Bangkok, Thailand – February 28, 2014

Contacts:
Mr. Shiba Phurailatpam, Asia Pacific Network of People Living with HIV/AIDS (APN+), +66-86-600-0738 (Thailand)
Ms. Karyn Kaplan, Treatment Action Group, +1-646-316-8979 (U.S.)
Ms. Chloé Forette, Médecins du Monde, +33-609-537-369 (France)

Thirty-eight activists from 22 countries joined forces at the first-ever Hepatitis C Virus (HCV) World Community Advisory Board (CAB) to demand equitable access to treatment for hepatitis C virus (HCV) from six multinational pharmaceutical companies. Yet AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche refused to provide a plan for equitable access to treatment for HCV, a curable infection that kills over 350,000 people each year.

AIDS activists, including people living with HIV, people living with HCV, people who inject drugs (PWID), and their allies, are fighting for access to a new generation of HCV drugs—called direct-acting antivirals (DAAs). These drugs offer the potential to eradicate HCV; they have cured up to 100 percent of people in clinical trials.

All of the companies refused to commit to price reductions that would allow affordable access for low- and middle-income countries (LMICs), home to more than 85 percent of the 185 million people living with HCV. Even Roche and Merck, producers of older, soon-to-be-obsolete HCV drugs, refused to lower prices to affordable levels.

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by Todd Campbell – The Motley Fool – Dec 5th 2013 5:53PM

Sometimes a drug comes along that’s special enough to capture regulators attention before it’s submitted for approval. That’s what appears to have happened in Europe for Bristol-Myers Squibb’s promising hepatitis C drug daclatasvir. The drug won regulator support as part of combination treatment with Gilead Sciences’s sofosbuvir for compassionate use in critical patients.

Combining for a cure
Despite Bristol having only filed the drug for approval in Japan, the European Medicines Agency, or EMA, has stepped up to recommend its use for EU patients who would otherwise succumb to liver failure without the treatment.

In a late November press release, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, issued a positive opinion for compassionate use of a combination therapy consisting of Bristol’s daclatasvir and Gilead’s sofosbuvir — a much more widely anticipated drug.

Gilead captured widespread attention when it secured sofosbuvir in an $11.2 billion acquisition of Pharmasset in 2011. Doctors and patients have eagerly anticipated sofosbuvir’s commercialization ever since, and their patience is likely to be rewarded soon given that the FDA has set a Dec. 8 decision date for sofosbuvir and that the CHMP in Europe issued a positive opinion for the drug in November.

Prompting by the Norse
The issue of compassionate use for Bristol’s drug was brought to CHMP by Sweden, which requested that CHMP consider the drug combination for the hardest-to-treat patients. As a result, CHMP is backing the use of Bristol’s drug in adults with the genotype 1 version of hepatitis C who would otherwise be expected to die within a year if left untreated.

CHMP’s special designation was based on a combination study in which the two drugs successfully treated hepatitis C, even in cases where patients had previously failed to respond to sofosbuvir.

The results from that combination trial were as impressive as any seen so far. In phase 2, combining daclatasvir with sofosbuvir cured 100% of patients after 12 weeks. That’s significant considering that the 40 patients in the trial had all failed to respond to Vertex’s Incivek and Merck’s Victrelis — two drugs that hit the market to fanfare in 2010.

This marks just the fourth time the CHMP has offered a compassionate use opinion, and it sets the stage for a new wave of combination therapies that cut across manufacturers and displace side affect laden ribavirin and interferon.

Walking away from the relationship
CHMP’s decision doesn’t give daclatasvir a free pass for use in Europe. It will only reach the most challenged patients and only if both doctors and their individual member states approve it. But it may indicate a willingness in Europe to embrace the drug for more widespread use, suggesting that Bristol may consider filing sooner rather than later.

It’s likely disappointing to many that Gilead chose to abandon going forward with an important phase 3 trial with Bristol on the combination therapy. Instead, Gilead chose to focus on ushering its own combination remedy through clinic. It’s hard to imagine that Gilead could hope to achieve 100% cure rates with its sofosbuvir and ledipasvir pair, but coming close appears good enough for Gilead. Particularly, since it can capture the entire revenue stream rather than share it with Bristol.

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The article How Europe’s Compassion for Hepatitis C Patients Helps Bristol-Myers originally appeared on Fool.com.

FROM: http://hepatitiscnewdrugs.blogspot.com/2013/09/sofosbuvir-and-daclatasvir-drug-therapy.html

Troy — A new drug regimen for liver transplant patients — tried for the first time ever at the University of Michigan Hospital — could bring hope to millions of hepatitis C suffers and the man who received the initial treatment has made it his mission to educate the public about the disease.

Robert Gholston Jr., a 59-year-old General Motors Co. durability test driver from Troy, contracted the hepatitis C virus from a blood transfusion he received after he was hit by a car at age 9. By 2011, it had destroyed his liver, and he received a transplant at U-M Hospital. But within six months, the virus was back — and aggressively attacked his liver.

Dr. Robert Fontana, professor of internal medicine and medical director of liver transplantation at U-M Health System, obtained emergency approval from the federal Food and Drug Administration to give Gholston a treatment that combined two oral antiviral medications, sofosbuvir and daclatasvir.
“Dr. Fontana said, ‘It hasn’t been tested, and if you take this, you’ll be the only one of 7 billion people taking this,’ ” Gholston recalled. “I thought, ‘If I’m the one supposed to test this medication, then so be it.’ ”

According to Fontana, the new therapy works faster and is effective in a greater percentage of patients than the standard treatment for people with genotype 1 hepatitis C, the strain infecting Gholston. It’s the most common strain of the virus, infecting about 70 percent of sufferers, and the most difficult to treat. The new drugs also have proven effective in people with other cases of the disease, Fontana said.

The new treatment provides an alternative for patients, like Gholston, who can’t tolerate the current standard of care. At present, patients with genotype 1 hepatitis C typically receive a weekly interferon injection, and ribavirin, boceprevir and telaprevir, pills that must be taken three times daily with food for six to 12 months. It’s a complicated regimen with lots of side effects. Patients often feel like they have a low-grade flu, and even if they do everything they’re supposed to, many patients won’t be cured or the virus will come back.

By comparison, Gholston took two oral tablets daily for six months, with no side effects.

“Clearly, we’re on the brink of a revolution in therapy,” Fontana told The Detroit News, noting the therapy is not yet available to the public and is awaiting FDA approval. “Probably 50 to 65 percent (are) clear (of the virus) in six to 12 months with standard drugs. With the new drugs, 80 to 90 percent (are) clear in three to six months.
“We’re all hoping they’ll be approved (by the FDA) in the next six months.”

Hepatitis C has emerged as a quiet killer among baby boomers. Those who are affected often show no symptoms at all for 10, 20 or 30 years. If left untreated, the virus causes cirrhosis, liver cancer, or liver failure, which Gholston experienced. According to the Centers for Disease Control and Prevention, chronic liver disease, often hepatitis C-related, is a leading cause of death among African- Americans age 45-64. The CDC says black Americans “have a substantially higher rate of chronic hepatitis C infection than Caucasians and other ethnic groups.”

An estimated 4 million to 5 million people are infected with the virus, and many don’t know it. Scientists didn’t know how to test for it until 1992. It was only then that Gholston, a consistent blood donor, got a letter from the Red Cross advising him to visit his doctor, and he learned he had the disease.

The CDC estimates if all baby boomers were to be screened at one time, nearly 1 million additional cases of hepatitis C infection would be diagnosed. Recently, the number of annual deaths in the U.S. attributed to the virus exceeded those due to HIV infection.

Gholston’s life was saved three times: when he was 9, when he received a liver transplantin 2011, and when the new drug treatment wiped out his hepatitis C.
An ordained minister and chaplain for United Auto Workers Local 653, he’s dedicated his life to giving those blessings back. A father of eight, with eight grandchildren, he also started taking better care of his health. He walks up to five miles a day and participates in 5K runs.

Gholston has struck up a relationship with the young son of the man who gave him his liver — Adam James Tuthill of Battle Creek, who died suddenly of an aneurism at age 26. Eyan Tuthill, 7, now lives with his great-grandparents in Hastings. Through the Gift of Life organ donation program, Gholston started a correspondence with the family shortly after his transplant in January 2011.

Gholston and some of his children traveled to Hastings to meet Eyan and his great-grandparents after Christmas last year. Since then, he’s started a savings account in Eyan’s name.

“I took him Christmas shopping — I told him Santa sent me because his Dad wasn’t here,” Gholston said. “He said, ‘I know who you are, you’re my father’s best friend.’ It was more exciting for me than it was for him.”

Gholston has become an advocate of testing for the virus, and for organ donation, especially among African-Americans. He does public speaking for the Gift of Life program, and has trained Secretary of State workers on the importance of encouraging people to sign up as organ donors when they renew their driver’s license.

“God didn’t give me this just to sit around around,” Gholston said. “It was all God’s plan; you can’t just write that. Somebody’s got to be in charge of that.”
Eyan’s great-grandmother, Lawanda Converse, said Gholston has been a blessing in their lives. Eyan is a “replica” of his dad, and “Robert makes him feel really good,” she said.

“It has been so wonderful to meet him — it feels good to see the results of an organ donation like that,” Converse said. “I just feel that my grandson would have been so pleased. That’s the kind of person he was — he would have wanted that.

Original article from The Detroit News: http://www.detroitnews.com/article/20130916/LIFESTYLE03/309160016#ixzz2f5rKnNNt

By John Carroll | Fierce Biotech

What if you had a great combination of rival drugs that worked in 100% of patients, but one of the companies involved refused to participate in the trials needed for an approval? If you’re Gilead, the answer is to continue to ignore compelling data, shun the competitor drug and stay focused on an in-house combo that could deliver a big segment of the market. But some patients and doctors appear willing to consider taking matters into their own hands.

Over the weekend investigators went over the numbers for sofosbuvir and daclatasvir, which demonstrated that after 12 weeks the combo cleared 100% of the virus among 40 patients who had already failed the two leading therapies, Incivek and Victrelis. That’s the toughest group of patients to target. And there was solid proof that the combination worked among patients in the genotype 3 group, a sizeable minority of the market in key regions of the world.

Gilead’s sofosbuvir is the $11 billion jewel the biotech acquired with the Pharmasset buyout. But after finding that it worked to perfection in combination with competitor Bristol-Myers’ great hep C hope, daclatsvir, Gilead determined its best market opportunity lay with its own in-house combination with ledipasvir (GS-5885). Investigators like Graham Cooke at Imperial College say that sofosbuvir/ledipasvir looks like a clear winner in the large genotype 1 population, but G3 patients may be missing out on sofosbuvir/daclatasvir.

“We probably have a better option for G3 that we could be using if the companies were cooperating,” Cooke told Bloomberg. “Daclatasvir and sofosbuvir looks much better but Gilead very clearly wants to develop in-house.”

Both daclatasvir, now combined in a number of clinical studies with outside drugs, and sofosbuvir appear headed for approvals. That opens the door to an off-label combo. Provided patients could afford it, payers would cover it and doctors can be satisfied that it’s safe without a pivotal Phase III study.

“Lots of investigators around Europe and the U.S. are itching for the opportunity to put together what they believe to be the optimum combination for our patients,” Mark Thursz, the secretary-general of the European Liver Society, told Bloomberg. “The only barrier to that is what is the combination cost going to be because I suspect there will be package deals to be had.”

By Simeon Bennett | Bloomberg Business

A hepatitis C drug combination from Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. (BMY) cured all patients in a trial, demonstrating the success of a cocktail that may never be approved.

In a study among 41 patients of Gilead’s sofosbuvir with Bristol’s daclatasvir, with or without the generic antiviral ribavirin, 40 were virus-free 12 weeks after six months of treatment, according to results presented yesterday in Amsterdam. The other patient didn’t turn up to the last appointment and was later found to be virus-clear. All the patients had failed prior treatment with either Vertex Pharmaceuticals Inc. (VRTX)’s Incivek or Merck & Co. (MRK)’s Victrelis.

The lack of a late-stage study, and the expense of the pills, will probably put the Gilead-Bristol combination out of reach for doctors and patients, said Geoffrey Dusheiko, a professor of medicine at the Royal Free Hospital in London.

“It’s a conundrum for us,” Dusheiko said in an interview after the results were presented at the European Association For the Study of the Liver’s conference. “It looks a very promising regimen, it really does. But I’m really not sure it’ll see the light of day.”

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SAN ANTONIO — Reported by: Leslie Bohl — WOAI

A local woman says she got a deadly disease from a common cosmetic procedure.

Margaret Dudley believes she contracted hepatitis C from permanent make-up tattooed on her face at a local salon in 2000.

Hep-C kills more people than AIDS, and millions of Americans are dealing with it right now. Clinical trials show there is a safe cure. But “the bottom line” appears to be standing in the way.

News 4’s Leslie Bohl talked to Margaret Dudley who says she needs your help to make that cure available to so many people whose lives depend on it.

Click here to see the video »

By Mark E. MurphySavannah Morning NewsPosted: February 25, 2013 – 10:35pm | Updated: February 26, 2013 – 12:06am

I was eight years old, making rounds at the hospital with my father, when I first met the Yellow Man.

His eyes were an astonishing saffron color. His skin was also striking — an iridescent bilious hue.

My father sat poring over the Yellow Man’s voluminous chart in the nurses’ station, reading glasses perched on the end of his nose, while I tried my best to stay quiet.

Ultimately, I couldn’t.

“Why is he that color?” I asked my dad in a whisper.

“He has hepatitis,” my father said matter-of-factly, never looking up.

I nodded. I was fascinated. I even talked to my third-grade class about the Yellow Man later that week in Show and Tell. But I had no clue what my father was talking about when he told me that the Yellow Man had “hepatitis.”

Today, I do.

You see, I am a gastroenterologist. In my medical specialty, we deal with Yellow Men (and Yellow Women) just about every day. And many of them have various forms of hepatitis, or inflammation of the liver.

Some get it from alcohol; some, from medication. But an emerging variable in the growing liver disease population is hepatitis C — a viral illness that is now the leading cause for liver transplants in this country.

Over 170 million people worldwide have hepatitis C. More than 4 million of those people are in the United States. A lot of those folks acquired hepatitis C through blood transfusions (there was no blood test for the virus before 1989); some got it through IV drug use, or through tattoos and body piercings. A shocking 30 percent have no risk factors for it, and have no idea how they became infected.

So why is hepatitis C a problem?

Because it is a stealth epidemic.

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