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1797925 tn?1341096204

Does Gilead hold the key to CURE!

I would be interested to know  how many  have signed the petition at Change.org targeting Gilead Sciences (GS-7977) to partner with Bristol-Myers (BMS-790052 daclatasvir) and to put "patients before profits".   Excerpts pasted below from various searches on the internet:

"Gilead, Bristol Hep C Drug Data at EASL: 100% Cure Rate with Bristol's phase II study of daclatasvir plus Gilead's GS-7977 in patients with genotypes 1, 2, and 3: SVR4 (early cure) rate in the genotype 1 patients: 100%. In genotype 2/3 patients, the SVR4 rate was 91%."

"But the combination might not find its way to the market because one pill is owned by Gilead Sciences and the other by Bristol-Myers Squibb. The companies have not agreed to collaborate, to the chagrin of some doctors."

"Dr. Douglas J. Manion, a senior vice president for Bristol-Myers, said his company was “keen” on working with Gilead but that “thus far, they have been unwilling to engage in that collaboration.”

If you have not signed it, I am curious to know your reasons.  I have been following this forum since I was diagnosed last September, and I have spent hundreds, probably thousands of hours searching for treatment without the side effects of interferon and/or ribavirin..  And now there appears to be a 100% early CURE rate for GT1s without interferon OR ribavirin, and a 91% early CURE rate for GT3s (my genotype)...with minimal side effects (nausea, headache, fatigue).

Thank you all in advance for your responses.

Link to petition:

http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c

Warmest Regards,
Margaret





52 Responses
1491755 tn?1333201362
It might be an easier cure for the patient, but millions have been cured of HCV already.  If you're a g4 it's not 100%. Also I'd like to see more people on it and their condition 1 year EOT.  Perhaps all the studies collectively are a large number, dunno.  It looks great through, and I am very happy for those who are on it, or going to be on it in the future.
Avatar universal
I don't understand not signing a petition because a person has time to wait for a cure. What about those that don't have time? Since when do we sign petitions only to benefit ourselves?
1797925 tn?1341096204
I started to add the option as:

NO- I have time to wait for trials that can beat the 100% cure rate they had with GS-7977 & daclatasvir WITHOUT interferon OR ribavirin (DUH)

But I didn't want to sound insulting to anyone.  But people...listen up...it doesn't get any better than 100%.  You need to educate yourself about the disease YOU have and the side effects of ribavirin!  At any rate, as rivil inferred,  SIGN the petition for those of US who know a good thing when we see it!  This is the biggest success in the history of HCV treatment!!!!  You will only be helping yourself in the long run!  So please go to the link and sign the petition!!!
Avatar universal
  "But I didn't want to sound insulting to anyone.
You need to educate yourself about the disease "
----------------------------------------------------------
I find that highly insulting.....
Will
1797925 tn?1341096204
My apology to you Willbb, and I am truly sorry that you were insulted.  I was just trying in perhaps a lame way to make the point that these drugs cured 100% of the GT1s (44 patients) with minimal side effects.  I, myself, am GT3 and the results were 91%. (42 out of 44 patients) .  Fibrosis progresses faster in GT3s, so I guess I am guilty of throwing out anything I can right now in a desperate effort to get somebody to help!

Again, my deepest apologies to you and anyone else who was hurt by my post!

Margaret
Avatar universal
It would be insulting if you were speaking solely to Will or some of the other folks here that really know Hep. C and all it entails but for the majority of us, there is no insult in what you said. You are right.
I have exhausted my list of people and they all signed. Wish I could dig up more.
Avatar universal
No worries and I believe that many if not most folks here have "educated themselves about HCV " as you say to at least some extent.

I wish you well in your quest for a successful therapy.

Will
Avatar universal
I can't remember how many times I've told people to arm themselves with knowledge, start reading threads, learn about the disease and it's treatment.  It's almost part of the basic template of what people get told by many members.

After 8 years it's as though I've still just scratched the surface.  Every new year brings new drugs, new treatments, new facts about the virus including.....so very often..... facts that seem to fly in the face of what we thought we knew.

I didn't see the post as offensive in any way.  

I *did* see some naughty remarks on the other side of the forum today though.  : )   : )   : )

willy
148588 tn?1465778809
NO- because petitions are not the mechanism by which safe and effective drug therapies gain FDA approval and are brought to market. Besides, it seems a little premature for a lay person to decide to move Heaven and Earth (based on a study with 44 people) to tell a multi-billion dollar company employing an army of trained and well educated biochemists, PhDs, and experienced researchers what drug combinations are safe, effective, (and profitable).  
Avatar universal
Excellent post desrt..
Will
Avatar universal
LOl; it's an excellent post; but it's excellent hyperbole.  : )

Heaven and Earth?  C'mon.  : )

The purpose of the petition isn't to part the sea, it's probably closer to asking Gilead to continue in the most direct, the straightest line, the shortest distance and least cost (since the expense is shared) to the most effective form of treatment that has yet arrived to treat HCV. (It might also be the safest too since triple therapy is very hard on cirrhotics, but too hard to extrapolate that from the numbers ......yet)

I think of the path akin to driving from Oakland to San Francisco.  The path that appears that Gilead is going to take is Oakland, by way of Reno.  : )

Partnering is a means of getting the most efficacious cure (have we seen a higher cure rate elsewhere?) to the people who need it in the shortest period of time.
(yes, I agree the numbers turned in are low, but the data on the two drugs is high and it appears that the ongoing trials are working well.  I just read of a null responder to triple therapy clearing in the collaboration.  If you think the numbers are low in the trial result, compare them to the numbers of people who have treated in any fashion w/ 7977 and 5885; how do those numbers look?)

The issue about delaying the drug compound probably would not affect me at all, but there is the simple calculus of human mortality rate in cirrhotics.  The longer the most effective treatment is kept from approval, people who need that; cirrhotics, null or non responders near the end of their rope.....some of these people will not last long enough for the launch date of what looks like what Gilead will do; team 7977 with 5885 which will take longer to gain approval, which is a longer and more uncertain path.

Read this and work the numbers;
-------------------------------------------------------
http://www.nytimes.com/2012/02/28/health/research/hepatitis-c-deaths-creep-past-aids-study-finds.html

"There were 15,106 deaths due to hepatitis C in 2007, almost 75 percent of them among people ages 45 to 64. The report appears in the Feb. 21 issue of The Annals of Internal Medicine."
-----------------------------------------------------------------

My math says that in 2007.........41 people died every day due to HCV.  That rate approaches almost 2 deaths per hour.  It is 1233 deaths per month give or take.  That was 2007 and we all know that as the population ages and the damage increases that the death rates were forecast to increase.

I think that the purpose of the petition is to tell Gilead that we are paying attention, that we know that they could do this, but seem to be taking the path of profits, the longer less direct, less certain path.  

I won't invoke names of people on this board who could be cured by the best form of treatment, or people who could have been saved but have passed, but people who spend time on boards know who some of these people are.  The fact is that for each day the best cure is delayed people will die, and perhaps without need.

If people didn't raise a stink about trans fats we would still be eating them.  My God; they were in everything.  The food industry didn't care that people died, that our health was impacted negatively; it was good business because the food products had a longer shelf life.  The *human cost* was ignored.  Only when enough people made it important, only when profits were threatened did the corporations respond.

In this case, it's the HCV infected cirrhotic people who have the shorter shelf life.  Taking the longer path to DAA approval will cost some people their lives.  

Many of the so called experts have been critical of Gilead.  The stock people say that there is only so many infected people, the window is only so big, the infected numbers are finite.  If you cure them once; that's the end of that.  Many of us will not need the "best in class" drug treatment to get cured.  There will be many coming, but this combination hold the potential of being truly best in class and first, and easiest to gain approval for.

I don't really need this combination to win approval, not for me.  But I know people who could benefit from it.  I have a friend with a meld score who slides in and out of ammonia control problems who lives in an area that they don't have a great shot at getting a liver.  We aren't all Steve Jobs.  This drug combination could save their life.  I know we all have people we know who cannot wait for an unnecessary delay.  My friend has recently stopped answering their phone.  Sometimes things happen in days.

That is what this petition is for.  People I know, people you know who can't do it themselves.

If it is a question of "moving heaven and earth", then this would be the motive.

Well, I've answered with my own hyperbole, but that is fine too I hope.  Sorry about the amount of it though.  : )

willy

Avatar universal
LOL..Suggesting someone else of hyberbole...now that IS my laugh of the day..

Desrt...As I can usually decide for myself what I think is an excellent post..
Again..I thought yours was excellent..and spot on..
Best..
Will
Avatar universal
Sorry ..Didn't mean to hijack your thread and again I wish you luck with this endeavour

Will
Avatar universal
I'm glad that you enjoyed it.  : )

I'm laughing myself, but the consequences for those who may expire are no laughing matter.  
You and I may share a few common traits.  : )

==========================
"http://www.medhelp.org/posts/Hepatitis-C/How-do-we-put-pressure-on-Gilead-Bristol/show/1720201#post_7879327
"Patience folks: As I have said many times in the past , "Pharma's insatiable appetite for profit will eventually bring us more effective treatment ...."
===========================

I know I DO rattle on, but I haven't taken to quoting myself yet.  : )

We will now return to our regularly scheduled programing....  : )

willy





Avatar universal
:)
962117 tn?1416358616
I know nothing about you from your profile, not even if you have Hep c. Just a hypothetical question...I couldn't help but wonder. If it were yourself or a loved one who could not afford to wait for a drug, that had a better than average chance of saving your lives... would you do everything in your power, including trying to "move heaven and earth" to help obtain it, or would you sit, wait, and do nothing? Not to say you would be successful, but wouldn't you at least try?

Personally, I feel very thankful for "the lay people" and the movers and shakers, in this world, who take the time to "at least try" to make a difference. Afterall..."Every journey begins with a single step."

@mdudley...Thank you!  

@Willy50...no apologies necessary for being so sincere and passionate!
Avatar universal
Can you be cloned dear Willy? You never cease to amaze me with your sharp mind and sweet disposition.
Avatar universal
desrt sounds awfully like someone else we know folks ;-)
148588 tn?1465778809
I've been undetected for over 9 years now. I've watched friends drag themselves to work while dying of ESLD to do pick and shovel jobs just so  they could afford another month's worth of meds back before there were 'compassionate care' programs - before Pegasys was FDA approved. I've followed people spending small fortunes on experimental treatments who still haven't cleared after multiple attempts at tx. I've followed the developement of protease inhibitors and seen PIs with fewer overt sides than tele' or boce' pulled from testing because parallel primate testing showed they had cardio' sx that hadn't shown up yet in stage 3 trials.
I've seen a lot of people pour time, effort, and emotion into letter writing campaigns that went nowhere.
If there were a way save myself or a loved one from dying of this disease I would do whatever was necessary
Avatar universal
I think that is what this petition is all about-no one can say it is "going nowhere" All we can do is try and I give kudos to Tanya and MDudley and any folks who are putting the effort out there to help themselves and others with this dread disease.
Avatar universal
Desrt has been around MH as long as I have and is the member I quoted from another thread who said that (paraphrase) "Gilead had 11 billion reasons to not collaborate".

He were also a sport about my teasing him about *hyperbole*, just as willbb was also a good sport during the back and forth.  : )

I also question whether one can effect any change in Gilead....

.... but..... to me it seems as though it is a worthwhile endeavor.

willy

willy



148588 tn?1465778809
Hyperbole? Hyperbola? I always get those two confused. I know one of them has asymptotes.
Thank you. At least this time I didn't get my computer hacked for simply expressing my opinion.
962117 tn?1416358616
Did not mean to attack your opinion. I find myself a bit emotional lately, especially when it comes to this subject. That being said...I suppose you do understand. Having seen all that, would affect one's opinion. Thanks for caring enough to hang around 9 years later. Best wishes to you desrt!
148588 tn?1465778809
And best wishes to you for SVR.
I know I come off as way too cynical and abrasive sometimes. When that happens my friends take me out back and kick my bvtt till I behave.
Take care and good luck.
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