INCIVEK offers hopeBy Maryanne Kocis MacLeod, Macomb Daily Staff Writer
ore than 4 million Americans are living with hepatitis C, an infection caused by a virus that attacks the liver causing inflammation. The vast majority don't know they have it.
"Hepatitis C can lead to liver failure, cancer and the need for transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half," said Ira Jacobson, M.D., chief of the division of Gastroenterology and Hepatology, Weill Cornell Medical College. Jacobson is also the principal investigator in a recent study of a new, FDA-approved drug, INCIVEK, shown to cure 79 percent of those treated.Through education, Kress learned that hepatitis C was treatable but not curable. Under Gordon's care, he started the standard treatment, which includes pegylated-interferon and ribavarin, designed to keep the virus in check — to a point.
"I never had to take time off work, but it does zap your energy level," Kress said.
After being invited to participate in the blind study — "I didn't know if I would get the new drug or not" — his energy level continued to lag. Although he developed a common allergic reaction to the new drug — extreme itching — and had to stop treatment before the trial was complete, Kress has been virus free for one year.
Note: In the below paragraph it appears there is either a typo, or an error relating to the two-drug regimen.
Which is standard therapy = pegylated-interferon and ribavarin.
The paragraph read as : via injections a few times a day
It should have read somewhat like this; Via injections (once a week of pegylated-interferon ) and ribavarin. .
The new drug Incivik (which is in pill form is taken three times a day).
Here is a link to the prescribing information. Thank you STARR for catching this !
"I feel great," said Kress, whose energy has returned to pre-treatment levels. "We live on a lake and enjoy water sports; we're traveling again and around the house. I can do everything I'm told to do."
That includes repair work and painting. Most recently Kress and his wife, Gail, remodeled their kitchen. In July, the couple plan a trip to the East Coast in their motor home.
"We are so pleased with the course this treatment has taken," Gordon said. "We are offering hope."
"I never had to take time off work, but it does zap your energy level," Kress said.
After being invited to participate in the blind study — "I didn't know if I would get the new drug or not" — his energy level continued to lag. Although he developed a common allergic reaction to the new drug — extreme itching — and had to stop treatment before the trial was complete, Kress has been virus free for one year.
Note: In the below paragraph it appears there is either a typo, or an error relating to the two-drug regimen.
Which is standard therapy = pegylated-interferon and ribavarin.
The paragraph read as : via injections a few times a day
It should have read somewhat like this; Via injections (once a week of pegylated-interferon ) and ribavarin. .
The new drug Incivik (which is in pill form is taken three times a day).
Here is a link to the prescribing information. Thank you STARR for catching this !
"The regimen is fairly complicated," Gordon explained. "INCIVIK has to be administered in combination with the standard two-drug treatment, "via injections a few times a day." It takes a motivated patient, committed for the entire course of therapy, 24 to 48 weeks, depending on a patient's response."
"I feel great," said Kress, whose energy has returned to pre-treatment levels. "We live on a lake and enjoy water sports; we're traveling again and around the house. I can do everything I'm told to do."
That includes repair work and painting. Most recently Kress and his wife, Gail, remodeled their kitchen. In July, the couple plan a trip to the East Coast in their motor home.
"We are so pleased with the course this treatment has taken," Gordon said. "We are offering hope."
"This is a major leap forward in the battle against hepatitis C," said Stuart Gordon, M.D., director of Hepatology at Henry Ford Hospital in Detroit. "Treatment results in the irradiation of the virus, which is quite remarkable. When people achieve this cure, physical damage is reversed."
As a result, hepatitis C — contracted through blood transfusions before 1990 or sharing dirty needles — is perhaps the only viral infection that can currently be cured, Gordon explained.
"In the next five years, we'll probably have this disease licked," Gordon said.
That's an especially relevant development given the current progression of the disease.
"As this group of patients gets older, the problems get worse," Gordon said. "We could have dire circumstances over the next decade if we don't turn this around."
Commerce Township's Robert Kress is one of the lucky ones.
Like the majority of patients, Kress did not know he was infected until about four or five years ago, when a Red Cross worker uncovered an anomaly in his blood.
"It was shocking," said Kress, 60, a DTE lineman for the past 41 years. He traced the infection back to a blood transfusion he received in his mid-20s as part of treatment for a collapsed lung. "You conjure ideas of how life is going to continue. You expect to live a long, healthy life. Then suddenly you find out: Maybe it's not going to be a great senior year."
http://macombdaily.com/articles/2011/06/14/lifestyles/srv0000012030566.txt
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Digestive Disease Week Wrap-up
Noninvasive assessment of liver fibrosis (and Biobsy) -
"The gold standard for detecting liver fibrosis remains percutaneous liver biopsy, although this procedure is not without its own inherent limitations.....Despite the proliferation of investigations and clinical experiences with noninvasive methods for detecting hepatic fibrosis, there remain a number of critical questions about the clinical effectiveness of these approaches"
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.From Scope
New online tool designed to boost clinical trial enrollment
on June 13th, 2011
The Medicine Show’s Matthew Herper has reported on another way for patients to identify research trials:
PatientsLikeMe, an online health data sharing platform, has come up with a more intuitive solution [for finding patients to enroll in clinical trials]. Patients enter their illness, age, and zip code and get a list of clinical trials into that they can enter. Hopefully this will help more patients find studies that might offer them some hope and help advance the speed of research.The new feature, which the company announced late last week, will update daily using trial information from ClinicalTrial.gov.
Previously: What motivates people to participate in clinical trials?
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FDA
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FDA Warns of Serious Risks Associated With Liraglutide
6/13/2011 Medscape Gastroenterology Headlines
Some primary care providers are not fully aware of the risks for thyroid C-cell tumors and acute pancreatitis associated with liraglutide, the FDA says. Medscape Medical News
Healthy You
The good life: Good sleepers have better quality of life and less depression
Study shows that a nightly sleep duration of six to nine hours is associated with higher ratings for quality of life and lower ratings for depression.
DARIEN, IL – Getting six to nine hours of sleep per night is associated with higher ratings for quality of life and lower ratings for depression, suggests a research abstract that will be presented Tuesday, June 14, in Minneapolis, Minn., at SLEEP 2011, the 25th Anniversary Meeting of the Associated Professional Sleep Societies LLC (APSS).
Results show that people with a "normal" sleep duration of six to nine hours per night had higher self-reported scores for quality of life and lower scores for depression severity compared to short and long sleepers. These differences were statistically significant in all comparisons. Among patients who reported having perfect health, there were a higher percentage of normal sleepers, who also had significantly lower scores for depression severity compared to short and long sleepers with perfect health.
"These results are important because they provide more information about the importance of getting enough sleep, which is usually six to nine hours per night," said principal investigator Dr. Charles Bae, neurologist at the Cleveland Clinic Sleep Disorders Center in Ohio. "People may already expect that their quality of life could be decreased when they do not get enough sleep, but they may not realize that sleeping too much can also have a negative impact."
Bae and colleagues analyzed data from 10,654 patient records, which were collected from January 2008 to May 2010. Study subjects had a mean age of about 52 years. Quality of life was assessed using the EQ-5D questionnaire, a standardized measure of health outcome. The nine-item Patient Health Questionnaire was used as a screening tool for depression. Generalized estimating equations were used to account for multiple visits per patient, and a multi-variable logistic regression model adjusted for demographic differences such as age, gender, race and marital status. Short sleep was defined as less than six hours per night, and long sleep was classified as more than nine hours per night.
"It was surprising to see that sleeping less than six hours and more than nine hours is associated with a similar decrease in quality of life and increase in depressive symptoms," said Bae. "I thought that there would be changes in quality of life and degree of depressive symptoms for short and long sleepers, but did not expect that those changes would be similar in both groups."
The American Academy of Sleep Medicine reports that individual sleep needs vary. However, most adults need about seven to eight hours of nightly sleep to feel alert and well rested during the day.
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The SLEEP 2011 abstract supplement is available for download on the website of the journal SLEEP at http://www.journalsleep.org/ViewAbstractSupplement.aspx. A joint venture of the American Academy of Sleep Medicine and the Sleep Research Society, the annual SLEEP meeting brings together an international body of more than 5,000 leading clinicians and scientists in the fields of sleep medicine and sleep research. At SLEEP 2011 (www.sleepmeeting.org), more than 1,000 research abstract presentations will showcase new findings that contribute to the understanding of sleep and the effective diagnosis and treatment of sleep disorders such as insomnia, narcolepsy and sleep apnea.
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Article outlines principles for a conservative approach to prescribing medication
CHICAGO – A shift toward more conservative medication-prescribing practices would serve patients better, according to a review article published Online First today by Archives of Internal Medicine, one of the JAMA/Archives journals. The article is part of the journal's Less Is More series.
As background, the article notes that the majority of patients under age 65 years receive at least one prescription drug annually. However, according to the authors, not every patient visit needs to result in a prescription. They point to "the recent spate of revelations of undisclosed and unexpected adverse effects of drugs in multiple therapeutic categories" as just one reason to take a more measured approach to medication usage.
Gordon D. Schiff, M.D., from Harvard Medical School, Boston, with colleagues in the medical and pharmacy divisions of the University of Illinois at Chicago, outlines a series of steps that can be taken to rein in prescription writing. "Although others have used labels such as healthy skepticism, more judicious, rational, careful, or cautious prescribing," they write, "we believe that the term conservative prescribing conveys an approach that goes beyond the oft-repeated physician's mantra, 'first, do no harm.'" Among the steps they recommend for conservative prescribing:
- Think beyond drugs. Would other interventions help? Would a medication simply mask symptoms without treating the problem? Can a condition be prevented instead of treated? Would waiting to see if the symptoms self-resolve be wise?
- Practice more strategic prescribing. Do you have a solid understanding of medication choices? Is there a valid reason to switch to a new drug? Is it the right drug for your patient? Can you avoid using multiple medications?
- Maintain heightened vigilance regarding adverse effects. Do you check with patients about potential drug reactions? Do you teach them the warning signs? Are the drugs you're choosing prone to withdrawal symptoms or relapse?
- Approach new drugs and new indications cautiously and skeptically. Where do you get your information about new treatments? Can you wait until a new drug has had a longer track record? Does the drug actually help resolve the core problem? Is it actually indicated for this problem? Does it deliver what it promises? Do studies tell the whole story on a drug?
- Work with patients for a more deliberative shared agenda. Can you persuade patients not to demand drugs they have seen or heard advertised? Is a patient's noncompliance with therapy the source of the problem? Has the patient already tried this drug without success? Can you encourage healthy skepticism in your patients?
- Consider longer-term, broader effects. Would a different therapy be less likely to cause future harm? Can you find a way to make the prescribing system better?
(Arch Intern Med. 2011;10.1001/archinternmed.2011.256. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Note: This work was supported in part by the Formulary Leveraged Improved Prescribing (FLIP) project, funded by the Attorney General Consumer and Prescriber Education Grant Program, and a Centers for Education and Research (CERT) grant from the Agency for Healthcare Research and Quality. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Commentary: Conservative Prescribing of OpioidsAn accompanying editorial suggests that, whenever reasonably possible, physicians scale back the use of opioids for treating pain. The piece, authored by Deborah Grady, M.D., M.P.H., and Seth Berkowitz, M.D., both from the University of California, San Francisco, and Mitchell Katz, M.D., from the Los Angeles Department of Health Services, is also part of the Less Is More series.
As background, the authors note that opioids are the most commonly prescribed drugs in the country, and that up to one in five office visits ends in a prescription for these medications. "This situation would be acceptable if the benefits of opioid treatment outweighed the risks," remark the authors. However, they say, the drugs do not always deliver substantial pain relief, and carry a high risk of addiction, side effects and death.
To reduce the reliance on opioids, the authors promote many of the same principles discussed by Schiff and colleagues. They advise pursuing nonpharmacologic treatments, starting therapy with trusted over-the-counter and nonopioid prescription drugs and referring patients to pain specialists as needed. Lastly, they point to the need to communicate effectively with patients. "The desire to relieve the pain and illness of others is the reason many of us went to medical school," they acknowledge. "However painful it is to explain to patients who are experiencing chronic pain that we do not have effective and safe treatments for their pain, we should be willing to do so when appropriate."
(Arch Intern Med. 2011;doi:10.1001/archinternmed.2011.213. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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By: M. ALEXANDER OTTO, Internal Medicine News Digital Network
HONOLULU – Low-normal serum folate, at a level between 2 and 7ng/mL, is associated with an increased risk of depression in diabetes patients, a finding that suggests that, as with other depressed patients, folate supplementation might boost responses to antidepressants.
HONOLULU – Low-normal serum folate, at a level between 2 and 7ng/mL, is associated with an increased risk of depression in diabetes patients, a finding that suggests that, as with other depressed patients, folate supplementation might boost responses to antidepressants.
Among 58 patients with diabetes and low-normal serum folate levels, the age-adjusted prevalence of depression in the study was 6.3%; it was 4.9% in 488 patients with serum folate at or above 7ng/mL. Low-normal folate was associated with a twofold increase in the odds of depression in patients with diabetes (odds ratio, 2.29; confidence interval, 1.01-5.18).
Although folate levels have been previously correlated with depression, the study seems to be the first to find the connection in people with diabetes. Supplementation "has the potential to reduce the dosage of antidepressants necessary for these patients and potentially minimize metabolic side effects," something to which people with diabetes are particularly prone. However, those with diabetes might need more than the typical daily dose of about 400 mcg to overcome the disease’s metabolic derangements, Dr. Kurt Peters reported at the annual meeting of the American Psychiatric Association.
Also, "this study indicates the need to include diabetic patients in future research regarding folic acid supplementation in depression," he and his colleagues concluded.
Dr. Peters, a psychiatrist in private practice in Colorado Springs, said that he routinely supplements his depressed patients with folic acid. "It’s fairly innocuous, and so I think many of us go ahead and treat people with folate. It’s hard to identify who’s going to respond," perhaps 20% in a month or two."
In addition, he said, he has found women to be more responsive to this approach than men, a finding that is consistent with the literature.
The study was based on National Health and Nutrition Examination Survey data collected in 1999-2006. Depression was assessed by either the World Health Organization Composite International Diagnostic Interview or the Patient Health Questionnaire, both of which match the DSM-IV criteria for major depression.
The researchers excluded diabetes patients who had frank folate deficiency (levels below 2 ng/mL). They also adjusted for depression risk factors, including age, sex, race, marital status, and smoking.
In a separate talk, Dr. Srijan Sen, a psychiatrist at the depression center of the University of Michigan, Ann Arbor, agreed that there’s a role for folic acid supplementation in treatment-resistant depression.
"Omega-3 fatty acids and SAM-e [S-adenosyl methionine] have also been shown [to help] in randomized trials. The number needed to treat and the absolute increase in remission rates [are] relatively small, but they seem to have very mild to no side effects, so they are worth considering and using," he said.
Psychiatrist John Greden, the depression center’s executive director, noted, however, that "methyl folate seems to be an inducer of hepatic enzymes that lower the level of mood stabilizers. If people are adding methyl folate, and these people are on mood stabilizers, you may need to adjust doses of mood stabilizers."
Dr. Peters said he has no relevant disclosures. The study was funded by the Philadelphia College of Osteopathic Medicine’s D’Alonzo Memorial Scholarship.
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Off The Cuff
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Illegal Organ Deals Strike Fear into Hearts of Chinese
Wang Aihua, Lai Yuchen and Wu Di
(Xinhua, China, June 8, 2011)
"There are no official statistics regarding the number of illegal organ deals taking place in China every year…fairly vibrant underground market…websites…for organ deals…[are] just a click away…fed by a massive supply gap. Statistics show there are about 1.5 million patients on China's organ transplant waiting list, but the number of registered donors is only about 10,000, accounting for less than one percent of the demand…In 2007 [China banned]…living people from donating organs, except for spouses, blood relatives and in-laws or adopted family members…this year, the Standing Committee of the National People's Congress…approved a revision to the country's Criminal Law. The revision states that 'organizing others to sell human organs' is a crime."
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.China: Medical Tourism Getting Popular Among the Rich
Shan Juan
(China Daily, June 4, 2011)
"Destinations popular with the Chinese, besides Switzerland, include South Korea for cosmetic surgery, Hong Kong and the United States for childbirth, and Germany for general health checkups, with special attention to cancer. A seven- to 10-day stay generally costs 300,000 to 500,000 yuan ($46,269 to $77,115), including first-class airfare, accommodations and health services…Internationally, about 6 million people -- largely from the United States, Japan, Europe and the Middle East -- went abroad last year seeking medical services, mostly for a lower price or shorter waiting period, experts estimated. About 1.2 million of them chose Thailand and 450,000 India.".
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Illegal Organ Deals Strike Fear into Hearts of Chinese
Wang Aihua, Lai Yuchen and Wu Di
(Xinhua, China, June 8, 2011)
"There are no official statistics regarding the number of illegal organ deals taking place in China every year…fairly vibrant underground market…websites…for organ deals…[are] just a click away…fed by a massive supply gap. Statistics show there are about 1.5 million patients on China's organ transplant waiting list, but the number of registered donors is only about 10,000, accounting for less than one percent of the demand…In 2007 [China banned]…living people from donating organs, except for spouses, blood relatives and in-laws or adopted family members…this year, the Standing Committee of the National People's Congress…approved a revision to the country's Criminal Law. The revision states that 'organizing others to sell human organs' is a crime."
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.China: Medical Tourism Getting Popular Among the Rich
Shan Juan
(China Daily, June 4, 2011)
"Destinations popular with the Chinese, besides Switzerland, include South Korea for cosmetic surgery, Hong Kong and the United States for childbirth, and Germany for general health checkups, with special attention to cancer. A seven- to 10-day stay generally costs 300,000 to 500,000 yuan ($46,269 to $77,115), including first-class airfare, accommodations and health services…Internationally, about 6 million people -- largely from the United States, Japan, Europe and the Middle East -- went abroad last year seeking medical services, mostly for a lower price or shorter waiting period, experts estimated. About 1.2 million of them chose Thailand and 450,000 India.".
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