Happy Thanksgiving

  • Thursday, November 27, 2014
  • Posted by HCV New Drugs


Happy Thanksgiving


Thanksgiving painting by Jean Gerome Ferris (1863-1930)



Bristol-Myers: FDA Blocks Hepatitis C Drug for Now

Related - Bristol-Myers Hepatitis C Drug Needs More Data on Combinations

Bristol-Myers Squibb gets FDA complete response letter for hepatitis C drug daclatasvir
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding Bristol-Myers Squibb's (BMS) new drug application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents to treat hepatitis C virus (HCV).

The initial daclatasvir NDA submitted by the company to the FDA focused on the drug's use in combination with asunaprevir, an NS3/4A protease inhibitor.

Given the withdrawal of asunaprevir by BMS in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for HCV treatment.

The company is currently in discussions with the US FDA about the scope of these data.
Bristol-Myers Squibb executive vice-president and chief scientific officer R&D Francis Cuss said: "Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area.

"Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the US as quickly as possible."

The company is dedicated to the ongoing clinical development program for daclatasvir, which is currently being evaluated globally in multiple treatment regimens for HCV patients with high unmet need.

The daclatasvir clinical trial program is focused on difficult-to-treat patients, including pre- and post-liver transplant (ALLY-1), HCV patients co-infected with HIV (ALLY-2) and patients with genotype 3 (ALLY-3)
Source


Bristol-Myers: FDA Blocks Hepatitis C Drug for NowNov 26, 2014, 2:33 PM ET
By LINDA A. JOHNSON AP Business Writer

U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir.

The company said Wednesday that data it submitted to the Food and Drug Administration to win approval of daclatasvir focused on that drug's use with asunaprevir.

However, the New York-based drugmaker in October withdrew its application for approval of asunaprevir, citing "the rapidly evolving hepatitis C ... treatment landscape in the U.S." The FDA then requested more data on the effects of daclatasvir in combination with other drugs for treating hepatitis C, currently one of the hottest areas in drug research.

Bristol-Myers Squibb Co., which has a strong focus on drugs for viruses, cancer, heart disease and gene-related disorders, said it's now discussing with the FDA the scope of additional data needed.

Meanwhile, the company said it is committed to further testing of daclatasvir, part of a drug class called NS5A inhibitors. Multiple studies of the drug are being conducted around the world, including ones on patients who have had or are facing a liver transplant, and on patients who also have HIV.

"Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need," Francis Cuss, the company's head of research and development, said in a statement. "We will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible."

Daclatasvir was approved in July in Japan for use in patients with one strain of the virus that's common in that country. It was approved in August in Europe for use along with other medicines in adult patients who have one of four strains of hepatitis C.

Multiple drugmakers have been trying to grab a piece of the hepatitis C drug market, given the millions of patients needing treatment for the liver-destroying virus and the ultra-high prices new drugs in the category are commanding.

Those include market leader Gilead Science Inc.'s Sovaldi and Harvoni. Their price tags ? $1,125-per-pill for the newest one, Harvoni ? have drawn criticism, but they spare patients the decades-old combination of months and months of antiviral pills and shots that cause flu-like side effects, yet barely cure half of patients.

Source - http://abcnews.go.com/Health/wireStory/bristol-myers-fda-blocks-hepatitis-drug-now-27202609

Thanksgiving: Eating Makes My Liver Happy

Thanksgiving: Eating Makes My Liver Happy

Thanksgiving is upon us, a perfect holiday to express gratitude, and spend time with the people we love.

I can't wait to sit down to a traditional feast of Thanksgiving comfort foods, if there was ever a time to indulge, its now.

Let yourself enjoy every bite of pie, ham, turkey, potatoes, yes with gravy, stuffing, rolls and veggies all smothered in butter.

I eat healthy all year long, but during the holidays all bets are off, I eat what I want, however, I skip the alcohol.

Drinking alcohol during the holidays or anytime has never been my thing, who knew my lifetime aversion to alcohol would play such an enormous role in my health later in life.

*Healthy Thanksgiving Menu For People Living With Liver Cirrhosis.

I was living with hepatitis C for some 20 years before I was diagnosed in 2000, fortunately after undergoing a popular diet with man-made interferon, for some 48 weeks, I was cured! After my health was in check, my determination to remain healthy was fierce. I started dancing to the oldies in the morning, counting calories all day, and attempted yoga on weekends.

Eating Healthy
They say with age comes wisdom, today I find walking in the morning enjoyable, and following a non-diet approach to eating right - a relief. The Mediterranean way of eating has treated my liver well, maintaining a healthy weight is especially important if you have hepatitis C, the risk for developing scarring of the liver; fibrosis and cirrhosis is higher in people who are obese and living with the virus.

The Liver Changes As We Age
Naturally as we age the liver undergoes changes, for instance blood supply to the liver at age 60 in comparison to age 20 is reduced by 40 to 50 percent. The outcome of reduced blood supply to the liver affects its ability to regenerate, especially after toxic injury from drugs, alcohol or illness. Reduced blood flow can significantly affect metabolism as well, which may interfere with how some drugs are absorbed. These age-related changes in the liver can make monitoring medications we use difficult, leaving the liver more vulnerable to injury.

How Old Is Your Liver?
Recently a study at the University of California, Los Angeles (UCLA) investigated whether obesity is associated with accelerated liver aging. The researchers looked at close to 1,200 human tissue samples, 140 were liver samples. Body mass index (BMI) height and weight were noted as well. According to the results, biological age of the liver increased by 3.3 years, for every ten additional BMI units.

*The body mass index (BMI), is a measure of relative weight based on an individual's mass and height.

Lets Do The Math
As an example, I am five feet seven inches tall, and weigh 138, my BMI is 21.6. A women who is also the same height but weighs 202 would have a BMI of 31.6. According to the study, her liver is over three years older than mine. Maybe I'll skip the gravy and buttered veggies.

Mediterranean Diet
Over the years a vast amount of clinical research on the Mediterranean diet has demonstrated adhering to foods named in the diet may help reduce both liver fat, inflammation, and help protect against liver cancer. This month the BBC published an article on obesity naming the Mediterranean diet as a winner for reducing risk of heart attacks and strokes.

Fatty Liver And HCV
Today close to 30% of American adults have nonalcoholic fatty liver disease (NAFLD). In people living with hepatitis C it rises to around 40% and even higher in people with genotype 3. Often referred to in the medical world as HCV-induced steatosis, 60% to 80% people with genotype 3 have moderate or severe steatosis.

Insulin Resistance and Treatment Response
In the World J Gastroenterol, November 2014 issue, HCV and Insulin resistance is investigated, with an emphasis on treatment response in patients with different genotypes, in particular genotype 3. Additional information on treating HCV genotype 3 is available in HCV Advocates November newsletter.

Just For Fun

So What Happens When We Eat Too Much??



What Thanksgiving Dinner Does To Your Body
With the average American consuming between 3,000 and 4,000 calories during Thanksgiving dinner, we look at what really happens to our bodies during this momentous feast, watch it here.

With all the research on liver disease, we know that obesity is associated directly with liver health. Following a healthy diet is beneficial in order to avoid additional liver related problems. Yes, maybe even during the holidays, I will be skipping that second piece of pie as well.

Stay healthy and happy all year long folks. Wishing you a cherished holiday.

Always Tina