SF Biz Times "Gilead has the Cure"

[purplecat]

http://www.bizjournals.com/sanfrancisco/print-edition/2013/03/01/gilead-reaches-for-a-cure.html
Fourteen months after buying a small biotech company with a promising hepatitis C treatment for $11 billion, Gilead Sciences Inc. is on the cusp of seeking approval for a potential cure.

But even with the drug’s accelerated pace, some say, Foster City-based Gilead is leaving behind an important player: patients with the debilitating and potentially deadly virus. Bristol-Myers Squibb Co. and a handful of vocal patients say the cure could arrive more quickly if Gilead cooperated with its competitor.

“I get that it’s all about their profit,” said Margaret Dudley, a San Antonio woman with hepatitis C who has launched ...
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This is all I can see of the Article or I have to pay 59.00 for subscription but this just was published in weekly "San Francisco Business Times"

Would like to see whole article but can afford the 59 bucks.

Anyone subscribe to SFBIZ?

[can-do-man]

Looks like all this Hype, misleading info, and Petition is for nothing.

In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.

There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects.

http://hepatitiscnewdrugs.blogspot.ca/2012/11/daclatasvir-and-sofosbuvir-promising.html
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So Mdudley maybe you ought to be ready to take your fight to the doctors instead of what is a sure losing cause... You cannot force two companys to work together, but you already know that from Senator John Cornyn office right? Since you posted this response..."And they will look into it but can't force two companies to work together..."

[rivll]

You are completely out of line with your response to Hector. You might try using whatever processes left to you to read Hector's profile. Then if you do not want to crawl back under your rock, you might try a heartfelt apology.

[Quest5245]

Really Hector???!!!!!  It seems you have forgotten about all of those poor souls that have treated with interferon and ribavirin, and have been told they are cured,  that now have to go on living their lives with new health problems caused by their drug toxicity.  Heart disease, thyroid disease, visual problems, kidney disease, diabetis, just to name a few.  With you the amount of time you spent with your answer, it seems you are the one with nothing better to do, nor does anyone else care to hear your thoughts on capitalism.

[rivll]

Thank you Margaret, you have answered my questions.

[mdudley]

Here is a link to the SVR24 results of the Gilead/Bristol trials Reported by Jules Levin | AASLD | Nov 9-13 2012 Boston

http://hepc-cured.com/new-clinical-studies-high-rate-of-sustained-virologic-response-with-the-all-oral-combination-of-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin/

And a link from TAG (Treatment Action Group) with available trial results from all studies including the daclatasvir/sofosbuvir trials:

http://www.pipelinereport.org/toc/HCV/dec-treatment-pipeline-update

We know trial results can be confusing and Jules Levin (NATAP) and Tracy Swan (TAG) have done an excellent job in order to make these results easier to understand.

The AIDS Healthcare Foundation is now lending their support on this petition:.

http://www.aidshealth.org/archives/15802

[mdudley]

Posted in San Francisco Business Journal & Medhelp March 2, 2013

http://www.aafp.org/afp/2005/0815/p655.html

Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment.

Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.

Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment. It is important to reinforce to patients that contraception must be maintained for a full six months after cessation of ribavirin.
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The combination of Gilead's sofosbuvir and Bristol's daclatasvir when administered together from day one for 24 weeks cured 100% of genotypes 1, 2, and 3... without TOXIC ribavirin or interferon.  These SVR24 results were released in November 2012 at the AASLD Liver Meeting in Boston.  There were a total of 88 people in the 24 week trial with three arms (we are referring only to the arm mentioned).  There were an additional 82 genotype 1 patients in a 12-week treatment clinical trial.  They only had SVR4 results on 68 of the 82 patients in this 12-week  trial at the AASLD Liver Meeting November 2012 and results were 95 to 98%.

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Leading Physicians Statements about this cure combining Sofosbuvir and Daclatasvir (without toxic ribavirin or interferon)


Quote from Dr. Mark Murphy – Savannah Morning News – February 26 2012

Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.

Quote from Dr. Paul Thuluvath - Wall Street Journal – November 2012:

"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."


Quote from Dr. Scott Friedman – New York Times – April 2012:

“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.”


Quote from EASL Secretary General Mark Thursz – New York Times – April 2012:
EASL Secretary General Mark Thursz wants to see the two companies work together.
"The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.

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Petition to the Obama Administration:

https://petitions.whitehouse.gov/petition/expedite-cure-hepatitis-c-drug-companies-hold-cure-without-toxic-ribavirin-or-interferon/tXC9B6S2

We petition the Obama Administration to:

Expedite Cure for Hepatitis C - Drug Companies Hold the Cure (without toxic ribavirin or interferon)

Hepatitis C infects almost 4 million Americans and more than 170 million people worldwide, and it now kills more people than AIDS.

Now a safe 100% cure exists, without toxic ribavirin or interferon, but is being held back by 'big pharma'. Immediate action is required to facilitate collaboration between the drug companies with this cure.


HCV Coalition for The Cure  
Representing over 17,000 people who have signed the petition at Change.org and/or the White House Petition.

www.HepC-Cured.org