Monday, October 24, 2011

Hepatitis News Ticker; Monday Afternoon Updates

New On The Blog

Vertex Initiates Phase 3b CONCISE-Study Incivek w-peg/riba

PEG-IFN α-2b/Ribavirin Following Treatment of Hepatitis C Virus-Associated Hepatocellular Carcinoma
FDA- Use of Jet Injectors with Influenza Vaccines
Roche: New Era Of Hepatitis Therapies
Abbott says hepatitis C combo may be a blockbuster
Etiology and Viral Genotype in Patients with End-Stage Liver Diseases admitted to a Hepatology Unit in Colombia
New drug boosts hepatitis treatment

In The News

At the Clinic, Care ... and Infection

As hospitals get better at keeping serious infections from spreading to patients, a new source of worry is emerging: outpatient clinics, where reports of dangerous transmissions of bacteria and viruses have been on the rise.

The Centers for Disease Control and Prevention on Tuesday is launching a campaign to reduce the rate of infection among the more than one million cancer patients a year who receive chemotherapy and radiation treatments in outpatient oncology clinics.....

Insulin resistance

Use of HOMA-IR in Hepatitis C
Insulin resistance can present in patients with chronic hepatitis C. This article discusses ways in which IR can be assessed in this subset of hepatitis patients.
Journal of Viral Hepatitis, October 2011
*Free registration required


Impact of delayed diagnosis time in estimating progression rates to hepatitis C virus-related cirrhosis and death

Bo Fu, Wenbin Wang and Xin Shi have a new paper in Statistical Methods in Medical Research. The paper is interested in the estimation of rates of progression from hepatitis C infection to cirrhosis and from cirrhosis to death. The primary complication in the model is that the time of cirrhosis development is interval censored, since it is only diagnosed at clinic examination times.

The model consists of a simple unidirectional 3-state model. A parametric Weibull approach is taken, where the time to cirrhosis from infection has a standard Weibull distribution and the time from cirrhosis to death has a Weibull distribution where the scale parameter is a function of the time between infection and cirrhosis.

Unsurprisingly, they show that a full likelihood approach which takes into account the interval censoring is much less biased than an approach that ignores the problem of interval censoring.

A criticism of the model, which the authors acknowledge, is that the possibility of death before cirrhosis is not accommodated. Potentially, even under their current model there might also be cases where death occurs after cirrhosis but before diagnosis of cirrhosis - a scenario which isn't accommodated in the three cases listed in their likelihood development. The rate of increase of the hazard of cirrhosis from infection is observed to increase after 30 years since infection. It is not clear whether this is a real effect, whether it is due to a small number of people at risk or whether it is an artifact of not accommodating the possibility of death without cirrhosis. Given the long follow-up time in the study it might have been more sensible to consider age rather than either time since cirrhosis or time to infection as the primary timescale, at least for time to death.

Finally, whilst the approach might be novel for HPV patients, the 3-state approach is clearly widely used in other contexts, most specifically in HIV/AIDS studies. For instance the penalised likelihood approach of Joly and Commenges would be highly applicable.

Liver Cancer

Hepatocellular Carcinoma, Potential Risk Factors Studies In European Cohort Study
24 October 2011
According to a cohort study published online October 21 in the Journal of the National Cancer Institute, risk factors for hepatocellular carcinoma (HCC),such as obesity, smoking, high alcohol consumption, and chronic... [read article]

Study Of Risk Factors For Hepatocellular Carcinoma
24 October 2011
Among known risk factors for hepatocellular cancer, smoking, obesity, and heavy alcohol consumption, along with chronic hepatitis B and C infection, contribute to a large share of the disease burden in Europe, according to a... [read article]

HCV Worldwide

Costly medicines mean debt or death for people with hepatitis C

People living with hepatitis C, International Treatment Preparedness Coalition - India (ITPC-India), and treatment activists at a press conference held recently in Delhi, questioned the silence maintained by the Indian Health Ministry on its response to the Hepatitis C virus (HCV) which is emerging as a growing public health threat, and in the absence of effective prevention programmes, millions are at risk of this deadly infection.

Be Prepared for Troublesome Tattoos, Problematic Piercings

By: SHERRY BOSCHERT, Family Practice News Digital Network

SAN FRANCISCO – Body modifications are all the rage, so physicians need to know that troublesome tattoos can interfere with MRIs, and should keep a pair of pliers handy to deal with problematic piercings.

Approximately 36% of Americans aged 25-29 years have one or more tattoos. Piercings are most common among 16- to 20-year-olds, 47% of whom have rings, anchors, studs, or other metallic objects poking through various body parts. Some 10% of Americans aged 12-15 years and 27% of people aged 21-25 years have body piercings, Dr. Rachel L. Chin said at the annual meeting of the American College of Emergency Physicians.

Patients aren’t the only ones favoring the fashion.
"I don’t think I can name a single night nurse who doesn’t have more than one piercing other than in the ear," said Dr. Chin of San Francisco General Hospital and a professor of emergency medicine at the University of California, San Francisco.

Tattoo pigments may contain heavy metals and iron that act as conductors during MRI and can cause a burning sensation and intense pain. Although a 2002 survey of 1,032 patients with tattoos who underwent MRI reported no serious soft-tissue reactions or adverse events, the popularity of tattoos has grown astronomically in the past decade, and there now are many case reports of severe burning associated with tattoos and MRI, Dr. Chin said.

If this happens, apply a cool compress or ice packs, she suggested.

It’s difficult to know what’s in an individual’s tattoo. There are no federal regulations of tattoo pigments or studios that offer tattoos, and international pigment suppliers rarely produce lists of ingredients. Tattoo artists also may mix their own colors, and some use printer’s ink or automobile paint, she said. Most tattoo artists have had no formal training in anatomy, infection control, or universal precautions.

The Red Cross prohibits blood donations from anyone who has gotten a tattoo or piercing in the past 12 months unless the tattoo was applied by a studio certified by the Association of Professional Piercers or the Alliance of Professional Tattooists.

Tattoo recipients may show up with another common problem: infection. One study of 766 college students found that tattoos were associated with infection in 45%, local skin reactions in 39%, and hepatitis in two cases (Clin. Nurs. Res. 1999;8:368-85). Infection with hepatitis B and C, HIV, Pseudomonas, Staphylococcus, tetanus, and syphilis have been associated with tattoos. Tattoos from unlicensed artists were associated with outbreaks of methicillin-resistant S. aureus in Ohio, Kentucky, and Vermont.

Tattoo infections can be deadly. If you see a febrile patient with a recent tattoo and no other source of infection, consider the possibility of infective endocarditis, Dr. Chin said.

Another body modification technique called scarification is legal in some states, and regulations of shops vary by county or city. Customers may be branded using an electrocautery knife or may undergo scarring via a chemical burn, a tattoo gun without ink, or a scalpel to remove the outer layer of skin tissue. The design result relies solely on how well the body scars.

Piercing is a common practice in many cultures. In the United States, it most often involves rings in the earlobes, but rings, posts, rods, and dermal anchors are increasingly frequent in other body parts, including the nose, tongue, eyelid, lips, ear cartilage, nipples, belly, genitals, and more. When pop artist Lady Gaga showed up at the Grammy Awards sporting subdermal implants on her forehead, some fans began copying her.

One survey of 225 adolescents with piercings who were seen at an urban hospital found associated infection in 74%, bleeding in 30%, allergic reactions in 26%, and keloids in 19%, Dr. Chin said.

The upper ear cartilage is largely avascular, and thus prone to poor healing and more serious infection from piercing. In such cases, treat infection for staphylococcus or streptococcus infection (as well as methicillin-resistant S. aureus, if it’s a significant infection in your geographical area), but if the patient doesn’t improve after a few days of treatment, switch to ciprofloxacin and assess for Pseudomonas aeruginosa infection, she advised.

Tongue piercings can chip or fracture teeth and significantly increase the risk for gingival recession requiring gum surgery. Aspiration of tongue piercings have been reported during contact sports. Tongue piercings also have been associated with blood-borne infections (such as hepatitis and HIV), endocarditis, significant blood loss, and lingering pain, including trigeminal neuralgia.

Systemic infections that have been seen from body piercings include tetanus, acute poststreptococcal glomerulonephritis, streptococcal septicemia, staphylococcal toxic shock syndrome, and pseudomonal abscesses.

Any piercing can cause a traumatic laceration, which may be sutured just like any other laceration, she said.

Some penile piercings can lead to paraphimosis, and without prompt treatment the tissue ischemia may cause gangrene and autoamputation of the distal penis. Urethral injuries, infections, prolonged priapism, and recurrent condyloma acuminatum are other risks from male genital piercing.

Female genital piercings increase the risk for vaginal lacerations, sexually transmitted diseases, and urinary tract infections

Remind any patients with genital piercings to use condoms for any sexual contact, and to be aware that condoms may be torn by the body jewelry, Dr. Chin said.

Learn how to remove the most common kinds of body piercing jewelry, she suggested. These include barbell studs, labret studs, and bead rings, which may be removed by unscrewing and/or pulling on parts of the jewelry. A captive bead ring is most easily removed using ring expanding pliers or external snap ring pliers.

Pearling is another body modification technique in which small objects of various materials are placed beneath the skin of the penis, hands, or other body parts. The risks and healing characteristics are similar to those of any subdermal implants, and rejection can occur but is rare. Migration of the implanted material is common, however, both during and after healing.

At Dr. Chin’s institution, it’s not uncommon to see problematic penis rings, in which a metal ring that the patient has placed over his penis to keep an erection becomes stuck and interferes with blood flow. "We call the fire department" to come cut off the ring, she said. These patients can’t be given too much sedation, because the room must be free of excess oxygen when the fire department’s saw sends sparks flying.

If you see this problem and your fire department won’t come, call the orthopedics department. "They have the right tools" for the job, she said.

Dr. Chin said she has no relevant conflicts of interest.

Surgeon Removes Eight Pound Liver Tumor

The cancerous tumor in Marcus Muhich's liver weighed 8 pounds and was nearly a foot across.

Doctors at three major academic medical centers in the Midwest told Muhich his high-grade tumor was inoperable.

Then he was referred to Dr. Margo Shoup, chief of the Division of Surgical Oncology at Loyola University Medical Center. Shoup was able to remove the entire tumor, and, two years later, Muhich remains cancer-free.

"Dr. Shoup is my miracle worker," he said.

Muhich learned he had cancer after visiting a cardiologist for a heart rhythm disorder. The tumor had been pressing against his vena cava, the largest vein in the body. This restricted blood flow to the heart, causing an irregular heartbeat called atrial fibrillation. While examining Muhich, the cardiologist felt the growth. This finding eventually led to the diagnosis of a rare cancer called hepatic sarcoma.

Shoup determined that, despite its size, the tumor was still contained and had not metastasized. During a delicate, five-hour operation, she removed the tumor. There was a significant risk of severe bleeding if the vena cava ruptured during the procedure. Severe bleeding also could erupt from the liver, or from the tumor itself.

But there were no major complications. Muhich fully recovered, and his heart rhythm has returned to normal. "The recovery was not difficult at all," Muhich said. "It hurt very little."

The highest risk of recurrence for hepatic sarcomas occurs during the first two years. "Since he has reached the two-year point without a recurrence, his prognosis is excellent," Shoup said.

Surgical oncologists at Loyola are high-volume surgeons who do very complex tumors. Surgical outcomes are excellent.

Surgical oncologic care at Loyola encompasses a wide range of malignancies, including those of the gastrointestinal tract, liver, pancreas, biliary system, breast, esophagus, melanoma and soft tissue sarcoma.

Patients are discussed in a tumor board that includes several experts in various fields of oncology. Minimally invasive approaches to surgery are offered in many cases. Also offered are microwave ablation of the liver and high-dose radiation to the pancreas.

Muhich's sister, Sarita Gilligan, said he received advanced and compassionate care.

"Loyola is a faith-based hospital," Gilligan noted. "We truly believe God sent us there."


Victrelis Keeps Hep C Viral Load Undetectable for 24 Weeks in 7 of 10 Coinfected Patients

Seventy percent of people coinfected with HIV and genotype 1 hepatitis C virus (HCV) have undetectable HCV viral loads after 24 weeks of treatment with Merck’s HCV protease inhibitor Victrelis (boceprevir) combined with pegylated interferon and ribavirin, according to interim study results reported at the annual meeting of the Infectious Disease Society of America (IDSA) on Saturday, October 22, in Boston.


Watchdog wants answers on Pfizer payments deal

THE pharmaceutical watchdog is demanding an urgent explanation from the Pharmacy Guild and the Pfizer drug company over payments to pharmacists for enrolling patients who have been prescribed Pfizer products.

The action has come as it emerges there may be at least 18 similar ''patient support'' programs under which pharmacists and other health professionals are paid a fee by drug companies to sign patients up to programs that enable drug companies to...


Minnesota eggs recalled in salmonella probe

WASHINGTON | Mon Oct 24, 2011 10:56am EDT

WASHINGTON (Reuters) - Larry Schultz Organic Farm of Owatonna, Minnesota, is recalling organic eggs after at least six people became ill from salmonella, state officials said.

The Minnesota Department of Agriculture and Department of Health are investigating the salmonella infections, which took place from August 12 to September 24, the agencies said in a statement on the U.S. Food and Drug Administration's website.

At least six people were infected. Three were hospitalized but have recovered, the statement said.

Five of the six cases have reported eating eggs from the Larry Schultz Organic Farm bought at grocery stores or co-ops.

Eggs being recalled were distributed in Minnesota, Wisconsin and Michigan, the statement said.

Eggs being recalled are:

-- Larry Schultz Organic Farm Label Extra Large, Large, Jumbo and Medium Cartoned

-- Larry Schultz Organic Farm Label Jumbo Bulk

-- Lunds & Byerly's Large and Extra Large Cartoned

-- Lunds & Byerly's Large Cartoned six-packs

-- Kowalski's Organic Egg Label.

Salmonella can cause serious and sometimes fatal infections in small children, frail or elderly people, and others with weakened immune systems.

To prevent illness, consumers should cook eggs thoroughly before eating in order to destroy any salmonella or other bacteria, the statement said.

(Reporting by Ian Simpson; Editing by Jerry Norton)

Roe, sandwiches recalled on listeria concerns

Reuters) - Capelin roe and cases of sandwiches are being recalled because of possible listeria contamination, the manufacturers said.

Yamaya USA Inc. of Torrance, California, is recalling capelin roe, or masago, distributed to retail stores in Los Angeles, Baltimore, Atlanta and Mexico, the company said in a statement on the Food and Drug Administration (FDA) website.

The masago was packed in two-pound containers and no illnesses have been reported, Yamaya said. The recall followed an FDA sampling of the Yamaya facility.

Landshire of St. Louis is recalling 1,751 cases of the 7.25 ounce Nike All-American sandwich, the company said in a statement posted on the FDA website. The sandwiches were distributed nationwide.

No illnesses have been reported. The recall was the result of a routine sampling taken by the North Carolina Department of Agriculture and Consumer Services.

An outbreak of listeria food poisoning in cantaloupes from a Colorado farm has killed at least 25 people and made at least 123 ill.

Listeria monocytogenes is a frequent cause of U.S. food recalls in processed meats and cheeses. The elderly, pregnant women and people with weakened immune systems are most at risk.

Symptoms include fever and muscle aches, sometimes preceded by diarrhea and other gastric problems.

(Reporting by Ian Simpson; Editing by Jerry Norton)


“Bath Salts” also called “Plant Food” may cause hallucinations, suicidal thoughts, agitation, chest pain, rapid heartbeat and paranoia. The temporary ban from the Drug Enforcement Agency lists methylone, mephedrone and methylenedioxypyrovalerone as the banned chemicals. The ban is for a year and future studies will determine whether the products will be banned permanently. The “Bath Salts” may be sold under the names vanilla sky, bliss, ivory wave and purple wave, these products are widely available in convenience stores, on line and tobacco stores.

SC lawmaker: Ban bath salts, synthetic marijuana
Posted: Sunday, October 23, 2011 3:58 pm | Updated: 1:03 pm, Mon Oct 24, 2011.

While South Carolina's health agency is getting ready to follow-up on federal action making synthetic stimulants like bath salts illegal, one state lawmaker tried to outlaw them earlier this year.

Rep. Anne Thayer sponsored legislation when lawmakers met in January to make the new compounds illegal. The proposal didn't get out of committee. But plenty has changed since this spring, with a rash of bizarre incidents across the state and even the death of a college athlete blamed on synthetic stimulants.

"I just don't think they think it's a big deal because you can buy it over the counter," said Thayer, R-Anderson. "`How bad could it really be?' I think that's what they really think."

Close to a dozen counties in South Carolina have either banned the sale of bath salts and synthetic marijuana or are in the process of passing a ban. The ordinances are civil, meaning that people found in violation of them receive tickets _ of $500, in some instances _ not jail time. The emergency ordinances expire in 60 days, giving the counties time, they hope, to pass permanent bans.

Actions taken Friday by the U.S. Drug Enforcement Administration mean they may not need to.

The state Department of Health and Environmental Control had been working on an emergency statewide ban. The DEA's action to classify the compounds in both bath salts and synthetic marijuana as illegal made the agency's efforts easier, said DHEC spokesman Adam Myrick.

On Monday, DHEC's board is expected to vote to mirror the federal designations. The DEA's decision means possessing and selling the substances are already illegal, Myrick said, but the vote will allow law enforcement agencies in South Carolina to immediately begin arresting people. Federal officers can already.

"We will aggressively pursue those who attempt their manufacture and sale," DEA Administrator Michele Leonhart said in a release Friday, noting the DEA has received an increasing number of reports in the last six months about the chemicals from poison control centers, hospitals and law enforcement.

According to the DEA, 37 states have already taken action to control or ban synthetic stimulants.

Myrick said legislative action in South Carolina would still be useful, to broaden the specific compounds that the DEA classified as illegal.

"It happened overnight," Myrick said of the sudden increase in incidents and hospitalizations from the drugs.

Just this month in Spartanburg County, deputies reported a man under the influence of bath salts fired his gun inside his home, endangering his neighbors, because he feared a nonexistent dead body inside. A woman who ingested the drug tried to steal a police car after being pulled over for erratic driving.

Bath salts cost about $25 and are especially popular among teens and young adults. They are perceived as mimics of cocaine, LSD and methamphetamine, according to the DEA.

Synthetic marijuana, known as "K2" or "Spice," is sold as blends of herbs and plant materials coated with chemicals _ most of which were created by a Clemson University scientist for research purposes in the 1990s. The drug produces a euphoric feeling when smoked. The compounds were never tested on humans, and the DEA has already made possession of the drugs a crime.

The coroner in Anderson County blamed the death of a 19-year-old basketball player at Anderson University on ingesting a chemical used to make the drug.

Since January, Dorchester EMS crews have taken eight confirmed cases and 35 more suspected cases of overdosing on the synthetic drugs to the hospital. Meanwhile, deputies find themselves taking more arrested suspects to the hospital instead of jail because they can't control them.

EMS crews and deputies have been responding to repeated calls of "hyper-excited" people doing things like tearing off their clothes and running down the street naked.

"It'd almost be safer for them to smoke real marijuana ... you're laid back and have the munchies," Thayer said.

Thayer said she wishes more of her fellow lawmakers had listened in January when she introduced a law to ban the drugs.

"It breaks my heart every time I hear one of those things," Thayer said.

The use of bath salts as recreational drugs has greatly escalated in recent years. Researchers from the University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma describe an incident of a man experiencing significant agitation, paranoia, and hallucinations who also exhibited violent behavior upon his emergency department arrival.

His case is not unique. Despite disclaimers of "not for human consumption" package warnings, according to the American Association of Poison Control Centers, calls for bath salt poisoning incidents have skyrocketed, with 1,782 since January 2011 compared with 302 in all of 2010. The inexpensive powdery substances with benign names contain stimulants not detectable through drug screens. However, they can produce a "high" along with increased blood pressure, increased heart rate, agitation, hallucinations, extreme paranoia, and delusions, not unlike the Oklahoma patient.

Treatment for ingesting these bath salts is sedation until the side effects wear off, along with supportive care. Although currently federally unregulated, 26 states have made these substances illegal. This new research was presented at CHEST 2011, the 77th annual meeting of the American College of Chest Physicians (ACCP), in Honolulu, Hawaii.

From Medscape Medical News ; Psychiatry

'Bath Salt' Street Drugs Temporarily Banned

October 24, 2011 — The US Drug Enforcement Administration (DEA) has temporarily banned 3 synthetic stimulants marketed as "bath salts" and "plant food" that mimic cocaine, LSD, MDMA, and/or methamphetamine when ingested.

According to a DEA news release, the emergency measure makes it illegal to possess or sell 3,4,methylenedioxypyrovalerone, mephedrone, and methylone for at least 1 year, with the possibility of a 6-month extension.

The chemicals, which are not approved for human consumption or medical use in the United States, have been the subject of an increasing number of reports from poison control centers, hospitals, and police during the last 6 months.

Marketed under names such as "Ivory Wave," "Purple Wave," "Vanilla Sky," or "Bliss" in retail stores, head shops, and over the Internet, the chemicals are especially popular among teenagers and young adults who sniff, inject, or smoke the crystals.

Users have reported impaired perception, reduced motor control, disorientation, extreme paranoia, and violent episodes. Long-term effects remain unknown, officials said.

"This action demonstrates our commitment to keeping our streets safe from these and other new and emerging drugs that have decimated families, ruined lives, and caused havoc in communities across the country," DEA Administrator Michele M. Leonhart said in a statement.

"These chemicals pose a direct and significant threat, regardless of how they are marketed, and we will aggressively pursue those who attempt their manufacture and sale," she added.

As previously announced, the DEA earlier this year banned 5 chemicals (JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol) found in "fake pot "that was marketed as herbal incense or smoking blends under such names as "Spice," "K2," "Blaze," and "Red X Dawn."

Complementary Medicine / Alternative Medicine News

Can Aromatherapy Produce Harmful Indoor Air Pollutants?
23 October 2011
Spas that offer massage therapy using fragrant essential oils, called aromatherapy, may have elevated levels of potentially harmful indoor air pollutants such as volatile organic compounds (VOCs) and ultrafine particles... [read article]

Abstract To Be Presented at The American Association for the Study of Liver Diseases November 2011 Annual Meeting

A Randomized, Placebo-Controlled Trial of Oral Silymarin (Milk Thistle) for Chronic Hepatitis C: Final Results of the SYNCH Multicenter Study

Michael Fried, et al. Tuesday, Nov. 08 – 8:00 AM Room 3000-3012

Healthy You

Study Calculates High Cost of Heavy Drinking
Art Chimes | St. Louis, Missouri

Excessive alcohol consumption in the United States costs Americans more than $200 billion a year, according to a new study.

That hefty bill includes the medical costs related to heavy drinking, plus the impact of alcohol abuse on law enforcement agencies and employers.

The researchers found the biggest contributor to the total costs of excessive alcohol use was a drop in workplace productivity, but the head of the U.S. Centers for Disease Control and Prevention, Thomas R. Frieden, MD, told reporters that heavy drinking also contributes to a wide range of chronic health problems, including cirrhosis of the liver, "cancers, including liver, mouth, throat; high blood pressure; mental health problems; injuries, such as motor vehicle crashes, burns, and firearm injuries; violence, including child maltreatment, homicide, suicide, and domestic violence. All are substantially contributed to by unhealthy patterns of alcohol intake."

This study is limited to excessive drinking, which is defined in the CDC study as more than one alcoholic drink per day for women, more than two per day for men, and any drinking at all by pregnant women and underage youth. Other research has found light-to-moderate drinking can often have benefits.

CDC director Frieden says the price of heavy alcohol use averages out to just under $2 a drink.

The estimated costs for 2006, the most recent year available, climbed $40 billion over the costs found in a similar 1998 study. And CDC Alcohol Program official Robert Brewer, MD, suggests that the findings may understate the problem.

"Now, I should tell you that our estimates here are very conservative, yet the number that we are reporting here - $223.5 billion - is huge," Brewer said.

The study on the costs of excessive drinking in the United States is published in the American Journal of Preventive Medicine.

In separate research on the health effects of alcohol, heavy drinkers were found to be at higher risk of lung cancer.

The study, by researchers at Kaiser Permanente in California, used data from a group of more than 125,000 people, who were followed for as long as 30 years to assess various lung cancer risk factors. Those who had more than three alcoholic drinks a day were more likely to get lung cancer, but the increased risk did not apply to more moderate drinkers.

The researchers, led by Stanton T. Siu, MD, presented their findings at the annual meeting of the American College of Chest Physicians in Hawaii.

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