May 23, 2012

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Friend’s birthday poem turned into a children’s storybook to help those dealing with cancer.

By ROXIE HAMMILL
Special to The Star

It began as a birthday present—a poem written by Laura Myer for her good friend Lori Lober, who at one time had been given only a 2 to 3 percent chance of living five years.

But for much longer than that, Lober’s cancer has been kept at bay. So has the hepatitis C that Myer contracted. But the poem has blossomed into a self-published book, “Princess Elle and her Isle of Capri.” The illustrated storybook, which came out in February, is aimed at children and parents dealing with a cancer diagnosis.

It’s been a long journey for the two friends, much of it uphill.

Lober, of Kansas City, North, had late-stage breast cancer that metastasized to her liver. She still takes regular chemotherapy treatments, but there’s been no sign of cancer for more than 10 years.

Myer, a former surgical nurse who now lives in Overland Park, has been undergoing difficult treatment for hepatitis C, but she, too, has been free of symptoms for about 10 years.

The illustrator, Angie Prindle of Lee’s Summit, also could relate to the topic. Her mother, Barbara Brewer, is a cancer survivor.

The book is part celebration, part mission. Lober hopes the comforting cadence of the poem and the storybook imagery will speak to children and family members affected by cancer.

Originally, Lober said, the women had hoped to donate the proceeds to Touched by Cancer, but that organization has dissolved. Now Lober, a wellness coach, is more interested in using the book as a tool to help parents and children.

If there are profits after she recoups the $2,000 publishing fee, Lober said, the money will be divided among everyone who donated their work to make it happen. She said she’d happily donate her share to charity. The book is available for $16.99 through Amazon and Barnes & Noble and from the authors and illustrator themselves.

Lober and Myer met about 15 years ago through their husbands’ work with the Home Builders’ Association of Greater Kansas City. At the time, they were typical girlfriends who shared common interests and business.

Then, about a year later, Lober suspected something was wrong and began asking doctors to check her for breast cancer.

She had a type of pre-menopausal cancer that was difficult to detect without a biopsy, though, and she says it was two years before she got a cancer diagnosis. By then, the cancer had spread to her liver.

Myer gave her the birthday poem after Lober had undergone her surgeries but before she’d been declared symptom-free. “She was just really hard to buy for,” Myer laughed.

Myer, in the meantime, developed her own health problems. A year after Lober’s cancer was diagnosed, Myer said, she was found to have hepatitis C, which may have been contracted during her earlier years as a surgical nurse.

The two went from being regular girlfriends to “wellness buddies,” just like that, said Lober.

They learned how to eat nutritiously, went to spas and even investigated a Tibetan monk who touted herbal remedies for metastatic breast cancer.

“Having someone who understands what you’re going through helps. It’s priceless,” Lober said. “You know you’re not the lone wolf, going through it all on your own.”

Lober, 48, has self-published two other books, “Love to Live” and “Still Bigger than Pink” about her experiences with cancer. So after she read and re-read the birthday poem, an idea formed.

“It hit me. Oh, my God, this is so good! We need to turn it into a children’s book and have it illustrated.”

Myer immediately took the poem out to a quiet lake dock and started writing.

“When Lori Lober asks you to do something, you usually end up doing it,” she said with a laugh.

“Princess Elle” is an allegorical tale of a little girl on an island. One day she notices things are amiss, and soon she is in the clutches of a powerful dragon called C for carcinoma. However, she makes it through the confrontation and is helped back to wellness by her many bird friends.

“Feathers are important to me,” said Lober. “Whenever I needed hope or a sign, I would find a feather in an unusual place, as if it had been put there by an angel. I think of feathers when I need hope.”

After Myer, 51, and Lober were done tweaking the words, they set out to find an illustrator by sending out emails. Prindle learned about the project through a student’s parent.

By that time, tragedy had struck Lober. Her son, Colby James McLain, 19, died in a car crash in November 2005. After Prindle got the job, she commemorated Colby by working his features into one of the birds in the story. Since publication, Prindle has given away 60 copies and has held a fundraising event at a Lee’s Summit coffee shop.

Prindle, 44, says she had always wanted to illustrate a children’s book, and so was thrilled when her work was chosen. The book is done in watercolor, ink and Photoshop images of a little girl wandering through the island and fighting the dragon. Coincidentally, the girl in the photos is Prindle’s niece, Ellie, who was 5 at the time.

“It’s always everyone’s hope that you have a happy ending, that you conquered it and can move forward with life,” she said. “People can imagine, if this little girl did it, I can do it, too.”

Story books can be useful for children trying to understand cancer, said Amber Masso, national program director for the American Childhood Cancer Organization in Kensington, Md. In fact, one of the group’s functions is to distribute books and materials it’s commissioned for people with cancer. Those include story books.

“Talking about a journey and turning it into a fantasy is definitely more relatable to children,” Masso said. “It’s good to relate it in terms a child can understand, and it’s also a good tool for a parent to have.”

In fact, one of the group’s functions is to distribute books and materials it’s commissioned for people with cancer. Those include some story books, Masso said.

Myer was struggling with a course of treatment, and could not talk long about her book. But she remains upbeat.

“It’s so funny. I got (the book) the day I started treatment,” she says of her most recent round. “So I’ve had to read my own words and walk my own walk.”

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Patients May Receive Too Much Acetaminophen in Hospital

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Use of drugs such as Tylenol, Percocet can exceed recommended daily dose, study finds

-- Mary Elizabeth Dallas

WEDNESDAY, May 23 (HealthDay News) -- Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according to a new U.S. study.

Patients on more than one drug containing acetaminophen often consume more than the recommended 4 grams per day of the drug, the researchers from Thomas Jefferson University Hospital in Philadelphia found.

Together, two tablets of extra-strength Tylenol contain 1 gram of acetaminophen, commonly used to relieve pain and reduce fever.

Over the course of two years, researchers led by Dr. Jesse Civan examined 46,000 hospital admissions and the medications those patients were given. They found that on at least one day of hospitalization, roughly 1,100 patients received more than 4 grams of acetaminophen in the form of Tylenol, Percocet and similar drugs.

The study authors also assessed the effects the acetaminophen had on the patients' livers and found only a small minority were given a blood test to check their liver function. The investigators noted that this test is typically used only when a doctor has a specific concern about possible problems with a patient's liver.

In the small number of patients who did have the blood test of liver function, the researchers noted that there were no serious liver injuries. They said there wasn't enough information to determine if abnormal test results were the result of excessive exposure to acetaminophen.

Civan and colleagues concluded that more research is needed to determine if new recommendations for the safe daily dosing of acetaminophen are necessary. They added that patients need better education on acetaminophen safety, particularly for use of the drug after they leave the hospital, when patients may try to duplicate the medications and doses they were given during their admission.

The study was presented Monday at the Digestive Disease Week meeting in San Diego. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The U.S. Food and Drug Administration has more about acetaminophen.

SOURCE: Digestive Disease Week, news release, May 22, 2012

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Herbal, Dietary Supplements Take Toll on Liver

    

By Cole Petrochko, Associate Staff Writer, MedPage Today

Published: May 22, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

SAN DIEGO -- Patients taking herbal and dietary supplements may be at risk for liver injury severe enough to warrant an organ transplant, researchers said here.

In a review of national data, supplements accounted for 18% of liver injuries in the U.S., Jose Serrano, MD, of the National Institutes of Health, reported during a press briefing at Digestive Disease Week.

"The number of cases in our network has increased over the years," Serrano said during the briefing. "There were no deaths, but 7% of patients needed a liver transplant. These are not trivial consequences."

It's estimated that as much as 40% of the U.S. population uses herbal or dietary supplements, but their potential side effects, including hepatotoxicity, are not well defined.

The researchers looked at data from the Drug Induced Liver Injury Network, which evaluated patient information from eight sites across the U.S. from 2003 to 2011.

Of 679 cases of liver injury, 93 were attributed to herbal or dietary supplements, Serrano said, adding that these patients tended to be younger than those who have similar liver injuries due to other medications. The majority of these patients were white.

Among patients that had used supplements, 33% used them for body building, 26% for weight loss, and the remaining 31% used a variety of other types of supplements.

Serrano said the symptoms of liver injury caused by supplements weren't different from those caused by other medications. But one factor that distinguished liver injury from body building supplements over the others was itching, which occurred in 86% of patients.

Those who had liver injury resulting from either body building or weight-loss supplements also tended to have a longer latency time between exposure and injury compared with liver injury from other medications or the miscellaneous category of dietary supplements.

Weight-loss products also appeared to be associated with a more hepatocellular pattern of injury, while body building supplements (usually anabolic steroids) had a more mixed pattern with increments on total bilirubin, Serrano said.

Most of the patients (66%) had to be hospitalized, and 11% developed alterations in liver function that persisted for at least 6 months, he added. The median serum alanine-aminotransferase (ALT) at presentation was 533 U/L, the alkaline phophatase was 166 U/L, and the total bilirubin was 7 mg/dL.

The R-value, which represents liver injury pattern, was in the hepatocellular range (>5%) in 65% of the patients with a median ALT of 1,275 U/L. The range for normal ALT is generally between 7 and 56 units U/L.

Symptoms included:

  • Jaundice (78% of patients)
  • Nausea (60%)
  • Itching (58%)
  • Abdominal pain (47%)

The majority of patients (60%) used only one type of supplement, while 23% used two or more supplements, and 16% used at least one supplement concurrently with prescription drugs.

While the most common injury pattern seen was hepatocellular, the distribution of overall causality scores was not significantly different across injury patterns (P=0.30), the authors stated.

The biggest risk to patients that use supplements is not reporting supplement use to a healthcare professional, noted Donald Jensen, MD, of the University of Chicago and DDW press conference moderator.

"Patients need to be label readers," Jensen told MedPage Today. "They can't just assume that everything out there is safe. There are things out there that can be potentially damaging."

He added that patients think supplements "are food or that they're very safe. And there are some herbal medicines that probably are safe and may even do some benefit for people. I don't want to throw everything in the trash can. But, on the other hand, there are enough [supplements] that are damaging."

He said that future research on supplements should focus on potential patient interactions with herbal supplements, noting that not all patients have negative interactions with them.

"I don't think we're going to stop people from taking herbal medicines," he said. "I'd like to see the FDA regulate the toxic ones better, but otherwise I think the important next step is some scientific understanding of why some people get damaged and others don't."

Navarro disclosed consultancy work for Merck.

Co-authors disclosed relationships with Boehringer-Ingelheim, Clinuvel, Novartis, American Porphyria Foundation, Iron Disorder Institute, Vertex, Lundbeck, Bristol-Meyers Squibb, GlaxoSmithKline, Siemens Medical Solutions, Roche, Gilead Sciences, Tibotec, and Catalent.

Primary source: Digestive Disease Week
Source reference:
Navarro VJ, et al "Herbal and dietary supplement induced hepatotoxicity in the U.S." DDW 2012; Abstract 167.

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HCV Patients May Be Able to Delay Therapy

By Kristina Fiore, Staff Writer, MedPage Today

Published: May 22, 2012

Take Posttest

SAN DIEGO -- Hepatitis C patients without significant fibrosis may be able to delay triple therapy and wait for simpler, shorter, and potentially all-oral regimens that are currently under investigation, researchers said here.

The addition of new protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) to previous standard therapy of interferon and ribavirin have significantly boosted sustained viral response for many patients, especially for blacks and Latinos, according to Maribel Rodriguez-Torres, MD, of the Fundacion de Investigation in Rio Piedras, Puerto Rico.

But patients with less severe disease may be able to hold off until a handful of newer agents -- offering less complex regimens that potentially cut the symptomatic interferon from the mix -- come to market, possibly within the next two years, Rodriguez-Torres said during a symposium at Digestive Disease Week (DDW) here.

"This is a slowly progressing disease and most of the time we have the time and opportunity to determine what's the best [treatment strategy] for our patients," she said. "Patients without significant fibrosis should wait. Those with more advanced disease should consider therapy today."

Triple Therapy Presents Challenges

Clinicians have cited a number of challenges with triple therapy. Both new agents are only indicated for patients with genotype 1 disease -- though this comprises the majority of patients -- and they add a significant cost to treatment, Rodriguez-Torres said.

The regimen is also complex and long-lasting, with both new agents adding multiple daily pills to ribavirin's four to six pills per day and weekly interferon injections, extending for 24 to 48 weeks.

There's also an increased risk of drug-drug interactions, as both new agents inhibit the common CYP34A metabolic pathway, potentially increasing levels of other drugs metabolized that way. That list includes some statins and ACE inhibitors, which "aren't unusual drugs," Rodriguez-Torres said.

Side effects include anemia, a concern because ribavirin already lowers blood hemoglobin levels, she said. Also, telaprevir appears to cause rash in more than 50% of patients.

Instead, a "dream regimen" is a simple one with fewer pills, contains only oral agents, spans all genotypes, and is highly effective with an excellent safety and tolerability profile -- though that possibility is not that far from reality, Rodriguez-Torres said.

Improvements Are on the Horizon

"We've never had such an explosion of drug development in the last 75 years compared to what we see now in chronic hepatitis C," she said. That robust pipeline includes not only a number of protease inhibitors and NS5A inhibitors -- which are typically genotype-specific -- but also nucleoside and cyclophilin inhibitors that are pan-genotypic.

Such robustness may help keep prices down as a result of increased competition, Rodriguez-Torres said. Also, the majority of drugs in development are dosed once or twice daily and some have a much shorter duration of therapy than the current standard of 24 to 48 weeks.

Early data also have shown that it's possible to drop interferon from the regimen. Last month at the European Association for the Study of the Liver meeting Barcelona, researchers reported that high proportions of patients has sustained virologic response rates with an all-oral regimen of ribavirin plus two investigational agents, ABT-450/r, a protease inhibitor, and ABT-072, a non-nucleoside NS5B polymerase inhibitor.

Also at that meeting, an early trial showed that a combination of daclatasvir, an NS5B inhibitor, plus GS-7977, a nucleotide NS5B inhibitor, led to rapid and sustained viral response in patients with genotypes 1-3, with or without ribavirin.

Treatment Issues Remain Complex

The pressing question facing clinicians, then, has been determining who to treat and when. Rodriguez-Torres said the simple answer is to treat those with severe fibrosis now, but hold off on treating those without significant fibrosis.

But Andrew Muir, MD, clinical director of hepatology at Duke University, told MedPage Today the decision should rest largely with the patient.

"I get concerned about us being too heavy handed deciding which patients should or should not get hepatitis C treatment," he said. "Our role should be to guide patients about potential options, and those discussions can take quite a bit of time."

He noted, however, that the side effects "will be much better for these patients with future therapies. But I have had patients elect to proceed with treatment even with early-stage disease. Some have felt it was the right time for them to proceed with treatment for a number of personal reasons. Some worried if they would have stable health insurance in the future."

On the other hand, Zobair Younossi, MD, of Inova Health System in Great Falls, Va., said some of his patients actually "warehouse themselves for regimens that do not include interferon."

Muir also noted that even some advanced fibrosis patients may be eligible for watchful waiting, since not all of them will progress quickly.

"If the patient has great risks to treatment, or if the patient does not think the chance of response is good enough to take on the side effects, then delaying therapy is the right thing for that individual [advanced fibrosis] patient as well," he told MedPage Today. "If they do not take treatment, they must get aggressive about liver wellness. That means no alcohol, get in shape and lose weight if needed, and get tight control of your blood sugars if you have diabetes."

Rodriguez-Torres reported relationships with Abbott Laboratories, Anadys, Bristol-Myers Squibb, Glaxo-SKB, Idera, Intarcia, Merck, Novartis, Pfizer, Pharmasset, Roche, Sanofi-Aventis, Valeant, Vertex Pharmaceuticals, ViroChem Pharma Inc, and Wyeth.

The other researchers reported no conflicts of interest.

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U.S. Liver Transplants Declining

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Last Updated: May 22, 2012.

Some livers available for transplant are discarded because they're not healthy enough, study finds.

TUESDAY, May 22 (HealthDay News) -- The number of liver transplants in the United States has decreased since 2006, a new study finds.

Researchers said one reason for the decline is that harvesting livers after cardiac death has become more commonplace, and many of those livers end up being discarded after doctors determine the organs aren't healthy enough to attempt a transplant. Another reason livers are discarded is because of damage due to a condition known as fatty liver disease, which is associated with metabolic syndrome and high cholesterol.

Researchers analyzed data from the United Network for Organ Sharing to assess factors that prompted doctors to discard a donated liver.

With standard donation, a patient is declared brain dead and kept on cardiovascular support so the organs continue to receive oxygen and blood until they are removed for transplant.

In recent years, there has been increasing use of donor organs after cardiac death. In these cases, organs are harvested for transplant after a patient dies and the heart stops on its own. This type of organ donation is promoted as a way to increase the total number of organs available for transplant, and now accounts for 12 percent of organ donations, compared with fewer than 2 percent less than 10 years ago.

Doctors are becoming increasingly reluctant to use organs donated after cardiac death, however, according to the study, which is scheduled to be presented Tuesday at the Digestive Disease Week meeting in San Diego.

The researchers found that the total number of donors who have at least one organ recovered for transplant has stopped increasing over the past few years, despite an increasing proportion of organs donated after cardiac death.

"Cardiac death donation is negatively impacting the overall number of liver transplants that we can do," study leader Dr. Eric Orman, a gastroenterology fellow at the University of North Carolina in Chapel Hill, said in a meeting news release.

He and his colleagues also found that donor characteristics associated with a condition called fatty liver -- including diabetes, obesity, old age and high blood pressure -- all were associated with discarding a donated liver.

Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The American Liver Foundation has more about liver transplantation.

SOURCE: Digestive Disease Week, news release, May 22, 2012

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Hepatitis C Causing Liver Damage in Greater Numbers: Study

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Last Updated: May 22, 2012.

An additional 300,000 Americans could develop advanced liver disease from the virus by 2015.

TUESDAY, May 22 (HealthDay News) -- Hundreds of thousands of Americans infected with chronic hepatitis C virus could develop potentially life-threatening liver complications over the next few years, according to a new study.

Researchers evaluated medical insurance claims data and found that more than 200,000 hepatitis C patients had advanced liver disease in 2008, and estimated that another 300,000 patients could have advanced liver disease by 2015.

The risk of developing advanced liver disease is especially high among baby boomers, who account for 82 percent of hepatitis C patients in the United States, according to the findings, which are scheduled to be presented Tuesday at the Digestive Disease Week meeting in San Diego.

The study was funded by Vertex Pharmaceuticals, makers of the hepatitis C drug Incivek (telaprevir).

"This alarming finding places additional stress on an already overburdened health care system, which will need to prepare for an increase in patients suffering from advanced liver disease," Ann Kwong, vice president and hepatitis C virus franchise lead at Vertex, said in a meeting news release. "It is critical to treat [hepatitis C] patients before they develop costly and irreversible liver complications."

Screening patients for hepatitis C infection can help doctors identify and potentially cure infection before liver complications occur. Available hepatitis C treatments are most effective in patients without advanced liver disease, so early diagnosis offers patients the best chance to be cured, Kwong said.

Up to 5 million U.S. adults have chronic hepatitis C, and as many as 75 percent of them don't know they have the infection. Chronic hepatitis C is the leading cause of liver cancer and the most common reason for liver transplant in the United States.

Last week the U.S. Centers for Disease Control and Prevention recommended that all Americans born between 1945 and 1965 -- the baby boom generation -- be tested for hepatitis C.

Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The American Academy of Family Physicians has more about hepatitis C.

SOURCE: Digestive Disease Week, news release, May 22, 2012

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New research examines impact of liver disease

Public release date: 22-May-2012

Contact: Amy Levey
alevey@gymr.com
202-745-5116
Digestive Disease Week

Health outcomes explored at DDW® 2012

SAN DIEGO, CA (May 22, 2012) — New research being presented at Digestive Disease Week® (DDW) offers key insights into the progression of diseases leading to liver damage, which affect diverse populations, including young people. Studies show that the increasing rates of obesity are putting teens at risk for developing nonalcoholic fatty liver disease and are decreasing the availability of healthy livers for organ donations, which are urgently needed as people continue to experience complications from diseases, such as hepatitis C and drug-induced liver toxicity.

"Liver disease often leads to lifelong problems and serious consequences," said Donald M. Jensen, MD, professor of medicine, and director, Center for Liver Diseases, University of Chicago Medical Center, IL. "With increasing incidence, it is more important than ever to investigate the causes, prevention and treatment for conditions like nonalcoholic fatty liver diseases and chronic hepatitis C, as well as to identify obstacles to liver transplantation." DDW is the largest international gathering of physicians and researchers in the field of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

Prevalence of Suspected NAFLD Is Increasing Among U.S. Adolescents (Abstract #705)

Suspected non-alcoholic fatty liver disease (NAFLD) is increasing in teens, affecting approximately 10 percent of the age group, leading to a host of conditions, including liver damage, diabetes, hypertension and cancer. While the common perception has been that there are an increasing number of children identified with NAFLD, previous studies have not demonstrated the rate of that increase nor whether the increase actually exists. Investigators led by Miriam Vos, MD, assistant professor of pediatrics at Emory University and Children's Healthcare of Atlanta, GA, sought to determine whether rates seem high because people are studying them more closely or whether there really are more cases of teenagers with NAFLD.

Investigators determined that the increase in NAFLD was not defined by the number of overweight children. When comparing the rate of increase in children with fatty liver disease to the rate of increase in overweight children, research showed that the increase in children with fatty liver was much greater than the increase in overweight children. This finding demonstrates that just having overweight kids does not explain the increase in fatty liver. Investigators also looked at cross-sectional data to explain the increase and found a link to increased NAFLD and waist circumference (the measure of the distance around the abdomen half way between the inferior margin in the last rib and the crest of the hip bone).

"We know that if a child is overweight, they are more likely to be overweight as an adult, and we know from national data that teens with fatty liver disease become adults with fatty liver disease, unless they improve their diet and lose a significant amount of weight," said Dr. Vos. She added that adolescents may have an easier time losing weight compared to adults because they have been overweight for a shorter period of time.

To increase the likelihood of weight loss success, Dr. Vos supports a multi-sector approach, including community programs and school programs that steadily support healthy food and exercise. These types of programs are increasing around the country, but need to be uniformly available so that entire communities and children are not excluded from their benefits. She also recommends instituting these supportive programs while children are young so that their parents can help them develop good habits at an early age. Dr. Vos added that she is hopeful that, in the future, we will have medications for the most severe cases of NAFLD to help complement a healthy regimen. This summer, the National Institutes of Health (NIH)-sponsored NASH Clinical Research Network will start a new clinical trial to research the treatment of fatty liver.

Dr. Vos and colleagues are also studying the connection between diet and fat in the liver and increased cardiovascular risk. Data show that cardiovascular disease is very high in adults with NAFLD, and multiple studies have shown that adolescents with NAFLD have markers that show increased risk for cardiovascular disease.

In this study, investigators reviewed nationally representative data of more than 10,000 12- to 18-year-olds from the National Health and Examination Survey datasets, spanning from 1988 to 2008, excluding subjects with missing data and known liver disease. Suspected NAFLD was defined as overweight/obese (those with a body mass index greater than the 85th percentile) with elevated alanine aminotransferase (ALT) levels greater than 25.8 for boys or 22.1 for girls, and also as overweight/obese with ALT levels greater than 30 to allow for comparison with previous studies. ALT is a blood test that is typically used to detect liver injury.

Funding for this study was provided by the NIH.

Dr. Vos will present these data on Monday, May 21 at 11:15 a.m. PT in Room 2 of the San Diego Convention Center.

Current and Future Disease Progression of HCV-Infected Patients Among Different Age Cohorts (Abstract# Sa1084)

Several hundred thousand Americans with chronic hepatitis C virus infection (HCV) are predicted to develop potentially life-threatening liver complications within the next few years, according to a new study from Vertex Pharmaceuticals. Risk was found to be dramatically higher among baby boomers, a segment of the population that accounts for 82 percent of all Americans with HCV.

To assess the future health needs of HCV patients, researchers evaluated medical insurance claims data to determine how many individuals with HCV already have advanced liver disease and how many more will develop complications in time. Researchers found that more than 200,000 HCV patients were suffering from advanced liver disease in 2008 and a projected 300,000 additional patients — mostly baby boomers — are on track to develop advanced liver disease by 2015. Without treatment, the number of patients with advanced liver disease is expected to triple by 2015.

"This alarming finding places additional stress on an already overburdened health-care system, which will need to prepare for an increase in patients suffering from advanced liver disease," said Ann Kwong, PhD, vice president and HCV franchise lead at Vertex. "It is critical to treat HCV patients before they develop costly and irreversible liver complications."

Dr. Kwong recommends that one important course of action is a focus on HCV diagnoses. By screening patients for HCV infection, there is a greater opportunity to identify and potentially cure infection before liver complications occur. Currently approved HCV therapies are most effective in patients without advanced liver disease, so diagnosing the virus earlier offers patients the best chance to be cured.

Researchers stressed that not all patients developing liver complications can be accurately identified with insurance claims data. Individuals with existing liver disease may not be diagnosed and therefore cannot be accounted for in this study. In the future, universal screenings for HCV infection are expected to help diagnose not only more cases of HCV, but also lead to more testing for liver complications.

Up to five million U.S. adults have HCV, and 75 percent of them are unaware of their infection. HCV is commonly called a "silent killer" because it often has no symptoms and can go decades without being detected. Chronic HCV is the leading cause of liver cancer and the most common reason for liver transplantation in the U.S.

This study was funded by Vertex Pharmaceuticals.

Dr. Kwong will present these data on Saturday, May 19 at noon PT in Halls C-G of the San Diego Convention Center.

The Number of Grafts Available for Liver Transplantation is Decreasing as a Result of Increasing Donor Age, Metabolic Syndrome and Donation After Cardiac Death (Abstract #841)

The number of liver transplants has declined in the U.S. since 2006, so investigators led by Eric S. Orman, MD, gastroenterology fellow, the University of North Carolina, Chapel Hill, looked at various donor factors to determine why. By studying the United Network for Organ Sharing (UNOS) database for all donor information, researchers assessed which factors prompted physicians to discard an organ.

With standard donation, a patient is declared brain dead and kept on cardiovascular support so the organs can continue to receive oxygen and blood before being removed for transplant. In recent years, surgeons have also increasingly used the method known as donation after cardiac death, which occurs when patients die and the heart stops on its own. Cardiac death donation is considered an alternative way to donate organs and has been promoted as a way to increase the total number of organ donors. An increasingly large percentage of organ donors are in the donation after cardiac death category; less than 10 years ago, it was fewer than 2 percent, but currently, the rate has increased to more than 12 percent.

However, there is a widespread pattern of health-care professionals becoming increasingly reluctant to use organs donated after cardiac death. In reviewing the UNOS database, researchers found that the total number of donors who have at least one organ recovered for transplant has stopped increasing over the past few years, despite an increasing proportion of donation after cardiac death donors.

Investigators looked at the group of organ donors who had at least one organ recovered for transplant to determine whether the donor liver was a fatty liver. By reviewing donor characteristics that are strongly associated with having a fatty liver, such as diabetes, obesity, older age and high blood pressure, researchers found that these factors were all associated with discarding a liver. "Cardiac death donation is negatively impacting the overall number of liver transplants that we can do," said Dr. Orman.

The next step of the research is to look more closely at why more livers are being discarded, how large of a role donation after cardiac death is playing in those organs discarded, and what is driving the increase in donation after cardiac death.

No pharmaceutical funding was provided for this study.

Dr. Orman will present these data on Monday, May 21 at 4 p.m. PT in Halls C-G of the San Diego Convention Center.

Patterns of Usage of Acetaminophen in Excess of Four Grams Daily in a Hospitalized Population at a Tertiary Care Center (Abstract #743)

Hospitalized patients who receive multiple orders of medication containing acetaminophen are likely to receive a higher than intended dose of the drug, even when provided by physicians, according to new research from Thomas Jefferson University Hospital, Philadelphia, PA.

Reviewing 46,000 hospital admissions over a two-year period, investigators led by Jesse Civan, MD, GI fellow, division of gastroenterology, Thomas Jefferson University Hospital, found that about 1,100 individuals received more than 4 grams of acetaminophen on at least one day. In other words, about 2.5 percent of all patients admitted to the hospital received more than what is currently considered the safe cumulative daily dose on at least one calendar day.

Investigators sought to determine exactly how much acetaminophen was being dispensed in a large tertiary-care hospital and how it compared to the generally accepted safe maximum dose. They reviewed a computer database tracking every patient admitted to their hospital and every dose of medicine prescribed and received. This allowed them to calculate exactly how much medication patients were exposed to, including any medication containing acetaminophen, such as Tylenol®, Percocet® and other similar medicines, and to generate a list of all patients who received more than 4 grams of acetaminophen on at least one calendar day.

Researchers also reviewed liver function and injury, which are reported in the same database, to determine potential detrimental effects of acetaminophen use on patients. By reviewing a specific blood test — the alanine amino-transferase (ALT) test, which is generally used to screen for liver injury possibly related to acetaminophen — Dr. Civan and his colleagues found that only a small minority of patients were administered an ALT test. They attribute this finding to the fact that the blood test is only usually checked when a physician is particularly concerned about a possible liver problem.

In the small minority of patients who did have an ALT checked, there was insufficient data to do a "formal cause analysis" to determine whether an abnormal ALT could be blamed on the acetaminophen exposure. Because of the paucity of ALT monitoring, no conclusion could be reached about whether the acetaminophen exposure might have had any detectable detrimental consequences.

Dr. Civan added that these findings could have implications on public health and the need to improve patient education regarding safe dosages at home, since many patients will likely attempt to emulate the medications provided at the hospital once they get home. He concluded that further study in this closely monitored population in which every dose of acetaminophen-containing medication administered is recorded might shed light on the ongoing discussion at the U.S. Food and Drug Administration and elsewhere regarding new recommendations for maximum safe daily dosing. Dr Civan stressed that although it remains unclear whether blood test abnormalities may have resulted from acetaminophen use, he did not find any evidence of any cases of serious liver injury.

Acetaminophen has been under increasing scrutiny in the U.S. — it is the leading cause of acute liver failure and emergent liver transplant, and previous studies have suggested that unintentional overdose is a significant problem. There has also been debate in the medical literature about whether a less severe form of acetaminophen-induced liver injury due to unintentional overdose may be important.

This study received no pharmaceutical funding.

Dr. Civan will present these data on Monday, May 21 at 2:15 p.m. in 6e, San Diego Convention Center.

Herbal and Dietary Supplement Hepatoxicity in the U.S.A. (Abstract #167)

Dietary supplements used for body building and weight loss are the most common of any supplements to cause liver injury, according to new research from the U.S. Drug Induced Liver Injury Network (DILIN). Dietary supplements include herbal remedies, bodybuilding supplements, health food supplements, or anything that people can buy over the counter or online that is not prescribed by a physician.

Liver injury from medication is the main reason why drugs are taken off the market. While estimates suggest that herbal/dietary supplement products are used by up to 40 percent of the U.S. population, their side effects, including potential toxicity, is not well defined. Researchers led by Victor J. Navarro, MD, an investigator funded by the National Institutes of Health-sponsored DILIN, and professor of medicine, pharmacology and experimental therapeutics, Thomas Jefferson University, Philadelphia, PA, sought to explore liver injury from herbal/dietary supplements by examining the types of products taken, and the severity and outcomes associated with liver injury due to them.

Investigators looked at 109 cases of patients in the DILIN who appeared to have liver damage due to dietary supplements; most were male, white and overweight. They found that the supplements most likely to be the cause of liver injury were those reported for body building and for weight loss.

"There is so little regulation of the many products on the market; we couldn't possibly begin to figure out which products to target first without doing this research," said Dr. Navarro. He added that now that they know that bodybuilding and weight loss supplements are the most common causes of dietary supplement-induced injury among the products, they can focus their efforts accordingly.

Investigators are also looking at targeted components of herbal/dietary supplements. For example, previous studies have shown that green tea extract, which can be added to herbal/dietary supplements in high concentrations in pill form, can potentially cause damage to the liver. So DILIN investigators have also sought to determine how common the ingredients of green tea are in dietary supplements when the manufacturer has not identified it as such.

They hypothesized that green tea extract is prevalent in many products but is not specifically identified — in fact, their research has shown that it is present in up to 40 percent of products in which it was not listed on the label. For this reason, investigators will always have difficulty linking liver injuries to green tea extract unless they do a careful analysis of each product.

Dr. Navarro cautioned that because it is not well known how common liver injury is due to dietary supplements, it is difficult to suggest how likely it is that someone would suffer liver damage, but that this is another area where investigators are looking to do more research.

Investigators now have many more cases to study and their next step is to understand how the supplements cause injury and why. They are working with the Food and Drug Administration to identify various contaminants and determine which of the products on the market are the most harmful, especially since herbal/dietary supplement are not tightly regulated. They are also studying possible factors that may predispose a consumer of herbal/dietary supplement to liver injury, such as genetic makeup.

Dr. Navarro will present the DILIN's research data on Saturday, May 19 at 2:15 p.m. PT in Halls C-G of the San Diego Convention Center.

###

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19 - 22, 2012, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

Follow us on Twitter @DDWMeeting; hashtag #DDW12. Become a fan of DDW on Facebook.

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PRESS RELEASE

May 22, 2012, 8:00 a.m. EDT

Total of 48 Subjects To Be Enrolled at Four Sites Across U.S.

ATLANTA, May 22, 2012 /PRNewswire via COMTEX/ -- GeoVax Labs, Inc. (otcqb/otcbb:GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced that the NIH-funded HIV Vaccine Trials Network (HVTN) has opened enrollment for a Phase 1 trial for the company's second-generation HIV vaccine. The second-generation vaccine is identical to the first generation (currently in a Phase 2a clinical trial) except for the inclusion of granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjuvant (additive) to enhance vaccine responses. GM-CSF is a normal human protein that promotes the initiation of immune responses. GeoVax's second-generation vaccine co-expresses GM-CSF with HIV proteins in the DNA priming vaccinations. GM-CSF is not included in the MVA boost for the GeoVax DNA prime-MVA boost regimen.

The trial, designated HVTN 094, employs a dose-escalation to evaluate the safety and immunogenicity of the GM-CSF adjuvanted vaccine. In the non-human primate model, co-expression of GM-CSF in the DNA prime achieved a 90% per exposure reduction in infection, a significant improvement over the unadjuvanated vaccine. This difference in vaccine efficacy translated into 70% of vaccinated animals being protected against 12 repeated rectal challenges. Assuming a successful outcome, the company expects the adjuvanted version of the vaccine to be carried forward into Phase 2a/2b efficacy testing.

The HVTN 094 trial will enroll a total of 40 vaccinated and 8 control/placebo subjects to be studied at four sites nationwide: the University of Alabama at Birmingham; Brigham and Women's Hospital, Boston; the University of Rochester, and the San Francisco Department of Public Health. The first inoculation was given at Brigham and Women's Hospital, Boston. Funding for HVTN's conduct of the trial will come from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).

Robert McNally, Ph.D, President and Chief Executive Officer of GeoVax, said, "We are extremely pleased the HVTN is conducting the trial with the adjuvanted vaccine. They have substantial experience with our unadjuvanted vaccine and possess appropriate expertise for this first human trial of our GM-CSF co-expressing vaccine that has shown such good promise in preclinical studies."

About GeoVax GeoVax Labs, Inc. is a biotechnology company developing human vaccines for HIV (Human Immunodeficiency Virus - that leads to AIDS). GeoVax's HIV/AIDS vaccine technology is exclusively licensed from Emory University in Atlanta, GA, and is the subject of more than 20 issued or filed patent applications. GeoVax vaccines are designed for use in uninfected people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected. GeoVax vaccines are also being tested as a therapeutic treatment (for people already infected with the HIV-1 virus).

GeoVax's core vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institute of Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC) and GeoVax. The technology uses recombinant DNA to prime the immune response and recombinant modified vaccinia Ankara (MVA) to boost the primed response. Both the DNA vaccine and the MVA vaccine express non-infectious virus-like-particles displaying the natural trimeric form of the HIV envelope protein.

GeoVax's vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. These trials have tested various combinations and doses of the DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported Phase 2 testing in an ongoing, fully enrolled, 299 participant trial in North and South America. The vaccine is also undergoing Phase 1 /2 testing as a therapeutic in HIV-infected individuals.

About the HVTN The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.

About NIAID NIAID conducts and supports research--at NIH, throughout the United States and worldwide--to study the causes of infections and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/ .

For more information, please visit www.geovax.com .

Forward-Looking Statements Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: HVTN will commence, complete enrollment, and generate data regarding GeoVax vaccine clinical trials as and when expected, GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective, less costly, or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

Contact The Investor Relations Group: Erika Moran, Investor Relations Janet Vasquez, Public Relations (212) 825-3210

SOURCE GeoVax Labs, Inc.

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Project ECHO™, University of New Mexico Office of Continuing Education, and Consensus Medical Communications are pleased to announce the annual Project ECHO™: Knowledge Networks for New HCV Therapies live teleconference continuing medical education weekly activity.

Englewood, CO (PRWEB) May 22, 2012

Project ECHO™, University of New Mexico Office of Continuing Education, and Consensus Medical Communications are pleased to announce the annual Project ECHO™: Knowledge Networks for New HCV Therapies live teleconference continuing medical education weekly activity. The target audience for the live teleconference CME activities is hepatologists, gastroenterologists, specialists (NPs)/(PAs), and other clinicians who treat or wish to treat patients with HCV. Project ECHO™ was an idea conceived by the activity’s executive director, Sanjeev Arora, MD, FACP. Dr. Arora has been involved with the management of hepatitis C for over 15 years as well as the implementation and development of the Hepatitis C Disease Management Program at UNMHSC. Project ECHO™ was developed as a service delivery, education, and evaluation platform. The ECHO model contains a key component known as knowledge networks, which allows for the expertise of a specialist to be shared with numerous primary providers through telehealth clinics. This component gives rural areas access to care without having to recruit, retain, and fund additional providers.

Project ECHO™: Knowledge Networks for New HCV Therapies conference call CME activities will be led by top faculty members in the fields of hepatology and gastroenterology. The program chairs are Sanjeev Arora, MD, FACP, and Michael W. Fried, MD. The regional meeting chairs are Robert G. Gish, MD; Norah Terrault, MD, MPH; Ira M. Jacobson, MD; and Mark Sulkowski, MD. The clinical team leaders are Isabel Juarez, RN, BSN; Lisa Catalli, BA, NP; Lisa Richards, MSN, FNP-BC; Sherilyn C. Brinkley, MSN, CRNP; and Monique Carasso, NP. The guest faculty experts are John Douglas Scott, MD, MSc; Adrian Di Bisceglie, MD, FACP, FCP (SA); Kenneth E. Sherman, MD, PhD; Bruce Bacon, MD; Paul Pockros, MD; Rajender Reddy, MD; and David Nelson, MD.

Each weekly teleconference meeting will be 60-75 minutes in length. Clinicians may participate as a guest faculty member and may receive a modest honoraria for submitting and presenting a patient case on calls.

Upon completion of these weekly teleconference CME clinics, the participant should be able to:

  • Identify and reinforce comprehensive best practices in HCV treatment.
  • Discuss how DAAs uniquely target the hepatitis C virus and detail their anticipated benefits, side effects, and role in therapy.
  • Identify appropriate candidates for triple therapy combinations and their expected outcomes.
  • Evaluate the viral kinetic responses that define the non-responder and relapse populations and assess the options and expected outcomes for retreatment with PEG-IFN and RBV vs triple therapy with PIs.
  • Identify and address AEs and potential drug-drug interactions related to PIs.
  • Evaluate viral resistance and implement strategies to prevent resistance and to identify when treatment should be halted.
  • Apply evolving data related to DAA therapies and discuss potential future applications.

Project ECHO™: Knowledge Networks for New HCV Therapies weekly teleconference meetings occur twice every Tuesday starting May 15, 2012 and ending October 23, 2012.

Teleconference option 1 will occur at 4:30pm EST, 3:30pm CST, 2:30pm MST, and 1:30pm PST.
Teleconference option 2 will occur at 7:30pm EST, 6:30pm CST, 5:30pm MST, and 4:30pm PST. For more information, please contact us:

Call us toll-free at 1-855-276-6855
or
Register online at http://www.echohcvexperts.com

About ProjectECHO™
Project ECHO™ (Extension for Community Healthcare Outcomes) is an innovative health care program that uses state-of-the-art technology to expand access to specialty health care in rural and medically underserved communities. Project ECHO™ is part of the Department of Internal Medicine at the University of New Mexico Health Sciences Center. For more information on Project ECHO™, please go to http://echo.unm.edu/.

Using this innovative approach to expanding health care through case-based learning, Project ECHO™ Knowledge Networks for New HCV Therapies is providing you with a unique opportunity to obtain real-time consultation with specialists, have your HCV management questions answered via web/teleconference activities held weekly on Tuesday afternoons, and receive CME credit for participating. Participate by submitting your patient cases for consultation, learn how to incorporate recent advances in HCV therapies, and take action to optimize outcomes in your patients.

About Consensus Medical Communications
Consensus Medical Communications strives to affect patient care and quality of life through strategically planned medical education for a wide array of health care professionals. We emphasize excellence, innovation, and outcomes in continuing medical education programming for physicians, pharmacists, nurses, and other clinical specialists.

We seek excellence through maintaining a balance of timeliness, accuracy, scientific rigor, and clinical relevance.

We strive for innovation in the design and implementation of educational initiatives that address the needs of highly targeted audiences.

We work toward outcomes that not only improve knowledge but motivate progress from current to best practices in modern medicine and pharmacology.

With more than 100 years combined experience in medical education and publishing, our leadership team and senior staff provide program creativity and scientific credibility, coupled with unparalleled customer service, all in accordance with Accreditation Council of Continuing Medical Education (ACCME) guidelines.

Release Issued by Audience Generation, LLC
Audience Generation is a forward-thinking agency at the forefront of the digital revolution and is a nationally and internationally recognized provider of integrated marketing, advertising, and technology services and solutions that offer a new way to find, generate, and engage live, online, social, and mobile audiences where they exist on demand.

Audience Generation is known for its creative strategy, actionable solutions and measurable approach to transforming the ways brands interact with their target audience, whether they exist in person, online, via social networks, or on their mobile devices.

Audience Generation has produced winning traditional, online, e-commerce, social and mobile campaigns including mobile application solutions for Fortune 500, small and medium businesses, not-for-profit organizations, national and international associations and societies, and venture-backed start-up companies across a variety of industry verticals around the world.

To learn how Audience Generation can find your ideal customer, reach them where they exist, build your brand, and grow your bottom line, please call us at 512-708-4678 or email us at growyourbusiness(at)audiencegeneration(dot)com or visit us at http://www.audiencegeneration.com.

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