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4309115 tn?1357606283

Gileads to pull the pin on Hep C cure

Is anyone else reading and getting the feeling that Gileads is stopping it's trials on HEP C cure
because it's not lucrative for them?
20 Responses
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4950316 tn?1394184585
I haven't read anything about Gilead stopping their trials.
Can you direct me to where you read this?
I know that the new nuke PIs that are being trialled by Vertix, Bristol-Myers Squibb and Idenix have had a hold put on their trials by the FDA because of toxicity concerns (Read on HepatitisCentral site).
Helpful - 0
Avatar universal
That's a silly "headline" to give a thread and post absolutely no data or rationale to support your idea.

Also..... most of the data I see says that they have succeeded with trials where many have failed...Vertex and BMS have both suffered setbacks.

So Gileads' competition has had setbacks, Gilead seems to be winning the race and they are going to walk away from approval after spending all the money on trials and when they have diminished competition?

Hhahahhahaha
No, I am not "getting that feeling".
Based on what?

willy
Helpful - 0
901131 tn?1293744553
I'm not sure where you guys are getting this ino from. Vertex had a partial hold put on a trial drug because of potential liver toxicity but Gilead is finishing up there trials and BMS which I just recently completed is to partner with Merck coming soon for another trial.
Helpful - 0
Avatar universal

"Is anyone else reading and getting the feeling that Gileads is stopping it's trials on HEP C cure
because it's not lucrative for them?"


Please post the links to any such readings.
Gilead may be doing less trial studies because they are getting ready upon FDA approval to market Sofosbuvir shortly.

Without back up, this sort of speculation only causes anxiety and confusion.
Helpful - 0
901131 tn?1293744553
The BMS setback was mid 2012 with a drug they purchased from Idenix which 3 people died. I started a BMS trial 2/1/13 and was UD by week 2. I just got my 12 week post results and still UD. As I said BMS and Merck are to partner later this year so keep your eyes peeled.
Helpful - 0
901131 tn?1293744553
Gilead has funded BILLIONS on there HCV drugs and have a once a day single pill combo drug CURING in the high 90% range for Genotype 1 & 4. I highly dought there holding anything, there trials are just winding down now......PERIOD
Helpful - 0
Avatar universal
Just as a side note

A summary of drugs currently in trials /with latest results posted.

Apologize if this has been posted here.

If his can not be veiwed ,you can sign up to the CCO site for free and access this info..

Will


http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Amsterdam%202013/Viral%20Hepatitis/Highlights_Slides.aspx
Helpful - 0
Avatar universal
It just dawned on me you were possibly asking me a question.

The positive data I am seeing from Gilead...the most recent is this;
http://www.natap.org/2013/HCV/050313_01.htm

Vertex just had a setback w/ VX-135;
http://www.thestreet.com/story/11990242/1/a-hep-c-breakdown-will-test-investors-love-for-vertex-pharma.html?puc=yahoo&cm_ven=YAHOO

Vertex was also partnered with Bristol (BMY) in one of the collaborations.
The data I saw with the lower doses seemed good, but not compelling and not competitive w/ what I have seen from Gilead;

http://clinicaltrials.gov/ct2/show/NCT01842451?term=vx-135&rank=3

It is not the end of Bristols HCV program, just a second dry well.
Yes, initially several died in the inhibitex trial, but there are more who were affected;
http://www.pharmalive.com/bristol-myers-tries-settle-hep-c-patient-claims

So far as I know Abbvie is doing quite well with their HCV program, but I do not believe it will be approved as early as Gileads, it will almost certainly require twice per say dosing, more pills and having seen one of the pills..... one is a monster.

OTOH it appears that Gilead may have a one pill per day course of treatment and a good chance at a high rate of cure in both 8 and 12 weeks.

I just don't see Gilead spending 11 plus billion for the compound, then all the money running the trials.... and then walking away when they are in what looks like to me, first place.

In the past year Gilead stock has more than doubled, so it appears that many other people have favorable opinion that Gilead will be able to wring out a bit of profit from the hep c program.  (stock has increased 225% in the past 2 years AND since pharmasett 7977 acquisition, but also due to their HIV programs)

willy

Helpful - 0
4309115 tn?1357606283
www.gileads.com/news/press-release/2013/5/gilead-reports-intrim-data-from-
phase-2-lonestar-study


it's at the bottom of the page under
Forward looking statment,there's plenty there just look for yourself.
Helpful - 0
Avatar universal
Hey, I'm sorry if I got after you for the title of this thread.
I know I may have taken you a little to task for the title and for not providing any reasoning or proof behind your question or assertion.
If it was a question.... the title of the thread shows no question mark.

re: this comment, you wrote to Rivil;

"since you need guiding by the hand it's at the bottom of the page under
Forward looking statment,there's plenty there just look for yourself"
===============================
Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from the clinical studies evaluating sofosbuvir and the sofosbuvir and ledipasvir fixed-dose combination, including from the ION-1, ION-2 and ION-3 and LONESTAR studies.
==================

Quale, all of the companies have to have such disclaimers; they are selling stock.  I've listened to stock pitches for years and they all must have some sort of disclaimer.
For example....Abbvie might say that "we think we are in a very good position to bring out drug combination for an interferon free regimen first to market".
It may or may not be true, but they have the license to shade a little,

Gilead is basically saying, this is what we expect to happen.... but if it doesn't, you can't sue us because of the disclaimer; they are saying what they are trying to do, but they have no crystal ball and things might not work out.

The disclaimer is a universal in these stock pitches.  Check it out.

willy
Helpful - 0
5839375 tn?1375213224
I will be starting Gilead's Hep C Phase 2 Trial  tomorrow, August
8th.  it's an open label study to investigate the safety and efficacy of Sofosbuvir and GS-5816.  Some of the participants will also be given  Reproviron as well.  This trial is for only three (3) months and from what I've read online including what this leading trial doctor told me, there is minimal side-effects.  I will keep everyone posted as I move forward.  I feel so grateful to be asked to do this by my regular Hep C doctor, but at the same time nervous. The only risk I read was, " Your  condition may or may not improve and could even get worse if I take part in this trial."  "These drugs may not completely  remove the virus and you could develop a drug resistance to other available drugs, as well as future drugs.
The risk is worth it to me only because I heard and know so many that were fine, like myself, meaning no cirrhosis of the liver and within 2-4 years died of this disease.   It's a very painful way to go.  At the same token I've  been through interferon and I would never do it again.  There are so many people out there why are still living with the long-term side affects of this drug.
if these drugs end up not being a cure stay so many of us, stay hopefully.
Helpful - 0
5839375 tn?1375213224
Sorry I about that. My nail accidentally hit the send or the done button.  Just ignore the last sentence.  Kathy
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4309115 tn?1357606283
I understand Willy50 nothing in life is 100% sure,and having family and myself
owning buisnesses,even if it works it's all about MONEY,and if you think it's for the sake of suffering people alone I'm sorry,if they won't make money
they won't go ahead,I'm on bocep riba and interfuron 13 weeks and believe me
when I say I hope they come yesterday,but they always cover their *** don't they.
Helpful - 0
766573 tn?1365166466
Sure it is all about money but "feeling that Gileads is stopping it's trials" is not exactly a fact based statement. I was a little alarmed when I first saw the title to this thread. Thanks to all the subsequent posts :)
Helpful - 0
Avatar universal
I too was alarmed and I am afraid I overreacted.
Knowing that you are currently treating with interferon, riba and bocep explains a lot to me and I apologize for my extreme response to you.
Good luck with your tx and may you attain svr and never have to face this sort of thing again.
Helpful - 0
317787 tn?1473358451
I did read that Vertex has had a trial drug put on hold by the FDA
Did you read that as well?

Good job Rivil, I looked that up as well. Quayle has had a rough time with his tx.

Hang in there Quayle, we are all rooting for you

D
Helpful - 0
Avatar universal
I posted a little bit about Vertex VX-135 trial.  Only ONE arm dosage is closed, not the entire study.

It remains yet unknown how this could affect other collaborations, but somewhere I thought I saw good but not great results w/ daclatasvir.

Even so, in lower VX-135 dosing it is yet one other potential pairing, just a little early to be seen or known.
If the dosing worked well w/ Daclatasvir in the 200 mg dosing it may be irrelevant and the collaboration may yet be well and viable.

================================


http://www.thestreet.com/story/11990242/1/a-hep-c-breakdown-will-test-investors-love-for-vertex-pharma.html?puc=yahoo&cm_ven=YAHOO

"The FDA placed a partial clinical hold on VX-135 because of elevated liver enzymes reported in patients treated with a 400 mg dose of the drug in a phase II study conducted in Europe. These patients stopped taking VX-135 and their liver enzymes returned to normal, the company said.

FDA reacted by barring Vertex from treating any new patients with doses of VX-135 higher than 200 mg in the U.S. Studies involving 100 mg doses of VX-135 continue, the company said.

Hepatitis C studies involving 100 mg and 200 mg doses of VX-135 in Europe are also continuing. "

====================
willy
Helpful - 0
4309115 tn?1357606283
How many billions of dollars have been spent on cancer,how many drugs shelved,is there a cure yet,No,what about the billions spent by drug co on MS
is there a cure? cancer in the US is a 8 Billion dollar industry alone per annum
What makes you think they want to have a cure,that puts alot of people out of work.and they stop making money,to those it does'nt make good financial sense.
Helpful - 0
3093770 tn?1389739126
Although this generalization of "the big pharma" is always used I cannot believe that thousands of scientist are actually having meetings to decide on strategies to make a drug inefficient or to make sure that the drug will get people sick so they have to use more drugs after that.

research is a very difficult field to work in. Everything starts from a concept and things are progressing from there. Yes, it costs billions and is a hit and miss way of doing things. All the assumptions start from an equation or a previous observation. It will quite difficult to make another variation who is less efficient. It is almost like saying: hey why did we not have this generation of computers right from day one?

Cancer drugs are starting to be more efficient and the truth is that the real progress started when it was recognise that it will be a need for different protocols for each tiype of cancer. Same with HCV, we have all this different protocols these days. There isn't a one fits all approach anymore

Are you actually saying that every individual working in the medical industry is corrupt and consciounsly decides not to cure people for the sake of money? I cannot honestly believe this

Yes, it is also about money as those indutries were created in response to a demand but I think the doctors and researchers involved are trying to do their best. But  maybe not all of them might be competent enough
Helpful - 0
707563 tn?1626361905
Hey everyone -

This thread is closed.

Thanks,

Emily

                   ***************   CLOSED THREAD   **************************
                                 NO MORE POSTS, PLEASE
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