Aa
Daclatatasvir & Sofosbuvir
Let's end the lack of cooperation between Gilead and Bistol Myers and get these two drugs on the maket to the people who need them. The only way we can do that is through our White House Petition. Pleas sign at www.hepc-cured.org we on have until 3/20/13 to get 100,000 signatures to have the white house intervene. Please have your friends, relative, neighbors sign and add it to their face book and twitter... we need to end this deadly disease now. 4 million in US have this disease, 170 million world wide, hepc killmore people today than AIDS, a 1000 people a day die waiting for a cure. Take action now---sign the petition. Thank you
Hi Willy
I agree with what you say.
7977+Daclatasvir is probably no longer the shortest path to approval.
If only phase 3 testing was started immediately after EASL, they would be close to filing for approval now, because both were already so advanced in testing,
and it may have been the best treatment ever developed, able to cure almost everybody.
But we will never know now.
It certainly deserved further development.
They could have been trialing 7977+Daclat with seriously ill, like pre transplants, instead of 7977+Ribavirin, which I am certain is less efficacious and more sx.
Anyway I don't think it hurts to support Magaret Dudley and the petition though.
She is just trying to get the best deal for all of us, by sacrificing her time, effort and probably funds.
I am pro private enterprise and the free market and creating profit and serving share holders.
But there needs to be some rules and regulations,
for instance a company can't just dump pollution into a river, because it is the cheapest thing,
especially if someone takes the trouble to complain.
And the regulations guiding big pharma are quite strict, to protect patient welfare.
Not saying Gilead broke any laws.
It just seems to me so wrong, what they did in this particular instance.
Sure, if they actually developed GS 7977, then they can do what they like, in my opinion.
But they purchased after it has shown excellent results in combination.
(and Pharmasett began development of it at a tax payer funded university - go figure)
Then they lock it up with their own drug, 5885 which causes a approval delay of at least a year.
And to me 5885 is clearly inferior to Daclatasvir in some ways.
ie. it will not work in GT2&3.
Which is probably why Gilead are testing other combinations, like in the new trial you mentioned.
And Gilead have talked about the new drug GS5816 + 7977, which may be more pan genotypic combo., but will still take years before approval.
Having said that, I personally would be ecstatic to get on the 7977+5885 combination, but its just not available here.
And I will probably just have to take my chances with Boceprevir triple tx,
and hope I am one of the lucky ones that survive intact.
I agree with what you say.
7977+Daclatasvir is probably no longer the shortest path to approval.
If only phase 3 testing was started immediately after EASL, they would be close to filing for approval now, because both were already so advanced in testing,
and it may have been the best treatment ever developed, able to cure almost everybody.
But we will never know now.
It certainly deserved further development.
They could have been trialing 7977+Daclat with seriously ill, like pre transplants, instead of 7977+Ribavirin, which I am certain is less efficacious and more sx.
Anyway I don't think it hurts to support Magaret Dudley and the petition though.
She is just trying to get the best deal for all of us, by sacrificing her time, effort and probably funds.
I am pro private enterprise and the free market and creating profit and serving share holders.
But there needs to be some rules and regulations,
for instance a company can't just dump pollution into a river, because it is the cheapest thing,
especially if someone takes the trouble to complain.
And the regulations guiding big pharma are quite strict, to protect patient welfare.
Not saying Gilead broke any laws.
It just seems to me so wrong, what they did in this particular instance.
Sure, if they actually developed GS 7977, then they can do what they like, in my opinion.
But they purchased after it has shown excellent results in combination.
(and Pharmasett began development of it at a tax payer funded university - go figure)
Then they lock it up with their own drug, 5885 which causes a approval delay of at least a year.
And to me 5885 is clearly inferior to Daclatasvir in some ways.
ie. it will not work in GT2&3.
Which is probably why Gilead are testing other combinations, like in the new trial you mentioned.
And Gilead have talked about the new drug GS5816 + 7977, which may be more pan genotypic combo., but will still take years before approval.
Having said that, I personally would be ecstatic to get on the 7977+5885 combination, but its just not available here.
And I will probably just have to take my chances with Boceprevir triple tx,
and hope I am one of the lucky ones that survive intact.
"If it were purely based upon efficacy, shouldn't one be interested in the efficacy of 7997 & 5885? "
"The 7977 daclatasvir combo isn't the ONLY combo which can cure. It isn't the ONLY one that can cure w/o Riba. It just isn't the only hope, and it probably is no longer the shortest distance to a cure."
Good point!
I'm in current trial with 7977/5885 or what I call 7985 because of what is stamped on the pill. I started with 19,700,000 VL Week 2 UND. Week 4 UND ALT 19 and AST 19. Side effects Headache and some GI problems.Seems the pill causes excess gas that causes stomach pain and nausea. I'm trying to control that with diet and doing much better. Alot of my favorite foods l can't eat right now, but small price to pay. I think others will have this problem. Will the Nausea be too great that they have to stop treatment? Headache too much to continue? Now that a bigger number of people are in these current trials I think this will be the case for a small precentage. Like all drugs they have some side effects. Nothing like INF/RIBA , I ran 6 miles last Sunday, I could hardly carry my dog upstairs to bed during SOC treatment. My numbers are pretty amazing with this 7985 combo, we shall see Very soon.
I well, I doubt they will collaborate as well..... unless there was something they determined to make it more attractive. Or a hurdle pops up somewhere. I think the trial I listed in my last post was just one more way of hedging their bets, spreading risk and I believe seeing what sort of compounds work with 7997. It was first posted at CT march 5; brand new,
Part of it was just pointing out; if you are going to force a collaboration; which collaboration?
If it were purely based upon efficacy, shouldn't one be interested in the efficacy of 7997 & 5885?
If the driver is the earliest to approval..... then it would now appear that the 7997 & 5885 combo is closest to that finish line.
Quest is taking some liberties with facts. The 7977 daclatasvir combo isn't the ONLY combo which can cure. It isn't the ONLY one that can cure w/o Riba. It just isn't the only hope, and it probably is no longer the shortest distance to a cure.
I am not going to take Gilead to task (well, I have already, but not now) over the motive to make a profit, since all the competitors are exactly the same. If you read up on any of these companies that is very clear. It doesn't mean they are heartless (cause I do not believe that), but they do exist to make profit and advance their company.
There have been a number of threads on the very topic, particularly back around EASL 2012.
That doesn't not mean I supported this initially; I didn't. The fastest path to approval *had* been 7997 & Daclatasvir.
Things change. : I
willy
Part of it was just pointing out; if you are going to force a collaboration; which collaboration?
If it were purely based upon efficacy, shouldn't one be interested in the efficacy of 7997 & 5885?
If the driver is the earliest to approval..... then it would now appear that the 7997 & 5885 combo is closest to that finish line.
Quest is taking some liberties with facts. The 7977 daclatasvir combo isn't the ONLY combo which can cure. It isn't the ONLY one that can cure w/o Riba. It just isn't the only hope, and it probably is no longer the shortest distance to a cure.
I am not going to take Gilead to task (well, I have already, but not now) over the motive to make a profit, since all the competitors are exactly the same. If you read up on any of these companies that is very clear. It doesn't mean they are heartless (cause I do not believe that), but they do exist to make profit and advance their company.
There have been a number of threads on the very topic, particularly back around EASL 2012.
That doesn't not mean I supported this initially; I didn't. The fastest path to approval *had* been 7997 & Daclatasvir.
Things change. : I
willy
"Speaking of collaboration......Gilead is still in a few. This one cured everyone they treated This one is Sofosbuvir and Simeprevir "
Gilead will not collaborate - not enough profit for them.
This trial was started when Pharmasett still owned Sofosbuvir (then PSI-7977)
Don't hold your breath for any further development of Sofos+Simeprevir,
even though both drugs are very advanced in testing any the combination could have been approved very quickly, and the results are excellent.
Just like Daclatasvir+Sofos, it will never see the light of day.
And the approval delay before a decent treatment arrives could well mean the death and suffering of thousands of us, unfortunately.
Other drug companies often collaborate on drug treatments,
and BMS is willing to work with Gilead.
Gilead overwelming motive is profit, not patient welfare,
which is not acceptable for a large pharmaceutical.
Anyway I have a feeling that what goes around, comes around and Gilead will get their just deserts eventually.
Gilead will not collaborate - not enough profit for them.
This trial was started when Pharmasett still owned Sofosbuvir (then PSI-7977)
Don't hold your breath for any further development of Sofos+Simeprevir,
even though both drugs are very advanced in testing any the combination could have been approved very quickly, and the results are excellent.
Just like Daclatasvir+Sofos, it will never see the light of day.
And the approval delay before a decent treatment arrives could well mean the death and suffering of thousands of us, unfortunately.
Other drug companies often collaborate on drug treatments,
and BMS is willing to work with Gilead.
Gilead overwelming motive is profit, not patient welfare,
which is not acceptable for a large pharmaceutical.
Anyway I have a feeling that what goes around, comes around and Gilead will get their just deserts eventually.
Here is a new trial I have not seen before listed
http://www.clinicaltrials.gov/ct2/show/NCT01805882?term=NCT+01805882&rank=1
NCT01805882
You'll note there are just two cohorts
Arms Assigned Interventions
Experimental: GS-7977/GS-5885 in treatment naive patients
GS-7977/GS-5885 for 12 weeks
Drug: Fixed Dose GS-7977/GS-5885
---------------------------------------
Experimental: GS-7977 + GS-9669 in treatment naive patients
GS-7977 + GS-9669 for 12 weeks
Drug: GS-7977 + GS-9669
-----------------------------------------
You'll note that both trial arms are 12 weeks. You'll note that there is no ribavirin in either arm.
I am inferring that ribavirin is possibly not needed to provide SVR's, as was asserted by Quest in this thread (the originating poster). I am assuming that this is based upon the ION 1 trials which commenced in Oct/Nov
2012.
willy
http://www.clinicaltrials.gov/ct2/show/NCT01805882?term=NCT+01805882&rank=1
NCT01805882
You'll note there are just two cohorts
Arms Assigned Interventions
Experimental: GS-7977/GS-5885 in treatment naive patients
GS-7977/GS-5885 for 12 weeks
Drug: Fixed Dose GS-7977/GS-5885
---------------------------------------
Experimental: GS-7977 + GS-9669 in treatment naive patients
GS-7977 + GS-9669 for 12 weeks
Drug: GS-7977 + GS-9669
-----------------------------------------
You'll note that both trial arms are 12 weeks. You'll note that there is no ribavirin in either arm.
I am inferring that ribavirin is possibly not needed to provide SVR's, as was asserted by Quest in this thread (the originating poster). I am assuming that this is based upon the ION 1 trials which commenced in Oct/Nov
2012.
willy
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