Research & Treatment News
September 29, 2005
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This is one of the best general audience articles we've come across on HCV in quite a while. There is lots of good info on treatment. Notice that even the doctor says the "cure" rate has only risen to about 50% (and that includes the over 80% for genotype 2) This indicates that, in real numbers, it is even lower than 50% for Genotype 1 patients.
Dr. Godofsky says he was encouraged about Tarvacin because it has low toxicity.
Clearly, this is the sort of treatment we are waiting for. We're just protecting and supporting our liver as best we can (through natural means) in the meantime.
For more info on how to protect and support your liver (if you aren't already aware) you can go to http://www.liversupport.com/interview.htm
Bradenton doctor chips away at hepatitis C virus
Medical office runs 10 to 20 drug trials a year
By KATHLEEN MCLAUGHLIN
kathleen.mclaughlin@heraldtribune.com
BRADENTON — When Eliot Godofsky started treating viral hepatitis in 1996, about 10 percent to 15 percent of patients could be cured.
After the introduction of some new drugs, that rate is up to 50 percent.
Godofsky likes those numbers, but he knows they could be even better. “HIV is controllable. Hep-C is potentially curable.”
That’s why his Bradenton-based medical office — the nation’s largest infectious disease practice specializing in viral hepatitis — runs 10 to 20 drug trials a year.
Private practice physicians get involved in clinical research for many reasons: money, experience with cutting-edge treatment, access to drugs for patients.
Godofsky says his prime motivator is fundamental: “The benefit to me is to cure people who thought they were incurable.”
The 46-year-old came to Bradenton to join Michael Bach, a pioneer in HIV/AIDS treatment who died of melanoma in 1998.
Bach & Godofsky, M.D. PA, which now employs six other doctors, still staffs the HIV/AIDS clinic that Bach opened in Manatee County. But Godofsky has expanded the scope of the practice and become an expert on viral hepatitis. Part of that includes doing early-stage drug trials, such as the one for Peregrine Pharmaceuticals that began Aug. 29.
He hopes to help find something that will work for the roughly 50 percent of people who don’t respond to treatment, which involves a yearlong course with debilitating side effects.
The virus
The hepatitis C virus is more widespread than HIV, but it gets relatively little attention.
About 4 million people in the United States are infected with hepatitis C, while about 1 million have HIV.
No national fund like the one established by the Ryan White CARE Act for HIV pays for hepatitis drugs. Treatment, not including lab work, costs about $20,000 per year, Godofsky said.
There are a lot of drugs under research for hepatitis C, but there is not a high-profile, independent center testing them head-to-head, said Lisa Ball, executive director of the Hepatitis Resource Network, a doctors education group.
Sharing needles is the most common cause forof the illness, representing 60 percent of new infections. Although commonly associated with illegal drug use, hepatitis crops up unexpectedly in many middle-aged people because the disease can stay in the body for 10 to 20 years without causing anything more than flu-like symptoms, said Michelle May, the nurse practitioner who runs clinical trials for Godofsky.
Some patients trace their risk back to recreational cocaine use, in which they shared straws, May said.
One woman’s only identifiable risk factor was the fact that she was a seamstress. She might have pricked her finger on a needle used by someone else.
A lot of people don’t realize they can be cured. Some go through the treatment, only to find themselves among the “non-responders.”
“The worst part of my job is helping them through 12 months of therapy, then six months later having to call and say, ‘Your virus is back,’” May said.
There are 12 to 15 companies trying to develop new drugs, and many of them contact Godofsky’s office for trials.
Godofsky thought Peregrine’s drug, Tarvacin, looked promising. The small California company realized the antibody treatment it was developing for cancer tumors might work against hepatitis and other viruses.
The Bradenton doctor agreed to the trial because the drug seems to have low toxicity, and it’s a novel approach: Patients will get one intravenous injection of the antibody, which might block the virus from invading liver cells and remove the virus from the body.
Supporting treatment
Godofsky was drawn to research as an intellectual pursuit, but he has become an expert on the ins and outs of using it to support the practice. He gave a presentation on it last year at the annual meeting of the Infectious Diseases Society of America.
Listed among the reasons for doctors to get involved in trials was “cost-effective income production.”
The medical office gets “good” reimbursement for patient visits and lab reviews with limited billing and collections overhead. Doctors spend no time with managed care, Godofsky notes.
One of his tips on setting up a budget for a clinical trial was “do not be afraid to negotiate.”
“Physicians are not usually terrific businessmen,” but can be, Godofsky says.
Research is not a profit center, Godofsky acknowledges, but by using it he can support the staff required to care for the disease.
Treating viral hepatitis requires a lot of patient monitoring and education.
It can also be very complicated. About 10 percent of viral hepatitis sufferers also have HIV. Doctors know little about how the drugs used to treat the two viruses separately might interact.
Making a living at that kind of medicine is difficult, said Ball, the executive director of the Puyallup, Wash.-based Hepatitis Resource Network.
“There’s no procedure, so it’s not particularly well-reimbursed,” she said. “But patients have lots of questions.”
Many doctors don’t want to be involved.
Godofsky is on the board of directors of the organization, which was started in 1997 to raise awareness of hepatitis C among physicians.
Infectious disease doctors proved to be more interested in the disease than liver or intestinal doctors, Ball said. They are used to dealing with trying to get paid for the time they spend consulting, and many, like Godofsky, do it for the intellectual challenge.
Bach is what brought Godofsky to Bradenton: “He had that zest or lust for research.”
After his partner died, Godofsky said, he worked seven days a week, 20 hours each day for the subsequent year and a half. “I kept the research going. I kept the HIV care going. I gradually added more and more doctors.”
Now the seven doctors, including Godofsky, cover the three hospitals in Manatee County and the Michael Bach Treatment Center. They also work with Infectious Disease Associates of Sarasota.
Bach and Godofsky also runs a wound care center and a large outpatient IV clinic. The IV clinic, which is open every day, sees 80 to 100 people each day.
Godofsky estimates that he has a patient base of about 1,000 and that he accepts about 300 new patients a year.
Patients
May, the nurse practitioner who runs trials for Godofsky, does not have to recruit patients, even for early phase trials where the focus is on establishing safe doses, not treatment.
“They clamor to do these phase-one trials,” she said. “They want to make something good out of something bad.”
Fort Lauderdale resident Philip Younger is the kind of patient who would benefit from a breakthrough drug. He’s among the 50 percent who didn’t respond to treatment, even after three courses.
The 56-year-old was diagnosed with the disease in 2000 and soon started treatment: three shots a week of one drug, interferon, and six pills a day of another, ribavirin.
Younger, hurt on his job moving furniture, took work as as telemarketer to accommodate the side effects: headaches, fever, muscle aches and loss of appetite. He went on three medications to counteract the insomnia and depression.
During that time, Schering-Plough came out with an improved drug,he tried that, too. Younger went through 15 months of treatment, but the virus came back six months after the treatment ended.
Younger tried another company’s drug. That didn’t work, either.
“It’s a freaky virus,” he said.
Younger, who now works for a patient advocacy group called Hep-C Alert, said the treatment at least bought time for his liver, which showed no cirrhosis in his latest biopsy.
“I live right, eat right, hope for the best and counsel people on hepatitis,” he said.
Younger said that if he could take the time off work, he would join a trial now.
“I’ve always said I would shoot toothpaste if it would get rid of this virus,” he said.
Posted by Ralph at 12:38 PM --- Printer-friendly version
September 28, 2005
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Phase 3 Trials are very advanced. If it works, Zandaxin is another enhancement for Interferon therapy. We are looking forward to alternatives to Interferon therapy, but this could be a very positive advance for patients who would consider Interferon and benefit from it. Especially considering that these tests are focused on non-responders, who currently have little recourse but to protect and support their livers with clinically proven natural approaches.
SciClone to Report Top-Line Data From First U.S. Hepatitis C Phase 3 Trial by Mid-December 2005
SAN MATEO, CA -- (MARKET WIRE) -- 09/27/2005 -- SciClone Pharmaceuticals (NASDAQ: SCLN) today announced that it expects to unblind and report top-line data by mid-December 2005 from the first of its two U.S. phase 3 hepatitis C virus (HCV) clinical trials evaluating its lead compound, ZADAXIN®, as a novel adjunctive treatment for hepatitis C patients who have failed prior therapy. Previously, SciClone planned to unblind the data from both trials together and report these data in the early part of 2006.
"Earlier access to the results from the first trial will provide us with valuable information for the design, prioritization and implementation of additional product development programs, ZADAXIN regulatory plans, marketing strategy and resource allocations," commented Dr. Ira Lawrence, President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "SciClone is at a very important point in its history, with final data from this first phase 3 trial available to us by mid-December of this year, as well as preliminary data from a phase 2 malignant melanoma trial run by Sigma-Tau by year-end and final data from the second HCV phase 3 trial released in the early part of 2006."
SciClone's two phase 3 hepatitis C trials are designed to determine the benefit of adding ZADAXIN to pegylated interferon alpha to treat hepatitis C non-responder patients. Complementary in design, the first trial enrolled over 500 HCV non-responder patients without liver cirrhosis, while the second trial enrolled over 500 HCV non-responder patients with early liver cirrhosis. Patients in the second trial have completed therapy and will finish their observation period in December 2005. Biopsies for the last patients enrolled in this second trial will be performed by the end of February 2006 and the data from this trial will be reported in the early part of 2006.
"Of course, at this time we cannot predict whether the results from either trial will be favorable or unfavorable," cautioned Dr. Lawrence. "In general, favorable results from both trials would be needed to proceed with the filing of an NDA."
SciClone's two U.S. phase 3 clinical trials are multi-center, randomized and double-blinded studies. All patients in each trial are assigned to a 48-week course of treatment of either ZADAXIN and pegylated interferon alpha or placebo and pegylated interferon alpha. After completing treatment, the patients are followed for a 24-week observation period. The primary endpoints of both trials are the achievement of a sustained virologic response (SVR), defined as the lack of detectable HCV RNA in the bloodstream measured by PCR test 24 weeks after the completion of 48 weeks of therapy, and improvement in liver histology.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one hepatitis C triple therapy clinical trial in Europe. ZADAXIN also is being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other principal drug development candidate is SCV-07, currently in phase 1 development, which is being evaluated for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations regarding the timing of availability of clinical trial data. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. Actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including unexpected difficulties in compiling or analyzing data, and the availability of information from third parties. as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. The availability of phase 3 trial data, even positive data, by itself, does not ensure that the company can successfully file an NDA or ultimately attain regulatory approval.
Posted by Ralph at 12:21 PM --- Printer-friendly version
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Another new approach in the pipeline. As We've always said, with millions of people infected, the drug and biotech companies are falling over each other to come up with viable treatments to improve on what is currently available.
NEW YORK, Sept 27 (Reuters) - Coley Pharmaceutical Group Inc. (COLY.O: Quote, Profile, Research) on Tuesday said it is starting an early-stage clinical trial of an experimental drug to treat chronic Hepatitis C virus.
Coley expects preliminary data from the Phase Ib study of the drug, Actilon, to be available in the second half of 2006.
The study will involve 60 patients infected with the virus, who will be divided into different treatment groups over a period of three months. Some patients will take only Actilon, some will take it in combination with one or two standard treatments, and some will take standard treatments without Actilon.
The company, which went public last month, has also attracted attention because of three other promising experimental drugs, especially ProMune, which is entering late-stage trials against non-small cell lung cancer. Coley, based in Wellesley, Massachusetts, is developing that product with Pfizer Inc. (PFE.N: Quote, Profile, Research)
Its drugs are designed to stimulate the immune system by acting on proteins called Toll-like receptors. Actilon acts through the Toll-like receptor 9 found in dendritic cells and B cells, which are mainstays of the immune system.
Shares of Coley were up $1.52, or 9.4 percent, to $17.64 on Nasdaq. (Additional reporting by Ransdell Pierson)
Posted by Ralph at 9:26 AM --- Printer-friendly version
September 14, 2005
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Sometimes business journals contain valuable information about emerging hepatitis C therapies. Given the fact Stanford University is involved in this venture (and the companies involved are putting up pretty big bucks), this is another one to watch closely.
We'll keep you posted.
September 13, 2005
Alnylam to align with West Coast firm on hep C treatment
Boston Business Journal
Alnylam Pharmaceuticals Inc. and a California company have signed a joint licensing deal for a gene that could help treat hepatitis C.
The Cambridge, Mass. company (Nasdaq: ALNY) and Isis Pharmaceuticals Inc. of Carlsbad (Nasdaq: ISIS) announced on Tuesday that they inked a combined licensing agreement with Stanford University.
They'll gain co-exclusive access to Stanford research regarding a MicroRNA gene found to be needed to replicate the hepatitis C virus in mammalian cells.
Researchers hope the discovery could lead to treatments for hepatitis C, a viral infection of the liver that can cause cirrhosis and liver cancer. Researchers estimate 170 million people globally have hepatitis c infections. Vaccines don't exist yet to prevent the disease.
Alnylam announced on Sept. 7 that it had signed a multi-year alliance with Novartis AG that could be worth more than $700 million if the deal produces commercial products.
Alnylam and Novartis (NYSE: NVS) will work on developing RNAi therapies. RNAi is a natural process within cells that selectively silences genes, and Alnylam believes RNAi can treat disease by silencing genes that cause disease.
In the short term, Novartis will pay Alnylam $56.8 million, through cash and a purchase of 4.2 shares of Alnylam common stock.
Posted by Ralph at 4:53 PM --- Printer-friendly version
September 2, 2005
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This is one of the most broad announcements regarding Hepatitis C I've seen in a long time. It appears to apply to all Hepatitis C patients.
And, while it seems to predict eventual doom and gloom for most HCV patients, it does so on a very shaky foundation.
And, oh boy,I've got a bit to say about the study this article refers to. Here is the actual conclusion of the study authors:
The prevalence of cirrhosis in patients with chronic HCV increases with increasing duration of infection. In Asian patients infected at birth, infection for over 60 years causes cirrhosis in 71% of infected individuals. Because relationship between the severity of fibrosis and age in Asian patients is similar to that seen in Caucasian patients it is likely that similar rates of cirrhosis will be seen in other patients who are infected for more than 60 years.
First of all, there is no mention of what genotype the "Asian" patients were infected with. According to data I have seen each genotype seems to progress at different rates and with differing levels of severity. 70% of North Americans have genotype 1. And Genotype 1b seems to progress differently than even 1a. And, in Asia, genotype 6 is fairly common. So, does the finding of this study really apply to genotype 1 (or 70% of Americans)?
The study also does not mention mode of infection, and other studies show there is a big difference in progression between those who were infected through transfusion and those infected through other means.
The broad conclusion of this study is that most HCV patients (up to 80%)will progress to cirrhosis after 60 to 80 years of chronic infection. Of course, this conclusion is drawn without taking into account certain variables (as mentioned above).
The actual report from Clinical Gastroenterology and Hepatology goes on to say this about one aspect of the study:
The authors also assumed that the Asian patients were infected at a very young age, largely on the basis of extrapolation of regression lines down to an age in which patients would presumably not have had fibrosis. This conclusion is speculative and goes well beyond the data presented in the study.
The study authors concluded that the majority of patients will progress to cirrhosis after 60 years. The Journal goes on to say this:
Such conclusions are currently premature. Specifically, additional studies are needed in other patient populations that overcome the design limitations of the current study and to address the alternative interpretation of the data that, although during a lifetime there might indeed be progression to cirrhosis, this might only seldom result in end-stage liver disease or the development of HCC.
So, while this looks pretty bad at first glance, closer scrutiny helps put it in clearer perspective.
Oh, one more thing. Most Americans were infected in their early 20's. 60 to 80 years puts them into their 80s to over 100. Hmmm, with an average life expectancy in this country of 72, it seems like HCV patients may do even better than average (wink).
Just shows you've got to take these preliminary study conclusions with a grain of salt. (By the way, be sure you note who helped sponsor this study. The info is near the bottom.)
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Public release date: 1-Sep-2005
American Gastroenterological Association
Most chronic hepatitis C sufferers will develop cirrhosis in later life
Study suggests cirrhosis and liver disease nearly inevitable for people with hep C
Bethesda, Maryland (Sept. 1, 2005) – Nearly 80 percent of chronic hepatitis C sufferers who have the disease for several decades will develop cirrhosis or end-stage liver disease later in life, according to a study published today in the American Gastroenterological Association (AGA) journal Clinical Gastroenterology and Hepatology. Researchers found that it is highly likely that people who are infected with hepatitis C (HCV) for more than 60 years will develop cirrhosis--the highest rate of hepatitis C-associated cirrhosis reported to date.
Hepatitis C is a virus that affects the liver and is spread primarily by contact with blood and blood products in transfusions and among drug users who share needles. Other common routes of transmission are infants born to HCV-infected mothers, tattoos and body piercings and risky sexual behavior. Of those who are infected, more than 80 percent will be chronic carriers of the disease.
HCV can cause long-term scarring of the liver and usually presents with mild and non-specific symptoms, if any. They include fatigue, nausea, poor appetite and muscle and joint pain. It is estimated that more than 4 million Americans are now infected with HCV (more than 170 million people worldwide) and nearly 10,000 Americans die from the disease each year.
"Hepatitis C begins generally as a silent acute infection, with a fraction of the patients developing cirrhosis, end-stage liver disease or liver cancer," according to an editorial appearing in this month's journal. "Although this is a generally accepted scenario in persons infected with HCV, there remains uncertainty about the true frequency of evolution of liver disease and its rate of progression."
According to results of the study from researchers at the Queen Mary's School of Medicine and Dentistry in London, the prevalence of cirrhosis in patients with chronic HCV increases with the duration of the disease. Nearly 80 percent of Asian patients who were infected at birth and lived with the disease for 60 years or more developed cirrhosis--a finding that researchers say can be applied to the general population because of the similarity in the way the disease progresses in all ethnic groups.
"This study suggests that prolonged infection with hepatitis C leads to cirrhosis in the majority of those who are infected," said Graham R. Foster, PhD, FRCP, study author and professor of hepatology at Queen Mary's School of Medicine and Dentistry in London. "While previous studies have found differences in disease progression in various ethnic groups, our findings confirm that fibrosis progression is the same across these groups and leads to development of cirrhosis and liver disease at the same rate in everyone."
Researchers conducted retrospective analyses of 382 patients diagnosed with hepatitis C at three hospitals in northeast London between 1992 and 2003. Study participants were divided into two groups: Asian patients presumably infected in childhood and Caucasian patients. While the prevalence of cirrhosis in Caucasian patients was similar to the findings of previous studies, the statistics in Asians were markedly higher than previously found. The higher prevalence was partially attributed to the longer duration of HCV in the Asian patient population, those patients having suffered with the disease nearly 30 years more than the Caucasian subjects.
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This study was funded by local investigators and an unrestricted research grant from Roche Pharmaceuticals.
About the AGA
The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is the oldest medical-specialty society in the United States. The AGA's 14,500 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. On a monthly basis, the AGA publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The AGA's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
About Clinical Gastroenterology and Hepatology
The mission of Clinical Gastroenterology and Hepatology is to provide readers with a broad spectrum of themes in clinical gastroenterology and hepatology. This monthly peer-reviewed journal includes original articles as well as scholarly reviews, with the goal that all articles published will be immediately relevant to the practice of gastroenterology and hepatology. For more information, visit www.cghjournal.org.
Posted by Ralph at 12:13 PM --- Printer-friendly version