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Anyone want to see a great article?
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Anyone want to see a great article?

http://www.natap.org/2012/HCV/072712_01.htm
Here is a summary of what Gilead is doing in it's atempt to get 7977 to market but in addition, it's attempt to go for the holy grail of creating a once a day pill for all genotypes.  They say in this article that they are very close. I believe them. I'm been involved in one of their clinical trials and this company literally brings tears to my eyes in how ethical and just plain decent they are in the way that they are treating patients.  so, here's a good one to give everyone the hope that a side effect free once a day pill is coming that can cure all genotypes.  It's coming..
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I was probably the initial person that cried foul when Gilead decided not to partner with BMS. However, I now see the bigger picture. Gilead are in fact combining 7977 with 5885 (their own NS5a) into one pill and the next trial will have it. I definitely see the reason for them wanting only one pill. If one pill can get to market, it's going to make eradicating this virus, that much easier. People can remember to take ONE pill, as opposed to several. 7977 is in phase 3 and 5885 has been around for a good while now. They actually know a lot about it and it's comparable to BMS' NS5a.
I don't understand anyone saying it's put the cure back ten years! Gilead will be filing for FDA approval next year for 7977+riba for geno's 2 and 3 and look to hopefully follow that up in 2014 for geno 1's with 7977+5885.
What does one mean that they'll stop research? When you have the cure, you have the cure! Gilead have never stopped research with HIV. In fact they're the leading pharma in that department and I would say that the world should be very happy about that. Personally, I'm feeling very good about what they have to offer.
40 Comments Post a Comment
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85962_tn?1329984690
Don't want to sound negative but I'll believe it when I see it, They just had a promising drug that was suppose to be like this but it had to be discontinued because of heart problems!, I was devastated!, Don't need another let down!
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Haven't read it yet, but I wonder does the article give any idea how much  delay has been imposed on bringing the cure to market by Gliead's refusal to work with a competitor? Gliead's desire to monopolize the market means that  hundreds of thousands of HCV sufferers won't have access to an interferon free cure for much longer than necessary. Now THAT shameful truth brings tears to my eyes.

A pan-genotypic cure has already been discovered, received fast track status  and is ready to start phase 3 testing: GS-7977 with BMS-790052.

To be fair, I will read that article. It would be nice to be pleasantly surprised. Frankly I am expecting spin.

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http://www.thestreet.com/story/11503957/1/grading-hep-c-stocks-exiting-easl-confab.html

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I don't think they go into that.  I was told it is Bristol Meyers that refuses to work with Gilead.  How do we find out the truth?  
Oh, just as an aside. I just went through their 7977 and Riba treatment with very very little side effects.  If you had gone through their treatment you might feel warm and fuzzy toward Gilead, believe me cause for type 2 and 3 it is a possible miracle, or at least close to one.
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3242225_tn?1348340121
Wow, I just read it.  That stinks that Gilead would do that. You know, they got it right for 2's and 3's and from what I have read recently, they feel that they are very close to getting it solved for 1's too so maybe that's why?  I hope really sincerely hope they do soon, or someone does soon.  I feel in my gut that it will be solved soon.  
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I do hope so too, but the drug they are testing, GS-5885, is too new at phase 1. Do we know if it has bad side effects, causes cancer, etc?

Gilead is testing 7977 with Interferon and Ribavirin which tells me that they are looking for a quick way to make money out of 7977 while preventing a competitor from gaining any market share. I would have thought that they would have made huge profits out of 7977 even working with BMS. If that had been the case, we would genuinely be very close to decent cure right now. It would be only months away. With Gilead's present attitude, it will be years, who knows how many. One journalist postured that Gilead's behaviour has set the cure delivery date back 10-years.

I have taken both Interferon and Ribavirin together. That experience has made want to avoid both drugs, even with 7977.

I can't feel in the least bit warm and fuzzy towards Gilead. They just want to monopolize the HCV treatment market like they did with AIDs. Monopoly is a very bad thing for patients. If Gilead achieve's a monopoly the company will stop research and improvements as soon as they have something they can sell for a profit. There will be no incentive for them to do better. Expensive research will stop. Everybody will start to think that HCV is beaten even if we are having to take drugs with horrible side effects. Gilead will be able to name whatever price they like for the drugs. That is what they are really aiming for.

Sincere best wishes to you for achieving a cure though.

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163305_tn?1333672171
No, Bristol  Myers has said it will not work with Gilead.
http://www.marketwatch.com/story/gilead-bristol-myers-hep-c-regimen-promising-2012-04-19

Please sign the petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
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If BMS really won't work with Gilead, then I stand corrected. I still don't retract what I said about Gilead wanting to monopolize the market and the final outcome of that though. No time today to follow this up but will definitely look at that petition page as soon as I can.
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Oops, I got that backwards. Sorry Gilead refuses to work with Bristol Myers.

I got up and out of the house too early this morning. Looks like my dyslexia has kicked in !
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446474_tn?1404424777
Wow. D71352 was just presenting information as Gilead's future plans. Why jump on D71352 with so little knowledge about GS-7977, how a pharmaceutical company runs their business?

Fmulder is was not a Gilead drug that had its trials stopped.
'Bristol-Myers Squibb has halted development of a potential hepatitis C drug after nine participants in a clinical trial of the therapy were hospitalized and one died.'

'Idenix Pharmaceuticals, based in Cambridge, Massachusetts, had a drug in trial that acted with a mechanism similar to that of BMS-986094. That trial has now been put on partial hold by the FDA as a result of the BMS trial failure'

OdinLovesLife
'GS-5885, is too new at phase 1.'
Actually GS-5885 is in Phase 2 now (Study 120) examining 12 weeks of treatment with GS-5885, GS-9451, tegobuvir (GS-9190) and ribavirin.

Please post your source for GS-5885 causing cancer.

Please post speculation regarding phrama companies in the Hepatitis Social Forum. We are try to present real data not opinions here so that people can learn about current and possible future treatments and people's experiences with these treatments.

D71352 thanks for presenting the info on the one pill. I'm sure some people are interest in this information.
Thanks for sharing!

Hector
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I was probably the initial person that cried foul when Gilead decided not to partner with BMS. However, I now see the bigger picture. Gilead are in fact combining 7977 with 5885 (their own NS5a) into one pill and the next trial will have it. I definitely see the reason for them wanting only one pill. If one pill can get to market, it's going to make eradicating this virus, that much easier. People can remember to take ONE pill, as opposed to several. 7977 is in phase 3 and 5885 has been around for a good while now. They actually know a lot about it and it's comparable to BMS' NS5a.
I don't understand anyone saying it's put the cure back ten years! Gilead will be filing for FDA approval next year for 7977+riba for geno's 2 and 3 and look to hopefully follow that up in 2014 for geno 1's with 7977+5885.
What does one mean that they'll stop research? When you have the cure, you have the cure! Gilead have never stopped research with HIV. In fact they're the leading pharma in that department and I would say that the world should be very happy about that. Personally, I'm feeling very good about what they have to offer.
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Avatar_m_tn
First time I ever heard the word decent and pharm company mentioned in the same sentence. The Pharm companies make a lot of people cry, but not because they adore the company :-)

Sorry but all pharm's treat their "guinea pigs" great! You are helping to make them billions in the future.
Don't get me wrong I was a lab rat myself. I'm very grateful to Vertex for "curing" me of HCV.

Anyway it is great the pharms continue to find better treatments. I don't see any single dose hcv drugs hitting the market for many years to come.

best of luck
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85962_tn?1329984690
Profits over life, Sad but a cold hard fact!
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446474_tn?1404424777
UKgirl, I agree with your assessment.

I guess some people think that having drugs the manage diseases like HIV and other potentially fatal diseases is 'bad' in their perfect 'everything should be free' world scenarios. Not sure what country they live in because the last time I went to the store I actually had to pay for what I wanted.

Let's see... Gilead paid 10.8 billion dollars to acquire Pharmasset. So they should give GS-7977 away for free? Does anyone work for a company that uses this business model? I doubt it. Your company wouldn't be in business for too long. Gilead has the only drug that achieves RVR 100% of the time, has a high barrier to resistance, has minimal side effects even when combined with ribavirin and has higher cure rates then the current triple therapy with interferon. They should just give it away? How about a little reality check.

Everyone is free to treat or not treat their hepatitis C, so it is not like Gilead or any other pharma company is forcing anyone to treat with or buy their drug. People are free to make their own choices as far as medical care is concerned. If you don't want to treat fine. But why criticise others for their choices?

Of course there there are people on this forum that have promoted their conspiracy theory's for years and said the same thing about telaprevir and boceprevir not that long along. It was the end of the world. Another scheme by pharma, the FDA and doctors to make more money and rip patients off. Nothing original here.

Please go to the Hepatitis Social forum where you can pontificate your theories. This forum is supposed to be for informing people about the facts of diagnosis and treatment. Not personal theories that have no factual basis.

It is depressing to realize that even others who have or have had hepatitis C have no compassion for those of us that have run out of options and are suffering the full consequences of hepatitis C, liver failure and/or liver cancer.

Hector

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3097131_tn?1357088481
I SECOND THE MOTION!!!
~Country~
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I think what people don't get is that if it wasn't for the profit we wouldn't have five companies with HCV drugs in Phase III trials right now.  And they ferociously compete against each other to get to market first so they can make those profits.

I think it's crazy when I hear people bash big pharma especially when the bashers are in other countries (I'm on an international hcv email list) but meanwhile most of the great drugs come out of the US and the US medical complex.  People want great drugs and then complain they are expensive and that they're being held up by pharmaceutical companies.  The drugs wouldn't be there if there wasn't this system and the capitalist profit motive.

I say more power to Gilead and this system.  They and their ilk are gonna have cures for us sooner than later.

Even the regulatory had picked up to get drugs through to market faster.  It's a little ridiculous how they have to do trials now but still the drugs are coming.  Witness all the people on this board trying them and many getting good results.
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Another thing the Big Companies do not realize is, if it wasn't for us THE PEOPLE that goes through these Trials, it's what's making it happen for ALL of Us..meaning Cure for All and $$ for the Companies and all research...
I myself, am on 1 of the GS7977 Phase 3 GT 1,4,5,6 Clinical Study.. Neutrino as I read in the Article above..Last week of tx started today..

Country~
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3242225_tn?1348340121
Wow, you know I really feel that you are making assumptions and kind of investing your own spin on things because you are angry at them for not doing what seems like a no brainer  and working with Bristol Meyers to bring a combo drug to market that any genotype can use.  BUT Odin, we are talking literally about Gilead spending 11 billion dollars to acquire 7977 and millions upon millions of dollars to now do trials etc. to begin to get it to market.  I really feel that we don't know what is happening.  They are saying they are close to having something ready and maybe they don't need to partner with Bristol.  Hey, I don't know and I am just a Hep C patient and that's it.  No vested interest other than to hopefully get well.  So, please, Odin, watch the clinical trials and get ready to sign up if you are still waiting for that cure.  I truly believe it's coming.  As for me, we'll see.  I'm not breaking out the champagne quite yet. Why not e-mail that person I wrote about from Gilead to ask. She is the coordinator or something for the trials for 7977.  I wish you the best so much.
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Avatar_n_tn
My 9/11/12 post on another thread ("Clinical trial GS-7977 and BMS-790052" in which many posters were lambasting Gilead for not going forward with BM in testing all oral combo therapy) is relevant to this thread, so I have copied that prior post below.


I have a different take on what is optimal.

The course Gilead is taking was clearly articulated in its 7/26/12 earnings call (transcripts available online) and seems like a "grand slam homerun" approach to me.   Gilead has gotten approval from the FDA for a Phase 3 study using GS-7977 and GS 5885 (like declatasvir, an NS5A inhibitor).  Other parameters will be set after the results of a small confirmatory Phase III study are reviewed (around the end of this calendar year, it would appear).  The time schedule is very aggressive -- if everything goes as planned, the fixed dose combination regulatory filings would be made in mid-2014 -- much faster than could be achieved if the study had to be coordinated between two different pharmaceutical companies, as would be the case if GS-7977 were paired with the Bristol Myers drug declatasvir rather than with the GS-5885.

Granted, there are some question marks (most notably whether GS 5885 will indeed prove to be the equivalent of declatasvir), but that will be known very soon.  I'd put my money on the notion that the GS- 7977/5885 combo will be the silver bullet and that will be borne out with lightening speed.

BTB
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163305_tn?1333672171
Hope you are right. No way I'd wager on it simply because we heard so much of the same type of talk with the triple tx. Even my hepatologist who goes to all the liver conventions said it would be approved a good two years or so before it was.
These things can drag on. Hope I'm wrong though and the new orals are available sooner than later.
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We are are treating with GS-7977 ourselves. We didn't ask others to hijack this thread for their own anti-capitalist anti-pharmaceutical 'theories'.

Some of us treated previously with peg-interferon and ribavirin. Some of us failed treatment with peg-interferon based treatment because we don't response to interferon. We have now have a non-interferon treatment that is working for us without all the side effects that the folks treating with triple therapy are experiencing. Why begrudge us our chance to treat and cure our hepatitis C???

In my case and the others in my clinical trial, hepatitis C has destroyed our livers and caused us to develop liver cancer for which the only cure is a transplant. We all have a need to get a transplant within the next 6 months before our cancer kills us. Knowing that during transplant hepatitis C universality reinfects the donor liver which can cause cirrhosis and liver failure in 5 years in 30% of hep C reinfected post transplant patients, why shouldn't we try to increase our longevity post transplant? I realize that the critics have no insight into what some of us have gone through living with decompensated cirrhosis and liver cancer, their ignorance is no excuse to rain on our hopes.

So for the critics the have nothing positive to say and know nothing about our treatment, please keep your ignorance and rants to yourselves. We didn't ask for your opinion. This forum is for people to share their experiences with treatment. We are trying to share our experiences among ourselves because we are treating or have treated with GS-7977. We have just as much right to do so as do the folks that are treating with triple therapy or have treated with triple therapy. This forum is not a place to promote utopian dreams and vent your hatred of capitalism or pharmaceutical companies. Please find the appropriate forum for that. I'm sure there of plenty of such places on the Internet. If you choose never to purchase any drug or never have any medical interventions that is your choice and you are free to practice what you preach. No one is forcing you to treat your hepatitis C or any other condition... although I don't know why you are on this forum because it is for persons interested in the appropriate treatment of hepatitis C and people struggle to over come hepatitis C using current treatment therapy's.

Hector

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All I can say Hector, is keep your eye on the prize and don't listen to so much dribble. It's wasted energy.
If people really want to be informed, why don't they go to the Gilead website and really listen to what's going on. I think they would be pleasantly surprised. I personally cannot wait for the upcoming screening and if I'm lucky enough to be give one pill for the cure, I will thank my lucky stars.....for the rest of my life.
Blessings to you!
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+1
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i just finished treating with incevik.  at the end-of-treatment talk the doc told me that if i relapsed, all is not lost because they will have the next drug for me to try in about 18 months - 7977.   agree with OH - me thinks that is a little optimistic. i recall in 2007 when the president of Vertex, said incevik would be approved in 2009. so i waited - 2 years turned into 4.  hope i am wrong about 7977, and that i can try again in 18 months if i relapse. i don't begrudge big pharma their due for the investments they make.  
blessing to all,
eric
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3242225_tn?1348340121
Yeah, I really hope that you are right.  It definitely makes sense to me.  And check this out:  http://www.ncbi.nlm.nih.gov/pubmed/22314425
And it's all about Geno. 1.  
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3242225_tn?1348340121
Oh, I forgot to tell you. Gilead is only testing 7977 with interferon because their goal is to eliminate interferon totally and have an all oral once a day pill for all genotypes. In order to do that, they must test 7977 and riba against interferon and riba and 7977 and interferon so that they can demonstrate that just the 7977 and riba is more effective and so much more humane than interferon.  Do you get what I mean? Just look at the clinical trials that they have done even recently and you will see it.  Hey, Odin, I agree it appears that they have done something not very nice, but they might just be working on something that is the answer to it all.  I know it is their wish.
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3242225_tn?1348340121
Thank you, Hector.  I feel sad for those who so want a cure to come to them and not have to go through the torture of interferon. I know it's coming.  I know that Gilead is working very hard to make it happen. They are literally betting 11 billion on it.  
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3242225_tn?1348340121
Thank you, Ukgirl55.  You know I just want to share something else having just gone through their 7977 and riba and now am UND at 4 weeks and we'll see.  I kinda fell in love with the company when I was first learning about them and waiting to get enrolled in the clinical trial  Reason is, they said that those who got on placebo would without exception receive the real medicine once the study was completed.  I thought that very humane and wonderful.  Now I just saw them act so wonderfully again.  Unfortunately one man in the study that I am in relapsed after completion of the study when blood was taken at 4 weeks post and Gilead pulled him and had him sign up for the study registry.  That registry is for all of their patients who relapse and they will be first in line when another treatment becomes available.  The study design is such that it says that they will not unblind it until 24 weeks post, and yet rather than let this poor man believe that he maybe was cured, they pulled him and put him in the registry now and reassured him that he would be in line for the next treatment for sure.  What they did by doing that was blow their whole cover on the double blind because the rest of us know that we are UND or they would have pulled us too.  But they did it anyway because they didn't want this guy to hope for another 20 weeks only to have him be relapsed at the end.  I call that a fine company with a conscience.  
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Yeah!!!! Smart man for sure!
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3242225_tn?1348340121
UK girl, are you about to begin a clinical trial?  
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God willing, I'm going to be screening this month for the 7977+5885, 12 and 24 weeks, with/without Riba trial. I pray that I'll pass the screening and pray that I only get the ONE PILL.
I've waited and turned down a lot of clinical trials. Would have done the last one 7977+BMS, but had some serious dental problems come up. I felt a little relieved as well because the only rescue meds were interferon and I knew that once Gilead got up and running on this trial, their rescue meds were going to be all orals from now on. Listening to Gilead's webcasts will give you plenty of information on how they want to proceed.
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163305_tn?1333672171
I am very excited for you.Please let us know how things turn out :)
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3242225_tn?1348340121
I can't wait to hear if you got accepted.  Why not also e-mail the Gilead clinical trial coordinator at ***@****.  She can answer your questions and make sure that you have located the best clinical trial for you. She is very nice. I e-mailed her at the start of my process when I first began looking for a clinical trial.
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3242225_tn?1348340121
I forgot I cannot post an e-mail on this. Will send you a PM
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Oh, I just saw this and thank you, I received your email, but no worries. I don't need to talk to anyone else, I know it's the best trial for me.
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3242225_tn?1348340121
That is great and if you have questions, she'll answer them.  She is so nice.  
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1797925_tn?1341099804
This is the 100% CURE we need (without ribavirin and/or interferon):

http://hepatitiscnewdrugs.blogspot.com/2012/09/challenges-remain-in-reaching-100-cure.html

And we need it NOW!
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Please keep us posted re what is entailed in the screening/selection, what arm you're in, and when dosing starts.  Thanks very much.

BTB
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2061362_tn?1353283118
Thanks for posting that Margaret.
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I certainly will. Gotta pass the screening first.
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