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Week Ending: November 5th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Other Disease Fighters Envy Breast Cancer Awareness
• Clinton Blood Scandal Exposed in New Film
• UMC Seeks Hepatitis C Patients
• Hepatitis B Education Needed in Asian-American Communities
• Studies Clarify Risk Factors for Mother-to-Child Transmission of Hepatitis C Virus
• Ask the Doctor: Hepatitis Column Questioned
• Bangladesh Paper on Looming Hepatitis C Catastrophe
• 'Unwanted Livers' for Hepatocellular Cancer in Cirrhosis
• Interferon with Ribavirin Is Safe and Effective for Children with Chronic Hepatitis C
• Dynavax Initiates US-Based Phase 1 Clinical Trial of HEPLISAV(TM) Hepatitis B Vaccine in Dialysis Population
• Lamivudine plus Interleukin-12 Enhances Immunity in Hep B
• Transplants May Be Easier for HIV Patients
• Public Health Groups to Hold L.A. Hepatitis C Summit
• RxKinetix and Indian Immunologicals Limited Collaborate on Development of Thermostable Hepatitis B Vaccines
• Study Links Hepatitis B to Gender Imbalance in Asia
• Hepatitis C: The Uncounted Disease—Parts 1 & 2
• Biolex Therapeutics Announces Initiation of Phase 1 Clinical Study of Hepatitis C Candidate Locteron(TM)
• Hepatectomy Is Safe for Hepatocellular Cancer without Cirrhosis
• HIV-Positive Patients Have Shorter Survival Periods While Awaiting Liver Transplants
• European Hepatitis B/C PEP Guidelines for Healthcare Workers Published
• Hepatitis C Caring Ambassadors Program Hopeful That Proposed Influenza Preparedness Plan Will Lead to Crucial Federal Response to Ongoing Hepatitis C Crisis
• Roche Announces Expansion of First Major Study to Examine Efficacy of Pegasys(R) in Hepatitis C Treatment in Latinos
• NHS ‘Bad’ Blood Files Destroyed
• WSU to Use Grant to Combat Hepatitis C
• Resonance Health Group Patent for Diagnosis of Liver Fibrosis
• Donor Screening Should Include Test for Hep C Virus RNA
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October 30th, 2005
Other Disease Fighters Envy Breast Cancer Awareness
SourceURL:http://www.stltoday.com
By Harry Jackson Jr.
ST. LOUIS POST-DISPATCH
Katherine Bryson has liver cancer and wants people to know that her disease needs attention, too.
But no one seems to be noticing.
She fears that her illness - and efforts by many other health movements - is eclipsed by the successful campaigns to raise awareness of breast cancer.
It's not that she's angry at breast cancer awareness campaigns. She even donates money.
But she's concerned that pink campaigns - "Think Pink," "Go Pink," pink ribbons - have become so pervasive that they have overshadowed other charities just as worthy of support.
Wakeup call
The American Heart Association - blood brother to the American Stroke Association - learned just how successful campaigns for breast cancer awareness had become when it commissioned a poll last year.
Almost a third of women believed breast cancer was women's No. 1 health problem.
African-American and Hispanic women were more likely to believe breast cancer was a greater threat to women's health than was heart disease.
Just 1 percent of women said stroke was a major cause of death. In fact, stroke is the third-leading cause of death among women, behind heart disease and all cancers combined. Taken together, heart attack and stroke account annually for more deaths among women than all other diseases - plus accidents - combined.
"Basically, that's our fault for not positioning heart disease," said Brian Walsh, spokesman for the Missouri office of the American Heart Association.
"Breast cancer is a passionate subject, and it deserves to be recognized," he said. "The (breast cancer) people have done a good job of positioning their cause. We have to do a good job of positioning our cause."
For the cause
In the battleground for awareness and attention, "positioning the cause" is the difference between heavy hitters and the forgotten few, say marketers who've observed the evolution of breast cancer awareness.
The process is called "cause marketing." It's nothing new. But like anything, some do it better than others.
"In an amazing turnaround, breast cancer went from being an unmentionable disease 20 years ago to one that everyone is talking about," said Dave Hessekiel, president and founder of the Cause Marketing Forum, a company that brings nonprofit corporations and businesses together.
The advocates had a lot to work with.
First, the success of breast cancer awareness has a lot to do with the nature of the disease itself.
"It's an appealing cause to women and an appealing cause to anyone with women in their lives," Hessekiel said. "It's not that there's a breast cancer giant stomping out competition. It's a very attractive cause."
On the other hand, diseases that affect smaller populations may "make people squeamish. They have their jobs cut out for them," Hessekiel said.
"It's hard work, and sometimes you have to be lucky that maybe a celebrity takes up your cause."
An example of such luck is colorectal cancer. "It was an unmentionable procedure for an unmentionable part of the body," Hessekiel said. That was until Katie Couric of the "Today Show" put her large intestine on TV.
Now, corporations are stepping up to help sponsor awareness programs, he said.
Path to openness
Anna DeLuca, director of communications for The Breast Cancer Research Foundation, says the campaign gets its strength from how widespread the disease is.
"If we were in a room with 1,000 people and said stand up if you had it, stand up if your mother had it, if a friend had it, eventually we'd have the whole room standing," DeLuca said.
Still, breast cancer awareness has overcome stigmas. For decades, breast cancer was an invisible disease. Social taboos squelched discussion about women's body parts or personal health in public.
Then, in September 1974, first lady Betty Ford announced she had breast cancer. As Ford championed breast cancer awareness, others imitated her openness.
Women's magazines ran cover stories. Television programs aired episodes about the disease. Each generation had examples: Edith Bunker in "All in the Family" found a lump in her breast, while Samantha Jones of "Sex in the City" yanked off her wig, revealing a head gone bald from chemotherapy.
In a recent display of solidarity, breast cancer survivor Melissa Etheridge performed bald - no wig, no hat, no crying - at the 2005 Grammy awards show.
"Some very high-profile people, very visible people have stepped up to the plate," DeLuca said. "Ten, 15 yeas ago, nobody spoke about it. Now people are open."
More than the celebrities, though, the people in the trenches - friends, relatives and survivors- have given the movement muscle, she said.
"I don't know anyone who isn't related to someone or doesn't know someone who has had breast cancer," DeLuca said. "The more open you are to a cause, the more open you are to wanting to help."
"Emotionally powerful"
Bill Finnie, adjunct professor of marketing at Washington University, said the marketing success of the breast cancer campaign is a combination of a lot of things.
"No. 1, it's a wonderful issue," Finnie said. "One in seven women will get breast cancer, and the other six are frightened of it. It's emotionally powerful with men and women."
And because the disease cuts across economic lines, the cause attracts those who can cut a check for millions as well as those who will put on pink shirts and run.
"Time and money go together," Finnie said. "If you have major volunteers, and if they're affluent, they'll give money. Those are the two big ones, time and money."
Finally, the awareness movement is saving lives. "Mammograms have saved a lot of lives," he said.
Product promotions
As for selling pink products to bring awareness, Finnie said that's not unusual in cause marketing.
Colored ribbons, the red dress pin by the Heart Association - "anyone can put a name on the back of a jacket," Finnie said.
But with breast cancer being a women's health issue, companies that sell consumer goods to women have women decision makers, employees and customers who will jump on the bandwagon.
"It's always better to have a few people who are emotionally involved," Finnie said. "Selling pink products makes customers and employees feel better."
Cindy Schneible, vice president of cause marketing and sponsorship for the Susan G. Komen Breast Cancer Foundation, said the result is awareness and support.
"Cause marketing programs are important to the Komen Foundation because they extend our reach to millions with lifesaving messages, provide an opportunity to educate women and their families about breast cancer and generate significant revenue," she said.
With respect to criticism that some companies exploit the cause and give very little, she said: "The important thing is that consumers be fully informed about the details of the programs or promotions they are thinking about supporting and the charity that will benefit. This is true whether the program benefits breast cancer or any other cause."
A disease with stigma
When Bryson learned of her hepatitis C in September 2003, "The first thing out of my mouth was, 'But I didn't do anything wrong,'" she recalled.
Doctors aren't sure how hepatitis C contributes to liver cancer, but when liver cancer strikes, hepatitis C is nearly always in the neighborhood.
The flip side is: Catch hepatitis C early, and you'll eliminate nearly all incidences of liver cancer.
Doctors caught Bryson's hepatitis C and liver cancer late. Doctors found a baseball-size tumor in her liver.
Liver cancer can carry a stigma because hepatitis C is spread through shared body fluids. It's often spread by intravenous drug use, irresponsible sex or unsanitary tattoos and body piercing.
"It's like you got it, and it's your own fault," Bryson said.
The stigma ignores health care workers, especially nurses. The American Cancer Society estimates that two of every 100 health care workers carry hepatitis C and may not know it.
That's why Missouri and other states need a mandatory testing requirement for health care workers, she said. But legislatures and other influential people prefer to throw their weight behind breast cancer awareness, Bryson said.
"It's a safe disease to support: There's no blame, no risk," she said. "But I don't care what you did to get a disease. No one deserves cancer. No one."
For our hearts
Meanwhile, the Heart Association is borrowing a page from breast cancer awareness. It has responded with the "Go Red for Women" campaign that peaks in February.
"February is Heart Month," said Walsh of the Heart Association. "Women should see a lot of things in February. We're working to get businesses to go red for that, get buildings and monuments to turn red lights on, any building we can get downtown."
Otherwise, getting more attention takes time, he said. "We just have to make our case."
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Clinton Blood Scandal Exposed in New Film
SourceURL:http://www.worldnetdaily.com/
By Joseph Farah
Documentary tying Arkansas guv to spread of AIDS to screen in Hollywood next week
WASHINGTON -- A documentary seven years in the making tying Bill Clinton to an Arkansas prison blood scandal that spread AIDS to thousands around the world is set to screen in Hollywood next week -- renewing controversy about the long-forgotten story.
The film, which premieres at the prestigious American Film Institute film festival next Tuesday, reportedly uncovers fresh evidence about how thousands in Europe contracted AIDS and hepatitis through tainted blood deliberately shipped even after widespread problems were discovered in Canada where some 10,000 had already been infected.
"Factor 8: The Arkansas Prison Blood Scandal," made by Kelly Duda, an Arkansas native, will reveal new details about how inmates at an Arkansas jail were paid to donate blood despite authorities knowing they had AIDS and hepatitis.
The documentary shows how senior figures in the state prison system altered prisoners' medical records to make it look like they were not carrying the deadly diseases.
"While making this documentary, I lost several things. I lost my president, my home state, my family, many friends, and my innocence," says Duda.
The film reveals how for more than two decades, the Arkansas prison system profited from selling blood plasma from inmates infected with viral hepatitis and AIDS. Thousands of unwitting victims who received transfusions of a product called "Factor 8" made from this blood died as a result.
Duda interviews victims in Canada who contracted the diseases, state prison officials, former employees, high-ranking Arkansas politicians, and inmate donors.
"In the early days of AIDS, we at the CDC (Centers for Disease Control) were surprised that the hemophiliac community was infected so rapidly," said Dr. Donald Francis, former head of the AID Laboratory for the CDC. "This shocking documentary tells why."
Duda, who has worked with CNN, the Canadian Broadcasting Company and Associated Press Television in their coverage of the blood-scandal story, says he was followed, sued, burglarized, had his tires slashed while working on the documentary. He was also part of the team for Fuji-TV that produced "The Hepatitis C Epidemic: A 15-Year Government Cover-up." The program won a George Foster Peabody Award in 2003 and was watched by more than 12 million viewers in Japan.
He also worked as a consultant in two major class-action lawsuits in Europe and Japan where plasma from Arkansas' prison system showed up. He also assisted the Royal Canadian Mounted Police in its investigation of the Arkansas prison plasma sales. He has also been in talks with the U.S. Department of Justice and the FBI about a possible investigation in the United States.
"Kelly Duda's film screams to be known about," says William Gazecki, producer-director of "WACO: The Rules of Engagement." "The blatant abuse of power, the criminal subjugation of prison inmates, and the complete absence of government oversight and accountability make for a compelling, must-see story."
"Prior to the making of 'Factor 8,' I never considered myself an investigative journalist," says Duda. "In fact, I had never written a newspaper article before in my life. I was an aspiring filmmaker who had a story thrown into his lap. Actually, it wasn't even a story at the time but a series of events that allegedly took place in my home state in the 1980s. It was a tale I didn't want to tell, but the more I looked into it, the more I found. It didn't take long before I realized that regardless of the cost and sacrifice, the story you're about to see which is a complicated one had to be told. There where quite literally lives at stake. I felt a moral responsibility, a civic duty to do something."
Last May, the Canadian Red Cross pleaded guilty to distributing blood tainted with HIV and hepatitis C in a health disaster that killed more than 3,000 people.
The organization, which distributed the blood in the 1980s, paid a fine of $4,000 for causing more than 1,000 Canadians to contract blood-borne HIV and as many as 20,000 to become infected with hepatitis C.
As part of the plea deal, Canadian Red Cross Secretary General Dr. Pierre Duplessis issued a public apology via videotape that was played in the courtroom to survivors of the victims.
As WorldNetDaily reported, Bill Clinton was at the center of a scandal in Arkansas in the 1980s involving the sale of AIDS-tainted blood to Canada, which was distributed through the Red Cross.
As governor of Arkansas, Clinton awarded a contract to Health Management Associates to provide medical care to the state's prisoners. The president of the company was a long-time friend and political ally of Clinton and later was appointed by him to the Arkansas Industrial Development Commission. Later, he was among the senior members of Clinton's 1990 gubernatorial re-election team.
The death toll from the tainted blood has grown since the figure of 3,000 was calculated in 1997, but recent estimates are not available, the Associated Press reported.
Duplessis said the organization accepted responsibility for "having distributed harmful products for those that rely on us for their health."
Prosecutors dropped criminal charges, including criminal negligence and common nuisance.
The Canadian Red Cross already has paid victims $55 million in a separate fund. Along with the fine, the charity will set aside $1.2 million for scholarships for family members of victims.
The Arkansas connection to Canada's blood scandal began with a deal Health Management Associates struck with the state allowing collection and sale of prisoners' blood in addition to treatment.
Because of the exploding AIDS crisis, U.S. regulations did not permit the sale of prisoners' blood within the country.
But HMA found a willing buyer in Montreal, which brokered a deal with Connaught, a Toronto blood-fractionator, which didn't know the source of the supplies.
Sales continued until 1983, when HMA revealed that some of the plasma might be contaminated with the AIDS virus and hepatitis. The blood was also marketed overseas.
Michael Galster, who conducted orthopedic clinics in the Arkansas prison system during the period the blood was collected, charged HMA officials knew the blood was tainted as they sold it to Canada and a half-dozen other foreign countries. He also alleged Clinton knew of the scheme and likely benefited from it financially.
"It may sound sensational, but I assure you it's true. In the process of making 'Factor 8,' I received strange phone calls, I was followed, my house was broken into, my tires slashed, and sensitive information -- including my personal notes -- mysteriously appeared on the Internet," recounts Duda. "I also had a gun pointed at the back of my head, there was a murder, and a key inmate informant was whisked out of state and put into isolation."
He says when he went looking for Clinton's governor's papers to find state documents relevant to his investigation, he was told that 4,000 boxes had been hidden away in private storage and could not be found.
"When I went to the Arkansas State Health Department to request records regarding disease rates at the prison and anything about the plasma program, I was stonewalled," he said. "I actually had to sue the state agency just to get access to its files that by law are supposed to be a matter of public record. When I went to the Arkansas State Police Headquarters key documents had disappeared. When complete strangers showed up out of the blue asking me what I was doing and with whom did I work for, I had to ask myself, 'What's going on here?
One thing is for certain, if I had a dollar for every time someone (in the past seven years I've been investigating this story) told me to "be careful!" I could have paid my rent several times over."
Duda says in 2004 he was sued shortly before "FACTOR 8" was to screen in Park City, Utah. A federal judge blocked the premiere. The case was eventually dismissed, but set his project back nearly two years.
Suzi Parker, writing in the Arkansas Times, described how the scandal unfolded: "At the Cummins Unit of the Arkansas penal system during the 1980s, while President Clinton was still governor, inmates would regularly cross the prison hospital's threshold to give blood, lured by the prospect of receiving $7 a pint. The ritual was creepy to behold: Platoons of prisoners lying supine on rows of cots, waiting for the needle-wielding prisoner orderly to puncture a vein and watch the clear bags fill with blood. Administrators than sold the blood to brokers, who in turned shipped it to other sates and to Japan, Italy, Spain and Canada. Despite repeated warnings from the Food and Drug Administration, Arkansas kept its prison plasma program running until 1994 when it became the very last state to cease selling its prisoners' plasma."
While working at the White House, Linda Tripp -- the former assistant to both Vincent Foster and Bernard Nussbaum -- said received a phone call from someone who mentioned the "tainted blood issue." The phone call came just after Foster's mysterious death. The phrase meant nothing to Tripp and when she tried to find out more from a White House computer, the database denied her access. Testifying in a Judicial Watch deposition, Tripp said, "It had been alarming to me that when I tried to enter data from a caller that I was working with on a tainted blood issue, that every time I entered a word that had to do with this particular issue, it would flash up either the word 'encrypted' or 'password required' or something to indicate the file was locked."
The Ottawa Citizen reported attorney Foster had defended a lawsuit against HMA, the Arkansas firm shipping tainted blood from prison inmates.
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October 31st, 2005
UMC Seeks Hepatitis C Patients
SourceURL:http://www.fresnobee.com
By Barbara Anderson / The Fresno Bee
Study to research different responses to treatment in Hispanics and whites.
Who should be tested?
- Anyone who ever injected illegal drugs, including those who injected once or a few times many years ago.
- Anyone who received a blood transfusion or organ transplant before July 1992.
- Anyone who received clotting factor concentrates before 1987.
- Anyone who was ever on long-term dialysis.
- Children born to hepatitis C-positive women.
- Health-care, emergency medical and public safety workers after needle sticks or other exposures to hepatitis C-positive blood.
- Anyone with evidence of chronic liver disease.
Information about enrolling in the Hepatitis C Latino Study at University Medical Center is available by calling (559) 459-3882. Source: Federal Centers for Disease Control and Prevention
Doctors at University Medical Center are looking for more patients like Ralph Salazar.
Salazar, 49, of Fresno, agreed to participate in a nationwide hepatitis C clinical trial when doctors at UMC approached him earlier this fall.
Hispanics and non-Hispanic whites with hepatitis C are needed for a Hepatitis C Latino Study sponsored by the health-care company Roche. The trial will look at the success of hepatitis C drugs in treating Hispanic patients versus non-Hispanic whites.
Researchers suspect there may be differences in the ways Hispanic and non-Hispanic white patients respond to treatment. Previous studies have shown patients who are black are less likely to be cured by drug therapy than white patients.
UMC is one of 60 medical centers in the country signing up participants for the Latino Study. Researchers hope to enroll 270 Hispanics and 270 non-Hispanic whites nationwide.
As of Oct. 24, the study included 244 non-Hispanic whites and 135 Hispanics. UMC had enrolled 15 patients, all of whom are Hispanic.
Those with hepatitis C in the Central San Joaquin Valley who are interested in joining the study shouldn't wait. Enrollment may end nationwide in the next six weeks, said Dr. Muhammad Y. Sheikh, principal study investigator in Fresno and chief of gastroenterology and hepatology at UMC.
According to the federal Centers for Disease Control and Prevention, an estimated 3.9 million Americans may be infected with the hepatitis C virus.
The Fresno County Selected Communicable Diseases Report for September 2005 shows 470 cases of hepatitis C reported in the county in 2004 and 289 cases thus far in 2005.
The hepatitis C virus causes inflammation of the liver. Damage from the virus can lead to cirrhosis (scarring of the liver) and eventually may lead to liver cancer.
The virus is spread through infected blood.
Those participating in the study take two anti-viral medications -- ribavirin pills and interferon shots. The treatment is the standard care provided for hepatitis C.
During the course of the 48-week study, patients will receive about $25,000 in free medications and an additional $20,000 to $25,000 in free doctor examinations and laboratory tests, said Dr. Douglas Dieterich, one of the trial investigators and professor of medicine at Mount Sinai School of Medicine in New York City.
The Latino Study is "a marvelous opportunity to find out what the differences are in response to interferon therapy for hepatitis C in the Latino population," Dieterich said.
Salazar, a disabled warehouseman, said he didn't hesitate when UMC doctors asked him to join the study.
For the first eight weeks, he came to the hospital every two weeks for blood tests. He now sees doctors once a month. After less than eight weeks of treatment, Salazar said the level of virus in his blood had dropped significantly. "This medication is working wonders."
Salazar doesn't know how or when he was infected: "Let's just say there were wrong choices made in my earlier days."
He learned he had hepatitis C from blood tests taken before a colonoscopy. Hepatitis C is often described as a "silent killer," because patients don't experience symptoms until later stages of the disease.
Anyone who has "thoughts at all that you may have been exposed, get in here" for testing, Salazar said.
Potential participants in the Latino Study are given screening tests, including blood tests, chest X-rays, an electrocardiogram and an eye examination. They also have a liver biopsy to determine the extent of their disease, Sheikh said.
The liver biopsy is an outpatient procedure. The test takes only a few minutes to complete, but patients remain at the hospital for six hours of observation, he said.
Not everyone with hepatitis C qualifies for the study. For example, patients cannot be actively using alcohol or illicit drugs, Sheikh said.
Researchers should know the results of the study in 2007.
The reporter can be reached at banderson@fresnobee.com or(559) 441-6310.
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Hepatitis B Education Needed in Asian-American Communities
SourceURL:http://www.allheadlinenews.com
Ayinde O. Chase - All Headline News Staff Writer
Research Triangle Park, NC (AHN) - One in three Asian-Americans surveyed in a recent poll report they had lost a family member due to complications of chronic hepatitis B.
However, about one in five respondents indicated they were not aware of the risks associated with the hepatitis B virus. Researchers believe these survey findings, outline the urgent need for more hepatitis B education in communities most prone to the deadly and communicable disease.
The survey, overseen by TNS Market Development, a national research firm, randomly selected and interviewed more than 800 Chinese, Vietnamese and Koreans living in cities with high Asian-American populations; including Los Angeles, San Francisco/Oakland, New York City, and Houston. Most of the survey takers were foreign born.
Eddie Cheung, M.D., president of the Chinese American Physicians Society, Oakland, CA, and clinical professor of internal medicine and gastroenterology/hepatology at the University of California-Davis School of Medicine says, "Simply being an Asian-American is not a risk factor in and of itself; however hepatitis B continues to be an important and ongoing health problem in Asian-American communities where a lot of immigrants are not screened and do not vaccinate their children, nor are they aware of the significant risks of hepatitis B."
Hepatitis B is a virus that is acquired from an infected mother at the time of birth or is spread through direct contact with blood and other bodily fluids, in ways such as: IV drug use with contaminated needles, sharing toothbrushes or razors, getting tattoos, and having sexual relations with infected persons.
Chronic infection with the virus can eventually lead to liver scarring, liver cancer and death. The Centers for Disease Control and Prevention (CDC) estimate one in ten people of Asian/Pacific Islander descent in the U.S. is infected with hepatitis B, and out of those one in four of whom, if left untreated, will die from the disease.
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Studies Clarify Risk Factors for Mother-to-Child Transmission of Hepatitis C Virus
SourceURL:http://www.sciencedaily.com
Breastfeeding does not raise the risk of mother-to-child transmission of hepatitis C virus (HCV), according to two new studies published in the December 1 issue of The Journal of Infectious Diseases, now available online.
One study found that infant girls are twice as likely to be infected as infant boys. Both studies provide new information with which to counsel pregnant women infected with HCV. Taken together, the two new studies expand upon preliminary data from smaller studies of mother-to-child transmission of HCV.
The larger of the two studies, conducted by the European Paediatric Hepatitis C Virus Network, involved 1,479 mother-and-child pairs enrolled at 33 centers in Italy, Spain, Germany, Ireland, the United Kingdom, Norway, and Sweden. The other study, by Eric E. Mast, MD, MPH, of the U.S. Centers for Disease Control and Prevention and colleagues, followed 244 infants born to infected mothers in Houston and Honolulu.
The finding of gender differences in HCV infection was reported by the European authors, who hypothesized that their result may reflect hormonal or genetic differences between men and women in susceptibility or response to infection. Other risk factors significantly associated with transmission were the time in labor (a risk factor in both studies) and use of internal fetal monitoring devices (a risk factor in the U.S. study only).
Although breastfeeding is a known risk for HIV transmission, both studies found it was not associated with transmission of HCV. The European study also found that caesarean section delivery, infant prematurity, and maternal history of injection drug use were not associated with HCV transmission.
The overall rate of transmission of the virus from infected mother to child was 6.2 percent in the European study and 3.6 percent in the U.S. study.
"Our results strongly suggest that women should not be offered an elective caesarean section or discouraged from breastfeeding on the basis of hepatitis C infection alone," said Pier-Angelo Tovo, MD, the lead author of the European study.
"Our findings support existing recommendations to avoid internal fetal monitoring and prolonged labor...in infected women," wrote the U.S. authors.
In an accompanying editorial, R. Palmer Beasley, MD, of the University of Texas at Houston, emphasized the European study's novel finding of a gender difference in transmission rates and suggested that higher HCV rates in female newborns may be due to excess mortality in infected males in utero. "Overall, the observation of higher hepatitis C virus infection rates in female infants is in accord with recent observations of similar excesses in HIV infection of female infants," Dr. Beasley said.
This story has been adapted from a news release issued by Infectious Diseases Society of America
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Ask the Doctor: Hepatitis Column Questioned
SourceURL:http://www.fortwayne.com
BY DR. BHARAT SANGANI
Knight Ridder Newspapers
Dear Readers:
Several months ago, this column focused on hepatitis with guest columnist Dr. Alfred McNair, a board-certified gastroenterologist.
I've never received so many responses to a column as I did with that one. Some were congratulatory and some were critical of his views and presentation of his interpretations.
When I talked to Dr. McNair about the responses, he was excited to hear that so many people read the column and that it helped him spread the message. He has kindly agreed to answer some of the questions to clarify his position.
Here is one of the letters of that series:
Dear Dr. Sangani:
After reading your false rhetoric that was printed in the Sun Herald, and also on the HCV Advocate Web site, I question your knowledge of the disease. Nearly every statistic and claim that you presented was false and misleading. As a person suffering from HCV, I was deeply offended, and have taken upon myself to use your remarks as a open reminder of the medical community's ignorance over HCV, and the overwhelming need for increased HCV awareness.
First, bodily fluids do not transmit HCV, only blood-to-blood transmission. As again, it is only transmitted by blood-to-blood contact. Second, the most common mode of transmission is via blood transfusions before the early '90s. Third, the cure rates you published are pure lunacy. You claim that there is substantial hope for the disease, yet thousands are dying because of the ignorance displayed by members of the medical community.
By the way, I'm 27 years old. I did not receive HCV via drugs, a transfusion, or any factor you claim. I was infected at birth, by my mother. I am a genotype 1a, and at 27 years old, already suffer from stage 3 bridging fibrosis. My chances of eradicating HCV from my body are only about 50 percent. If the meds I'm on currently do not work, I am basically stuck in limbo to try alternative medications and diet.
If you take it upon yourself to speak of a disease you obviously know nothing about, at least represent the real facts. HCV is growing and people are dying because of the lack of awareness and the misrepresentation of the truth. Get your facts straight, or keep your mouth shut.
Govern yourself accordingly.
_ Somebody Who Has Been There
Dear Been There:
Your aggressive language sure makes me respect your passion for the disease. Not everything you mentioned is completely true, so I asked Dr. Alfred McNair to readdress some of your issues.
Here is the response from Dr. McNair:
Thank you very much for your comments regarding the article on hepatitis C. I know as a person with hepatitis C, you are extremely passionate about this disease, much more so than the general population. I thank you for your comments.
Q: How is hepatitis C transmitted?
A: The question about transmission of the disease is valid and our data comes directly from the CDC Web site (www.cdc.gov/ncidod/diseases/hepatitis/) and also from M.J. Alter, M.D., "Prevention and Spread of Hepatitis C," Hepatology 2002, Volume 36. The comment to be made is the most common source of transmission of hepatitis C today is from IV drug use, which is said to be about 50 percent.
The second most common source is from sexual transmission and this primarily refers to patients with multiple sexual partners, which the CDC defines as more than 10 partners in a person's lifetime.
Here the incident approach is 15 percent of transmission of this disease. The rate is extremely low in monogamous couples. A recent article from Italy shows that it may be almost non-existent.
Recommendations from the CDC for the general population are aimed at trying to decrease the incidence of the spread of the disease as much as possible. That is why the comment of condoms even in monogamous partners is being used to make the transmission rate close to zero. In this country we have a 50 percent divorce rate, thus, the article that shows almost no transmission may not necessarily hold up in other countries where the divorce rate is higher.
Q: What is the response to therapy?
A: Current data show that patients who adhere to therapy, which means taking more than 80 percent of their medications during the prescribed period and being especially diligent during the first three months of therapy, which seems to be the most important time for the response to occur, currently shows even with the most difficult to treat genotype 1a and 1b that the sustained viral response rate approaches 55 percent.
To be very specific, if you have a young Caucasian female with a low viral titer and good histology, she follows the regimen of therapy and takes the medication as prescribed approaches more than 55 percent. In patients with genotype 2 and 3 disease response rate approaches 80 percent and often those patients require only six months of therapy.
The data in African-Americans so far has not been quite as good. The most recent comes from Dr. Lenny Jeffers, chief of hepatology, University of Miami, which showed only 30 percent response rate.
The findings were published in "Hepatology" June 2004, Lenny Jeffers, MD.
I hope this data and the references are helpful to you. I hope you can help me spread the word so that further citizens can seek evaluation and treatment of hepatitis C and hopefully enjoy the response rate that we are seeing in a large percentage of our patients.
Q: Where can I find more information about hepatitis C?
1. J.G. McHutchinson, "Gastro" 2002 Volume 123 Pages 1068
2. D.B. Strater, "Hepatology," 2004, Volume 39, Pages 1147.
3. www.cdc.gov/ncidod/diseases/hepatitis/
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Bangladesh Paper on Looming Hepatitis C Catastrophe
SourceURL:http://www.rednova.com
Text of report by Moazzem Hossain entitled: "Hep-C catastrophe looming" published by New Age website in English on 29 Oct 05
Hepatitis C virus, which has infected more than 40 lakh [1 lakh = 100,000] people in Bangladesh, might lead to a health disaster in the near future as the country has all the favourable conditions for quick spread of the killer virus, warned experts.
"Our findings force us to predict that the Hepatitis C virus will infect millions of people in our country soon," said AKM Shahidul Islam, an associate professor of the virology department of Sir Salimullah Medical College.
Hepatitis C is a liver disease caused by the Hepatitis C virus which destroys liver cells, eventually leading the infected organ to cirrhosis, the final stage of liver disease, and even liver cancer, he said.
About 17 crore [one crore is 10 million] people around the world are infected with the dangerous virus, making it more common than HIV infection, according to a report of the World Health Organization [WHO] issued in 2004. In Bangladesh, the number of affected people is over 40 lakh, about 3 per cent of its population.
But prevalence of the infection in the country, according to health experts, is much higher than apprehended by the WHO report, as 85 per cent of the infected people may become chronically infected.
The number of people affected by the Hepatitis C is four times higher than the number of HIV patients, and the deadly virus presently attacks about 30 to 40 lakh people every year in the world, the report added.
India, Pakistan and Egypt are the three countries most affected by hepatitis in the world, with respectively 3 crore, 1.1 crore and 1.4 crore of their population infected by the virus.
Although Hepatitis C damages liver in up to 70 per cent of the cases, it turns grave in 80 per cent of the cases without showing any symptom for 10-20 years or even longer.
Persons at risk of Hepatitis C virus infection might also be vulnerable to infection by Hepatitis B virus or HIV, said Shahidul Islam.
Harunur Rashid, a virology expert at Roche Bangladesh Limited, said random transfusion of untested blood, sharing of needles in injecting drugs and widespread use of the same shaving razor and blade by several persons have made the people of Bangladesh more vulnerable to the disease.
A national survey report, released in December 2004, found that addicts who take drugs through injections account for about 60 per cent of the Hepatitis C affected people.
The survey was conducted by the National AIDS/STD Programme of the government, Family Health International of the USAID and the International Centre for Diarrhoeal Disease Research, Bangladesh.
Although the urban people have now learnt to use disposable syringes, a huge number of people living in villages still use single needles in more than one occasion, said the report.
An assistant professor of microbiology of the Sir Salimullah Medical College, SM Shamsuzzaman, said barbers in both urban and rural areas are putting the people at high risk of infection by the Hepatitis C virus.
Besides in many cases, especially during emergencies, patients receive blood from unknown donors who have not been properly tested, and their contaminated blood may infect the receivers with the deadly virus, he added.
Although the authorities of all three blood banks - the Bangladesh Red Crescent Society, Sandhani Blood Bank and the Quantum Foundation Blood Bank - claimed that they have labs to test blood for finding the presence of the Hepatitis C virus, there are allegations that blood is not tested properly by them.
However, experts said that infection by the virus could be resisted to a large extent by conducting a widespread awareness campaign.
"Besides, we have good treatment facilities. If the infection is detected at the earlier stages, the patients can be cured easily," said Shahidul.
Source: BBC Monitoring South Asia
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'Unwanted Livers' for Hepatocellular Cancer in Cirrhosis
SourceURL:http://www.gastrohep.com
Liver transplantation with 'livers that nobody wants' constitutes an additional option for patients with hepatocellular carcinomas and cirrhosis, finds this month's issue of Transplantation.
Liver transplantation is recognized as the treatment of choice for small hepatocellular carcinomas in patients with end-stage liver failure.
However, because of limited organ availability, not all those who qualify can benefit from it.
Dr Georgios Sotiropoulos and colleagues accepted and transplanted 10 deceased donor liver allografts over a 3-year period.
The donor liver allografts were allocated through Eurotransplant.
These organs had previously been officially offered to and rejected by other transplant centers a total of 40 times due to medical or logistical reasons.
The investigators implanted these livers into patients in the waiting list with hepatocellular carcinomas and cirrhosis.
Recipients without hepatocellular carcinomas transplanted with such "undesirable" grafts were not included in this study.
The investigative team observed that 2 patients had initial poor graft function but subsequently recovered.
All patients are currently alive, with follow-up periods from 5 to 36 months – Transplantation
There was 1 arterial complication requiring reintervention.
The team noted that median intensive care unit and hospital stays were 6 and 28 days, respectively.
The investigators reported that 1 patient developed renal insufficiency, but recovered after 3 months.
Another patient had hepatocellular carcinoma recurrence in the allograft and underwent a successful atypical liver resection 23 months after transplantation.
The investigators reported that all patients are currently alive, with follow-up periods ranging from 5 to 36 months.
Dr Sotiropoulos' team commented, "Liver transplantation with such 'livers that nobody wants' constitutes an additional option for patients with hepatocellular carcinomas and cirrhosis."
"The risk-benefit ratio in these instances should be evaluated on a case-by-case basis."
Transplant 2005: 80(7): 897-902
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November 1st, 2005
Interferon with Ribavirin Is Safe and Effective for Children with Chronic Hepatitis C
SourceURL:http://www.eurekalert.org
Side effects are common, but mostly mild
Nearly half of 118 children with chronic Hepatitis C virus (HCV) treated with a combination of interferon-alpha-2b and an optimized dose of ribavirin achieved sustained viral response, and side effects were generally mild. These results are reported in the November 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD).
Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at http://www.interscience.wiley.com
/journal/hepatology.
HCV is usually asymptomatic in children though it can lead to serious liver damage. Treatment with interferon is standard and induces lasting remission in more than a third of infected children. The addition of ribavirin to treatment with interferon has been shown to markedly improve outcomes for adults with HCV, but the combination has not been extensively studied in children. Led by Regino González-Peralta, M.D. of the Division of Pediatric Gastroenterology, Hepatology, and Nutrition at the University of Florida, researchers addressed combination therapy for children with a twofold program.
The first part searched for the optimal dose of ribavirin for children with HCV while testing the drug's safety and efficacy. Fifty-six children, ages five to 16, were randomly assigned to take interferon along with ribavirin in varying doses for 48 weeks. They were evaluated for efficacy and side effects at regular intervals, and followed-up for an additional 24 weeks. By the end of the follow-up period, 35 percent of children taking 8 mg/kg/day of ribavirin, 37 percent taking 12 mg/kg/day, and 47 percent of 15/mg/kg/day had undetectable levels of HCV in their blood. Side effects were similar among all doses. Based on this data, the researchers selected the dosage 15 mg/kg/day for further study.
In all, 118 children with HCV received the optimized treatment--interferon with 15 mg/kg/day of ribavirin. They were evaluated regularly throughout treatment and follow-up to determine viral response and assess and manage side effects. At the end of the study, 46 percent had achieved sustained viral response. Children with HCV genotype 2/3 had higher sustained virologic response rates than those with HCV genotype 1.
All subjects experienced some side effects, but most were mild, the most common being flu-like symptoms. Severe side effects included anemia, neutropenia, depression and suicidal thoughts, and one child in the study attempted suicide. The researchers responded to adverse side effects by dose modification, and 8 subjects completely discontinued treatment because of adverse events.
As in previous studies, children in this one exhibited growth inhibition while receiving the therapy, however, they typically experienced height and weight catch-up gains after it ended. Interestingly, none of the African-American children in the study had a sustained virologic response to combination therapy. "The number of African-American children studied was too small to draw firm conclusions," say the authors. But this observation matches previous reports that African-American adults have lower response rates to combination therapy.
Overall, "our studies demonstrate that interferon alfa 2b in combination with oral ribavirin is effective and reasonably safe for the treatment of childhood chronic hepatitis C," the authors conclude. Importantly, "sustained virologic response rates in children with chronic HCV given interferon alfa-2b with ribavirin in these studies are higher than in those using interferon alone."
Article:
"Interferon Alfa-2b in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Children: Efficacy, Safety, and Pharmacokinetics," by Regino P. González-Peralta, Deirdre A. Kelly, Barbara Haber, Jean Molleston, Karen F. Murray, Maureen M. Jonas, Mark Shelton, Giorgina Mieli-Vergani, Yoav Lurie, Steven Martin, Thomas Lang, Andrew Baczkowski, Michael Geffner, Samir Gupta, Mark Laughlin for the International Pediatric Hepatitis C Therapy Group, Hepatology; November 2005 (DOI: 10.1002/hep.20884)
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Dynavax Initiates US-Based Phase 1 Clinical Trial of HEPLISAV(TM) Hepatitis B Vaccine in Dialysis Population
SourceURL:http://www.rednova.com
BERKELEY, Calif., Nov. 1 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation announced the initiation of a Phase 1 clinical trial of HEPLISAV, its ISS-based hepatitis B (HBV) vaccine in patients with end-stage renal failure (pre-dialysis). The trial will be conducted at multiple centers in the United States and will compare HEPLISAV to GlaxoSmithKline's Engerix-B(R) vaccine. The trial is designed to yield safety, tolerability, pharmacokinetic and efficacy data and is anticipated to be completed within 12-18 months.
"We believe that the dialysis population is largely undeserved by current hepatitis B vaccines and that Dynavax's HEPLISAV could offer meaningful medical benefits to these patients who are at high risk of infection," said Dan Levitt, MD, chief medical officer. "In previous clinical studies, we have demonstrated HEPLISAV's superior ability to confer rapid and durable seroprotection and its magnitude of immune response in an older adult population that is difficult to immunize with conventional vaccine. Conventional dosing of HBV vaccines only confer approximately 50% seroprotection in dialysis patients. The goal of our clinical and regulatory strategy in pre-dialysis patients is to determine an appropriate dosing regimen that could demonstrate the ability to provide superior protection for this vulnerable population."
"The cornerstone of Dynavax's commercial strategy for HEPLISAV is targeting high-risk populations with an urgent need for protection against HBV," said Dino Dina, MD, president and chief executive officer. "Simultaneous with pursuing a global regulatory strategy that is designed to obtain broad registration of our HBV vaccine, we are expanding our clinical program with targeted studies in people with compromised immune systems who are at risk for HBV infection and for whom we believe HEPLISAV may offer therapeutic benefit, such as pre-dialysis patients. These populations could also include people infected with HIV or hepatitis C."
HEPLISAV has demonstrated statistically significant superior seroprotection in clinical trials to date when compared to the industry standard HBV vaccine, Engerix-B. In June 2005, Dynavax initiated the first of two pivotal Phase 3 trials for HEPLISAV and anticipates initiating a second pivotal Phase 3 trial in the first half of 2006.
HEPLISAV Phase 1 Trial Design
HEPLISAV is based on Dynavax's proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR-9) to stimulate an innate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection.
The Phase 1 trial will enroll 96 patients with diagnosed chronic renal failure, aged 40 or older, who are seronegative for HBV and who have not been previously vaccinated against HBV. Patients will be randomized in a three-to-one ratio, HEPLISAV to Engerix-B, and dosed in three sequential, dose-escalating cohorts of 32 patients. The trial will compare three immunizations with HEPLISAV with four immunizations with Engerix-B. HEPLISAV-treated patients will receive immunizations at weeks zero, four and 24, and a placebo injection at week eight. Engerix-B-treated patients will receive immunizations with the vaccine on the same zero, four, eight and 24-week schedule.
The primary endpoint of the trial is safety and tolerability through week 28. The secondary endpoints are seroprotection (HBsAg antibody titers greater or equal to 10 mIU/mL, four weeks after each immunization) and Geometric Mean Concentrations (GMCs) four weeks after each immunization. A pharmacokinetic analysis will be performed on a subset of trial participants. All trial participants will be followed for 50 weeks.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial, and in a supportive clinical trial in ragweed allergic children; a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the ability to provide seroprotection for pre-hemodialysis patients and other populations with compromised immune systems, to demonstrate the superiority of HEPLSAV compared to conventional vaccines, and to execute on its regulatory strategy for HEPLISAV; statements concerning the company's other clinical programs and its ability to demonstrate the potential of its ISS technology. Words such as believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: the clinical outcome of the trial in pre-dialysis patients; the ability to demonstrate safety, efficacy and superiority in a clinical trial of HEPLISAV compared to Engerix-B in pre-dialysis patients; the timelines for completing the clinical trial of HEPLISAV in pre-dialysis patients; plans to initiate a second pivotal Phase 3 clinical trial for HEPLISAV; the progress and timing of clinical trials for the company's other products in development; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its HBV and other products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" sections of Dynavax's Annual Report on Form 10-K filed on March 18, 2005, Dynavax's quarterly report on Form 10-Q filed on August 9, 2005, and Dynavax's Prospectus Supplement filed on October 11, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Dynavax Technologies Corporation
CONTACT:
Jane M. Green, PhD, Vice President, Corporate Communications of Dynavax Technologies Corporation, +1-510-665-4630, or jgreen@dvax.com
Web site: http://www.dynavax.com/
Source: PRNewswire-FirstCall
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November 2nd, 2005
Lamivudine plus Interleukin-12 Enhances Immunity in Hep B
SourceURL:http://www.gastrohep.com
The most recent issue of Hepatology shows that the addition of interleukin-12 to lamivudine enhances T-cell reactivity to Hepatitis B virus, and interferon-gamma production.
Interleukin-12 is an immunomodulatory cytokine that promotes cellular immunity.
Pre-clinical data suggest that interleukin-12 inhibits Hepatitis B virus replication by stimulating interferon-gamma production.
Dr Nikolai Naoumov and colleagues from England investigated if a combination treatment will prolong suppression of Hep B replication.
The researchers assessed lamivudine plus recombinant human interleukin-12 in comparison with lamivudine monotherapy.
The research team included 15 patients with Hepatitis B e-antigent-positive and chronic Hepatitis B.
The patients were randomized to receive either lamivudine alone for 24 weeks in Group 1.
Interleukin-12 monotherapy does not abolish Hepatitis B replication – Hepatology
Group 2 included patients randomized to a combination of lamivudine for 16 weeks and recombinant human interleukin-12 ng/kg twice weekly.
The combination treatment started 4 weeks after initiation of lamivudine, and continued for 20 weeks.
In Group 3, the same schedule was followed as for group 2, only with lamivudine and a higher dose of recombinant human interleukin-12 of 500 ng/kg.
Serum Hepatitis B virus DNA levels, T-cell proliferation, frequency of virus-specific T-cells, and interferon-gamma production were evaluated.
The researchers evaluated these markers serially during and 24 weeks posttreatment.
The team found that lamivudine plus recombinant human interleukin-12 showed greater antiviral activity than lamivudine monotherapy.
However, after stopping lamivudine in Groups 2 and 3, serum Hepatitis B virus DNA increased significantly despite continued use of recombinant human interleukin-12.
Lamivudine plus recombinant human interleukin-12 treatment was associated with a greater increase in virus-specific T-cell reactivity, and interferon-gamma production.
The researchers noted an inverse correlation between the frequency of interferon-gamma producing CD4+ T-cells and viremia.
The research team observed that the T-cell proliferative response to Hepatitis B c-antigen did not differ between the 3 groups.
Dr Naoumov's team concludes, "The addition of interleukin-12 to lamivudine enhances T-cell reactivity to Hepatitis B virus and interferon-gamma production."
"However, interleukin-12 does not abolish Hepatitis B replication in Hepatitis B e-antigen-positive patients."
"It also does not maintain inhibition of Hepatitis B virus replication after lamivudine withdrawal."
Hepatol 2005: 42(5): 1028-36
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Transplants May Be Easier for HIV Patients
SourceURL:http://news.yahoo.com
By DAVID CRARY, AP National Writer
Buoyed by a legislative victory in California and a court ruling in Arizona, advocacy groups say they are making significant headway in efforts to ensure that HIV-positive people have the same access as other patients to kidney and liver transplants.
California recently became the first state to prohibit insurers from denying coverage for organ transplants based solely on a patient's HIV status. In Arizona, a judge ruled that the state's Medicaid program can't deny a liver transplant to an HIV-positive woman on the basis of her health status.
"There are a lot of optimistic signs," said Jon Givner, who heads the HIV Project at the Lambda Legal Defense and Education Fund, a New York-based gay-rights group. "When presented with the evidence, reasonable people have a hard time coming to the conclusion that an HIV-positive person should be denied a transplant."
In the past, insurers often refused to pay for transplants for HIV-positive patients and many transplant centers also balked at approving such procedures, believing that the always-tight supply of donor organs should be directed toward patients whose survival prospects weren't clouded by the complication of HIV.
However, the development of effective anti-retroviral therapy extended the longevity of HIV-positive people and changed the thinking of many experts. An ongoing pilot study at the University of California, San Francisco, has found no evidence of lower survival among HIV-positive patients after more than 30 organ transplants, said Dr. Peter Stock, the study's leader.
Still, Arizona's Medicaid program had maintained a policy of refusing to pay for transplants for HIV-positive people. But last month, in a case pressed by Lambda Legal, an administrative law judge said the program can't cite HIV as sole grounds for denying a liver transplant for Brenda Gwin, a 49-year-old from Phoenix who was diagnosed with end-stage liver disease in November 2004.
"We're relieved that the judge saw that Medicaid's decision to deny this woman a transplant was not based on good medicine or sound science," said Jen Sinton, a Lambda Legal attorney.
Though abiding by the judge's order, the Medicaid agency did not immediately overhaul its transplant policy. Spokeswoman Liz Olson said the agency would "explore modifications" to the policy based on an evaluation of medical evidence.
Gwin, meanwhile, can now begin the process of qualifying for a transplant through a national organ-donor network, with doctors evaluating her prospects along with other transplant candidates on a case-by-case basis. One of her Phoenix-based lawyers, Srini Varadarajan, said the delay caused by the legal proceedings did not seriously harm her health prospects, assuming a donor liver can be found.
The pioneering California legislation was signed into law in September by Gov. Arnold Schwarzenegger
"There are many reasons why a patient with HIV may not be suitable for a transplant, but the sole fact that they are HIV-positive is no longer considered a legitimate reason," said the bill's sponsor, Assemblyman Paul Koretz.
Givner said he hoped the legislation would send a message to insurers and health-care providers across the country, several of whom have been successfully challenged by Lambda Legal after transplants were denied. One target of a challenge, the federal Department of Veterans Affairs subsequently agreed to offer transplants to appropriate HIV-positive patients.
"In the experience of our clients and others like them, their HIV is under control and they had been living very active lives before they experienced complications from organ failure," Givner said. "There is no justifiable reason to deny lifesaving treatment."
Givner said transplant access is a critical issue because roughly one-third of people living with HIV are co-infected with Hepatitis C, which can often progress to potentially fatal liver disease.
National trends are difficult to track because most states and medical insurers -- unlike Arizona's Medicaid agency -- do not have written policies citing HIV status as grounds for denying transplants, Givner said. Instead, he said transplant coverage is sometimes denied in HIV cases on the less specific ground that the procedure is "experimental."
"Some insurance companies are holding onto policies that are a decade out of date," Givner said.
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Public Health Groups to Hold L.A. Hepatitis C Summit
SourceURL:http://www.drugpolicy.org
The Alliance and other public health groups are teaming up to hold the third annual Hepatitis C Summit in in Los Angeles on November 17.
The summit will provide a forum for education and discussion among local elected and appointed officials, community-based organizations, medical experts and consumers on the emerging hepatitis C epidemic and the impact of the disease on infected individuals and at-risk populations in Los Angeles County.
"Our aim in this third year is to raise awareness about a potentially deadly disease that lacks community and media attention," said Alliance Southern California regional director Alberto Mendoza, who is also the Los Angeles County Hepatitis C Task Force co-chair. "We will educate the public, honor key leaders and share the latest information on this disease through this important summit."
The California Department of Corrections estimates that half of the female prison population and 40 percent of male prisoners are infected with the hepatitis C virus (HCV). Coinfection with HIV, especially among injection drug users, is a significant problem, with some estimates suggesting that as many as one-quarter of people with HIV are coinfected with HCV. HCV infection is more serious in HIV-infected persons, leading to liver damage more quickly and possibly affecting the treatment of HIV infection.
Los Angeles Mayor Antonio Villaraigosa and Supervisor Gloria Molina will co-chair the summit, which will also be attended by Assemblymember Paul Koretz (D-West Hollywood), who will receive an award for his work to combat hepatitis C through sound public policy. The keynote address will be delivered by L.A. City AIDS Coordinator Stephen David Simon.
The general public is welcome at the summit and attendance is free, but space is limited so advance registration is advised. For information on how to register please call (213) 381-0515.
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RxKinetix and Indian Immunologicals Limited Collaborate on Development of Thermostable Hepatitis B Vaccines
SourceURL:http://biz.yahoo.com/
LOUISVILLE, Colo., Nov. 2 /PRNewswire/ -- RxKinetix Inc., a specialty pharmaceutical company developing new therapeutics focused on un-met needs in oncology care, and Indian Immunologicals Ltd, a leading manufacturer of veterinary and human vaccines, today announced they will collaborate in the development of thermostable Hepatitis B vaccines with improved stability at non-refrigerated temperatures. This project is funded by a grant awarded to RxKinetix from the Foundation for the National Institutes of Health through the Grand Challenges in Global Health Initiative.
As part of the collaboration, Indian Immunologicals Limited will supply RxKinetix with Hepatitis B vaccine, which will be formulated by RxKinetix in its ProJuvant(TM) vaccine delivery platform and tested for thermostability. Formulations showing good potential will then be tested in vivo.
"Indian Immunologicals is an ideal collaborator for RxKinetix in this project," said Marazban Sarkari, Ph.D., Principal Investigator for the Grand Challenges Grant. "They are aggressively pursuing a strategy that would increase vaccinations to improve health in India and other Asian countries and so they have a great interest in seeing this project succeed."
"We are very pleased to be working with RxKinetix," said Dr. V. A. Srinivasan, Research Director, Indian Immunologicals Limited. "Their ProJuvant technology has shown real promise in improving the efficacy of certain vaccines. The additional demonstration of thermostability will mean these vaccines could potentially be of great value, especially in tropical countries."
About RxKinetix
RxKinetix, Inc. is a specialty pharmaceutical company developing new therapeutics focused in oncology care. Using proven pharmaceuticals and proprietary polymer-based drug delivery technologies, RxKinetix creates new drugs or enhances existing drugs. The Company's strategy improves timelines and reduces risk during clinical development. RxKinetix has a strong intellectual property portfolio in support of its products and technologies. More information regarding RxKinetix is available at www.rxkinetix.com.
About Indian Immunologicals
Indian Immunologicals Limited (IIL) is a wholly owned subsidiary of the National Dairy Development Board and was set up in 1983 to manufacture Foot and Mouth Disease (FMD) vaccine in India. IIL is the fifth largest player in the animal health market in India and the market leader in veterinary vaccines. Human Biologicals Institute (HBI), a division of Indian Immunologicals Limited, manufactures purified Vero cell rabies vaccine (PVRV) marketed under the brand name 'Abhayrab' and is shortly planning to launch a range of pediatric vaccines, including hepatitis B and combinations. More information regarding Indian Immunologicals is available at www.indimmune.com.
Source: RxKinetix Inc.
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Study Links Hepatitis B to Gender Imbalance in Asia
SourceURL:http://seattletimes.nwsource.com
By Ching-Ching Ni
Los Angeles Times
BEIJING --If left entirely to nature, the number of newborn boys and girls in the world should be roughly equal. But in some cultures that balance artificially has been tipped in favor of boys.
In China, the problem commonly is attributed to gender discrimination, which leads to selective abortions and even female infanticide. But a new study suggests that disease might have as much to do with a baby's gender as preference.
In a soon-to-be-published paper in the Journal of Political Economy, Harvard economist Emily Oster posits that the high rate of female infant mortality in some parts of Asia is linked to the prevalence of the hepatitis B virus.
Using recent vaccination data, Oster shows that mothers infected with hepatitis B are 1.5 times more likely to give birth to a boy. While not the sole explanation for the gender-ratio imbalance, Oster concludes that the liver disease might account for nearly half of the so-called missing-girl population previously linked primarily to gender discrimination.
The issue of gender ratio is so complex and entwined with the social and economic context of a particular region that some experts are skeptical it can be explained away by a simple virus. But Oster's findings, if substantiated, could help explain the growing gender divide in China, where boys are prized for carrying on the family name and providing for parents.
The country's strict one-child policy has led to the abortion of healthy female fetuses as well as the killing of baby girls in some areas, despite laws forbidding such practices. The shifting demographics also threaten to turn China into a country of surplus bachelors who desperately outnumber potential brides.
In 1982, China's gender ratio was about 100 girls to 109 boys. By 2000, it jumped to 100 girls to 117 boys. The current figure is closer to 100 to 119. In some rural areas, the ratio has hit 100 to 133. According to Oster, as much as 75 percent of the disparity in China could be related to hepatitis B, which infects as much as the 10 percent to 15 percent of the population.
But in India and Pakistan the liver disease accounted for less than 20 percent of gender imbalance, the study said.
Oster's study has some detractors. Siri Tellier, a United Nations Population Fund representative in China, pointed to two factors that undercut the findings: In Tibet, where hepatitis B is widespread, the birthrate of males is relatively low. And in China, the gender ratio among first-borns is close to normal but shoots up for subsequent children. According to Tellier, the girl-boy ratio for second births is 100 to 152.
"This makes it very unlikely that the sex ratio is caused by hepatitis B -- otherwise why would it go up by birth order?" Tellier said. "I'm not saying it's impossible, but you definitely need further discussion on this before you decide that's the final causal mechanism."
Observers said that even if hepatitis were proved to be a key culprit in the imbalance, it does not change the fact that gender bias exists and will continue to influence people's reproductive choices.
"The only way to solve the problem of sex-ratio differences is to get rid of gender discrimination in the system and guarantee gender equality," said Lu Jiehua, a population-studies expert at Peking University.
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Hepatitis C: The Uncounted Disease
SourceURL:http://www.nhpr.org
Reported by Jon Greenberg
Hepatitis C is the most common blood borne infection in the United States. And it's the leading cause of liver transplants. About three million people are walking around with the virus and according to the Centers for Disease Control, most of them are ompletely unaware that they are infected.
Hepatitis C often hides in the body for two or more decades before it becomes life threatening. And it is very unpredictable. Only one out of four people with a chronic infection is likely to develop the most serious liver diseases.
New Hampshire Public Radio has found evidence of a building wave of Hepatitis C hitting the state's health care system. But unlike many other infectious disease, the state does not track Hepatitis C and does not require doctors to report when they find patients who carry it.
NHPR's Jon Greenberg has more. (see http://www.nhpr.org/node/9845)
Complete table of NH hospital charge trends (http://www.nhpr.org/images/stories/Hep-C-Charge-Trends.pdf)
NIH Fact Sheet on Hepatitis C (http://digestive.niddk.nih.gov/ddiseases
/pubs/hepc_ez/index.htm)
Vietnam Veterans and Hepatitis C (http://www.hcvadvocate.org/hcsp
/articles/vietvet.html)
News and Information from HCVAdvocate.org (http://www.hcvadvocate.org/index.asp)
A rough transcript follows:
The Gastroenterology Department at Dartmouth Hitchcock Manchester gets a lot of referrals for Hepatitis C patients.
CUT Let me get your blood pressure
Today Bonnie, an energetic woman in her late 30's, is here for a check up. She started interferon treatment for Hepatitis C about two months ago but she's known she's carried the virus for seven years.
CUT I was getting more pains in my liver, weakness, the tiredness so I basically took a chance and went on interferon.
Bonnie listens as Dr. Aydamir Alrakawi reviews her latest test results.
CUT Your liver enzymes are looking good and your virus counts are down. You started at 1 million and now it is 10,000.// That's very good.
If Bonnie's progress continues, her viral count will fall below detectable levels and she will be considered cured, which would make her doubly fortunate. With current treatments, the cure rate is only about 50%.
Dr. Alrakawi says many of his patients are in much worse shape than Bonnie was when she first came to him.
CUT Most people get infected in their late teens and twenties and then it takes them another 20-30 years to develop liver disease and that's when they present to us. Some of them progress to cirrhosis and some develop complications and end up dying from the disease.
The Centers for Disease Control forecast that the number of deaths related to Hepatitis C will triple in the next ten years. By all indications, the impact on New Hampshire's hospitals and its people is already underway. NHPR asked the New Hampshire Center for Public Policy Studies to run an analysis of the state's hospital discharge data base starting in 1996 and going as far forward as the data permit, 2003.
In that time, the number of visits by patients with Hepatitis C skyrocketed. It increased on average, 24 percent every year. Total hospital charges rose from under 2 million dollars a year to over 17 million — nearly an eight fold increase in 7 years.
But while the state of New Hampshire tracks other forms of hepatitis, it doesn't track this one. And Hepatitis C has caught some of the people on the front lines by surprise.
CUT Ok, and just make sure you take your meds and get something to eat, Ok? call me and we'll talk it through.
At Lebanon's HIV/AIDS counseling center, ACORN, a case worker checks in with a client. Acorn's Director, Tom Mock, knew very little about Hepatitis C, until, about two years ago, it became obvious that he needed to learn a lot.
CUT : 100% of people who worked with in the previous 3 years who had died were all co-infected with Hep C.
Mock went to the web to learn about the disease. He learned that today, injection drug users are the people most at risk for new infections. However, anyone, anyone at all, who received a blood transfusion before 1992 is considered at high risk. Until then, there was no test for Hepatitis C and upwards of 200 thousand people a year were getting infected. Mock says he turned to the web because state officials couldn't help him.
CUT I first turned to the health dept. but there wasn't a lot they could tell me. Especially in NH. I asked what they could tell us about the prevalence of Hep C. They couldn't tell me.
The concern about Hepatitis C is not new. Back in 1998, the CDC issued a recommendation that every state keep track of the virus. In 1999, the CIA wrote a national intelligence estimate that said "the most dangerous known infectious diseases likely to threaten the United States over the next two decades will be HIV/AIDS, hepatitis C, TB, and new, more lethal variants of influenza."
Dr. Jose Montero recently took over as New Hampshire State Epidemiologist. Montero says no one in the public health division doubts the importance of Hepatitis C. The state prison now tests every new inmate. Community health clinics are fully aware. Montero says there's no plan to add Hepatitis C to the state's reportable disease list because those reports would pick up infections that took place a long time ago. The state's appropriate focus, Montero says, is on stopping the spread of the disease.
CUT who do we target? People who will be exposed today or people who have already been infected and we have no power to change their level of infection? Our goal is to prevent new infections. We have nothing we can do in public health in people who is already infected. What we need to know is what is the risk, how many is newly infected so we can impact that number.
The state has spent more than two years putting together a draft Hepatitis C Strategy. Under that plan, the state would do much more to reach out to front line workers who come in contact with high-risk populations. It would try to get a better idea of who is infected through surveys at HIV and sexually transmitted disease clinics.
The guiding principal behind the state's strategy is to prevent the spread of the disease. But some physicians doubt it will have much effect on the rising impact of the disease today. The president of the New Hampshire Medical Society, Dr. Gary Sobelson, says he sees no reason for the state not to track Hepatitis C. Sobelson says, that would provide key information needed to slow the progression of the disease in chronically infected patients.
CUT It would seem to me that we need to have more understanding about the incidence of this illness, effect of treatment, tracking people and their access to care. The other diseases that we track to protect public health and address health needs, are at least parallel and in some cases less important than Hep C.
New Hampshire is one of only a handful of states that don't track the virus. But state officials here resist such a change with a vigor normally reserved for matters of tax policy. And there is at least a thematic connection. State epidemiologist Montero says not only would adding it to the reportable disease list add little value, it would be expensive, requiring two full time people at the department of health and human services.
CUT when we put a disease on the list, we investigate every single case that comes, that's the reason. It allows them to identify the risk. where they got infection and who was exposed. That is why I say if we collect data, it has to have a purpose. Not just as a repository of data, not for disease control purposes.
What Montero describes is the standard approach. But all of the other New England states track Hepatitis C and not all of them contact each and every person who is identified. They keep count they say, to track their progress and to boost awareness of the disease. Because in government, that which is not counted can easily slip through the cracks.
Hepatitis C: The Uncounted Disease Part Two
Yesterday, we reported on the rapidly growing impact of Hepatitis C on New Hampshire. Hepatitis C kills about 10,000 people a year in the U-S, about the same number as die from AIDS. But unlike with AIDS, the death toll from this virus is expected to triple in the next ten years. That increase has little to do with the spread of the disease today. It is due almost entirely to infections that took place two and three decades ago. That 20 to 30 year gap is important because the types of people who got infected in the past are different from the people who get infected today.
A rough transcript follows:
Hepatitis C presents public health officials with a puzzle. Which tactic should take priority? A -- go to places where you find the people most likely to have the virus, or B -- find the people most likely to become sick from the virus in the next ten years? The two groups are not the same.
The state has chosen option A with a focus on substance abusers, HIV clinics and prisons. When pressed on the point, State Epidemiologist, Jose Montero is quite clear about where the problem lies.
CUT Would you say that most of the people walking around infected today are in the IV drug or prison community? Based on national data, yes.
National reports do find that 60% of new cases come from intravenous drug use. That's generally thought to explain in large measure the prevalence of the virus among drug addicts and prisoners. But the data do not support the conclusion that most of the people with the virus are IV drug users.
Nationally, the number of people with the virus outnumber all IV drug users ten to one.
Kevin O'Conner with the Centers for Disease Control says there's good reason to give a lot of thought to taking a broader view of who is at risk.
CUT: There was a lot of transmission in the 70's and 80's which leave us with a large group of people that have been exposed and may have chronic liver disease as a result of that exposure. So a lot of what we do is try to identify people who have been exposed for a long time and try help them avoid complications.
The CDC encourages states to both prevent the spread of the virus and reduce its impact. O'Conner says it's easy to go after what he calls the low-hanging fruit — the people engaged in high risk behaviors, like injecting heroin. But the people who don't fit that description are much more difficult to find and they are the source of the skyrocketing impact of the disease.
In New Hampshire, NHPR found that hospital charges for patients with the disease grew by leaps and bounds — nearly an 800% increase in seven years.
Most of those people have one thing in common — they got a blood transfusion or some blood product before 1992. That was the year that testing of the blood supply began.
Contaminated blood put many unlikely people at risk.
CUT 6:12 I was on my back. I didn't even feel like I could raise my knees because I could feel the bullets passing over.
In 1966, Howard was a 21-year-old private in the 101st Airborne Division in Vietnam. He was on his way back from a night ambush when his unit came under fire.
CUT 7:39 I was one of the first to get hit. They only had my helmet and shoulders to aim at. It came in the top of my arm, it shattered my bone, saved my life, worked as a shield.
At a field hospital, Howard received the first of several transfusions. It is the only explanation he has for how he became infected with Hepatitis C. He returned from Vietnam, got married and became a salesman of fire alarm systems. Today, he is 60, a slender man with graying brown hair -- he calls himself just an Average Joe. His treatment for Hepatitis C was exhausting, but successful
Studies at VA hospitals have found that 8% of Vietnam Era vets have Hepatitis C — that's four times more likely than in the general public. The VA has moved more aggressively than any other government agency to track down the virus. Dr. Johann Rothwangl and Nurse Marie Gavin run the hepatitis program at the Manchester VA.
CUT: 21:35 If someone comes in here from the Vietnam era he automatically gets offered to get tested for Hep C (Marie) This the brochure that the physicians use the first risk factor is Vietnam Era vet.
But Nurse Gavin is quick to point out, it wasn't just blood transfusions that produced infections in Vietnam.
CUT 25:08 From having a husband who was in Vietnam who swears he never did IV drugs and I believe that, he could not believe the number of his friends and co-workers who did. It was the only way they could get through the day. So, as much as the veterans don't want to admit that they did IV drugs over there, I guess it was pretty rampant.
Clinicians talk about the mental wall that people put up around drug use in the distant past. They don't think of themselves as drug users today and they have no desire to open the door into those memories. Add to that the general stigma attached to viral hepatitis and it becomes even more difficult to uncover the tens of thousands of people in New Hampshire who are walking around with the virus and have no idea of their infection.
To get over that hurdle, some New England states have launched broad public information campaigns. This ad ran in Massachusetts.
PSA CLIP "I had a C section before 1992, the blood supply is safe but I had my operation it was a totally different story. It was one time, one needle. If you are at risk, get tested, protect your health --fade
That ad had its roots in a look back program launched by the Red Cross in the mid-1990's. That was an effort to reach donors and blood recipients. Paul Loberti with the Rhode Island Health Department says that study prompted many health officials to re-think their assumptions about Hepatitis C.
CUT :43 I think what struck all of us was that we were looking at an epidemic was not exclusive to injection drug users, although it was high, we were seeing other things happening in RI as well as across the country. For example, a significant group of individuals was women who had C-sections and hadn't realized that having that would put them at risk for Hep C.
To find the largely unsuspecting carriers of Hepatitis C requires the help of doctors' offices statewide. States like Rhode Island, Massachusetts and Maine have done extensive outreach to front line health care practitioners. New Hampshire has not. In general, it is several years behind its regional neighbors.
In 2000, Maine set Hepatitis C as its number one infectious disease priority. Paul Kuehnert, Director of Public Health Emergency Preparedness, says the virus was costing the state Medicaid program at least 10 million dollars a year. Early detection seemed like a fiscally responsible strategy.
CUT We have 20,000 people. If we invest money up front, identify those folks as early as possible and get them into less expensive care, even though we may be spending more money up front, we'll save money in the long run.
New Hampshire's former state epidemiologist says there's no proof that such interventions save money. But Keuhnert says it's hard to see how it wouldn't.
Maine set a goal of identifying 7 thousand cases by the year 2010. It was part of the state's plan, Healthy People 2010.
New Hampshire has its own Healthy People 2010 plan. It has no mention of Hepatitis C.
For NHPR News, I'm Jon Greenberg
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Biolex Therapeutics Announces Initiation of Phase 1 Clinical Study of Hepatitis C Candidate Locteron(TM)
SourceURL:http://biz.yahoo.com
PITTSBORO, N.C., Nov. 2 /PRNewswire/ -- Biolex Therapeutics today announced the dosing of the first cohort of subjects in a Phase 1 study of Locteron(TM), a next-generation controlled-release form of alfa interferon. Biolex is co-developing Locteron in collaboration with the drug delivery and development company OctoPlus (Leiden, the Netherlands), initially for the treatment of patients with chronic hepatitis C. Locteron combines BLX-883, a recombinant alfa interferon produced by Biolex in its patented LEX System(TM), with PolyActive(TM), an advanced controlled-release drug delivery technology developed by OctoPlus.
The Phase 1 study is designed to evaluate the safety and pharmacology of Locteron in 27 healthy volunteers. The randomized, blinded, controlled study is being conducted in the Netherlands and will evaluate single administrations of three different doses of Locteron with comparison to controls consisting of the delivery vehicle, a placebo, and PEG-Intron® (a currently marketed long- acting pegylated alfa interferon).
More than four million people in the United States, and more than 200 million people worldwide, are currently infected with hepatitis C. The standard treatment for patients with chronic hepatitis C is pegylated alfa interferon administered in combination with the anti-viral drug ribavirin. The size of the hepatitis C market is approximately $3 billion, and is expected to grow at a rate of 10%. The currently available pegylated alfa interferon products require administration once per week for up to 48 weeks and are associated with substantial side effects, particularly during the period following each administration.
In contrast to the currently available interferon products, it was demonstrated in pre-clinical studies that Locteron has linear release characteristics after injection without the high peak plasma levels that have the potential to increase side effects and without the low trough plasma levels that may impair efficacy. Locteron is intended to be administered only once every two weeks as compared to the once-a-week administration of the currently licensed pegylated interferon products. Locteron will be evaluated in clinical studies in combination with either ribavirin or with any of the next-generation anti-viral drug candidates currently under development for the treatment of patients with chronic hepatitis C.
In a completed Phase 1 study, Biolex' BLX-883 was safely administered at a clinically relevant dose and demonstrated bioactivity and a side effect profile consistent with Intron® A, a currently marketed alfa interferon used as a comparator. Locteron combines BLX-883 with PolyActive, a second- generation polymer-based microsphere delivery technology that facilitates controlled-release of interferon. PolyActive was developed by OctoPlus for the controlled-release of proteins. Locteron, with PolyActive has been designed to address the reported shortcomings of current pegylated technologies used to deliver alfa interferon.
"We are very pleased to have moved into the clinic with a product candidate designed to address major areas of unmet clinical need in the treatment of chronic hepatitis C," said Jan Turek, Chief Executive Officer of Biolex. "By collaborating with companies such as OctoPlus we are able to take full advantage of the LEX System's capabilities to develop products that provide clinical advantages as well as lower capital investment requirements and enhanced scalability than what is currently available."
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.
About Biolex Therapeutics
Biolex Therapeutics applies its unique drug development capabilities and expertise to commercialize complex proteins and monoclonal antibodies that until now have been impossible or very expensive to develop through traditional means. Biolex' patented LEX System(TM) uses Lemna as a transgenic host in its GMP biopharmaceutical manufacturing facility to produce therapeutic proteins to support its own development programs as well as the programs of its strategic partners. The company is advancing a proprietary pipeline of product candidates, including its lead program Locteron(TM) under joint development with OctoPlus. Biolex has a multi-protein strategic alliance with Centocor and collaborations with other pharmaceutical/biotech companies including Medarex and Kringle Pharma. Biolex is a venture-capital backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex' web site at www.biolex.com.
Contact:
Michelle Linn
Linnden Communications
508-419-1555
linnmich@comcast.net
Intron® A is a registered trademark of Schering-Plough Corporation
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November 3rd, 2005
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