Aa
Sovaldi Ledipasvir news
Gilead to raise price for new hepatitis C drug above $84,000
http://www.reuters.com/article/2014/09/12/us-gilead-sovaldi-idUSKBN0H72KR20140912
anyone surprised?
http://www.reuters.com/article/2014/09/12/us-gilead-sovaldi-idUSKBN0H72KR20140912
anyone surprised?
Thanks for the reminder of the Ion trials. That seem just too good to be true but at least they had a significant data set
I'm game for 12 weeks - or 8 weeks?
I always wonder though if I would have achieved SVR on the Sovaldi/Olysio combo if I had gone 24 weeks?
Here's a good summary I found:
http://blogs.nejm.org/now/index.php/keeping-up-with-novel-hepatitis-c-genotype-1-trials/2014/05/14/
I am going to my in person support group next week to meet with many knowledgeable people in our boat
Will pose the question there and report back
~Linda
I'm game for 12 weeks - or 8 weeks?
I always wonder though if I would have achieved SVR on the Sovaldi/Olysio combo if I had gone 24 weeks?
Here's a good summary I found:
http://blogs.nejm.org/now/index.php/keeping-up-with-novel-hepatitis-c-genotype-1-trials/2014/05/14/
I am going to my in person support group next week to meet with many knowledgeable people in our boat
Will pose the question there and report back
~Linda
Not sure of what triple therapy my doctor was referring to so I will let you know Oct 16 when I see him.If anybody is suffering from horrible itching have you found any solution besides cholestyramine.The stuff has given me so much stomach pain that I had to cut down to a minimum but the itching is back to the torture stage,just non stop scratching.Plus it makes it so hard at work cause you cant always get to a bathroom immediately and the cholestyramine gives you no extra time when it strikes.I really want to eliminate the stuff completely,it makes it scary to leave the house.Please help if you have found a solution to the itching.
Hi Pat and Linda
not sure what to think except declatasvir is not available just yet so if needed that could be my next option? and dunno what to think about sov/led 12 vs 24 I just know I want to be rid of this hep c thing
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4627-easl-2014-sofosbuvirledipasvir-cures-more-than-90-of-first-time-and-retreated-genotype-1-patients
excerpt:
ION-2: Treatment-experienced
Nezam Afdhal from Deaconess Medical Center in Boston presented findings from ION-2, which looked at previously treated participants who did not achieve a cure with prior interferon-based therapy.
This trial included 440 chronic hepatitis C patients in the U.S. About 65% were men, about 80% were white, and the average age was about 56 years. Nearly 80% had HCV 1a and -- as is typical for prior non-responders -- most had unfavorable non-CC IL28B variants. 20% had compensated cirrhosis.
About 45% were prior non-responders who never reached undetectable viral load on interferon-based treatment -- a harder group to treat than people who relapsed after finishing treatment. Half had failed a previous regimen that included a first-generation HCV protease inhibitor -- boceprevir (Victrelis) or telaprevir (Incivek or Incivo) -- plus pegylated interferon/ribavirin.
Again, participants were randomly assigned to receive the sofosbuvir/ledipasvir coformulation, with or without ribavirin, for either 12 or 24 weeks.
Here too, SVR12 rates were high for all treatment arms, and similar to those seen in treatment-naive patients:
94% with sofosbuvir/ledipasvir for 12 weeks;
96% with sofosbuvir/ledipasvir plus ribavirin for 12 weeks;
99% with sofosbuvir/ledipasvir for 24 weeks;
99% with sofosbuvir/ledipasvir plus ribavirin for 24 weeks.
In the 12-week arms, cure rates were a bit lower for people with cirrhosis: 86% with sofosbuvir/ledipasvir alone and 82% with sofosbuvir/ledipasvir plus ribavirin. However, all cirrhotic patients treated for 24 weeks with either regimen achieved SVR.
There was a single case of on-treatment viral breakthrough, again in a person with undetectable drug levels. Among the 14% who had resistance-associated variants at baseline, 89% still achieved SVR12.
Out of the 11 participants who relapsed, 7 had cirrhosis. Further evaluation of this group did not reveal any specific clinical factors -- such as platelet count or low albumin -- that predicted who would relapse.
Sofosbuvir/ledipasvir was again generally well-tolerated. Nine patients (2%) had treatment-emergent serious adverse events, but no one stopped treatment early for this reason. Overall, adverse events occurred more often in the ribavirin-containing arms. Anemia occurred in 5% of ribavirin recipients but none who used sofosbuvir/ledipasvir alone.
Again, the researchers concluded that sofosbuvir/ledipasvir was highly effective for treatment-experienced patients, and that adding ribavirin or extending treatment duration did not significantly increase the likelihood of a cure.
Asked whether people with cirrhosis should be treated for 12 or 24 weeks, Afdhal noted that among the more than 200 cirrhotic patients in the 3 ION studies, only 4% relapsed.
"We would have to overtreat 9 out of 10 people to get a benefit for extended treatment," he explained. "It does not make clinical or fiscal sense to overtreat these patients."
not sure what to think except declatasvir is not available just yet so if needed that could be my next option? and dunno what to think about sov/led 12 vs 24 I just know I want to be rid of this hep c thing
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4627-easl-2014-sofosbuvirledipasvir-cures-more-than-90-of-first-time-and-retreated-genotype-1-patients
excerpt:
ION-2: Treatment-experienced
Nezam Afdhal from Deaconess Medical Center in Boston presented findings from ION-2, which looked at previously treated participants who did not achieve a cure with prior interferon-based therapy.
This trial included 440 chronic hepatitis C patients in the U.S. About 65% were men, about 80% were white, and the average age was about 56 years. Nearly 80% had HCV 1a and -- as is typical for prior non-responders -- most had unfavorable non-CC IL28B variants. 20% had compensated cirrhosis.
About 45% were prior non-responders who never reached undetectable viral load on interferon-based treatment -- a harder group to treat than people who relapsed after finishing treatment. Half had failed a previous regimen that included a first-generation HCV protease inhibitor -- boceprevir (Victrelis) or telaprevir (Incivek or Incivo) -- plus pegylated interferon/ribavirin.
Again, participants were randomly assigned to receive the sofosbuvir/ledipasvir coformulation, with or without ribavirin, for either 12 or 24 weeks.
Here too, SVR12 rates were high for all treatment arms, and similar to those seen in treatment-naive patients:
94% with sofosbuvir/ledipasvir for 12 weeks;
96% with sofosbuvir/ledipasvir plus ribavirin for 12 weeks;
99% with sofosbuvir/ledipasvir for 24 weeks;
99% with sofosbuvir/ledipasvir plus ribavirin for 24 weeks.
In the 12-week arms, cure rates were a bit lower for people with cirrhosis: 86% with sofosbuvir/ledipasvir alone and 82% with sofosbuvir/ledipasvir plus ribavirin. However, all cirrhotic patients treated for 24 weeks with either regimen achieved SVR.
There was a single case of on-treatment viral breakthrough, again in a person with undetectable drug levels. Among the 14% who had resistance-associated variants at baseline, 89% still achieved SVR12.
Out of the 11 participants who relapsed, 7 had cirrhosis. Further evaluation of this group did not reveal any specific clinical factors -- such as platelet count or low albumin -- that predicted who would relapse.
Sofosbuvir/ledipasvir was again generally well-tolerated. Nine patients (2%) had treatment-emergent serious adverse events, but no one stopped treatment early for this reason. Overall, adverse events occurred more often in the ribavirin-containing arms. Anemia occurred in 5% of ribavirin recipients but none who used sofosbuvir/ledipasvir alone.
Again, the researchers concluded that sofosbuvir/ledipasvir was highly effective for treatment-experienced patients, and that adding ribavirin or extending treatment duration did not significantly increase the likelihood of a cure.
Asked whether people with cirrhosis should be treated for 12 or 24 weeks, Afdhal noted that among the more than 200 cirrhotic patients in the 3 ION studies, only 4% relapsed.
"We would have to overtreat 9 out of 10 people to get a benefit for extended treatment," he explained. "It does not make clinical or fiscal sense to overtreat these patients."
I think that is what I will be advocating for, Lynn
But 24 weeks, not 12
And, no Riba
October is right around the corner.
Please, please, please be the miracle regimen for us!
~ Linda
But 24 weeks, not 12
And, no Riba
October is right around the corner.
Please, please, please be the miracle regimen for us!
~ Linda
I am wondering if the daclatasvir/sovaldi might not be a better choice for you since it appears to be @ 100% SVR in 12 or 24 wks w/all genotypes, and with people who have had multiple tx w/o success, and w/cirrhotics. My Dr seems very excited about that combo. Pat
There ya go Lynn, that name sounds like the one in the article I I read. I just remembered that it was not a med I had heard/ read about. ((Tried to get back to that site, but it was in yeaterday's free newslertter and I couldn't get there from here, so to speak. Someone w/more computer savvy than I could probably access it.)
Nan: Thanks for the Clinical Trial info!
Everybody just keep on keeping on. We will ALL reach our SVR goal in the, not to distant, future!
Pat
Nan: Thanks for the Clinical Trial info!
Everybody just keep on keeping on. We will ALL reach our SVR goal in the, not to distant, future!
Pat
Hi Lynn
Found this new clinical trial that includes Sofosbuvir/ledipasvir and a drug called Vedroprevir with or without Rbv.
http://clinicaltrials.gov/ct2/show/study/NCT02226549?term=Sofosbuvir+ledipasvir&rank=10
Never heard of this drug Vedroprevir before. The trial is for treatment experienced participants with Cirrhosis.
Nan
Found this new clinical trial that includes Sofosbuvir/ledipasvir and a drug called Vedroprevir with or without Rbv.
http://clinicaltrials.gov/ct2/show/study/NCT02226549?term=Sofosbuvir+ledipasvir&rank=10
Never heard of this drug Vedroprevir before. The trial is for treatment experienced participants with Cirrhosis.
Nan
I did see they were testing Sov/led with good old Ribavirin but from what I read there wasn't any difference in the with and without Ribavirin arms of the clinical trial
I read a release yesterday from Fierce BioTech - a link was provided to the site , possibly Gilead - which referred to Gilead adding a third drug into its single pill Sol/Led cocktail. I don't know enough about the other drug to understand exactly what their point was - still reading anything I can find to try to clarify all these new drugs coming out in the fall.
Basically, it sounded to me like they were trying to boost the efficacy of the new combo to match or surpass the results of BMS's daclatasvir plus Sovaldi, but that could just be my (maybe flawed) interpretation. I went to fiercebiotech.com and looked at a heading referring to the cost of the new Sol/Led combo. @ the bottom of that article were several links to further info, which is where I found the 3rd drug mentioned. I will see if I can get there again and get the name and why the combo -- but make no guarantees - I am not really computer literate and stumble onto sites and then can't get back there. : -(. Oh well, try, try again. Pat
Basically, it sounded to me like they were trying to boost the efficacy of the new combo to match or surpass the results of BMS's daclatasvir plus Sovaldi, but that could just be my (maybe flawed) interpretation. I went to fiercebiotech.com and looked at a heading referring to the cost of the new Sol/Led combo. @ the bottom of that article were several links to further info, which is where I found the 3rd drug mentioned. I will see if I can get there again and get the name and why the combo -- but make no guarantees - I am not really computer literate and stumble onto sites and then can't get back there. : -(. Oh well, try, try again. Pat
Hi
I also relapsed on Sovaldi Olysio and an a 3 time null responder GT 1a with cirrhosis dx in January 08. I have an appointment with my doctors office to see about getting set up on Olysio ledipasvir when it is approved.
Kinda curious what other med you might be talking about because I have heard of no other for October this year. So far as I know it is the new next best thing.
Best to you
Lynn
I also relapsed on Sovaldi Olysio and an a 3 time null responder GT 1a with cirrhosis dx in January 08. I have an appointment with my doctors office to see about getting set up on Olysio ledipasvir when it is approved.
Kinda curious what other med you might be talking about because I have heard of no other for October this year. So far as I know it is the new next best thing.
Best to you
Lynn
Hi Lynn
My doc said there was a triple therapy due in Oct that he wanted to put me on.I am not good with names.I do not think that single pill would be approved for me after relapsing on S&O.Also pretty scared after reading what Nan was saying since I am stage 4 cirrhosis.I would hate to see them sweep me under the rug.If they blow me off and tell me it's hopeless I wonder if they would allow me to pay for it myself.By remorgaging along with a 401k loan I could and would pay for it.
My doc said there was a triple therapy due in Oct that he wanted to put me on.I am not good with names.I do not think that single pill would be approved for me after relapsing on S&O.Also pretty scared after reading what Nan was saying since I am stage 4 cirrhosis.I would hate to see them sweep me under the rug.If they blow me off and tell me it's hopeless I wonder if they would allow me to pay for it myself.By remorgaging along with a 401k loan I could and would pay for it.
Dunno Nan
I just hope they continue to do so. And still the meds are less expensive than a transplant
Hoping for the best for you both
Lynn
I just hope they continue to do so. And still the meds are less expensive than a transplant
Hoping for the best for you both
Lynn
Hi GP
This is the Solvaldi ledipasvir single pill fixed dose combo that is supposed to be approved October 10th. I personally don't know anything about a triple therapy for this year.
Just a one pill a day of Sovaldi/Ledipasvir possibly with or without ribavirin but that is yet to be determined. Treatment length is also unknown at this time.
This is the Solvaldi ledipasvir single pill fixed dose combo that is supposed to be approved October 10th. I personally don't know anything about a triple therapy for this year.
Just a one pill a day of Sovaldi/Ledipasvir possibly with or without ribavirin but that is yet to be determined. Treatment length is also unknown at this time.
Yes, I had seen those recommendations on who should be treated first.
The fact is these patients are also the hardest to get a successful outcome. That is the basis of my concern. At such high costs for these new treatments, at what point can they justify these huge total costs if treatments continue to fail for hard to treat patients like my husband (transplant recipient with cirrhosis again). I am praying that one of these treatments will prove successful. I just don't want them to give up on his potential to do so due to the costs involved.
Nan
The fact is these patients are also the hardest to get a successful outcome. That is the basis of my concern. At such high costs for these new treatments, at what point can they justify these huge total costs if treatments continue to fail for hard to treat patients like my husband (transplant recipient with cirrhosis again). I am praying that one of these treatments will prove successful. I just don't want them to give up on his potential to do so due to the costs involved.
Nan
Is this treatment you are talking about the new triple therapy that is supposed to be approved by the FDA sometime in October.
This makes me think of Dallas Buyers Club.
Health consumers need to become more engaged in this. It hasn't been our style as patients and caregivers, but there is a critical role for our engagement. Government does not exercise purse power with drug companies by negotiating better rates for medicare. This would set the stage for private insurers to seek similar rate adjustments. We know how this works.
Health consumers need to become more engaged in this. It hasn't been our style as patients and caregivers, but there is a critical role for our engagement. Government does not exercise purse power with drug companies by negotiating better rates for medicare. This would set the stage for private insurers to seek similar rate adjustments. We know how this works.
Hi
As far as cost for Olysio
"Cost: The wholesale acquisition price for a 28-days supply of simeprevir is $22,120. Thus, a typical 12-week treatment course with simeprevir when used with peginterferon plus ribavirin will cost approximately $66,360"
http://www.hepatitisc.uw.edu/page/treatment/drugs/simeprevir-drug
Heck cheep at twice the price
Not
What are these people taking?
As far as cost for Olysio
"Cost: The wholesale acquisition price for a 28-days supply of simeprevir is $22,120. Thus, a typical 12-week treatment course with simeprevir when used with peginterferon plus ribavirin will cost approximately $66,360"
http://www.hepatitisc.uw.edu/page/treatment/drugs/simeprevir-drug
Heck cheep at twice the price
Not
What are these people taking?
If one considers how much the Olysio costs, then the new treatment will actually be less expensive (since it is only one pill)
The cost of Olysio is often overlooked because it is less expensive than Sovaldi but I think it cost another $ 40,000 (?) for a 12 week regimen
The cost of Olysio is often overlooked because it is less expensive than Sovaldi but I think it cost another $ 40,000 (?) for a 12 week regimen
I saw that too from the new AASLD HCV Treatment Recommendations Now Includes Information on Prioritizing Patients Under Limited Resources
http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy
Treatment is assigned the highest priority for those patients with advanced fibrosis (Metavir F3), those with compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C
So we're number one on a list I wish I was not on
Best to all
Lynn
http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy
Treatment is assigned the highest priority for those patients with advanced fibrosis (Metavir F3), those with compensated cirrhosis (Metavir F4), liver transplant recipients, and patients with severe extrahepatic hepatitis C
So we're number one on a list I wish I was not on
Best to all
Lynn
Nan,
I think the recommendations are that those who are most ill should be at the top of the list
I can't find the recommendations at the moment but it is in a thread somewhere
It's both exciting and terrifying to be living with Hep C at this point in history.
Exciting that people are reaching SVR at an unprecedented rate and terrifying that not everyone makes it
And that all of us are the guinea pigs of this medical breakthrough
I am so grateful to everyone who endured the harshest treatments with a slim chance for a cure. Their experiences provided data to inform the research pioneers in this brave new world
I think the recommendations are that those who are most ill should be at the top of the list
I can't find the recommendations at the moment but it is in a thread somewhere
It's both exciting and terrifying to be living with Hep C at this point in history.
Exciting that people are reaching SVR at an unprecedented rate and terrifying that not everyone makes it
And that all of us are the guinea pigs of this medical breakthrough
I am so grateful to everyone who endured the harshest treatments with a slim chance for a cure. Their experiences provided data to inform the research pioneers in this brave new world
Just this last Thursday I was telling my doctor, a gastroenterologist, the price will be higher for Ledipasvir/Sovaldi and his optimistic response was "well then, no one will get it." I'd been thinking seriously about waiting to treat since I'm having a hard time appealing denial of Olysio and keep seeing relapses here and there, but with that attitude I think I'd better get what I can NOW.
caveat - this is Oregon, the state of rationed health care
caveat - this is Oregon, the state of rationed health care
Amen - whar more is ther to say? Wonder if there execs ever had something that required special meds/ treatment which was beyond their capability? I see only greed, not caring.
They can make a really good profit, and they deserve one for coming up with these meds and working on others, BUT not these obsene profits they are getting!
They can make a really good profit, and they deserve one for coming up with these meds and working on others, BUT not these obsene profits they are getting!
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