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Week Ending: December 10th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Hepatitis C: Diagnosis Is Critical
• HIV/Hepatitis C Symposium Announced for North Carolina
• Hep C RNA Levels Predict End-Stage Liver Disease
• Graft Volume Estimates for Screening Living Donors
• Study Finds Coffee Reduces Liver Risk
• 'Too Few' on Hep C Treatment
• Vertex Pharma Launches Midstage Trial for Hep C
• Scientists Discover How a Hepatitis C Protein Promotes Liver Cancer
• Idenix to Finalize Pivotal Trial of Hepatitis C Drug
• Hepatitis B Virus Sparking Concerns
• Rotting Away: Thousands of New York Inmates Have Hepatitis C. Only a Few Hundred Get Treatment.
• Acetaminophen Hepatoxicity Main Cause of Liver Failure
• Dynavax to Present Data on Phase 2/3 Clinical Trial of HEPLISAV(TM) Hepatitis B Vaccine at ICAAC 2005
• Three Rivers Gets FDA Approval of Drug
• Vertex Hepatitis C Drug Will Get Fast Track Review
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December 3rd, 2005
Hepatitis C: Diagnosis Is Critical
SourceURL:http://www.wowt.com
Hepatitis C is the number-one cause of liver transplant. It kills approximately 10,000 people a year and yet many people harbor the virus for years without knowing it.
Every day, Dr. George Abdelsayed tries to educate his patients about the blood-borne virus Hepatitis C.
He says, "It's a chronic infection of the liver which has some potentially serious, possibly even fatal consequences."
Fifty-four-year-old Gary Jerkovich knew he'd been exposed to hepatitis C. A girlfriend died from it but he felt good and did nothing for years until the pains started.
"I started getting symptoms," he says. "Uh, my side would ache. I would sweat every time I went out. I was having problems. I was so tired, still am."
Now Gary has serious liver damage and faces an uphill battle to get well.
He says, "It's a mistake I made a long time ago. I should have had treatment done."
Experts say many middle-aged men and women carry the virus and are shocked to learn they have it.
Dr. Abdelsayed says, "This disease is largely asymptomatic, at least for the first 10 to 20 years, once they acquire the infection."
A new ad campaign features a beat-up face to show what this silent killer can do to the liver sight unseen.
Dr. Abdelsayed says, "The major problem that we have is not enough people being diagnosed, not enough people being treated. We've got to get more people to the table, we've got to get more people to have a better education."
You can find out if you have hepatitis C with a simple blood test and while the treatment isn't as easy, it does work.
Dr. Abdelsayed says, "Many patients who feel that they cannot eradicate this virus need to understand this point: that we can physically get rid of this virus."
The hepatitis C virus is spread through contact with infected blood. Any blood-to-blood contact can transmit it including tainted blood transfusions, drug users sharing needles and health workers having needle-stick accidents. Because hepatitis C often goes undetected for years, it can be difficult to pinpoint exactly how the infection happened.
Supplemental Information
Fast Facts:
- Hepatitis C is commonly known as the "silent epidemic" due to its rare symptoms.
- An estimated 3.9 million Americans have been infected with HCV and 2.7 million of them are chronically infected but have not yet been diagnosed.
- At least 20 percent of patients with chronic hepatitis C develop cirrhosis.
- Recent advances in treatment provide a successful cure in 50 to 80 percent of cases.
Hepatitis C
Hepatitis C is a prevalent blood-borne infection caused by the hepatitis C virus (HCV). The virus causes an infection of the liver, which initiates swelling. The swelling may then lead to scarring of the liver, liver failure, or liver cancer (cirrhosis of the liver). HCV is curable if detected and treated early enough.
Hepatitis C is the leading cause for liver transplants in the United States. According to government estimates, over 4 million Americans have been exposed to the virus, and over 170 million people worldwide. It has been estimated that HCV causes approximately 10,000 to 12,000 deaths each year in the United States.
Treatment
Treatment for HCV was approved more than 10 years ago with alpha interferon, a host protein that is made to attack and protect the body from viral infections. The body produces a steady amount of interferon, but injecting interferon 3-4 times a week adds more protection than the body would produce naturally.
Newer treatment replacing the alpha interferon injection includes pegylated interferon (peginterferon) taken simultaneously with ribavin, an oral medication that fights certain viruses. Peginterferon has been modified chemically from alpha interferon by the adding a large molecule of polyethylene glycol.
The combination of peginterferon and ribavin creates a constant level of interferon in the blood, keeps the protective proteins in the bloodstream longer, and helps to keep the virus away for greater periods of time.
Hepatitis Awareness Campaign
Hepatitis C RNA (a fragment of HCV virus that can be detected using an acid) is usually detectable as early as 1 to 2 weeks following exposure. Although the virus may be detected by blood tests at an early date, 80% of people have little or no symptoms and in turn do not get treatment until it is too late. The symptoms to be aware of are flu-like, such as fatigue, loss of appetite, and nausea. Other more serious symptoms include jaundice, abdominal pain, and dark urine.
According to hepatitis specialists, a person is largely asymptomatic for the first 10 to 20 years after exposure to the virus. New magazine ads are being produced using a human face with scarring to visually showcase what may be happening to a liver infected by HCV. The hope is to create a visual for people who have been exposed to the virus, but neglect getting tested due to "feeling just fine."
Transmission of HCV is most common when a person comes in contact with the blood of an infected individual. Some transmission situations include: if a person had a blood transfusion or organ transplant before 1992 (there was no detection for HCV before then), and if a person had a blood clotting problem before 1987. HCV is also transmitted if a contaminated needle to inject drugs is used, if a healthcare worker has had contact with blood in the workplace, especially through needle stick injuries, and if a mother has HCV when she gives birth to a baby. A less common transmission is through sex with an infected partner. The risk of receiving the virus through sex is low, but still possible.
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HIV/Hepatitis C Symposium Announced for North Carolina
www.prweb.com
The 2006 North Carolina Symposium on Hepatitis C and HIV is set for March 30 and 31, 2006 in Durham. The first-ever event for medical professionals and community organizations was announced yesterday at a meeting of partners in the PHICAS project, one of the symposium’s sponsors.
Durham, N.C.(PRWEB) December 3, 2005 – The chairman and CEO of Hepatitis Foundation International, Thelma Teil, will keynote the 2006 North Carolina Symposium on Hepatitis C and HIV, set for March 30 and 31, 2006 in Durham. The first-ever event for medical professionals and community organizations was announced yesterday at a meeting of partners in the PHICAS project, one of the symposium’s sponsors.
“We are seeing a steady rise in Hepatitis C and HIV infections in North Carolina,” said Beth Stringfield, Executive Director of the Piedmont HIV Health Care Consortium. “We estimate that about 30 percent of the 25,000 state residents with HIV also have Hep C, which greatly impacts their treatment. As we implemented the PHICAS project to address co-infection issues, we saw a need to present comprehensive information to the medical community, which this symposium will accomplish.”
The conference is sponsored by PHICAS (Piedmont HIV Integrated Community Access System), the North Carolina Department of Health and Human Services HCV Program and Wake Forest University. It will be held at the Sheraton Imperial Hotel in Durham.
"The symposium is intended to increase both providers’ and patients’ basic understanding of Hep C, HIV, and co-infection,” Stringfield said. “We’ll also look at how to integrate Hep C treatment, discuss treatment guidelines and learn about the emotional and mental effects of the disease and treatments.”
Sessions for medical providers are targeted to primary care physicians, physician assistants, nursing professionals and medical specialists. Among the confirmed speakers is Dr. Sam Pegram of Wake Forest University and North Carolina epidemiologist Jeff Engle.
Community provider sessions are designed for educators, mental health providers, health department personnel, and counselors. Presenters include Laurie Schowalter from the National Alliance of State and Territorial AIDS Directors, and Dr. Peter Leone, an associate professor of infectious diseases at the University of North Carolina at Chapel Hill School of Medicine.
Dr. Glenn Treisman, associate professor in the Department of Psychiatry at Johns Hopkins School of Medicine, will address a joint session on mental health and substance abuse in special populations.
"There will also be several networking events,” Stringfield said. “One of the strengths of this symposium is the opportunity to communicate across disciplines and begin building the kind of comprehensive care system that is needed by people impacted by HCV and HIV.”
More information on PHICAS and the Symposium can be found at www.phicas.org.
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December 5th, 2005
Hep C RNA Levels Predict End-Stage Liver Disease
SourceURL:http://www.gastrohep.com
Hepatitis C RNA level is a predictor of end-stage liver disease death among persons with chronic Hepatitis C infection, reports the latest issue of Hepatology.
Persons chronically infected with Hepatitis C virus, some of whom are coinfected with HIV and human T-lymphotropic virus type II, are at high risk for end-stage liver disease.
Dr Michie Hisada and colleagues from Maryland evaluated whether end-stage liver disease death was associated with premorbid Hepatitis C RNA level.
The research team also assessed whether end-stage liver disease death whether it was associated with specific Hepatitis C protein antibodies.
The team evaluated a cohort of 6570 injection drug users with or without HIV/ human T-lymphotropic virus type II coinfection.
The patients were enrolled in 9 cities in the USA between 1987 to 1991.
The researchers compared 84 end-stage liver disease descendents and 305 randomly selected cohort participants with detectable Hepatitis C RNA.
Hep C RNA levels remained significant after adjustment for alcohol use – Hepatology
The team stratified the patients by sex, race, HIV, and human T-lymphotropic virus type II strata.
Relative hazard of end-stage liver disease death was derived from the proportional hazard model.
The team found that risk of end-stage liver disease death was unrelated to the intensity of antibodies against the Hepatitis C virus.
The team noted that the risk of end-stage liver disease increased with Hepatitis C RNA level.
The association between Hepatitis C RNA level and end-stage liver disease death remained significant after adjustment for alcohol consumption.
The team observed that the 45 deaths from AIDS and 43 from other causes were unrelated to Hepatitis C RNA.
HIV infection was not associated with end-stage liver disease risk in multivariate analyses adjusted for Hepatitis C RNA.
The researchers found that men had an increased risk of end-stage liver disease death in unadjusted analyses but not in multivariate analysis.
Non-black patients were at increased risk for end-stage liver disease death.
Dr Hisada's team concluded, "Hepatitis C RNA level is a predictor of end-stage liver disease death among persons with chronic Hepatitis C infection."
Hepatol 2005: 42(6): 1446-52
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Graft Volume Estimates for Screening Living Donors
SourceURL:http://www.gastrohep.com
Formula-derived estimates of graft volume should be routinely used in the initial screening of potential living donors, reports the most recent issue of Transplantation, as long as their limitations are appreciated.
Estimation of graft volume is critical in living donor liver transplantation.
Dr Paolo Salvalaggio and colleagues examined the accuracy of formula-derived graft volume estimates.
The investigators compared them to both radiogically-derived estimates and actual measurements.
The investigative team first compared formula-derived estimates of graft volume with actual volumes.
The team provided estimates for both right lobe and left lateral segment graft volume and applied these formulae to a validation cohort.
Formula-derived calculations had lower error ratios than radiologic estimates – Transplantation
Finally, the team evaluated both formula-derived and radiologically-derived estimates by comparing them to actual graft volume measurements.
There is a marginal concordance between formula-derived calculation and graft volume for right lobe donors.
However, the investigators noted that the error ratio was lower than for radiologic estimates.
In contrast, magnetic resonance imaging measurements for left later segment grafts demonstrated a lower error ratio than formula-derived estimation.
Dr Salvalaggio's team concluded, "Formula-derived estimates of graft volume should be routinely used in the initial screening of potential living donors as long as their limitations are appreciated."
Transplant 2005: 80(9): 1181-5
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Study Finds Coffee Reduces Liver Risk
SourceURL:http://www.reutershealth.com
WASHINGTON (Reuters) - Coffee and tea may reduce the risk of serious liver damage in people who drink alcohol too much, are overweight, or have too much iron in the blood, researchers report in the American Gastroenterological Association journal Gastroenterology.
The study of nearly 10,000 people showed that those who drank more than two cups of coffee or tea per day developed chronic liver disease at half the rate of those who drank less than one cup each day.
The study, conducted by the National Institute of Diabetes and Digestive and Kidney Diseases and Social & Scientific Systems, Inc., found that coffee provided no protection to people at risk of liver disease from other causes, such as viral infections.
"While it is too soon to encourage patients to increase their coffee and tea intake, the findings of our study potentially offer people at high-risk for developing chronic liver disease a practical way to decrease that risk," said Dr. Constance Ruhl, who helped lead the study.
"In addition, we hope the findings will offer guidance to researchers who are studying liver disease progression."
Ruhl and colleagues said caffeine seemed to hold the key.
They analyzed the records of 9,849 participants in a government survey whose coffee and tea intake was evaluated and who were followed for about 19 years.
SOURCE: Gastroenterology
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'Too Few' on Hep C Treatment
SourceURL:http://www.theaustralian.news.com.au
Adam Cresswell
THOUSANDS more people could receive treatment for hepatitis C, costing taxpayers a projected $56 million extra a year, if the federal Government accepts a recommendation to ease restrictions on the drugs.
The recommendation from a government committee overseeing access to taxpayer-funded drug subsidies comes amid concern about the rising number of deaths from hepatitis C, a viral disease transmitted through infected blood.
Estimates for the numbers of Australians infected with hepatitis C range from 150,000 to 250,000, but hardly any – fewer than 1300 in 2003 –are on treatment programs.
As untreated infection can lead to liver cirrhosis, then liver failure or liver cancer, experts say this dismal treatment rate must be turned around to avoid a tidal wave of more serious health costs in 10 or 15 years.
At the moment, patients must undergo an unpleasant and painful liver biopsy to establish if their condition is severe enough to warrant treatment. But the Pharmaceutical Benefits Advisory Committee has recommended that requirement be dropped, because it is putting too many people off.
However, the drugs cost about $16,000 per patient for a year-long course, so any move to increase access will involve a significant budget hit, even if it does save the system money down the track.
Another deterrent is the drugs' side effects, which include depression, extreme fatigue, hair loss and anaemia.
Greg Dore, head of the viral hepatitis clinical research program at the University of NSW's National Centre in HIV Epidemiology and Clinical Research, said he hoped the numbers of people in treatment could be trebled. He said hepatitis C was already killing more Australians than HIV, and the number of people needing liver transplants was increasing – a sign that people with untreated infection were getting sicker.
"The current levels of treatment are not high enough to make an impact on the projected burden of hepatitis C," Associate Professor Dore said.
Australian Hepatitis Council executive officer Helen Tyrell said the PBAC's recommendation was "a very welcome step".
A spokeswoman for federal Health Minister Tony Abbott said any application would be considered.
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Vertex Pharma Launches Midstage Trial for Hep C
SourceURL:http://boston.bizjournals.com
Vertex Pharmaceuticals Inc. has launched a midstage human clinical trial for VX-950, its drug to treat hepatitis C.
The Cambridge, Mass., company (Nasdaq: VRTX) announced on Monday that the midstage, or Phase II, trial would last 28 days and explore the drug's safety and effectiveness when combined with two other hepatitis C treatments.
Vertex expects to launch multiple midstage trials for the compound in 2006.
Vertex has made strides in reorganizing its financing as well as clinical progress. Late last month the company announced it would exchange 6.7 million shares of its common stock for $95 million of its convertible notes.
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Scientists Discover How a Hepatitis C Protein Promotes Liver Cancer
http://www.newswise.com
Newswise — Scientists at the University of Texas Medical Branch at Galveston (UTMB) have identified a key biochemical connection between the hepatitis C virus and liver cancer.
The molecular mechanism is similar to the one that links the human papilloma virus (HPV), the cause of genital warts, and cervical cancer, according to Dr. Stanley M. Lemon, the senior author of a paper on the discovery that will be published this week in the online early edition of the Proceedings of the National Academy of Sciences.
“What we’ve found is that one of the hepatitis C virus proteins targets a cell protein that is crucial for suppressing the development of tumors, interfering with its ability to control cell proliferation,” Lemon said. “By knocking out this ‘tumor suppressor’ and promoting the proliferation of liver cells, this viral protein is setting up the liver for cancer.”
According to the federal Centers for Disease Control and Prevention, about 85 percent of liver cancer cases in the United States occur in people infected by the hepatitis C virus. Approximately 200 million people worldwide suffer from chronic hepatitis C, which can persist in the body for decades after an initial infection, often causing so much liver damage that a transplant may be a patient’s only chance for survival. The most effective treatment available, interferon therapy, works only about half the time and often causes debilitating side effects. Those who fail treatment are at risk for fatal cirrhosis or developing liver cancer.
Researchers have known for a long time that hepatitis C virus infection can lead to liver cancer. But how the virus goes about this has been unclear.
The UTMB group discovered that the tumor-suppressing retinoblastoma protein is present at markedly reduced levels in cells containing a hepatitis C virus “replicon,” a large piece of hepatitis C genetic material that is able to reproduce itself in cultured cells and also able to produce proteins made by hepatitis C viruses. “The replicon experiments enabled us to identify a protein known as NS5B that attaches to the retinoblastoma protein, a critical tumor suppressor, and accelerates its breakdown,” Lemon said. He continued: “The way NS5B docks with the retinoblastoma protein is biochemically almost identical to the way a protein made by human papilloma virus does so to produce similar cancer-promoting results. That’s interesting, because the two viruses are so different —HPV is a DNA virus, while hepatitis C is composed of RNA.”
Understanding just how hepatitis C infection leads to the development of cancer is of critical importance, Lemon said. With no one “silver bullet” cure for hepatitis C on the horizon, he explained, researchers must use new knowledge to maximize the effectiveness of various virus-fighting therapies now under development, managing the care of chronically infected patients in ways that will best help them avoid liver cancer.
Source: University of Texas Medical Branch at Galveston
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Idenix to Finalize Pivotal Trial of Hepatitis C Drug
SourceURL:http://www.pharmaceutical-business-review.com
After a meeting with the FDA, Idenix Pharmaceuticals has said that it anticipates finalizing the study design for a phase III clinical trial of its hepatitis C candidate, valopicitabine, in treatment-refractory patients by the end of the first quarter of 2006.
5 Dec 2005, 16:51 GMT - At the meeting, the FDA requested additional information from the two ongoing phase IIb clinical trials evaluating valopicitabine. In response, Idenix plans to provide the FDA with comprehensive 24-week data from the ongoing phase IIb clinical trial in treatment-refractory patients.
The company also expects to provide initial data from the ongoing phase IIb trial evaluating valopicitabine in treatment-naive patients, which includes a patient cohort receiving valopicitabine 800mg plus pegylated interferon beginning on day one of treatment. This is the treatment regimen that the company currently expects may be evaluated in phase III clinical trials.
The company anticipates that it will provide in January 2006 the further data that have been requested and thereafter meet with the FDA. At that meeting, the company anticipates further discussing with the FDA the proposed phase III clinical trial protocol.
"We are pleased with the interaction we have had with the FDA to date regarding valopicitabine development," said Jean-Pierre Sommadossi, CEO of Idenix. "We are optimistic that we will continue to advance the valopicitabine clinical program, particularly in view of the serious unmet need in the treatment-refractory patient population in hepatitis C."
Source: Datamonitor Newswire
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December 6th, 2005
Hepatitis B Virus Sparking Concerns
SourceURL:http://www.asahi.com
The Asahi Shimbun
Doctors are urging tougher treatments for hepatitis B to deal with a surge in cases caused by a Western-type virus that carries a greater risk of leading to liver cancer.
The Japan Society of Hepatology plans to revise its treatment guidelines next spring to reflect the different types of virus – the Asian and the Western – that cause hepatitis B.
A team led by Masashi Mizokami, a professor at the Nagoya City University School of Medicine, conducted genetic testing of blood serum taken from 301 patients with acute hepatitis B treated between 1982 and 2004 at 17 institutions, including the Kyoto Prefectural University of Medicine and the Shinshu University School of Medicine.
The results of the study showed that only 5 percent of the cases between 1982 and 1990 involved the Western virus. But the prevalence of that virus increased to 6 percent between 1991 and 1995, to 12 percent between 1996 and 2000 – and to 24 percent between 2001 and 2004.
In contrast, 29 percent of the cases between 1982 and 1990 involved the Asian virus. The prevalence of such cases decreased to 10 percent of the total between 2001 and 2004, according to the study.
A research team set up by the Ministry of Health, Labor and Welfare collected data from patients at national hospitals treated for acute hepatitis. The team's study also showed that the more dangerous Western virus has increasingly caused hepatitis B in Japan since 1991.
"With the increased prevalence of the Western-type virus among Japanese patients, there has been a spread of the disease among Japanese," said Hiroshi Yatsuhashi of the National Hospital Organization Nagasaki Medical Center, who headed the research team. "There is a need to strengthen measures to prevent infection."
The hepatitis B virus is spread through blood and body fluids. Both the Western and Asian viruses are believed to be transmitted through sexual contact.
If adults are infected with the Western virus, the disease is more likely to become chronic and could develop into liver cancer. Although the strain that has been prevalent in Japan can cause fulminant hepatitis, it is generally believed not to develop into a chronic disease.
The Asian virus can lead to an increase in liver cancer among children if passed on from the child's mother, but it is rare for it to develop into a chronic disease among adults.
Unless treatment is adapted to deal with the increase in hepatitis B caused by the Western virus, there could be a surge in liver cancer cases.
Takeshi Okanoue, a professor of gastroenterology at the Kyoto Prefectural University of Medicine, is in charge of the review process at the Japan Society of Hepatology.
"We hope to add diagnostic and treatment methods that respond to the different genetic types," Okanoue said. "There will be a difference in the types of drugs used for treatment."
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Rotting Away: Thousands of New York Inmates Have Hepatitis C. Only a Few Hundred Get Treatment
SourceURL:http://villagevoice.com
by Kai Wright
Jimi Hammerstein learned he was sick with hep C only after leaving prison.
It's hard to imagine how a doctor could miss Jimi Hammerstein's primary health risk. The graying Brooklyn native spent most of the last 10 years upstate for slinging dope in Park Slope – back when the neighborhood was still in transition. "I remember when this neighborhood wasn't nothing like this," he says, laughing as he sits in a drop-in center for ex-offenders on Fourth Avenue, the Slope's still-gritty border with Downtown Brooklyn. "This was like, dope land!"
Dope land's geography extended into the prison compounds Hammerstein bounced between. His habit continued once he was inside, and just as intensely. Most inmates snort heroin rather than inject it, but as Hammerstein describes the scene, "You got the die-hard dope fiends like I was, where there's only one way to fly. If you're going to do any kind of substance, you might as well shoot it."
Hammerstein's commitment to the needle made him a textbook candidate for two of the modern era's most aggressive communicable diseases: HIV and hepatitis C – a deadly virus that, when left untreated, slowly devours your liver. He tested positive for HIV back in 1989, before he entered prison. He says he copped to the infection at the beginning of his two bids, but he'd never heard of hep C and claims no one – certainly not corrections health officials – ever asked him about it.
Only after his release last year did the questions begin. "People used to say to me, 'Oh, you're HIV; are you hep C too?' " Hammerstein remembers. "I'd say no. And they'd say, 'Oh, that's unusual.' " He'd shrug the idea off. "I'd been taking tests up north for years, and no one mentioned anything about hep C." His doc on the outside finally insisted he get tested, and in what should have been no surprise, he was positive.
Like Hammerstein, thousands of prisoners around the country are slowly dying from a wholly treatable disease because corrections officials are doing everything possible to avoid caring for them. New York is among the worst offenders, as by most estimates it boasts more inmates living with hep C than any other state. But after years of advocates and inmates fruitlessly lobbying for change, a series of recent lawsuits, including a class action case now pending in federal court, appears to have finally forced the state's hand.
Over the last three decades, hep C has been a stealthy but virulent sidekick to its celebrity sister HIV. Nearly 3 million people nationwide now have chronic infections – triple the HIV caseload. They are uniquely concentrated in prisons: At least 14 percent of New York's inmates are known to have hep C. And as these legions barrel toward the disease's end stage, in which the inflamed liver turns cirrhotic, they promise to collapse the teetering liver-transplant market. Already, hep C is the number one reason for swapping out a liver; the waiting list for transplants is 17,000 people deep and growing. The sooner you start treatment, the less likely you'll need one.
In response to growing awareness about the epidemic – and its concentration among drug users who cycle in and out of incarceration – the state corrections department says it now offers tests to all incoming prisoners whose profiles raise red flags, as Hammerstein's should have. But even for those who get screened, learning you've got the disease is where, for most, the process ends. According to a Justice Department census, as of 2000, only about 300 of the state's estimated 10,000 hep C-positive inmates were being treated.
Prison health advocates charge this dismal rate is no accident. Coincidentally or not, treating hep C is one of the more expensive tasks in medicine. The multi-drug regimen can cost as much as $35,000 per patient. Corrections already spends almost $23 million a year on AIDS meds, nearly 40 percent of its whole pharmacy budget.
Until mid October, when the department began revising its policies in response to ongoing litigation, any inmate needing hep C treatment who had a history of using drugs – as does almost everyone with the virus – was required to first enroll in a six-month class for users. The official approach, which has been slowly shifting over the last couple of years, originally forced inmates to complete the course before getting treatment. It was expansive and unbending: If you'd ever done drugs or alcohol in your life, you had to take the class.
"You got guys that been in the system eight, nine, 10 years," scoffs Rahiem (not his real name), a hep -positive lifer at the medium-security facility in Auburn who refused to take the drug class and so hasn't gotten treatment. "They don't have no record of drug use from disciplinary actions. But they're denied treatment." Rahiem wears long gray dreadlocks and stares with measured intensity when insisting that he last got high in 1973. But his old girlfriend once got charged with smuggling whiskey into the visiting room, he says, so now he's stuck with a user label.
"These rules are barriers that they set up," complains Romeo Sanchez, a hep C-positive ex-offender who organizes prison activism at the New York City AIDS Housing Network, "because they don't want to pay for it."
But as Robert Hilton found out, even if you go along with the rules, the outcome is often the same: no treatment. Hilton is the lead plaintiff in the new class action, filed in federal court on August 17.
Hilton began treatment for hep C at Bellevue in 2002. But a few months after starting, he became homeless, and his treatment was interrupted. In August 2004, he was locked up on a parole violation and shipped upstate to Altona. Upon intake there, he underwent a routine exam at which he told doctors about his infection, the resulting liver disease, and his treatment history.
But the medical staff waited two months to conduct its own tests, according to the complaint, and a full seven months to recommend him for treatment. Then Chief Medical Officer Lester Wright ruled Hilton couldn't start until he took drug addiction classes, even though no previous doctor in or out of the system had suggested it and even though Hilton professed to have not used drugs in 13 years – much of which time he spent passing drug tests as a parolee.
Hilton acquiesced and signed up for the class – only to be put on a lengthy waiting list. He was then transferred to another facility, where counseling staff again tried to enroll him in an addiction class. This time, his enrollment was turned down because he would be eligible for parole before the class finished. "As antiretroviral treatment continues to be denied on the basis of this catch-22," the class action complaint notes, "Mr. Hilton's liver continues to deteriorate."
The state declined to comment on this and other suits it now faces.
In previous suits, the corrections department has offered a reasonable-sounding defense. Hep C treatment is no joke – at least a shot a week and daily pills that can cause depression and flu-like symptoms similar to those of heroin withdrawal. Even the regular needle use can be traumatic for someone kicking an old habit. So the department worries about triggering relapses. And all credible medical guidelines stress that no one who's actively using drugs or alcohol should start treatment without getting sober, lest they fail to complete the regimen.
The stakes are high: If you start and don't finish, your virus will likely mutate, developing the sort of drug resistance we've heard so much about with HIV.
Critics, however, point out that all of the guidelines cited by corrections warn only against treating active users. The concern over relapse is the department's own.
In early November, the prison officials submitted a sweeping policy change to the U.S. District Court for the Northern District of New York, asking that a central part of Hilton's case be dismissed based on that change. The new policy removes the drug abuse class requirement but maintains an insistence that inmates have "no evidence of active substance abuse" in the previous six months. Those with evidence of such will be evaluated on a case-by-case basis.
Alexander Rienert, an attorney with Koob & Magoolaghan, which is leading the Hilton class action and has led a number of previous hep C suits, says that's not near good enough. He wants to see a far more detailed portrait of how the system will scale up treatment – and how it will get those it has previously turned away into treatment. "What Dr. Wright is saying is, trust us, you don't have to be involved anymore," scoffs Rienert. "But our experience is, the only time an individual gets treated is when an attorney has stepped in."
Moreover, Rienert says he's already received at least one new complaint from an inmate who has been denied treatment based on his failure to take a drug abuse class.
Milton Zelermyer, a staff attorney with Legal Aid's Prisoners' Rights Project, adds that there remain plenty of ways for corrections to ration treatment. Already, the prisons only test certain inmates for hep C, and as Hammerstein's experience shows, many likely candidates slip through unscreened. But effective hep C screening and treatment also require extensive diagnostics, including regular blood tests and a liver biopsy – just the sort of thing the department delayed for months before denying Hilton based on the drug class rule. So the new policy looks like progress, Zelermyer says, but "how it works in reality is another question."
Prison health advocates say the system's failure to deal adequately with hep C is just the latest disaster to come from letting prison guards control public health. Even as the narrow legal battle over hep C intensifies, advocates are pressing a broader legislative reform. Of course, for activists in Albany, reforms for guys like Rahiem and Hammerstein and Hilton have been the most dead on arrival.
The corrections department's health care challenge is already massive – it runs what amounts to the nation's largest HIV medical practice, for instance. Yet it is exempt from Department of Health oversight because state law considers its facilities more akin to private colleges than public hospitals. The state assembly wants that law changed, but neither the health department nor corrections wants to be part of an arranged marriage; bills calling for it have twice stalled in the senate.
And that leaves dying inmates' futures in the hands of the courts. "There could be something out there for you – whatever medicine, whatever program, whatever doctor you have to see – and they ain't telling," Hammerstein complains, "because the facility don't want to go for the money."
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December 7th, 2005
Acetaminophen Hepatoxicity Main Cause of Liver Failure
SourceURL:http://www.gastrohep.com
Acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the USA, and the patients have depression, chronic pain, alcohol or narcotic use, finds this month's Hepatology.
Severe acetaminophen hepatotoxicity frequently leads to acute liver failure.
Dr Anne Larson and colleagues determined the incidence, risk factors, and outcomes of acetaminophen-induced acute liver failure.
The investigative team gathered prospective data from 662 patients at 22 tertiary care centers in the United States over a 6-year period.
The patients fulfilled standard criteria for acute liver failure including coagulopathy and encephalopathy.
Of these, 42% were determined to result from acetaminophen liver injury.
The annual percentage of acetaminophen-related acute liver failure rose during the study from 28% in 1998 to 51% in 2003.
The team reported that the median dose ingested was 24 g.
81% were taking acetaminophen and/or other analgesics – Hepatology
The investigators found that unintentional overdoses accounted for 48% of cases, intentional for 44%, while 8% were of unknown intent.
In the unintentional group, 38% took 2 or more acetaminophen preparations simultaneously.
The team noted that 63% used narcotic-containing compounds.
A further 81% of unintentional patients reported taking acetaminophen and/or other analgesics for acute or chronic pain syndromes.
Overall, 65% survived, 27% died without transplantation, and 8% underwent liver transplantation.
The investigators observed that 71% were alive at 3 weeks.
Furthermore, the team observed that transplant-free survival rate and rate of liver transplantation were similar between intentional and unintentional groups.
Dr Larson's team concluded, "Acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States."
"Susceptible patients have concomitant depression, chronic pain, alcohol or narcotic use, and/or take several preparations simultaneously."
"Education of patients, physicians, and pharmacies to limit high-risk use settings is recommended."
Hepatol 2005: 42(6): 1364-72
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Dynavax to Present Data on Phase 2/3 Clinical Trial of HEPLISAV(TM) Hepatitis B Vaccine at ICAAC 2005
SourceURL:http://biz.yahoo.com
BERKELEY, Calif., Dec. 7 /PRNewswire-FirstCall/ – Dynavax Technologies Corporation (Nasdaq: DVAX - News) announced that safety and efficacy data from the company's Phase 2/3 clinical trial of HEPLISAV, its ISS-based hepatitis B vaccine, compared to GlaxoSmithKline's Engerix-B® vaccine in an older adult population will be presented in a poster session at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in Washington, DC.
The data will be presented by Dr. Seng Gee Lim, Department of Medicine, Division of Gastroenterology, National University Hospital, Singapore.
The poster is entitled, "Recombinant Hepatitis B Surface Antigen (rHBsAg) Co-administered with an Immunostimulatory Phosphorothioate Oligonucleotide (1018 ISS) Provides Superior Protection in Older Subjects." The Phase 2/3 trial was conducted by Dr. Lim and by Dr. Chow Wan Cheng of the Singapore General Hospital. The poster session, number 87, is scheduled for Saturday, December 17, 2005, 10:00-11:30 am Eastern Time, in Exhibit Hall B of the Washington Convention Center. The Dynavax poster number is 221. The poster will be available on the ICAAC website at the time of the poster session.
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: TOLAMBA(TM), a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial and in a supportive clinical trial in ragweed-allergic children; HEPLISAV(TM), 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 therapeutic and commercial potential of HEPLISAV, its HBV vaccine; 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 ability of the company to demonstrate safety and effectiveness of its HBV vaccine in Phase 3 clinical trials; the progress and timing of initiating its Phase 3 clinical program in HBV; the ability of the company to develop and implement effective commercial strategies for its HBV vaccine; 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 November 14, 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.
Source: Dynavax Technologies Corporation
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December 8th, 2005
Three Rivers Gets FDA Approval of Drug
SourceURL:http://www.bizjournals.com
The U.S. Food and Drug Administration gave final approval to a Hepatitis C treatment from Three Rivers Pharmaceuticals Inc.
Three Rivers said it will immediately ship 200 mg, 400 mg and 600 mg tablets of ribasphere, the generic form of Roche Pharmaceutical's Copegus, which has annual U.S. sales of about $200 million.
The Cranberry Township, Pa., company said it would launch Ribasphere in conjunction with its marketing partner, PAR Pharmaceuticals Inc. (NYSE:PRX), of Spring Valley, N.Y.
Privately held Three Rivers Pharmaceuticals filed its first application with the FDA in July 2001 but had to overcome patent infringement lawsuits and certain regulatory issues to reach this stage.
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Vertex Hepatitis C Drug Will Get Fast Track Review
SourceURL:http://today.reuters.com
BOSTON, Dec. 8 (Reuters) - Vertex Pharmaceuticals Inc. (VRTX.O:) said on Thursday that U.S. regulators will review its experimental hepatitis C drug on an accelerated basis.
The Cambridge, Massachusetts-based company said the U.S. Food and Drug Administration granted "fast track" status to the drug, VX-950, a designation given to drugs aimed at treating serious or life-threatening conditions.
The drug is currently in early clinical trials and the company won't be ready to submit a marketing application until 2008, according to Joshua Boger, its chief executive officer.
Fast track status will, however, speed the drug's journey to the market as Vertex will have more frequent contact with the FDA, and it will be able to submit data from its clinical trials as it comes in, rather than waiting until the entire package is complete.
Hepatitis C is a liver disease caused by a virus in the blood. It affects about 3.4 million people in the United States.
Vertex's drug is an oral treatment that goes into the blood stream and blocks the HCV protease, a protein the hepatitis C virus makes in the liver cells. Blocking the protein prevents the virus from reproducing.
The company hopes that the drug will dramatically shorten the time it takes to eliminate the virus from the blood stream. Current treatments typically take a year to reduce the virus to undetectable levels and only work in about 50 percent of patients.
The current standard of care is a combination of pegylated interferon and ribavirin. Vertex plans to test its drug in combination with pegylated interferon next year.
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