Research & Treatment News
July 29, 2011
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Just like any drug, the two newly approved medications for Hepatitis C have side effects.
by Nicole Cutler, L.Ac.
With the addition of two new medicines approved by the FDA in May 2011, significant progress against chronic Hepatitis C has officially been made. For many years, the standard treatment for this prevalent, infectious virus has been subpar. Hovering at just a 50 percent success rate, Hepatitis C combination therapy is a gamble - with grueling side effects that often prevent people from completing treatment. Adding one of the two new drugs to the Hepatitis C arsenal has greatly increased the likelihood of wiping out this virus. However, the side effects accompanying these new medications could make treatment even more of a challenge than standard combination therapy.
Both of the new Hepatitis C drugs, Victrelis (boceprevir) and Incivek (telaprevir) are explicitly for use in conjunction with the current combination of pegylated interferon and ribavirin. Thus, any side effects occurring with Victrelis or Incivek are in addition to the side effects seen with the previous standard treatment regimen.
Pegylated Interferon and Ribavirin Side Effects
Used to treat Hepatitis C for decades, interferon and ribavirin have been improved upon to enhance their effectiveness at treating chronic Hepatitis C infection. Now, treatment typically includes pegylated interferon (a form that enables it to stay in the bloodstream longer) and weight-based ribavirin (allowing for higher, more effective doses for heavier recipients). These changes have increased combination therapy's ability to eliminate Hepatitis C from more people, but have done little to ease these drugs' side effects.
Often emulating flu-like symptoms that can be severe enough to halt treatment, the most common side effects of pegylated interferon and ribavirin include fatigue, headache, myalgia, fever, arthralgia, nausea, anorexia, diarrhea, depression, irritability, insomnia, itching, rash, hair loss, anemia, cough and shortness of breath.
Incivek and Victrelis
Both Victrelis and Incivek boost the chances that Hepatitis C treatment will result in a sustained viral response (SVR), the closest measurement currently available to a Hepatitis C cure. Both of these new drugs target the Hepatitis C protease enzyme, making it nearly impossible for the virus to replicate. Although the virus quickly becomes resistant to either drug used alone, combination therapy with pegylated interferon and ribavirin prevents drug resistance.
Standard treatment with pegylated interferon and ribavirin lasts 48 weeks, yet results in an SVR for fewer than half of patients. As shown in clinical trials, adding Incivek or Victrelis to this regimen boosted SVR rates 20 to 45 percent more than the standard treatment in about half the time (24 weeks). Thus, while Incivek or Victrelis may add to the side effects that must be endured, they typically need to be tolerated for less time than a regimen consisting solely of interferon and ribavirin.
The most common side effects are similar between the two drugs, with some being potentially serious:
1. Incivek - Skin rashes (possibly severe), anemia (possibly severe), itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and fatigue.
2. Victrelis - Fatigue, anemia (possibly severe), low white blood cell count, headaches, nausea and taste changes.
Incivek and Victrelis have not yet been evaluated side-by-side, so there is no evidence yet of which is more effective or which one causes more deleterious side effects.
As with any newly released drug, many questions remain as to the long-term safety profiles of these medications. Regardless of whether tackling HIV, Hepatitis C, cancer or the flu, a greater number of drugs taken equals a greater potential for side effects. Unfortunately, Incivek and Victrelis are not exempt from this natural law. We are hoping that the benefits of these protease enzyme inhibitors overpower their faults so that more people can triumph over chronic Hepatitis C - in spite of any side effects these drugs may cause.
References:
http://www.aidsbeacon.com/news/2011/04/30/new-drugs-for-hepatitis-c-part-2-boceprevir-and-telaprevir-dosing-regimens-and-side-effects/, New Drugs For Hepatitis C: Part 2 - Boceprevir And Telaprevir Dosing Regimens And Side Effects, Courtney McQueen, Retrieved July 24, 2011, Light Knowledge Resources, 2011.
http://www.drugs.com/victrelis.html, Victrelis, Retrieved July 24, 2011, Drugs.com, 2011.
http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp, Interferon and Ribavirin Treatment Side Effects, Retrieved July 24, 2011, US Department of Veteran Affairs, 2011.
http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf, Victrelis, Retrieved July 24, 2011, Merck & Co., Inc., 2011.
http://www.rxlist.com/incivek-drug.htm, Incivek, Retrieved July 24, 2011, RxList, Inc., 2011.
http://www.vrtx.com/current-projects/approved-medicines/incivek.html, Incivek ™, Retrieved July 24, 2011, Vertex, 2011.
http://www.webmd.com/hepatitis/news/20110525/new-hepatitis-c-drug-incivek-gets-fda-approval, New Hepatitis C Drug Incivek Gets FDA Approval, Daniel J. DeNoon, Retrieved July 24, 2011, WebMD, LLC, 2011.
Posted by Editors at 12:06 PM --- Printer-friendly version
July 25, 2011
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Representing the European Union's first approved Hepatitis C drug in a decade, Victrelis (boceprevir) can now be used in Europe to battle the most persistent strain of this prevalent liver virus.
VICTRELIS(TM) (boceprevir), First-in-Class Oral Hepatitis C Virus Protease Inhibitor, Approved in the European Union for Treatment of Chronic Hepatitis C
WHITEHOUSE STATION, N.J., Jul 18, 2011 (BUSINESS WIRE) -- Merck MRK -0.64% , known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved VICTRELIS(TM)(boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated 4 million people in Europe.
The European Commission's Decision grants a single marketing authorisation that is valid in the 27 countries that are members of the European Union (EU), as well as unified labeling applicable to the European Economic Area members, Iceland, Liechtenstein and Norway.
Continue reading this entire article:
http://www.marketwatch.com/story/victrelistm-boceprevir-first-in-class-oral-hepatitis-c-virus-protease-inhibitor-approved-in-the-european-union-for-treatment-of-chronic-hepatitis-c-2011-07-18?reflink=MW_news_stmp
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July 22, 2011
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In an Italian study of people co-infected with HIV and Hepatitis C, taking Maraviroc helped reduce liver stiffness.
Maraviroc improves liver fibrosis in HIV/hepatitis C co-infected patients
by Michael Carter
July 20, 2011
Treatment with maraviroc is associated with the regression of liver fibrosis in HIV-positive patients co-infected with hepatitis C, a small randomised study presented to the Sixth International AIDS Society conference in Rome shows.
Investigators from the University of Brescia in Italy believe that the beneficial impact of maraviroc (Celsentri) was due to its inhibition of CCR5.
Continue reading this entire article:
http://www.aidsmap.com/page/1882378/
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In a Phase 2b study with pegylated interferon and ribavirin, Pharmasset's PSI-7977 had a 100 percent success rate against Hepatitis C genotypes 2 and 3.
Pharmasset Announces Final SVR Data from PROTON trial with PSI-7977 in Subjects Infected with Hepatitis C Infection Genotype 2 or 3
-- 24 out of 24 subjects with HCV genotype 2 or 3 achieved an SVR after 12 weeks of treatment with PSI-7977 400mg QD and pegylated interferon and ribavirin
-- SVR12 results from PROTON in HCV genotype 1 subjects are expected in second half of 2011
PRINCETON, N.J., July 20, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the final sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 2 or 3 who have not been treated previously. Twenty four out of twenty four subjects (100%) who completed treatment achieved an SVR, defined as HCV RNA below the limit of detection (<15 IU/ml) 24 weeks after the completion of treatment. No subject exhibited breakthrough on treatment or relapse after treatment.
Continue reading this entire article:
http://www.prnewswire.com/news-releases/pharmasset-announces-final-svr-data-from-proton-trial-with-psi-7977-in-subjects-infected-with-hepatitis-c-infection-genotype-2-or-3-125877113.html
Posted by Editors at 10:56 AM --- Printer-friendly version
July 21, 2011
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For the estimated 60 million Americans without health insurance, the Hepatitis C drug companies have programs in place to finance the cost of antiviral medications.
by Nicole Cutler, L.Ac.
People with Hepatitis C should not automatically assume they are priced out of this illness's notoriously expensive treatment. Unfortunately, too many people let pride get in the way of what could be, like their improved health. Especially for those with chronic Hepatitis C who don't have health insurance, it is important to recognize that there are various financial programs available to reduce the monetary burden of treatment - and there is no shame involved in getting this help.
The financial depression that has taken hold for the past few years has changed the way many people manage their money. For some that means giving up what most think to be luxury items; for others that translates into giving up on what a majority deem to be necessities. Letting go of a vacation home may seem like a major sacrifice to those on the upper range of the economic scale. However, a growing number of Americans with middle and lower portion earnings have had to forfeit a relative essential in our society - the security of health insurance. For those who find themselves without a health insurer to pick up their medical expense tab, needed care is often dismissed as a luxury not obtainable to them. Fortunately, people with chronic Hepatitis C have several options available to finance the immense cost of antiviral medications.
An unprecedented number of American adults under the age of 64 do not have any health insurance. This might be a result of:
• losing a job
• having an employer who can no longer offer health benefits
• the rising costs of health insurance coverage
The U.S. Centers for Disease Control estimate that nearly 60 million Americans are uninsured - many of whom belong to the "middle class." From 2006 to 2009, the number of adults aged 18 to 64 years old without health insurance increased by an average of about 1.1 million per year.
About half of the total increase in the uninsured (550,000 people) occurred among those with family incomes two to three times more than the federal poverty level. In fact, this government survey found that individuals without health insurance were seven times more likely than those with health insurance to forgo needed health care. Unfortunately, these statistics mean that at the very least, tens of thousands of Americans with Hepatitis C don't have health insurance and can't afford medical treatment. At least that is what uninsured people with Hepatitis C might mistakenly assume.
The key to getting Hepatitis C treatment without health insurance is twofold; let go of the idea that you are asking for a handout AND commit to the extra paperwork necessary. Costing anywhere from several thousand to several hundred thousand dollars, Hepatitis C drugs are expensive. Interestingly, the same drug can have a dramatically different price for different buyers. Costs can differ greatly depending on the country dispensing it and the financial status of the patient. Thankfully, the medications approved for Hepatitis C treatment in the U.S. are connected with a compassionate care or financial assistance program.
In order to provide free or low cost medicines to those who qualify, patient assistance programs were created by the pharmaceutical industry. Besides helping with medication costs, patient assistance programs may offer other services, such as a 24-hour on-call nurse, motivational information to help patients adhere to their medications and tips on side-effect management. To find out if you qualify for an assistance program, you can visit the Partnership for Prescription Assistance website at www.pparx.org or call 1-888-477-2669.
For help specifically with Hepatitis C medications, you can also contact the companies directly:
• Roche:1-877-734-2797 - The manufacturers of Pegasys plus Copegus have the Pegassist Patient Assistance Foundation.
• Schering:1-800-521-7157 -The manufacturers of PegIntron plus Rebetol have the Commitment to Care program.
• Vertex: 855-837-8394 - The manufacturer of the recently approved Hepatitis C drug Incivek, has the Vertex Free Medicine Program. This program will provide telaprevir (Incivek) at no cost to people who do not have insurance, are not covered by other benefits programs, and have an annual household income of $100,000 or less.
• Merck: 866-363-6379 - The manufacturer of the recently approved Hepatitis C drug boceprevir (Victrelis) also has a Patient Assistance Program. This program covers boceprevir, PegIntron, and Rebetol (the company's brand of ribavirin) for low-income people who do not have private insurance and are not covered by any other benefits programs.
Managing chronic Hepatitis C is hard enough, so don't let the financial burden of treatment interfere with your prognosis. Regardless of how you have weathered today's economic climate, a lack of health coverage or money needn't prevent you from battling Hepatitis C. If pegylated interferon, ribavirin, telaprevir or boceprevir are warranted and financial help is needed, take advantage of the programs in place. By doing so, you have a better chance of being freed from the Hepatitis C virus - without having to climb the economic ladder.
References:
http://www.economicpopulist.org/content/26-americans-do-not-have-health-insurance, 26% of Americans Do not have Health Insurance, Robert Oak, Retrieved June 19, 2011, Economic Populist, 2011.
http://www.hcvadvocate.org/hepatitis/factsheets_pdf/PAP.pdf, Patient Assistance Programs, Retrieved June 19, 2011, Hepatitis C Support Project, 2011.
http://www.hivandhepatitis.com/hep_c/news/2011/0531_2011_a.html, Boceprevir (Victrelis) Patient Assistance Program, Retrieved June 19, 2011, hivandhepatitis.com, 2011.
http://www.hivandhepatitis.com/hep_c/news/2011/0531_2011_b.html, Telaprevir (Incivek) Patient Assistance Program, Retrieved June 19, 2011, hivandhepatitis.com, 2011.
http://www.insuranceproviders.com/how-many-americans-have-health-insurance/, How many Americans have health insurance?, Retrieved June 19, 2011, Insurance Providers, 2011.
Posted by Editors at 10:23 AM --- Printer-friendly version
July 20, 2011
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Learn more about the Hepatitis A virus and the two summer mainstays in which it can be detected.
by Nicole Cutler, L.Ac.
As one of five known hepatitis viruses that infect the liver, Hepatitis A is the only common food-borne disease preventable by vaccine. For those who have not yet been vaccinated against this virus, the summer season harbors two risks that increase the likelihood of Hepatitis A transmission.
About Hepatitis A
Hepatitis A is a contagious illness that travels in feces, and can spread from person to person, or can be contracted from food or water. Although not everyone experiences them, symptoms of Hepatitis A typically appear one month after infection and include:
• Fever
• Weakness and fatigue
• Muscle aches and headache
• Low appetite
• Nausea and/or vomiting
• Stomach cramps
• Diarrhea
• Dark urine
• Jaundice - yellow skin and eyes
Some facts about the Hepatitis A virus include:
• The incubation period (the time from initial exposure to the virus to the onset of symptoms) ranges from 15 to 60 days.
• About half of those infected never show signs of the illness, but they can still spread the Hepatitis A virus.
• Only a blood test can confirm a Hepatitis A diagnosis.
• Those who have had Hepatitis A acquire lifelong immunity to the virus.
• An infected person can spread the virus for 1 to 2 weeks before symptoms start and up to 10 days after jaundice.
• An infected person may potentially shed Hepatitis A viral particles for almost a month.
• Aside from bed rest and over-the-counter medicines, no specific treatment for Hepatitis A is usually required.
• While Hepatitis B and C can turn into chronic hepatitis, Hepatitis A is generally self-limiting. However, complications (especially if someone already has a different type of liver ailment) can and do occur.
Two Summer-Related Causes of Hepatitis A
Mostly transmitted by person-to-person contact through fecal contamination, Hepatitis A is known to stem from contaminated food and water. The disease spreads when it enters the mouth of a person who has not had Hepatitis A before or is not immunized against Hepatitis A. Two sources prevalent in the summer that allow the virus to gain entrance into the mouth are cold foods and public pools.
1. Cold Foods - Infected food handlers may carry the virus on their hands and contaminate foods if they do not use good hand washing practices after every restroom visit and they have bare-hand contact with food. Since cold foods are not cooked, a viral particle transferred from contaminated hands to the food can survive.
Cold cuts and sandwiches, fruits and fruit juices, milk and milk products, vegetables, salads, shellfish and iced drinks are commonly implicated in Hepatitis A outbreaks. All of these foods are cold - a temperature that most of us prefer during the heat of summer. Some of the most refreshing consumables that cool us off - water, raw shellfish and salads - are the most frequent sources of Hepatitis A infection.
2. Public Pools - A favorite summertime activity, swimming carries a small risk of Hepatitis A exposure. Especially problematic when large numbers of people congregate without adequate sanitation, Hepatitis A infection can occur by swallowing pool water containing feces.
Hepatitis A is easily spread by raw sewage, thus it can become a danger in a recreational swimming environment when a person accidentally has a bowel movement in the pool or if heavy rainfall or flooding infects pool water with an overburdened sewage system. For more detailed information about Hepatitis A from a pool, read Hepatitis Transmission and Swimming Pools.
By all means, summer should be enjoyable! Luckily, exposure to contaminated food or water is not a problem if the person has Hepatitis A immunity - attainable through either previous Hepatitis A infection or receipt of the Hepatitis A vaccination. Make certain that your summer is not ruined by confirming your immunity to the Hepatitis A virus, and feel confident cooling off with a tall glass of ice tea and a fresh salad at your local pool.
References:
http://jced.jocogov.org/food_safety/safety/fs_hepatitis.htm, Hepatitis A and Food Handlers, Retrieved July 17, 2011, Johnson County Environmental Department, 2011.
http://www.defendingfoodsafety.com/food-safety-law/common-food-borne-pathogens/hepatitis-a/, Hepatitis A Fact Sheet, Retrieved July 17, 2011, Gass Weber Mullins, LLC, 2011.
http://www.fda.gov/Food/FoodSafety/FoodborneIllness/FoodborneIllnessFoodbornePathogensNaturalToxins/BadBugBook/ucm071294.htm, Bad Bug Book: Hepatitis A Virus, Retrieved July 17, 2011, US Department of Health and Human Services, 2011.
http://www.fmi.org/foodsafety/HepatitisAGuide.pdf, Hepatitis A Information Guide, Retrieved July 17, 2011, Food Marketing Institute, 2011.
http://www.foodborneillness.com/hepatitis_food_poisoning/, Hepatitis A, Retrieved July 17, 2011, OutBreak, Inc., 2011.
http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/hepatitisa.html, Hepatitis A, Retrieved July 17, 2011, US Department of Health and Human Services, 2011.
http://www.hepatitis-central.com/mt/archives/2007/08/is_hepatitis_tr.html, Hepatitis Transmission and Swimming Pools, Nicole Cutler, L.Ac., Retrieved July 17, 2011, Hepatitis Central, 2011.
Posted by Editors at 3:57 PM --- Printer-friendly version
July 13, 2011
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Hoping to simplify and improve Hepatitis C treatment, Achillion is testing several proprietary compounds - including the recent start of a Phase 1 trial to assess ACH-2684.
Achillion Pharmaceuticals Inc. (ACHN) Begins Dosing for Hepatitis C Treatment, Prepares for Clinical Milestones
By QualityStocks | July 12, 2011
Achillion Pharmaceuticals Inc., focused on developing treatments for infectious disease, today announced it has begun dosing in a phase 1 clinical trial of ACH-2684 for the treatment of chronic hepatitis C virus (HCV) infection.
The study is a randomized, double-blind, placebo-controlled trial designed to determine the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684, and will include up to 78 healthy volunteers and up to 40 HCV-infected patients.
"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans," Elizabeth A. Olek, D.O., vice president and chief medical officer of Achillion stated in the press release. "It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development."
Continue reading this entire article:
http://hken.ibtimes.com/articles/177911/20110712/achillion-pharmaceuticals-inc-achn-begins-dosing-for-hepatitistreatment-prepares-for-clinical-milest.htm
Posted by Editors at 10:18 AM --- Printer-friendly version
July 12, 2011
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New research reveals more factors than previously recognized that can raise the risk of relapsing after Hepatitis C treatment.
by Nicole Cutler, L.Ac.
One of the reasons we desperately need better treatments for Hepatitis C is because many who initially respond to treatment relapse. By recognizing which individuals are more likely to have a Hepatitis C relapse, healthcare practitioners may be able to make useful adjustments to their treatment protocol. For those most susceptible to a relapse, such an adjustment might improve their odds of remaining free of Hepatitis C.
About Hepatitis C Relapse
Often used to describe a recurrence of an autoimmune disease or return to a substance abuse disorder, the term relapse can be confusing. Technically, relapse is the act of falling or sliding back into a former state, regressing after partial recovery from illness or backsliding.
During the course of Hepatitis C therapy, there are various times when a person's response to his or her medications is measured. By looking for RNA (genetic material) from the virus, this measurement determines if the drugs are defeating Hepatitis C. Unfortunately, a good percentage of people show an initial response to the Hepatitis C drug treatment only for the viral particles to resurface later.
A Hepatitis C relapse does not necessarily mean that a person achieved sustained virologic response - the inability to detect Hepatitis C RNA six months after treatment completion. In reality, the number of people who relapse after attaining sustained virologic response is very low. More commonly, a Hepatitis C relapse is regarded when individuals achieve an end-of-therapy response (an undetectable level of Hepatitis C RNA at the conclusion of therapy) and then the virus returns.
The Research Identifying Who Is Relapse Prone
Due to its potentially severe side effects, persevering through Hepatitis C therapy is quite a feat. This is especially true for those with genotypes 1 and 4, since they must complete a full 48 weeks of treatment. For those who are lucky enough to achieve an end-of-therapy response, there is still another hurdle to go. An estimated 30 percent of people who achieve an end-of-therapy response will relapse. For these people who have their Hepatitis C virus return, the factors rendering them more susceptible was relatively unknown until French researchers presented their study.
At the 2010 American Association for the Study of Liver Diseases "Liver Meeting" in Boston, interesting research by Christiane Stern and colleagues from Beaujon Hospital in Clichy, France was presented. The research team determined what variables made someone more likely to relapse after receiving the standard Hepatitis C treatment consisting of pegylated interferon and ribavirin.
The researchers followed 249 previously untreated chronic Hepatitis C patients who were given pegylated interferon alfa-2a (Pegasys) or pegylated interferon alfa-2b (PegIntron) plus weight-adjusted ribavirin. As is the norm, patients with genotypes 2 or 3 were treated for 24 weeks, while those with genotypes 1 or 4 were treated for 48 weeks. Several factors were found to play a role in higher rates of relapse in participants who achieved an end-of-therapy response. The factors that seemed to increase the risk of relapse include:
1. Being infected with Hepatitis C genotype 1
2. Having a significant amount of liver steatosis
3. Receiving a reduced dose of pegylated interferon
4. Being obese
5. Being menopausal
Several of these factors come as no surprise to the Hepatitis C community; genotype 1 is notoriously stubborn, greater steatosis is known to hinder treatment and interferon dose reductions have repeatedly led to lowered treatment success rates. However, knowing that obesity and menopause also contribute to Hepatitis C relapse gives practitioners new information.
Whether lengthening treatment time, increasing drug dosages or adding another medication to Hepatitis C therapy, modifying antiviral treatment for obese or menopausal patients could help these more vulnerable individuals avoid a relapse.
References:
http://hepatitisdoctor.com/, Hepatitis Doctor Home, Retrieved December 26, 2010, Bennet Cecil, MD, 2010.
http://www.hcvadvocate.org/hcsp/articles/Keeffe-3.html, Management of Hepatitis C Treatment Failure, Emmet B. Keefe, MD, Retrieved December 26, 2010, Hepatitis C Support Project, 2010.
http://www.hivandhepatitis.com/2010_conference/aasld/docs/1210_2010_b.html, Menopause and Obesity Linked to HCV Relapse after Interferon-based Treatment, Liz Highleyman, Retrieved December 25, 2010, hivandhepatitis.com, 2010.
http://www.natap.org/2010/AASLD/AASLD_91.htm, Steatosis, Obesity, Peg-IFN Dose Reduction & Menopause are Associated with Relapse in Chronic Hepatitis C Patients Treated with Pegylated Interferon Plus Ribavirin, Jules Levin, Retrieved December 25, 2010, AASLD 61th Annual Meeting of the American Association for the Study of Liver Diseases, 2010.
http://www.thefreedictionary.com/relapse, Relapse, Retrieved December 26, 2010, Farlex, Inc., 2010.
Posted by Editors at 10:04 AM --- Printer-friendly version
July 11, 2011
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In a newly released action plan, eight strategies are outlined by the U.S. Department of Health and Human Services to battle our nation's viral hepatitis epidemic.
by Nicole Cutler, L.Ac.
Known as the silent epidemic, there is a pronounced lack of symptoms associated with most types of hepatitis. As such, a majority of Americans are unaware that they have viral hepatitis - and the health danger that puts them in. Thankfully, after several reports indicating the need for a public health campaign on viral hepatitis, the U.S. Department of Health and Human Services has acknowledged this omission and has outlined a plan for improving viral hepatitis awareness, prevention, diagnosis and treatment.
The Silent Epidemic
Viral hepatitis can be compared to a buried minefield, full of live explosives that could be unearthed at any moment. People may not know they exist, but the minefields are primed to blow. Despite being a leading infectious cause of death, viral hepatitis remains virtually unknown to:
• the general public
• at-risk populations
• policymakers
• some healthcare providers
Regrettably, most of the estimated four to five million Americans living with some form of viral hepatitis do not know they are infected. This ignorance places these individuals at an alarmingly high risk of passing their illness on to others and to developing severe or even fatal complications.
Some of the facts demonstrating the scope of this problem include:
• According to the U.S. Department of Health and Human Services, up to 75 percent of those infected with viral hepatitis are unaware of their infection.
• Usually caused by the Hepatitis B or the Hepatitis C virus, viral hepatitis is a leading cause of liver cirrhosis and liver cancer in the United States.
• Viral hepatitis is the leading cause of liver transplantation in the United States.
• In the absence of treatment, an estimated 15 to 40 percent of those with viral hepatitis are expected to develop serious liver disease, such as cirrhosis or cancer in the next 10 years.
• A 2007 survey of almost 200 primary care providers found that more than half could not identify laboratory markers of chronic Hepatitis B.
Policymaker Recognition
The new initiative announced by the U.S. Department of Health likely gained momentum from a 2010 Institute of Medicine study finding that Hepatitis B and C are not widely recognized as serious public health problems. The investigators in this Institute of Medicine study found that there was a great need to increase viral hepatitis awareness, to improve surveillance for Hepatitis B and Hepatitis C and to better integrate how viral hepatitis is addressed. As is the case with most demands to improve our quality of life, all of these needs require adequate resources to come to fruition.
In a statement by the U.S. Centers for Disease Control director Thomas R. Frieden, "Far too many Americans are unaware of the serious impact of viral hepatitis and the devastating consequences that can result from leaving it untreated. The time for action is now."
The 2011 Action Plan
As outlined in the 2011 U.S. Department of Health and Human Services Action Plan for the Prevention, Care & Treatment of Viral Hepatitis, the following goals were set:
• Increase the percentage of patients infected with Hepatitis B who are aware of their disease status from one-third to two-thirds by the year 2020.
• Increase the percentage of patients infected with Hepatitis C who are aware of their disease status from 45 percent to 66 percent by the year 2020.
• Decrease the number of new cases of Hepatitis C by 25 percent by the year 2020.
• Eliminate the transmission of Hepatitis B from mothers to infants by the year 2020.
Eight strategies to reduce the burden of viral hepatitis were outlined in the U.S. Department of Health and Human Services initiative. They include:
1. Ensuring that infected individuals are identified earlier in the disease course.
2. Improving testing infrastructure to increase early diagnosis.
3. Improving provider education about screening, diagnostic tests and up-to-date treatments.
4. Increasing the utilization of health information technology to ensure that those infected receive timely referrals and supportive care.
5. Providing comprehensive hepatitis education and prevention programs to the public.
6. Setting up monitoring systems to determine the adequacy of testing and treatment programs, and to ensure that disparities in care are removed.
7. Providing post-exposure Hepatitis B prophylaxis to all neonates born to infected mothers.
8. Achieving universal Hepatitis A and B vaccination among vulnerable populations.
According to Health Resources and Services Administrator Mary K. Wakefield, RN, PhD, "This action plan is our best chance at stopping the disease with increased access to information and quality care for those at risk and those who are already infected."
Allocation of our nation's resources is essential for making the Viral Hepatitis Action Plan successful. The U.S. Department of Health and Human Resources is banking on policy-related support brought about by the Affordable Care Act. Wherever the funding for these eight important strategies is found, this initiative represents the most serious and comprehensive attempt to tackle the viral hepatitis epidemic - our best hope for disarming the minefields waiting to wreck havoc on the livers of millions of Americans.
References:
http://www.hepatitis-central.com/mt/archives/2010/05/hepatitis_aware.html, Hepatitis Awareness Needed!, Nicole Cutler, L.Ac., Retrieved May 29, 2011, Hepatitis
Central, 2011.
http://www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf, Combating the Silent Epidemic of Viral Hepatitis, Retrieved May 29, 2011, US Department of Health and Human Services, 2011.
http://www.medpagetoday.com/InfectiousDisease/Hepatitis/26472, HHS Launches Action Plan to Target Hepatitis, Nancy Walsh, Retrieved May 29, 2011, Everyday Health, Inc., 2011.
Posted by Editors at 11:43 AM --- Printer-friendly version
July 8, 2011
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Focusing on an all-oral treatment, Pharmasset and Tibotec are working together to simplify and improve Hepatitis C treatment.
Pharmasset inks collaborative deal with J&J unit to develop hep C combo drug
July 6, 2011 by Brad Lemaire
Pharmasset (NASDAQ:VRUS) reported Wednesday it signed a collaboration agreement with pharmaceutical company Tibotec, a Johnson & Johnson (NYSE:JNJ) unit, to conduct clinical trials to develop an all-oral treatment for hepatitis C.
The study, which is slated to begin later this year, will assess the potential of Pharmasset's drug PSI-7977, in combination with Tibotec's TMC435, to achieve "sustained virologic response" 12 weeks post treatment, in patients infected with hepatitis C.
Princeton, New Jersey-based Pharmasset said the trial will also assess the safety and effects after 12 and 24 weeks of the combined treatment. Some patients will also take ribavirin in addition to PSI-7977 and TMC435.
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http://www.proactiveinvestors.com/companies/news/16090/pharmasset-inks-collaborative-deal-with-jj-unit-to-develop-hep-c-combo-drug-16090.html
Posted by Editors at 11:48 AM --- Printer-friendly version
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Striving to create a preventative Hepatitis C vaccine, a European project will focus on nanogels.
Innovative vaccines with nanotechnology
European Research Consortium wants to develop novel vaccination against hepatitis C
Public release date: 1-Jul-2011
HCVAX is a European joint project that reaches out to develop a vaccine against hepatitis C based on nanotechnology. The German Helmholtz Centre for Infection Research (Helmholtz-Zentrum für Infektionsforschung, HZI) in Braunschweig and its department "Vaccinology and Applied Microbiology" is now a part of the transnational consortium with researchers from Germany, France and Switzerland.
More than 170 million people are infected with the hepatitis C virus (HCV) worldwide. Also in Europe this form of hepatitis is a big problem with three per cent of the population affected. The virus is transmitted in operations such as transplantations or by the re-use of syringes for drug usage. Anti-viral treatments are very expensive, have serious side effects and are only effective for some patients. Most of the patients carry the infection for the rest of their lives, with the threat of later developing liver cirrhosis and cancer. Certainly, the most effective way to combat hepatitis C would be a vaccine against the virus - but to date no efficacious vaccine exists.
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http://www.eurekalert.org/pub_releases/2011-07/haog-ivw070111.php
Contact: Dr. Bastian Dornbach
bastian.dornbach@helmholtz-hzi.de
49-531-618-11407
Helmholtz Association of German Research Centres
Posted by Editors at 11:44 AM --- Printer-friendly version
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Boasting several benefits over the currently approved Hepatitis C drugs, Medivir's TMC435 has been granted fast track status by the FDA. Additionally, TMC435 will partake in a new trial to assess its validity within an interferon-free regimen.
Medivir: TMC435 has Received Fast Track Designation from the FDA and TMC435 will be studied in combination with Pharmasset's PSI-7977 for HCV genotype-1
HUDDINGE, Sweden, Jul 06, 2011 (BUSINESS WIRE) -- Regulatory News:
Medivir AB (sto:MVIRB)(omx:MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases.
Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the treatment of chronic hepatitis C (CHC) genotype-1 infection. This is based on TMC435's potential to address unmet medical needs in the treatment of CHC infection compared to currently approved therapies.
TMC435 may offer:
-- High sustained virological response (SVR) rates in genotype-1 HCV-infected patients, including hard-to-treat subgroups
-- Short treatment duration
-- Favorable overall safety and tolerability profile
-- A convenient once-daily (q.d.) dosing regimen
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http://www.marketwatch.com/story/medivir-tmc435-has-received-fast-track-designation-from-the-fda-and-tmc435-will-be-studied-in-combination-with-pharmassets-psi-7977-for-hcv-genotype-1-2011-07-06?reflink=MW_news_stmp
Posted by Editors at 9:25 AM --- Printer-friendly version
