INCIVO (telaprevir), (CHMP) of the European Medicines Agency (EMA) recommending approval of hepatitis c drug
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. Telaprevir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and is marketed by Vertex Pharmaceuticals under the brand name INCIVEK[TM]. Following marketing authorization approvals, telaprevir will be marketed in the EU and certain other global territories under the brand name INCIVO by the Janssen Companies.
Any correlation to HCV genotype/viral load,-ALT, AST, ALP, bilirubin, gender,age-to disease progression?
HCV infection may lead to hepatic fibrosis. In this study, we tried to determine whether there is any correlation of HCV genotypes and viral load to the clinical parameters such as ALT, AST, ALP, bilirubin, Hb level, patient's age and gender; and then correlated this association with disease progression in liver biopsy samples
WHO warns of deadly hepatitis spread
The World Health Organisation (WHO) today warned of a rampant epidemic in South and Southeast Asia including Sri Lanka that has already taken more lives than malaria, dengue and HIV/AIDS combined in the past 10 years.
“More than five million people in South and Southeast Asia will die from viral hepatitis over the next decade as experts warn of a rampant epidemic,” the WHO said.The crisis is compounded by lack of awareness about the disease and the increasing resistance of drugs, the World Health Organisation (WHO) says. More than 130 million people from 11 Asian countries carry hepatitis B and C, out of a total of 520 million globally.
A statement released by WHO today said that “seemingly healthy people may be infected, and can continue to spread the infection”, while chronic hepatitis B and C are “among the leading causes of preventable deaths” in Bangladesh, Bhutan, Burma, East Timor, India, Indonesia, Maldives, Nepal, North Korea, Sri Lanka and Thailand.
“These viruses are 30 times more prevalent than HIV in these countries. However, due to the asymptomatic nature of these infections, about 60 percent of infected individuals remain unaware that they are infected, until they show symptoms of cirrhosis or a type of liver cancer called hepatocellular carcinoma; this may take over 20 years. It added that more than half of the total deaths attributed to hepatitis E, which can be contracted by eating or drinking contaminated for or water, occur in this region. Vismita Gupta-Smith, from the WHO’s regional office in India, said that the lack of public awareness meant the organisation was struggling to find accurate data for each country in the region.
“We’re asking national governments to give us all their data and advocating that monitoring [of the spread of hepatitis] should be strengthened,” she said. “We want disease to be on the radar for the general public so that people can go and test themselves.”
Financial Help for Old and New Hepatitis C Drugs
July 21, 2011
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.
The Hepatitis A Virus Loves Summertime
July 20, 2011
Learn more about the Hepatitis A virus and the two summer mainstays in which it can be detected.
Teacher Allows Students to Check Blood Sugar Levels With Same Needle
The education department has been inspecting a case where a primary school teacher had allowed 16 students to check their blood sugar levels using the same needle.
West Australian Department of Education Deputy Director General, David Axworthy was disappointed by the incident and stated that when the department came to know about the blunder committed by the teacher, they called up a meeting for managing the medical issues.
The parents of those 16 children have been advised by the health department to have their children tested for blood-borne viruses like hepatitis B, C and HIV.
Mr. Axworthy stated that the staff members will be advised to be familiar with the Department's HIV/AIDS and hepatitis policy so that they learn about the precautions to be taken at the time of dealing with blood sugar level checks.
"The (education) department has written to parents to notify them that the teacher's actions are being investigated by the department's standards and integrity unit", he said.
The teacher will be questioned about the inappropriateness of his dealings. The enraged parents have asked for the teacher’s dismissal for such a careless act.
Meanwhile, the Police and the Corruption and Crime Commission have also been notified about the incident
Scavenger Cells Accomplices To Viruses
22 July 2011Mucosal epithelia do not have any receptors on the outer membrane for the absorption of viruses like hepatitis C, herpes, the adenovirus or polio, and are thus well-protected against pathogenic germs...
Journal of Viral Hepatitis, Volume 18, Number 8
The liver-cytokine-brain circuit in interferon-based treatment of patients with chronic viral hepatitis
Authors: Stasi, C.; Zignego, A. L.; Laffi, G.; Rosselli, M. Source: Journal of Viral Hepatitis, Volume 18, Number 8, 1 August 2011 , pp. 525-532(8) Publisher: Wiley-Blackwell
Abstract
Summary
Psychiatric symptoms are commonly identified in patients with viral hepatitis. They may have been present prior to the onset of disease and may include symptoms related to addiction issues. Furthermore, the virus and antiviral therapy, in particular interferon, may induce or modify psychiatric symptoms. Recent data support chronic hepatitis C replication in the brain and subsequent changes of cerebral metabolite spectra and magnetic resonance alterations. In chronic viral hepatitis and in other chronic inflammatory diseases, an alteration of the neuro-endocrine-immune system response has been observed. Catecholamines and glucocorticoids modulate this immune/inflammatory reaction. Psychiatric assessment and monitoring before, during and after antiviral therapy can identify patients whose psychiatric symptoms preclude therapy, and those who may benefit from psychopharmacological therapy and counselling, thereby improving therapeutic results. This review will discuss current insights into the complex interplay between cytokines, liver and brain in chronic viral hepatitis closely associated with psychiatric issues, especially in the case of antiviral therapy, with the aim of indicating future research and possible treatments.
Document Type: Review article DOI: 10.1111/j.1365-2893.2010.01418.x Affiliations:1: Department of Internal Medicine, University of Florence, Florence, Italy Publication date: 2011-08-01
Hepatitis B vaccination for health care students lags behind recommendations
Chicago, IL (July 21, 2011)—A study in the August issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America (SHEA), suggests that documentation of hepatitis B vaccination for health care students may fall short of current recommendations.
Researchers led by Dr. Rania Tohme of the Centers for Disease Control and Prevention (CDC) analyzed hepatitis B immunization records of 4,075 health care students who matriculated at a university in the southeastern U.S. between January 2000 and January 2010. The study found that only 59.8 percent of students had documentation of complete vaccination against hepatitis B, and that only 83.8 percent were protected against hepatitis B infection when tested for the presence of hepatitis B antibodies. These rates are lower than the U.S. government's Healthy People 2010 goal of 90 percent hepatitis B vaccination coverage among health care workers.
The study also found that very few students had been vaccinated during childhood according to the CDC and the Advisory Committee for Immunization Practices (ACIP) recommendations in effect at the time. In 1995, CDC and ACIP recommended routine vaccination of previously unvaccinated children aged 11-12 years, and vaccination for all children 18 and under in 1999. However, the majority of students with documented vaccination were only recently vaccinated, either during or a few years prior to matriculation.
CDC and ACIP currently recommend vaccinating all infants at birth, as well as all adolescents and at-risk adults who have not yet received the vaccine. Additionally, all health care workers who may be exposed to blood or blood-contaminated products should be both vaccinated for hepatitis B and tested for antibodies to ensure protection against infection.
Although health care students are exposed during their training to blood-borne pathogens, including hepatitis B, little or no information was available regarding hepatitis B vaccination coverage at matriculation among this group in the United States prior to the publication of this study, the researchers say.
Health care students are at risk of exposure to hepatitis B virus during their training and later during their career. Previous studies have documented frequent needle stick injuries among medical students, with 8 percent of occurrences involving a known hepatitis B carrier. Therefore, vaccination and documentation of protection would help decrease risk of infection.
The researchers caution that these results are limited to one university, and may not be generalizable to other institutions.
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Rania A. Tohme, Bruce Ribner, Michael J. Huey, Philip R. Spradling, "Hepatitis B Vaccination Coverage and Documented Seroprotection among Matriculating Health Care Students at an Academic Institution in the United States." Infection Control and Hospital Epidemiology 32:8 (August 2011).
Infection Control and Hospital Epidemiology provides original, peer-reviewed scientific articles for anyone involved with an infection control or epidemiology program in a hospital or healthcare facility. The journal is ranked in the top 20 Public, Environmental & Occupation Health Journals globally in the latest Journal Citation Reports from Thomson Reuters. It is published by a partnership between The Society of Healthcare Epidemiology of America and The University of Chicago Press.
SHEA is a professional society representing more than 1,900 physicians and other healthcare professionals around the world with expertise in healthcare epidemiology and infection prevention and control. SHEA's mission is to prevent and control healthcare-associated infections and advance the field of healthcare epidemiology. The society leads this field by promoting science and research and providing high-quality education and training in epidemiologic methods and prevention strategies. SHEA upholds the value and critical contributions of healthcare epidemiology to improving patient care and healthcare worker safety in all healthcare settings. www.shea-online.org
Healthy You
Dr. Joe Galati: “Your Health First”, the Radio Program
by Dr. Joe Galati on July 18, 2011
Recorded off my trusty iPad, this is the first segment of Your Health First from this past Sunday evening, July 17, 2011.
Reducing Fever in Children: Safe Use of Acetaminophen
To find out if an over-the-counter medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest. This could be a dangerous mistake. This use of concentrated drops in much larger amounts—as would be given with a teaspoon—can cause fatal overdoses, says Sandra Kweder, M.D., deputy director of the Food and Drug Administration’s Office of New Drugs. You can’t just give an older child more of an infant’s medicine, adds Kweder. “Improper dosing is one of the biggest problems in giving acetaminophen to children.”
Confusion about dosing is partly caused by the availability of different formulas, strengths, and dosage instructions for different ages of children. Sold as a single active ingredient under such brand names as Tylenol, acetaminophen is commonly used to reduce fever and relieve pain. It is also used in combination with other ingredients in products to relieve multiple symptoms, such as cough and cold medicines. Acetaminophen can be found in more than 600 over-the-counter (OTC, or non-prescription) and prescription medicines. Improper dosing is one of the biggest problems in giving acetaminophen to children.
Acetaminophen is generally safe and effective if you follow the directions on the package, but if you give a child even a little more than directed or give more than one medicine that contains acetaminophen, it can cause nausea and vomiting, says Kweder. In some cases—in both adults and children—it can cause liver failure and death. In fact, acetaminophen poisoning is a leading cause of liver failure in the U.S. Advice From Outside Experts An FDA Advisory Panel of outside experts met May 17-18, 2011, to discuss how to minimize medication errors and make children’s OTC medicines that contain acetaminophen safer to use.
The panel recommended: That liquid, chewable, and tablet forms be made in just one strength. Currently, there are seven strengths available for these forms combined. That dosing instructions to reduce fever be developed for children as young as 6 months.
Current instructions apply to children ages 2 to 12 years and for those under 2, only state “consult a doctor.” That dosing instructions be based on weight, not just age. Setting standards for dosing devices, such as spoons and cups, for children’s medicines. Currently, some use milliliters (mL) while others use cubic centimeters (cc) or teaspoons (tsp). “FDA is considering these recommendations,” says Kweder, and for those that the agency adopts, “we will work with manufacturers to try to get them in place on a voluntary basis.” The process of getting a regulation finalized could take several years, she adds, so having the drug industry act voluntarily would help make acetaminophen safer sooner. Drug makers have already agreed to phase out the concentrated infant drops to reduce confusion for parents who try to use them for older children. On May 4, 2011, the Consumer Healthcare Products Association, a trade group representing the makers of OTC medicines, announced plans to convert liquid acetaminophen products for children to just one strength (160 mg/5 mL). In addition, the industry is voluntarily standardizing the unit of measurement “mL” on dosing devices for these products. back to top FDA Acts to Change Prescription Labels Under a 2009 FDA regulation, manufacturers must place the word “acetaminophen” on the front of the package of all OTC products that contain the ingredient and on the “Drug Facts” label on the container and packaging. However, prescription medicines don’t have Drug Facts labels. Instead, the pharmacy places a computer-printed label based on the doctor’s prescription on the container before giving it to the consumer.
Pharmacies often use the acronym “APAP” (N-acetyl-p-aminophenol) or a shortened version of acetaminophen to represent the ingredient. If parents don’t know these abbreviations, they might not recognize that a prescription medicine contains acetaminophen and could accidentally overdose a child by giving a prescription and an OTC acetaminophen medicine at the same time. FDA’s Safe Use Initiative, which fosters collaborations within the health care community to help prevent harm from medications, has been working to bring about the complete spelling of acetaminophen on prescription containers. back to top Tips for Giving Acetaminophen to Children Never give your child more than one medicine containing acetaminophen at a time. To find out if an OTC medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” For prescription pain relievers, ask the pharmacist if the medicine contains acetaminophen. Choose the right OTC medicine based on your child’s weight and age. The “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child’s weight or age is not listed on the label or you can’t tell how much to give, ask your pharmacist or doctor what to do. Never give more of an acetaminophen-containing medicine than directed. If the medicine doesn’t help your child feel better, talk to your doctor, nurse, or pharmacist.
If the medicine is a liquid, use the measuring tool that comes with the medicine—not a kitchen spoon. Keep a daily record of the medicines you give to your child. Share this information with anyone who is helping care for your child. If your child swallows too much acetaminophen, get medical help right away, even if your child doesn’t feel sick. For immediate help, call the 24-hour Poison Control Center at 800-222-1222, or call 911. This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. July 21, 2011
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
USDA Proposes Changes for Meat Additive Labeling
Meat producers would have to clearly specify which additives are added to raw meats and poultry under a rule proposed by the U.S. Department of Agriculture.
The department "wants consumers to know when there's less chicken in their chicken," reported the Associated Press.
Additives such as chicken broth, teriyaki sauce, salt or water would have to appear on the product's label. The department said about 33 percent of raw poultry, 15 percent of raw beef and 90 percent of raw pork may contain additives. Ground beef would be exempt from the new rule, the wire service reported.
Current labels aren't as visible or clear as the USDA would hope. The new rule would require that additives be part of the product's title, as in "Chicken Breast - 40 Percent Added Solution of Water and Teriyaki Sauce," the AP said.
Reaction among manufacturers was mixed. A spokesman for the National Chicken Council said his industry is divided on the issue. The American Meat Institute called the proposal "wasteful," noting it would lead to a rise in meat prices, the AP reported.
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FDA Evaluating Some Osteoporosis Drugs for Possible Cancer Link
Studies on oral bisphosphonate drugs used to treat osteoporosis are being reviewed by the U.S. Food and Drug Administration, which is investigating whether there's a link between the bone-disease medicines and an increased risk of esophageal cancer, the agency said Thursday.
The FDA, citing "conflicting findings" from past studies, said it hasn't found proof of a link between the drugs and esophageal cancer. But the agency said in a news release that it would "continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available."
The U.S. National Institutes of Health says more than 40 million women in the United States have osteoporosis "or are at high risk due to low bone mass."
People taking a bisphosphonate who develop symptoms including "swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing" should contact a physician, the FDA advised. Candidates for these drugs also should speak with a doctor "about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them," the agency added.
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Gay Men With HIV at Increased Risk of Hepatitis C
While it's considered rare to acquire the hepatitis C virus via sexual intercourse, a new study finds that gay men infected with HIV who have unprotected sex are at increased risk of transmitting hepatitis C, the U.S. Centers for Disease Control and Prevention said Thursday, citing a new study.
In the agency's Morbidity and Mortality Weekly Report, CDC researchers working with scientists from the Mount Sinai School of Medicine said they uncovered "substantial evidence" of hepatitis C transmission during unprotected gay sex. Hepatitis C primarily is transmitted through exposure to blood and by drug users who share needles.
The researchers said that between 2005 and 2010, they found 74 men infected with HIV -- the virus that causes AIDS -- who had documented new infection with hepatitis C. These men reported no other risk factor for hepatitis C infection.
But when compared with other gay men who were HIV-positive but hadn't contracted hepatitis C, the men with recent hepatitis C infection were 23 times more likely than the other group to have had unprotected anal sex, the study found.
"The good news," wrote the researchers, "is that the cure rate for new [hepatitis C] infection is very high with early treatment, but without regular testing of the men at risk, these largely asymptomatic infections may be missed."
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Fewer Americans See Smoking as Risky: Survey
Fewer Americans perceived a serious risk from smoking a pack of cigarettes a day in 2008-2009 than they did in 2007-2008, a nationwide survey by the U.S. Substance Abuse and Mental Health Services Administration released Thursday found.
The percentage of people who perceived a serious smoking risk dropped from 73.7 percent to 72.3 percent among all survey participants. Teens showed an even greater drop in perceived smoking risk during the span, from 69.3 percent in 2007-2008 to 67.7 percent in 2008-2009, the survey found. No state posted in an increase in the perceived risk of smoking, an agency news release said.
The National Survey on Drug Use and Health interviewed more than 137,000 people during 2008-2009. Among the report's additional findings:
No state reported an increase in illicit drug use between 2002-2003 and 2008-2009. Among people aged 12 to 17, illicit drug use fell in 17 states during the period.
The 10 states and the District of Columbia that had the highest rates of illicit drug use during the prior month among people 12 and older also led the nation in marijuana use during the same period. In alphabetical order, those locales were: Alaska, Colorado, District of Columbia, Hawaii, Maine, Massachusetts, New Hampshire, Oregon, Rhode Island and Vermont.
Between 2007-2008 and 2008-2009, 11 states showed declines in cocaine use among people 12 and older.
Rhode Island led the United States in terms of the number of people age 18 and older with serious mental illness (7.2 percent), while Hawaii and South Dakota shared the lowest rate (3.5 percent).
Off The Cuff
Pure gets disinfectant label expansion
Thursday, July 21, 2011 at 9:52 a.m.
Federal regulators approved expansion of the list of organisms killed by its Hard Surface disinfectant appearing on the product's label.
The new label, which was reviewed by the Environmental Protection Agency, will include Hepatitis B, Hepatitis C and several drug-resistant bacteria, the El Cajon company said. It also will note that the disinfectant kills many viruses in as little as 30 seconds after contact and the Hepatitis viruses within a minute.
The label will continue to claim that the product kills HIV, the virus that causes AIDS, in 30 seconds.
Those claims meet federal guidelines for controlling blood-borne pathogens in hospitals and other medical facilities, the company said.
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