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,
This is the latest. :)
http://www.gilead.com/pr_1804362
Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission.
This is the latest. :)
http://www.gilead.com/pr_1804362
Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission.
Hi,
I'm in uk... Geno 3....
Anyone any idea when Europe may approve sofosbuvir and rbv for us??
Also Britain did named patients thing for telaprevir before it was properly out... Does this happen in usa and might it happen for sofosbuvir in uk?
Can we ever get direct info from gilead?? Would they communicate at all with us to let us know of trials a d named patient intentions etc.. Anyone know!
Cheers...
Read all above posts with interest.. We at every much in the hands of the drug companies!,,
Ali X
I'm in uk... Geno 3....
Anyone any idea when Europe may approve sofosbuvir and rbv for us??
Also Britain did named patients thing for telaprevir before it was properly out... Does this happen in usa and might it happen for sofosbuvir in uk?
Can we ever get direct info from gilead?? Would they communicate at all with us to let us know of trials a d named patient intentions etc.. Anyone know!
Cheers...
Read all above posts with interest.. We at every much in the hands of the drug companies!,,
Ali X
I'm guessing 5885+7977 will be entirely adequate for GT1.
And a huge improvement on IFN based tx.
I've been hearing from several people on the ION trials, and they all seem to be UD by week 2 or 3, with reasonably mild sx.
And we have the 100% results of the Electron trial arm.
For GT2&3 7977+Riba is not the greatest, but still a huge improvement, and at least it will be launched soon.
You have some good ideas on encouraging collaboration.
I think BMS were willing to work with Gilead.
But maybe that was because they thought the best NS5B nuc (7977) was more valuable than the best NS5a non nuc (Daclatasvir).
Gilead do seem to be more profit driven than some other pharmas.
And really it is a question of degree.
All drug companies are profit driven to some extent, and rightly so,
but maybe some possibly to the exclusion of too many other considerations.
The HIV community is protesting vocally about the exorbitant prices of some of their AIDS drugs, compared to other companies.
Don't really know much about that issue though.
Anyway I just wish we could encourage the FDA to speed up the approval process.
8 to 12 months seems such a long time, from initial filing and all the trial results being in.
I would have thought that a committee working full could review that data in a month or two, at most.
Especially if there are no major adverse events in the trials, and the SVR rate is high.
Its just that there is such a huge need for these new drugs.
And a huge improvement on IFN based tx.
I've been hearing from several people on the ION trials, and they all seem to be UD by week 2 or 3, with reasonably mild sx.
And we have the 100% results of the Electron trial arm.
For GT2&3 7977+Riba is not the greatest, but still a huge improvement, and at least it will be launched soon.
You have some good ideas on encouraging collaboration.
I think BMS were willing to work with Gilead.
But maybe that was because they thought the best NS5B nuc (7977) was more valuable than the best NS5a non nuc (Daclatasvir).
Gilead do seem to be more profit driven than some other pharmas.
And really it is a question of degree.
All drug companies are profit driven to some extent, and rightly so,
but maybe some possibly to the exclusion of too many other considerations.
The HIV community is protesting vocally about the exorbitant prices of some of their AIDS drugs, compared to other companies.
Don't really know much about that issue though.
Anyway I just wish we could encourage the FDA to speed up the approval process.
8 to 12 months seems such a long time, from initial filing and all the trial results being in.
I would have thought that a committee working full could review that data in a month or two, at most.
Especially if there are no major adverse events in the trials, and the SVR rate is high.
Its just that there is such a huge need for these new drugs.
(George wrote;)
Sorry you missed out on the 7977+5885 trial by one place.
How about the second group of 600 starting soon, did you get into that ?
===================================
I think they are just winding up the first leg of it and assessing SVR-4 PCR's.
If that trial started Nov 1(maybe not every single person dosed by Nov 1), 12 weeks of TX would be Nov, Dec, Jan. 4 weeks of Feb for a PCR and the results should be in about NOW. I believe you will be seeing second leg trial participants on the boards withing a week or two, but we will see. They should have the results now and they have had the response rates/viral kinetics (not SVR-4 cure rates) for a long time now.
This is a good place to mention as I did earlier, that if the contention that 5885 is inferior to Daclatasvir, this will be one bit of evidence to support or disprove the contention (although, it is never 100% clear since the mix of trial participants can also skew results)
==============
I have wondered if there could be a sort of medical bill (such as there are for "orphan drugs") which could serve to create an incentive for companies to consider such collaborations. I'm sorry, but they are in it for the money, so how could this help drive their decision making to increase considerations such as Margaret is proposing?
A few ideas I had might be some sort of government co-pay for trials if the two drugs meet "best in class" designation, It could afford some type of expedited approval by the FDA, some tax considerations, maybe even an extension of the period before the drug would roll over to generics.
If you put together a package like this.....perhaps Gilead or BMS might have continued the collaboration. Obviously, their competitors might say this could give incentive to bid up the price of first in class drugs, something which already happened here. It could tend to get these best in class drugs to approval sooner and potentially deliver the best combination sooner instead of second or third best couplings. (likewise, it could just be one more government programs which could be "gamed". )
Just a random idea.
willy
Sorry you missed out on the 7977+5885 trial by one place.
How about the second group of 600 starting soon, did you get into that ?
===================================
I think they are just winding up the first leg of it and assessing SVR-4 PCR's.
If that trial started Nov 1(maybe not every single person dosed by Nov 1), 12 weeks of TX would be Nov, Dec, Jan. 4 weeks of Feb for a PCR and the results should be in about NOW. I believe you will be seeing second leg trial participants on the boards withing a week or two, but we will see. They should have the results now and they have had the response rates/viral kinetics (not SVR-4 cure rates) for a long time now.
This is a good place to mention as I did earlier, that if the contention that 5885 is inferior to Daclatasvir, this will be one bit of evidence to support or disprove the contention (although, it is never 100% clear since the mix of trial participants can also skew results)
==============
I have wondered if there could be a sort of medical bill (such as there are for "orphan drugs") which could serve to create an incentive for companies to consider such collaborations. I'm sorry, but they are in it for the money, so how could this help drive their decision making to increase considerations such as Margaret is proposing?
A few ideas I had might be some sort of government co-pay for trials if the two drugs meet "best in class" designation, It could afford some type of expedited approval by the FDA, some tax considerations, maybe even an extension of the period before the drug would roll over to generics.
If you put together a package like this.....perhaps Gilead or BMS might have continued the collaboration. Obviously, their competitors might say this could give incentive to bid up the price of first in class drugs, something which already happened here. It could tend to get these best in class drugs to approval sooner and potentially deliver the best combination sooner instead of second or third best couplings. (likewise, it could just be one more government programs which could be "gamed". )
Just a random idea.
willy
Hi Willy, I agree with what you said
I have pretty much resolved to move on from the GS7977+Daclatasvir issue, for a while now.
Not much we can do about it.
Just like to have a bit of a whinge occasionally, and wonder what may have been, if one company owned both drugs.
I agree too that Gilead is a good company to move the approval process through relatively quickly.
Sorry you missed out on the 7977+5885 trial by one place.
How about the second group of 600 starting soon, did you get into that ?
George
I have pretty much resolved to move on from the GS7977+Daclatasvir issue, for a while now.
Not much we can do about it.
Just like to have a bit of a whinge occasionally, and wonder what may have been, if one company owned both drugs.
I agree too that Gilead is a good company to move the approval process through relatively quickly.
Sorry you missed out on the 7977+5885 trial by one place.
How about the second group of 600 starting soon, did you get into that ?
George
I think we look at this from similar angles but we may not agree 100%.
Initially, I went on and on about Gilead and their decision. At a certain point you have to accept; *this is what's happening now*.
I'm not sure that they have any heavy Karma issues to deal with. If anything, they are responsible for many HIV positive people surviving for decades. Even that though..... is not the result of having pure hearts...... they do it as a for profit business. IMHO, you can have profit incentive and good intentions.
Fact is, they just ran a very small trial, probably cherry picked the applicants (as can happen in trials). Whatever they did the outcome is just too small to use as proof; this was the ideal. It may have been, it might not have been. We didn't run 1000+ people through so we really don't know. I occasionally mention my father who was an early vioxx patient. There was a drug that went all the way through trials and was on the market for..... maybe 5 years and was responsible for.....maybe 1/2 a million deaths. My father died about midpoint through before they recalled it. So figure 5 years trials and 5 years of use= 10 years and the drug got recalled.
Point is..... you need many trials, many groups, large numbers to be able to really make statements and be fairly sure you are correct. Even then, ya ain't.
I love the idea of combining best of class. So..... how does one do that?
I don't know how to reinvent our system. I agree it is flawed. In spite of this the United states has a pretty large pool of companies working on curing HCV. HCV is a virus that has had a cure for over a decade. Most viruses we have not been able to cure, but the medical community had done a good job with our disease.
I have to wonder if you are correct about calling it a year delay. The discussions about the end of the collaboration happened right at EASL; mid april, 2012. Add 6 months to that, lets call that a delay; mid may is 1 month, june-2, july-3, august 4,september-5, mid October would be 6 months. The first naive trials for 7997 & 5885 started in october, almost exactly 6 months. If you check boards I think you'll find some may have even treated earlier, but I got my call in october 2012. The naives trials were filled by about 1/3d week in October. I know cause I missed out by one slot.
One might even argue that lives were saved because Gilead bought this compound and had the money and know how to push it through trials.
Look at Vertex and their second phase trials of quad therapy or their polymerase inhibitor. That second phase trial started several years ago, I think and has yet to start phase 3.
(answer; NCT01080222 Telaprevir, vx-222, IFN and rbv
First received: March 1, 2010) 3 years- has not started phase 3 yet.)
Vertex started w/ telaprevir long before boceprevir, but...... do you remember which got approved first? : )
My point is that Gilead has done a reasonable job at moving these trials through the approval process. They have possibly done a superior job.
Do we need pan-genotypic cures or specific compounds that get approved sooner? In the United States we most need a cures for genotype 1's and null responders and a treatment that cirrhotics can tolerate safely. I believe that there will be several treatments for g-2s and 3's.
The issue w/sofosbuvir and riba for g-2's is that in not adding one more new compound the TX gets approved 1+ year earlier. It was about getting it to market.
The drive to beat competitors is one thing that caused these treatments to come to market quickly. : I
I'm just saying.... it isn't all bad.
willy
Initially, I went on and on about Gilead and their decision. At a certain point you have to accept; *this is what's happening now*.
I'm not sure that they have any heavy Karma issues to deal with. If anything, they are responsible for many HIV positive people surviving for decades. Even that though..... is not the result of having pure hearts...... they do it as a for profit business. IMHO, you can have profit incentive and good intentions.
Fact is, they just ran a very small trial, probably cherry picked the applicants (as can happen in trials). Whatever they did the outcome is just too small to use as proof; this was the ideal. It may have been, it might not have been. We didn't run 1000+ people through so we really don't know. I occasionally mention my father who was an early vioxx patient. There was a drug that went all the way through trials and was on the market for..... maybe 5 years and was responsible for.....maybe 1/2 a million deaths. My father died about midpoint through before they recalled it. So figure 5 years trials and 5 years of use= 10 years and the drug got recalled.
Point is..... you need many trials, many groups, large numbers to be able to really make statements and be fairly sure you are correct. Even then, ya ain't.
I love the idea of combining best of class. So..... how does one do that?
I don't know how to reinvent our system. I agree it is flawed. In spite of this the United states has a pretty large pool of companies working on curing HCV. HCV is a virus that has had a cure for over a decade. Most viruses we have not been able to cure, but the medical community had done a good job with our disease.
I have to wonder if you are correct about calling it a year delay. The discussions about the end of the collaboration happened right at EASL; mid april, 2012. Add 6 months to that, lets call that a delay; mid may is 1 month, june-2, july-3, august 4,september-5, mid October would be 6 months. The first naive trials for 7997 & 5885 started in october, almost exactly 6 months. If you check boards I think you'll find some may have even treated earlier, but I got my call in october 2012. The naives trials were filled by about 1/3d week in October. I know cause I missed out by one slot.
One might even argue that lives were saved because Gilead bought this compound and had the money and know how to push it through trials.
Look at Vertex and their second phase trials of quad therapy or their polymerase inhibitor. That second phase trial started several years ago, I think and has yet to start phase 3.
(answer; NCT01080222 Telaprevir, vx-222, IFN and rbv
First received: March 1, 2010) 3 years- has not started phase 3 yet.)
Vertex started w/ telaprevir long before boceprevir, but...... do you remember which got approved first? : )
My point is that Gilead has done a reasonable job at moving these trials through the approval process. They have possibly done a superior job.
Do we need pan-genotypic cures or specific compounds that get approved sooner? In the United States we most need a cures for genotype 1's and null responders and a treatment that cirrhotics can tolerate safely. I believe that there will be several treatments for g-2s and 3's.
The issue w/sofosbuvir and riba for g-2's is that in not adding one more new compound the TX gets approved 1+ year earlier. It was about getting it to market.
The drive to beat competitors is one thing that caused these treatments to come to market quickly. : I
I'm just saying.... it isn't all bad.
willy
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
I haven't heard of these two drugs, not that I remember .
I too hope willing is SVR, the last time he was here he was
treating. Yes, he was a huge asset to this forum. I hope
he will pop in some time and let us know.
I too hope willing is SVR, the last time he was here he was
treating. Yes, he was a huge asset to this forum. I hope
he will pop in some time and let us know.
Great info Willy, thanks.
As you suggest, TMC435 is an NS3 protease inhibitor similar to Incivek or Victrelis. This brings up again the thorny question of resistance for people like me who have already failed tx with a protease inhibitor. There may be an assortment of drugs in development but resistance is still the same old minefield. Lately this topic seems to have been placed on the back burner because 7977 apparently has such a high barrier to resistance that it is not an issue with 7977 (the jury is still out in my opinion). That is not so for any other drug currently in development, at least to my knowledge.
So for my next tx selection, ideally I will be trying to avoid a protease inhibitor. Also, if I am having an NS5A inhibitor like the BMS drug then I'll want to see a planB that doesn't include one of those either.
Until the cure rate is 100%, nobody can afford to run out of options because they are resistant to all available tx. That is the name of the game we've got here. At least that's how I see it.
dointime
As you suggest, TMC435 is an NS3 protease inhibitor similar to Incivek or Victrelis. This brings up again the thorny question of resistance for people like me who have already failed tx with a protease inhibitor. There may be an assortment of drugs in development but resistance is still the same old minefield. Lately this topic seems to have been placed on the back burner because 7977 apparently has such a high barrier to resistance that it is not an issue with 7977 (the jury is still out in my opinion). That is not so for any other drug currently in development, at least to my knowledge.
So for my next tx selection, ideally I will be trying to avoid a protease inhibitor. Also, if I am having an NS5A inhibitor like the BMS drug then I'll want to see a planB that doesn't include one of those either.
Until the cure rate is 100%, nobody can afford to run out of options because they are resistant to all available tx. That is the name of the game we've got here. At least that's how I see it.
dointime
No one cares about Hepatitis C! It's still a drug addict disease as far as the public is concerned!, I'm tired of waiting, I'll take my chances!
You brought up willing, what a huge loss to this place when he left. By far one of the best this site ever had........ I sure hope in his last treatment he made it to SVR...
Speaking of collaboration......Gilead is still in a few. This one cured everyone they treated This one is Sofosbuvir and Simeprevir (TMC435, a PI, very similar to Incivek or Victrelis, but a cleaner side effect profile)
http://www.bloomberg.com/news/2013-03-04/gilead-medivir-hepatitis-c-drug-clears-virus-in-patients.html?cmpid=yhoo
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also a more technical write up is on Natap but you have to go there to find the article. There is a chart, but the bottom line is that in every category which they treated they cured. To be fair, I believe they were all null responders, but with minimal staging damage F-0 to F-2
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From another natap article;
" Simeprevir is being investigated in combination with PegIFN/RBV in phase III trials and is also being evaluated with Direct-acting Antiviral (DAA) agents in four other phase II interferon-free combinations both with and without ribavirin (RBV)."
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one of the Simeprevir trials is with Vertex's VX-135, a compound very similar to Gilead's sofosbuvir.
http://www.news-medical.net/news/20121102/Janssen-Vertex-to-evaluate-TMC435-and-VX-135-in-Phase-2-HCV-study.aspx
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My point is that there are many many drug treatments being developed which will work. There are actually more drugs in development. This is one reason why the stockholders were so critical of Gilead's high priced buy of 7997 for 11 billion, and it is part of the reason they may have felt they could not afford to share in the profits with Bristol.
Note that many most of these trial will also have trial arms both with and without riba. When they cure everyone such as in the first trial I referenced you can kind of imagine that they probably don't need the riba.
I rather think they will find that adding a third DAA compound might be cleaner, quicker and higher efficacy than using riba.
willy
http://www.bloomberg.com/news/2013-03-04/gilead-medivir-hepatitis-c-drug-clears-virus-in-patients.html?cmpid=yhoo
========
also a more technical write up is on Natap but you have to go there to find the article. There is a chart, but the bottom line is that in every category which they treated they cured. To be fair, I believe they were all null responders, but with minimal staging damage F-0 to F-2
========
From another natap article;
" Simeprevir is being investigated in combination with PegIFN/RBV in phase III trials and is also being evaluated with Direct-acting Antiviral (DAA) agents in four other phase II interferon-free combinations both with and without ribavirin (RBV)."
===========================
one of the Simeprevir trials is with Vertex's VX-135, a compound very similar to Gilead's sofosbuvir.
http://www.news-medical.net/news/20121102/Janssen-Vertex-to-evaluate-TMC435-and-VX-135-in-Phase-2-HCV-study.aspx
=============================
My point is that there are many many drug treatments being developed which will work. There are actually more drugs in development. This is one reason why the stockholders were so critical of Gilead's high priced buy of 7997 for 11 billion, and it is part of the reason they may have felt they could not afford to share in the profits with Bristol.
Note that many most of these trial will also have trial arms both with and without riba. When they cure everyone such as in the first trial I referenced you can kind of imagine that they probably don't need the riba.
I rather think they will find that adding a third DAA compound might be cleaner, quicker and higher efficacy than using riba.
willy
"all they are asking for is some sort of consideration for using the 2 "best in class" drugs in combo."
As I remember, Willing was calling for this years ago and was equally dubious that it would ever happen. Her take on it seems prescient now.
As you say, there's many a slip twixt cup and lip. It's surprising really that anybody ever gets their ducks all lined up in a row. Good luck with yours. Mine have still to hatch apparently, never mind line up.
dointime
As I remember, Willing was calling for this years ago and was equally dubious that it would ever happen. Her take on it seems prescient now.
As you say, there's many a slip twixt cup and lip. It's surprising really that anybody ever gets their ducks all lined up in a row. Good luck with yours. Mine have still to hatch apparently, never mind line up.
dointime
Looks like we got ourselves another wise ***. Ho hum. Just when I was managing to forget the last one, somethinglady, wasn't it? Is there a factory somewhere churning these guys out?
dointime
dointime
Well I have to say I found Willy's explanation in the post you attacked as one of the better posts I have read about this. I noticed once again you use the term "we" and "us" and it has become quite clear who "we" are. To be brought here just to mislead and attack is not helping the cause. There is more knowledge about Hep C on this forum then both of you have combined...... Go play elsewhere as there are forums out there that you can get by with your nonsense.
In answer to your question; how do you suppose that Gilead is going to treat genotype 2 and 3 patients when (as you maintain) they will only provide co-formulated 7977/5885 compounds in a single pill?
Answer; they are treating, currently in fda trial approval to treat g-2 and 3 with 7997/sofosbuvir and riba. If you knew your subject you would know that. They will not co-formulate it (w/5885) to treat genotypes 2 and 3.
Good luck with the endeavor.
Willy
Rivll, Unless we get the cure here the rest of world doesn't stand a chance. Yes there maybe "other things in pipeline" but why should be continue to used as laboratory animals when we have found a cure. I have to say, that when people decide to pick on a word or two that may sound rash or out of sorts to them or not acceptable to them......that is not the point here!. We are dying from Hepatitis C, we are being given toxic drugs over and over again with horrible side effects, , people are dying every day waiting for a cure.. It would be nice if we all could see past our "hen picking"!
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