Aa
Daclatasvir
Bristol Myers Squibb has been turned down by the FDA for approval of Daclatasvir as a drug to be used in combo with another DAA. Thank you Gilead for your selfish part in this. Not allowing BMS to go ahead with further studies of this drug with sovaldi not only kept hepatitis patients from having a chance at cure likely a year earlier then the approval of Harvoni, the profile of this drug was amazing. Now it is once again on hold.
No need to apologize. I am very open to constructive criticism and you made a good point. It is a fine line we walk sometimes....how to provide information and not scare everyone. I totally understand.
You will do fine and I bet you get that SVR. I am a huge advocate for treatment. Even before these amazing drugs I tried to get rid of this virus more times than I care to count. I have been cirrhotic since my first biopsy in 1991. I treated for the first time in 1992 when the success rate was 10%. I treated over and over again, each time something new became available...ribavirin, peg, different interferons. I never responded until I entered a clinical trial last year. I am a believer that everyone who wants to treat, deserves to be able to do so. It is killing me that insurance companies are putting up barriers that make patients jump through hoops, or worse, not get the treatment they need. And some are even making people wait until they are very sick with late stage disease. In a way you can understand because the drugs are ridiculously expensive. I understand that Medicaid in some states even has some horrible rule, that only one doctor in the state can write prescriptions for sovaldi. Talk about making it hard for patients to get treated!!!
We are fighting daily with providers, payers and pharma to do the right thing. I am excited, and hopefully will not be disappointed, when the next approvals are made by the FDA. We have met with both companies that have the next drugs due to be approved. They have promised to be creative and get more people on treatment. I pray that is the truth.
You will do fine and I bet you get that SVR. I am a huge advocate for treatment. Even before these amazing drugs I tried to get rid of this virus more times than I care to count. I have been cirrhotic since my first biopsy in 1991. I treated for the first time in 1992 when the success rate was 10%. I treated over and over again, each time something new became available...ribavirin, peg, different interferons. I never responded until I entered a clinical trial last year. I am a believer that everyone who wants to treat, deserves to be able to do so. It is killing me that insurance companies are putting up barriers that make patients jump through hoops, or worse, not get the treatment they need. And some are even making people wait until they are very sick with late stage disease. In a way you can understand because the drugs are ridiculously expensive. I understand that Medicaid in some states even has some horrible rule, that only one doctor in the state can write prescriptions for sovaldi. Talk about making it hard for patients to get treated!!!
We are fighting daily with providers, payers and pharma to do the right thing. I am excited, and hopefully will not be disappointed, when the next approvals are made by the FDA. We have met with both companies that have the next drugs due to be approved. They have promised to be creative and get more people on treatment. I pray that is the truth.
Hi WM,
Thank you, for response to me & for your advocacy, info & your constant involvement )I see you here all the time)
Please forgive, for getting on soapbox last night!
If I had to be 150% :) honest & I do, while I'm a patient advocate & my passion is to help those in need, today is tx- day 1 for me & I'm pretty sure most of concern had to do with me :(
(Side effects, ... Etc.)
So thank you for encouragement & much needed areas to advocate about !
Blessings to you
Randy
Thank you, for response to me & for your advocacy, info & your constant involvement )I see you here all the time)
Please forgive, for getting on soapbox last night!
If I had to be 150% :) honest & I do, while I'm a patient advocate & my passion is to help those in need, today is tx- day 1 for me & I'm pretty sure most of concern had to do with me :(
(Side effects, ... Etc.)
So thank you for encouragement & much needed areas to advocate about !
Blessings to you
Randy
First of all, I wish you an easy time, no side effects, and an SVR with Harvoni. It is an amazing drug. I am so sorry if my post gave you pause or caused any worry at all. That is not my intent.
As an advocate who has worked in the HCV community for 20 years, I am committed to always telling the truth. I think it helps patients ask their physicians good questions and it helps with the decision making process. Big pharma and their multi million dollar marketing teams often make out their drugs to be better than it turns out in the real world.
The good news is that the SVR rates are incredible compared to just a few years ago. AND, if one treatment fails a patient, there are more great drugs just around the corner. All of these drugs provide an opportunity for everybody to be cured.
As an advocate who has worked in the HCV community for 20 years, I am committed to always telling the truth. I think it helps patients ask their physicians good questions and it helps with the decision making process. Big pharma and their multi million dollar marketing teams often make out their drugs to be better than it turns out in the real world.
The good news is that the SVR rates are incredible compared to just a few years ago. AND, if one treatment fails a patient, there are more great drugs just around the corner. All of these drugs provide an opportunity for everybody to be cured.
Greetings:)
I'm rather new to our community(August). A newbie, actually c, you might say. Your research is, perhaps, spot on and I understand and agree with much of what you wrote; especially, other GT's & hard to treats. And, no, the waiting is surely not fair( nor big $ pharma's(all)!!
I don't know what you've walked through, sure it's been super rough! I am so in awe of & sad for so many that have gone through, more than I know w/o SVR/cure!
That being said, while truth is ALWAYS important for us all, I want to share how, sometimes, it can be deleterious.
I'm starting ledipasvir & sofosbuvir tomorrow & so are many naive or experienced treating w/ Harvoni currently.
We all have one thing in common; belief that it will work & that hope seems to be an integral part of going through tx & getting to cure. I was disheartened by your last paragraph. Don't mean to offend, sincerely, I'm just praying that it doesn't dissuade or scare folks from/ while treating, or alter a positive attitude. Again, I know you're concerned, and everyone cares also, across the board, like family. So I voice my reaction & concern respectfully, as I care about you.
All prayers for all tx's that will lead to cure~
All best to you,
Randy <3
I'm rather new to our community(August). A newbie, actually c, you might say. Your research is, perhaps, spot on and I understand and agree with much of what you wrote; especially, other GT's & hard to treats. And, no, the waiting is surely not fair( nor big $ pharma's(all)!!
I don't know what you've walked through, sure it's been super rough! I am so in awe of & sad for so many that have gone through, more than I know w/o SVR/cure!
That being said, while truth is ALWAYS important for us all, I want to share how, sometimes, it can be deleterious.
I'm starting ledipasvir & sofosbuvir tomorrow & so are many naive or experienced treating w/ Harvoni currently.
We all have one thing in common; belief that it will work & that hope seems to be an integral part of going through tx & getting to cure. I was disheartened by your last paragraph. Don't mean to offend, sincerely, I'm just praying that it doesn't dissuade or scare folks from/ while treating, or alter a positive attitude. Again, I know you're concerned, and everyone cares also, across the board, like family. So I voice my reaction & concern respectfully, as I care about you.
All prayers for all tx's that will lead to cure~
All best to you,
Randy <3
I am happy there is competition as well. However, I don't agree with your statement that all the other pharmas want to ride on the back of Gilead. If I remember correctly, long before sovaldi was approved, it was tested with Daclatisvir. Patients were ecstatic because it appeared to work perfectly across all genotpes. However, Gilead refused to let the testing continue because they had a drug they hoped would work, and it does, but treatment could have started a year earlier than it did. And, had Ledisprevir not panned out, we still wouldn't have had a combo drug. How many billions does a company have to make to be happy? the drug, while expensive to bring to market, actually costs pennies to make.
Gilead has not been willing to work with the advocates or the Fair Pricing Coalition and has just kept one step ahead of doing things ethically and legally. No one understands how they got approval for some of their indications such as for cirrhotics. They used the stats from a conglomerate of trials ( and those were tiny numbers of people) to say their drug worked in specific populations. That is scientifically just wrong.
When you look at theMerck Trials (MK 2 & 3), they have tested their up and coming DAA's with all populations and with a good sampling. So has AbbVie.
Not saying Sovaldi and Harvoni aren't good drugs, just not happy what Gilead did to the patient community with making them wait and with pricing that forces the payers to put all kinds of barriers in the way of treating patients.
Already we can see a large number of treatment failures....non responders and relapses. We always see that in real world treating rather than in trials, but I am curious to see what percentage of patients fail to achieve SVR with some of the other drugs, especially in the cirrhotics, co-infected, and other hard to treat populations.
Gilead has not been willing to work with the advocates or the Fair Pricing Coalition and has just kept one step ahead of doing things ethically and legally. No one understands how they got approval for some of their indications such as for cirrhotics. They used the stats from a conglomerate of trials ( and those were tiny numbers of people) to say their drug worked in specific populations. That is scientifically just wrong.
When you look at theMerck Trials (MK 2 & 3), they have tested their up and coming DAA's with all populations and with a good sampling. So has AbbVie.
Not saying Sovaldi and Harvoni aren't good drugs, just not happy what Gilead did to the patient community with making them wait and with pricing that forces the payers to put all kinds of barriers in the way of treating patients.
Already we can see a large number of treatment failures....non responders and relapses. We always see that in real world treating rather than in trials, but I am curious to see what percentage of patients fail to achieve SVR with some of the other drugs, especially in the cirrhotics, co-infected, and other hard to treat populations.
No disrespect to any post but you can never make everyone happy, it's just how the ball rolls unfortunately. The one thing I find disturbing is that all the other big Pharmas want to make the almighty dollar just as bad as Gilead but want to ride on the backs of Gilead to do it. So what does that really tell you. I'm just happy there is competition because it gets these guys off their collective butts into the labs to find the best cure for ALL of us...just my nickels worth of logic and about all it's worth. Sorry to sound harsh. Having one of those "ism" days.....
Blessings everyone
Deb
Blessings everyone
Deb
No, we don't want Gilead to make their formula available to everyone. We just want them to quit making it so hard to get the sovaldi with other meds (i.e. Daklinza). Also, to make their prices a little more reasonable so Ins Cos are more willing to pay and more prompt to approve.
Harvoni is a wonderful new med, BUT there are some of us are in the hard to treat catagories which require a different combination than Sol/Led which was tested on Gt1s. No offense to Gt1s.
I love the fact that they have this wonderful med which will cure their hepc.
I just want to be able to have the Sol/Dac, IF I need retreatment. Dac has been tested with Sol on Gt3s AND on other Gts who have been treated with other meds and failed, AND on cirrothics - ALL with really good results.
Gilead wouuld also benefit from that as their sales of Sovaldi would continue, thus profiting the company.
Pat
Harvoni is a wonderful new med, BUT there are some of us are in the hard to treat catagories which require a different combination than Sol/Led which was tested on Gt1s. No offense to Gt1s.
I love the fact that they have this wonderful med which will cure their hepc.
I just want to be able to have the Sol/Dac, IF I need retreatment. Dac has been tested with Sol on Gt3s AND on other Gts who have been treated with other meds and failed, AND on cirrothics - ALL with really good results.
Gilead wouuld also benefit from that as their sales of Sovaldi would continue, thus profiting the company.
Pat
Say what you will about Gilead and how bad they are. A lot of people,incl myself had amazing results w S/O and more will with Harvoni. Is it your contention that Gilead is suppose to make their formulary known to any pharma co that wants to combine it w something they developed and then market it? There is a reason that things are proprietary for a set period of time.
Gosh this just goes on and on. The repercussion of what Gilead did just continue to be felt.
Thanks for sharing. I had not heard about this
Dee
Thanks for sharing. I had not heard about this
Dee
Never mind....found it. It appears to me there will be a delay since BMS withdrew Asunaprevir. Makes sense and could turn out to be a good thing if FDA approves Daclatasvir with Sovaldi and it doesn't require an 'off label' script.
http://hepatitiscnewdrugs.blogspot.com/2014/11/bristol-myers-fda-blocks-hepatitis-c.html
Given the withdrawal of asunaprevir by BMS in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for HCV treatment.
The company is currently in discussions with the US FDA about the scope of these data.
Bristol-Myers Squibb executive vice-president and chief scientific officer R&D Francis Cuss said: "Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area.
"Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the US as quickly as possible."
http://hepatitiscnewdrugs.blogspot.com/2014/11/bristol-myers-fda-blocks-hepatitis-c.html
Given the withdrawal of asunaprevir by BMS in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for HCV treatment.
The company is currently in discussions with the US FDA about the scope of these data.
Bristol-Myers Squibb executive vice-president and chief scientific officer R&D Francis Cuss said: "Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area.
"Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the US as quickly as possible."
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