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Hep C Discussion Forum -> General Discussion -> GILEAD REFUSAL
Post Info TOPIC: GILEAD REFUSAL
ios9


Senior Member

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RE: GILEAD REFUSAL
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Hi Nancy,

No, Gilead had a Trial for cirrhotic patients who was no responders. One of my friend has been on it. She is UND 12 weeks after EOT.

I beleive Matt has found the right answer.

Thanks for your concern smile

 

Do



__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 
52baddog


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I think Gilead only allows people in their studies if they have not been exposed to any other treatment.

I wasn't aware of this situation. Here in the states if you ask your doctor, he can try to get you in the free trial.

But, you have to meet certain criteria.

 



__________________

Geno type 1b, F1 vl 640,000 enrolled in Gilead's sofosbuvir/ledipasvir -week 1 66, week 2 <25
Matt Chris


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Hey y'all 

Gilead seems to be playing its Sofosbuvir cards very carefully. 

We really should not be surprised by this choice of Gilead, they already proved that their decisions are based on highest possible financial / dollar return not what's best for needy desperate patients.
 
Gilead's thinking  likely  would Incorporate not wanting a bad or spurious medical report regarding the use of Sofosbuvir come come to light from France right before its approval  by the FDA. If that happened it would cost millions in stock devaluation. 
So again it's all about the money.
 
The USA does not have a law on the books like France , regarding forcing drug company to treat patients with late stage developing drugs. I believe they can do it but they are not required to do so.
 
Capitalism at its worse, I give praise to the French for such a merciful considerate medical law. Laws are wrote and put into action for the people's benefit but some governmental systems can't seem to both encourage big Pharma to develop a profitably drug products and still be have the best interest of its consumer in mind. (they are greedy SOB's)
 
I should mention that not every America drug corporation has taken this stance but some have.
 
Matt  


__________________

"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 
ios9


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Hello Matt !

Your idea is very clever, Gilead does not want to take any risk before getting approval for Sofosbuvir.

Hope Europe countries will get together to have same law to save people's lives.

Have a nice suny w.e. smile

Do



-- Edited by ios9 on Saturday 7th of September 2013 06:06:35 PM

__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 
Loopy Lisa


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I am slightly stunned but Gilead's response. Of course it is logical that others are also in need, but I can't see why they can't help those on the danger list?

I asked my Doctor if I would be shelved because of possible cost and others being in more need. The answer was no, you don't want any patient to go on to develop the need for future care, and the insurance will have to pay as it is a needed drug regardless of cost. I think this is the problem, they probably want to charge an arm and a leg and it is not incorperated into this....I am European though, not from over the pond.....

I have to say, I have never heard of a pharmaceutical company not allowing compassionate use for those in desperate need, or those who can't obtain medicines in areas that are poor.

I would be interested to see what the board has to say on all of this? Perhaps Hep C patients should make a protest to Gilead about their greed, which defeats the whole logic of producing a life saving drug to cure when they don't allow it to be given to people on the danger list!

Indeed, a sad day!

 

 



-- Edited by Loopy Lisa on Saturday 7th of September 2013 08:50:24 AM

__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
ios9


Senior Member

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Posts: 177
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Hi,

As I wrote before, there is a special way for people living in France to get medicamentation not on the market yet if their doc explain to the Health Department their patient is in danger or so. It's called ATU (temparary authorization of use).

Normally labs says yes as French Goverment pay for it and it's a matter of life or so. However, I have been told yesterday that Gilead has refused to sell Sofosbuvir to France for some patients in urgent need and can't wait till next year.

Here the English translation :

"GILEAD REFUSES ACCESS TO TREATMENT TO SERIOUSLY ILL HEPATITIS C PATIENTS

People living with HCV who are in a urgent need of new treatments should get an early access to compounds that are in their latest stage of development, and therefore not yet on the market. The French early access system called ATU (Temporary Authorization of Use) allows this early access.

The French national regulation agency (Agence Nationale de Sécurité du Médicament, ANSM) has granted patient name-based temporary authorization of use (ATU) of sofosbuvir, a Gilead new compound, to people on the waiting list for a hepatic graft and to cirrhotic patients with no therapeutic option. Gilead Sciences Inc refuses to provide their new compound sofosbuvir.

The delivery of this Direct Acting Antiviral (DAA) agent against Hep C virus is refused by Gilead on the ground of fairness between European countries and of a so called limited capacity of production. Yet, a European market application for sofosbuvir has been filed two months ago by Gilead Sciences, which implies that Gilead does actually have a large-scale production capacity.

Regarding fairness between European countries, this is an argument we cannot accept. In the other European countries, there are many patients with no therapeutic option who are also in an urgent need to have access to new compounds. Unlike France, many European countries do not have the legal system that allows early access to therapeutic innovations. But considering the fact that some patients are at great risk to lose their lives, a European initiative should allow to set up early access programs without delaying the provision of the compounds in the countries with adequate regulatory and medical agencies."

 

If it was a French Lab. Gilead would be prosecuted for violation of the French law of "non-assistance à personne en danger" (deliberately failing to provide assistance to a person in danger), which can be punished by up to 5 years imprisonment and a fine of up to $100,000.

"Anyone who fails to render assistance to a person in danger will be found liable before French Courts (civil and criminal liability). The penalty for this offence in criminal courts is imprisonment and a fine (under article 2236 of the Criminal Code) while in civil courts judges will order payment of pecuniary compensation to the victims".

Does the US have same kind of law which could force Gilead to sell Sofosbuvir right now to cirrhosis patients fighting for their life ?

To day is a sad day no

Do

 

 



-- Edited by ios9 on Saturday 7th of September 2013 08:58:42 AM



-- Edited by ios9 on Saturday 7th of September 2013 08:59:46 AM

__________________

Geno 1b. VL 17. M. AbbVie Turquoise II. UND EOT 4. 8. 12. SVR.

"Our task must be to free ourselves by widening our circle of compassion to embrace all living creatures and the whole of nature and its beauty."Albert Einstein

 

 

 
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