- File Under HCV News
A Cure For Hepatitis C-The Pharmaceutical Companies and Us
This review covers the newly approved HCV protease inhibitors boceprevir and telaprevir, along with the promise of interferon free therapies.
Hepatitis C-Telaprevir: A Novel NS3/4 Protease Inhibitor
We evaluated the literature on telaprevir, a new, oral, covalent, reversible NS3/4A HCV protease inhibitor. A MEDLINE search (January 1996–July 2011) was performed to identify relevant clinical trials, and abstracts from hepatology and human immunodeficiency virus (HIV) conferences were reviewed. In large clinical trials, the addition of telaprevir to peginterferon and ribavirin resulted in high sustained virologic response rates in both treatment-naive and treatment-experienced patients infected with HCV genotype 1. Clinical data with telaprevir in the HIV-HCV coinfected population are emerging, as well as data on potential drug-drug interactions with this agent. Preliminary data describe the resistance profile of telaprevir; however, more information is needed in this evolving area. Telaprevir's most common adverse events included rash, pruritis, and anemia. Based on available data, this new anti-HCV drug will likely be widely used and may revolutionize the treatment of HCV-infected individuals.
In The News
“They said well, there’s something on your liver,” she said.
That something was a tumor. Her cancer had spread to her liver. Normally, that’s not a good thing.
"So in her case she was--I don't know if she would want to use the word lucky, but she was lucky that it was contained,” said James Park, MD, University of Washington Medical Center.
Contained means the tumor is still small and hasn't spread farther so doctors can operate.
In Cheryl's case they plan on removing part of the left lobe - about 20 percent of her liver - which should grow back within weeks. They'll also be using a new technique.
"The incision for removing this part of the liver would be something on the order of just below your breast bone to your belly button and the incision required to do this procedure is about an inch in size,” said Dr. Park.
That's because of a device called the Davinci Robot. Dr. Park is the first surgeon in the Pacific Northwest to use the robot for what’s called a liver resection. Not only is the incision smaller. Recovery is quicker......
MORE INFORMATION UWMC Liver Tumor Clinic
da Vinci Surgical System used for precise minimally invasive surgery.
Drug Company Stated in Document Filed with the FDA the Increase in Hepatitis C Outbreaks is Attributed to the 50mL and 100mL Infusion Vials of the Sedative Propofol
LAS VEGAS, Oct. 26, 2011 /PRNewswire/ -- This is being released by SCM:
Mainor Eglet Attorneys Robert Adams, Artemus Ham and Robert Eglet on behalf of plaintiffs Joanne Allen and Kenneth G. Allen, and William Bilger Jr., began opening statements in the fourth hepatitis C trial in Clark County District Court in Las Vegas, Nevada before Judge Jerry Weiss.
During opening statements lead trial attorney Rob
ert Eglet stated that in a document filed with the FDA by the drug company, the increase in outbreaks is attributed to the 50mL and 100mL vials of Propofol and that a 20mL vial is sufficient and the most commonly used vial and does not present the same opportunity for reuse. Further, there is no safety issue associated with the 20mL pre-filled syringes. According to Eglet, "In spite of what they told the FDA, production of the 20mL pre-filled syringes of Propofol was halted and the drug company continued to produce, market and distribute 50mL vials to the endoscopy centers because profit dictated the choice to produce the larger vials in spite of the knowledge that the 20mL vials were safer."....
IDSA: Boceprevir Plus Peginterferon/Ribavirin for the Treatment of HCV/HIV Co-Infected Patients
Slides-Late Breaker Oral Abstract LB-37
Infectious Diseases Society of America (IDSA) 49th Annual Meeting Boston MA
October 22nd, 2011
Screening inventories to detect depression in chronic hepatitis C patients
To settle the best cutoffs for inventories to diagnose depression in chronic hepatitis C (CHC) patients.
Seventy-five CHC patients were assessed using a standard psychiatric interview (Mini International Neuropsychiatric Interview) to establish Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) major depression diagnosis and the following inventories: the Beck Depression Inventory (BDI), its short form for Primary Care (BDI-PC) and the Hospital Anxiety and Depression Subscale for Depression (HAD-D). According to the receiver operative characteristic (ROC) curve, the best cutoff to screen for depression was settled, and sensitivity, specificity, and positive and negative predictive values were calculated. Agreement between each inventory and the diagnosis of depression was calculated through Cohen's Kappa. Internal consistency was measured through Cronbach's alpha.
Twenty-one (28%) individuals met criteria for a depressive disorder. BDI, BDI-PC and HAD-D best scores were settled at 18, 5 and 8 points, respectively. They showed the following discriminative properties: sensitivity 81%, 76.2%, 85.7%; specificity 92.6%, 88.9%, 77.8%; positive predictive value 81%, 72.7%, 60%; negative predictive value 92.6%, 90.6%, 93.3%, respectively. ROC curve areas were similar between BDI and BDI-PC, but slightly lower for HAD-D. The agreement between inventories and DSM-IV depression diagnosis was substantial for BDI (0.91) and BDI-PC (0.91) and moderate for HAD-D (0.86). Internal consistency was 0.90, 0.86 and 0.75, respectively.
BDI, BDI-PC and HAD-D showed good discriminative properties to screen for depression in CHC patients and should be considered in clinical practice.
Should federal authorities be able to close medical marijuana dispensaries in California?
According to the Controlled Substances Act, marijuana is a Schedule I drug, placing it among narcotics like heroin, DMT, and Ecstasy in the country's most serious drug classification. Still, research has suggested that compounds found within marijuana may have therapeutic use in treating ailments like multiple sclerosis, hepatitis C, Parkinson's disease, and even cancer. The FDA's official stance on the medical efficacy of marijuana states: "Marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision."
The story of medical marijuana in the United States began in 1978, when Robert Randall was arrested for using marijuana to treat his glaucoma. Randall sued the United States and won, and the ruling required the FDA to provide Randall with marijuana for medicinal use. Since then, 16 states and the District of Columbia have approved marijuana or marijuana-derived substances for medicinal use. In states like California and Colorado, marijuana can be purchased at state-sanctioned dispensaries, and this business has become the epicenter of a national dialogue because growing, selling, and purchasing marijuana remain decidedly illegal under federal law.
Two rulings since 2001, United States v. Oakland Cannabis Buyers' Cooperative and Gonzales v. Raich, reaffirmed the federal government's commitment to prosecuting buyers and sellers in states where marijuana has been approved for medical use. Yet, in the early days of the Obama administration, the Department of Justice announced that federal prosecutors would not target dispensaries that obey state laws. In California, subsequent lack of regulation caused the multiplication of dispensaries. On October 7, the four U.S. attorneys for the state of California announced plans to shut down large-scale, for-profit dispensaries in the state, alleging that they do not comply with state regulations.
Should federal authorities be able to close medical marijuana dispensaries in California? Here is Debate Club's take: Join The Debate
Illegal HIV test kits imported from China for sale online could give an incorrect diagnosis, a Government health watchdog warned today.
The Medicines and Healthcare Products Regulatory Agency (MHRA) plans to shut down six websites based in the UK which have sold kits without the necessary CE quality mark.
The websites also sold non-compliant testing devices for other sexually transmitted infections, including hepatitis, gonorrhoea, chlamydia and syphilis.
Almost 500 people have already bought the kits, which allow users to test themselves for infection in their own homes.
People have been browsing the internet to buy the products as an anonymous alternative to being tested in a clinic.
Some of the kits came with no instructions at all, while others were confusing or insufficient.
The Health Protection Agency (HPA) has written to people who have bought the kits, warning them that they do not comply with UK guidelines.
The purchase details were contained in sales records uncovered during the MHRA investigation.
The agency regularly scans the internet to catch websites selling illegal devices.
In order to comply with EU rules, kits must carry the CE kite mark and the name and address of the manufacturer or an EU-based representative.
It is illegal in the UK to sell any kits to test for HIV, but not for other sexually transmitted infections.
The HPA stressed that free and confidential tests are available on the NHS.
Susanne Ludgate, the MHRA's clinical director of services, said: "As far as self-test kits for sexually transmitted infections are concerned, purchasers should check that any kits purchased from internet sites are CE marked, which should denote conformity with the relevant European legislation.
"We're concerned that there may be a number of self-test kits being sold online that may not be compliant with the relevant piece of legislation and we're urging people not to consider the internet as a method of anonymous testing.
"These kits may be unreliable and there is a significant risk they could be providing the user with a false result."
Dr Fortune Ncube, a consultant epidemiologist at the HPA, said: "The HPA has sent letters to members of the public across the UK who are known to have purchased these kits online to inform them that the result may be unreliable."
:: Anyone worried about a self-test kit they bought online can contact their GP, pharmacist or sexual health clinic for advice, or email devices.compliancemhra.gsi.gov.uk.
UPDATE 2-US advisers recommend diabetics get Hep B vaccine
* Diabetics under 60 "should" get vaccine
* People with diabetes likelier to get infected with Hep B
By Alina Selyukh
Oct 25 (Reuters) - U.S. vaccine advisers on Tuesday voted to recommend vaccination against Hepatitis B for adults with diabetes under the age of 60, and said people older than 60 may get the vaccine.
The Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention, voted 12-2 to include diabetics in the high-risk group of unvaccinated adults that should get vaccinated.
It is the first time the panel made a Hepatitis B vaccine recommendation for people with diabetes, after studies showed those under the age of 60 were more than twice as likely to get infected than people without diabetes.
Studies found no observed significant increase of Hepatitis B in diabetics over the age of 60, researchers said in a presentation on Tuesday.
Hepatitis B is a serious disease that can turn chronic and lead to liver damage or cancer. People infected with the virus can spread it to others through contact with blood or other body fluids even if they show no symptoms. Although there is no cure, the disease can be prevented with a vaccine.
The CDC has recommended routine Hepatitis B vaccination for children and adolescents since 1991. The recommendation also applies to unvaccinated adults at risk of getting infected, such as people with chronic liver or kidney disease, men who have sex with men, people with more than one sex partner or those whose jobs expose them to human blood.
If the CDC follows its advisers' recommendation, that list will be expanded to include people with diabetes under the age of 60. For older diabetics, the panel allowed flexibility for consultation with doctors on the need for the vaccine.
The vote on Hep B followed the panel's recommendation on Tuesday that boys should be vaccinated with Merck & Co's Gardasil against human papillomavirus.
Merck also makes one of the two Hepatitis B vaccines available in the United States, Recombivax. GlaxoSmithKline makes the other, Engerix-B. Dynavax Technologies Corp's has another Hepatitis B vaccine targeted at adults, Heplisav, in clinical trial.
People with diabetes have been the focus of Hepatitis B vaccination discussions for several years, as studies started pointing to their increased likelihood of having the virus, generally acquired through blood glucose monitoring.
The test involves puncturing skin to get a drop of blood to put on a strip of a device that gives a reading. Any lapse in sterility, such as several people being tested using the same device or supplies, can increase risk of exposure to infected blood.
Younger people are more responsive to the vaccination, the effectiveness of which could wane over time, researchers said. Earlier vaccinations may also start protecting newly-diagnosed patients sooner, as studies find two-thirds of diabetes diagnoses have been made by age 60.
The cost of immunization versus gained benefits also quadruples from people in their forties to people in their fifties, but then it leaps almost six-fold for people over 60.
Bearing in mind that healthcare law makes the panel's recommendations binding for insurance coverage, members voted for age-specific Hepatitis B recommendations with the caveat that they could further detail them later to ensure vaccinations were covered for those who needed them regardless of age.
If I Had Red Eye
Dr. James Farmer, Assistant Professor of Ophthalmology at Queens University, talks about the common conditions that can cause a red eye and their treatment.
The most popular piece in the New York Times today is an Op-Ed published on Monday by Jennifer Ackerman, “How Not to Fight Colds.” It’s an interesting piece and points out something that a lot of people probably don’t know—it’s the immune system, not the virus itself, that causes the cold’s nasty symptoms. But in my opinion, Ackerman takes her assertions a little too far, in the process confusing multiple aspects of the immune response. While it’s probably true that certain immune responses worsen symptoms once a cold infection has been established, Ackerman also implies that a strong immune system does not help the body stave off infections in the first place. And based on the scientific evidence I’ve been able to find, I don’t think that’s a fair conclusion.
The immune system is a machine made of many parts. When a virus attempts to invade the body, the innate immune response, a non-specific system that basically throws darts at the intruder, is the first thing that ramps up. If the virus nevertheless manages to set up shop, the adaptive immune response kicks in, which among other things produces the inflammatory molecules that cause cold symptoms as well as the antibodies that protect you against the same cold in the future. So the immune response that initially fights the invading virus isn’t the same one that kicks in once the infection has established its roots. It stands to reason, then, that while some aspects of immunity (particularly adaptive immunity) may well worsen symptoms, other aspects of immunity may not, and may in fact be very important in protecting against infection. Yet Ackerman writes:
In any case, the supplements, remedies and cereals that claim to strengthen immunity (and thereby protect you from colds) do no such thing. It would be one thing if by some magic they made your body produce antibodies to any particular virus. But they don’t. And though some of these products contain ingredients that have been shown in studies to affect elements of the immune system, there’s scant evidence that they bolster protection against infection by cold viruses. No one knows which immune agents — other than antibodies — accomplish that.
Ackerman argues that antibodies are the body’s only known defense against colds. This would be surprising, given that antibodies are but one tiny part of the immune response to most pathogens; it’s also not backed up by existing evidence. An antiviral protein known as viperin is now thought to play a role in fighting cold infection, for one: a 2008 study published in Respiratory and Critical Care Medicine reported that when viperin activity is stifled during cold infections, the virus replicates more quickly. A 2004 study published in the Journal of Immunology suggests that a protein called human -defensin (HBD)-2 plays a role in host defense against the cold virus, too.
Granted, there is still much left to be learned about how viperin and human -defensin (HBD)-2 affect host protection, and they may not even be the most important players. But the point is, immune proteins other than antibodies do seem to help fight infection—they help to make you better, and perhaps even stave off infection from the getgo. So while Ackerman may be right that ramping up certain aspects of immunity with supplements and vitamins might make you feel more miserable once you have a cold, a robust immune system may not a bad thing when it comes to preventing and fighting the nasty bugs. If it were, then the best defense against a cold would be to stay up all night drinking and then attempt to run a marathon—because that’s a surefire way to pull the body’s resources away from immunity. I don’t know about you, but to me, that really doesn’t seem like a good idea.
Proud, D., Turner, R., Winther, B., Wiehler, S., Tiesman, J., Reichling, T., Juhlin, K., Fulmer, A., Ho, B., Walanski, A., Poore, C., Mizoguchi, H., Jump, L., Moore, M., Zukowski, C., & Clymer, J. (2008). Gene Expression Profiles during In Vivo Human Rhinovirus Infection: Insights into the Host Response American Journal of Respiratory and Critical Care Medicine, 178 (9), 962-968 DOI: 10.1164/rccm.200805-670OC
Proud D, Sanders SP, & Wiehler S (2004). Human rhinovirus infection induces airway epithelial cell production of human beta-defensin 2 both in vitro and in vivo. Journal of immunology (Baltimore, Md. : 1950), 172 (7), 4637-45 PMID: 15034083
Hall Of Shame
JPMC charging patients for Hepatitis tests
MOHAMMAD BILAL TAHIR
The Jinnah Postgraduate Medical Centre (JPMC) is charging fee from patients, who visit the facility for Hepatitis B and C tests, despite the fact that the provincial government-run health facilities offering the tests free of cost, Business Recorder learnt on Tuesday. Sources said that JPMC's central laboratory administration was charging Rs 500 for the tests of Hepatitis B and C from pregnant women, who visit the hospital for gynecology and OPD examinations.
They said that patients were also asked to get their tests from some specific laboratories, whereas tests from other than the 'prescribed' laboratories were not accepted. "These tests are provided free of cost at other Sindh government-run hospitals whereas the same facility is not available at the JPMC," they added.
Deputy Director JPMC Dr Seemin Jamali could not be reached for her version over the issue despite repeated attempts. In-charge Hepatitis Control Programme (HCPD), Sindh Dr Majeed Chutto told Business Recorder that JPMC's Hepatitis control programme did not fall under the HCPD.
"Despite devolution of the JPMC to the province, we have not yet taken over the said facility," Dr Chutto pointed out. He condemned this JPMC administration for charging patients for the tests, saying that he was going to hold meeting with Sindh health minister to take up the issue with him.
"After the meeting with health minister, Hepatitis Control Program Sindh will take over the hepatitis control programme of the JPMC," Dr Chutto said, adding that transparency would be ensured in order to facilitate the patients. He said that the diagnosis and tests of the hepatitis were offered free of charge in the government-run teaching hospitals of entire province.
He said strict action would be taken against those government-run hospitals that were making money out of it.
Those facilities providing free of cost hepatitis treatment include Civil Hospital Karachi (CHK), Sindh Government Qatar Hospital, Korangi General Hospital and Lyari General Hospital. Business Recorder also learnt that due to lack of check and balance on supply and distribution of Hepatitis B and C vaccines and costly medicines, a large quantity of vaccines and medicines were pilfered from the stores of the facility.
We're Number One
By George Lundberg, MD, Editor-at-Large, MedPage Today