The maker of antiviral and antibacterial treatments is hunting for big partners, similar to its agreement with Gilead Sciences, to test and produce new products

By Gene Marcial

Investors scouting for depressed stocks that could spring positive surprises are turning to the biotechnology sector, which didn't significantly participate in the market's frenzied three-month rally. Analysts note that what's being pursued are biotech companies with compounds that show promise to become compelling drugs and whose stocks are still at depressed levels.

One young biotech that some pros say possesses this kind of profile is Achillion Pharmaceuticals (ACHN), which is developing antivirals and antibacterials aimed at chronic hepatitis-C, HIV, and serious hospital-based bacterial infections. Although the company is tiny and unprofitable, its research and products under development have lured some big pharmaceutical companies such as Gilead Sciences (GILD). (See my previous Inside Wall Street column.)

Achillion's stock price "doesn't adequately account for potential advancements of the company's clinical programs, possible new partnerships, and potential for royalty revenue generation," says biotech analyst Brian McCarthy of Noble Financial Capital Markets. The stock has climbed from a 52-week low of 62¢ on Dec. 31, 2008, to 1.35 on June 26. That is still way below its 52-week high of 3 on July 23, 2008.

McCarthy figures that based on its current cash position of about $27 million and near-term clinical advancement of the company's hepatitis drug programs, "Achillion's shares could drive up to a fair value approaching 4.50 a share." (Noble Financial expects to do banking for Achillion.)
FDA Trial Approval Expected

Achillion's attraction centers on its two hepatitis-C virus candidates--ACH-1625 and ACH-1095, which are expected to undergo their first in-human clinical trials soon. ACH-1625 is capable of once-daily dosing and has been tested for safety, says Michael Kishbauch, Achillion's president and CEO.

The Food & Drug Administration is expected to approve this month Achillion's application to start the in-human clinical trials, according to some industry sources. Achillion is in active talks to partner with a big pharmaceutical company to further develop and commercialize the ACH-1625 protease inhibitor, says Kishbauch.

As for ACH-1095, the leading drug candidate for an oral treatment for hepatitis, Achillion has restructured its partnership with Gilead in its development, deciding to go it alone, with Gilead still retaining its basic rights to the drug. (However, Gilead could rejoin in the drug's development later in its production.) So far, Achillion has received $8 million in up-front licensing payments and an additional $2 million in Achillion stock purchased by Gilead. The original partnership agreement projected that Gilead would pay up to $157 million to Achillion, plus an undisclosed royalty on net sales for 10 years from the date of the first sale, according to McCarthy.

Finding a partner for ACH-1625 and the imminent in-human clinical trials of the drug are two positive developments that should drive the stock higher, analysts say. For ACH-1625, McCarthy assumes a market penetration of 20% when launched, a 10% success rate based on clinical studies, and a 2013 launch of the product, "with a peak annual risk-adjusted royalty-based sales nearing $16 million as early as 2015."

Meanwhile, ACH-1095, which Achillion says has demonstrated "significant potency in laboratory assays," is also expected to gain a market penetration of 20%, a 10% success rate, a launch in 2013, and peak sales of $16 million by 2015, according to McCarthy.
HIV Co-Formulation Product

Achillion's third major product, called Elvucitabine, is aimed at treating HIV and has an "attractive safety profile at appropriate doses," says Phil Nadeau, biotech analyst at investment firm Cowen (COWN), who rates the stock outperform. (Cowen expects to do business with Achillion.) Elvucitabine could be a product for "co-formulation" with existing HIV products to enhance treatment of the disease, he adds.

The company expects to sign a commercial partner for Elvucitabine in the next 12 months, says Nadeau. Achillion has disclosed that several companies have signed confidentiality agreements concerning the product and received confidential data packages from the drug's phase 2 clinical trials, he notes.

"This is a smart strategy, as a strong partner, particularly one with the ability to co-formulate Elvucitabine with another class of antiviral, could add significantly to Elvucitabine's potential," says Nadeau. And by teaming up with Achillion and creating a "combo" pill, the partner would get a share of the $2 billion cytosine inhibitor in the HIV treatment market, he adds. Achillion will move Elvucitabine into phase 3 clinical trials once a partner is signed up, says Nadeau.

Adam Cutler, biotech analyst at Canaccord Capital, believes Achillion's stock is inexpensive and rates it a buy. "Achillion could start clinical trials of HCV protease inhibitor ACH-1625 very soon and move ACH-1095 into trials by the end of 2009," he says. Cutler thinks the next catalyst for Achillion could be a partnership announcement or initiation of ACH-1625 trials. His 12-month price target is 2.75. (Canaccord has done banking for Achillion.)

Analyzing and assessing the true market value of biotechs can give investors headaches, since the companies usually have to spend a lot of money and expend a lot of time in developing new drugs. Without doubt, patience and a lot of diligent research are required to find hidden gems in the complex biotech sector. But therein lie the big rewards, as returns could be quite healthy for investors from these tiny, and often risky, biotechs.

Marcial writes the Inside Wall Street column for BusinessWeek. In 2008, FT Press published the book Gene Marcial's 7 Commandments of Stock Investing.

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URL for Article Source:
http://www.businessweek.com/investor/content/jun2009/pi20090628_268277.htm

24-June-2009

By Staff Reporter

CTS-1027 is an oral, small molecule compound that inhibits the activity of matrix metalloproteinases

Conatus Pharmaceuticals (Conatus) has initiated the second phase-II clinical trial with a drug candidate, for the treatment of liver disease associated with Hepatitis C Virus (HCV) infection. The trial will enroll patients for whom treatment with approved standard of care treatments is not currently advised.

CTS-1027 is an oral, small molecule compound that inhibits the activity of key members of a class of protease enzymes, the matrix metalloproteinases or MMPs. CTS-1027 had previously shown to be effective in multiple preclinical models of inflammatory liver disease and HCV infection.

The clinical trial is a double-blind, placebo-controlled trial, testing an optimized dose of CTS-1027 alone or in combination with ribavirin. Dosing will last for up to 24 weeks. The company expects approximately 70 patients to be enrolled. The clinical trial will be conducted at 25 medical centers in the US.

Results from an earlier clinical trial in HCV patients who failed standard of care treatment, are expected to be reported later this year.

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URL for Article Source:
http://www.pharmaceutical-business-review.com/news/conatus_pharmaceuticals_initiates_second_phaseii_hepatitis_trial_090624

On medical leave from his company since mid-January, Apple CEO Steve Jobs has received a liver transplant. Because Jobs is an extremely wealthy man, his receipt of a liver transplant from Methodist University Hospital Transplant Institute in Memphis has prompted people to question if money can impact how organs are allocated.

Jobs' Health
Jobs' received surgery five years ago for a rare form of pancreatic cancer, an islet cell neuroendocrine tumor. Several doctors without firsthand knowledge about Jobs' health said the type of pancreatic cancer he had tends to be slow and if it were to spread, the liver is the first likely target.

In the beginning of 2009, Jobs reported that he was suffering from an easily treatable hormone imbalance and would remain Apple's CEO. Less than two weeks later, he said his medical problems were more complex, and that he would take a medical leave of absence for the first half of the year. While it is likely that the ambiguity surrounding his illness was intended to ease investor's fears, Jobs' receipt of a liver transplant confirms that he must have been extremely ill.

Top of the List
Many with end-stage liver disease spend years on the liver transplant list - hoping for a chance at survival. Especially because Jobs had not been previously linked with liver problems, it appears as if Jobs unjustly jumped to the top of the liver transplant waiting list.

In response to this concern, Methodist Healthcare assured the public that Jobs followed all protocols for evaluation and the liver transplant wait list. Methodist Healthcare added that Jobs was the sickest patient on the waiting list at the time a donor organ became available. In the U.S., the wait list for liver transplants is based on how sick a patient is, not how long they have been on the wait list.

In a June 24, 2009 press release from the United Network for Organ Sharing (UNOS), "whenever a person known to the public receives a transplant, it is tempting to compare that person's waiting time to national averages. Any comparison of one person's experience to that of thousands of others can be misleading." Known as a MELD score, liver waiting time is greatly influenced by a formula that assigns priority for organ offers based on the candidate's risk of dying within three months without a transplant. MELD uses objective calculations of common laboratory tests of liver and kidney function.

Improving the Odds
While UNOS' system aims to assure that livers are allocated based on need, Jobs found that there is a way to improve your chances of scoring an organ transplant. With the resources to travel upon a moment's notice and pay out of pocket for his medical care, Jobs obviously did his homework on liver transplantation. The following three strategies for improving transplant odds may have helped Jobs:

1. Finding a transplant center - The Scientific Registry of Transplant Recipients is an Internet database that gives average wait times, success rates and other details on every transplant program in the nation. "Anyone can go to that website and see which transplant centers transplant quicker than others," said Dr. Anthony D'Alessandro, liver transplant chief at the University of Wisconsin-Madison. According to UNOS, a transplant in Tennessee has a median waiting period of just 48 days, while the national median wait is 306 days.

2. Getting on a list - To get on a transplant center's list, a prospective patient must go there, be evaluated by the staff and have tests to confirm medical need. If accepted, the patient must be able to get to that center within seven or eight hours if an organ becomes available.

3. More than one - People can get on as many wait lists as they like as long as they can travel there and meet the transplant center's terms. According to UNOS, accepting someone already on another waiting list is at each transplant program's discretion.

By better understanding how the transplant system works, it is apparent that Jobs could not have "cheated" the system. Instead, he researched all of his options and used his resources to give him the best possible chance of survival. In addition to trusting that UNOS allocates organs based on need, researching the nation's liver transplant centers could help expedite a much-needed liver transplant.

References:

http://www.cbsnews.com/stories/2009/06/21/eveningnews/main5101417.shtml, Jobs' Liver Transplant Raises Questions, Retrieved June 26, 2009, CBS Interactive, Inc., June 21, 2009.

http://www.unos.org/news/newsDetail.asp?id=1265, PTN Statement Regarding Liver Transplant Waiting Times and Allocation, Retrieved June 27, 2009, United Network for Organ Sharing, June 24, 2009.

http://www.usatoday.com/news/health/2009-06-25-jobs-transplant_N.htm, Jobs' liver transplant shows money can make a difference, Marilynn Marchione, Retrieved June 26, 2009, USA Today, June 2009.

http://www.webmd.com/cancer/pancreatic-cancer/news/20090624/steve-jobs-liver-transplant-confirmed, Steve Jobs' Liver Transplant Confirmed, Miranda Hitti, Retrieved June 26, 2009, WebMD Health News, June 24, 2009.

Contact: Aimee Frank
newsroom@gastro.org
301-941-2620
American Gastroenterological Association
Liver disease: Better monitoring, better prognosis
Health outcomes explored at DDW 2009

CHICAGO, IL (June 1, 2009) - The latest research in liver disease being presented at Digestive Disease Week® 2009 (DDW®) has important implications for tracking disease development in patients and for current and future transplant recipients. Researchers are making great strides in diagnosing and treating liver disease.

"The research being presented during DDW shows how widespread our efforts are in understanding and treating liver disease," said Brent Tetri, MD, Saint Louis University. "These studies take us one step closer to better monitoring of liver disease, improving our ability to accurately determine prognosis, more appropriate organ allocation and lower rejection rates in liver transplantation."

DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Text Messaging Reduces Rejection in Pediatric Liver Transplant Recipients (Abstract #175)

Text messaging may improve compliance rates in pediatric liver transplant recipients, reduce organ rejection and provide significant cost savings with medications and hospitalizations, according to a new study. Children and adolescents who receive liver transplants often have trouble remembering to take their medication regularly; in addition to being less vigilant than adults, liver patients also suffer memory problems. Missing medication is especially dangerous since their bodies can reject the transplanted liver after only two missed doses of medication. But because young people are generally technologically savvy, researchers sought to determine whether sending text messages would result in improved adherence.

The study looked at 41 young people who were on average 15 years old and at various stages after receiving a liver transplant. The MediM AS system from CareSpeak Communications, which funded the study, was used to decide which time of day patients/or caregivers preferred to receive a medication reminder via text message, which were then sent accordingly. To ensure that patients not only received the message but also took their medication, patients had 15 minutes to send a reply text confirming intake. If they did not, MediM AS system would automatically alert their parents to follow up with their child via another text message. Researchers tracked by computer how many times patients replied, did not reply or had to have parental intervention.

To determine the effectiveness of the text reminders, researchers looked at two factors: the level of medication in the patient's blood and whether their bodies rejected the liver transplant. Patients who took medication erratically had a higher deviation of medication in their blood, compared to patients who took their medication regularly. In the year prior to the study, 12 of 41 patients experienced rejection that required hospitalization and treatment because the patient's body rejected the transplant due to improper medication dosage. But one year into this study, just two patients suffered rejection of the liver.

Lead investigator Tamir Miloh, MD, assistant professor in pediatric hepatology and surgery at Mount Sinai Hospital in New York, said that since one liver transplant for graft loss costs a few hundred thousand dollars, and with the costs associated with rejection therapy, the text reminders may help save resources and reduce complications of rejection therapy. "The implications for this study are vast because this practice could be used for many other chronic diseases," said Dr. Miloh, who is currently conducting another randomized study with more patients.

Previous studies have looked at the effectiveness of text reminders, but not on liver patients and not on a scale of this size.

Dr. Miloh will present these data on Sunday, May 31 at 2:45 p.m. CDT in South Hall, McCormick Place.

The Point of Care 13C Methacetin Breath Test Accurately Predicts Long Term Prognosis with Chronic Liver Disease: A Non-Invasive Liver Function Test (Abstract #S1837)

Researchers at the Hadassah Hebrew University Medical Center in Israel have discovered an effective new tool for assessing the prognosis of patients with chronic liver disease that could have important implications in determining which patients are most appropriate candidates for liver transplantation.

Previously, prognosis in patients with chronic liver disease has been determined by using a combination of blood tests. However, this method is limited to predicting prognosis for up to three months and may only change after a life threatening complication has occurred.

Using a test called the 13C-Methacetin breath test, a rapid, non-invasive procedure, investigators were able to accurately predict the survival of liver disease patients for a period of up to two years. The test is conducted with the patient drinking a cup of water containing a dissolved substrate. The device then measures the appearance of tagged CO2 (the product of the hepatic metabolism of the 13C-Methacetin) in the exhaled breath; the patient does not do anything except sitting and breathing normally.

Studying 575 patients with varying types and degree of liver disease, investigators showed that the breath test can predict which patients will develop complications that will affect their prognosis.

"The potential for this test is tremendous," said Gadi Lalazar, MD, of the liver unit at the Hadassah Hebrew University Medical School. "Not only can we predict long term prognosis in patients with chronic liver disease, but we can also use it in acute liver disease to determine liver function on a daily basis and determine how well therapy is working. This is something we have never been able to do before."

Researchers believe that the accuracy of the test, and its capacity to assess liver function, makes the breath test a potentially powerful new tool in predicting prognosis of liver related complications, prioritizing patients for organ transplantation, and predicting their ability to survive surgery.

Dr. Lalazar will present these data on Sunday, May 31 at 8 a.m. CDT in South Hall, McCormick Place.

Cumulative Incidence and Risk Factors of Hepatocellular Carcinoma (HCC) in Patients with End-Stage Liver Disease Secondary to Nonalcoholic Steatohepatitis (Abstract #290)

There is a significant risk of developing of liver cancer in patients with nonalcoholic steatohepatitis, or NASH, according to a study from the Cleveland Clinic. The study also found that mild alcohol consumption may significantly increase the risk of developing liver cancer in patients with end stage liver disease.

NASH is one of two stages of non-alcoholic fatty liver disease, the most common liver disease in the U.S. Unlike the benign stage known as fatty liver, NASH has the potential to cause cirrhosis and liver failure. Until now, evidence linking NASH with liver cancer has been limited and inconsistent.

In a retrospective study of more than 500 patients with either HCV-cirrhosis (hepatitis C) or NASH-cirrhosis over a three year period, researchers found that 20 percent of patients with HCV-cirrhosis and 12.8 percent of patients with NASH-cirrhosis developed hepatocellular carcinoma (liver cancer). The annual risk for developing liver cancer in HCV patients is 4 percent per year and that of NASH patients is 2.6 percent per year. The annual risk for NASH patients was previously unknown. While the rates are higher for patients with HCV, the risk of developing liver cancer for NASH patients is significant.

Investigators also sought to identify modifiable risk factors in effort to potentially reduce the burden of liver cancer in this patient population. They found that even mild alcohol consumption may significantly increase the liver cancer risk in patients with end-stage liver disease.

"This study offers valuable insight into the care of patients with NASH," said Nizar N. Zein, MD, chief of hepatology and medical director of liver transplantation at the Cleveland Clinic. "Not only do we need to adjust the way we follow these patients, including tracking and preparing for the potential development of liver cancer, but we may also need to counsel this patient population against any alcohol intake given its risk."

Dr. Zein will present these data on Monday, June 1 at 8:45 a.m. CDT in S105, McCormick Place.

Public Awareness and Attitudes towards Non Alcoholic Fatty Liver Disease (NAFLD) (Abstract #T1006)

Patient awareness of non-alcoholic fatty liver disease (NAFLD) and its complications is poor and must be improved to ensure prevention, detection and treatment of the condition. NAFLD is the most common cause of abnormal liver enzymes and one of the most common causes of cirrhosis of the liver in the U.S. It poses a significant health burden worldwide. In the U.S., chronic liver disease and cirrhosis are the tenth leading cause of death.

Researchers conducted a survey of 5,000 outpatient adults asking about awareness levels of NAFLD and its risk factors. Ninety-eight percent of the patients said their physicians had never talked about NAFLD with them. By contrast, a previous study on colorectal cancer found that 40 percent were aware of that disease and its risk factors.

"It is both disturbing and significant that a surprisingly high number of respondents were uninformed about this silent but deadly disease," said Sury Anand, MD, chief of gastroenterology at Brooklyn Hospital Center.

The survey also found that 95 percent did not realize that fat in the liver could cause serious health problems and 80 percent had never heard of cirrhosis. Dr. Anand said prevention is especially critical since treatment options for NAFLD are limited. Public awareness of NAFLD must rise to the level of other chronic diseases and conditions, which can best be achieved with the active participation of primary care physicians, pediatricians and other providers in counseling their patients to adopt preventive lifestyle modifications.

He recommends that doctors encourage patients to maintain healthy weight by having a good balanced diet and regular exercise to fend off NAFLD in the similar way that patients need to limit their carbohydrate intake in order to prevent prediabets and diabetes. The study subjects were all from Brooklyn, New York, and Dr. Anand said investigators may consider a follow-up study that surveys a larger group throughout the country. His group intends to survey primary physicians' and residents' awareness about NAFLD.

Dr. Nan Sandar will present these data on Tuesday, June 2 at 8 a.m. CDT in South Hall, McCormick Place.

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DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the AGA Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 - June 4, 2009, at the McCormick Place Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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URL for Article Source:
http://www.eurekalert.org/pub_releases/2009-06/aga-ldb052809.php

16-June-2009

By Staff Reporter

Phase-III direct trial of once-daily Infergen with Ribavirin in Hepatitis C virus treatment failures.

Pennsylvania-based Three Rivers Pharmaceuticals has announced positive results from phase-III direct trial of once-daily Infergen with Ribavirin in Hepatitis C virus treatment failures.

Among participants who failed initial treatment with PEG-IFN/RBV, retreatment with Infergen in combination with RBV, yielded sustained virological response rates (as high as 31.6%) in interferon-sensitive patients with low baseline liver fibrosis scores. Overall intent to treat analysis was 6.9% among the 9 mcg/day group and 10.7% in the 15 mcg/day group.

Direct trial, a phase III, randomized, open-label, multicenter, US-based trial was conducted to investigate the efficacy, tolerability, and safety of daily Infergen at dosages of 9 and 15 mcg/day, administered with daily weight-based RBV.

Patients with cirrhosis were less likely to benefit from retreatment with Infergen and RBV, unless they displayed previous interferon sensitivity of at least 1-log drop in viral levels on prior therapy.

Donald Kerrish, President and CEO of Three Rivers Pharmaceuticals, said: "These results represent a significant step forward for HCV patients who deserve a second chance at a potential cure for this chronic viral infection."

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URL for Article Source:
http://www.pharmaceutical-business-review.com/news/three_rivers_presents_positive_results_for_phaseiii_hepatitis_c_trial_090616

By combining prescribed medications, alternative medicine and lifestyle modifications, many people with Hepatitis C are able to triumph over this liver infection. However, Hepatitis C can cause irreparable damage to the liver if it is not detected and addressed early enough. Characterized by the hardening and shrinking of the liver, cirrhosis is the late stage of liver disease where this organ is unable to properly function. Unfortunately, cirrhosis not only presents challenges to Hepatitis C treatment, but it is also a leading cause of mortality. While no simple solution exists to help cirrhosis, experts offer several suggestions to help a person live with this Hepatitis C complication.

Globally, approximately 170 million people are chronically infected with Hepatitis C, with an estimated four million living in the U.S. The longer a person harbors this virus, the more opportunity it has to cause liver damage. Although it typically takes one or two decades, researchers estimate that about one in five Americans with chronic Hepatitis C develops cirrhosis.

Combination Therapy
Consisting of pegylated interferon and ribavirin, combination therapy is the current standard of treatment for Hepatitis C infection. Although this treatment has a success rate of approximately 50 percent, those whose liver disease has advanced to cirrhosis don't fare as well. There are two main reasons for this disadvantage:

1. Every Viral Particle - For treatment to be effective, every single viral particle must be eliminated. The scar tissue in a cirrhotic liver provides many places for the Hepatitis C virus to hide. Because some surviving viral particles dodge the treatment, it is common for people with cirrhosis to relapse after combination treatment.

2. Side Effects - Even though the originally prescribed dosage offers the best hope for success, the severe side effects of combination therapy prohibits many from persevering through treatment at full strength. Unfortunately, those with cirrhosis typically don't tolerate full doses of interferon and ribavirin very well. Because of a cirrhotic liver's limitations, white blood cell and platelet counts often drop quickly, causing many people with cirrhosis to become anemic on combination therapy.

Six Tips for Managing Cirrhosis
In order to prevent cirrhosis from shutting down the liver, those affected must prioritize their health. As such, learning about and incorporating the following tips will help those with advanced liver disease to prevent complications and maintain their health for as long as possible:

Tip 1: Alcohol Abstinence - Alcohol is a well-known toxin and accelerator of liver damage and Hepatitis C viral replication. Thus, there is no amount of alcohol that is safe for someone with cirrhosis.

Tip 2: Multivitamins in Moderation - While many take vitamins to support their health, certain ingredients can be dangerous with cirrhosis.

· Vitamin A is toxic to the liver, so those with cirrhosis should not exceed 5,000 units per day. When ingested in the form of beta-carotene, there is no liver toxicity.

· If taken in doses over 1,200 IU per day, Vitamin E could cause bleeding. Because bleeding varices is a common complication of cirrhosis, Vitamin E intake should be carefully monitored.

· Since iron promotes the formation of scar tissue in the liver, those with cirrhosis who are not iron deficient should not take multivitamins with iron.

Tip 3: Milk Thistle - Those with cirrhosis don't want to lose any more functioning liver cells. Because milk thistle has been shown to strengthen and thus protect liver cells from damage, supplementing with this popular herb may help shield this organ from further scarring.

Tip 4: Immunizations - Because multiple hepatitis infections will worsen cirrhosis, patients with Hepatitis C should be immunized against Hepatitis A and Hepatitis B. In addition, influenza and pneumococcal vaccines are advised because those with cirrhosis are more likely to die from these infections than otherwise healthy people.

Tip 5: Yearly Dentist Visits - Dental care is crucial to those with advanced liver disease. Gingivitis or infection of the gums can leak bacteria into the blood stream, causing potentially severe infections in those with cirrhosis. Additionally, if a liver transplant is needed, the presence of gingivitis is cause to deny that person from receiving a liver.

Tip 6: Diabetes Awareness - People with Hepatitis C and cirrhosis have a higher incidence of diabetes. Thus, those with cirrhosis are urged to adopt lifestyle changes, such as a low sugar diet and regular exercise, to prevent diabetes. In addition, detecting, monitoring and treating diabetes is essential for maintaining good health.

Managing cirrhosis and chronic Hepatitis C infection requires learning about these illnesses and being committed to staying as healthy as possible. There is no magic pill to simplify this process. However, the six tips described can help a person with advanced liver disease to persevere until a better treatment to eradicate Hepatitis C - even with cirrhosis - is finally devised.

References:

http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/, Chronic Hepatitis C: Current Disease Management, Retrieved May 10, 2009, National Institutes of Health, 2009.

http://www.hcvadvocate.org/hcsp/articles/Cecil-2.html, HCV cirrhosis is a life threatening disease, Bennet Cecil, MD, Retrieved May 10, 2009, Hepatitis C Support Project, 2009.

http://www.hcvadvocate.org/hcsp/articles/Herrera.html, Cirrhosis in Chronic Hepatitis C Infection, Jorge L. Herrera MD, Retrieved May 10, 2009, Hepatitis C Support Project, 2009.

Floating in the earth's atmosphere absorbing solar radiation, ozone molecules are composed of three oxygen atoms. Used to treat various health issues since the late 19th century, ozone therapy infuses ozone into air or liquids and introduces them into the body. Even though there are limited scientific studies of ozone therapy's safety and efficacy, its proponents tout it as a valuable, economical alternative treatment for the Hepatitis C virus.

As the spread of the Hepatitis C (HCV) continues to gain momentum, more attention is focused on alternative methods to eliminate it. Some believe that introducing ozone molecules into the bloodstream may provide an immunity boost capable of overpowering HCV.

Part of the Immune Response
Research conducted in 2002 at The Scripps Research Institute in La Jolla, California demonstrated that ozone plays a part in the body's immune response of destroying bacteria and viruses. The team of investigators reported that in addition to the immune cells known to destroy foreign invaders, antibodies also participate in this task. Previous to this discovery, antibodies were believed only to signal an immune response, not carry out destruction. Additionally, the Scripps team found that when antibodies destroy bacteria or viruses, they produce ozone gas.

As reported in a November 2002 issue of the journal Science, ozone may be part of a previously unrecognized killing mechanism that enhances the defensive role of antibodies. This role is actualized because antibodies can produce hydrogen peroxide - a compound mostly known as a foamy antiseptic. Hydrogen peroxide is lethal to pathogens because it pokes holes in their cell walls, bursting them and causing death. In this newly recognized function of antibodies, the researchers found that antibodies make what appears to be ozone. The proposed mechanism for this reaction involves the following steps:

1. Antibodies find single oxygen molecules capable of causing oxidation and, thus, cellular damage.

2. To remove the threat of cell damage, antibodies combine the single oxygen molecules with water to make hydrogen peroxide.

3. When hydrogen peroxide is formed, ozone is a byproduct of the reaction.

Although this study proposes that ozone may be involved in a strong, healthy immune system, it also spawns many questions. Exactly how ozone ties in with antibodies destroying bacteria and viruses remains unclear, and it does not answer any questions about ozone therapy's aptitude to fight viral hepatitis.

Ozone Therapy
For over a century, some scientists have supported the idea that ozone has the potential to inactivate many types of bacterial and viral pathogens. The method favored for fighting HCV is blood ozonation, a process whereby:

· A portion of blood is withdrawn from the patient with HCV;
· An ozone/oxygen mixture is added to the withdrawn blood;
· The ozone/oxygen-rich blood is then returned to the patient;
· This process is typically repeated until viral load reduction is documented.

According to one of its principals, Dr. Gerard Sunnen, "Blood ozonation is an innovative technique of interfacing blood with minuscule amounts of ozone/oxygen mixtures that enhance natural cytokine and interferon production for purposes of viral clearing. This process, if successful, could greatly reduce the cost of current treatments for Hepatitis C."

Some viruses are suspected to be more susceptible to ozone's action than others. Researchers have confirmed that lipid-enveloped viruses are the most sensitive to ozone. As a lipid-enveloped virus, HCV stands to be one of the pathogens most easily affected by ozone therapy.

Lack of Hard Evidence
While the concept of blood ozonation stirs excitement in those concerned with fighting HCV, there is little concrete evidence to support its value. As of the end of 2007, ozone therapy has not been proven safe by scientific studies. While few treatments are completely devoid of risks, ozone therapy has been associated with some serious side effects including:

· Shortness of breath
· Blood vessel swelling
· Poor circulation
· Heart problems
· Stroke

Specific to blood ozonation, also known as autohemotherapy, a few associations must be eliminated before this treatment becomes accepted:

· Transmission of viral hepatitis
· Dangerously low blood cell counts

Even though blood ozonation is considered an alternative therapy, it does involve the removal and replacement of human blood. In order to assure patient safety, this process demands sterile equipment and competent practitioners upholding all aspects of sterile technique. In addition, the patient must be closely monitored to assure that a safe amount of blood is withdrawn.

Since the twentieth century, ozone therapy has been used as an alternative method of eliminating many pathogens. Although there are numerous anecdotes about successful treatment with ozone therapy, its effectiveness and safety remain inconclusive. When global interest in the role of ozone in the immune response mounts, new studies evaluating blood ozonation for HCV will ensue. Meanwhile, the advocates of ozone therapy are waiting in the wings for studies proving the safety and efficacy of this alternative method of healing. If and when that time comes, blood ozonation could triumph over Hepatitis C - a victory the world is more than ready for.

References:

Arab Health World, Hepatitis C and Blood Ozonation: Interview with G. Sunnen of Ozonics International, Arab Health World Magazine, July-August 2007.

Palmer, Melissa, MD, Dr. Melissa Palmer's Guide to Hepatitis and Liver Disease, Avery Publishing, New York, 2004.

www.intelihealth.com, Ozone Therapy, Natural Standard, Harvard Medical School, 2007.

www.mediwiss.de, Ozone Therapy in Patients with Viral Hepatitis "C" - A Clinical Study, Prof. Dr. Mohamed Nabil Mawsouf, et al., Cancer Institute, Cairo University, 2007.

www.ozonicsint.com, Ozone, A Physiological Gas, is Created in Vivo, Gerard Sunnen, MD, Ozonics International, 2007.

www.pressreleasenetwork.com, New York State Department of Health (NYSDOH) Stops a World First U.S. - Egyptian Collaborative Study on Hepatitis C and Blood Ozonation, Press Release Network, November 2007.

www.scripps.edu, Antibodies Produce Ozone During Bacterial Killing and Inflammation, Jason Socrates Bardi, The Scripps Research Institute, 2007.

www.triroc.com, Hepatitis C and Ozone Therapy, Gerard V. Sunnen, MD, 2007.

6/5/2009

Roche, the giant Swiss drug maker, plans to advance an experimental hepatitis C drug being developed with technologies from San Diego-based Metabasis Therapeutics into the clinic, Metabasis said June 5.

Under an agreement signed last year, Metabasis will be eligible to receive up to $193 million in milestone payments on top of a $10 million payment it already received.

The companies entered into a two-year research collaboration in August to develop new treatments for the hepatitis C virus, a contagious liver disease that counts 3.2 million people in the United States as chronic sufferers, according to the Centers for Disease Control and Prevention.

Roche saw potential in Metabasis' HepDirect technology, which helps guide antiviral drugs into the liver. Metabasis said it received a $2 million milestone payment recently in recognition of advances made on their research collaboration.

The announcement comes on the heels of a major restructuring at the struggling biotech, which is evaluating whether it has enough financial support to remain in business. On May 27, the company trimmed its previously reduced staff from 45 employees to seven. It reported $11.8 million in cash as of March 31.

Metabasis stock trades on the Nasdaq as MBRX. Shares closed June 5 up 4 cents, or 12.5 percent, to 36 cents.

-- Heather Chambers

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URL for Article Source:
http://www.sdbj.com/article.asp?aID=16718836.2104046.1790971.6331106.4376853.243&aID2=137758

June 5th, 2009

For patients with the most common form of hepatitis C, the addition of a hepatitis C-specific protease inhibitor called telaprevir to the current standard therapy can significantly improve the chances of being cured, and it does it in half the time of standard therapy alone.

Results of the Phase IIb clinical trial -- led by Duke Clinical Research Institute (DCRI) and 36 other sites, including NewYork-Presbyterian Hospital/Weill Cornell Medical Center -- are published in the April 30th issue of the New England Journal of Medicine. The study was funded by Vertex Pharmaceuticals Incorporated, the maker of the drug telaprevir. The drug works by blocking an enzyme that the hepatitis C virus needs in order to replicate itself.

"These findings point the way to a new era in the treatment of hepatitis C," says Dr. Ira M. Jacobson, a co-author of the study and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Clinical Medicine at Weill Cornell Medical College. "Not only does adding telaprevir make standard hepatitis C treatment more effective, but it makes it work much more quickly. We showed that the duration of therapy can be reduced from 48 weeks to 24 weeks for most patients. This could help reduce the potentially severe side effects of longer regimens with standard therapy."

The randomized, double-blinded trial followed 250 patients with untreated hepatitis C genotype 1. Researchers measured rates of sustained viral response or viral cure -- an undetectable quantity of hepatitis C virus -- 24 weeks after the end of completion of therapy. They compared a 12-week regimen of telaprevir combined with two different durations of the standard therapy -- peginterferon alfa-2a and ribavirin -- to a control group taking 48 weeks of standard therapy alone. Results showed that 67 percent of patients taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 36 weeks were cured; and 61 percent of those taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 12 weeks were cured. This is compared to 41 percent cure rate in the 48-week control group.

The study also showed that the percentage of patients who relapsed in the 24-week and 48-week telaprevir-based groups (2 percent and 6 percent, respectively) was much lower than the control group (23 percent).

The most common reported side effect in the telaprevir groups was rash, and contributed to some patients discontinuing the therapy.

Peginterferon alfa-2a is an antiviral drug given by injection that is also used to treat HIV and hepatitis B; it works in conjunction with a drug called ribavirin, a nucleoside analogue, to suppress the viral activity of hepatitis C. Side effects can include severe flu-like symptoms, depression, fatigue, insomnia and anemia.

"Treating genotype 1 hepatitis C, the most common form of the infection in the United States, can be challenging because the side effects are difficult for many people to endure, the duration of treatment is long, and traditionally less than half of patients are able to be cured of their disease," says Dr. Andrew Muir, a gastroenterologist at Duke Clinical Research Institute and a senior investigator on the study. "Even though telaprevir does produce side effects of its own, its addition to standard therapy was able to improve response rates and shorten the duration of treatment necessary -- either one alone would have been an advance, and to be able to achieve both is a significant step in the right direction when it comes to treating hepatitis C."

The study's lead author is Dr. John McHutchison, a hepatologist and gastroenterologist and researcher at the Duke Clinical Research Institute. Additional co-authors include Drs. Gregory Everson of the University of Colorado Health Science Center; Stuart Gordon of Henry Ford Hospital; Mark Sulkowski of Johns Hopkins School of Medicine; and Robert Kauffman, Lindsay McNair and John Alam of Vertex Pharmaceuticals.

Drs. Jacobson, McHutchison and Muir have received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon) and Schering-Plough (maker of ribavirin).

The study's results match those of a similar study conducted in Europe that was reported on in the same issue of the New England Journal of Medicine. An accompanying editorial recounts the history of hepatitis C treatments, beginning 25 years ago with the discovery of interferon. It comments on the two studies: "Telaprevir appears to be a material advance in the therapy of hepatitis C, beginning a new era of treatment -- an era of antiviral agents developed specifically to target this virus."

Two Phase III studies currently under way at NewYork-Presbyterian/Weill Cornell and centers worldwide will attempt to confirm the results, potentially leading to FDA approval of telaprevir. One study is looking at 12 weeks of telaprevir in combination with standard therapy (peginterferon alfa-2a and ribavirin) followed by either 12 or 36 weeks of standard therapy alone depending on patients' response to therapy. A second study is comparing 8-week and 12-week regimens of telaprevir in combination with standard therapies followed by at least 12 weeks of standard therapy, depending on patients' response to therapy, to a placebo group taking 48 weeks of standard therapy alone. Both studies are currently closed to recruitment.

Hepatitis C

Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. HCV is a serious public health concern, affecting 3.4 million individuals in the United States. There are six major genotypes of the hepatitis C virus, which are indicated numerically. About 70 percent of hepatitis C patients in the United States have genotype 1. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death. It is the leading reason for liver transplantation in the United States. Co-infection with HIV is common and rates among HIV positive populations are higher. Most people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs.

Source: New York- Presbyterian Hospital (news : web)

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URL for Article Source:
http://www.physorg.com/news163418460.html

Nobody wants to be sick - especially with a form of viral hepatitis that causes chronic liver disease. Such a desire for wellness has spawned some to fear being in close contact with individuals (or their bodily fluids) of those harboring an infectious disease. Since several hepatitis viruses are known to be highly contagious, there is a valid concern about encountering these pathogens in public places.

As a communal location where the release of bodily fluids (and solids) occurs, few locations are as feared as a public bathroom. Bacteria and viruses lurk on toilet seats, door handles and wash basin faucets. Compounding the worry over potential disease transmission, partially disrobing in a restroom can make some feel increasingly vulnerable. Despite concerns of picking up an infectious disease in a public bathroom, attention to hygiene nearly nullifies this worry. Learning about the transmission and prevention of the most common hepatitis viruses will ease apprehension about using a communal toilet.

The three most prevalent, contagious hepatitis viruses are differentiated by the letters A, B and C. Although they all cause liver inflammation, each of these hepatitis viruses are different illnesses caused by different pathogens.

Hepatitis A
Thanks to its vaccine, a majority of Americans are already protected from the Hepatitis A virus. In addition, this typically short-lived illness creates lifelong immunity in those who have been previously infected.

Hepatitis A is spread through the fecal/oral route. Sparking the attention of those afraid to use public restrooms, this virus is passed on through feces. Unless a potentially contaminated toilet seat is licked, the hands are the most likely vehicle for delivering fecal particles to your mouth.

Thoroughly washing your hands after using the restroom eliminates the possibility of picking up Hepatitis A from a toilet. The most effective hand washing sequence involves:

· Using hot water

· Lathering up with soap for at least 20 to 30 seconds

· Washing your palms, backs of your hands, in between your fingers and under your fingernails with friction

Because you can't rely on everyone thoroughly washing their hands after defecating, experts advise using a paper towel to turn off the water faucet and to open the bathroom door. This way, you can prevent re-contaminating your hands with someone else's germs. Of course, your hands could pick up germs anywhere, so washing your hands before eating is an equally important way to protect yourself from Hepatitis A.

Hepatitis B
Although the Hepatitis B virus could cause a chronic infection, the available vaccine has protected many people from this disease. Hepatitis B is primarily transmitted through blood, but has also been detected in other bodily fluids such as sweat, tears, saliva, semen, vaginal secretions and breast milk. However, exposure to any of these fluids must make contact with blood or a mucous membrane for transmission to occur.

Therefore, the risk of acquiring Hepatitis B from using a public restroom is extremely small unless you sit directly on a contaminated toilet with open sores on your behind or backs of your legs. If you do have wounds that could touch the seat, squatting above the seat and/or covering it with a liner or toilet paper will provide an extra level of protection.

Hepatitis C
Unfortunately, there is no vaccine to prevent Hepatitis C, a virus that causes chronic liver disease in over 80 percent of infected individuals. Since Hepatitis C is only spread from blood to blood contact, it is nearly impossible to catch in a bathroom unless you have open sores that make contact with fluid containing contaminated blood.

Basic hygiene practices and common sense should remove any fears about picking up a hepatitis virus during a public restroom visit. Stay safe by keeping open sores off the toilet seat, using a paper towel to touch faucets and door handles, and washing your hands well after visiting the restroom and before eating. In addition, the following tips are intended to reduce viral transmission risk even further:

· To keep others' germs away from your hands, flush with your shoe.

· When flushing, keep your face turned away from the bowl in case of any splashing.

· Wipe a wet throne before taking a seat.

· If there is no hot water for washing, or no paper towels to open the door, rub some hand sanitizer vigorously between your hands.

· In case there is an improperly disposed of, contaminated needle hiding in the trash, never push your hand into the garbage can.

Despite the relatively high amount of germs lurking in public bathrooms, it is very simple to circumvent disease transmission there. Aside from taking advantage of the vaccinations currently available, following the essentials of restroom cleanliness can effectively protect you from picking up a hepatitis virus from a public bathroom.

References:

http://centretownnewsonline.ca/index.php?option=com_content&task=view&id=226&Itemid=98, Tossed needles a hazard in public restrooms, Courtney Symons, Retrieved May 24, 2009, Centretown News Online, 2009.

http://www.askmen.com/sports/health_60/68_mens_health.html, What Can You Catch from Restrooms?, Joshua Levine, Retrieved May 18, 2009, IGN Entertainment Inc., 2009.

http://www.livescience.com/health/060603_popsci_toilet_seats.html, The Truth About Toilet Seats, Melissa A. Calderone, Retrieved May 18, 2009, Imaginova Corp., June 2006.

http://www.straightdope.com/columns/read/1598/what-diseases-can-you-catch-from-toilet-seats, What diseases can you catch from toilet seats?, Straight Dope Science Advisory Board, Retrieved May 18, 2009, Straight Dope, 2009.

Successfully overcoming a battle with Hepatitis C is more complex than taking a simple, one time test. If you are one of the millions living with the most common blood-borne virus, understanding the terminology for its eradication and implications for a healthful future are valuable when assessing your treatment and maintenance options. Today's conventional therapy for Hepatitis C, combined interferon and ribavirin therapy, mostly focuses on its effect on the recipient's viral load. However, supporting the health of the organ taking the brunt of Hepatitis C's beating is a crucial part in healing from this disease.

The ultimate goal of defeating Hepatitis C is twofold - complete eradication of the virus and reversal of the damage done by the virus. While getting rid of the virus capable of multiplying at dizzying rates appears to be medicine's top priority, an increasing amount of attention is also being directed at helping the liver recover from Hepatitis C's wrath.
Hepatitis C recovery is evaluated in terms of the virologic and histologic responses:

· Virologic Response - The most common way to perceive Hepatitis C treatment success is via the virologic response. To measure virologic response, doctors use a blood test to measure how much Hepatitis C virus is in the blood. While Hepatitis C RNA may be undetectable immediately following treatment, this test must be repeated six months later to see if any of the virus remained and reproduced. Also referred to as viral load, the best outcome is a sustained virologic response (SVR). When the virus remains undetectable in the blood six months (or more) following Hepatitis C therapy, SVR is considered attained. So far, studies following Hepatitis C patients for two to three years after SVR have demonstrated a low relapse rate.

· Histologic Response - Another way to evaluate the effectiveness of Hepatitis C therapy, a histological response indicates a diminished level of liver inflammation. Conventionally determined via biopsy, a positive histologic response that indicates reduced liver inflammation can occur even if SVR is not reached. Improvements in histologic scores directly reflect a decreased tendency toward cirrhosis, hepatocellular carcinoma and liver failure.

While a person could have both a virologic and histologic response to Hepatitis C treatment indicating virus elimination, these events do not always go together.

In a Swiss study published in the December 2006 edition of AIDS, researchers determined that while SVR generally correlated with histologic response, a substantial proportion (33 to 43 percent) of study participants achieved a histological response even though they did not achieve SVR. In this study, post-treatment biopsies were taken approximately six months after the end of treatment. There is a possibility that further fibrotic improvement would have occurred after longer durations in those who attained SVR. Because the liver's topography changes slowly, the study's authors concluded that looking for a histologic response two to three years after treatment may be more indicative of successful Hepatitis C treatment. Alternatively, it appears that SVR is always accompanied by histologic improvement.

Claiming SVR relieves the liver from Hepatitis C's daily onslaught of cellular destruction, giving the person a chance to recover and return to health. However, possessing the fortitude to re-grow healthy liver cells and reverse the damage previously done is necessary for achieving optimum health. Thus, histologic improvement is an important component in overcoming Hepatitis C infection. Just as important as eliminating Hepatitis C RNA from the blood, fostering the liver's recovery from the virus is the only protection against the development of hepatocellular carcinoma or cirrhosis.

While the pharmaceutical industry continues to race toward the best elixir for viral eradication, doing everything within your power to support and protect the liver is a person's best hope for histological improvement. Fostering the ideal environment for the liver to re-grow healthy cells and protect the cells it has gives anyone a better chance for living with and recovering from Hepatitis C. Experts in the field agree on these seven tips for supporting and protecting the liver:

1. Avoid alcohol and recreational drugs.
2. Consistently use a high quality milk thistle supplement.
3. Fill your diet with wholesome, nutritious foods.
4. Reduce your contact with toxins (ingested and environmental) to an absolute minimum.
5. Maintain a regular physical activity program.
6. Find ways to relax and enjoy every moment you can.
7. Make a good night sleep your priority.

Even though most physicians consider SVR as evidence of curing Hepatitis C, this is clearly only the first step in the fight against this virus. A positive histologic response is actually the long-term indicator of liver health recovery. In addition to striving for viral eradication, take every step possible to support and protect your liver, whether choosing to pass on combination therapy, in the middle of therapy, if you are a non-responder or if you are one of the lucky ones to achieve SVR.

References:

www.amfar.org, Dim Outlook for Hepatitis C Treatment, Daniel Raymond, amFar, 2007.

www.hepcsource.com, What is Successful Treatment?, Hoffman-La Roche Inc., 2007.

www.hivandhepatitis.com, IP-10 Levels Predict Treatment Response in Patients with Hepatitis C, Liz Highleyman, hivandhepatitis.com, 2007.

www.medicinenet.com, Doctor's Dialogue Index, MedicineNet, Inc., 2007.

www.medscape.com, Antiviral Therapy of patients with Chronic Hepatitis C, Jenny Heathcote, MB, MS, MD, FRCP, et al., Seminars in Liver Disease, 2000.

www.medscape.com, Histological Response to pegIFNα-2a (40KD) Plus Ribavirin in HIV-hepatitis C Virus Co-infection, Eduardo Lissen, et al., AIDS, December 2006.

www.medscape.com, Sustained Virologic Response Associated with Quality of Life, Maureen P. Neary, Ph.D, et al., Seminars in Liver Disease, 1999.

www.medicalnewstoday.com, New Data From Largest U.S. Hepatitis C Trial Provide Insights Into Optimizing Treatment For Patient Populations, MediLexicon International, Ltd., 2007.

www.natap.org, Predictive Value of Early Virologic Response in HIV/Hepatitis C Virus-Coinfected Patients Treated With an Interferon-Based Regimen Plus Ribavirin, Montserrat Laguno, MD, Journal of Acquired Immune Deficiency Syndromes, February 2007.

Drug could reverse liver disease

There are hopes a blood pressure drug could reverse the effects of early-stage liver disease in some patients, and help them avoid a transplant.

During a clinical trail, researchers at Newcastle University gave Iosartan, normally prescribed for hypertension, to 14 people with Hepatitis C.

All the patients had liver scarring, but in half of them the scars shrank, allowing the organ to repair itself.

The findings are described as promising and further studies are planned.

These would involve patients with liver disease caused by obesity and then, to follow, alcohol, hereditary and autoimmune diseases.

Professor Derek Mann from Newcastle University said: "At the moment we have no proven effective way of treating people with chronic liver disease other than transplantation.

"This early stage trial has shown that we can shrink liver scarring in some patients and shows promise for a treatment that could make a huge difference to the lives of thousands of people."

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URL for Article Source:
http://news.bbc.co.uk/2/hi/uk_news/england/tyne/8076692.stm

May 28th, 2009

A new combination therapy of daily consensus interferon (CIFN) and ribavirin is effective for some people with chronic hepatitis C (HCV) who do not respond to standard therapy. The treatment works particularly well in interferon-sensitive patients who have lower fibrosis scores, according to a new study in the June issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD).

Nearly half of all HCV patients do not respond to the standard therapy of pegylated interferon and ribavirin. They remain at risk for developing life-threatening liver disease. So far, other alternative therapies have not been particularly successful in these nonresponders.

One new treatment with the potential to help patients with persistent HCV involves high doses of daily consensus interferon (CIFN) combined with ribavirin. Researchers, led by Bruce Bacon of St. Louis University, conducted a multicenter trial to examine the efficacy, tolerability and safety of this approach.

The researchers studied 487 patients whose HCV had not responded to initial treatment with standard therapy. Many had characteristics that generally bode poorly for treatment response. Nearly all had HCV genotype 1; 80 percent had not responded strongly to their previous treatment; 68 percent had high baseline levels of the virus in their blood; 60 percent had advanced liver disease; and about 20 percent were African-American. These factors have all been shown to reduce rates of sustained viral response after treatment.

The patients were divided into three groups. Two would receive the new therapy at different doses, and the third would receive no therapy. After 24 weeks, the control group was stratified into one of the treatment arms.

Ultimately, 245 of the patients received 9 mcg of CIFN daily along with ribavirin, and 242 others took 15 mcg of CIFN daily along with ribavirin. After 24 weeks, patients with detectable HCV RNA were considered non-responders and stopped the therapy. Responders continued taking their therapy up through week 48, and were then followed-up through week 72. If HCV RNA was detected between weeks 48 and 72, the patient was classified as a relapser.

Nearly 7 percent of the patients taking 9 mcg of CIBN, and 10.7 percent of those taking 15 mcg, achieved a sustained viral response. The rates were even higher among patients who had responded better to the standard therapy and among those who had lower baseline fibrosis scores.

"The best response rate, 31.6 percent, was observed in noncirrhotic patients who had a partial virologic response with a greater than 2-log10 decline in HCV RNA during their previous course of peg-IFN treatment," the authors report.

While adverse events were common, most patients continued their treatment in spite of them. Common side effects were neutropenia, fatigue, leucopenia, depression, nausea, muscle pain, lymphopenia and anemia.

"The present study demonstrated that some patients with chronic hepatitis C who have failed to respond to treatment with peg-IFN and RBV can be successfully retreated with daily CIFN and RBV," the authors conclude. "The greatest SVR rate during retreatment in the present study was observed in F0-F3 patients who had a partial virologic response during their prior course of treatment."

More information: "Retreating Chronic Hepatitis C with Daily Interferon Alfacon-1/Ribavirin after Nonresponse to Pegylated Interferon/Ribavirin: DIRECT Results." Bacon, Bruce R.; Shiffman, Mitchell; Mendes, Flavia; Ghalib, Reem; Hassanein, Tarek; Morelli, Giuseppe; Joshi, Shobha; Rothstein, Kenneth; Kwo, Paul; Gitlin, Norman. Hepatology; June 2009.

Source: Wiley (news : web)

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URL for Article Source:
http://www.physorg.com/news162739824.html

By Jason Nevel
jason.nevel@lee.net

SPRINGFIELD -- A proposal to legalize medical marijuana squeaked through the Illinois Senate on Wednesday and will now head to the House for further debate.

The measure would allow patients to use marijuana to alleviate chronic pain and nausea when other treatments have failed. The list of applicable conditions includes cancer, glaucoma, HIV/AIDS, Hepatitis C, Crohn's disease and Alzheimer's disease.

"This bill allows the use of marijuana in limited circumstances," said Senate sponsor William Haine, D-Alton, who was the former state's attorney for Madison County. "Someone doesn't have to go down the criminal element to buy marijuana."

The controversial issue sparked heated debate on the Senate floor but reached the necessary 30 votes to move to the House. Supporters noted the benefits of alternative treatment for ailing patients and that it's more natural than synthetic drugs.

"God grows these seeds," said state Sen. Mike Jacobs, D-East Moline, who voted for the legislation.

Opponents claimed the legislation lacked the police supervision and that the number of marijuana users could potentially increase.

"This is an invitation for trouble," said state Sen. Dale Righter, R-Mattoon.

State Sen. Tim Bivins, R-Dixon, added, "Once you say something is legal usage will go up."

The proposal would allow qualified patients to grow three plants in their home.

Along with Bivins and Righter other senators voting "no" included: Larry Bomke, R-Springfield; Bill Brady, R-Bloomington; and Dan Rutherford, R-Chenoa.

The legislation is Senate Bill 1381.

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URL for Article Source:
http://www.pantagraph.com/articles/2009/05/27/news/doc4a1ddc9e949f2170172413.txt

Patients that received a 48-week boceprevir regimen achieved a 75 per
cent SVR rate, nearly twice the efficacy rate provided by current
standard therapies

KIRKLAND, QC, May 26 /CNW/ - Schering-Plough Canada announced today that
final results of the HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1)
study showed boceprevir - its investigational oral hepatitis C protease
inhibitor - in combination with PEGETRON(R) (peginterferon alfa-2b and
ribavirin), significantly increased sustained virologic response (SVR)(1)
rates with either 28- or 48-week therapy regimens in treatment-naive genotype
1 patients, compared to current standard of care, peginterferon and ribavirin
(P/R) for 48 weeks.
When boceprevir was added to PEGETRON(R), 75 per cent (77/103) of
hepatitis C patients assigned to a 48-week regimen had undetectable levels of
virus after treatment completion. That was nearly double the 38 per cent
(39/104) response rate of patients who only received current standard of care
treatment (p(less than)0.0001)(2).
"I am very excited about the response. The response rates from this study
are extremely encouraging, especially when you consider the challenges
associated with hepatitis C management and the difficult nature of the
hepatitis C virus genotype 1 infection in this study's patient population,"
said Dr. Frank Anderson MD FRCP(C), one of the SPRINT-1 Investigators and
presentation co-author. "I believe that the findings of this study will help
further develop and improve hepatitis C treatment. The Phase III boceprevir
studies are currently underway in naive and treatment failure patients, both
are fully enrolled."
The results from this Phase II study - involving 595 patients who were
infected with the virus but had not previously been treated - were presented
at the 44th European Association for the Study of the Liver 2009 Annual
Meeting in Copenhagen, Denmark(3).
"Each HCV-infected patient responds differently to treatment. The results
of the SPRINT-1 study shed important light on response-guided therapy with
boceprevir," said Dr. Jenny Heathcote MD FRCP(C), Professor of Medicine at
University of Toronto and Toronto Western Hospital and a SPRINT-1 study
investigator. "Importantly, the results of SPRINT-1 show how one may best
individualize treatment duration based on the patients' week 4 and week 12
responses to boceprevir therapy. Based on the rate of response observed in
SPRINT-1, the majority of G1-infected treatment naive patients may have the
potential to be treated for a total of 28 weeks."
The HCV SPRINT-1 study was a randomized, controlled, multinational study
conducted at sites across the United States, Canada and Europe. The study
enrolled trial participants infected with HCV genotype 1, the most common and
hardest to treat form of hepatitis C, as well as patients with severe liver
disease, including cirrhosis.
Boceprevir works through a novel mechanism, by inhibiting the function of
a viral protein called 'protease' that the virus needs to replicate. Hepatitis
C is a serious and potentially life-threatening chronic liver disease caused
by the hepatitis C virus (HCV). An estimated 250,000 individuals are infected
with HCV in Canada(4) and there are 3,200 to 5,000 newly infected individuals
each year(5). It is the leading cause of liver transplants in Canada(6).

ABOUT THE HCV SPRINT-1 STUDY

During the first month of the study, all patients received PEGETRON(R),
which is a combination therapy of the two standard hepatitis C treatments: a
long-acting form of interferon called peginterferon alfa-2b and the anti-viral
pill ribavirin. Some patients also received PEGETRON(R) in combination with
boceprevir from the beginning of the study.
After four weeks, one group of PEGETRON(R)-only patients then added
boceprevir for 44 weeks and another group added boceprevir for 24 weeks.
Patients who received a 48-week boceprevir regimen achieved a 75 per cent
SVR rate (n=77/103) in patients who received four weeks of (P/R) followed by
the addition of boceprevir for 44 weeks (boceprevir P/R lead-in regimen). This
represents a near doubling of the 38 per cent SVR rate (n=39/104) for patients
in the control group (p(less than)0.0001). In a 28-week boceprevir P/R lead-in
regimen 56 per cent of patients (n=58/103) achieved SVR (p=0.005)(2).
In the HCV SPRINT-1 study, anemia occurred in approximately half of the
patients in the boceprevir arm and over a third of patients in the control
arm. A key finding of the HCV SPRINT-1 study is that treatment-emergent anemia
appeared to be associated with higher SVR, with anemic patients (hemoglobin
decreasing to less than 10 g/dL) having higher SVR rates than those without
anemia (hemoglobin did not decrease to less than 10 g/dL). Anemia is a known
adverse event with combination therapy for hepatitis C and this association
with higher SVR has been seen in other clinical studies with peginterferon and
ribavirin, including the IDEAL study(7). Boceprevir is associated with about a
1 g/dL incremental decrease in hemoglobin. Erythropoietin (EPO)
supplementation was allowed in the study at the discretion of the investigator
and was used by 26 per cent of patients in the control arm and 39 to 51 per
cent of patients in the boceprevir arms with standard-dose ribavirin.

ABOUT SCHERING-PLOUGH

Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs more than 950 people across Canada. Schering-Plough
Canada Inc.'s web site is WWW.SCHERING-PLOUGH.CA.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription, animal health and consumer health care
products. Schering-Plough's vision is to "Earn Trust, Every Day" with the
doctors, patients, customers and other stakeholders served by its colleagues
around the world. The company is based in Kenilworth, N.J., and its Web site
is WWW.SCHERING-PLOUGH.COM.

References:
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1. SVR, the protocol specified primary efficacy endpoint, is defined as
achievement of undetectable HCV-RNA at 24 weeks after the end of
treatment. Per protocol, if a patient does not have a 24-week post-
treatment assessment, the patient's 12-week post-treatment assessment
will be utilized.

2. Intention-To-Treat (ITT) analysis - includes any patient who has
taken at least one dose of any study drug.

3. Kwo P, Lawitz E, McCone J, et al. HCV SPRINT-1 Final Results: SVR 24
from a Phase 2 study of Boceprevir Plus PegIntron (Peginterferon
alfa-2b)/Ribavirin in Treatment-Naive Subjects with Genotype.

4. Health Canada. http://www.phac-aspc.gc.ca/hepc/index-eng.php Accessed
April 27, 2009.

5. Health Canada.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php.
Accessed April 29, 2009.

6. Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/
Accessed April 27, 2009.

7. Sulkowski M, Shiffman M, Afdhal N, et al. Hemoglobin decline is
associated with SVR among HCV genotype 1 infected persons treated
with peginterferon (PEG)/ribavirin (RBV): Analysis from the IDEAL
Study. 44th European Association for the Study of the Liver (EASL)
2009 Annual Meeting; April 22-26, Copenhagen, Denmark; oral
presentation, Abstract No. 126.

For further information: Media Contact: Mona Aubin, Schering-Plough
Canada, mona.aubin@spcorp.com, (514) 428-8833; Julia Alter, Edelman, (416)
979-1120 ext. 340, julia.alter@edelman.com; Schering-Plough Canada Inc., 16
750, route Transcanadienne, Kirkland, QC, H9H 4M7, www.schering-plough.ca

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URL for Article Source:
http://www.newswire.ca/en/releases/archive/May2009/26/c7468.html