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Week Ending: July 2nd, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Lower Doses of Tacrolimus for Liver Transplants in Hep C
• Congressman Jesse Jackson, Jr. Teams up with the American Liver Foundation to Launch Hepatitis C Public Awareness Campaign
• Pharmasset to Develop Clevudine for the Treatment of Chronic Hepatitis B Under a License from Bukwang Pharmaceuticals
• Tainted-Blood Victim Still Feels Left Out
• Looking, Feeling Healthy No Guarantee
• CORRECTED - Tests Compare Drugs for Hepatitis B
• Data Evaluating Long-Term Therapy with Hepsera for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Published in the New England Journal of Medicine
• Executive Takes On 'Killer' Virus
• AVI BioPharma Submits IND for NEUGENE Antisense Drug Targeting Hepatitis C Virus
• Huge Posters Focus on Hepatitis C
• Panel Backs Tougher Hepatitis B Guidelines
• Science Making Headway against Hepatitis B
• Smoking and Hepatitis C Up Risk of Lymphoma
• Governor, Lawmakers Split over Hepatitis C Drugs
• Innogenetics Confirms Three-Year Delay in Hepatitis C Vaccine Launch
• Canada Red Cross Tries to Put Blood Scandal to Rest
• National Strategy to Attack Hep C
• Resistance to Long-Term Lamivudine Treatment in Hep B
• Abnormal Liver Tests in Mediterranean Population
• More Midcoast Youth Afflicted with Hepatitis
June 27th, 2005
Lower Doses of Tacrolimus for Liver Transplants in Hep C
SourceURL:http://www.gastrohep.com
Liver transplant recipients with Hepatitis-C virus require lower oral doses of tacrolimus to achieve the same blood levels compared to non-Hepatitis-C virus patients, finds the latest issue of Alimentary Pharmacology & Therapeutics.
Hepatitis-C virus is the most common indication for liver transplantation.
Dr Trotter and colleagues from Colorado noted higher relative blood levels of tacrolimus in their patient cohort compared to patients without Hepatitis-C virus.
The research team verified this observation and determined its clinical significance.
The team performed a comparison of doses and blood levels of tacrolimus in Hepatitis-C virus and non- Hepatitis-C virus liver transplantation recipients.
The total mean tacrolimus dose in Hepatitis-C virus patients was lower by 73% during year 2 – Alimentary Pharmacology and Therapeutics
The team included patients with Hepatitis C who received a transplant from a deceased donor at the center between 1995 and 1999.
The researchers recorded tacrolimus dose and trough level, as well as mean alanine aminotransferase.
The recordings were done at monthly intervals during the first 24 months following transplantation and compared to patients without Hepatitis-C virus.
The researchers found that tacrolimus levels for Hepatitis-C virus and non-Hepatitis-C virus were not different at any of the monthly intervals, except month 9.
In addition, the team noted that the overall mean tacrolimus levels for Hepatitis-C virus and non-Hepatitis-C virus patients were not significantly different.
However, the researchers observed that the mean tacrolimus dose was significantly higher for Hepatitis-C virus patients at 12, 15, 18, 21 and 24 months.
The team found that the total mean tacrolimus dose in Hepatitis-C virus patients was lower during year 1 by 39% and by 73% during year 2.
The total difference in cost of tacrolimus for years 1 and 2 administered to Hepatitis-C virus patients was $4920.
The researchers reported that the serum alanine aminotransferase was higher in Hepatitis-C virus patients at each monthly interval except month 1.
Dr Trotter's team concluded, "Liver transplant recipients with Hepatitis-C virus require significantly lower oral doses of tacrolimus to achieve the same blood levels compared to non-Hepatitis-C virus patients."
"This difference may result in a significant reduction in the cost of tacrolimus in Hepatitis-C virus patients."
"The most likely explanation for these findings is decreased hepatic clearance of tacrolimus caused by mild hepatic injury from recurrent Hepatitis-C virus."
Aliment Pharmacol & Ther 2005: 22(1): 37
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Congressman Jesse Jackson, Jr. Teams up with the American Liver Foundation to Launch Hepatitis C Public Awareness Campaign
SourceURL:http://biz.yahoo.com/
- THINK C Campaign Looks to Wake Up Americans to 'Silent Disease'-
Chicago, June 27 /PRNewswire/ -- Congressman Jesse Jackson, Jr., the 5th ranking Democrat on the Subcommittee on Labor, Health and Human Services, has teamed up with The American Liver Foundation (ALF) to launch "THINK C" (The Hepatitis Information you Need to Know), a public awareness campaign aimed at educating Americans about hepatitis C and urging those at risk to get tested for the disease and discuss treatment options with their physician. Hepatitis C is a life threatening viral disease of the liver that infects approximately four million Americans and is the leading cause of liver transplants in the United States.
Hepatitis C is known as the "silent disease" because most people infected do not experience symptoms, causing the disease to go undetected. In fact, more than 70 percent of those infected with hepatitis C -- almost 2.8 million Americans -- have not yet been diagnosed because most people with the disease can feel and appear perfectly healthy for years, not knowing that the disease is slowly attacking their liver. If left untreated, hepatitis C can lead to severe liver injury and even death.
"The number of people infected with hepatitis C who have not been diagnosed is astounding. Many people are walking around with the disease, some up to 10 to 20 years, without even knowing they have it," said Congressman Jackson, Jr. "I partnered with the American Liver Foundation to lend a voice to this campaign to educate the public about the risk factors for hepatitis C, to encourage testing if they believe they are at risk and to seek treatment if they are positive."
Hepatitis C is a blood-borne virus that is transmitted primarily through blood-to-blood contact. People at risk of contracting the disease are injection drug users, people who received a blood transfusion prior to 1992, health care or public safety workers who have been accidentally stuck by a needle, intranasal cocaine users, and those who have tattoos or body piercings. Vietnam veterans are also at high risk for the disease.
The combination therapy of pegylated interferon and ribavirin is the current standard of care for hepatitis C. Clinical trials have shown that this combination treatment eradicates the hepatitis C virus in more than half of the patients who are treated. There is no vaccine available for hepatitis C.
"The treatments for hepatitis C were designed to suppress the hepatitis C virus and stop or slow liver damage," said Dr. Theresa Wright, chief of the Viral Hepatitis Clinic and the Gastroenterology Section at the Veterans Administration Medical Center in San Francisco. "It is important for those who have been diagnosed with hepatitis C to speak with their doctor to determine if treatment is right for them."
More About Hepatitis C
Approximately 80 percent of people infected with acute hepatitis C develop a chronic infection, which can lead to severe liver problems, such as cirrhosis, permanent scarring of the liver. Cirrhosis is the seventh leading cause of death by disease, the third leading cause of death for people between the ages of 25 and 29 and kills approximately 27,000 Americans each year. Patients with cirrhosis are at risk for developing liver cancer and, eventually liver failure. In fact, about five percent of all people with hepatitis C will eventually need a liver transplant as a result of liver cancer or liver failure.
While hepatitis C affects people from all walks of life, studies show that the disease disproportionately affects minorities, particularly African and Hispanic Americans. African Americans not only have the highest rates of chronic hepatitis C, but also a higher mortality rate than Caucasians from resulting liver disease (i), a number that is expected to triple in the next ten years (ii).
As for the U.S. Hispanic population, about one out of every 50 Hispanics is infected with hepatitis C (iii). Additionally, Hispanics are 40 percent more likely to be infected with hepatitis C when compared to the general population (iv), according to a study published in the Journal of the American Medical Association on October 4, 2000.
About the Campaign
The THINK C campaign will begin today with public service announcements (PSAs) featuring Jesse Jackson, Jr. airing on radio stations around the country and appearing on the Web.
The PSA spots, scheduled to air for the next three months, urge people who believe they are at risk for hepatitis C to contact The American Liver Foundation at (800) GO-LIVER or visit http://www.liverfoundation.org
About the ALF
The ALF has 26 chapter offices nationwide, with the newest just created in Hawaii. It provides educational workshops and seminars, runs support groups, works with the media to increase the awareness of hepatitis and other liver diseases, and meets with local, state and federal policy makers to affect positive change. ALF supports research primarily in two ways: first, by advocating federal policy makers to secure increases in government funding for liver disease; and second, by directly funding young scientists in order to attract them to the lifelong study of liver disease and patient care. ALF sponsors numerous fundraising events and campaigns to support all of these efforts.
(i) "Group Issues Guidelines To Educate African Americans About Viral Hepatitis" October 2001. The National Medical Association (NMA). http://www.hivandhepatitis.com/hep_c
/news/102401a.html
(ii) "Group Issues Guidelines To Educate African Americans About Viral Hepatitis" October 2001. The National Medical Association (NMA). http://www.hivandhepatitis.com/hep_c
/news/102401a.html
(iii) HIVandHepatitis.com - Digestive Disease Week Report, LOLA, http://www.lola-national.org/press/press1.htm
(iv) LOLA fact sheet, http://www.lola-national.org/resources/hep-c.htm and "Racial differences in knowledge regarding hepatitis C virus infection." JAMA. 2000 Oct 4;284(13):1651-2.
Source: American Liver Foundation
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Pharmasset to Develop Clevudine for the Treatment of Chronic Hepatitis B Under a License from Bukwang Pharmaceuticals
SourceURL:http://biz.yahoo.com
ATLANTA, June 27 /PRNewswire/ -- Pharmasset, Inc. and Bukwang Pharm. Co., Ltd. announce that they have entered into an exclusive license agreement under which Pharmasset will develop and commercialize Clevudine, also known as L-FMAU, for the treatment of chronic hepatitis B virus (HBV) infections in the Americas, Europe, and other select territories. Clevudine is a potent HBV antiviral currently in Phase 3 clinical trials in Korea and has been the subject of earlier stage clinical trials under an Investigational New Drug application filed with the US FDA. The financial terms of the agreement were not disclosed.
Clevudine is an oral, once-daily nucleoside analog drug candidate for the treatment of HBV that was shown to be well tolerated and potent in previously completed clinical studies. Clevudine also demonstrated a unique sustained therapeutic effect, observed as a prolonged rebound of virus to pretreatment levels, after the cessation of 24 weeks of treatment in clinical trials. Several advanced-stage clinical trials of Clevudine are ongoing, including a 48-week, Phase 3 clinical trial that is being conducted in Korea in over 200 patients. These individuals are receiving 24 weeks of treatment with 30 mg of Clevudine, followed by 24 weeks of treatment with 10 mg Clevudine. Two other 24-week Phase 3 clinical trials are being concluded in both HBeAg(+) and HBeAg(-) patients in Korea. Preliminary results of these trials have indicated that Clevudine reduced the HBV viral load to undetectable levels after 24 weeks in 59% and 92% of trial participants, respectively.
Schaefer Price, Pharmasset's President & CEO, stated, "As new, better therapies are introduced into the HBV market, we believe the market will grow and the standard of care for the treatment of chronic Hepatitis B will evolve into a combination therapy similar to HAART therapy used to combat HIV. Based on the current clinical findings, we believe Clevudine has the potential to be a key component of future combination therapy for chronic HBV. With their different mechanisms of action against the hepatitis B virus, Clevudine and Racivir®, Pharmasset's Phase 2 drug candidate, have the potential to address this anticipated need for HBV combination therapy."
Under the terms of the agreement, Pharmasset gained development and commercialization rights to Clevudine, and Bukwang received an option to Racivir for the treatment of chronic Hepatitis B in Korea. Bukwang granted Pharmasset commercialization rights to Clevudine for North, Central and South America, Europe, the Caribbean, and Israel, but has retained rights to certain other countries, excluding those Asian territories that were licensed by Bukwang to Eisai Pharmaceuticals in November 2004.
"We are confident in Pharmasset's ability to successfully develop Clevudine," noted Sung-Koo Lee, Bukwang's President and Representative Director of the Board. "Bukwang and Pharmasset possess the combined expertise required to accelerate the development of Clevudine into a viable, once-daily treatment option for patients chronically-infected with HBV."
About Hepatitis B
Hepatitis B is a serious disease caused by the hepatitis B virus (HBV). According to the World Health Organization (WHO), more than 350 million people worldwide are chronically infected with the hepatitis B virus, including approximately 1.25 million the United States. Chronic Hepatitis B infection can lead to cirrhosis of the liver, liver failure, and liver cancer, which collectively cause over 1 million deaths worldwide each year.
Pharmasset, Inc. is an emerging pharmaceutical company committed to the discovery, development, and commercialization of novel antiviral drugs. The company leverages its expertise in nucleoside chemistry to develop therapeutics to combat infections caused by drug-resistant human immunodeficiency virus (HIV) and hepatitis viruses. Pharmasset has two drugs in Phase 2 clinical trials for the treatment of HIV, Reverset(TM) and Racivir®, and several other antiviral compounds in advanced preclinical studies. In 2003, Pharmasset entered into a collaborative licensing agreement with Incyte Corporation for the development and commercialization of Reverset in certain territories. In 2004, Pharmasset entered into a collaboration agreement with Hoffmann-La Roche for the development and commercialization of PSI-6130 in certain territories for the treatment of Hepatitis C. Pharmasset retains proprietary development and commercialization rights to the balance of its clinical and preclinical pipeline.
Pharmasset's expanding portfolio of antiviral therapeutics aims to improve the lives of individuals around the world.
Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 40 years, and anticipates achieving US$130 million in net sales in 2005. Sales are primarily derived from products licensed from Europe, the United States, and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of antiviral diseases, diabetic neuropathy and cancer.
With a vision of delivering better human healthcare products, Bukwang has expanded its R&D activities through a subsidiary (Anterogen Co., Ltd.) focusing on adult stem cell research for heart tissue regeneration from bone marrow derived stem cells.
STATEMENTS IN THIS COMPANY PRESS RELEASE MAY CONSTITUTE FORWARD-LOOKING STATEMENTS AND ARE SUBJECT TO NUMEROUS RISKS AND UNCERTAINTIES, INCLUDING THE FAILURE OF PHARMASSET'S TECHNOLOGY TO PERFORM AS EXPECTED, THE COMPANY'S FUTURE CAPITAL NEEDS TO FUND ITS DEVELOPMENT PROGRAMS, THE COMPANY'S ABILITY TO OBTAIN ADDITIONAL FUNDING, THE COMPANY'S ABILITY TO OBTAIN REQUIRED REGULATORY APPROVALS, THE DEVELOPMENT OF COMPETITIVE PRODUCTS BY OTHERS, THE EXISTENCE OF THIRD-PARTY PATENT RIGHTS, AND OTHER RISKS INHERENT IN DISCOVERY AND DEVELOPMENT STAGE PROGRAMS AT A BIOTECHNOLOGY COMPANY. THE ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THIS COMPANY PRESS RELEASE. THE COMPANY DISCLAIMS ANY OBLIGATION TO UPDATE THE STATEMENTS CONTAINED IN THIS COMPANY PRESS RELEASE.
Contact:
Alan Roemer
Pharmasset, Inc.
(678) 395-0035
aroemer@pharmasset.com
Source: Pharmasset, Inc.
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Tainted-Blood Victim Still Feels Left Out
Brockville Recorder & Times
By NICK GARDINER, Staff Writer
SMITHS FALLS -- Still on the outside looking in.
That's how Tina Lyon feels even as the Canadian Red Cross awaits formal sentencing Thursday for distributing tainted blood that left her with hepatitis C after a blood transfusion in 1985.
The Red Cross was fined $5,000 after pleading guilty in Hamilton court May 30 to violating the Food and Drug Regulation Act.
The agency also agreed to set up a $1.5-million scholarship fund that Lyon hoped could help pay for her son John's second year at Carleton University starting next fall.
It turns out, however, her family is ineligible for the scholarship just like it was for the original $1.1 billion federal compensation packaged announced in 1998.
"Once again, we're separated. We're a different class of citizen," she said.
"(The scholarship) would help and we feel we deserve it, too. But from what we understand..."
The wife of Ron Lyon and mother of two boys, Tina Lyon estimates she has lost $250,000 in wages and benefits since 1990 when she was forced to quit her job at Hershey Canada because it left her feeling exhausted.
"What this has done to me, it's changed my life completely," she said.
Lyon fell outside the controversial federal compensation package, which included only people who received tainted blood between 1986 and 1990.
Moreover, she's skeptical about the chances of receiving funds, despite a unanimous decision of Parliament last April to expand the compensation deal and include victims outside the original dates.
At that time, Health Minister Ujjal Dosanjh linked any additional compensation to the existing package, noting the issue will depend on a study to determine how much money remains in the fund.
"They're still waiting for the actuarial study. It was supposed to be done in June and now it's delayed until the fall," said Lyon.
Meanwhile, she added, some people covered under the original agreement are fighting efforts to bring more victims into the package.
"It's just talk. It's discouraging (but) we're still battling."
Lyon did receive provincial compensation totalling $25,000 from 1999 to 2001 and her husband's workplace insurance covered an aggressive drug treatment valued at $25,000 that she needed for two years around the same time.
Otherwise, however, the family has been forced to live on a single income for 15 years, she said.
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June 29th, 2005
Looking, Feeling Healthy No Guarantee
SourceURL:http://www.thejakartapost.com/
Emmy Fitri, The Jakarta Post, Jakarta
In a country where moralists and the judgmental are quick to condemn the sick, such as people with HIV/AIDs, it is not surprising that many people are reluctant to take blood tests.
This is particularly the case when a suspected ailment is seen as being closely related to moral values, such as those diseases that can be passed through sexual intercourse and intravenous drug use.
A booklet available to patients of the hepatology unit at Cipto Mangunkusumo Hospital reads as follows: "You look healthy, you feel healthy ... but you may be one of seven million Indonesians who are infected with the Hepatitis C Virus."
Health experts say that Hepatitis C is a silent killer as it quietly attacks the human body, especially the liver. "You will not feel the symptoms at all," the brochure explains.
Professor Ali Sulaiman, a hepatologist, said there was as yet no vaccine to prevent the spread of the Hepatitis C Virus (HCV). Those infected would notice no change in their state of health until years after the virus entered their liver through the blood.
"The virus is very smart and adaptable. It is really like a chameleon. Studies on the virus are being conducted in laboratories throughout the world," Ali said.
Preventative efforts can, of course, still be carried out. In Ali's words, "What we can do is to provide education through the media to the public about this disease. How this virus is transmitted and through what medium. We have to do this all the time."
Regular blood tests are not recommended, but those who are particularly at risk of contracting the disease should take such a test.
"People who have sexual contact with people infected with HCV, children of mothers with HCV, and drug users who often share syringes should all have blood tests done."
Today, the prevalence of Hepatitis C is between 3 percent and 4 percent. "So, for every 100 people, there are three or four people infected with HCV."
"In our clinic, we often get patients who have advanced liver disease. They then find out that it was the result of something that happened 10 or 20 years ago, when they received a blood transfusion, for example," said Ali, who is a specialist at the Cipto Mangunkusumo Hospital in Central Jakarta.
"Most of them come with chronic hepatitis or even liver cancer."
Against this background, Aydi Sukoco considers himself "very lucky" as he received early warning.
The otherwise healthy father of two, who is employed by a private sector firm, said he was shocked when he received a letter from the Indonesian Red Cross (PMI) urging him to take a blood test for HCV.
Shocking because colleagues told him Hepatitis C was a "morality" disease in the same way as HIV/AIDs.
"I was clean and healthy. I never took drugs and had a healthy sex life," he said.
He continued, "It all started in 2002 when my colleagues invited me to participate in a blood donation drive at the office. I was healthy and had no serious diseases that I knew of, so why not? A month later, I got a letter telling me to take a blood test as it was suspected that my blood was infected with HCV."
"A visit to the hepatologist confirmed that I had the virus."
Aydi said his health had always been excellent, and he had only been hospitalized once when he was involved in an accident back in 1987 when he was a teenager.
"It was a traffic accident. I was riding with a friend on a motorbike in Cilacap. I received a blood transfusion from a local hospital there," the Pekalongan native told The Jakarta Post. His hepatologist explained to him that the blood transfusion might have been infected. In all, it took him a total of 48 weeks to get rid of the virus.
"Once a week, I was injected with Peg-Interveron. I guess it was the latest breakthrough as it took less time to get rid of the virus than the normal treatment. However, it also had side-effects like loss of appetite, hair loss and fatigue. Some people say it's similar to chemotherapy treatment for cancer," he added.
Aydi is willing to share his experiences with HCV in order to make people more aware of the dangers posed by the disease -- looking healthy and feeling healthy is no guarantee that one is free of the virus.
Infected blood transfusions are now becoming a less important factor in the spread of HCV, however, as blood donations and transfusions are nowadays taken care by the PMI. This "monopoly" on providing blood supplies should help curtail the spread of the virus.
PMI's special concerns
PMI spokesperson Ria Tahir said that under Government Regulation No. 18/1980, the PMI has the authority to run the blood transfusion service in a bid to prevent the spread of certain viruses.
"We pay special attention to Hepatitis B, C, Syphilis and HIV/AIDs."
Potential blood donors are interviewed about their health, with those suffering from health problems hopefully being persuaded not to give blood.
After the interview, the blood donation is taken and the blood tested using the Eliza Method for Hepatitis B, C, Syphilis and HIV/AIDs.
"At this stage, we send letters out to individuals who are suspected of being infected. Except in the case of HIV/AIDs, because of its sensitivity, we directly report our suspicions to the Ministry of Health," she said.
"Actually, we examine between 600 and 800 blood bags per day -- not an easy task. So this monopoly (of running the blood transfusion service) is a big undertaking for us," she explained.
In the past, when private hospitals could take blood donations themselves, patients could also ask the PMI to test their blood.
"But nowadays time, what we do (sendingo out letters) is a great help. In a private sector laboratory, it would cost hundreds of thousands of rupiah just for a virus test," she said.
The latest data from the World Health Organization says that in Indonesia alone in 2000 there were at least 10 million people infected with HCV.
While the PMI is doing great work in helping prevent the spread of this virus, there are also other ways that can be employed to combat HCV, such as campaigning for safe sex, the use of clean syringes (for drug users), and the employment of sterile equipment for tatooing and piercing. While it might sound preachy, if it saves lives, why not?
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CORRECTED - Tests Compare Drugs for Hepatitis B
SourceURL:http://www.alertnet.org/
By Gene Emery
In Boston story headlined "Tests compare drugs for hepatitis B," please read in last paragraph, ... after nearly three years of treatment ... instead of ... after 12 years of treatment" (Corrects length of treatment period.) A corrected story follows.
BOSTON, June 29 (Reuters) - Swiss drugmaker Roche's brand of interferon can help control hepatitis B, a potentially deadly liver infection, better than a competitor's drug can, according to a new study published on Wednesday.
After 48 weeks of treating patients with Roche's drug, researcher George Lau and his team at Queen Mary Hospital in Hong Kong found that Pegasys suppressed the virus better than British company GlaxoSmithKline Plc drug lamivudine.
A separate hepatitis B study found a third drug, Foster City, California-based Gilead Sciences Hepsera, is effective only with continued use. Its effects disappear within weeks after patients stopped taking the medicine.
The studies were published in the latest edition of the New England Journal of Medicine. The drug companies financed the studies, held and analyzed the data and more than half of the named authors had financial ties to those companies.
Some 400 million people worldwide are believed to be infected with hepatitis B, which attacks the liver and can lead to liver cancer and death. The disease is caused by a virus, often spread through having unprotected sex or sharing needles with an infected person.
A handful of drugs have been approved to treat the condition, but their relative usefulness is a matter for debate, especially when treatment costs can range from $5,000 to $15,000 per year.
While patients treated with Pegasys suffered more side effects like depression, fatigue, headache, fever and muscle pain, the researchers said their finding supports the use of Pegasys, formally known as peginterferon alfa-2a, as a go-to drug for a common type of long-term hepatitis B.
The study of Hepsera, also known by the generic name adefovir dipivoxil, followed people with another form of hepatitis B, HbeAg-negative, which accounts for about 14 percent of U.S. cases and even more elsewhere.
A team led by Stephanos Hadziyannis of Henry Dunant Hospital in Athens, which has been following 185 volunteers, some of whom who have gone on and off the drug for as long as 144 weeks, discovered that Hepsera continues to work in more than two out of three patients.
However they found that when patients stopped taking the drug, the hepatitis B virus became reactivated, with amounts of the virus returning to pre-treatment levels within a month.
"Long-term therapy will be needed for the majority of patients," they concluded.
In a Journal editorial, Anna Suk-Fong Lok said she was disappointed that the treatment did not wipe out hepatitis B from the body.
The Hadziyannis team also reported in the Journal that after nearly three years of treatment, only 6 percent of patients had developed a mutation that made the virus resistant to the drug. By comparison, when lamivudine is given, the drug typically loses its effectiveness in 20 percent of patients each year.
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Data Evaluating Long-Term Therapy with Hepsera for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Published in the New England Journal of Medicine
SourceURL:http://biz.yahoo.com
FOSTER CITY, Calif.--(BUSINESS WIRE)--June 29, 2005--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced that data through 144 weeks supporting the efficacy and tolerability of its oral antiviral drug Hepsera® (adefovir dipivoxil) in patients chronically infected with hepatitis B "e" antigen-negative (HBeAg-negative) chronic hepatitis B were published in the June 30th edition of the New England Journal of Medicine (NEJM). Continued viral suppression and changes in laboratory markers of liver function were evaluated through three years.
"The sustained efficacy and tolerability we have observed among patients receiving continuous therapy in this study indicates that Hepsera is a valuable long-term treatment option for patients with HBeAg-negative chronic hepatitis B," said Stephanos Hadziyannis, MD, Department of Medicine, Henry Dunant Hospital, Athens, Greece, a lead investigator for the study and lead author of the paper. "There is a great need for treatments with proven long-term effectiveness among patients with this form of the disease, which often requires indefinite therapy and which has an increasing prevalence around the world."
Study 438 is a multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy, tolerability and safety of Hepsera. One-hundred eighty-five (185) patients were randomized in a 2:1 ratio to receive Hepsera or placebo orally once daily for 48 weeks. Hepsera patients on therapy at week 48 were randomized again to either receive an additional 48 weeks of Hepsera ("adefovir-adefovir," n=80) or switch to placebo ("adefovir-placebo," n=40). Patients who initially received placebo were switched to Hepsera ("placebo-adefovir," n=60). Long-term efficacy and safety (144 weeks) was evaluated in patients treated with Hepsera between weeks 48 and 96 of the study.
These data through 144 weeks further describe the profile seen at 48 weeks, which was published in the NEJM on February 27, 2003. Among patients in the adefovir-adefovir group, 71 percent achieved undetectable levels of serum HBV DNA (less than 1000 copies/mL, Roche Amplicor Monitor(TM) PCR assay) at week 96, compared with 76 percent in the placebo-adefovir group. In patients who switched to placebo at week 48, HBV DNA levels increased compared to those continuing on Hepsera, with only 8 percent in patients of the adefovir-placebo group remaining with undetectable levels at week 96 (p less than 0.001). Among patients treated with Hepsera, 79 percent had undetectable levels of serum HBV DNA at week 144.
Treatment with Hepsera also resulted in changes in laboratory markers of liver function, as measured by serum levels of alanine aminotransferase (ALT). The proportion of patients with ALT levels above the upper limit of normal at baseline whose ALT levels returned to normal at 96 weeks was 73 percent in the adefovir-adefovir group and 80 percent in the placebo-adefovir group. In patients who switched to placebo at week 48, ALT levels increased, compared to those who continued Hepsera, with only 32 percent in the adefovir-placebo group remaining normal at week 96 (p less than 0.001). Sixty-nine percent of patients in the adefovir-adefovir group exhibited normalized ALT levels at week 144. Hepatitis B surface ("s") antigen seroconversion was observed in two patients, one in the adefovir-adefovir group and the other in the placebo-adefovir group.
The safety profile of Hepsera over 96 and 144 weeks was consistent with that reported over 48 weeks, which was similar to placebo. The most common adverse reactions reported through 96 weeks were headache, abdominal pain and pharyngitis. Three patients in the adefovir-adefovir group had a confirmed increase in serum creatinine of greater than or equal to 0.5 mg/dL from baseline by week 144. All cases resolved, one while continuing Hepsera therapy and two with discontinuation of Hepsera therapy. Thirteen adefovir-placebo patients (32.5 percent) experienced significant elevations in ALT levels (greater than or equal to 10 times the upper limit of normal), most of which (10/13) occurred within 12 weeks of discontinuing therapy.
Two mutations (rtN236T and rtA181V) in the viral polymerase have been associated with resistance to Hepsera. In patients treated with Hepsera in this study, viral resistance emerged in six patients in the adefovir-adefovir group in the second year of the study. The emergence of rtN236T was associated with a rebound in HBV DNA and ALT levels. Two of the three patients with the rtA181V mutation experienced a rebound in HBV DNA levels.
About Hepsera
Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.
In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks up to a maximum of 109 weeks. Changes in serum creatinine were observed very commonly in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com.
About Chronic Hepatitis B
Chronic hepatitis B is a serious disease that can lead to potentially fatal complications such as cirrhosis and liver cancer. More than 400 million people are estimated to be chronically infected with HBV worldwide, with approximately 1.25 million people infected in the United States alone. HBeAg-negative hepatitis B accounts for approximately 14 to 33 percent of chronic hepatitis B cases worldwide.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2004 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
Hepsera is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
Contact:
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Edgley, 650-522-5635 (Media)
Source: Gilead Sciences, Inc.
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Executive Takes On 'Killer' Virus
SourceURL:http://newsvote.bbc.co.uk
Proposals to tackle Scotland's "hidden killer" Hepatitis C have been unveiled by Health Minister Andy Kerr.
An estimated 50,000 people in Scotland have been infected with the disease, about a third of whom live in the Greater Glasgow area.
This accounts for 1% of the population, compared with a figure of about 0.5% for the rest of the UK.
The proposals include the development of new guidelines and more information for injecting drug users.
Mr Kerr said: "This is a wide-ranging piece of work which outlines actions for a number of bodies to tackle Scotland's hidden killer.
"I want to see NHS boards, the voluntary sector, Health Protection Scotland and professionals from a range of specialities getting involved with helping Hepatitis C sufferers and promote understanding of the condition.
“Action needs to be taken to reduce the transmission of Hepatitis C” – Professor Peter Donnelly, Deputy chief medical officer
"Once we have a finalised plan, these measures will help us make great strides in taking forward actions to improve prevention, diagnosis and treatment of the virus."
Deputy chief medical officer Professor Peter Donnelly said Hepatitis C was a "significant public health problem" across the world and one for which there is currently no vaccine.
He said prevention of new infections was particularly important.
Prof Donnelly added: "It can infect a patient for decades before being discovered, but around 20 to 30% of people with chronic Hepatitis C will eventually face life-threatening symptoms.
"Particularly prevalent among injecting drug users, action needs to be taken to reduce its transmission, so I am pleased to see the proposed action plan for consultation being published today."
The draft plan will now go out to public consultation for three months.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/uk_news/scotland/4634391.stm
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June 30th, 2005
AVI BioPharma Submits IND for NEUGENE Antisense Drug Targeting Hepatitis C Virus
SourceURL:http://biz.yahoo.com
PORTLAND, Ore.--(BUSINESS WIRE)--June 30, 2005--AVI BioPharma, Inc. (Nasdaq:AVII - News), today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its NEUGENE® antisense drug AVI-4065 targeting hepatitis C virus (HCV). The application provides the FDA with preclinical safety, toxicology and manufacturing data in support of clinical evaluation of AVI-4065 in humans who are chronically infected with HCV.
"With a response rate of less than 50 percent for patients receiving existing treatments for the most common type of HCV infection, there remains a large unmet medical need for new and effective treatments," said Denis R. Burger, Ph.D., chief executive officer at AVI. "Our previous work in other viral research, including West Nile virus, has given us valuable insights on dosing, administration and pharmacokinetic data with which to begin this clinical program. That data, combined with the strong safety results we have seen in over 250 patients treated with NEUGENE drugs to date, greatly increases our confidence in the potential success of AVI-4065 for treating HCV."
As proposed in the IND application, the initial multicenter Phase IB clinical trial will include up to 50 patients in three treatment groups: normal subjects and two groups of patients with chronic, active HCV, including patients who are newly diagnosed, and those who have failed the current standard of care, which is interferon and ribavirin. The study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 at two dosage levels for a specific period of time.
Mark Holodniy, M.D., F.A.C.P., C.I.C., associate professor of medicine at Stanford University School of Medicine and director of the HIV Clinical Program and AIDS Research Center at Veterans Affairs Medical Center in Palo Alto, Calif., will serve as the principal investigator for this intended multicenter study.
HCV is a single-stranded RNA virus known to undergo a high rate of mutation, which may help the virus develop resistance to many current and development-stage antiviral medications. Because HCV and other single-stranded RNA viruses have relatively simple genetic structures, they are attractive targets for AVI's NEUGENE antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time, after drug exposure.
Another NEUGENE drug, AVI-4020, is currently being studied in a clinical trial of patients exhibiting presumptive neuroinvasive disease caused by West Nile virus. In addition, NEUGENE drugs are being tested against a variety of hemorrhagic, infectious and toxin-producing agents in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Walter Reed Army Institute of Research (WRAIR), and the Centers for Disease Control and Prevention (CDC).
About Hepatitis C
Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. According to the World Health Organization, approximately 170 million people worldwide are chronically infected with HCV. It is the most common chronic blood-borne infection in the developed world and the leading cause of liver transplants in the United States. The CDC estimates that approximately 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected. The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually in the United States from HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to 48 weeks of therapy with PEG-interferon alpha and ribavirin, is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S. In addition, this treatment has numerous side effects, some of them severe, which make it difficult for many patients to tolerate the recommended dosages and duration of treatment.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis and cancer. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, and Ebola virus. More information about AVI is available on the company's Web site at http://www.avibio.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.
Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
hubbard@avibio.com
or
Lippert/Heilshorn & Associates Inc.
Investor Contacts
Bruce Voss, 310-691-7100
bvoss@lhai.com
or
Jody Cain, 310-691-7100
jcain@lhai.com
or
Waggener Edstrom Bioscience
Press Contact
Wendy Carhart, 503-443-7000
wendyc@wagged.com
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Huge Posters Focus on Hepatitis C
SourceURL:http://news.bbc.co.uk
Nick Green was not diagnosed for 20 years
A lecturer who had hepatitis C for 20 years without knowing it will be featured in a new awareness campaign.
Nick Green of Nottingham was diagnosed with the disease a year ago, two decades after blood tests showed problems with his liver.
An exhibit, to run across the UK, will include a 3m-high poster of Mr Green.
Hepatitis C can be transmitted by drug use and unsafe sex - and symptoms can include fatigue, weight loss, insomnia and depression.
Mr Green has the disease despite falling outside the high risk categories, which include drug users and those who practice unsafe sex.
People need to take a few minutes out of their day to step back and face their pasts
David Marks, Hepatitis C sufferer and ex-Beach Boy
"My main symptom was a lot of extreme pain in my liver - and stomach area, also extreme fatigue, loss of concentration, mood swings and depression.
"I felt ill every day and still do - with insomnia alongside that - not able to relax and sleep well."
The photo exhibit of people living with hepatitis C - prepared by photographer Michele Martinoli, was first unveiled in London's Leicester Square in March.
The Nottingham exhibit at the city's Market Square will be held on 7 and 8 July.
'Social stigma'
Former Beach Boys band member David Marks, who also has hepatitis C, said 80% of the estimated 200,000 people infected in the UK are unaware of their condition, which can go undetected for up to 30 years.
Mr Marks said: "People need to take a few minutes out of their day to step back and face their pasts, have I ever injected drugs using shared equipment, even just once?
"Have I had an unsafe tattoo or piercing? If the answer is yes, call the Hepatitis C Information Line for advice about hepatitis C and whether you should consider being tested."
Ms Martinoli, who also had hepatitis C, said: "There is a social stigma around the disease caused by lack of awareness.
Blood transfusions
"It's important that we bring hepatitis C out of the shadows to get people to face up to the illness in the same way we did with HIV in the eighties and nineties."
Hepatitis C is usually spread by the transfer of blood from person-to-person, for example through the sharing of needles or syringes when injecting drugs.
Those at risk include people who have had a blood transfusion before screening for hepatitis C was introduced in 1991.
Many people have no symptoms, while others may feel tired and have mild abdominal discomfort.
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Panel Backs Tougher Hepatitis B Guidelines
SourceURL:http://news.yahoo.com
By Anita Manning, USA TODAY
Vaccine experts voted Wednesday to strengthen a recommendation that all healthy newborn babies get a hepatitis B shot before leaving the hospital, saying "exceptions should be rare" and should require documentation and follow-up.
The current guidelines say the first shot should "preferably" be given while the newborn is still in the hospital but say it can be given up until the child reaches 2 months old if tests show the mother is not infected. The recommendation, which will not be final until approved by the Centers for Disease Control and Prevention, says a doctor's written order to delay the vaccine is needed, along with a lab report showing that the mother was not infected with the virus.
Since routine infant vaccination began in 1991, "we've essentially eliminated hepatitis B infection in children," Eric Mast of the CDC
CDC's National Center on Infectious Diseases reported at a meeting of the Advisory Committee on Immunization Practices. Studies show that immunization rates for children 19 months to 35 months increased from 8% to 92.4% from 1992 to 2003. Nationally, rates of infection in those age 19 and younger have dropped from 3.03 per 100,000 in 1990 to .34 per 100,000 in 2002. Among children age 4 and younger, the incidence declined 94%.
In 2001-02, 42% of cases in children who were born after 1991 were in those born overseas. The advisory committee also is recommending hepatitis B screening for children from Asia, the Pacific Islands, Africa and other countries where the prevalence of the disease is 2% or greater.
Hepatitis B can cause chronic liver disease that is fatal in up to 25% of cases. It is carried in blood and body fluids and can be transmitted to adults through sex, needle-sharing or in health care settings and to babies born to infected mothers.
Screening for the virus is part of prenatal testing. But about 5% of mothers do not have prenatal care, and their infection might not be detected.
The updated recommendation "indicates exceptions should be highly rare and provides guidelines that there be a laboratory report," said Edgar Marcuse of Children's Hospital and Regional Medical Center in Seattle.
The meeting continues today, when the committee will decide whether to recommend newly licensed tetanus-diphtheria-pertussis (whooping cough) vaccines to battle the growing number of outbreaks among adolescents. The new vaccine would be given in place of the tetanus-diphtheria booster shot for 11- and 12-year-olds. The committee also will discuss boosters for adults.
Chanuntell Viet, 37, of Harahan, La., who represents Parents of Kids with Infectious Diseases, urged the committee to consider whooping cough boosters for both adults and teens.
Viet developed whooping cough when her baby, Geoffrey, was 1 month old, too young to get his first DTP shot. He caught it from her and had to be hospitalized for nine days. He's now a healthy 6-month-old.
"The most shocking part was the fact that my 'cold' was pertussis," Viet said. "Adults don't realize they can have this disease and pass it to others."
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Science Making Headway against Hepatitis B
SourceURL:http://www.healthcentral.com
By Amanda Gardner
HealthDay Reporter
Two studies point to best therapies for specific patients.
WEDNESDAY, June 29 (HealthDay News) -- Two new studies suggest researchers are moving closer to finding the best treatments for chronic hepatitis B, a viral infection affecting some 400 million people worldwide.
Chronic hepatitis B is an enormously complicated disease, one that strikes different people differently and which requires nuanced treatment approaches.
"Hepatitis B patients are not alike," said Dr. Anna S.F. Lok, a professor of internal medicine and director of clinical hepatology at the University of Michigan. "Having more treatment options is good for the patient [but] it can be confusing for physicians who are not as familiar with the disease."
"It's just like going into a shop," continued Lok, who wrote an editorial that accompanies the studies in the June 30 issue of the New England Journal of Medicine. "If they only sell white blouses, that's very easy. But if they have many different styles and colors, you end up standing there for half an hour and not deciding."
Hepatitis B kills about one million people each year worldwide. The disease is caused by a virus that attacks the liver and can cause lifelong infection, scarring of the liver, liver cancer, liver failure and death. The virus can be spread from a mother to the fetus, as well as through sex and intravenous drug use.
Now, more treatments are more easily available in pill form (as opposed to injection) and scientists are racing to discover the best way to deliver different options.
One study in the new issue of the journal found that longer-term treatment with the drug adefovir dipivoxil benefited patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B.
HBeAg-negative disease tends to represent a later phase in the course of infection and also tends to be more aggressive.
This study involved 185 HBeAg-negative patients assigned to receive adefovir dipivoxil daily or a placebo for 48 weeks. The international study was based in Athens and supported by Gilead Sciences, which makes the drug.
When the 48-week point had been reached, the patients taking the drug were again randomly assigned either to take adefovir dipivoxil for another 48 weeks or to switch to a placebo. After 96 weeks, patients taking adefovir dipivoxil were offered continued therapy and continued to be monitored.
When treatment was discontinued after 48 weeks, any benefits achieved were lost. Patients who received adefovir dipivoxil for the full 144 weeks, however, maintained the benefit, suggesting that long-term therapy will be needed in most patients, the authors stated.
A second international study, supported by drug maker Roche and led by researchers in Hong Kong, compared peginterferon alfa-2a given in conjunction with another drug, lamivudine, against each of the two therapies alone. These patients were HBeAg-positive, which usually represents an earlier phase of infection.
More than 800 patients, most of them Asian, were randomly chosen to receive one of the three treatment regimens.
After 24 weeks of follow-up, more patients receiving peginterferon either alone or in combination were showing a benefit on multiple end points.
This supports the use of peginterferon alfa-2a as a first-line therapy for people with this type of chronic hepatitis B, the authors stated.
Still, there are many issues to be worked out.
One issue involves side effects. "Many of these drugs were approved based on one year but then we found out that one year was not good enough, that we needed to continue the drugs," Lok said. "Then we started getting worried. Do we really know these drugs are safe?"
Another issue is that the virus can develop resistance to specific drugs. "Unfortunately, it's like taking the same antibiotics for a long, long time. After a while they no longer work," Lok pointed out.
Then there are the perennial questions of when to start treatment and when to stop it. "It becomes important for us to think very carefully -- 'Should I be starting this patient on treatment? Do the benefits really outweigh the risks? What, actually, is the best treatment for this particular patient?' " Lok said. "We need to balance all the benefits as well as the potential problems."
More information
The U.S. Centers for Disease Control and Prevention (www.cdc.gov) has more on hepatitis B.
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Smoking and Hepatitis C Up Risk of Lymphoma
www.reutershealth.com
NEW YORK (Reuters Health) - Results of an Italian study confirm that heavy smoking doubles the risk of developing non-Hodgkin lymphoma (NHL), a cancer of the lymph nodes. The study also shows that hepatitis C virus (HCV)-positive individuals who are heavy smokers have an approximately 4-fold elevated risk of developing NHL.
According to researchers, about 5 percent to 10 percent of NHL cases could be prevented by persuading people to quit smoking and by integrated policies and health programs aimed at reducing HCV infection.
"Smoking is a well-documented risk factor for several cancers, but the role of cigarette smoking in the etiology of NHL is inadequately understood," lead researcher Dr. Renato Talamini from the National Cancer Institute in Aviano told Reuters Health. HCV infection has been associated with NHL, he noted, but the interplay between tobacco use and HCV has not been studied.
Talamini and colleagues studied relationships between HCV, smoking habits and NHL in 225 consecutive patients who were hospitalized with a new diagnosis of NHL and 504 matched control patients who were hospitalized for a wide range of acute conditions not related to cancer or tobacco.
Compared with never smokers, current smokers of 20 or more cigarettes per day had a greater than 2-fold increased risk of NHL, the investigators report in the International Journal of Cancer. This finding was consistent for both sexes and all age groups.
Being positive for HCV infection also increased the risk of NHL significantly.
"The effects of tobacco smoking and HCV infection seemed to act independently on NHL risk, leading to a grossly elevated risk for heavy smokers who are HCV positive," Talamini told Reuters Health. "Tobacco and HCV seem to act at different stages of the process of NHL carcinogenesis."
"Health professionals could play a key role in reducing NHL incidence in the population," Talamini contends, by promoting healthy lifestyles and behaviors, engaging in anti-smoking campaigns, providing support for people who are quitting, and, in the absence of proven HCV vaccine, promoting interventions against risky behaviors including intravenous drug use and unprotected sexual intercourse.
SOURCE: International Journal of Cancer July 1, 2005.
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Governor, Lawmakers Split over Hepatitis C Drugs
SourceURL:http://www.oregonlive.com
MICHELLE COLE
The Oregonian
The debate centers around the state's ability to control the cost of prescription medication under the Oregon Health Plan
SALEM -- Gov. Ted Kulongoski and the Oregon Legislature are battling over whether the state has the right to decide what types of drugs are prescribed to Oregon Health Plan patients with Hepatitis C.
An estimated 900 patients may be directly affected by House Bill 2480, which would prohibit the Department of Human Services from limiting the types of prescription drugs used to treat the infectious and potentially deadly disease. But if HB2480 became law, critics say, the pharmaceutical industry would be the biggest winner.
At issue is the state's ability to control prescription drug costs under the Oregon Health Plan.
"Drug companies are very powerful. They want to protect themselves," said Rep. Mitch Greenlick, a Portland Democrat who is also associate director of the Evidence-based Practice Center at Oregon Health & Science University.
Proponents of the bill -- ranging from grass roots organizations to two pharmaceutical companies -- say they understand the state's need to control prescription drug costs. But they argue that Hepatitis C is difficult to treat and physicians caring for Oregon Health Plan patients should have the full menu of drug choices.
"This is not a case where you can save a few dollars. People are dying of this disease," said Lorren Sandt, executive director of the Hepatitis C Caring Ambassadors Program, a national advocacy group based in Oregon City.
The 2001 Legislature created a law that included a list of lower cost drugs doctors must prescribe to Oregon Health Plan patients. The requirement did not apply to prescription drugs used to treat mental illness, HIV, AIDS and cancer. HB2480 would put Hepatitis C drugs in a similar category.
Hepatitis C is spread by blood contact and can be transmitted by IV drug use, sharing razor blades, body piercing or tainted blood transfusions. An estimated 61,585 Oregonians may be infected with the disease and the majority may not know it.
Untreated, Hepatitis C can lead to cirrhosis, liver failure and cancer. But treatment is expensive, costing between $20,000 to $36,000 for six to 12 months of drug therapy.
Though the governor's staff has voiced concerns, HB2480 has received broad bipartisan support.
Last month, the Republican-led House endorsed HB2480 on a 41-15 vote. The bill recently passed the Senate Rules Committee and is headed for a floor vote within the week. Observers say it has a good chance of passing the Senate and making it to the governor's desk.
On Wednesday, Kulongoski spokeswoman Anna Richter Taylor could not say whether the governor would veto the bill. But Taylor said he wants to protect the state's ability to provide the most cost-effective care through the Oregon Health Plan.
A recent evaluation found 27 percent of the Oregon Health Plan fee-for-services patients who started Hepatitis C drug therapy did not complete it. The wasted cost of ineffective treatment was estimated by the state to be as much as $22,000 per patient.
Barney Speight, a former administrator of Oregon's Office of Medical Assistance, said the state developed a protocol to ensure that the right people are matched with the right Hepatitis C drugs.
"The kinds of protocols and guidelines we've developed are not developed in a bureaucratic vacuum," Speight said. "But the pharmaceutical industry dislikes government-imposed approaches."
Hasina Squires, a lobbyist for Roche Pharmaceuticals, said HB2480 is not about government but about "allowing patients to access all types of treatment."
Sen. Alan Bates, D-Ashland, a family practice physician, comes down somewhere in between.
"The pharmaceutical industry will always be pushing their products," said Bates.
Still, Bates said he's willing to push for HB2480 -- and risk a governor's veto -- because doctors "not bureaucrats in Salem" should be making treatment decisions.
Michelle Cole: 503-294-5143; michellecole@news.oregonian.com
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Innogenetics Confirms Three-Year Delay in Hepatitis C Vaccine Launch
SourceURL:http://www.forbes.com
BRUSSELS (AFX) - Biotechnology company Innogenetics NV said the launch of its hepatitis C vaccine will be delayed by at least three years due to an extension of clinical trials.
Innogenetics said earlier this month the trials were 'inconclusive' and have to be extended by 15 months, causing its shares to plunge 30 pct.
'With a total duration of 3 years, final results of the second Phase IIb trial are now expected to be announced in the second half of 2007,' the group said in a statement.
Guy Buyens, chief therapeutics officer of Innogenetics, said: 'The good tolerability, robust immunological response, and relevant effect of the E1-based candidate vaccine on fibrosis certainly warrants a prolongation of the study.'
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Canada Red Cross Tries to Put Blood Scandal to Rest
SourceURL:http://www.alertnet.org
Source: Reuters
TORONTO, June 30 (Reuters) - Victims of Canada's tainted blood scandal had a chance to air their stories in an Ontario court on Thursday as the Canadian Red Cross was formally sentenced for distributing blood products contaminated by donors who suffered from HIV and hepatitis C.
A court in Hamilton, Ontario, handed the agency the maximum fine of C$5,000 ($4,065) for violating the Food and Drugs Act. It has already provided C$70 million in compensation to more than 10,000 victims and Canadian governments agreed in 1998 on a C$1.1 billion compensation plan.
The Red Cross was sentenced after nine people read victim-impact statements in a hearing that spanned 3-1/2 hours.
"They talked about how devastating the disease is to them," said John Plater, a lawyer and member of the Canadian Hemophilia Society, who was also made ill by the tainted blood. "But they also talked about how devastating and how frustrating (it was) trying to get answers and bring these people to account and how many years it has taken.
"That really struck a chord with me ... the wasted time."
About 1,000 Canadians were infected with HIV, the virus that causes AIDS in the 1980s before the Red Cross began testing blood donations. An estimated 20,000 people have been infected with hepatitis C, a debilitating and often deadly liver disease.
The Red Cross pleaded guilty in May to violating the country's Food and Drugs Act -- the first time the charity admitted it broke the law.
Thursday's sentence included C$1.5 million for a scholarship fund for students affected by the tragedy and for a project to improve health care practice. According to the Red Cross the sentence "closed a sad chapter in its history."
"This afternoon was particularly painful and I have maybe only one word to describe that -- tragedy," said Pierre Duplessis, the Canadian Red Cross's chief executive.
The Red Cross was forced to seek bankruptcy protection in the late 1990s and has transferred its blood supply operations to a government-funded agency.
"Blood is over, it's done, it's finished, so hopefully for us, we will be able to turn that page in our history," Duplessis said.
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July 1st, 2005
National Strategy to Attack Hep C
SourceURL:http://dailytelegraph.news.com.au
By Adam Gartrell
HIGH hepatitis C infection rates from the use of illicit drugs was a key health problem in Australia, Health Minister Tony Abbott said today.
At the launch of the second National Hepatitis C Strategy today, Mr Abbott said it was important the public understood the link between hepatitis C and drug-taking if infection rates were to be reduced.
About 90 per cent of infections result from unsafe illicit drug-taking practices such as sharing or reusing needles, according to figures compiled by the Australian Injecting and Illicit Drugs Users League.
"Hepatitis C is a very serious health problem in our community," Mr Abbott said.
"It is vitally important that we continue to raise public awareness and it is important that people do not continue to get infected through ignorance.
"It is important that the message gets out there that there is no entirely safe way to use illicit drugs."
Hepatitis C is a blood-borne viral disease that is believed to affect about 250,000 Australians, with an estimated 16,000 new infections every year.
It causes liver disease and failure and is the most common cause of the need for liver transplants in Australia.
The federal government strategy focuses on improving prevention and education, treatment and diagnosis, surveillance, research, and care and support.
Australian Hepatitis Council president Stuart Loveday welcomed the strategy but said it needed to be backed up with action.
"Without a concrete and achievable plan of action, this strategy will remain simply a policy document," he said.
Many issues surrounding resource allocation were still not clear, he said.
Mr Abbott said the Government would provide the states with $1.8 million to improve surveillance of hepatitis C in addition to the more than $40 million a year the government already spends to combat the disease.
Mr Abbott said the government had also asked the Pharmaceutical Benefits Advisory Committee to review the requirement of a liver biopsy for hepatitis C sufferers before they are eligible for treatment.
"A lot of people with hep C live in difficult circumstances and a liver biopsy is a painful, invasive procedure and, given everything else that's happening in their lives a lot of people do choose not to have the biopsy and therefore, under current rules, they can't get the treatment," he said.
There is no vaccine to protect against Hepatitis C and experts say it is unlikely that one will be developed in the near future.
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Resistance to Long-Term Lamivudine Treatment in Hep B
SourceURL:http://www.gastrohep.com
Research in July's issue of the Journal of Viral Hepatitis finds no influence of Hepatitis B genotype on the development of resistance to lamivudine, however liver disease severity is influenced by genotype.
Lamivudine is effective in suppressing viral replication, normalizing alanine aminotransferase, and improving histological appearance in Hepatitis B e-positive and negative hepatitis.
It is unclear whether Hepatitis B virus genotype influences the response to lamivudine.
Dr Moskovitz and colleagues from Canada investigated the long-term response of lamivudine.
74% of YMDD mutations detected had no association with a particular genotype – Journal of Viral Hepatitis
The researchers included patients with chronic Hepatitis B with and without cirrhosis at baseline treated with lamivudine according to Hepatitis B genotype.
The research team retrospectively reviewed charts of all patients treated with lamivudine monotherapy between 1993 and 2002.
Response to therapy was defined as alanine aminotransferase in the normal range, and undetectable Hepatitis B DNA.
The team defined response to therapy in the Hepatitis B e antigen positive group as loss of Hepatitis B e antigen and/or the development of anti-Hepatitis B e.
The researchers measured Hepatitis B DNA by the Digene Hybrid capture assay at a sensitivity of 1.4 with 106 copies/mL.
YMDD mutation at rtL180M and rtM204V/I were measured by restriction digest of amplified products.
The researchers performed genotyping by sequencing and phylogenetic tree analysis of the preS region of the virus genome.
The team reported that 71 patients were treated with lamivudine for 6 months or more, of which 53 were male with an average age of 47 years.
The researchers also reported that 38 of the patients were Hepatitis B e antigen-positive and 33 were Hepatitis B e antigen-negative.
The team noted that mean baseline Hepatitis B DNA viral titre was 1280 copies/mL and 518 copies/mL respectively.
Cirrhosis was present in 30 patients.
The researchers examined sera for YMDD mutations at last patient visit in 86%, and were detected in 74%, there being no association with a particular genotype.
The team observed that data from up to 5 years on lamivudine indicated no difference in biochemical or virological response between genotypes.
The research team found that cirrhosis was more prevalent with specific genotypes.
Dr Moskovitz's team concludes , “We found no influence of Hepatitis B genotype on the development of resistance to lamivudine, however liver disease severity was influenced by genotype.”
J Viral Hep 2005: 12(4): 398
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Abnormal Liver Tests in a Mediterranean Population
SourceURL:http://www.sciencedaily.com
A recent population-based study in a small town in Southern Italy found that one in eight residents had abnormal liver tests. While alcohol consumption was the most common causative factor, nonalcoholic fatty liver disease (NAFLD) is an increasingly prevalent source of the problem. The study is published in the May 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., the journal is available online via Wiley InterScience at www.interscience.wiley.com/journal/hepatology.
Chronic liver disease is a serious public health issue in many communities. It can be caused by high alcohol consumption, hepatitis B and C, and nonalcoholic fatty liver disease, a condition associated with obesity, insulin resistance, high cholesterol and the like. The importance of these causative factors varies from one location to another. For example, in the U.S., the majority of altered liver enzymes are related to NAFLD, while in northern Italian populations, much is related to alcohol. Factors leading to liver disease had not been thoroughly studied in Southern Italy, so researchers, led by Gaspare Maria Pendino of Reggio Calabria, assessed the prevalence and etiology of altered liver tests in the general population of Cittanova, a small southern Italian town.
They generated a random sample of residents 12 years or older and screened 1645 participants for abnormal liver values, antigens to hepatitis B and C and alcohol consumption. From each individual, they also gathered socioeconomic data, medical history and body mass index.
More than 12 percent of those screened had abnormal liver values, with prevalence increasing with age. The age-trend was mainly due to chronic HCV infection, which affected 6.5 percent of the study population overall and increased in prevalence with age. More men than women had elevated liver tests, which was probably attributable to greater alcohol consumption among men.
Almost 46 percent of the altered liver values in Cittanova were attributable to excessive alcohol consumption. Nearly 20 percent was due to hepatitis (18.6 percent hepatitis C, 1 percent for hepatitis B.) A combination of alcohol and hepatitis caused 9 percent of cases. A tiny percentage was caused by rare conditions. And researchers estimated that the remaining 24 percent of cases were due to NAFLD. High BMI, high cholesterol, and hyperglycemia were independently associated with those cases, and 63.3 percent had a bright liver at echography.
While the use of medications could not be excluded as a cause of the abnormal test results in the suspected NAFLD cases, "it must be stressed," say the authors, "that in almost all cases the medication was for one of the possible alterations related to the metabolic syndrome (i.e. anti-hypertensive, lipids lowering, antidiabetic)."
Cittanova is involved in the epidemic of obesity, with nearly 17 percent of the population having a BMI above 30, however, that rate is still far below other parts of the world, like the U.S. where more than 30 percent of the population has a BMI of 30 or more.
"The leading causes of altered liver tests are alcohol, HCV and NAFLD in Cittanova," the authors conclude, "NAFLD is emerging as an important etiology."
Article: "Prevalence and Etiology of Altered Liver Tests: A Population-Based Survey in a Mediterranean Town." Gaspare Maria Pendino, Andrea Mariano, Pasquale Surace, Carmelo Antonio Caserta, Maria Teresa Fiorillo, Angela Amate, Stefania Bruno, Carmelo Mangano, Irene Polito, Fulvia Amato, Rodolfo Cotichini, Tommaso Stroffolini, Alfonso Mele, and the ACE Collaborating Group, Hepatology; May 2005; Volume 41, Issue 5.
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July 2nd, 2005
More Midcoast Youth Afflicted with Hepatitis
SourceURL:http://knox.villagesoup.com
By Lynda Clancy, Staff Reporter
MIDCOAST (July 2): Silent, potentially deadly and able to lie dormant for decades, hepatitis C has been called the Baby Boomer revenge. Now it is infecting older teens and young adults and causing alarm among state epidemiologists and local doctors. Dr. Neil Smith, a Rockport physician who specializes in gastroenterology and hepatology, has seen a marked increase in the number of 20-somethings carrying the blood-borne virus. His office is one of the few along the coast -- and perhaps the only one in the Midcoast -- that specializes in hepatitis C.
He sees four or five newly diagnosed patients on a monthly basis. And in 10 or 20 years, the number of those infected is expected to double or triple. About 85 percent of individuals acutely infected with hepatitis become chronically infected. Once that happens, a person almost never heals completely without treatment.
"It's a public health problem," said Smith, who has been treating hepatitis patients for more than 15 years. "One of the frightening aspects of the disease is that most feel fine. Yet over a period of time, the liver can be damaged. Twenty years from now, these young people could have liver cirrhosis, liver cancer and even face death."
The state is also concerned and has recently completed its Viral Hepatitis Prevention and Control: An Action Plan for Maine, which followed on its 2001 statewide assessment by the Maine Hepatitis C Infection Needs Assessment Steering Committee. The plan calls for a stepped-up public awareness campaign, and better streamlined testing and care across the state.
What happens to a body suffering from hepatitis is not pretty. Patients are constantly fatigued, and their stomachs can become swollen and their eyes and skin jaundiced.
In the United States there are now an estimated 4 or 5 million people infected with the virus and its rise is attributed to a proportionate rise in the number of people injecting opiates such as heroin, cocaine and OxyContin with dirty needles. There is no shortage of drugs on the streets these days, and every day there are new reports of drug busts of cocaine, heroin and pharmaceuticals taking place locally and in the small cities of Maine.
Just last week a Maine State Prison guard was arrested on charges of bringing heroin into the prison in Warren.
Tracy Harjula, a registered nurse at Smith's office, sees the effect of drug use both at her job and in the small fishing community she calls home, "where it's rampant," she said.
"Walking along my road I'm finding multiple needles that have been thrown from vehicles," she said. "We have to worry about our kids riding a bike down the road because of needles lying on the side of the road."
She even noticed that when the road was recently paved, needles were embedded in the tar.
But the virus is not merely contracted by dirty needles or snorting cocaine through contaminated straws. It can be acquired by being accidentally pricked by infected needles while on the job in a hospital, sharing a toothbrush, or getting a tattoo or a simple manicure. It is a virus that mutates so a vaccine is hard to develop, and the particular genotype of hepatitis C that is predominant in Maine and the Northeast is not always treatable with the current therapy of interferon and ribavarin.
"These are society issues and it affects a large cross section of the culture -- socially, economically and culturally," said Smith. "I have this little window into behavior in this corner of the world. I don't see [hepatitis C] decreasing and that's scary for me."
It's equally concerning to Harjula, who educates patients about the treatment programs, which she likens in their side effects -- thinning hair, nausea and depresssion -- to chemotherapy.
At the same time, insurance programs (including Medicaid systems and HMOs) are becoming increasingly burdened by the costs of hepatitis C treatment and will be further challenged in the next 10 to 20 years by the costs of care for end-stage hepatitis-related liver disease, according to the Maine Bureau of Health.
The cost per month of hepatitis C treatment averages $2,500, said Harjula. And that treatment is 50 to 85 percent effective, depending on the virus's genotype
Smith is seeing younger patients in his Rockport office, most of whom look and feel deceptively healthy. He does not see the prisoners from the prison in Warren, where another whole local population is contending with hepatitis C.
"When I started seeing [hepatitis C] in the 1990s, the patients were primarily in their 30s and 40s," he said. They may have been diagnosed after taking a blood test to get health insurance. Since then, many of them have been treated, "some successfully, some not," he said. "Some go on to get a liver transplant."
"Now it's changed," said Smith. And young people are much more open about talking about their behaviors, he said.
Not all of those younger patients choose to be treated, said Harjula. A person must be alcohol and drug free for at least six months, and not everyone is ready to stop using drugs.
"The demographics in this area have clearly changed," said Smith. "These are young, healthy people."
Because of the disease's initial asymptomatic presentation, people aren't generally aware they have it until a blood test is administered. But healthy people don't often seek out blood tests. And many young people have the notion that mortality doesn't apply to them.
"How one values one's life and how one sees the future is clearly involved in this increase," said Smith.
The brighter aspects, however, include the willingness of individuals to get a doctor's help.
"For all the negatives of our health-care system and Medicaid, people are much more willing to seek out health care," said Smith. "These kids who are suddenly on their own at 19 or 20 are seen in the emergency room. That's when a blood test can indicate abnormalities. And there is more openness and a willingness to talk about it."
Despite constant attempts to develop a vaccine for hepatitis C, it remains "a moving target," said Smith. While the body can rid itself of hepatitis B works in almost 90 percent of cases, hepatitis C is far more insidious. In just20 percent of infections does the body eliminate the virus. That leaves liver transplants as the last recourse for the infected, and even then the virus remains in the body because it remains in the blood stream.
As is the case with HIV and AIDs, Smith sees an urgent need for public education about hepatitis C.
"I would like to see better health education and public awareness of high risk behavior," he said. "It's never an easy road. It requires many interested people in our community and at the state. It also requires some willingness on the part of our society to address the issue and to be willing to work on changing behavior."
Maine State Prison tests, treats prisoners
By Dave Munson
Prison inmates with hepatitis often learn they have the disease during routine physical examinations conducted as they enter the facility. While prisoners are not tested for hepatitis specifically, unusual enzyme counts found during the course of other testing can indicate the disease is present, according to Maine State Prison Director of Nursing Holly Howieson.
"If the admission tests reveal anything unusual, we do a more extensive exam," said Howieson. "Inmates that suspect that they have hep C can request to be tested at any time."
Inmates are offered educational materials about hepatitis and other health concerns during the admission process and may request additional information or consultation whenever they feel it is needed.
Howieson said inmates who test positive for hepatitis are treated according to a standard set of protocols identical to those used by health officials outside the prison. She said the response to the prison’s treatment programs has been positive.
About Hepatitis
Hepatitis means inflammation of the liver, and viruses are often -- but not always -- the cause. Other forms of the disease include drug-induced, fatty liver and auto-immune hepatitis. There are six types of hepatitis related to viruses: A, B, C, D, E and G. Some do not result in serious disease, and vaccines are given for A and B. But chronic hepatitis C (or "hep C" or "HCV") is the most common form and the hardest to treat. It is also what doctors are seeing more of in the Midcoast.
It can result in cirrhosis (a permanently scarred liver that prevents blood from flowing through it), liver failure and liver cancer. Liver failure due to hepatitis C is currently the leading cause of liver transplants in this country.
Hepatitis C is a virus and can be contracted in the following ways:
* Accidental pricks from needles used on patients carrying the disease
* Getting a tattoo with dirty needles or piercing ears and the body with dirty needles
* Injecting drugs with contaminated needles
* Snorting drugs with a straw that has become contaminated
* Sharing a razor, toothbrush or other personal item used by someone with hepatitis C
* Undergoing kidney machine treatment
* Undergoing an organ transplant or blood transfusion prior to 1992
* Getting a manicure with contaminated instruments
* Acupuncture
In other words, it's fairly easy to pick up the virus, and many patients -- as many as 40 percent of the almost 5 million in the United States -- don't know how they picked up the disease. Former U.S. Surgeon General C. Everett Koop called it "an epidemic for anyone."
Once infected with hepatitis C, a person can be contagious to others in as short a time span as two weeks. Because the disease arrives virtually asymptomatic in its early stages, a blood test is the only way to detect it. Some develop problems within five years of getting the virus; others feel fine even 20 years later. In 15 percent of cases, the liver rids itself of the virus.
Until the early 1990s, there was no test for hepatitis C and patients infected with it were merely diagnosed as having a form of hepatitis different from the familiar forms.
Complicating the virus is its tendency to mutate into diverse genotypes. In the Midcoast, doctors see predominantly genotype 1a (which is also common in South America and Australia), whereas in Europe and Asia genotype 1b is more common.
There are currently approximately 4 million people in the United States afflicted with hepatitis C and 60 to 85 percent of all infections develop into chronic infections, with individuals living with the virus for years.
Treatments include doses of interferon and ribavarin, but they don't always work. Liver transplants are also becoming more common.
About Needle Use
Opiates are most commonly associated with needle use. According to the U.S. Drug Enforcement Administration, Massachusetts-based Dominican traffickers continue to be the primary suppliers of heroin and cocaine to Maine distributors.
Oxycodone products such as Percocet, Roxicet and OxyContin are readily available. Dilaudid is found in Washington County, including in the city of Calais.
While use is more prevalent in southern communities, heroin is also used in coastal and Canadian-border communities and has spread into rural and remote areas. Heroin abuse has increased, particularly among younger teenagers in Bridgeton, Rockland, Penobscot and York counties, the DEA said.
The National Drug Intelligence Center said heroin users in Maine generally are 18 to 30 years old and typically snort the drug until their tolerance levels increase; at that point, they start injecting the drug.
Interstate 95, "The New England Pipeline," remains the main funnel since it travels through the interior of the state, connects several of the larger cities and terminates at the Canadian border. It is an important north-south transportation route for traffickers traveling to sources of drug supply in several northeastern Massachusetts cities.
Maine's 228 miles of coastline and 3,478 miles of shoreline are also opportunities for maritime smugglers.
The I-95 distributors, who typically transport the drug in passenger vehicles, provide for an increasing availability of heroin, cocaine and phamaceuticals in the state. They transport heroin into the state from Boston, Lowell, Lawrence, Haverhill, Lynn, New Bedford and Worcester, Mass., and Hartford, Conn., said the center.
Heroin is produced in South America (Colombia), Southeast Asia (principally Burma), Mexico, and Southwest Asia and the Middle East (principally Afghanistan).
Based in Camden, Staff Reporter Lynda Clancy can be reached at 207-236-8468 or by e-mail at lclancy@villagesoup.com.
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