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3242225 tn?1348336521

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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Avatar universal
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 universal
I certainly will. Gotta pass the screening first.
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2061362 tn?1353279518
Thanks for posting that Margaret.
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Avatar universal
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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1797925 tn?1341096204
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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3242225 tn?1348336521
That is great and if you have questions, she'll answer them.  She is so nice.  
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Avatar universal
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?1348336521
I forgot I cannot post an e-mail on this. Will send you a PM
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3242225 tn?1348336521
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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163305 tn?1333668571
I am very excited for you.Please let us know how things turn out :)
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Avatar universal
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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3242225 tn?1348336521
UK girl, are you about to begin a clinical trial?  
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3242225 tn?1348336521
Yeah!!!! Smart man for sure!
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3242225 tn?1348336521
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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3242225 tn?1348336521
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?1348336521
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?1348336521
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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Avatar universal
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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Avatar universal
+1
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Avatar universal
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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446474 tn?1446347682
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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163305 tn?1333668571
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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Avatar universal
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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3242225 tn?1348336521
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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3097131 tn?1357084881
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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