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Hep C Discussion Forum -> General Discussion -> Is It Ethical for Pharmaceutical Companies to Advertise Agressively
Post Info TOPIC: Is It Ethical for Pharmaceutical Companies to Advertise Agressively
Cinnamon Girl


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Is It Ethical for Pharmaceutical Companies to Advertise Agressively
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Hi Lizzie, welcome back and thanks for your post.  I just want to mention that actually Ron Gilbert is no longer a member of this forum.

Gilead`s FDA application for its fixed dose Sofosbovir/Ledipasvir treatment has been discussed already here on the forum and here`s another link.  I`ve removed the one you posted as it required people to register with a community in order to access it. 

http://hepatitiscnewdrugs.blogspot.co.uk/2014/02/gilead-files-for-us-approvalledipasvirs.html

Thanks again, and wishing you all the best. 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Lizzy


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I'm just reading your comment now, after two and a half years.  Sorry to get back to you so late.  The drug I was talking about then is now called Sofosbuvir.  And it's really a cure, not just a temporary treatment.

by Alan Franciscus 


On February 10, 2014 Gilead announced that it had applied to the Food and Drug Administration (FDA) for the marketing approval of the combination of sofosbuvir (Sovaldi) and ledipasvir. 

Watershed Moment 
This is the first HCV combination therapy for genotype 1 that does not include interferon or ribavirin. The treatment period of 8 weeks for some is also shorter than prior therapies for HCV genotypes 1 a & b (12 to 48 weeks). Another big bonus is that the side effects are minimal especially when compared to the side effects of interferon and ribavirin. 

One Pill, Once a Day 
The new therapy consists of sofosbuvir, a polymerase inhibitor (400 mg), combined with ledipasvir, an NS5A inhibitor (90 mg)formulated into one pill that is taken once-daily. 

The treatment duration will be based on HCV health statustreatment naïve, treatment experienced, cirrhosisfor 8 or 12 weeks. 

Gilead submitted the data from their ION studies that included about 2,000 HCV genotype 1 patients. The studies included people who had never been treated (treatment naïve), people who had not achieved a viral cure with a prior course of HCV therapy (including people who had previously been treated with HCV protease inhibitor combination therapy), and people with compensated cirrhosis. 

The Ion Studies 
The ION studies included about 2,000 patients who were treated with ledipasvir and sofosbuvir with and without ribavirin. The study included 1,512 treatment-naïve and 440 treatment-experienced patients. One hundred, thirty six of the treatment-naïve patients and 88 treatment-experienced patients had compensated cirrhosis. The SVR or cure rates are listed below for the 8 and 12 weeks groups that did not receive ribavirin. 

Treatment naïve 94% cure rate for 8 weeks of treatment 

Treatment naïve 95.4 to 97.7% cure rate for 12 weeks of treatment 

Treatment experienced 93.6% cure rate for 12 weeks of treatment 

The drugs were awarded breakthrough status by the FDA which will help to speed up the FDA approval process. Gilead stated that the combination of drugs should be approved in 2014.



-- Edited by Cinnamon Girl on Tuesday 4th of March 2014 06:43:31 PM

__________________

genotype 1a with a mutation called Q80K polymorphism

have avoided treatment since diagnosis in 2001 with the knowledge that a safe and effective cure would be developed

have no idea how or when I contracted the virus
Ron Gilbert


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There is no way to even guess what "cure" you are talking about unless you give a reference of some sort.

The only clue I have is your referance to "Princeton NJ" in one of your other posts.

Why would you be so obscure about this information if its something you think is real?? 



__________________

Genotype 1a Diagnosed in 1991. Started tx April 27 2011 for 48 wks. VL before tx  1.6 - 4.6 million. RVR-week 4, UND-week 8 

Vitamin D3 suppliments can increase chances of reaching SVR. See Nutrition section for links.
Lizzy


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When I read that Pharmasset was able to clear the Hepatitis C virus in two weeks (including genotype 1) in 15 out of 16 patients without using interferon, I immediately had a strong suspicion that other pharmaceutical companies were going to start pushing their long and drawn out cures.  Within a week, people were telling me about a cure for Hepatitis C that they had heard about, and it wasn't the Pharmasset treatment.  My suspicion was confirmed.   I'd like to hear how people feel about this.confuse



__________________

genotype 1a with a mutation called Q80K polymorphism

have avoided treatment since diagnosis in 2001 with the knowledge that a safe and effective cure would be developed

have no idea how or when I contracted the virus
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