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New Hep C drug fast -tracked by FDA
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New Hep C drug fast -tracked by FDA

http://www.drugstorenews.com/article/achillon-receives-fast-track-designation-hepatitis-c-drug?utm_source=GoogleNews.

Its in the making-surprized that nobody has talked about this.Its been in the news for 2 days now.
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21 Comments Post a Comment
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1797925_tn?1341099804
It certainly sounds exciting and promising!  I am as surprised as you that no one else has discussed this.  I am avidly reading all I can about it right now.  So ALL knowledgeable forum members....what is the scoop???   I am newly diagnosed so still very uninformed...but trying to learn as much as I can as fast as I can....but aren't we all :)

Thanks for the post EyesofBlue55!
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190885_tn?1333029491
i'll bet in the new trials without interferon they're going to want the folks that failed triple...and a pl with less sx then the incivek out in 6 months!!  things are moving so fast....thanks....billy
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1253246_tn?1332076910
Might be worth the wait-if you can afford to wait,and less sx.I might be watching the stock reports soon !!!
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Avatar_f_tn
That would b great
As I start Vic 3x end of north and there r allot of pills and SE I hear to deal with

If u look at clinical trial.gov
There are tons of  3x trials with inf, and some all oral

I would almost b tempted to wait for one of them

Only thing that worrys me is pharmassett 938 that just got pulled from quantum study was also awarded FDA fast track, and was still pulled due to negative results

So nothing is a sure thing, the best odds is if approved and even then u never know SE and cure rate
Fingers crossed
I am jumping from the plane 1/31
I hope 3x tx with Vic is my parachute
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1669790_tn?1333666195
Will posted the following thread a few days ago.  More promising news for trt in the future and giving more options.

http://www.medhelp.org/posts/Hepatitis-C/FDA-fast--tracks-another-Protease-Inhibitor/show/1658390
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Avatar_m_tn
Great that they are still pursuing new treatments for HCV.

Unfortunately fast track with the FDA still means several years away. Nothing moves fast with the FDA. They are one of the most inept government agencies.
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1747881_tn?1358189534
Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete.

Telaprevir was fast tracked in 2005 and reached the market in may 2011
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Avatar_m_tn
This was a brand new concept Vertex and Merck were coming out with .Because they have led the way with this class of drug,.it shouldn't take near as long for  Tibotec(TMC435) and  Achillion to get their same class drugs (protease) to market . JMO
Will
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1253246_tn?1332076910
Exactly my thoughts Will .There is alot of talk in other places about this and I was surprized that I didnt see it here.I thought that surely it had been brought up-didnt see your post 8~)  cindy
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1815939_tn?1377995399
Happy to read about all of these new drugs being fast tracked. Hopefully treatment will be easier in the future.
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148588_tn?1407125204
A brand new concept? The first protease inhibitor was FDA approved in 1995. They've been used on HIV for years and I remember them being tested on HCV since at least 2003. The two we have now have doubled the number of people that have had to discontinue tx altogether and an arguement could be made that they're being over-prescribed by a factor of 4 to 1 More trials have been halted than have moved through phase III for reasons such as cardiotoxicity.
The patent on the HCV virus expires in 3 years. I would be surprised if anything now in trials will get approval before that patent is unlocked and doctors will be able to know which meds are appropriate for which patients. When that happens, watching the stock market to make tx decisions will make even less sense.
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Avatar_m_tn
Possibly you misunderstood my post or a poor choice of phrasing on my part.
"A brand new concept"   Maybe a  "Brand new concept clinically available for the tx. of HCV"  Having been on the market for 6 months that is "exactly" what it is.
I disagree with the idea the DAA"s are over prescribed ,however I appreciate your opinion,and as far as seeing more protease"s on the market prior to the three years ,, in (my opinion only) as I stated there will be others used before the three years.

As far as watching the stock market to make tx. decisions...on that we are in complete agreement,however in my post above I never mentioned anything  about the correlation of the two..
Best to you..
Will
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Avatar_f_tn
I am new to hep c info

Do I understand u that there is a patent on the " diagnosis of hepatitis c"

And that when that patent expires the drug company's and mds will know better how to cure it?

How could something like that be legally allowed to be withheld from people in need of treatment?
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1707536_tn?1334977677
I, too, do not understand what "The patent on the HCV virus expires in 3 years." Could you please explain? Thanks.
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Avatar_f_tn
Patents are normally enforced for three years.  If they are not able to keep their patent, due to fees, FDA, govt, etc....the drugs could go generic and cause the stock of the company to tank.  Patents just ensure they will be the only one to use that drug, combination of drugs, etc.  It also makes the company much more lucrative from a dollar point of view.

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1707536_tn?1334977677
Oh, desrt stated that the patent for the hcv virus expires in three years- hence my confusion. I think the Victrelis patent is for ten years. I'm surprised Incivek is only for three years- I thought patents were usually for longer.
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148588_tn?1407125204
http://lists.essential.org/pipermail/pharm-policy/2000-October/000385.html

The virus itself is patented.
International patent law in the late '80s early '90s was such that the first company to clone a disease held a patent on it and no one could do research on that disease, or medication for that disease, or tests to detect that disease without paying the patentholder.
This is the patent that expires in 2015.

The entire idea is an obscenity.
In my opinion.
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148588_tn?1407125204
My apologies for the misunderstanding and my generally cr@ppy mood when I posted.
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Avatar_m_tn
Absolutely no problem ...

Hope you are feeling better :)

Will..
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Avatar_f_tn
OMG Desrt
That is absolutely an insane conflict of interest amount the FDA, government, drug companies and big business

To own a disease
Thus the cures

How insane is that?

What's to stop them from inventing diseases?

Is this only done in the USA
Or are disease patents international
Thank you for educating me about this
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148588_tn?1407125204
Note in the link that Dr. D.W. Bradley, who was a party in the suit disputing patent rights to HCV, had been working on isolating the virus since 1977 and had been employed by the CDC since 1982. This means that it was U.S. tax dollars that produced the HCV tainted blood from which the virus was cloned.
Note also in paragraph 3, that part of the settlement was an agreement to supply the CDC with funds to research a vaccine against HCV. Twenty two years later  -  still no vaccine. It would be interesting to compare the $$ in patent fees collected from companies working on treatment drugs and viral load testing compared to $$ spent researching preventing infection.
That might also be viewed as a conflict of interest.
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