WASHINGTON -- The FDA's professional staff believes the investigational hepatitis C drug boceprevir (Victrelis) is effective and reasonably safe, according to a briefing document made public in advance of a Wednesday advisory committee meeting.
But before the agency approves the drug, it wants the panel's views on certain marketing claims that the drug's manufacturer, Merck, is proposing to make. These include the drug's efficacy in patients with "null" responses to the standard regimen of pegylated interferon and ribavirin as well as the benefits of so-called response-guided therapy.
The Antiviral Drugs Advisory Committee will also be asked to review risks of anemia and other hematologic abnormalities associated with boceprevir.The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during a two-day meeting this week. The other is telaprevir -- no brand name has been proposed as yet -- which will have its day on Thursday.
The two drugs would be the first HCV protease inhibitors to reach the market. They have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
These data suggest that adding one of the drugs to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates.
For example, among treatment-naive patients in one of the boceprevir trials, 40% of a control group receiving the conventional regimen had a sustained response versus about 70% of patients with the protease inhibitor added.
A separate trial in patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round, whereas approximately 60% did with the addition of boceprevir.
In the briefing paper prepared for Wednesday's panel meeting, the FDA staff reviewers could find little to fault in these data.
But they did question Merck's arguments in favor of "response-guided therapy," particularly in African-American patients and raised concerns about the drug's hematologic side effects.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on viral responses after eight and 24 weeks.
In particular, Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the FDA staff reviewers pointed to data in one of the trials indicating a slightly lower sustained-response rate in previous treatment failures receiving the response-guided therapy compared with fixed-duration treatment (59% versus 66%).
They also noted that black participants in a study of treatment-naive patients also had a lower sustained-response rate with response-guided therapy (42% versus 53%).
"The 11% numerical difference ... is of some concern and will be an issue for discussion," the briefing paper said.
Another issue is whether a proposed indication for patients who completely failed previous peginterferon-ribavirin therapy is justified, considering that such patients were excluded from trials of previously treated patients.
Merck is arguing that its major trial in treatment-naive patients included null responders, identified as those with negligible responses during the lead-in with standard therapy, and the drug's efficacy in this population can be gauged from those results.
However, the FDA reviewers indicated that responses at week four do not perfectly predict who will ultimately respond. The lack of a trial designed expressly to test the drug in null responders "raises questions about using [standard therapy] lead-in responses as a surrogate," they wrote in the briefing document.
About a quarter of the briefing document was devoted to boceprevir's adverse hematologic effects, primarily anemia but also including neutropenia and thrombocytopenia.
In the drug's two main phase III trials, half the patients taking the drug had nadir hemoglobin values of 10 g/dL or below and more than 40% required erythropoietin therapy -- with both rates about twice those seen in the control groups.
The other hematologic effects were far less common, but still a potential concern, according the briefing document.
Counting all cases, the incidence of neutropenia was about the same with or without boceprevir, but the drug was associated with a greater rate of serious cases. Eight of 1,057 patients taking the drug discontinued the study because of neutropenia compared with none in the control groups.
Similarly, severe thrombocytopenia was seen in 15 boceprevir-treated patients compared with three control patients.
The FDA plans to ask the advisory panel to comment on these adverse events, as well as to discuss postmarketing studies that Merck should conduct if the product is approved.
The only formal voting issue, however, is whether "the available data support approval" of boceprevir for treating HCV genotype 1 in combination with peginterferon and ribavirin.
FDA says Merck drug successfully fights hepatitis
Federal health officials said Monday a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have been used for 20 years. The agency has questions about how the drug should be combined with older medicines for the maximum effect.
The Food and Drug Administration posted its review of Merck & Co. Inc.'s boceprevir ahead of a public meeting Wednesday to consider whether to approve the medication. The meeting comes after more than 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S
STI watch: myths about Hepatitis C
Posted on 26 April 2011
Hepatitis means inflammation of the liver. Hepatitis C virus (HCV) causes damage to the liver and this can lead to cirrhosis, (scarring of the liver), and eventually liver failure and death.
Some popular misconceptions about hepatitis C are:
• Hepatitis C is incurable. Wrong: hepatitis C can be curable. Currently there is effective antiretroviral treatment for hepatitis C, but it is highly dependent on the subtype of the virus (genotype), the health of your liver and how well you cope with treatment.
• Once you’ve had hepatitis C you can’t catch it again. This is incorrect: even if you clear the virus, you can be re-infected with a different genotype of hepatitis C.
• Only guys who do drugs can get Hepatitis C. Not true: there is increasing evidence that hepatitis C can be passed on during sex – and especially where blood is involved (e.g. fisting, toys, S&M or longer, harder fucking sessions).
info: Information on hepatitis C and STIs is available at www.thedramadownunder.info or www.wrappedorraw.org.au; or for Hepatitis Australia www.hepatitisaustralia.com.au
Frequency Distribution of HCV genotypes among Chronic Hepatitis C Patients of Khyber Pakhtunkhwa
Hepatitis C Virus (HCV) genotypes frequency is important for the predication of response to therapy and duration of treatment. Despite variable response rates experienced in the case of Interferon (IFN) -based therapies, there was scarcity of data on HCV genotypes frequency in Khyber Pakhtunkhwa (KPK).Study DesignA total of 200 blood samples were collected from chronic HCV patients prior to the initiation of anti-viral therapy.
The study population included patients from 6 districts of KPK. Active HCV infection was confirmed in case of all the patients by real time PCR.
HCV genotypes were determined in each case by Type-specific PCR.
Results: The analysis revealed that out of 200 PCR positive samples; 78 (39%) were 2a, 62 (31%) were 3a, 16 (8%) were 3b, 34 (17%) were untypable while 1a, 2b and 1b were 3 (1.5%), 2 (1%) and 5 (2.5%), respectively.
Conclusion: Genotype determination is not carried out prior to therapy in KPK. Although, the abundantly prevalent types (2a and 3a) of HCV in KPK are susceptible to combination therapy, yet resistance experienced in some of the chronic HCV patients may partly be attributed to the prevalence of less prevalent resistant genotypes (1a,1b) of HCV among the population.
Author: Sajid AliIjaz AliSadiq AzamBashir Ahmad
Credits/Source: Virology Journal 2011, 8:193
Compass and Arecor to Develop Heat-Stable Hepatitis B Vaccine
Compass Biotechnologies is acquiring a worldwide exclusive license to U.K. firm Arecor’s drug stabilization technology Arestat™, initially for the development of a heat stable hepatitis B vaccine that can be stored at room temperature. The vaccine will be developed by Compass’ C-Pharma subsidiary, which is focused on developing hepatitis products. The firm will in addition look at the potential for developing heat stable formulations of other products.
Compass says studies with the Arestat-formulated hepatitis B vaccine have demonstrated that the product retains greater than 70% potency when stored at 37oC, and is just as effective after 12 months of storage at 37oC as after storage at refrigeration temperatures. In contrast, the firm notes, a commercially available heptatitis B vaccine lost its effectiveness completely and demonstrated a 100-fold drop in antihepatitis B titer when stored at 37oC.
Arestat is essentially a set of formulation tools to address the principal pathways of degradation that lead to the loss of drug structural integrity and biological activity, Arecor explains. The three resulting technologies utilize FDA- and EMEA-approved buffers and excipients to achieve the desired stability. Arestat-T™ has been developed to stabilize biologics during storage at refrigerated, ambient ,or elevated temperatures. Arestat-C™ allows the stabilization of proteins, particularly antibodies, at high concentrations. Arestat-R™ is used to stabilize biologics exposed to ionizing radiation (e.g., gamma radiation). Arestat can be readily incorporated into standard manufacturing practice, without covalent modification of the biological, using excipients approved for the route of delivery, Arecor adds.
From HCV Advocate;
Maintaining Your Disability Claim,
by Jacques Chambers, CLU
Whether you are receiving disability benefits from Social Security, from private disability insurance, or from both, your medical condition will be periodically reviewed to see if you remain eligible to receive benefits, i.e., whether or not you still meet the plan’s definition of disability and are entitled to have your benefits continued.
Top 10 HCV Downloads of the Month
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Healthy You
What’s So Special About Blueberries?
Newswise — Recently a study out of the Texas Women’s University looked at whether blueberries with their high polyphenol content could help in fighting obesity. Blueberries after all have already been cited as having positive health effects on other conditions like cardiovascular disease and metabolic syndrome. The study was conducted in Petri dishes (not live animals) using a blueberry polyphenol extract and tissue cultures from mice. On the surface the findings look positive. The purpose was to examine the effect that the polyphenol in blueberries had in counteracting the development of fat cells. The result was a 73 percent reduction in the number of fat cells using the highest dose and a 27 percent reduction with the smallest dose. Positive but, what does this actually mean?
“I wanted to see if using blueberry polyphenols could inhibit obesity at a molecular level. We still need to test this dose in humans to make sure there are no adverse effects and to see if the doses are as effective.
Determining the best dose for humans will be important. The promise is there for blueberries to help reduce adipose tissue from forming in the body,” says Shiwani Moghe the head researcher for the study.
“This sounds like the basis for a new drug development company instead of encouraging people to shop the produce section of their local supermarket,” say co-authors Dian Griesel, Ph.D. and Tom Griesel. In their new book, TurboCharged: Accelerate Your Fat Burning Metabolism, Get Lean Fast and Leave Diet and Exercise Rules in the Dust (BSH, 2011), the Griesel’s point out that anyone can become lean and healthy and that fruits and veggies are one of the essentials.
“Take a look at the 25 highest known polyphenol rich foods and you will see that the list is almost entirely fruits, vegetables, nuts and seeds. These are the same “natural” foods we have consumed for tens of thousands of years. French scientists have identified 452 foods and 502 different types of polyphenols. Odds are they all play an important part in our health in one way or another,” according to Tom Griesel.
A Spanish scientist working at the institute of Food Research in Norwich looked at apples, peaches and nectarines. She found that the non-extractable polyphenol content is up to five times higher in the actual fruit than the extractable compounds. “The extracted compounds are obtained by treating with acid to obtain them from the cell walls of the fruit in the lab,” according to Sara Arranz of the Spanish Council of Scientific Research (CSIC) in Madrid.
“If non-extracted polyphenols are not considered, the levels of beneficial polyphenols such as proanthocyanidins, ellagic acid and catchin are substantially underestimated.” The Spanish research group has been working to show that non-extractable polyphenols, which generally are not considered in analysis and nutritional studies, are a major part of the bioactive compounds in a healthy diet.
Polyphenols might also work with fibers like pectin and have a positive effect in large intestine accessibility. Dr. Paul Kroon explains “In the human body, these compounds will be fermented by bacteria in the colon, creating metabolites that may be beneficial, for example with antioxidant activity.”
What this all means according to Dian Griesel, who has worked with cutting edge biotechnology and drug development companies for the past 15 years is that, “Fruits, vegetables, nuts and seeds are best consumed in their natural unadultered form as designed and the way they have been consumed for tens of thousands of years during our evolution. It’s not smart to fool with Mother Nature.”
“Consuming a variety of fresh fruits, vegetables, nuts, seeds and many spices will help maintain high levels of polyphenols in your body and blood stream all day long. Foods with rich colors are usually the best and contain the highest amounts of all known polyphenols and antioxidants. Even tea, coffee, red wine and chocolate have been shown to have high levels of polyphenols,” says Tom.
“Another key is to avoid dietary sources that increase free radicals and destroy the beneficial properties of polyphenols like deep fried foods, processed and over cooked or chemically treated meats like luncheon cuts and bacon. In addition, your body will use up antioxidant polyphenols much faster if you are under stress which makes a regularly practiced stress reduction technique essential, “says Dian.
The Griesels conclude: “Do not wait for any conclusion or recommendation of these ‘scientific’ studies. For ideal health, fresh fruits and vegetables are ideal foods. They are naturally high in all known and unknown polyphenols and antioxidants. Eat plenty of fruits, vegetables, nuts and seeds daily and no additional drugs or ‘extract’ supplements are required to maintain optimal health.”
To purchase a copy of TurboCharged, please visit: www.amazon.com/dp/1936705001
NAPLES, Fla., April 26, 2011 /PRNewswire/ -- With April marking National Alcohol Awareness Month, Caroline J. Cederquist, M.D. shares new evidence that shows America's alcohol consumption is contributing to the nation's growing obesity epidemic.
"Alcoholic beverages give us a fake sense of feeling full," says Dr. Cederquist. "Scientific studies show that when we drink alcoholic beverages, this fluid intake typically isn't sufficient to trigger production of the hormones that alert the brain that you are full. This is called 'satiety' and most of us use it as a trigger to stop eating."
Caroline J. Cederquist, M.D. is a board-certified bariatric physician, and the founding physician behind BistroMD, the number one physician-designed, chef-prepared diet meal delivery program in the nation.
"As a physician who specializes in the field of weight management, I work with many patients in regards to alcohol consumption, and the negative impact it can have on their diet," says Dr. Cederquist.
Due to their high carbonation and dehydrating effects, alcoholic beverages give us a bloated feeling that can be mistaken for feeling full. When we strictly drink alcohol without eating a nutritious meal, our bodies take in empty calories, which prevents our metabolism from getting the energy it needs to burn excess stored fat.
"What most people don't realize is that alcohol keeps the liver busy, because it immediately begins working to detoxify the body of alcohol," says Dr. Cederquist. "When the liver is occupied, fat breakdown and weight loss come to a halt. Additionally, alcohol only provides empty calories, as it lacks protein and vitamins that you get from food. If your body is not getting the appropriate balance of essential nutrients from food, then your metabolism won't be able to break down this fat, and you will keep gaining weight."
Beer alone is a $47 billion a year industry, and with many people turning to alcohol for comfort in stressful economic times, the rise in alcohol sales has contributed to the increase of overweight Americans.
"With recent spikes in alcohol sales, it is no surprise that there have also been increases in statistics of overweight Americans, as well as those suffering from obesity and other health-related conditions," says Dr. Cederquist.
In recognition of National Alcohol Awareness Month, it's important that you are aware of the negative effects alcohol can have on your diet.
"If you are going to drink, do so in moderation, which means an average of one to two drinks per day for men, and one drink per day for women," says Dr. Cederquist. "It's also important to make sure that you eat a well-balanced meal that has quality lean protein like chicken or fish, but still contains a good combination of vegetables and complex carbohydrates and other nutrients, before you start drinking. This will still fuel your metabolism, without ruining your weight loss progress."
To learn more about the healthy weight loss meals developed for BistroMD by Caroline J. Cederquist, M.D., please visit: http://www.bistromd.com, or call: (866) 401-DIET.
Facebook: http://www.facebook.com/pages/BistroMD/330994205482
Twitter: http://twitter.com/bistromd
Watch and subscribe to our YouTube channel: http://www.youtube.com/user/BistroMD?feature=mhum
BistroMD is a leader in gourmet diet delivery offering home delivery of physician-designed, chef-prepared meals as well as free dietitian support to help customers reach their goals. For more information, go to http://www.BistroMD.com, or call (866) 401-DIET.
Contact: Amanda Paul
Phone: (239) 514-0700
Email: amanda@bistromd.com
This press release was issued through eReleases(R). For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.
Caroline J. Cederquist, M.D. is a board-certified bariatric physician, and the founding physician behind BistroMD, the number one physician-designed, chef-prepared diet meal delivery program in the nation.
"As a physician who specializes in the field of weight management, I work with many patients in regards to alcohol consumption, and the negative impact it can have on their diet," says Dr. Cederquist.
Due to their high carbonation and dehydrating effects, alcoholic beverages give us a bloated feeling that can be mistaken for feeling full. When we strictly drink alcohol without eating a nutritious meal, our bodies take in empty calories, which prevents our metabolism from getting the energy it needs to burn excess stored fat.
"What most people don't realize is that alcohol keeps the liver busy, because it immediately begins working to detoxify the body of alcohol," says Dr. Cederquist. "When the liver is occupied, fat breakdown and weight loss come to a halt. Additionally, alcohol only provides empty calories, as it lacks protein and vitamins that you get from food. If your body is not getting the appropriate balance of essential nutrients from food, then your metabolism won't be able to break down this fat, and you will keep gaining weight."
Beer alone is a $47 billion a year industry, and with many people turning to alcohol for comfort in stressful economic times, the rise in alcohol sales has contributed to the increase of overweight Americans.
"With recent spikes in alcohol sales, it is no surprise that there have also been increases in statistics of overweight Americans, as well as those suffering from obesity and other health-related conditions," says Dr. Cederquist.
In recognition of National Alcohol Awareness Month, it's important that you are aware of the negative effects alcohol can have on your diet.
"If you are going to drink, do so in moderation, which means an average of one to two drinks per day for men, and one drink per day for women," says Dr. Cederquist. "It's also important to make sure that you eat a well-balanced meal that has quality lean protein like chicken or fish, but still contains a good combination of vegetables and complex carbohydrates and other nutrients, before you start drinking. This will still fuel your metabolism, without ruining your weight loss progress."
To learn more about the healthy weight loss meals developed for BistroMD by Caroline J. Cederquist, M.D., please visit: http://www.bistromd.com, or call: (866) 401-DIET.
Facebook: http://www.facebook.com/pages/BistroMD/330994205482
Twitter: http://twitter.com/bistromd
Watch and subscribe to our YouTube channel: http://www.youtube.com/user/BistroMD?feature=mhum
BistroMD is a leader in gourmet diet delivery offering home delivery of physician-designed, chef-prepared meals as well as free dietitian support to help customers reach their goals. For more information, go to http://www.BistroMD.com, or call (866) 401-DIET.
Contact: Amanda Paul
Phone: (239) 514-0700
Email: amanda@bistromd.com
This press release was issued through eReleases(R). For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.
Pharmaceuticals
Johnson & Johnson Turns Its Back On AIDS Patients ?
The ongoing refusal by Johnson & Johnson to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and offering lower prices in poor countries, has now generated a scolding from Doctors Without Borders, the international humanitarian organization.
Complementary Medicine / Alternative Medicine
Herbal Medicines: 'Natural' Doesn't Always Mean Safe, Says Royal Pharmaceutical Society
26 April 2011
A new EU Directive on herbal medicines comes into force on 1 May which introduces a registration scheme governing the quality and safety of herbal products making medicinal claims for their use...
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Off The Cuff
FTC freezes fake news on acai berries
On the NPR "Shots" blog, Scott Hensley reports: "This Just In: Fake News Is No Way To Sell Acai Berries." Excerpt:
"Some marketers of weight-loss products containing acai berries are also purveyors of news you shouldn't use, the Federal Trade Commission says.
The FTC has asked federal courts to put a stop to the activities of 10 different outfits that the commission alleges use "fake news websites" to tout acai berry weight-loss products.
Chances are you've stumbled across the sites, which often sport the logos of major mainstream news organizations, such as ABC, CNN and Consumer Reports. (See this example posted by the FTC.)
Take, for example, the FTC's complaint against Beony International LLC, a company based in San Diego.
The company allegedly ran sites with names such as "News 6 News Alerts," "Health News Health Alerts," and "Health 6 Beat Health News." The sites feature purportedly objective investigative reports of acai products by reporters, who supposedly tried the stuff "and experienced dramatic and positive results."..(To View Video)Click here.
India: Medical Tourism in the Superbug Age
Shobha John(The Times of India, April 17, 2011)"Currently, India receives more than 100,000 foreign patients a year. The Confederation of Indian Industry expects the sector to grow to $2 billion by 2012. But might the NDM-1 gene cause a thriving growth industry to sicken and die? Doctors and those who administer India's leading private hospitals say the sector is stronger than that…NDM-1 would have to get a lot more scary before it could challenge India's biggest selling point -- low-cost medical care."
The Failure of the Genome
Opinion
Jonathan Latham, executive director of the Bioscience Resource Project(The Guardian, London, online, April 17, 2011)"[T]he human genome was sequenced...10 years ago...Among all the genetic findings for common illnesses, such as heart disease, cancer and mental illnesses, only a handful are of genuine significance for human health. Faulty genes rarely cause, or even mildly predispose us, to disease, and as a consequence the science of human genetics is in deep crisis…The most likely explanation for why genes for common diseases have not been found is that, with few exceptions, they do not exist…A much better use of that money would be to ask: if inherited genes are not to blame for our commonest illnesses, can we find out what is?"
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