Showing posts with label HCV treatment. Show all posts
Showing posts with label HCV treatment. Show all posts
Monday, July 16, 2012
University of Florida researchers develop nanorobot to target Hepatitis C...
Posted 7/16/12 on the University of Florida website. Nanotechnology represents a fascinating, potentially less lethal and more efficacious way to treat disease states without the side-effects common with oral and injectable drugs. Using Nanotechnology, University of Florida researchers have designed a nanozyme that hyper-targets the Hepatitis C virus. Using a two pronged attack - a DNA oligonucleotide that recognizes the genetic material to be destroyed and instructs it's partnered enzyme to destroy the virus' mRNA. Should it become feasible, we may have a hyper-targeted therapy to treat Hepatitis C that would avoid the majority of adverse events and side effects we see with traditional medicinal oral and injectable therapies.
UF researchers develop “nanorobot” that can be programmed to target different diseases
Monday, July 16, 2012.
GAINESVILLE, Fla. — University of Florida researchers have moved a step closer to treating diseases on a cellular level by creating a tiny particle that can be programmed to shut down the genetic production line that cranks out disease-related proteins.
In laboratory tests, these newly created “nanorobots” all but eradicated hepatitis C virus infection. The programmable nature of the particle makes it potentially useful against diseases such as cancer and other viral infections.
The research effort, led by Y. Charles Cao, a UF associate professor of chemistry, and Dr. Chen Liu, a professor of pathology and endowed chair in gastrointestinal and liver research in the UF College of Medicine, is described online this week in the Proceedings of the National Academy of Sciences.
“This is a novel technology that may have broad application because it can target essentially any gene we want,” Liu said. “This opens the door to new fields so we can test many other things. We’re excited about it.”
During the past five decades, nanoparticles — particles so small that tens of thousands of them can fit on the head of a pin — have emerged as a viable foundation for new ways to diagnose, monitor and treat disease. Nanoparticle-based technologies are already in use in medical settings, such as in genetic testing and for pinpointing genetic markers of disease. And several related therapies are at varying stages of clinical trial.
The Holy Grail of nanotherapy is an agent so exquisitely selective that it enters only diseased cells, targets only the specified disease process within those cells and leaves healthy cells unharmed.
To demonstrate how this can work, Cao and colleagues, with funding from the National Institutes of Health, the Office of Naval Research and the UF Research Opportunity Seed Fund, created and tested a particle that targets hepatitis C virus in the liver and prevents the virus from making copies of itself.
Hepatitis C infection causes liver inflammation, which can eventually lead to scarring and cirrhosis. The disease is transmitted via contact with infected blood, most commonly through injection drug use, needlestick injuries in medical settings, and birth to an infected mother. More than 3 million people in the United States are infected and about 17,000 new cases are diagnosed each year, according to the Centers for Disease Control and Prevention. Patients can go many years without symptoms, which can include nausea, fatigue and abdominal discomfort.
Current hepatitis C treatments involve the use of drugs that attack the replication machinery of the virus. But the therapies are only partially effective, on average helping less than 50 percent of patients, according to studiespublished in The New England Journal of Medicine and other journals. Side effects vary widely from one medication to another, and can include flu-like symptoms, anemia and anxiety.
Cao and colleagues, including graduate student Soon Hye Yang and postdoctoral associates Zhongliang Wang, Hongyan Liu and Tie Wang, wanted to improve on the concept of interfering with the viral genetic material in a way that boosted therapy effectiveness and reduced side effects.
The particle they created can be tailored to match the genetic material of the desired target of attack, and to sneak into cells unnoticed by the body’s innate defense mechanisms.
Recognition of genetic material from potentially harmful sources is the basis of important treatments for a number of diseases, including cancer, that are linked to the production of detrimental proteins. It also has potential for use in detecting and destroying viruses used as bioweapons.
The new virus-destroyer, called a nanozyme, has a backbone of tiny gold particles and a surface with two main biological components. The first biological portion is a type of protein called an enzyme that can destroy the genetic recipe-carrier, called mRNA, for making the disease-related protein in question. The other component is a large molecule called a DNA oligonucleotide that recognizes the genetic material of the target to be destroyed and instructs its neighbor, the enzyme, to carry out the deed. By itself, the enzyme does not selectively attack hepatitis C, but the combo does the trick.
“They completely change their properties,” Cao said.
In laboratory tests, the treatment led to almost a 100 percent decrease in hepatitis C virus levels. In addition, it did not trigger the body’s defense mechanism, and that reduced the chance of side effects. Still, additional testing is needed to determine the safety of the approach.
Future therapies could potentially be in pill form.
“We can effectively stop hepatitis C infection if this technology can be further developed for clinical use,” said Liu, who is a member of The UF Shands Cancer Center.
The UF nanoparticle design takes inspiration from the Nobel prize-winning discovery of a process in the body in which one part of a two-component complex destroys the genetic instructions for manufacturing protein, and the other part serves to hold off the body’s immune system attacks. This complex controls many naturally occurring processes in the body, so drugs that imitate it have the potential to hijack the production of proteins needed for normal function. The UF-developed therapy tricks the body into accepting it as part of the normal processes, but does not interfere with those processes.
“They’ve developed a nanoparticle that mimics a complex biological machine — that’s quite a powerful thing,” said nanoparticle expert Dr. C. Shad Thaxton, an assistant professor of urology at the Feinberg School of Medicine at Northwestern University and co-founder of the biotechnology company AuraSense LLC, who was not involved in the UF study. “The promise of nanotechnology is extraordinary. It will have a real and significant impact on how we practice medicine.”
Credits
Monday, April 30, 2012
Canadian Association of Hepatology Nurses (CAHN) speak on HCV treatment and patient care.....
Media Advisory posted on 4/30/12 on MarketWatch.com. If there is one thing I can take out of my long exposure to the virology medical space, it's that nurses, nurse practioners and physician assistants are the true unsung heroes of HCV care. More than not, it's these providers that are doing the heavy lifting - fielding call backs, managing adverse events, ensuring patients are compliant to difficult regimens as well as managing clinical trials. They are medical personnel, cheerleader and social support system all rolled up into one. It's nice to see groups form on the basis of specialty to trade best practices and market themselves, such at the Canadian Association of Hepatology Nurses (CAHN). I hope they get the media attention they truly deserve.
April 30, 2012, 7:00 a.m. EDT
Media Advisory - Interview Local Nurses Dedicated to the Hepatitis C Community: National Nursing Week - May 7 to 13, 2012
TORONTO, April 30, 2012 /PRNewswire via COMTEX/ -- During National Nursing Week, Canadians will recognize and celebrate the important contributions nurses make daily to patient care in Canada. The role nurses play in the prevention and management of chronic hepatitis C, a potentially life-threatening virus, provides a powerful example of their impact as supporter, educator and counsellor.
Canadians living with chronic hepatitis C often fear the judgment of others because the virus infecting them is often associated with injection drug use. The reality is that people can contract the virus through a number of different ways including, body piercings, tattoos, blood transfusions or personal care items (razors).
Members of the Canadian Association of Hepatology Nurses (CAHN) build trusted relationships with patients by not focusing on how the hepatitis C virus was contracted, but rather on providing care and support that is beneficial, respectful and can lead to a cure.
The road to a cure is a difficult journey for patients living with chronic hepatitis C. While treatments can be very successful at getting rid of the virus, the stigma associated with the disease often requires patients to struggle through chemotherapy-like side effects in isolation.
CAHN wants to shatter the stigma for those people living with chronic hepatitis C by helping Canadians recognize that anyone, including someone they know and love, could be living with this virus. Stigma must not be a barrier to detection and treatment.
This National Nursing Week, celebrate the leadership provided by CAHN nurses in the prevention and management of chronic hepatitis C.
What: Interview opportunities with nurses and individuals living with chronic hepatitis C willing to share their stories Who: Cheryl Dale, President of the Canadian Association of Hepatology Nurses, CAHN members and individuals living with chronic hepatitis C Where: The following communities across Canada: Ontario (Toronto, Oakville, Mississauga, Guelph, Hamilton, Kitchener-Waterloo, Newmarket, Sutton, Sudbury, North Bay, and London), Quebec (Montreal), British Columbia (Vancouver, Kelowna, and Nanaimo), Alberta (Edmonton), Nova Scotia (Halifax), and Saskatchewan (Prince Albert) When: National Nursing Week (May 7-13, 2012)
SOURCE Canadian Association of Hepatology Nurses
Copyright (C) 2012 PR Newswire. All rights reserved
Monday, March 12, 2012
New Hep C meds may override watchful waiting for patients with no symptoms
Article posted on 3/11/12 on MedCityNews.com - Viral Matters editor comments following: Contrarians exist everywhere, some good at pointing out where mainstream thinking has gone awry, and some just embracing the opposite point of view for reasons beyond the scope for this blog. Here is an article authored by Michael Kirsch, MD a community physician and frequent writing contributor to various on-line medical-related blogs and websites. His opinion is to watch, wait and observe. I'm sure that this is a valid approach with some patients, but it's helpful to keep in mind that liver disease progression is non-linear and cannot be predicted. Aside from the reasons that Dr. Kirsch lists below to treat, there are others as well that come with active replicating Hepatitis C virus - lymphoma, neurological impairment and osteoporosis. The decision to treat or not to treat should be an active dialog between patient and provider, nevertheless both parties should be fully informed when it comes to treating or not treating Hepatitis C.
New Hep C meds may override watchful waiting for patients with no symptoms
I seemany patients with hepatitis C (HCV). None of them are under treatment and they all feel quite well. Why don’t I treat them? After all, potential consequences of HCV include:
* Cirrhosis
* Hepatocellular carcinoma. or liver cancer
* End stage liver disease with all the trimmings
* Liver transplantation
* Death
One would think that a portentous list like this would justify any treatment, even hazardous therapies. But, I’ve never seen it this way, and my hepatitis C patients are all doing well under periodic observation.
Yes, I know that the disease can be serious. I recall one patient with advanced disease whom I referred for consideration of a liver transplant many years ago. There may have been one or two others along the way who received treatment for the disease also.
The vast majority of hepatitis C patients I see in my community practice feel entirely well and the diagnosis was discovered by accident. In other words, these patients did not exhibit symptoms or abnormal findings on the physical examination that led a physician to suspect a liver condition, which then led to testing for hepatitis C. Some of them were picked up by the blood bank when their gift of life was declined. Sometimes, a life insurance company makes the diagnosis during their health assessment as they try to cull out from their enrollees those destined to ascend skyward prematurely. In most cases, patients are diagnosed with hepatitis C when physicians like me order diagnostic HCV blood test to evaluate abnormal liver blood tests. Nearly all of these patients have no symptoms of liver disease and the abnormal liver blood tests may not be a HCV manifestation.
What should we advise patients with HCV who feel perfectly well? Of course, patients should make the call after they have been informed of the risks and benefits of treatment. In my experience, after this discussion, none of these patients wants to proceed. Hopefully, I am meeting my obligation to present the issues to them fairly. I am certainly aware of my bias, and do my best to compartmentalize it.
I think that there has been a rush to treatment with these patients. Academic centers tend to be more enthusiastic about racing for the HCV cure with toxic medicines, although in fairness, their HCV population is very different from mine. Their patients are much more ill, so the risk/benefit analysis of treatmentmay calculate out differently. Nevertheless, academicians in writing and on the speaking circuit tend to extol the virtue of treatment, which they regard as the default response. Watchful waiting just doesn’t have the red meat appeal for liver gurus. They argue that eradicating the virus will prevent the dire consequences I listed at the top of this post. However, when there was only treatment available 20 years ago -injectable interferon - academics were gaga over this it, which had a full page of side effects and was effective in less than 20% of patients treated. I’m amazed that interferon slid by the FDA. Now,HCV can be cured in a majority of patients, according to data from two drugs approved in 2011 to treat the disease, although there remains substantial toxicity from the medications.
Even experts acknowledge that only a minority of HCV patients will develop serious complications. I’m not persuaded that we have a reliable method to determine who will progress and who won’t. And if we did, how firm is the evidence that treating a patient who is destined for cirrhosis will avert this outcome? Those who believe in HCV treatment will find data to support their view and practice. And those of who are skeptics will do the same. That’s the beauty of medicine. There’s always conflicting studies to choose from to support any view.
What would Newton say?
Many of my HCV patientscan date with some precision whenthey contracted the virus. The event may have been a blood transfusion decades ago or from intravenous drug use during a youthful period of hard times and bad judgement.Many of these patients, therefore, have had the virus for decades and are not suffering any illeffects. While I cannot guarantee a sanguine outcome, I view this in Newtonian terms.
An HCV virus that is asleep tends to remain asleep.
Other physicians don’t share my approach and may be dismissive of my nihilism. I wonder how many of them would accept a treatment with enormous toxicity and cost for themselves as readily as they prescribe it to others? This question applies to all physicians, including me, who prescibe medicine and advise patients. Remember, we physicians discuss the risks of all treatments with patients in advance. But, we don’t suffer the complications.
HCV patients, get informed. Make sure the treatment won’t be worse than the disease.
Friday, November 18, 2011
Medscape article: Adverse CNS Effects of HCV Treatment Discourage Adherence
Medscape interviews clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City and Raymond Chung, MD,vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston regarding a large prospective study looking at CNS effects of Peg + riba and the resulting effect on adherence because of depression and/or 'brain fog'.
Adverse CNS Effects of HCV Treatment Discourage Adherence
Neil Canavan
November 18, 2011 (San Francisco, California) — Patients infected with hepatitis C virus (HCV) can experience a marked decline in neuropsychological cognitive function in the first 14 weeks of combination pegylated interferon and ribavirin therapy. This poses a potential treat to treatment adherence, said clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City, here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
These data are from a large prospective study looking at early treatment discontinuation and the onset of neuropsychiatric symptomatology in HCV monoinfected and HCV/HIV coinfected treatment-naïve patients receiving combination pegylated interferon/ribavirin therapy, Dr. Weiss explained.
"A lot of work has focused on depression, and not to the decrements in cognitive function," said Dr. Weiss. A host of neuropsychiatric symptoms should be considered when initiating a new treatment.
"In this era of direct-acting antivirals, when we're asking patients to take medications 3 times a day (every 6 to 9 hours)..., we need to be aware that, just at baseline, 40% to 50% of patients...[have] substantial deficits in cognitive functioning."
This investigation established the degree of neurocognitive decline during the first 12 and 48 weeks of treatment. Both HCV-infected and HCV/HIV-coinfected patients were evaluated. Neuropsychological instruments were used to explore which domains of cognitive functioning are most affected by combination pegylated interferon/ribavirin treatment, and whether being coinfected with HIV adds to the decrements in cognitive functioning.
There were no significant differences at baseline between the HCV-infected and HCV/HIV-coinfected cohorts for age, sex distribution, ethnicity, HCV RNA viral load, HCV genotype, or stage of liver disease. There were also no differences between the 2 groups at baseline for neuropsychological scores. However, although the same percentage of patients in the HCV and HCV/HIV cohorts reported depression, HCV patients had significantly worse depression scores.
After treatment, global neuropsychological function declined significantly in HCV patients during the first 24 weeks of HCV treatment. Domains with the greatest declines were memory, executive function, and motor function. "The HCV monoinfected group also had a greater decline in neuropsychological function than the coinfected group in the first 12 weeks," said Dr. Weiss. "This is probably due to more depression among HCV patients at baseline."
How a patient's declining neuropsychological function affects their behavior is key, and can depend on clinical history, Dr. Weiss explained. "Patients who have a history of cognitive dysfunction might respond less to the onset of new symptoms. Patients with a significant pathology who are already well engaged in psychiatric treatment tend to do quite well on [antiretroviral] treatment because they are familiar with the symptoms and are being well managed." Those who are high functioning at baseline will have more trouble; to be successfully managed, the healthcare provider must be aware of the potential for central nervous system (CNS)-related treatment nonadherence.
CNS and the Hepatologist
Raymond T. Chung, MD, vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston, agrees that the hepatologist must be part psychiatrist. "We field these patients rather then pass them off since there can often be overlap with true advanced hepatic disease and hepatic encephalopathy."
He is mindful of the potential impact of HCV medications. "It has been a modest issue with both HCV/HIV and HCV alone." Symptoms are often called "brain fog," Dr. Chung explained. "This fog does get in the way, in high-functioning individuals, of their ability to carry out intricate calculative functions and memory at work, for instance." It would not be surprising for such a patient to become frustrated and consider forgoing medication, he observed.
Dr. Chung considers the issue manageable if it is proactively addressed. However, like many clinicians at the meeting, he's looking more toward preventing than managing adverse effects by eliminating pegylated interferon from standard HCV treatment.
Dr. Weiss reports being a consultant for Vertex Pharmaceuticals and Kadmon Pharmaceuticals. Dr. Chung has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 972. November 6, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Adverse CNS Effects of HCV Treatment Discourage Adherence
Neil Canavan
November 18, 2011 (San Francisco, California) — Patients infected with hepatitis C virus (HCV) can experience a marked decline in neuropsychological cognitive function in the first 14 weeks of combination pegylated interferon and ribavirin therapy. This poses a potential treat to treatment adherence, said clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City, here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
These data are from a large prospective study looking at early treatment discontinuation and the onset of neuropsychiatric symptomatology in HCV monoinfected and HCV/HIV coinfected treatment-naïve patients receiving combination pegylated interferon/ribavirin therapy, Dr. Weiss explained.
"A lot of work has focused on depression, and not to the decrements in cognitive function," said Dr. Weiss. A host of neuropsychiatric symptoms should be considered when initiating a new treatment.
"In this era of direct-acting antivirals, when we're asking patients to take medications 3 times a day (every 6 to 9 hours)..., we need to be aware that, just at baseline, 40% to 50% of patients...[have] substantial deficits in cognitive functioning."
This investigation established the degree of neurocognitive decline during the first 12 and 48 weeks of treatment. Both HCV-infected and HCV/HIV-coinfected patients were evaluated. Neuropsychological instruments were used to explore which domains of cognitive functioning are most affected by combination pegylated interferon/ribavirin treatment, and whether being coinfected with HIV adds to the decrements in cognitive functioning.
There were no significant differences at baseline between the HCV-infected and HCV/HIV-coinfected cohorts for age, sex distribution, ethnicity, HCV RNA viral load, HCV genotype, or stage of liver disease. There were also no differences between the 2 groups at baseline for neuropsychological scores. However, although the same percentage of patients in the HCV and HCV/HIV cohorts reported depression, HCV patients had significantly worse depression scores.
After treatment, global neuropsychological function declined significantly in HCV patients during the first 24 weeks of HCV treatment. Domains with the greatest declines were memory, executive function, and motor function. "The HCV monoinfected group also had a greater decline in neuropsychological function than the coinfected group in the first 12 weeks," said Dr. Weiss. "This is probably due to more depression among HCV patients at baseline."
How a patient's declining neuropsychological function affects their behavior is key, and can depend on clinical history, Dr. Weiss explained. "Patients who have a history of cognitive dysfunction might respond less to the onset of new symptoms. Patients with a significant pathology who are already well engaged in psychiatric treatment tend to do quite well on [antiretroviral] treatment because they are familiar with the symptoms and are being well managed." Those who are high functioning at baseline will have more trouble; to be successfully managed, the healthcare provider must be aware of the potential for central nervous system (CNS)-related treatment nonadherence.
CNS and the Hepatologist
Raymond T. Chung, MD, vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston, agrees that the hepatologist must be part psychiatrist. "We field these patients rather then pass them off since there can often be overlap with true advanced hepatic disease and hepatic encephalopathy."
He is mindful of the potential impact of HCV medications. "It has been a modest issue with both HCV/HIV and HCV alone." Symptoms are often called "brain fog," Dr. Chung explained. "This fog does get in the way, in high-functioning individuals, of their ability to carry out intricate calculative functions and memory at work, for instance." It would not be surprising for such a patient to become frustrated and consider forgoing medication, he observed.
Dr. Chung considers the issue manageable if it is proactively addressed. However, like many clinicians at the meeting, he's looking more toward preventing than managing adverse effects by eliminating pegylated interferon from standard HCV treatment.
Dr. Weiss reports being a consultant for Vertex Pharmaceuticals and Kadmon Pharmaceuticals. Dr. Chung has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 972. November 6, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Thursday, June 23, 2011
Join "Viral Matters" HCV drug development discussion group on LinkedIn....
Enjoy Viral Matters on LinkedIn by clicking here
Thursday, May 26, 2011
Fair Pricing Coalition puts Merck and Vertex on notice....
Drug pricing is tricky business, to be sure. The drug developer, payors, public policy experts and the patients themselves struggle for equitable outcomes. Variables such as struggling economies, rising healthcare costs and disparate abilities to cover costs all make the pricing policy even more arduous. There are no shortage of arguments to support all sides of the pricing equation. Here,the Fair Pricing Coalition, an ad hoc group of activists who advocate with the pharmaceutical industry regarding the price of HIV and hepatitis drugs, raises their collective concern regarding the price tags of Victrelis and Incivek.
May 25, 2011
Fair Pricing Coalition Says Vertex’s Incivek Price 'Outrageous'
The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.
“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”
According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.
“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.
“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.
“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”
Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.
“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.
“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”
May 25, 2011
Fair Pricing Coalition Says Vertex’s Incivek Price 'Outrageous'
The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.
“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”
According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.
“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.
“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.
“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”
Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.
“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.
“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”
Tuesday, April 26, 2011
New drug targets raise hopes for hepatitis C cure
Article appearing in the online "news" section of the journal Nature, discussing how the best in HCV treatment - and prevention of resistance - may be yet to come with drugs currently in the development pipeline. Companies mentioned are Pharmasset, BMS and iTherX.
New drug targets raise hopes for hepatitis C cure
As the first targeted therapies edge towards regulatory approval, attention turns to the next drugs in line.
Heidi Ledford
A cocktail of tailored drugs will be needed to defeat the hepatitis C virus.
This week, a panel of advisers to the US Food and Drug Administration (FDA) will decide whether the regulator should approve the first therapies tailored to target the hepatitis C virus (HCV). The drugs, called protease inhibitors, are expected to win approval, but observers say that they are only the beginning of a revolution in HCV treatment.
The most exciting developments for patients, they say, may still be in the drug-development pipeline. Researchers are working on drugs that target many aspects of the virus's biology. Used in combination, these might thwart HCV's ability to evolve resistance.
About 3% of the world's population is infected with HCV, an RNA virus that can cause chronic liver disease. Current therapy — a year-long regimen of the antiviral compounds interferon-alpha and ribavirin — cures only about half of cases. Side effects of this treatment can be severe: interferon-alpha can cause flu-like symptoms, fatigue, anaemia and depression.
On 27 and 28 April, the FDA's Antiviral Drugs Advisory Committee will meet to discuss the first anti-HCV drugs to target HCV proteins. Both these drugs — boceprevir, made by pharmaceutical giant Merck, headquartered in Whitehouse Station, New Jersey, and telaprevir from Vertex Pharmaceuticals, based in Cambridge, Massachusetts — target a protein called the NS3-4A protease, which is required to make essential viral proteins.
Each drug, when combined with standard therapy, boosts the cure rate to about 75%.
"I am very excited," says Michael Houghton, a virologist at the University of Alberta in Edmonton, who was a member of the team that discovered the virus in 1989. "These drugs are great news for HCV patients."
The long road to a blockbuster
Nevertheless, these drugs are only the beginning. "These first-generation protease inhibitors will enjoy their day in the sun for maybe two or three years," says Raymond Chung, head of hepatology at the Massachusetts General Hospital in Boston. "But I don't see them having staying power once we have many more of these targeted drugs getting into the game."
The hope is to eventually use several drugs in combination, avoiding the need for interferon-alpha while staving off drug resistance. Houghton estimates, based on mathematical models and clinical studies, that it will take a cocktail of three targeted therapies to prevent drug resistance.
There are about 60 compounds in preclinical and clinical development as companies jostle to grab a slice of a multi-billion-dollar market.
In 2010, researchers at Bristol-Myers-Squibb's lab in Wallingford, Connecticut, reported their discovery of an HCV protein called NS5A that is essential for the assembly of infectious viral particles and the amplification of viral RNA1. In early clinical trials of an NS5A inhibitor, the level of HCV RNA in the blood dropped almost 2,000-fold after only one day of treatment. This drug is now in phase 2 clinical trials.
Combining the NS5A inhibitor with a protease inhibitor wiped out the virus in four of 11 patients whose infections had not responded to standard therapy. The virus remained undetectable for at least 24 weeks.
These latest results, presented at the International Liver Congress annual meeting in Berlin on 1 April, are exciting because they suggest that interferon may eventually be dispensable, says Chung. He anticipates a flurry of such combination studies in the next few years.
Access denied
Another approach is to stop HCV spreading inside patients by targeting its ability to enter cells. "To contain the virus in a subset of cells rather than allowing it to spread would be a huge boost for containing liver damage," says Michael Gale, a virologist at the University of Washington in Seattle.
In a study published in Nature Medicine on 24 April, a team led by virologist Thomas Baumert of the University of Strasbourg, France, reports that HCV relies on a cellular receptor protein, the epidermal growth factor receptor (EGFR), to enter human cells2. EGFR inhibitors are already on the market as cancer therapies and Baumert's team plans to begin clinical trials of the EGFR inhibitor erlotinib in HCV patients by the end of the year.
Another drug that blocks entry, ITX-5061, is being developed by iTherX, a pharmaceutical company based in San Diego, California, and is in phase 2 clinical trials.
Chung, meanwhile, believes that drugs called nucleoside polymerase inhibitors, which prevent the virus from copying its genome, will be a key ingredient of any future HCV drug cocktail. These compounds set a high barrier for the virus, he notes, and early tests suggest that resistance to them is rare.
Pharmasset, a pharmaceutical firm in Princeton, New Jersey, has several such drugs in development. One called RG7128 is in phase 2 clinical trials and is being developed by Pharmasset together with the Swiss drug giant Roche, based in Basel.
"We used to live in a monochromatic world," says Chung. "Now we realize there are several roads to the same destination."
References
1.Gao, M. et al. Nature 465, 96-100 (2010).
2.Lupberger, J. et al. Nature Med. doi:10.1038/nm.2341 (2011).
New drug targets raise hopes for hepatitis C cure
As the first targeted therapies edge towards regulatory approval, attention turns to the next drugs in line.
Heidi Ledford
A cocktail of tailored drugs will be needed to defeat the hepatitis C virus.
This week, a panel of advisers to the US Food and Drug Administration (FDA) will decide whether the regulator should approve the first therapies tailored to target the hepatitis C virus (HCV). The drugs, called protease inhibitors, are expected to win approval, but observers say that they are only the beginning of a revolution in HCV treatment.
The most exciting developments for patients, they say, may still be in the drug-development pipeline. Researchers are working on drugs that target many aspects of the virus's biology. Used in combination, these might thwart HCV's ability to evolve resistance.
About 3% of the world's population is infected with HCV, an RNA virus that can cause chronic liver disease. Current therapy — a year-long regimen of the antiviral compounds interferon-alpha and ribavirin — cures only about half of cases. Side effects of this treatment can be severe: interferon-alpha can cause flu-like symptoms, fatigue, anaemia and depression.
On 27 and 28 April, the FDA's Antiviral Drugs Advisory Committee will meet to discuss the first anti-HCV drugs to target HCV proteins. Both these drugs — boceprevir, made by pharmaceutical giant Merck, headquartered in Whitehouse Station, New Jersey, and telaprevir from Vertex Pharmaceuticals, based in Cambridge, Massachusetts — target a protein called the NS3-4A protease, which is required to make essential viral proteins.
Each drug, when combined with standard therapy, boosts the cure rate to about 75%.
"I am very excited," says Michael Houghton, a virologist at the University of Alberta in Edmonton, who was a member of the team that discovered the virus in 1989. "These drugs are great news for HCV patients."
The long road to a blockbuster
Nevertheless, these drugs are only the beginning. "These first-generation protease inhibitors will enjoy their day in the sun for maybe two or three years," says Raymond Chung, head of hepatology at the Massachusetts General Hospital in Boston. "But I don't see them having staying power once we have many more of these targeted drugs getting into the game."
The hope is to eventually use several drugs in combination, avoiding the need for interferon-alpha while staving off drug resistance. Houghton estimates, based on mathematical models and clinical studies, that it will take a cocktail of three targeted therapies to prevent drug resistance.
There are about 60 compounds in preclinical and clinical development as companies jostle to grab a slice of a multi-billion-dollar market.
In 2010, researchers at Bristol-Myers-Squibb's lab in Wallingford, Connecticut, reported their discovery of an HCV protein called NS5A that is essential for the assembly of infectious viral particles and the amplification of viral RNA1. In early clinical trials of an NS5A inhibitor, the level of HCV RNA in the blood dropped almost 2,000-fold after only one day of treatment. This drug is now in phase 2 clinical trials.
Combining the NS5A inhibitor with a protease inhibitor wiped out the virus in four of 11 patients whose infections had not responded to standard therapy. The virus remained undetectable for at least 24 weeks.
These latest results, presented at the International Liver Congress annual meeting in Berlin on 1 April, are exciting because they suggest that interferon may eventually be dispensable, says Chung. He anticipates a flurry of such combination studies in the next few years.
Access denied
Another approach is to stop HCV spreading inside patients by targeting its ability to enter cells. "To contain the virus in a subset of cells rather than allowing it to spread would be a huge boost for containing liver damage," says Michael Gale, a virologist at the University of Washington in Seattle.
In a study published in Nature Medicine on 24 April, a team led by virologist Thomas Baumert of the University of Strasbourg, France, reports that HCV relies on a cellular receptor protein, the epidermal growth factor receptor (EGFR), to enter human cells2. EGFR inhibitors are already on the market as cancer therapies and Baumert's team plans to begin clinical trials of the EGFR inhibitor erlotinib in HCV patients by the end of the year.
Another drug that blocks entry, ITX-5061, is being developed by iTherX, a pharmaceutical company based in San Diego, California, and is in phase 2 clinical trials.
Chung, meanwhile, believes that drugs called nucleoside polymerase inhibitors, which prevent the virus from copying its genome, will be a key ingredient of any future HCV drug cocktail. These compounds set a high barrier for the virus, he notes, and early tests suggest that resistance to them is rare.
Pharmasset, a pharmaceutical firm in Princeton, New Jersey, has several such drugs in development. One called RG7128 is in phase 2 clinical trials and is being developed by Pharmasset together with the Swiss drug giant Roche, based in Basel.
"We used to live in a monochromatic world," says Chung. "Now we realize there are several roads to the same destination."
References
1.Gao, M. et al. Nature 465, 96-100 (2010).
2.Lupberger, J. et al. Nature Med. doi:10.1038/nm.2341 (2011).
Tuesday, March 1, 2011
From CROI: Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions
(Jules Levin of NATAP.org reports on a session at CROI looking at Boceprevir drug interactions. Fortunately, with the notable exception of Efavirenz, it looks like BOC is a pretty clean drug in terms of DDI's)
Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - see attached full slide report
Reported by Jules Levin
CROI – March 1, 2011
Boston, MA
C Kasserra, E Hughes, M Treitel,
S Gupta, and E O'Mara
AUTHOR CONCLUSIONS
•Radiolabeled data support a primarily hepatic-mediated clearance of BOC
•CYP3A4 probes
–Marked ↑ in midazolam exposure in the presence of BOC indicates that BOC is a strong, reversible inhibitor of CYP3A4
–↑ exposure to BOC with ketoconazole suggests involvement of another non–CYP3A4-mediated pathway
•Metabolic inhibitors (even in combination) did not alter BOC PK profile substantially to change BOC’s dose or schedule
–Diflunisal (AKR inhibitor) did not alter BOC exposure
–Ritonavir (CYP 3A4 inhibitor) did not substantively affect exposure to BOC
–Clarithromycin (CYP3A4, P-gp inhibitor) did not affect exposure to BOC
•No dosage adjustment is needed for the coadministration of BOC with tenofovir or peginterferon
•Clinical implications of a ↓ mean BOC trough concentration when coadministered with efavirenz will be clearer as data from coinfected populations are obtained
•Boceprevir did not affect the exposure to drospirenone/ ethinylestradiol in a manner that would be anticipated to reduce contraceptive efficacy
Clinical Pharmacology of Boceprevir: Metabolism, Excretion, and Drug-Drug Interactions - see attached full slide report
Reported by Jules Levin
CROI – March 1, 2011
Boston, MA
C Kasserra, E Hughes, M Treitel,
S Gupta, and E O'Mara
AUTHOR CONCLUSIONS
•Radiolabeled data support a primarily hepatic-mediated clearance of BOC
•CYP3A4 probes
–Marked ↑ in midazolam exposure in the presence of BOC indicates that BOC is a strong, reversible inhibitor of CYP3A4
–↑ exposure to BOC with ketoconazole suggests involvement of another non–CYP3A4-mediated pathway
•Metabolic inhibitors (even in combination) did not alter BOC PK profile substantially to change BOC’s dose or schedule
–Diflunisal (AKR inhibitor) did not alter BOC exposure
–Ritonavir (CYP 3A4 inhibitor) did not substantively affect exposure to BOC
–Clarithromycin (CYP3A4, P-gp inhibitor) did not affect exposure to BOC
•No dosage adjustment is needed for the coadministration of BOC with tenofovir or peginterferon
•Clinical implications of a ↓ mean BOC trough concentration when coadministered with efavirenz will be clearer as data from coinfected populations are obtained
•Boceprevir did not affect the exposure to drospirenone/ ethinylestradiol in a manner that would be anticipated to reduce contraceptive efficacy
Tuesday, February 22, 2011
Antiviral Activity of Boceprevir Monotherapy inTreatment-Naive Subjects With Chronic Hepatitis C Genotype 2/3...
(From the APASL conference in Thailand. Thanks to Jules Levin and NATAP for the info. Looks like higher trough concentrations of BOC may result in better viral suppression of Genotype 2/3.)
"4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA"
Reported by Jules Levin
Presented at the 21st Conference of the Asian Pacific Association for the Study of the Liver; February 17-20, 2011; Bangkok, Thailand.
M. Silva,1 C. Kasserra,2 S. Gupta,2 M. Treitel,2 E. Hughes,3 E. O'Mara2 1Hospital Universitario Austral, Pilar, Argentina; 2Merck Research Laboratories, Kenilworth, NJ, USA;3Former employee of Merck Research Laboratories, Kenilworth, NJ, USA
AUTHOR CONCLUSIONS
· Boceprevir 400 mg TID is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection that is comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study
· Boceprevir trough concentrations in the 400 mg TID group were higher than the other BID groups and may be associated with the better viral responses that were observed
· Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects is of potential clinical interest
· Overall, boceprevir was well tolerated at doses of 200 mg BID, 400 mg BID, and 400 mg TID
ABSTRACT
Aim: To examine the effect of boceprevir, a novel hepatitis C virus (HCV) protease inhibitor, on HCV-RNA levels in subjects with HCV genotype (G) 2/3 infection.
Methods: This was a randomized, placebo-controlled study evaluating the antiviral activity of boceprevir monotherapy 200 mg BID (n = 11), 400 mg BID (n = 12), and 400 mg TID (n = 6) or placebo (n = 10) for 14 days in treatment-naive subjects.
Results: The maximum mean decrease in HCV-RNA was -0.37 log, -0.24 log, -1.60 log and 0.21 log in the 200 mg BID, 400 mg BID, 400 mg TID and placebo groups, respectively. Decreases in HCV-RNA in subjects receiving 200 mg BID and 400 mg BID were similar to placebo; however, the decrease in HCV-RNA in subjects receiving 400 mg TID was markedly different from placebo. At end of treatment, 4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA. Although the sample size was small, responses appeared similar in G2 (n = 9) and G3 (n = 30) subjects. Pharmacokinetic analysis revealed a less than dose proportional increase in bioavailability. Overall, boceprevir was well-tolerated.
Conclusion: Boceprevir (400 mg TID) is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection, comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study. Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects with detectable HCV RNA at week 4 is of potential clinical interest.
"4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA"
Reported by Jules Levin
Presented at the 21st Conference of the Asian Pacific Association for the Study of the Liver; February 17-20, 2011; Bangkok, Thailand.
M. Silva,1 C. Kasserra,2 S. Gupta,2 M. Treitel,2 E. Hughes,3 E. O'Mara2 1Hospital Universitario Austral, Pilar, Argentina; 2Merck Research Laboratories, Kenilworth, NJ, USA;3Former employee of Merck Research Laboratories, Kenilworth, NJ, USA
AUTHOR CONCLUSIONS
· Boceprevir 400 mg TID is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection that is comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study
· Boceprevir trough concentrations in the 400 mg TID group were higher than the other BID groups and may be associated with the better viral responses that were observed
· Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects is of potential clinical interest
· Overall, boceprevir was well tolerated at doses of 200 mg BID, 400 mg BID, and 400 mg TID
ABSTRACT
Aim: To examine the effect of boceprevir, a novel hepatitis C virus (HCV) protease inhibitor, on HCV-RNA levels in subjects with HCV genotype (G) 2/3 infection.
Methods: This was a randomized, placebo-controlled study evaluating the antiviral activity of boceprevir monotherapy 200 mg BID (n = 11), 400 mg BID (n = 12), and 400 mg TID (n = 6) or placebo (n = 10) for 14 days in treatment-naive subjects.
Results: The maximum mean decrease in HCV-RNA was -0.37 log, -0.24 log, -1.60 log and 0.21 log in the 200 mg BID, 400 mg BID, 400 mg TID and placebo groups, respectively. Decreases in HCV-RNA in subjects receiving 200 mg BID and 400 mg BID were similar to placebo; however, the decrease in HCV-RNA in subjects receiving 400 mg TID was markedly different from placebo. At end of treatment, 4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA. Although the sample size was small, responses appeared similar in G2 (n = 9) and G3 (n = 30) subjects. Pharmacokinetic analysis revealed a less than dose proportional increase in bioavailability. Overall, boceprevir was well-tolerated.
Conclusion: Boceprevir (400 mg TID) is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection, comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study. Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects with detectable HCV RNA at week 4 is of potential clinical interest.
Thursday, January 20, 2011
Telaprevir FDA review date set for May 23, 2011.
The FDA review date for Telaprevir has been set for May 23rd of this year. Merck still hasn't stated (as of 1/20/11) exactly when their review is taking place, but there is no shortage of interest in the investment community on who gets to market first. Given the advancing pipelines of the competition who will strive to offer increasingly tolerable drugs with less dosing frequency and perhaps better efficacy, I give both Merck and Vertex a year to a year and one half before HCV treaters start another period of 'watch and wait' - essentially holding patients from treatment who are at low risk for progression of disease - for these new compounds to make it to market.
Thursday January 20, 2011 - 07:30 AM EST
Business Wire News Releases
Released By Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company’s request for six-month Priority Review. Telaprevir is Vertex’s lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s approval decision, which is four months earlier than the standard review time of 10 months.
Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
“Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”
Data to Support the Telaprevir Submissions
The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months – half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
Hepatitis C in the United States
Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 The majority of people with hepatitis C in the U.S. were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 Three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 Each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15
Additional resources for media are available at: http://investors.vrtx.com/press.cfm.
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
(VRTX - GEN)
References:
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
2 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
3 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
4 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
7 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
8 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
9 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed May 25, 2010.
12 Public Health Agency of Canada. Hepatitis C: Get the facts. You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php. Updated September 21, 2010. Accessed January 18, 2011.
13 Public Health Agency of Canada. Modeling the incidence of prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php. Updated October 20, 2010. Accessed January 18, 2011.
14 Public Health Agency of Canada. A renewed public health response to address hepatitis C: A summary report of the priority-setting process and strategic framework to action. http://www.phac-aspc.gc.ca/hepc/sr-rs/pdf/srhepc-eng.pdf. Updated June 2009. Accessed January 2011.
15 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.
Thursday January 20, 2011 - 07:30 AM EST
Business Wire News Releases
Released By Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company’s request for six-month Priority Review. Telaprevir is Vertex’s lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s approval decision, which is four months earlier than the standard review time of 10 months.
Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
“Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”
Data to Support the Telaprevir Submissions
The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months – half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.
Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.
About Telaprevir
Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.
Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10
Hepatitis C in the United States
Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 The majority of people with hepatitis C in the U.S. were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 Three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 Each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15
Additional resources for media are available at: http://investors.vrtx.com/press.cfm.
PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
(VRTX - GEN)
References:
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
2 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
3 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
4 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
7 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
8 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
9 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed May 25, 2010.
12 Public Health Agency of Canada. Hepatitis C: Get the facts. You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php. Updated September 21, 2010. Accessed January 18, 2011.
13 Public Health Agency of Canada. Modeling the incidence of prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php. Updated October 20, 2010. Accessed January 18, 2011.
14 Public Health Agency of Canada. A renewed public health response to address hepatitis C: A summary report of the priority-setting process and strategic framework to action. http://www.phac-aspc.gc.ca/hepc/sr-rs/pdf/srhepc-eng.pdf. Updated June 2009. Accessed January 2011.
15 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.
Monday, December 6, 2010
Achillion To Present Data From Studies Of ACH-1625 In Hepatitis C At Asian Pacific Liver Conference
Achillion To Present Data From Studies Of ACH-1625 In Hepatitis C At Asian Pacific Liver Conference
GlobeNewswire
12/06/10 - 07:00 AM EST
NEW HAVEN, Conn., Dec. 6, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011 in Bangkok, Thailand.
ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The presentation, entitled "Viral Kinetics Modeling of Short-term Monotherapy Data of ACH-1625, an HCV Protease Inhibitor," will be presented by Dr. Atul Agarwal, Senior Director of Computational Chemistry of Achillion. (Abstract A-315-0024-00792.) The presentation describes a mathematical analysis of HCV RNA data collected after oral administration of ACH-1625 in HCV genotype 1 infected subjects. This analysis shows rapid and near complete hepatitis C virus clearance following ACH-1625 administration at all dose levels tested. In addition, mathematical modeling of HCV viral kinetics provided information that allowed for subsequent dose selection for Phase II clinical development of ACH-1625.
"These data support and further demonstrate ACH-1625's robust antiviral activity," said Dr. Agarwal. "With clinical data that demonstrated reductions in viral RNA between 3-4.25 log10, these mathematical data quantitatively show the percentage of total virus cleared after five days of ACH-1625 monotherapy. This data also identifies specific patient population characteristics."
"We are pleased to continue to put forward a large body of scientific and clinical data on ACH-1625," commented Michael D. Kishbauch, Chief Executive Officer of Achillion. "We look forward to completing the current Phase II clinical trial of ACH-1625 to further support its profile as a potential best-in-class protease inhibitor for the treatment of HCV."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies, HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
GlobeNewswire
12/06/10 - 07:00 AM EST
NEW HAVEN, Conn., Dec. 6, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011 in Bangkok, Thailand.
ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The presentation, entitled "Viral Kinetics Modeling of Short-term Monotherapy Data of ACH-1625, an HCV Protease Inhibitor," will be presented by Dr. Atul Agarwal, Senior Director of Computational Chemistry of Achillion. (Abstract A-315-0024-00792.) The presentation describes a mathematical analysis of HCV RNA data collected after oral administration of ACH-1625 in HCV genotype 1 infected subjects. This analysis shows rapid and near complete hepatitis C virus clearance following ACH-1625 administration at all dose levels tested. In addition, mathematical modeling of HCV viral kinetics provided information that allowed for subsequent dose selection for Phase II clinical development of ACH-1625.
"These data support and further demonstrate ACH-1625's robust antiviral activity," said Dr. Agarwal. "With clinical data that demonstrated reductions in viral RNA between 3-4.25 log10, these mathematical data quantitatively show the percentage of total virus cleared after five days of ACH-1625 monotherapy. This data also identifies specific patient population characteristics."
"We are pleased to continue to put forward a large body of scientific and clinical data on ACH-1625," commented Michael D. Kishbauch, Chief Executive Officer of Achillion. "We look forward to completing the current Phase II clinical trial of ACH-1625 to further support its profile as a potential best-in-class protease inhibitor for the treatment of HCV."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies, HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
Friday, November 19, 2010
NEWSMAX.com lists the Top 10 Hepatitis Treatment Centers...
I'm sure Newsmax, being the fair balanced news source it is *cough* has very good intentions with this top 10 list of centers that treat Hepatitis C. However, they don't reveal to us regular folks on what the criteria is to get in the Top 10. Outcomes? Patient satisfaction? quality of clinical research? High-dollar Republican campaign contributions? Anyway, it is what it is - Chris
Hepatitis C: Top 10 Treatment Centers
Tuesday, November 16, 2010 12:00 PM
Hepatitis C is a viral liver disease that may include pain in the liver or abdominal area, and jaundice like symptoms where both the white of the eyes and the skin turn yellow. Hepatitis may cause the urine to appear dark in color while stools appear pale. The disease is also marked by fatigue, confusion, and irritability.
Other symptoms during the onset of the infection include a loss of appetite, diarrhea, nausea, and vomiting. Some chronic Hepatitis C cases have symptoms of sleep disturbance, itchy skin, vomiting blood, hallucination, edema or fluid retention, and swelling of the abdomen, legs, and face.
The top ten treatment centers for Hepatitis C are:
1. Gastroenterology Associates of East Bay Medical Group, Berkeley, California
2. Atlanta Gastroenterology Associates, Atlanta, Georgia
3. Idaho Gastroenterology Associates, Meridian, Idaho
4. Johns Hopkins University, Baltimore, Maryland
5. Carolinas Center for Liver Diseases, Charlotte, North Carolina
6. Baylor University Medical Center, Dallas, Texas
7. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin
8. University of Massachusetts Memorial Medical Center, Worcester, Massachusetts
9. Washington Hospital Center, Washington, District of Columbia
10. University of Miami Center for Liver Diseases, Miami, Florida
Hepatitis C: Top 10 Treatment Centers
Tuesday, November 16, 2010 12:00 PM
Hepatitis C is a viral liver disease that may include pain in the liver or abdominal area, and jaundice like symptoms where both the white of the eyes and the skin turn yellow. Hepatitis may cause the urine to appear dark in color while stools appear pale. The disease is also marked by fatigue, confusion, and irritability.
Other symptoms during the onset of the infection include a loss of appetite, diarrhea, nausea, and vomiting. Some chronic Hepatitis C cases have symptoms of sleep disturbance, itchy skin, vomiting blood, hallucination, edema or fluid retention, and swelling of the abdomen, legs, and face.
The top ten treatment centers for Hepatitis C are:
1. Gastroenterology Associates of East Bay Medical Group, Berkeley, California
2. Atlanta Gastroenterology Associates, Atlanta, Georgia
3. Idaho Gastroenterology Associates, Meridian, Idaho
4. Johns Hopkins University, Baltimore, Maryland
5. Carolinas Center for Liver Diseases, Charlotte, North Carolina
6. Baylor University Medical Center, Dallas, Texas
7. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin
8. University of Massachusetts Memorial Medical Center, Worcester, Massachusetts
9. Washington Hospital Center, Washington, District of Columbia
10. University of Miami Center for Liver Diseases, Miami, Florida
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