You mentioned that having insurance is irrelevant to getting tx. Is the group finding that a lot of people are not being approved for tx because their health insurance is refusing to pay for it? Or was you comment related to the large number of people who do not have insurance.
Yes, many people are not being approved despite being well insured. Most insurance companies are following the AASLD guidelines which means they are only covering those with the most advanced liver disease (F-3 - F-4) for now. It appears to be the same for both private and public payers. There are exceptions but this is the trend we are seeing.
It might actually help to be uninsured because a payment assistance program or Gilead may provide the drugs easier than your insurance company would. I say that only partially in jest.
Lon said
Nov 30, 2014
Hi Isis,
I agree with you that it would have been great to see BMS and Gilead come together in 2013 and get something on the market. Gilead's move to not work with BMS was a shock to the world.
My comment about boycotting Gilead was meant to be a joke. It was along the lines of someone who is unhappy with a particular store, saying that they are going to take their business elsewhere. With Hep C, there is no place else to take our business.
You mentioned that having insurance is irrelevant to getting tx. Is the group finding that a lot of people are not being approved for tx because their health insurance is refusing to pay for it? Or was you comment related to the large number of people who do not have insurance.
Best regards,
Lon
Isiscat2011 said
Nov 30, 2014
Hi Lon:
I appreciate what you are saying but I wasn't thinking of my own joy and happiness when I wrote this. I was referring to the 17,000+, many of whose blood is on Gilead's hands, who will never experience joy again, and that is just in the USA. Not allowing the needless suffering of others that Gilead's greed is responsible for to steal my joy, if only for awhile, would not be possible....but that's just me.
I'm sure you know that having insurance is irrelevant to getting tx for many people right now not only in the USA but world-wide.
I didn't understand your comment about boycotting but I suppose it has something to do with the AIDS & HCV conversation.
Best regards.
Lon said
Nov 30, 2014
Hi Isis,
You're absolutely right. I would boycott them in a heartbeat but unfortunately they are the only game in town.
At $1175 a pill, they aren't fooling anyone.
For me, I'm thankful that someone came up with a cure, regardless of their ulterior motive, in this case money. I'm also thankful that I have health insurance that hopefully, God willing, will pay for my treatment.
Gilead's greed is certainly frustrating. However it's beyond our control and it's important that we don't allow them to steal our joy. They can take my money but I refuse to allow them steal my happiness.
My prayers go out to all those people who don't have insurance and can't afford treatment.
Have a good day Isis and thanks for your comments.
Lon
Isiscat2011 said
Nov 30, 2014
It is important to remember that Sovaldi and Daclatasvir were being tested together a few years ago, with phenomenal results, when Gilead decided to pull the plug on clinical trials. Gilead's opted to create its own NS5A inhibitor, Ledipasvir, in order to maximize profits. Gilead has subsequently done everything in its power to ensure dominance of its own NS5A inhibitor. Had Gilead cooperated with BMS to pair Sovaldi with Daclatasvir it is probable that the Sovaldi/Daclatasvir combo would have been FDA approved in 2013 if not sooner.
17,000+ people per year die of HCV causes. IMO, Gilead has been responsible for many of these deaths because it placed profits ahead of human lives. The incidences of decompensation, HCC, and suffering must be included in the toll Gilead's greed has taken on HCV patients. And the suffering continues while Gilead shareholders calculate their profits.
As Gilead presents itself to the public as the caring Pharma (as evidenced by its "Support Path" program) we should remember the patients for whom a cure came too late due to Gilead's unmitigated greed.
Dac/Sov is still in trials in the US, see the ALLY 1,2,and 3 studies currently underway according to the Clinical Trials website. As for Harvoni from Gilead, it's a combination drug containing Sovaldi and Ledispavir and has been approved and available (sort of) since Oct 10th. You can do a search here or review our homepage for many discussions currently underway here on the forum.
The FDA approval of Daclatasvir has been delayed and I would not expect it to be a major player in HCV tx in the US in the near future. Even if/when it is approved it would presently need to be used in combination with Sovaldi in the US and that would probably be more expensive than Harvoni.
Harvoni was FDA approved October 10, 2014, and that is likely to be the drug of choice of prescribers for GT1s, at least for the next year or two. Gilead is working on a next generation that should be out by 2016 and there are a couple of other combos that will arrive soon (Abbvie: 12/21/14) and Merck in 2015.
Hope this info helps!
Lon said
Nov 29, 2014
Hi Everyone,
My Gastro was waiting for Daclatasvir to be approved this month so he could get insurance approval for the Sovaldi and Daclatasvir combo treatment. I read that U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called Asunaprevir. To confuse matters further, Gilead apparently has the Harvoni drug on the horizon. I hadn't heard of the Harvoni drug before.
Can some fill me in on what's going on with all this? Has Daclatasvir been approved for use with Sovaldi but not with Asunaprevir?
Yes, many people are not being approved despite being well insured. Most insurance companies are following the AASLD guidelines which means they are only covering those with the most advanced liver disease (F-3 - F-4) for now. It appears to be the same for both private and public payers. There are exceptions but this is the trend we are seeing.
It might actually help to be uninsured because a payment assistance program or Gilead may provide the drugs easier than your insurance company would. I say that only partially in jest.
Hi Isis,
I agree with you that it would have been great to see BMS and Gilead come together in 2013 and get something on the market. Gilead's move to not work with BMS was a shock to the world.
My comment about boycotting Gilead was meant to be a joke. It was along the lines of someone who is unhappy with a particular store, saying that they are going to take their business elsewhere. With Hep C, there is no place else to take our business.
You mentioned that having insurance is irrelevant to getting tx. Is the group finding that a lot of people are not being approved for tx because their health insurance is refusing to pay for it? Or was you comment related to the large number of people who do not have insurance.
Best regards,
Lon
Hi Lon:
I appreciate what you are saying but I wasn't thinking of my own joy and happiness when I wrote this. I was referring to the 17,000+, many of whose blood is on Gilead's hands, who will never experience joy again, and that is just in the USA. Not allowing the needless suffering of others that Gilead's greed is responsible for to steal my joy, if only for awhile, would not be possible....but that's just me.
I'm sure you know that having insurance is irrelevant to getting tx for many people right now not only in the USA but world-wide.
I didn't understand your comment about boycotting but I suppose it has something to do with the AIDS & HCV conversation.
Best regards.
Hi Isis,
You're absolutely right. I would boycott them in a heartbeat but unfortunately they are the only game in town.
At $1175 a pill, they aren't fooling anyone.
For me, I'm thankful that someone came up with a cure, regardless of their ulterior motive, in this case money. I'm also thankful that I have health insurance that hopefully, God willing, will pay for my treatment.
Gilead's greed
is certainly frustrating. However it's beyond our control and it's important that we don't allow them to steal our joy. They can take my money but I refuse to allow them steal my happiness. 
My prayers go out to all those people who don't have insurance and can't afford treatment.
Have a good day Isis and thanks for your comments.
Lon
It is important to remember that Sovaldi and Daclatasvir were being tested together a few years ago, with phenomenal results, when Gilead decided to pull the plug on clinical trials. Gilead's opted to create its own NS5A inhibitor, Ledipasvir, in order to maximize profits. Gilead has subsequently done everything in its power to ensure dominance of its own NS5A inhibitor. Had Gilead cooperated with BMS to pair Sovaldi with Daclatasvir it is probable that the Sovaldi/Daclatasvir combo would have been FDA approved in 2013 if not sooner.
17,000+ people per year die of HCV causes. IMO, Gilead has been responsible for many of these deaths because it placed profits ahead of human lives. The incidences of decompensation, HCC, and suffering must be included in the toll Gilead's greed has taken on HCV patients. And the suffering continues while Gilead shareholders calculate their profits.
As Gilead presents itself to the public as the caring Pharma (as evidenced by its "Support Path" program) we should remember the patients for whom a cure came too late due to Gilead's unmitigated greed.
http://www.nasdaq.com/article/bristol-myers-squibb-cos-hep-c-drug-denied-gilead-sciences-inc-smiling-for-now-cm418259
Hi Lon,
Dac/Sov is still in trials in the US, see the ALLY 1,2,and 3 studies currently underway according to the Clinical Trials website. As for Harvoni from Gilead, it's a combination drug containing Sovaldi and Ledispavir and has been approved and available (sort of) since Oct 10th. You can do a search here or review our homepage for many discussions currently underway here on the forum.
http://news.bms.com/press-release/rd-news/bristol-myers-squibb-statement-about-asunaprevir-us
http://hcvadvocate.blogspot.com/2014/04/phase-3-studiessovaldiolysio-and.html
Tig
Hi Lon:
The FDA approval of Daclatasvir has been delayed and I would not expect it to be a major player in HCV tx in the US in the near future. Even if/when it is approved it would presently need to be used in combination with Sovaldi in the US and that would probably be more expensive than Harvoni.
Harvoni was FDA approved October 10, 2014, and that is likely to be the drug of choice of prescribers for GT1s, at least for the next year or two. Gilead is working on a next generation that should be out by 2016 and there are a couple of other combos that will arrive soon (Abbvie: 12/21/14) and Merck in 2015.
Hope this info helps!
Hi Everyone,
My Gastro was waiting for Daclatasvir to be approved this month so he could get insurance approval for the Sovaldi and Daclatasvir combo treatment. I read that U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called Asunaprevir. To confuse matters further, Gilead apparently has the Harvoni drug on the horizon. I hadn't heard of the Harvoni drug before.
Can some fill me in on what's going on with all this? Has Daclatasvir been approved for use with Sovaldi but not with Asunaprevir?
Thank you,
Lon