HCV News; Telaprevir & Boceprevir SVR - Fibrosis/Ethnicity Reported at FDA Hearing

From NATAP Executive Director: Jules Levin

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Boceprevir & Telaprevir SVR Rates Reported at FDA Hearling

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Telaprevir & Boceprevir SVR - Fibrosis/Ethnicity Reported at FDA Hearing 

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From HIV and Hepatitis

Liz Highleyman, Editor-in-Chief and Publisher
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.HBV Breakthrough Common in Patients Taking Oral Meds
Nearly half of patients taking nucleoside/nucleotide analogs to treat hepatitis B experienced viral breakthrough over 5 years, and about 40% of these were not attributable to drug resistance mutations.

FDA Committee Unanimously Recommends Telaprevir (Incivek)
The FDA Antiviral Drugs Advisory Committee last week voted 18-0 to recommend approval of the HCV protease inhibitor telaprevir (Incivek) for people with genotype 1 chronic hepatitis C.

Legal Barriers To Wide HIV Testing Now Mostly Gone
10 minutes ago
Most states and U.S. jurisdictions now have HIV testing laws compatible with the 2006 recommendations of the CDC, researchers reported.

9 Healthcare Companies Expecting May Catalysts
Merck (MRK) has an FDA PDUFA date for Victrelis on May 7th. However it must be noted that this date is an estimate, as an exact date was not given by Merck or the FDA. Victrelis is also a Hepatitis C drug. This means that two new Hepatitis C drugs could be approved this month and marketed in 2011. It is tough to make any calls on Victrelis since the action date is not set in stone, but an approval should give a small boost to Merck shares as investors will want to take advantage of the possible market of a Hepatitis C drug..
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.New Era of Hepatitis C Infection Treatment Dawning With Publication of Two Milestone Studies on New HCV Protease Inhibitor

A pair of studies published in the March 31 issue of The New England Journal of Medicine supports the use of boceprevir to boost the effectiveness of peginterferon–ribavirin therapy in people with chronic hepatitis C virus genotype 1 infection.

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ISSUE: MAY 2011 | .
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Addiction Wars: Marijuana: Medicine or Easy High?

Full story: Ivanhoe

Marijuana is the most commonly-used illegal drug in the U.S. Now, in 15 states and Washington DC, it is legal but only if your doctor says you need it.

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Transplant 

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After liver transplant as babies, young adults have good QOL

Last Updated: 2011-05-03 19:30:28 -0400 (Reuters Health)

By Nancy Lapid

PHILADELPHIA (Reuters Health) - Two decades after undergoing liver transplantation as infants, young adults have good health-related quality of life (HRQOL), a new study suggests.

Yesterday at the American Transplant Congress, Dr. Saeed Mohammad reported on 35 patients who received liver transplants between 1988 and 1992, at a median age of roughly one year.
When those same patients responded to a survey at a mean age of 23, 62% had attended college, 69% lived with their parents, and 80% of those over 23 were employed. Those education and employment statistics are equivalent to what's reported for their peers in the general population, Dr. Mohammed said.
The liver recipients' mean total score on the PedsQL 4.0 Generic Core Scale was 76, which was not significantly different from the score of 78 found in 1,171 controls.
Overall, based on that scale and on their Short Form (SF)-36 scores, these young adults have a HRQOL that's comparable to their healthy peers, except in the physical domain (53. 25 vs. 53.50, p=0.03).
But the lower physical domain scores "don't reflect how they're managing in life," senior investigator Dr. Estella M. Alonso said in an interview. Instead, they reflect the fact that patients need to "check yes" on more of those "have you ever been diagnosed with..." questions, she said.
In fact, liver recipients and controls had comparable scores for domains of vitality, bodily pain, mental health, social function, and emotional and physical roles. The transplant patients, however, had better scores than reported standards for age-matched patients with chronic diseases.
Dr. Alonso and Dr. Mohammed, both from Northwestern University in Chicago, told Reuters Health that the transplant group had a lower-than-average score on the Health Utility Index, but not by much. The best possible score is 1.0, the norm is 0.8, and the pediatric transplant survivors' average score was 0.75 (p<0.0001). That score is equivalent to scores for cancer survivors and higher than for people who have liver transplants as adults, Dr. Alonso said.
The two researchers said an earlier study by their group, done with younger liver transplant survivors, had shown lower school function and social function scores in patients compared to controls. The new findings in this older group suggest that most of those issues may resolve with time, Dr. Alonso said.
In the same session on pediatric liver transplantation at which Dr. Mohammad gave his talk, other presenters highlighted the importance of ensuring that teenagers make a smooth transition from pediatric to adult care. Dr. Alonso said the difficulty of that process is reflected in the fact that her team could only locate two thirds of the survivors from the original cohort.
Altogether, 181 children had been transplanted between 1988 and 1992 at the University of Chicago, where Dr. Alonso was working at the time. Social security records confirmed that 95 were still alive. (Most deaths had occurred relatively early after transplant, according to the researchers.) Of those 95 survivors, 36 had been lost to follow-up.
"We called the doctors the patients' records had been sent to, the doctors who the patients told us would be taking care of them, and often those doctors didn't have any information on them," Dr. Alonso said. "They hadn't seen or heard from them in years."

Healthy You

New evidence that caffeine is a healthful antioxidant in coffee

Scientists are reporting an in-depth analysis of how the caffeine in coffee, tea, and other foods seems to protect against conditions such as Alzheimer's disease and heart disease on the most fundamental levels. The report, which describes the chemistry behind caffeine's antioxidant effects, appears in ACS' The Journal of Physical Chemistry B.
Annia Galano and Jorge Rafael León-Carmona describe evidence suggesting that coffee is one of the richest sources of healthful antioxidants in the average person's diet. Some of the newest research points to caffeine (also present in tea, cocoa, and other foods) as the source of powerful antioxidant effects that may help protect people from Alzheimer's and other diseases. However, scientists know little about exactly how caffeine works in scavenging the so-called free radicals that have damaging effects in the body. And those few studies sometimes have reached contradictory conclusions.
In an effort to bolster scientific knowledge about caffeine, they present detailed theoretical calculations on caffeine's interactions with free radicals. Their theoretical conclusions show "excellent" consistency with the results that other scientists have report from animal and other experiments, bolstering the likelihood that caffeine is, indeed, a source of healthful antioxidant activity in coffee.

Ask the Experts June 2011

Q: A recent study about things that can trigger a heart attack included coffee. I thought coffee was good for you. What’s up?

A: Caffeine can raise blood pressure and heart rate briefly, especially in those not used to it, and thus may trigger a heart attack. But in the great majority of people, especially those used to caffeine, the transient boost in blood pressure isn’t a danger.

The analysis you mention, in The Lancet, estimated that 5 percent of heart attacks are triggered by caffeine. It based this solely on a 2006 study, which found that in light or occasional coffee drinkers, the risk of heart attack quadrupled in the hour after drinking coffee. In moderate drinkers, who had built up some tolerance to caffeine, the increase was much smaller; in heavy drinkers there was no increased risk. People who had multiple cardiac risk factors were at highest risk.

Keep in mind that many things can trigger a heart attack in high-risk people, notably physical exertion, alcohol, anger, a heavy meal, and sexual activity.

Most research has found that habitual coffee drinking does not increase the risk of hypertension or coronary artery disease. And coffee has indeed been linked to several potential benefits, including a reduced risk of type 2 diabetes, gallstones, and Parkinson’s disease. Most recently, a Swedish study in the journal Stroke found that women who drink coffee at least once a day are 25 percent less likely to have a stroke than those who rarely or never drink it.

The Cold War Isn’t Over

Zinc may help prevent colds after all, though not all forms may work

A cure for the common cold has been the holy grail for medical researchers, drug companies, and marketers of dietary supplements. So far nothing has stood up to scientific scrutiny, though you wouldn’t know it if you read the claims often made for most over-the-counter cold medicines and countless supplements. Besides vitamin C and echinacea (neither found to be of value), the most widely promoted supplement for colds has been zinc in various forms. Enthusiasm for zinc has seesawed over the years as positive and negative studies have alternated in the news.

A thumbs-up

Earlier this year zinc made headlines again, thanks to a review from the Cochrane Collaboration, which evaluates scientific research. It concluded that, compared to a placebo, zinc can shorten colds by about a day and reduce their severity somewhat, particularly when started within 24 hours of the first symptoms.

This is not new research, but an analysis of data from 15 “good-quality” studies done since 1987. The studies included 1,360 healthy people who took lozenges, tablets, or syrup in the form of zinc gluconate, acetate, or sulfate, usually at the first sign of a cold; doses ranged from 30 to 190 milligrams a day. Not all the studies found a benefit. The main adverse effects were nausea and a bad taste in the mouth.

In two of the studies in the review, children who took lower-dose zinc syrup for five to seven months developed fewer colds. This was the only evidence of a preventive effect, but these studies were of poorer quality.

It’s not certain how zinc may help. Lab tests have found that zinc in the mouth and throat can deactivate cold viruses, block them from adhering to the nasal membranes, and/or stop them from replicating. The mineral may also have some anti-inflammatory and antioxidant effects.

But hardly a eureka moment

The Cochrane review left many infectious disease experts still unconvinced, however, largely because the studies varied so much. Even the Cochrane authors concluded that, due to these inconsistencies, they couldn’t make recommendations about what dose or formulation of zinc should be used or for how long. Questions remained about whether the subjects may have known they were taking zinc, rather than a placebo, since zinc has a strong unpleasant taste—if so, that could have affected the results. Further, because of possible side effects and questions about the effectiveness of some formulations, the Cochrane authors concluded that zinc is “advised with caution.”

More positive is Dr. Ananda Prasad, a leading zinc researcher at Wayne State University School of Medicine in Detroit, two of whose studies were included in the Cochrane review. Zinc as a cold treatment, he said, “is controversial because people have used all kinds of preparations and doses and often did not take lozenges within 24 hours of the first symptoms. If zinc is used properly, and you take lozenges that release it effectively—zinc acetate, though gluconate may also be okay—you can cut the duration of a cold by some 50 percent and the severity very significantly as well.” But, Dr. Prasad warned, ingredients that are often added to the products to mask the zinc taste—including ascorbic acid (that is, vitamin C), citric acid, and sorbitol—may inactivate the zinc.

Think about zinc

Like many nutrients, zinc has its good-guy/bad-guy aspects. It is needed for cell division, growth, wound healing, and the proper functioning of the immune system, and also plays a role in acuity of taste and smell. Zinc is plentiful in some foods, such as meat and seafood. The recommended dietary allowance, or RDA, for zinc is 8 to 11 milligrams a day for people 14 or older; 3 to 8 milligrams for children, depending on their age.

Prolonged use of high doses of zinc can interfere with the body’s absorption of copper, as well as depress the immune system, impair blood cell formation, and have other potential adverse effects. In adults, even 50 to 75 milligrams of zinc a day for long periods can be a problem, and it would take even less to adversely affect children. In short-term studies the common complaints have been nausea and bad taste, along with diarrhea, vomiting, cramps, and mouth sores.

One of the worst side effects of zinc as a cold treatment is loss of smell, called anosmia, but this is caused only by forms applied directly to the nose. Thus, in 2009 the FDA warned against the use of Zicam gels and nasal swabs. Don’t buy nasal zinc products if you see them around.

Bottom line: If you want to try zinc lozenges when you have a cold, start as soon as you have symptoms and follow the dosing advice on the label (usually every two hours), though admittedly this is a shot in the dark. Don’t take them for more than a week, and don’t take them long term to prevent colds.

Pharmaceuticals

 Poligrip - GlaxoSmithKline has paid at least $120 million to resolve lawsuits
Over the past nine months, GlaxoSmithKline has paid at least $120 million to resolve more than 100 lawsuits claiming some of its Poligrip products caused neurological disorders because the denture cream contains zinc, according to Bloomberg News. The lawsuits allege the drugmaker failed to warn consumers about zinc-related health risks.

Re-engineering the drug-development process to speed medical advances
In a recent Opinionator blog entry, Stanford's Ben Barres, MD, PhD, gives his perspective on how the conventional approach for drug development can impede the process of turning biomedical discoveries into commercial products:

“I always sort of assumed that if I made a discovery that had immediate implications for new treatment for disease, big pharma would pick up on it and do the drug development step,” explained Ben A. Barres, Professor and Chair of Neurobiology at Stanford University School of Medicine, whose lab works with the M.R.F. “That’s infrequently the case. Usually things just sort of languish.”

For a discovery to reach the threshold where a pharmaceutical company will move it forward what's needed is called "translational" research - research that validates targets ......

FDA

The Food and Drug Administration on May 3 announced a nationwide recall of a single lot of warfarin manufactured by Bristol-Myers Squibb after testing of one tablet showed a higher than expected potency. Bristol-Myers Squibb initiated the voluntary recall.

"The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle," according to the FDA statement dated May 2 but released on May 3.

The recalled product is one lot of 1,000-count bottles of Coumadin Crystalline 5-mg tablets, with the lot number in the United States of 9H49374A and an expiration date of Sept. 30, 2012. Patients who think they have the affected tablets should not stop treatment but should consult a pharmacist, and, if in possession of the affected lot, should consult their physician for medical guidance.

Adverse reactions associated with this product should be reported to the FDA’s MedWatch program or at 800-332-1088.

Off The Cuff

Celebrity Diagnosis

By: Michele R. Berman, MD  |  May 03, 2011

Steven Tyler seems to be making a major comeback. The Aerosmith frontman has gotten favorable reviews in his new role as American Idol judge, showing a sympathetic, humorous side that few knew was there. He's on the cover of People magazine this week, had an interview with Today show host Matt Lauer, and will be releasing his memoir Does the Noise in My Head Bother You? on May 3rd. But Tyler says it's amazing that he has made it this far. As he told People:

The hepatitis C virus (HCV) is one of the most important causes of chronic liver disease in the United States. It accounts for about 15% of acute viral hepatitis, 60% to 70% of chronic hepatitis, and up to 50% of cirrhosis, end-stage liver disease, and liver cancer. Of the U.S. population, 1.6%, or an estimated 4.1 million Americans, have antibody to HCV (anti-HCV), indicating ongoing or previous infection with the virus. Hepatitis C causes an estimated 10,000 to 12,000 deaths annually in the United States.....