCommunication@chu-angers.fr.
These studies are published in Hepatology. Media wishing to receive a PDF of the articles may contact healthnews@wiley.com.

About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Hepatology’s current impact factor is 10.885.Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350 .

About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Source: Wiley-Blackwell

High Rates of Disability and Health Care Use for Older American with Cirrhosis

2012-01-10T10:42:00.000-08:00

Cirrhosis Burden Expected to Climb in this Frail Population

New research shows that older Americans with cirrhosis have significantly worse health status and greater functional disability compared to those without this potentially deadly disease. In fact, findings now published in Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases, show that elderly patients with cirrhosis require twice the amount of informal caregiving and contribute added strain on the health care system. Given the increase in obesity and aging of those with hepatitis C (HCV), researchers expect the prevalence of cirrhosis to climb in this frail population.

Cirrhosis is a chronic condition that causes the liver to slowly deteriorate, with scar tissue replacing healthy tissue and impairing liver function. Studies have shown that non-alcoholic fatty liver disease (NAFLD)—ranging in severity from fatty liver to nonalcoholic steatohepatitis (NASH) to cirrhosis—has become the most prevalent cause of chronic liver disease worldwide, affecting up to 30% of the general population and found in 75% of obese individuals. The Action Plan for Liver Disease Research estimates that 5.5 million Americans have chronic liver disease or cirrhosis, which is one of the most expensive digestive diseases costing $1.6 billion annually in healthcare costs and lost work days.

“With the obesity epidemic contributing to a rise in NAFLD cases along with the aging HCV patient population, cirrhosis among the elderly is expected to become increasingly prevalent,” said Dr. Mina Rakoski with the University of Michigan Medical School in Ann Arbor. “Therefore, understanding the health and economic burden on older cirrhotic patients, their caregivers, and the health system is extremely important.” In the present study Dr. Rakoski and colleagues identified 317 patients with cirrhosis and 951 age-matched individuals without the disease from the Health and Retirement Study (HRS) and Medicare claims files. Researchers assessed patients’ health status which included comorbidities, healthcare utilization and functional disability. Informal caregiving, measured by hours of care and associated cost, was also examined.

Study results reveal that patients with cirrhosis were more likely to be Hispanic, have less education, and have lower net worth. Older cirrhotic patients had worse self-reported health status and more medical comorbidities compared to those without the disease. Utilization of health care services, including physician visits, nursing home stays and hospitalizations, was more than double in those with cirrhosis compared to non-cirrhotic peers.

Greater functional disability was also significant among those with cirrhosis as measured by activities of daily living (ADL) and instrumental activities of daily living (IADL). Overall, 14% of cirrhotic patients could perform only one to two ADLs, such as dressing oneself, while 10% could perform none or only one IADL, such as housework. Given their inability to perform common everyday tasks, it is not surprising that informal caregiving was much higher in individuals with cirrhosis—twice the number of informal caregiving hours per week at an annual cost of $4,700 per person—compared to their elderly counterparts without the disease.

“Our population-based study confirms that cirrhosis in the elderly poses a significant burden to patients and their caregivers in terms of health-related and economic costs,” concludes Dr. Rakoski. “A greater focus on comprehensive delivery of patient care by involving caregivers and improving care coordination will help to optimize disease management for older cirrhotic patients.” The authors recommend that future studies should investigate the impact of functional disability on outcomes such as hospital readmission and mortality in older patients with cirrhosis.

Full Citation: “Burden of Cirrhosis on Older Americans and Their Families: Analysis of the Health and Retirement Study.” Mina O. Rakoski, Ryan J. McCammon, John D, Piette, Theodore J. Iwashyna, Jorge A. Marrero, Anna S. Lok, Kenneth M. Langa, Michael Volk. Hepatology; December 21, 2011 (DOI: 10.1002/hep.24616); Print Issue Date: January 2012. http://onlinelibrary.wiley.com/doi/10.1002/hep.24616/abstract.

Author Contact: To arrange an interview with Dr. Rakoski, please contact Mary Masson with the University of Michigan at mfmasson@umich.edu or 734-764-2220.

Source: Wiley-Blackwell

Achillion Reports Clinical Data on Portfolio of Protease Inhibitors

2012-01-09T11:56:00.000-08:00

Once-daily ACH-1625 safe, well-tolerated and achieves 100% cEVR after 12 weeks of treatment

Pilot study of ACH-1625 in HCV genotype 3 achieves maximal 3.68 log10 reduction

ACH-2684 safe, well tolerated and achieves HCV genotype 1 maximal 4.63 log10 reduction; Additional dosing on-going

NEW HAVEN, Conn., Jan. 9, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported new clinical trial results on its portfolio of protease inhibitors including: Phase 2 interim 12-week treatment results with ACH-1625 for the treatment of genotype 1 treatment-naive hepatitis C virus (HCV), exploratory data on ACH-1625 for the treatment of HCV genotype 3, and initial proof-of-concept data for ACH-2684. Based upon these results, Achillion is planning further exploration of ACH-1625 in combination with other oral antiviral agents for the treatment of all HCV genotypes and continues to evaluate ACH-2684 in a Phase 1 clinical trial.
Michael D. Kishbauch, President and Chief Executive Officer of Achillion commented, "ACH-1625 is emerging as a fascinating and potentially superior, once-daily protease inhibitor that competes well against all other DAAs in development, regardless of their mechanism, based upon ACH-1625's safety, efficacy, genotypic coverage and emerging resistance mutation profile. Further, ACH-2684 shows preliminary promise in its ability to treat HCV, with a safety profile that looks very good, and over the next few months we will expand our clinical experience to define the dose response for its use across all HCV genotypes."

ACH-1625: Phase 2 12-Week Study Design and Interim Results
In the second segment of this ongoing Phase 2a trial, three doses of once-daily ACH-1625 (200 mg, 400 mg or 800 mg) in combination with pegylated interferon alfa-2a and ribavirin (P/R) were dosed over 12 weeks of therapy in patients with treatment-naive HCV genotype 1. Subjects were randomized and stratified by IL28B genotype, including CT and TT, which is a marker of a patient's diminished response to interferon.

Enrollment in this study of approximately 60 patients has been completed, and data on the first 35 patients enrolled were evaluated in this interim analysis. Of the patients enrolled, the majority had HCV genotype 1a (n=23/35 (66%)), with remaining patients having HCV genotype 1b (n=10) or genotype 1 (n=2). Approximately 66% of the patients were IL28B genotype CT/TT, the more difficult to treat mutation, 74% were male and approximately 14% were African American. No viral breakthroughs were observed during treatment. Preliminary results for the first 35 patients enrolled demonstrated rapid virological response (RVR) at week 4, and complete early virologic response (cEVR) and viral load reduction at week 12 as follows:


	ACH-1625
Segment 2: 12-week treatment duration assessments	200 mg N=12	400 mg N=11	800 mg N=12
Week 4 RVR: Subjects with HCV RNA < 25 IU/mL	(8/12) 67%	(8/10) ¹ 80%	(12/12) 100%
Week 12 cEVR: Subjects with HCV RNA undetectable < 25 IU/mL	(11/11) ² 100%	(8/8) ³ 100%	(12/12) 100%
CC	(4/4) 100%	(3/3) 100%	(4/4) 100%
CT or TT	(7/7) 100%	(5/5) 100%	(8/8) 100%
Mean maximum HCV RNA decline through Week 12 (log10)	4.79	5.12	4.59
(1) One patient discontinued before week 4. Three patients discontinued treatment after week 4 but before week 12 of treatment including (2) one patient in the 200 mg group and (3) two patients in the 400 mg dose group.

"We were pleased to note that regardless of IL28B status, 100% of patients treated through 12 weeks achieved cEVR and remained undetectable at this point in the study, and the potency and unique pharmacokinetic properties of ACH-1625 appear to provide very potent antiviral coverage for all of these genotype 1 patients," commented Dr. Elizabeth A. Olek, Chief Medical Officer of Achillion. "Patients appear to have continued on-treatment viral suppression, and we therefore look forward to determining end-of-treatment response rates for the fully enrolled study and to presenting complete study results in April."

Safety results from this segment of the trial were similar to those observed in the previously reported clinical trials of ACH-1625. Over 12 weeks of co-administration of ACH-1625 plus P/R, there was one reported serious adverse event (SAE) that was deemed unrelated to ACH-1625. Most reported adverse events (AEs) in patients receiving ACH-1625 were classified as mild to moderate and were transient. The most common AEs were consistent with pegylated interferon alfa-2a and ribavirin treatment.

ACH-1625: Pilot Phase 1 Study Evaluating Antiviral Activity against HCV Genotype 3 and Clinical Virology Assessment of HCV Genotype 1
Based upon in vitro virology, as well as evolving clinical pharmacokinetic and pharmacodynamic data, a Phase 1 pilot study was conducted to evaluate the antiviral activity of ACH-1625 for the treatment of HCV genotype 3. A total of seven patients infected with HCV genotype 3 were enrolled and treated with monotherapy consisting of 400 mg ACH-1625 twice daily for 4.5 days. In this exploratory study, ACH-1625 was safe and well tolerated. The maximum HCV genotype 3 RNA viral load reduction achieved was 3.68 log10 among the six out of seven patients that achieved an antiviral response.

In addition, clinical virology analysis of patient samples obtained during the first Phase 2 28-day study segment of ACH-1625 in combination with P/R examined the resistance mutation profile following treatment. The results indicated that following 28 days of treatment with ACH-1625 the presence of highly resistant variants were not detected.

"These findings suggest that ACH-1625 maintains high concentrations in the liver, the site of infection, resulting in a unique pharmacokinetic drug profile. These positive clinical results in genotype 3, along with the strong virologic profile of ACH-1625, have led us to take a broad look at the role of ACH-1625 in our future proprietary combination regimen," commented Milind Deshpande, Ph.D., President of Research and Development and Chief Scientific Officer.

ACH-2684: Phase 1 Healthy Volunteers and HCV Genotype 1 and 3 Segments
This Phase 1 clinical study is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684. Healthy volunteers in the single ascending dose (SAD) segment received doses of ACH-2684 ranging from 10 mg once daily to 300 mg twice daily. The first cohorts of HCV-infected patients were enrolled and treated with ACH-2684 administered as 400 mg twice daily for 2.5 days.

ACH-2684 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, ECGs, or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.

Proof-of-concept was achieved with ACH-2684 in HCV genotype 1 demonstrating a maximum HCV RNA viral load reduction of 4.63 log10. Antiviral activity with ACH-2684 in HCV genotype 3 was seen with a maximum HCV RVA viral load reduction of 2.03 log10. Additional cohorts of patients with either HCV genotype 1 or HCV genotype 3 are currently being enrolled to further explore doses and viral kinetics for ACH-2684.

All-Oral Protease Inhibitor and NS5A Inhibitor Combination Will Play an Important Role
During 2012 Achillion plans to conduct a number of clinical trials to further characterize its portfolio of protease inhibitors, including ACH-1625 and ACH-2684, and its NS5A inhibitors, including ACH-2928 and ACH-3102. In addition to the ongoing Phase 1 trials with ACH-2684 and ACH-2928, Achillion plans to submit an investigational new drug (IND) application and initiate a Phase 1 clinical trial with ACH-3102 during the second quarter of 2012. During the second half of 2012, Achillion plans to initiate an all-oral interferon-free combination study which will evaluate a protease inhibitor and a NS5A inhibitor, with or without ribavirin, for the treatment of HCV.

"We believe that the protease and NS5A inhibitor combination will play an important role in the future treatment of HCV across all genotypes," commented Mr. Kishbauch. "With the robust portfolio we have discovered and developed here at Achillion, we believe we are uniquely positioned to advance a potentially best-in-class all-oral, interferon-free combination and are looking forward to initiating clinical development with this regimen later in the year."

About ACH-1625
ACH-1625 is a pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM. ACH-1625 is currently in a Phase 2 clinical trial and has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV.

About ACH-2684
ACH-2684 is a next-generation HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-2684 is a macro-cyclic, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-2684 demonstrated pico-molar potency, excellent pharmacokinetic properties and safety profile at high drug exposures. ACH-2684 also exhibits rapid and extensive partitioning to the liver, as well as high liver/plasma ratios in preclinical studies. ACH-2684 has shown pico-molar potency against NS3 protease that is specific to HCV. It has preclinical activity against the 6 known genotypes of HCV and exhibits equipotent activity against HCV genotypes 1a and 1b at an IC50 of approximately 100 pico-molar. The drug candidate was discovered internally and is being advanced by Achillion.

About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.

About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000 .

Read complete release here

Presidio Pharmaceuticals Reports Progress with Hepatitis C Antiviral Programs

2012-01-09T11:51:00.000-08:00

SAN FRANCISCO, Jan 09, 2012 (BUSINESS WIRE) -- Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a dose-ranging assessment of PPI-668, a potent, pan-genotypic second-generation hepatitis C virus (HCV) NS5A inhibitor, in healthy volunteers and subsequent advancement to a Phase 1b assessment of the dose-related efficacy in hepatitis C patients.

The Phase 1a dose-ranging assessment of PPI-668 was conducted with 32 healthy volunteers in New Zealand. The trial was a randomized, double-blind, placebo-controlled assessment of the safety and pharmacokinetics of three oral doses of PPI-668, initially assessed as single doses and subsequently as a multi-day regimen, in which the highest PPI-668 dose was given once daily for five successive days. The trial results indicated that all dose regimens of PPI-668 were well-tolerated. There were no serious or severe clinical adverse events, no patterns of treatment-related adverse events or laboratory abnormalities, and all subjects completed the trial successfully.

Pharmacokinetic (PK) analyses of subjects' plasma samples in the Phase 1a trial indicated that substantial blood levels of PPI-668 were rapidly and consistently achieved and dose proportional. PPI-668 plasma concentrations were orders of magnitude above those shown to inhibit HCV replication in vitro and were maintained at predicted effective concentrations for more than 24 hours. These PK results support once-daily dosing for PPI-668 in future studies. Also important was the observation that in the 5-day multi-dose regimen, steady-state PK was achieved rapidly (by Day 2), with no evidence of subsequent accumulation or changes in the clearance profile of PPI-668.

"These first clinical data for PPI-668 indicate excellent tolerance in healthy subjects for up to five days," said Nathaniel A. Brown, M.D., Presidio's Chief Medical Officer. "Equally important, the pharmacokinetic profile of PPI-668 is very encouraging, suggesting that effective plasma concentrations can be obtained with relatively low, once-daily doses of PPI-668 - which will facilitate co-formulation of PPI-668 with other HCV antivirals in future combination therapies for hepatitis C."

Patient screening for the Phase 1b evaluation of PPI-668 in hepatitis C patients has begun in New Zealand and the United States and will soon include Australia. Dosing of the first cohort of hepatitis C patients will begin this week. Presidio expects to have results regarding the antiviral efficacy of PPI-668 in HCV patients in the second quarter of 2012.

In a second HCV research program focused on inhibitors of the HCV NS5B polymerase, Presidio has discovered a lead chemical series of non-nucleosidic NS5B inhibitors with potent activity against all major HCV genotypes. Preclinical profiling is ongoing with a goal of nominating a candidate for clinical development in the coming months.

With its novel NS5A and NS5B inhibitors, Presidio's objective is to provide two complementary HCV antivirals that will be appropriate for broad use in optimized future combination therapies for patients with HCV infection. Presidio anticipates that such therapies will have a convenient oral dosing regimen (once or twice daily), will exhibit rapid pan-genotypic efficacy and will be well-tolerated.

ABOUT HEPATITIS C AND NS5A INHIBITORS

Chronic hepatitis C is a persistent, potentially progressive inflammatory liver disease caused by chronic infection with the hepatitis C virus (HCV). Worldwide there are an estimated 130 to 170 million persons with chronic HCV infection. There are 7 major genotypes (strains) of HCV, which have differing geographic distributions. Globally, about 40-60% of patients are infected with HCV genotype-1, with the remaining patients infected with HCV genotypes 2 through 7.

Patients with advanced hepatitis C can develop potentially fatal liver failure or liver cancer, and hepatitis C is estimated to account for over 350,000 deaths per year worldwide (WHO estimate). The current standard-of-care treatment for hepatitis C in the United States, for patients with HCV genotype-1 infection, is combined administration of pegylated-interferon, ribavirin, and first-generation HCV protease inhibitors. This multi-drug treatment is characterized by incomplete efficacy for HCV genotype-1 patients, variations in efficacy according to patients' underlying human genetic factors, no established efficacy for patients infected with other HCV genotypes, substantial tolerance issues, and dosing inconveniences. Thus, there is a continuing need for more consistently effective and better tolerated HCV inhibitors that can be orally administered in future combination therapies for hepatitis C patients worldwide, regardless of HCV genotype, patient genetic factors, or disease stage.

Inhibitors of the HCV NS5A protein represent an exciting, relatively new class of HCV inhibitors that, when optimized, exhibit potent activity across all HCV genotypes, with a mechanism that is distinct from other classes of HCV antivirals, which commonly target the HCV protease or polymerase. PPI-668 is a novel, optimized, second-generation HCV NS5A inhibitor, which exhibits highly potent and selective activity against all HCV genotypes in replicon assays, with favorable toxicology and pharmacology profiles in preclinical assessments.

ABOUT PRESIDIO

Presidio Pharmaceuticals, Inc. is a San Francisco-based clinical stage specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics for hepatitis C virus (HCV). For more information, please visit our website at: www.presidiopharma.com .

SOURCE: Presidio Pharmaceuticals, Inc.

Idenix Reports Advancement of HCV Development Pipeline

2012-01-09T11:40:00.000-08:00

-- Idenix advances HCV clinical development pipeline with initiation of phase I study of pan-genotypic NS5A inhibitor, IDX719
-- Idenix selects next-generation HCV nucleotide inhibitors, IDX19368 and IDX19370, to enter IND-enabling studies
-- Management to host conference call webcast at 5:30 a.m. PT/8:30 a.m. ET today

CAMBRIDGE, Mass., Jan. 9, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the advancement of its hepatitis C virus (HCV) development pipeline.

IDX719: NS5A ProgramIdenix announced today the initiation of a phase I clinical trial of the Company's NS5A inhibitor, IDX719. The first part of the study will evaluate safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers. A subsequent part of the study will evaluate three days of IDX719 treatment in treatment-naïve genotype 1 HCV-infected patients and is expected to begin in the second quarter of 2012. Preclinical studies have shown that IDX719 has potent, pan-genotypic activity in vitro with the potential for once-daily dosing.

IDX19368 and IDX19370: Nucleotide Prodrug ProgramFurther, the Company has selected two additional nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates. The Company anticipates Investigational New Drug (IND) filings in mid-2012.

"Over the past year, Idenix has made significant progress in both our core nucleotide and NS5A programs," commented Ron Renaud, President and Chief Executive Officer of Idenix. "The preclinical profile of IDX719 is very competitive, and we are leveraging the Company's significant nucleotide chemistry expertise to discover novel nucleotides with promising properties as well as continuing to strengthen our IP position. We are excited about the potential of our novel antiviral compounds in the evolving HCV field in the coming year."

2011 Year-end Cash BalanceIdenix today reported that it ended 2011 with approximately $118.3 million of cash and cash equivalents. The Company's 2011 financial results have not yet been audited.

ABOUT IDENIXIdenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

CONFERENCE CALL AND WEBCAST INFORMATIONIdenix will hold a conference call today at 8:30 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 40631574. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until January 23, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 40631574.

Read complete release here

Idenix Reports Positive Interim Data for HCV Nucleotide Inhibitor, IDX184

2012-01-09T11:38:00.000-08:00

- No serious adverse events observed in phase IIb study of IDX184; Data Safety Monitoring Board (DSMB) recommends continuation of the clinical trial
- In the 100 mg IDX184 arm, 73% of patients achieved a rapid virologic response (RVR) and 87% were undetectable at most recent visit; In the 50 mg IDX184 arm, 63% of patients achieved an RVR and 94% were undetectable at most recent visit
- Management to host conference call webcast at 5:30 a.m. PT/8:30 a.m. ET today

CAMBRIDGE, Mass., Jan. 9, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced interim data from a 12-week phase IIb clinical trial of IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection. IDX184, a pan-genotypic oral nucleotide polymerase inhibitor, has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies.

IDX184 Phase IIb Study Design
In July 2011, the Company initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with pegylated interferon and ribavirin (PegIFN/RBV). Study objectives include safety and tolerability, and antiviral activity endpoints.

IDX184 Phase IIb Interim Study Results
The first 31 patients have completed 28 days of treatment, and the interim data have shown that IDX184 was well-tolerated and that there were no serious adverse events associated with therapy. The side effect profile was consistent with that seen with PegIFN/RBV. The independent DSMB has reviewed the data for the first 31 patients and has recommended continuing enrollment of the study. The Company has submitted the interim data, along with the DSMB's recommendations, to the U.S. Food and Drug Administration (FDA) and is requesting the continuation of this study and removal of the partial clinical hold for IDX184.

RVR findings demonstrated that 73% of patients in the 100 mg IDX184 arm (n=15) and 63% in the 50 mg arm (n=16) had undetectable virus (LLOQ < 25 IU/ml) at 28 days. Currently 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of 8 weeks of treatment. There have been no virologic breakthroughs observed in the study to date.

"These interim results are encouraging as they confirm the antiviral activity and safety of IDX184 in combination with pegylated interferon and ribavirin," Eric Lawitz, M.D., of Alamo Medical Research, Camden Medical Center, stated. "Nucleotide drugs such as IDX184 are becoming an important component in the rapidly evolving treatment regimens for HCV. Eventually, the goal for treatment will be to reduce or eliminate reliance on interferon and to shift to all oral combinations of direct-acting antiviral agents that can reduce potential side effects and decrease the amount of time on therapy."

Ron Renaud, President and Chief Executive Officer of Idenix, commented, "We are very pleased with the interim results for IDX184 and with the progress we made in 2011 across our programs. In 2012, we will build on this progress and believe we are well positioned to play a major role in treating HCV patients for the foreseeable future."

ABOUT IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. IDX184 is currently being developed under a partial clinical hold.

ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 8:30 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 40631574. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.

A replay of the conference call and webcast will be available until January 23, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 40631574.

Read complete release here

Bristol-Myers Squibb to Acquire Inhibitex

2012-01-08T11:41:00.000-08:00

Strategic Acquisition Supports Long-Term Growth Potential of the Company
Builds on Company’s Strong Legacy and Commitment in Virology
Enhances Company’s Broad HCV Portfolio with Addition of INX-189, a potent NS5B Nucleotide

NEW YORK & PRINCETON, N.J. & ATLANTA--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Inhibitex, Inc. (Nasdaq:INHX) announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire Inhibitex for $26.00 per share in cash pursuant to a cash tender offer and second step merger. The transaction, with an aggregate purchase price of approximately $2.5 billion, has been approved by the boards of directors of both companies. The board of directors of Inhibitex has agreed to recommend that Inhibitex’s shareholders tender their shares in the tender offer. In addition, shareholders with beneficial ownership of approximately 17% of Inhibitex’s common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the tender offer.

Inhibitex is a clinical-stage biopharmaceutical company dedicated to the development of innovative products that can treat or prevent serious infections, whose primary focus is on the development of nucleotide/nucleoside analogs for the treatment of hepatitis C virus (HCV). Its lead HCV asset is INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development that has exhibited potent antiviral activity, a high barrier to resistance and pan-genotypic coverage. Nucleotides/nucleosides are emerging as an important class of antivirals that may play a critical role as the backbone of future direct-acting antiviral-only combination approaches to HCV treatment.

“The acquisition of Inhibitex builds on Bristol-Myers Squibb’s long history of discovering, developing and delivering innovative new medicines in virology and enriches our portfolio of investigational medicines for hepatitis C,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “There is significant unmet medical need in hepatitis C. This acquisition represents an important investment in the long-term growth of the company.”

“This transaction puts INX-189 and the Company’s other infectious disease assets in the hands of an organization that can more optimally develop them and which believes as strongly as we do in INX-189’s potential in the treatment of chronic HCV,” said Russell Plumb, President and Chief Executive Officer of Inhibitex. “Bristol-Myers Squibb’s expertise in antiviral drug development, and its existing complementary portfolio, will assure that the potential of INX-189 is realized as part of future oral combination therapies for millions of patients in need around the world.”

“Bristol-Myers Squibb continues to drive advances in the field of hepatitis C research and development through internal development and selective partnerships,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, Bristol-Myers Squibb. “The addition of Inhibitex’s nucleotide polymerase inhibitor to our own promising portfolio, which includes other direct-acting antivirals, brings additional options to develop all-oral regimens with better cure rates, shorter duration of therapy and lower toxicity than the current standard of care.”

The transaction is expected to be dilutive to earnings for Bristol-Myers Squibb through 2016, with an expected impact on earnings per share of approximately $0.04 in 2012 and approximately $0.05 in 2013.

Under the terms of the definitive agreement, Bristol-Myers Squibb will commence a cash tender offer to purchase all of the outstanding shares of Inhibitex’s common stock for $26.00 per share. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares that constitutes at least a majority of Inhibitex’s outstanding shares of common stock (on a fully diluted basis) and expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $26.00 per share in cash. The merger agreement contains a provision under which Inhibitex has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close approximately thirty days after commencement of the tender offer.

Citi is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition and Kirkland & Ellis LLP is its legal advisor. Credit Suisse Securities (USA) LLC is serving as financial advisor to Inhibitex in connection with the acquisition and Dechert LLP is its legal advisor.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company’s clinical-stage pipeline includes three Phase 2 development programs: INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections, FV-100, a nucleoside inhibitor in development for the reduction of shingles-associated pain, and Aurexis, a humanized monoclonal antibody in development for the treatment of serious S. aureus bloodstream infections. The Company also has other HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM^® protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit www.inhibitex.com. Inhibitex^®, MSCRAMM^®andAurexis^® are registered trademarks of Inhibitex, Inc.

Read complete release here

Researchers Identify Liver Cancer Risk Factors

2012-01-07T11:17:00.000-08:00

Hepatitis C, obesity contribute to rising rates, new studies find

FRIDAY, Jan. 6 (HealthDay News) -- Two new studies from the Mayo Clinic find that hepatitis C infection and obesity could be to blame for a surge in liver cancer cases, which have tripled over the last 30 years.

Late-stage hepatocellular carcinoma (HCC), or liver cancer, has only a 10 percent to 12 percent five-year survival rate, according to figures in a Mayo news release. The researchers say their findings could help doctors diagnose the disease earlier and save lives.

Both studies appear in the January issue of Mayo Clinic Proceedings

Read more....

HCV Antivirals Cost-Effective for Injecting Drug Users

2012-01-07T11:03:00.000-08:00

Antivirals are cost-effective for injecting drug users where the chronic prevalence of hepatitis C virus infection is less than 60 percent, according to a study published in the January issue of Hepatology.

FRIDAY, Jan. 6 (HealthDay News) -- Antivirals are cost-effective for injecting drug users (IDUs) where the chronic prevalence of hepatitis C virus (HCV) infection is less than 60 percent, according to a study published in the January issue of Hepatology.

Natasha K. Martin, D.Phil., of the University of Bristol in the United Kingdom, and colleagues compared the cost-effectiveness of providing antiviral treatment for IDUs, ex or non-IDUs, or no treatment. They developed a model of HCV transmission and disease progression which incorporated assumptions including: a specified number of antiviral treatments to be given at the mild HCV stage over a period of 10 years, no retreatment for those who failed treatment, potential reinfection, and scenarios for baseline IDU HCV chronic prevalence of 20, 40, and 60 percent. Long-term costs and outcomes measured in quality adjusted life years (QALYs) were performed and the incremental cost-effectiveness ratio (ICER) was compared for no treatment, antiviral treatment for IDUs, and antiviral treatment for ex/non-IDUs.

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Protecting yourself from Hepatitis B

2012-01-05T11:45:00.000-08:00

Nancye Swanson does her own nails these days. Six months ago, she almost died from something she picked up at a salon.

Her skin looked yellow. Doctors told her that was a clear sign of Hepatitis B, a serious liver infection. It happened while she was getting a pedicure.

A clinical professor at UC San Diego Dr. Robert Gish said of salons, "A lot of these places use sharp instruments, and they could be re-using those."

Read more.........

Therapies Can Extend Life in Infiltrative Liver Cancer

2012-01-04T16:29:00.000-08:00

SAN FRANCISCO – Both sorafenib and transcatheter arterial chemoembolization/radiofrequency ablation can extend the lives of patients with infiltrative hepatocellular carcinoma, according to a retrospective review of 155 patients.

The radiologic-based therapy gave patients a median of 3 additional months of life; sorafenib (Nexavar) gave them a median of 4.5 months. The difference between treatments was not statistically significant.

Read more...

Experimental hepatitis C vaccine shows early promise

2012-01-04T16:26:00.000-08:00

(Reuters) - A new vaccine against the chronic liver disease hepatitis C has shown promising results in an early-stage clinical trial in humans, British and Italian scientists said Wednesday.

They said the experimental vaccine, which is based on a modified cold virus and was safety-tested in 41 people, generated immune responses similar to those seen in people who have a rare but natural defense against the disease.

Read more....

ACH-1625 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C

2012-01-04T10:45:00.000-08:00

NEW HAVEN, Conn., Jan. 4, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, announced today the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-1625 for the treatment of chronic hepatitis C virus (HCV). ACH-1625 is a once-daily protease inhibitor with broad genotypic coverage against HCV that was discovered by Achillion and is currently being evaluated in a Phase 2 clinical trial.

Fast Track designation was granted to ACH-1625 for its potential to provide:

- Improved safety and tolerability as compared to the current standard of care;

- Convenient once-daily dosing;

- Broader genotypic coverage of HCV;

- An improved drug-drug interaction profile with greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation; and

- Development in a once-daily interferon-free oral combination.

"We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor's attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."

Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases which demonstrate the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical development time and review period.

About ACH-1625

ACH-1625 is a HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM.

In the first segment of a Phase 2a clinical study, treatment-naïve genotype 1 HCV patients received doses of 200 mg, 400 mg, or 800 mg of ACH-1625 in combination with pegylated interferon and ribavirin (SOC) and achieved a rapid viral response (RVR) of 75 — 81% compared to an RVR of 20% for patients receiving SOC only. ACH-1625 was well tolerated at all doses with no serious adverse events reported and adverse events which were reported as mild to moderate and transient. The second segment of this Phase 2a, randomized, double-blind trial is evaluating the safety, tolerability and antiviral activity of once daily ACH-1625, at doses of 200 mg, 400 mg or 800 mg, in combination with SOC for 12 weeks of dosing. The primary endpoint for this trial is complete early virological response (cEVR). Following 12 weeks of therapy, patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and be eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.

Read complete release here

Experts Issue Early Guide for Hep C Protease Inhibitor Therapy in People Living with HIV

2012-01-03T16:21:00.000-08:00

A small but influential group of hepatitis C virus (HCV) experts has published provisional guidelines on the use of HCV protease inhibitors (PIs) in people living with HIV. The guidelines, published ahead of print by Clinical Infectious Diseases, are based in part on recommendations made to the Maryland AIDS Drug Assistance Program (ADAP) to help guide the use of these drugs in people coinfected with both viruses in the absence of official approvals from the U.S. Food and Drug Administration (FDA) and complete clinical trial results.

“Until additional data or alternative treatments are available,” David Thomas, MD, of the Johns Hopkins School of Medicine and his colleagues write, “some experts believe that HCV PIs should be used in combination with peginterferon and ribavirin in certain HIV/HCV-coinfected persons.”

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Can-Fite BioPharma Announces Successful Results of its Phase I/II Liver Cancer Study with its CF102 Drug; the Study Achieved the Primary and Secondary Endpoints

2012-01-03T11:20:00.000-08:00

PETAH-TIKVA, Israel, Jan 03, 2012 (BUSINESS WIRE) -- Can-Fite BioPharma Ltd (tase:CFBI), a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC).

The company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study's main objectives of safety and pharmacokinetic behavior.

The HCC study which was conducted under the supervision of Dr. Salomon M. Stemmer, Institute of Oncology, Davidoff Center, Rabin Medical Center, included 18 patients with HCC, most of them had failed prior treatment with Sorafenib (Nexavar), the only currently approved drug for this indication. The primary study objectives were to evaluate the safety profile of long-term administration of CF102 at 3 different dose levels in patients with HCC, and to determine the pharmacokinetic behavior of CF102 in this patient population. The secondary objective of the trial was to document evidence of clinical efficacy and to look at the correlation between A3 adenosine receptor expression levels at base line and patients' response to CF102.

The study data demonstrate that the trial objectives were successfully achieved, showing a very favorable safety profile for CF102 in a patient population with hepatocellular carcinoma and Child-Pugh cirrhosis classes A and B. In addition, the median overall survival time was 7.8 months, which is very encouraging data given that most patients were treated in the second-line setting and some were Child-Pugh class B. Remarkably, the median overall survival time of the Child-Pugh B patients was 9.4 months, the longest overall survival time that has been reported in the literature for this patient population.

Out of the 18 patients, 9 were infected with Hepatitis C. In 7 patients treated with the high CF102 dosages, a reduction in HCV load was observed.

According to Dr. Keith Stuart, MD, Chairman, Department of Hematology and Oncology, Lahey Clinic Medical Center, Professor of Medicine, Tufts University School of Medicine: "The safety and efficacy data of the CF102 Liver Cancer study are impressive and encouraging in the context of other investigational drugs. Therefore, I would recommend further clinical development of this drug for the treatment of patients with hepatocellular carcinoma. I hope that the present data will be reproducible and that patients could benefit from this drug."

In parallel, the company also announced today that a separate phase 1/2 study in patients with Hepatitis C (HCV) reached the study's primary objectives of safety and pharmacokinetic behavior. However, a reduction in the HCV viral load was not observed. It should be noted that patients on this study were treated for several months only with the low dose of CF102.

According to Dr. Pnina Fishman, the company CEO, "We are very pleased that the study achieved all of its objectives in patients with HCC, most of whom had failed prior treatment with Nexavar. The impressive results in the HCC study encourage us to continue development of CF102 in patients with Liver Cancer. We will focus on this disease and will continue to observe the viral load of HCC patients who also suffer from HCV."

CF102 is a small orally bioavailable drug which binds with high affinity and selectivity to the A3 adenosine receptor. The latter is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. The drug induces a robust anti-tumor effect via de-regulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells agonist at the A3 adenosine receptor.

About Can-Fite Biopharma Ltd.

Can-Fite Biopharma Ltd is a public company, trading on the Tel Aviv Stock Exchange. The company, which commenced business activity on 2000, was founded by Prof Pnina Fishman, researcher in the Rabin Medical Center, and Dr Ilan Cohen, patent attorney and senior partner at Reinhold Cohen Patent Attorneys. Prof Fishman serves as CEO of the company. The company was founded on the basis of Prof Fishman's scientific findings, and is focused on the development of small molecule drugs, ligands to the A3 adenosine receptor. The latter mediates anti-inflammatory and anti-cancer effects and is suggested as a biological predictive marker. The company's lead drug, CF101, is in advanced clinical development for the treatment of autoimmune inflammatory diseases. The CF102 drug candidate is being developed for the treatment of liver diseases. Can-Fite has a wealth of clinical experience: to date, more than 700 patients have participated in clinical trials conducted by the company. Can-Fite recently licensed its activity in the ophthalmic field to OphthaliX Inc.

About OphthaliX Inc (formerly Denali Concrete Management Inc).

OphthaliX Inc. DCMG 0.00% is an advanced clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders. Denali's product candidate, CF101, is being developed to treat three ophthalmic indications: dry eye syndrome; glaucoma and uveitis. Can-Fite holds 82.3% in OphthaliX Inc.

Can-Fite BioPharma
Pnina Fishman, Ph.D., Chief Executive Officer
Tel: +972-3-9241114
Fax: +972-3-9249378
pnina@canfite.co.il

http://www.canfite.com

SOURCE: Can-Fite BioPharma Ltd

Hepatitis C virus hijacks liver microRNAs to survive

2012-01-03T10:54:00.000-08:00

Washington: A new study has discovered how hepatitis C virus survives in the liver – helping medical scientists understand why a new antiviral drug appears to be effective against the virus.

Scientists at the University of North Carolina at Chapel Hill, working with colleagues from the University of Colorado, have found for the first time how the hepatitis C virus hijacked a small RNA molecule that regulates gene expression in human liver cells to ensure its own survival.

Read more....

Mayo study links hepatitis C to liver cancer

2012-01-03T10:52:00.000-08:00

St. Paul, Minn. — The Mayo Clinic released a study today that identifies hepatitis C as a cause of rising liver cancer rates. Researchers say with that information, more people can be screened for hepatitis C and prevent cancer.

The finding may have a particular impact on the Somali community. That's because a second study published by Mayo today says hepatitis C rates among Somalis are much higher than previously suspected.

Read more...

As part of new program, two St. Luke’s patients receive liver transplants

2012-01-01T13:50:00.000-08:00

A new liver transplant program at St. Luke’s Hospital is reporting that it has performed its first two procedures.

The first patient, a 54-year-old Parkville man diagnosed with hepatitis C, cirrhosis and liver cancer, received his liver transplant Nov. 19. The patient, Charles Jones, was on the waiting list for a donor liver for 110 days, the hospital said. He was in surgery for about four and a half hours and discharged from the hospital after six days.

Read more here: http://www.kansascity.com/2011/12/31/3346988/as-part-of-new-program-two-st.html#storylink=cpy

Free pipes distributed to curb disease

2011-12-31T12:30:00.000-08:00

Free crack pipes are being handed out to addicts in Vancouver's Downtown Eastside as part of a Vancouver Coastal Health harm-reduction project aimed to stop the spread of HIV and hepatitis B and C.

One distribution centre has handed out roughly 3,500 of the kits - which include shatterproof glass pipes - since the beginning of the month. The intention is to provide safe pipes that should reduce injury to users' lips and mouths that can make them more susceptible to disease.

Participants Needed for Hepatitis C Treatment Study. Reimbursement Available.

2011-12-29T11:23:00.000-08:00

RIS Christie, a Market Research Company, is currently recruiting respondents to participate in an on-line survey.

The objective of the study is to understand the opinions of Americans living with hepatitis C virus (HCV). The main purpose of the survey is to learn how a person may think about different treatments for the hepatitis C virus.

The online survey will take approximately 30-40 minutes to complete. Respondents will be asked to imagine being in a situation where they are being treated for Hepatitis C, and these situations will vary slightly in their attributes. Then, we would like to understand their opinion or preference for these scenarios. We will conclude by asking some demographic and clinical questions.

For their time, participants will be compensated $50.00. A cheque will be mailed to them upon completion of the survey.

Please feel free to contact us if you have any questions or would like additional information. You can reach us at 1-800-277-7530 ext. 218 or you can email us at beau@rischristie.com

Our interviewers can be reached at 1-800-277-7530 Ext. 217 or 246 (ask to speak with Antonia).

Depending on the state the person is calling from, they may not be able to get through to our 1-800 number, in which case they can send an email to fai@rischristie.com and we’ll take it from there.

Regards,

Beau Rakhra
Director of Operations
R.I.S. Christie
14 Verral Avenue
Toronto, ON M4M 2R2

Tel 1-800-277-7530 ext 218
email: beau@rischristie.com
http://www.rischristie.com

Gregg Allman touts importance of hepatitis C testing, reflects on his recovery

2011-12-29T10:56:00.000-08:00

The soft-spoken co-founder of the Macon-based Allman Brothers Band, who peppers his conversation with “sweetheart” and “my dear,” is using his visibility to inform others about the quiet symptoms of hep C – mostly fatigue – on the website, www.TuneInToHepC.com.

“People have gotta listen to what this site has to say. Doing nothing is not an option,” Allman said. “It is a blood disease and I had it since I was 20 and didn’t know it until 1999. Everybody needs to get checked for this diabolical disease. If I hadn’t had a liver transplant, I wouldn’t be talking to you right now.”

Read more....

Peregrine Provides Update on HCV Clinical Program

2011-12-29T10:52:00.000-08:00

Preliminary Data From Phase II Study Shows Antiviral Activity and Positive Safety Profile at Both Bavituximab Doses Evaluated; Supporting Further Dosing and Combination Studies; Company to Seek Collaboration to Advance HCV Program While Continuing to Focus on Its Lead Bavituximab Clinical Program in Multiple Solid Tumor Indications Including Lung Cancer

TUSTIN, CA -- (MARKET WIRE) -- 12/29/11 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today provided an update from its randomized Phase II bavituximab study in patients infected with genotype-1 chronic hepatitis C virus (HCV). Patients were randomized in the three-arm study to receive one of two doses of bavituximab (0.3mg/kg or 3mg/kg) or pegylated interferon alpha-2a, in combination with ribavirin. The goals of the study were to determine if bavituximab plus ribavirin has a better safety profile as compared to interferon plus ribavirin, to confirm that the combination of bavituximab and ribavirin has antiviral activity defined as 12 week early virologic response (EVR)(1) and to compare antiviral activity of peg-interferon plus ribavirin versus bavituximab plus ribavirin.

A preliminary data analysis indicates that the combination of bavituximab and ribavirin appeared safe and well tolerated with patients reporting fewer side effects than in the interferon-containing arm. Initial data from the study also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, however the antiviral effects in patients receiving the 0.3 mg/kg dosing level were more pronounced. A comparison of the viral data indicated that the kinetics of antiviral activity were different between the interferon and bavituximab treatment groups with a high percentage of those patients achieving EVR in the interferon arm of the study doing so between week 4 and 8 and the majority of patients achieving EVR in the bavituximab groups doing so at the week 12 end of study timepoint. More patients had achieved EVR in the interferon-containing group by the end of the study, however based on the nature of late EVR development in the bavituximab containing arms at the very end of the 12 week trial, a longer-term evaluation is needed to adequately compare the effectiveness of bavituximab and interferon. The company plans to present full results from the study at a medical conference in 2012.

"We are pleased with the initial results we have seen from this clinical study evaluating the combination of bavituximab with an established antiviral drug in HCV patients. We see good evidence that the combination of bavituximab with ribavirin has a better safety profile than an interferon containing regimen which was one of the primary objectives of the study," said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "In addition, we also see that while both dose levels of bavituximab were active, the lower dose level appears more active in HCV patients than the high dose level. Taken together, these early results are very important in validating that the combination of bavituximab with its immunological mechanism of action with an active antiviral agent has a good safety profile and promising antiviral activity. These results suggest that future studies evaluating longer bavituximab treatment durations at or around the lower dose level in combination with ribavirin and potentially direct acting antivirals in certain patient populations may hold promise as interferon-free HCV therapeutic regimens."

"The early data from this trial are promising and suggest that continued development of bavituximab in HCV patients is warranted to explore the full immune-modulating potential of the compound in combination with antiviral agents," said Steven W. King, president and chief executive officer of Peregrine. "With this data in hand, we plan to actively seek development partners interested in working with us to move the PS-targeting antiviral program forward while we continue to focus our resources on the advancement of our bavituximab oncology clinical program in multiple solid tumor indications including non-small cell lung cancer (NSCLC) and pancreatic cancers as well as other indications with high unmet medical need. With as many as six data points coming over the next six months or so from our ongoing phase II trials in front and second line NSCLC and the additional possible data points coming from five additional oncology trials, this is a good time to seek partners for the antiviral program which has shown promise in this study. We look forward to sharing full data from the HCV trial in 2012 and to moving the program forward in the future."

1. EVR is defined as equal or greater than a 2 log reduction in HCV RNA from baseline.

About the Phase II HCV Trial
In this multicenter Phase II randomized trial, 66 patients with previously untreated genotype-1 chronic HCV infection were randomly assigned to one of three treatment arms. Patients received daily oral ribavirin (1000 mg) with either weekly bavituximab (0.3 mg/kg or 3 mg/kg) or pegylated interferon alpha-2a (180 µg) for up to 12 weeks and were tested for safety parameters and antiviral activity.

About Bavituximab's Antiviral Approach
Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body's immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Read complete release here

State denies benefits for cop's widow

2011-12-28T10:37:00.000-08:00

(FOX 25 / MyFoxBoston.com) - The widow of an honored Boston police officer is fighting the state for accidental death benefits 13 years after her husband died.

Maura Shaw believes her husband, Kenneth Shaw, who processed grisly crime scenes as part of the Boston Police Department's identification unit, was essentially killed in the line of duty, but the state has denied her application over and over again because she can't show exactly how he contracted hepatitis C decades ago.

FDA Hepatitis Update - Tyzeka (telbivudine) labeling updates re: use with pegylated interferon alfa-2a

2011-12-23T11:33:00.000-08:00

On December 23, 2011, the Food and Drug Administration approved revisions to the product labeling for Tyzeka (telbivudine) to include a contraindication regarding the use of Tyzeka with Pegasys (pegylated interferon alfa-2a) due to increase risk and severity of peripheral neuropathy. The Medication Guide was also revised accordingly. The following sections were revised:

Contraindications
Combination of Tyzeka with pegylated interferon alfa-2a is contraindicated because of increased risk of peripheral neuropathy

Warnings and Precautions

Peripheral Neuropathy
Peripheral neuropathy has been reported with Tyzeka alone or in combination with pegylated interferon alfa-2a and other interferons. In one clinical trial, an increased risk and severity of peripheral neuropathy was observed with the combination use of Tyzeka 600mg daily and pegylated interferon alfa-2a 180 micrograms once weekly compared to Tyzeka or pegylated interferon alfa-2a alone [see Contraindications (4) and Drug Interactions (7)]. Such risk cannot be excluded for other dose regimens of pegylated interferon alfa-2a, or other alfa interferons (pegylated or standard). The safety and efficacy of Tyzeka in combination with pegylated interferons or other interferons for the treatment of chronic hepatitis B has not been demonstrated. Patients should be advised to report any numbness, tingling, and/or burning sensations in the arms and/or legs, with or without gait disturbance. Tyzeka therapy should be interrupted if peripheral neuropathy is suspected, and discontinued if peripheral neuropathy is confirmed

Drug Interactions:
A clinical trial investigating the combination of Tyzeka, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of peripheral neuropathy occurrence and severity, in comparison to Tyzeka or pegylated interferon alfa-2a alone

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Incivek and Victrelis Usage as Part of Triple Therapy Hepatitis C Regimen is Emerging as the New Standard of Care for Genotype 1 Patients According to a Newly Released Report by BioTrends Research Group

2011-12-23T10:59:00.000-08:00

EXTON, Pa.--(BUSINESS WIRE)-- Six months post-launch of Vertex’s Incivek (telapravir) and Merck/Roche’s Victrelis (boceprevir), specialists report a significant increase in usage of both products in their genotype 1 HCV patients compared to one month post-launch. Incivek remains the market share leader, though the gap in preference for Incivek over Victrelis is beginning to narrow compared to previous waves of research. Surveyed hepatologists reported using significantly more Incivek than infectious disease specialists.

Not all Genotype 1 patients are being treated with this new standard of care, however. Patient resistance to being re-treated with any interferon regimen is still quite high. On the flip side, 49% of the surveyed physicians do report trial for the protease inhibitors in other genotypes despite a lack of supportive clinical data. With regards to products in development, surveyed physicians report the greatest familiarity with Pharmasett’s PSI-7977, an investigational nucleoside polymerase inhibitor that is currently being tested in a phase 3 clinical trial without the use of interferon.

Read more....

Updated: Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

2011-12-23T10:48:00.000-08:00

Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Hepatitis B virus (HBV) causes acute and chronic infection of the liver leading to substantial morbidity and mortality. In the United States, since 1996, a total of 29 outbreaks of HBV infection in one or multiple long-term–care (LTC) facilities, including nursing homes and assisted-living facilities, were reported to CDC; of these, 25 involved adults with diabetes receiving assisted blood glucose monitoring (1; CDC, unpublished data, 2011). These outbreaks prompted the Hepatitis Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) to evaluate the risk for HBV infection among all adults with diagnosed diabetes. The Work Group reviewed HBV infection–related morbidity and mortality and the effectiveness of implementing infection prevention and control measures. The strength of scientific evidence regarding protection was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology,* and safety, values, and cost-effectiveness were incorporated into a recommendation using the GRADE system. Based on the Work Group findings, on October 25, 2011, ACIP recommended that all previously unvaccinated adults aged 19 through 59 years with diabetes mellitus (type 1 and type 2) be vaccinated against hepatitis B as soon as possible after a diagnosis of diabetes is made (recommendation category A). Data on the risk for hepatitis B among adults aged ≥60 years are less robust. Therefore, ACIP recommended that unvaccinated adults aged ≥60 years with diabetes may be vaccinated at the discretion of the treating clinician after assessing their risk and the likelihood of an adequate immune response to vaccination (recommendation category B). This report summarizes these recommendations and provides the rationale used by ACIP to inform their decision making.

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Incivo approved in Scotland

2011-12-23T10:41:00.000-08:00

Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland¹

Janssen PharmaceuticalPosted on:23 Dec 11

Shortens the course of treatment for many (58%) treatment naive genotype-1 chronic hep C patients compared to current standard treatment²

High Wycombe, 12th December 2011 – Today the Scottish Medicines Consortium (SMC) has recommended that INCIVO® (telaprevir)* should be made available for the treatment of genotype-1 chronic hepatitis C (hep C), in combination with peginterferon alfa and ribavirin (i.e. current standard treatment), in adults in Scotland who have not previously had treatment and adult patients for whom treatment has previously failed¹.

Telaprevir, a new direct acting antiviral (DAA) protease inhibitor (PI), one of a new class of medicines which directly targets the Hep C virus, now offers significantly more patients infected with genotype 1 chronic hep C in Scotland the chance of clearing the virus (achieving sustained virologic response, SVR)^2,3,4 compared to current standard treatment.

“I welcome the news that telaprevir can now be prescribed for patients living with chronic genotype-1 hep C in Scotland. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus” said Dr John F Dillon, Consultant Hepatologist and Gastroenterologist, University of Dundee Ninewells Hospital. “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”

In Scotland, it is estimated that 50,000 individuals are infected with hep C⁵. Hep C is a significant public health threat. It is highly infectious, often has no symptoms and can lead to fatal liver conditions. Of those who develop hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation⁶. Hep C is the most common reason for liver transplants in Europe7. A model, developed in Scotland, which looks at transmission rates for hep C has shown that effective treatment of the disease, assuming a 62.5% SVR rate, could reduce the onward transmission of the virus and its occurrence in the community. Taking this into account it could be expected that effective treatment of hep C with a treatment regimen that achieves a higher SVR rate will, in the longer term, reduce the risk of transmission among the population and lower the burden of hep C on NHS Scotland⁸. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in only about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome⁶.

Clinical trials have shown that a telaprevir based regimen is significantly more effective than standard treatment in all genotype-1 patient types, including those with advanced liver disease such as cirrhosis. The addition of telaprevir cleared the Hep C virus in almost twice as many previously untreated patients (79% vs. 46%, p<0.0001) and almost four times as many who had previously relapsed following treatment (84% vs. 22%, p<0.001)^3,4,9. It also offers the potential to halve the current total treatment duration to just six months in many (58%) previously untreated patients and prior treatment relapsers^2,3,9.

The marketing authorisation for telaprevir was based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE^3,4,9 which evaluated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin in more than 2,290 treatment-naïve and previously-treated chronic genotype 1 hep C patients. Data from ADVANCE and REALIZE were published in the 23rd June 2011 edition of the New England Journal of Medicine (NEJM). Data from the ILLUMINATE study were published in the 15th September 2011 edition of the NEJM. This marked the sixth paper to be published on telaprevir in the NEJM^10,11,12.

The overall safety and tolerability profile of telaprevir is based on the phase II and III clinical development programme. The most frequently reported moderate adverse reactions (incidence = 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea2.Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients².

* INCIVO® (telaprevir), a direct acting antiviral protease inhibitor, was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceutical Companies of Johnson & Johnson, and the company responsible for marketing telaprevir in Europe.

References
1.The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed December 2011
2.Telaprevir Summary of Product Characteristics 2011
3.Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.
4.Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.
5.Hepatitis C Action Plan for Scotland Phase II May 2008-March 2011
6.TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 2010
7.Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
8.Martin NK, Vickerman P, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility. J Hepatol 2011 Jun;54(6):1137-44
9.Sherman et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011: 365; 1014-24.
10.McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303.
11.Hezode et al. Telaprevir and Peginterferon Alfa with or without Ribavirin for Chronic HCV. Engl J Med 2009; 360; 1839-50.
12.McHutchinson et al. Telaprevir with Peginterferon Alfa and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009; 360: 1827-38.

For more information:
http://www.janssen.co.uk

Hepatitis outbreak grows

2011-12-23T10:36:00.000-08:00

Health Department secures vaccine; now seven cases confirmed

--Outbreak comes as the Lincoln County Commission has scheduled to close the local Health Department office on Friday, Dec. 30, for budget cuts--

An outbreak of Hepatitis C has surfaced in Lincoln County, according to Marci Johnson, communicable diseases coordinator of Lincoln County.

“We’re still investigating it, but right now we’ve got seven confirmed cases,” Johnson said Sunday afternoon. “I’ve been in contact with the state, and they have agreed to supply us with the vaccines for Hepatitis A and B at no charge.”

Read more....

Bristol-Myers liver cancer drug Brivanib fails

2011-12-22T16:54:00.000-08:00

BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed

--Primary endpoint of study not met--

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today reported that the Phase III BRISK-PS (Brivanib Study in HCC Patients at Risk Post Sorafenib) clinical trial in patients with hepatocellular carcinoma (HCC; liver cancer) who failed or are intolerant to sorafenib did not meet the primary endpoint of improving overall survival versus placebo.

BRISK-PS is a multicenter, double-blind, randomized study of the investigational agent brivanib plus best supportive care (BSC) versus placebo plus BSC in HCC in patients who have progressed on sorafenib. Bristol-Myers Squibb and the lead investigators plan to present the findings of the study, including secondary efficacy and safety endpoints, at an upcoming scientific meeting. The BRISK-PS study is one of four Phase III clinical trials evaluating brivanib in different HCC patient populations. These ongoing Phase III studies continue as planned.

“The treatment options for patients with HCC following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer, and the ongoing study investigating brivanib ‘first-line’ is expected to complete in 2012.”

About Bristol-Myers Squibb’s Commitment to Liver Disease and Brivanib

Bristol-Myers Squibb is advancing a portfolio of compounds that aim to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. Brivanib is an investigational, oral, anti-tumorigenic being developed by Bristol-Myers Squibb for the treatment of hepatocellular carcinoma (HCC). Brivanib inhibits vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptors (FGFR). Brivanib has been investigated in 29 studies to date, including more than 4,000 patients around the world.

Read complete press release here

Child gets hepatitis C from transplant at Boston hospital

2011-12-22T16:46:00.000-08:00

A child treated at Children’s Hospital Boston was infected with hepatitis C by a piece of a blood vessel that was transplanted in September from a donor who was infected. Two people in Kentucky who received kidneys from the same donor also were infected, the federal Centers for Disease Control and Prevention reported today.

The agency traced the transmission in Massachusetts to an error in tissue testing and delays in communication between the Kentucky transplant center and public health officials. The incident highlights the need for improvements in transplant safety and tracking, said Dr. Matthew J. Kuehnert, director of the Office of Blood, Organ, and Other Tissue Safety at the CDC.

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Drug Users in California to Have Better Access To Clean Needles

2011-12-21T11:33:00.000-08:00

Starting next year, injection drug users will have easier access to clean syringes. Two new laws are part of an effort to prevent transmission of diseases such as Hepatitis C and HIV.

Studies show needle exchange programs are effective in reducing HIV transmission.

California has thirty-seven exchange programs, and a new law could help authorize more.

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Bioethicist: Slashing funds for clean needles is risky for rest of us

2011-12-20T10:52:00.000-08:00

Giving clean needles to IV drug addicts saves lives – and money. That’s why the federal government should be spending your tax dollars to keep drug users -– and the people who have sex with them -- from getting AIDS and hepatitis.

But Republicans in Congress have decided that despite a veritable mountain of scientific evidence showing that needle-exchange work, they are not going to pay for this sort of program any more.

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Chinese doctors find way to detect liver cancer earlier

2011-12-19T11:04:00.000-08:00

SHANGHAI, Dec. 19 (Xinhua) -- A simple test using just one milliliter of a patient's blood can tell whether the patient has liver cancer -- even if the tumor is less than two centimeters in diameter, new medical research in Shanghai shows.

Doctors at the Zhongshan Hospital, a major medical institution affiliated with Fudan University, have found that seven microRNAs, or ribonucleic acid molecules, are strongly related to liver problems. This discovery can raise the accuracy of tests for early-stage liver cancer to almost 90 percent.

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Safe injection site plan is scientifically sound: health official

2011-12-18T11:48:00.000-08:00

Despite Ottawa's opposition, strategy reduces ODs, infections, doctors agree

A report released Friday by the Montreal public health department recommends that three supervised injection sites and a mobile one be established next year in city neighbourhoods where intravenous drug use is rampant.

"We are convinced - and all the scientific studies back us up on this point - that supervised injection sites do not create new problems," Lessard told The Gazette. "On the contrary, they reduce the problem of syringes found on the streets and in the parks, and they reduce the number of overdose deaths."

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Congress to Restore Federal Syringe Exchange Funding Ban as Part of 2012 Spending Package

2011-12-17T11:07:00.000-08:00

Drug Policy Alliance

www.drugpolicy.org

For Immediate Release: December 16, 2011
Contact: Tony Newman or Bill Piper

Congress to Restore Federal Syringe Exchange Funding Ban as Part of 2012 Spending Package

Ban on Allowing States to Use HIV Prevention Money on Life-Saving Syringe Programs was Overturned in 2009 After 20-Year Struggle

Reinstatement of Ban will Lead to Thousands of New HIV/AIDS, Hepatitis C Cases Annually

As part of the 2012 spending package being voted on today, Congress is restoring a ban on using federal funding for syringe exchange programs that reduce the spread of HIV/AIDS, hepatitis C, and other infectious diseases. The ban, enacted in the 1980s and repealed in 2009, was largely responsible for hundreds of thousands of Americans contracting HIV/AIDS directly or indirectly from the sharing of used syringes. Advocates warn that restoring the ban will result in thousands of Americans contracting HIV/AIDS, hepatitis C or other infectious diseases next year alone.

“The federal syringe funding ban was costly in both human and fiscal terms – it is outrageous that Congress is restoring it given how overwhelming and clear the science is in support of making sterile syringes widely available,” said Bill Piper, director of national affairs for the Drug Policy Alliance. “Make no mistake about it – members of Congress who supported this ban have put the lives of their constituents in jeopardy.”

House Republicans passed restrictive language in three separate appropriations bills, and succeeded in getting two of three bans in the current House-Senate compromise omnibus for Fiscal Year 2012 being voted on today. In addition to the overarching ban on domestic use of federal funds contained in the Labor-HHS spending bill, House republicans also succeeded in imposing a ban on use of State Department funds for syringe access in international programs. In large parts of the world the HIV/AIDS epidemic is being driven by injection drug use. The international syringe funding ban will mean the global HIV/AIDS epidemic will continue to grow.

The existing federal syringe exchange policy, signed into law by President Obama in December of 2009, allows states and local public health officials to use federal funds for syringe access, in consultation and with the consent of local law enforcement. The policy change is widely credited with having prevented thousands of new cases of HIV and Hepatitis C, thereby saving many lives and improving public health and safety.

The Centers for Disease Control and Prevention (CDC), American Medical Association, National Academy of Sciences, American Public Health Association, and numerous other scientific bodies have found that syringe exchange programs are highly effective at preventing the spread of HIV/AIDS and other infectious diseases. Increasing the availability of sterile syringes through exchange programs, pharmacies and other outlets also helps injection drug users obtain drug education and treatment. Eight federal reports have found that increasing access to sterile syringes saves lives without increasing drug use.

“We may have lost this battle, but we have just begun to fight,” said Piper. “The Republicans who insisted on restoring the ban, and the Democrats who didn’t fight hard enough to oppose it, will be responsible for thousands of Americans contracting HIV/AIDS or hepatitis C. We will make sure Americans know which members of Congress care about their health and well-being and which do not.”

Safety (Still) Trumps Acquisitions in Hep C

2011-12-17T11:03:00.000-08:00

The euphoria over Gilead Sciences' (Nasdaq: GILD ) acquisition of Pharmasset (Nasdaq: VRUS ) and Roche's purchase of Anadys Pharmaceuticals seems to have caused memory loss in investors.

But they got a reminder of reality today, when Pharmasset announced it was discontinuing all treatment arms in one of its phase 2b trials that contain the drug PSI-938. The drug candidate caused laboratory abnormalities in tests associated with liver function.

This is nothing new.

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Research could solve donor liver shortage

2011-12-16T16:30:00.000-08:00

Research from Curtin University could see bio-engineered liver tissue used instead of donor tissue for liver transplants.

The research aims to address the increasing burden of liver disease and shortage of donor organs occurring in all Western countries.

Dr Nina Tirnitz-Parker, research fellow at Curtin’s School of Biomedical Sciences, has spent the past eight years developing a method of bio-engineering liver cells, or hepatocytes, to replace tissue lost to disease or injury.

Read more.......

Outbreak of Hepatitis A on Vancouver Island Hitting Aboriginals Hard

2011-12-16T12:00:00.000-08:00

Aboriginal people on the West Coast of Vancouver Island are being hit hard by an outbreak of Hepatitis A, according to Vancouver Island Health Authority (VIHA) chief medical health officer Paul Hasselback.

“Of the last 17 cases that were diagnosed, 15 of them are from the Alberni Valley and West Coast,” Hasselback said in early December. “We’ve seen clusters of Hep A in various locations, but right now the cluster is there.”

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Pharmasset Halts Studies with PSI-938

2011-12-16T11:04:00.000-08:00

Pharmasset Inc. has discontinued use of an experimental hepatitis C drug in a clinical trial because of safety concerns, but the drug maker said the setback wouldn't derail its planned sale to Gilead Sciences Inc. for nearly $11 billion.

The company said Friday it discontinued use of a drug code-named PSI-938 in a midstage study of people with hepatitis C infection, citing "laboratory abnormalities associated with liver function." However, it will continue testing its lead hepatitis C drug candidate, PSI-7977, which was the primary selling point behind the Gilead deal and ...

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Merck and Roche team up for hepatitis C studies

2011-12-16T11:01:00.000-08:00

The first study will look at a regimen based on Merck's recently-approved oral NS3/NS4a inhibitor Victrelis (boceprevir) alongside Roche's investigational NS5B inhibitor mericitabine (RO5024048) and already-marketed drugs Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).

The phase II study - called DYNAMO 1 - will enrol adult patients with HCV genotype 1 infection who have failed to respond to prior treatment with peginterferon alfa/ribavirin therapy.

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Clinical Care Options Launches CCO Hepatology inPractice™, Adding a Third Specialty to its Comprehensive Online Resource

2011-12-16T10:50:00.000-08:00

RESTON, Va., Dec. 15, 2011 -- /PRNewswire/ -- Clinical Care Options (CCO), a leader in the development of innovative online, print, and live medical education programs and medical education technologies for healthcare professionals, is proud to announce the launch of CCO Hepatology inPractice™, the third specialty area for the free, online point-of-care resource for clinicians that provides critical information for the management of viral hepatitis. CCO HIV inPractice™ and CCO Oncology inPractice™, now used around the world, are available at inPractice.com.

CCO Hepatology inPractice™, authored by 14 world-renowned experts and led by Editors in Chief Nezam H. Afdhal, MD, FRCPI, of Harvard University; Norah Terrault, MD, MPH, of the University of California, San Francisco; and Stefan Zeuzem, MD, of JW Goethe University Hospital, provides a single easy-to-use search interface. Performing a search on Hepatology inPractice initially allows the busy clinician direct access to the first 10 original, expert-authored chapters designed specifically for point-of-care use, integrated with drug information, treatment guidelines, conference coverage, PubMed abstracts, and ClinicalTrials.gov.

Read more: http://www.sacbee.com/2011/12/15/4125174/clinical-care-options-launches.html#ixzz1gj0rNIog

Pharmasset Announces Intent to Amend QUANTUM Trial

2011-12-16T10:37:00.000-08:00

PRINCETON, N.J., Dec. 16, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the company will amend the design of the QUANTUM Phase 2b trial of the guanine nucleotide analog PSI-938 and discontinue all treatment arms with a regimen containing PSI-938. There are 235 individuals with hepatitis C virus (HCV) in the study who are receiving treatment with PSI-938 alone or in combination with PSI-7977 or PSI-7977 and ribavirin. During routine safety monitoring, the company detected laboratory abnormalities associated with liver function in subjects receiving PSI-938 300 mg once daily. These laboratory abnormalities have not been observed in patients receiving PSI-7977 and ribavirin in the QUANTUM study or in other trials evaluating PSI-7977. Both the 12 and 24-week PSI-7977 and ribavirin arms will continue unchanged, data from which will support NEUTRINO, an interferon free, 12-week Phase 3 study of PSI-7977 and ribavirin in patients with HCV genotype 1 (GT-1).

The subject of today's announcement does not trigger the "key product event" clause set forth in section 4.1(t) of the Agreement and Plan of Merger entered into by Pharmasset and Gilead Sciences, Inc. on November 21, 2011 and does not alter either party's rights and obligations under the terms of the agreement. Pharmasset anticipates that the transaction announced on November 21, 2011 will conclude in the first quarter of 2012.

SOURCE Pharmasset, Inc.

URGENT ACTION REQUESTED: Syringe Exchange Federal Ban

2011-12-15T11:12:00.000-08:00

The House Republican Leadership has released an appropriations omnibus bill that includes language banning the use of federal funding for syringe exchange programs. This policy-rider is included in the bill, despite proven evidence that syringe exchange programs are a key tool in our viral hepatitis and HIV/AIDS prevention arsenal. Additionally, this is particularly troubling in an era in which reducing new infections is a principle goal of the HHS Viral Hepatitis Action Plan. While the House bill has been released to the public, there remain opportunities to oppose this measure.

Viral hepatitis and HIV/AIDS community advocates continue a multi-pronged strategy to ensure this measure is not included in the final FY2012 appropriations bill, including reaching out to key House and Senate allies. While the House has made its bill public, there is an opportunity to weigh-in with the Senate (i.e., both your own U.S. Senators and key Senate Leadership negotiating the scope of the bill and any potential policy-riders). Calls on this issue to individual offices can make a difference.

Please take a couple of minutes to call the White House, your Senator (click here to access the Senate directory) and Senate Leadership in this order:

Harry Reid, Senate Majority Leader - 202-224-3542

Dick Durbin, Senate Majority Whip - 202-224-2152

Chuck Schumer, Democratic Policy Committee Chair - 202-224-6542

Daniel Inouye, Appropriations Chairman - 202-224-3934

Tom Harkin, HHS Appropriations Subcommittee Chair- 202-224-3254

President Obama- 202-456-1414

YOUR SENATORS (click here to access the Senate directory)

Here is a script you can use for calls:

“My name is _______ and I’m from ______, __ (city, state). I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for syringe exchange. This evidence-based prevention approach will reduce new HIV and viral hepatitis infections, which is a key goal of the National HIV/AIDS Strategy and the Viral Hepatitis Action Plan. The House proposed bill includes a ban on the use of federal resources for these important programs, which will harm HIV and viral hepatitis prevention efforts. Please do not allow a change in the current law. Thank you.”

Please take the time to call and to pass this message on to your other contacts! Please contact Oscar Mairena if you have any questions.

Oscar Mairena

Senior Associate, Viral Hepatitis/Policy and Legislative Affairs

National Alliance of State & Territorial AIDS Directors (NASTAD)

444 North Capitol Street NW, Suite 339

Washington, DC 20001

Phone: (202) 434.8058 Fax: (202) 434.8092

omairena@NASTAD.org www.NASTAD.org

"Bridging Science, Policy, and Public Health"

Obesity and Diabetes Epidemics Spur Increase in Nonalcoholic Steatohepatitis

2011-12-14T10:53:00.000-08:00

Liver Transplantations for NASH-Cirrhosis Grew More than 600% over Past Decade

Nonalcoholic steatohepatitis (NASH) occurs when fat builds up in the liver. This accumulation of fat damages the liver and leads to cirrhosis. NASH is rapidly increasing in the U.S. mainly related to the epidemics of obesity and diabetes. As a result, the proportion of liver transplantations performed for NASH cirrhosis rose dramatically from roughly 1% in 1997-2003 to more than 7% in 2010. However, according to new research published in Liver Transplantation, a peer-reviewed journal of the American Association for the Study of Liver Diseases, post-transplantation survival for NASH patients is excellent, with one-year survival rates near 88%.

Excessive fat in liver cells in the absence of alcohol is known as non-alcoholic fatty liver disease (NAFLD) and is the most common liver disease in the U.S., affecting nearly 30% of the general population experts say. Previous research found that 15% to 20% of those with NAFLD have NASH—the most severe form of fatty liver causing inflammation and fibrosis. Primary risk factors for both NAFLD and NASH are central obesity, insulin resistance, and diabetes, all of which are increasingly prevalent and could impact the future demand for liver transplantation. In fact, prior studies suggest that by 2025 more than 25 million Americans may have NASH, which may progress to cirrhosis, liver cancer, and liver failure in 20% of these cases. This influx of new cases has the potential to dramatically worsen the shortage of organs available for transplantation.

In the current study, Dr. Anita Afzali and colleagues from the University of Washington in Seattle investigate the proportion of liver transplantations of NASH-related cirrhosis in the U.S. and estimate survival rates of those patients following transplantation. “With the epidemics of obesity and diabetes giving rise to cases of NAFLD and NASH, it is important to understand the impact of these metabolic conditions on the outcomes after liver transplantation,” says Dr. Afzali.

The researchers used data collected by the United Network for Organ Sharing (UNOS) for all liver transplants performed in the U.S. from January 1, 1997 to October 31, 2010. A total of 53,738 transplant patients 18 years of age or older were included in the analysis. The team collected data on primary diagnosis for all study patients, categorizing those as NASH, cryptogenic cirrhosis, hepatitis C virus (HCV), alcohol-related cirrhosis, primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), hemochromatosis, autoimmune hepatitis, acute hepatic necrosis, and hepatocellular carcinoma (HCC).

The research found that only 279 transplantations for NASH-cirrhosis (1.2%) were performed between 1997 and 2003, but increased dramatically to 1,531 (7.4%) between 2004 and 2010. The team found that by the end of the study period NASH was the fourth most common indication for transplantation behind HCC (34%), HCV (22%), and alcohol-related liver disease (11%). Survival was excellent among patients with NASH with 88% surviving at one year, 82% at three years, and 77% at five years following liver transplantation.

Patients with NASH had higher survival rates than patients with HCC, HCV, alcoholic liver disease, acute hepatic necrosis, hemochromatosis and cryptogenic liver disease, but were lower than those with PBC, PSC, autoimmune hepatitis and HBV. Post-transplantation survival was similar in NASH patients compared to non-NASH patients, despite being older, more obese, and more likely to have diabetes. Their analysis shows deaths caused by recurrent disease occurred in roughly 9% of NASH patients compared to 17% of patients without NASH. The authors believe this is likely due to a greater frequency of recurrence of diseases such as HCV in those without NASH.

“Our study confirms post-transplantation survival in recipients transplanted for NASH is excellent and comparable to patients with other liver diseases,” concludes Dr. Afzali. “With the shortage of available donor organs, appropriate allocation of livers is an important concern for transplant centers and our findings indicate NASH-cirrhosis patients are potentially good candidates for liver transplantation. However, careful screening for cardiovascular disease prior to transplantation and monitoring of underlying cardiac and metabolic conditions following transplantation is recommended to ensure optimal survival for patients with NASH.”

Full citation: "Excellent Post-Transplantation Survival in Patients with Non-Alcoholic Steatohepatitis in the United States.” Anita Afzali, Kristin Berry, George N. Ioannou. Liver Transplantation; (DOI: 10.1002/lt.22435) Print Issue Date: January 2012. http://onlinelibrary.wiley.com/doi/10.1002/lt.22435/abstract.

Author Contact:To arrange an interview with Dr. Afzali, please contact Carrie Silverman with the University of Washington at carries@medicine.washington.edu or at 206-235-3223.

About the Journal
Liver Transplantation. is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society . Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation. delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation.

About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Hepatitis B genotype B associated with poorer liver-related outcomes in Taiwanese patients co-infected with HIV and hepatitis B

2011-12-13T11:46:00.000-08:00

Liver-related outcomes are poorer in HIV-positive patients who are co-infected with hepatitis B virus genotype B compared to co-infected patients with hepatitis B genotype C, Taiwanese investigators report in the online edition of Clinical Infectious Diseases.

The prospective, observational study involved individuals who commenced antiretroviral therapy containing 3TC (lamivudine, Epivir, also in the combination pill Combivir), a drug which has activity against both viruses. The patients were recruited between 1997 and 2008, and followed until 2010.

Read more....

Co-infection with hepatitis B worsens HIV-related outcomes

2011-12-13T11:05:00.000-08:00

Co-infection with hepatitis B virus increases the risk of AIDS or death for patients newly diagnosed with HIV, investigators from the US military report in the online edition of the Journal of Infectious Diseases.

Individuals with chronic hepatitis B infection were twice as likely to progress to AIDS/death compared to patients who were only infected with HIV.

Read more.....

Important sign-on for viral hepatitis and HIV/AIDS organizations: Support a High National Standard for Essential Health Benefits

2011-12-12T17:07:00.000-08:00

Note that sign-ons are needed by noon Eastern time this Wednesday, 12/14. To sign, email Ryan Clary at rclary@projectinform.org

Dear NVHR member:

Reports are that the essential health benefits package rules may already be at the Office of Management and Budget(OMB) and may be issued as guidance rather than regulations. Additionally - states will have significant flexibility in determining the benchmark for their EHB package (see clip below).

The HIV and viral hepatitis communities are circulating the attached letter to send to Secretary Sebelius and OMB calling for a robust national standard for people with HIV and viral hepatitis to reduce health disparities among these populations and improve our nation’s public health.

To sign on – please email Ryan Clary at rclary@projectinform.org by noon on Wednesday (12/14). Apologies for the quick turnaround.

From InsideHealthPolicy:

Essential Health Benefits

Several sources confirmed last week to IHP's Rachana Dixit that the Office of Management and Budget had received paperwork on the health law's Essential Health Benefits package. The OMB hasn't posted information yet, leading many to believe that the paperwork is likely guidance rather than a proposed rule – which it would be required to post.

Meanwhile, as Dixit notes, business and insurance groups have been urging HHS in private discussions to craft an essential health benefits package that is not only affordable but also flexible in nature and are anxiously awaiting to see how specific the EHB regulation or guidance will be in terms of benefits and cost-sharing. Industry sources say they were encouraged by several of the recommendations in the highly anticipated Institute of Medicine report on essential health benefits, including that the initial EHB package should be guided by a national average premium target and it should be linked to the actuarial value of a typical small employer plan. Yet industry officials remain concerned that the rule will not provide the flexibility they seek, worrying that HHS may follow CMS' more rigid approach with Medicare benefits and that a recent decision with respect to preventive services coverage could serve as a signal for what direction the department will take with EHB, sources say.

Sign-on letter text:

December XX, 2011

The Honorable Kathleen Sebelius
Secretary
United States Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Sebelius:

We are writing on behalf of the more than 5 million people with hepatitis B or C (viral hepatitis) and 1.2 million with HIV/AIDS in the United States to express serious concerns regarding reports about the pending release of the federal standards for the EHB package. Specifically, we are concerned that the EHB package rules may be issued as guidance rather than regulations and that the guidance will offer significant flexibility to states in selecting the benchmark for their EHB package.

The ACA offers unprecedented opportunity to ensure people with HIV/AIDS and viral hepatitis have affordable access to the medical care that they need to stay healthy and productive regardless of where they reside in the United States. In addition, the EHB package will apply to a wide range of populations – including newly-eligible Medicaid beneficiaries, those eligible for subsidized insurance in the Exchanges, and those eligible for coverage through Basic Health Plans – and the standard set by HHS must be able to meet the needs of these populations. However, allowing considerable state and local discretion with regard to the EHB definition runs counter to the protections for vulnerable populations explicitly articulated in the ACA, including ensuring that the package is designed in ways that do not “discriminate against individuals because of their age, disability, or expected length of life” and ensuring that the package “take into account the health care needs of diverse segments of the population, including women, children, persons with disabilities, and other groups.” (§ 1302(b)(4). Setting a high national standard for the EHB package for benefits coverage and benefits design is critical to realizing the potential of the ACA and for ending the cruel disparities and gaps in coverage experienced by these populations due in part to the significant state variation in public and private health coverage programs and rules.

Many people with HIV/AIDS and viral hepatitis are currently uninsured or underinsured as a result of insurance practices that bar them from coverage entirely or policies that impede access to medically necessary care. These practices include unreasonable cost-sharing, limits on services or complex administrative and utilization management processes driven by reducing expenditures rather than promoting the standard of care. A failure to set a high national EHB standard will undermine the new insurer rules intended to end these discriminatory practices and increase state-based health disparities.

The National HIV/AIDS Strategy and National Viral Hepatitis Plan were developed in recognition of our failure to adequately address the prevention and care needs of people with HIV and viral hepatitis in the United States. A robust national EHB standard is critical to strengthen our response to these epidemics and to improving our nation’s public health. We strongly urge you to ensure people with HIV/AIDS and viral hepatitis gain meaningful health coverage by setting the highest possible EHB standard and issuing explicit regulations (as opposed to guidance) on how the EHB package is to be implemented so that there is a meaningful standard across the United States.

Respectfully submitted,

Doctors say they have no duty to lock up sedatives

2011-12-12T10:51:00.000-08:00

DENVER (AP) — Denver doctors tell lawyers they don't have a duty to lock up surgery sedatives in a lawsuit over a surgery technician who infected patients with hepatitis C.

Dr. Sherry Gorman says she was not responsible after Joshua Kraft got infected by a dirty needle in 2009. Kristen Parker later pleaded guilty to several charges of tampering with a consumer product and illegally obtaining a controlled substance.

Read more...

Amick: The needle exchange debate

2011-12-12T10:47:00.000-08:00

For those working to achieve sensible public-health policies in New Jersey, two important questions await answers in the waning days of 2011.

Question 1: The Legislature completed action last week on a bill to allow pharmacies to sell up to 10 hypodermic needles to adults without a prescription. By enabling intravenous drug addicts to obtain clean syringes, the measure would reduce the spread of HIV, hepatitis C and other blood-borne diseases. Will Gov. Chris Christie sign it into law? As of this writing, his administration says only that the bill “will get careful review and consideration.”

Read more....

Federal funding for syringe exchange is under attack!

2011-12-12T10:33:00.000-08:00

Harm Reduction Coalition

Dear friends:

Advocates went to the Senate this morning and we have heard that negotiations on the federal spending bills, including policy riders which would ban syringe exchange funding, are taking place at the highest levels. Syringe exchange may be in danger. We need to get calls to the offices below. Please take 5 minutes to make some calls ASAP while there is still time!!

Please make 4 calls (in this order) TODAY to the President, Senate Majority Leader Reid, Senator negotiators and leadership from your state, and Speaker Pelosi.

Calling the President:

Please call President Barack Obama: 202-456-1414

The message for the President is: My name is _______. I live in . Thank you for your past support of syringe exchange. I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange. Please do not allow the Senate or House to change the current law in the Fiscal Year 2012 Appropriations negotiations. Thank you

Calling Senate Majority Leader Reid and Other Senators:

*Harry Reid (D-NV) Majority Leader: 202-224-3542

The Message for all of the Senators including Senator Reid is:

My name is _______. I live in . I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange. Please do not change the current law in the Fiscal Year 2012 Appropriations negotiations. Thank you

Alaska

Lisa Murkowski (R): 202-224-6665

Arkansas

Mark Pryor (D) : 202-224-2353

Hawaii

*Daniel Inouye (D) Appropriations Chairman: 202-224-3934

Illinois

*Dick Durbin (D) Majority Whip, Financial Services Subcommittee Chair: 202-224-2152

Mark Kirk (R): 202-224-2854

Iowa

*Tom Harkin (D) Labor, HHS Subcommittee Chair: 202-224-3254

Louisiana

Mary Landrieu (D): 202-224-5824

Montana

Jon Tester (D): 202-224-2644

Nebraska

Ben Nelson (D): 202-224-6551

New York

*Chuck Schumer (D) Democratic Policy Committee Chair: 202-224-6542

Kirsten Gillibrand (D): 202-224-4451

--- (Note although not a negotiator or leadership, Sen. Gillibrand has been very responsive on HIV/AIDS issues ask her to weigh in with Schumer and her appropriations colleagues)

Rhode Island

Jack Reed (D-RI): 202-224-4642

South Dakota

Tim Johnson (D-SD): 202-224-5842

Vermont

Patrick Leahy (D-Vt.): 202-224-4242

Washington

Patty Murray (D-Wash): 202-224-2621

Calling Speaker Pelosi:

Please call Speaker Nancy Pelosi: 202-225-0100

The message for the Speaker is: My name is _______. I live in . Thank you for your past support of syringe exchange. I support maintaining current language that allows local officials to make their own decisions to use federal and local Washington DC funds for Syringe Exchange. Please do not allow the Senate or House to change the current law in the Fiscal Year 2012 Appropriations negotiations. Thank you

Thank you for your attention to this issue. Please call now – Share with your friends. We absolutely need to keep up the calls as long as we can.

You can also email a message to your Senators, telling them to refuse to compromise on syringe exchange.

Decisions are being made today - Monday, December 12th - so we have to act now!

Click here to send an email to your Senators. Feel free to customize the letter, telling your Senators why syringe exchange matters to you and your state.

Please take action today - time is critical

Please let Senate leadership and conferees know that these policy riders are unacceptable. HIV and hepatitis C prevention is too important to trade away.

Take action now

Thanks for your help - and please feel free to forward this message widely.

Sincerely,
Daniel Raymond

Hepatitis C cases drop in P.E.I. since opening of needle exchange

2011-12-12T10:24:00.000-08:00

SUMMERSIDE, P.E.I. - The chief health officer in P.E.I. says there a fewer cases of hepatitis C in the province thanks in part to an expanding needle exchange program.

The program started in Charlottetown in 2009.

Read it on Global News: Hepatitis C cases drop in P.E.I. since opening of needle exchange

Patient Advocate Foundation Announces $9.3 Million Donation to their Co-Pay Relief (CPR) Program

2011-12-10T11:46:00.000-08:00

-- Additional Funding to CPR Program Will Serve Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Breast Cancer, Colon Cancer, Rheumatoid Arthritis, Hepatitis C Patients in Need of Financial Assistance--

WASHINGTON, Dec. 9, 2011 /PRNewswire-USNewswire/ -- Patient Advocate Foundation (PAF) is pleased to announce that it has received a $9.3 million contribution, from an existing partner, providing further support through its Co-Pay Relief Program (CPR) for patients suffering from nonsquamous non-small cell lung cancer (NSCLC), breast cancer, colon cancer, rheumatoid arthritis and hepatitis C who are unable to afford their medical co-payments. These funds are currently available to qualified patients.

PAF's CPR Program provides direct financial support for pharmaceutical co-payments to insured patients, including Medicare Part D beneficiaries, who financially and medically qualify. Since the program's inception in April 2004, CPR has distributed more than $130 million in assistance to more than 50,000 patients nationwide who were unable to afford their pharmaceutical co-payments.

Read more:

Hepatitis C Medicines Save Lives in Cambodia

2011-12-09T16:48:00.000-08:00

Merck and AmeriCares Partner to Provide Treatment for Patients in Need

Tan Sou Chin, who suffers from Hepatitis C, did not have access to the treatment she needed for her life-threatening illness. Like many impoverished families in Cambodia, Mrs. Sou Chin, 54, and her husband, who recently lost his job as a fisherman, struggled daily to provide for their six children. Thanks to a hepatitis treatment program supported by AmeriCares and product donations from Merck (known as MSD outside the U.S.), she was able to get the treatment she needed to survive.

Nearly 10 percent of the population in Cambodia is infected with the Hepatitis C virus, but few have access to treatment. Merck’s donations have allowed physicians to effectively treat the disease for those in need, reducing the risk of liver cirrhosis, liver cancer and liver failure.

Read more....

Boehringer Ingelheim completes patient entry for Phase III trial programme in Hepatitis C

2011-12-09T11:25:00.000-08:00

INGELHEIM, Germany, December 9th, 2011 – Boehringer Ingelheim today announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2,000 treatment-experienced as well as treatment-naïve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia.

The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat. The study programme evaluates “sustained viral response” (SVR) as the primary clinical endpoint, which is considered viral cure. Results from the Phase III studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the entire BI 201335 programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

“We are progressing our BI 201335 programme with a high priority to leverage its potential to improve cure rates in HCV treatment,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide.”

Phase IIb results presented last month showed that the interferon-free combination of BI 201335, with Boehringer Ingelheim’s polymerase inhibitor BI 207127 (SOUND-C2), led to 76% of patients achieving a virological response at week 12, with 63% achieving SVR12 (undetectable virus, 12 weeks post-treatment) with 16 weeks treatment. These results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, alongside SILEN-C1 and SILEN-C3 study results which showed the potential for BI 201335/ PegIFN/RBV to shorten treatment duration and improve the likelihood of viral cure (SVR). These Phase IIb results provide a strong basis for further development as BI 201335 progresses through Phase III.

SOUND-C2
SOUND-C2 is an open-label, randomised, Phase IIb study where 362 treatment-naïve GT1 HCV patients were randomised into five interferon-free treatment groups, each with 120mg BI 201335 once daily but with different dosing of BI 207127 and treatment durations as follows:

BI 201335 120mg QD + BI 207127 600mg TID + RBV for 16 weeks;
BI 201335 120mg QD + BI 207127 600mg TID + RBV for 28 weeks;
BI 201335 120mg QD + BI 207127 600mg TID + RBV for 40 weeks;
BI 201335 120mg QD + BI 207127 600mg BID + RBV for 28 weeks; or
BI 201335 120mg QD + BI 207127 600mg TID without RBV for 28 weeks.

SILEN-C1 SILEN-C1 is a double-blind, placebo-controlled trial, that randomised 429 treatment-naïve GT1 HCV patients (1:1:2:2) to receive either placebo or
BI 201335 120 mg with three days Lead-in (LI) of PegIFN/RBV, BI 201335 240 mg QD with three days LI or BI 201335 mg 240mg QD without LI. In each treatment group, BI 201335 was given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Patients were evaluated for SVR according to various baseline characteristics.

SILEN-C3 In this open-label Phase II trial, 159 treatment-naïve GT1 HCV patients were randomised to receive 120 mg QD BI 201335 for 12 or 24 weeks, each after three days lead-in (LI) with pegylated interferon and ribavirin (PegIFN/RBV). In both groups, PegIFN/RBV was given for 24 weeks. Patients who did not achieve an eRVR, continued PegIFN/RBV to week 48. eRVR was defined as viral load less than 25 IU/mL at week 4 and undetectable at weeks 8-18.

BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials currently ongoing. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

Read complete release here

Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C

2011-12-09T11:17:00.000-08:00

Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C-

-Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012-

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alios BioPharma, Inc. today announced the initiation of two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, which are inhibitors of the hepatitis C NS5B polymerase. The studies will evaluate the safety and tolerability of ALS-2200 and ALS-2158 in healthy volunteers followed by a seven-day evaluation to observe the effects on viral kinetics in people with chronic genotype-1 hepatitis C. Data are expected in the second quarter of 2012, which could enable the initiation of studies to evaluate multiple all-oral, interferon-free combination regimens for chronic hepatitis C in the second half of 2012. Vertex has worldwide development and commercialization rights for ALS-2200 and ALS-2158, which were discovered by Alios BioPharma. Alios and Vertex are jointly conducting the Phase 1 studies announced today.

"These studies are an important step in our ongoing efforts to strengthen our leadership position in hepatitis C by developing all-oral regimens that could further improve the future treatment of this disease," said Peter Mueller, Ph.D., Executive Vice President, Global Research and Development, and Chief Scientific Officer for Vertex. "The studies of ALS-2200 and ALS-2158 announced today are designed to generate data that may provide the opportunity to rapidly advance into Phase 2 development where we could evaluate a number of nucleotide-based regimens beginning in the second half of next year, including regimens with INCIVEK or VX-222."

Study Design
The two Phase 1 studies announced today will be randomized, double-blind, placebo-controlled studies. The primary goals are to evaluate the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C. A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.

Dosing is now underway for the study of ALS-2200, and dosing is expected to begin next week for the study of ALS-2158. Vertex and Alios BioPharma expect to have complete data, including seven-day viral kinetic data, from each trial in the second quarter of 2012, which could enable the initiation of all-oral, interferon-free Phase 2 combination studies in the second half of 2012. These Phase 2 studies are expected to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK (telaprevir) or VX-222, potential dual nucleotide regimens and other interferon-free combination regimens that may also include ribavirin. INCIVEK is Vertex's FDA-approved protease inhibitor for chronic genotype-1 hepatitis C, and VX-222 is Vertex's investigational hepatitis C non-nucleoside polymerase inhibitor. The combination studies will be designed to generate sustained viral response (SVR or viral cure) data.

About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are highly potent pan-genotypic nucleotide analogues that appear in in vitro and non-clinical studies to have a high barrier to drug resistance and the potential to be dosed orally once-daily. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound is structurally distinct and has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens, including regimens with INCIVEK^TM (telaprevir) and VX-222. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in those in vitro studies, both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.

Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.

About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 1,900 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

About Alios BioPharma
Alios BioPharma is a biotechnology company located in South San Francisco, California, that is developing novel medicines aimed at the treatment of viral diseases. Alios has an innovative team of highly experienced scientists and clinical researchers who are developing direct acting antiviral agents against several human viral pathogens of public health importance including, hepatotropic and respiratory viruses and other chronic, acute and emerging viral diseases. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability. Alios is the recipient of the 2011 BayBio Pantheon Outstanding Partnering Award.

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HCV Infection May Predict Coronary Artery Disease

2011-12-08T11:51:00.000-08:00

NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.

"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.

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Lipid-modifying enzyme: New target for pan-viral therapeutics

2011-12-07T11:10:00.000-08:00

Presented at ASCB annual meeting, Dec. 3 to 7, Denver

Three different disease-causing viruses -- poliovirus, coxsackievirus, and hepatitis C -- rely on their unwilling host for the membrane platforms enriched in a specific lipid, phosphatidylinositol 4 phosphate (PI4P) on which they can replicate, Rutgers University researchers said on Dec. 7, at the American Society for Cell Biology annual meeting in Denver.

The viruses carry proteins that enable them to gain access to the P14P lipid for replication. The proteins snare one of the host's own lipid-modifying enzymes, a Type III PI4-kinase (PI4-kinase), reported Nihal Altan-Bonnet, Ph.D., of Rutgers University.

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Biotron brings hope for Hepatitis C sufferers

2011-12-07T11:08:00.000-08:00

Performed in Thailand, the phase 2a trial of its drug BIT225 with conventional treatment showed that 87 per cent of those who used the drug had undetectable levels of the virus in their blood after three months.

That is a significant advance on conventional anti-viral treatment alone and holds out hopes that a new combination treatment could one day completely rid the body of a Hep C infection.

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HBV and HCV Advocate Hepatitis Blog

Hepatitis A vaccination rates vary greatly from state to state

Cardiopulmonary Exercise Testing May Predict Post-Liver Transplantation Survival

Cell Permeable Peptide Identified that Inhibits Hepititis C Replication

Stem cells may shed light on hepatitis, MIT researchers find

Alcohol Treatment Boosts Hep C Cure Rates Among Drinkers

Syringe Exchange Program Ban Position Statement

Sign the Position Statement

Cortland sees spike in Hepatitis C in drug users

Statins May Stave Off Liver Cancer in People With Hepatitis B

Study found lower risk of developing disease for people taking these cholesterol-cutting drugs

VIHA moves cautiously to step up efforts for harm reduction

Urgent Online Petition on Essential Health Benefits

The sharp side: B.C. hospitals aim to safeguard health professionals from sharp instruments

Drop in effectiveness of HCV treatment in national VA practice

New NC Law Aims to Prevent Infectious Diseases

“B A Hero” PSA Video Contest Announced by Hep B Free Philadelphia and Hepatitis B Foundation

Genoscience, BioLineRx to develop and commercialize BL-8020 for HCV

Pharmasset’s Hepatitis C Drug: How it Could Change Australia

Hep C victim holds hope for others

Entry point for hepatitis C infection identified

Vertex Vows to Fight On With Alios Drugs in High-Stakes Hepatitis C Race

New National Hepatitis C Helpline Promises "One Call – Lots of Help"

Community Health Center launches new video conferencing technology

New law will slow spread of pathogens

Funding for needle exchange programs drying up

Advocates say the public should consider the cost-effectiveness of the programs, which help to prevent the spread of diseases.

A second chance at life

Common side-effects of hepatitis C protease inhibitors: clinical management advice published

DOH receives $40k for hepatitis education efforts

Many high-risk Americans don't get hepatitis B vaccine

Harm reduction programs threatened

Hepatitis C infection identified as leading risk factor for HCC

Hope for Hepatitis C

First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published

Scientists show brain vulnerable to Hepatitis C virus

Israelis find vitamin D helps against liver diseases

Kidney failure risk higher for liver transplant patients following allocation policy change

Researchers Discover Means for Blocking Hepatitis C Infection

FREE HIV and Hepatitis C testing coming to Guerneville Jan 18, 2012

CDC Warns Against Sharing Insulin Pens

Doing so exposes people with diabetes to blood-borne infection risk

Hep C threat to health services

Merck Hepatitis C Drug May ‘Anchor' Future Worldwide Regimen

Alarming Incidence of Hepatitis C Virus Re-Infection After Treatment of Sexually Acquired Acute Hepatitis C Virus Infection in HIV-Infected MSM

New Target and FDA-Approved Cholesterol-Lowering Drug Identified for HCV Therapy

No link yet between hepatitis B, C cases and Ottawa clinic

New Fibrosis Classification Improves Accuracy of Diagnosis in Hepatitis C

High Rates of Disability and Health Care Use for Older American with Cirrhosis

Achillion Reports Clinical Data on Portfolio of Protease Inhibitors

Presidio Pharmaceuticals Reports Progress with Hepatitis C Antiviral Programs

Idenix Reports Advancement of HCV Development Pipeline

Idenix Reports Positive Interim Data for HCV Nucleotide Inhibitor, IDX184

Bristol-Myers Squibb to Acquire Inhibitex

Researchers Identify Liver Cancer Risk Factors

Hepatitis C, obesity contribute to rising rates, new studies find

HCV Antivirals Cost-Effective for Injecting Drug Users

Protecting yourself from Hepatitis B

Therapies Can Extend Life in Infiltrative Liver Cancer

Experimental hepatitis C vaccine shows early promise

ACH-1625 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C

Experts Issue Early Guide for Hep C Protease Inhibitor Therapy in People Living with HIV

Can-Fite BioPharma Announces Successful Results of its Phase I/II Liver Cancer Study with its CF102 Drug; the Study Achieved the Primary and Secondary Endpoints

Hepatitis C virus hijacks liver microRNAs to survive

Mayo study links hepatitis C to liver cancer

As part of new program, two St. Luke’s patients receive liver transplants

Free pipes distributed to curb disease

Participants Needed for Hepatitis C Treatment Study. Reimbursement Available.

Gregg Allman touts importance of hepatitis C testing, reflects on his recovery

Peregrine Provides Update on HCV Clinical Program

State denies benefits for cop's widow

FDA Hepatitis Update - Tyzeka (telbivudine) labeling updates re: use with pegylated interferon alfa-2a

Incivek and Victrelis Usage as Part of Triple Therapy Hepatitis C Regimen is Emerging as the New Standard of Care for Genotype 1 Patients According to a Newly Released Report by BioTrends Research Group

Updated: Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Incivo approved in Scotland

Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland1

Hepatitis outbreak grows

Bristol-Myers liver cancer drug Brivanib fails

Child gets hepatitis C from transplant at Boston hospital

Drug Users in California to Have Better Access To Clean Needles

Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland¹