Aa
Incivek to end sells.
Incivek to end sells. The good news is it might make getting ones insurance to cover these new drugs easier the bad news is one less treatment drug will not help to lower the cost or provide another option. I wouldn't be surprised if Boceprevir is not next..
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Three years after being heralded as the fastest drug launch ever and quickly racking up $1 billion in sales, the Incivek hepatitis C treatment will be discontinued this coming October by Vertex Pharmaceuticals.
http://blogs.wsj.com/pharmalot/2014/08/12/from-riches-to-rags-vertex-discontinues-incivek-as-sales-evaporate/?mod=yahoo_hs
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Three years after being heralded as the fastest drug launch ever and quickly racking up $1 billion in sales, the Incivek hepatitis C treatment will be discontinued this coming October by Vertex Pharmaceuticals.
http://blogs.wsj.com/pharmalot/2014/08/12/from-riches-to-rags-vertex-discontinues-incivek-as-sales-evaporate/?mod=yahoo_hs
I for one am happy to see the poison go, from personal experience an absolutely toxic med......wasn't aware of lawsuits...THX Cando.
Take care
Deb
Take care
Deb
Just Google "Incivek Lawsuits". Lots to read and lots of lawyers to file on for you.
Best to you
Best to you
can you provide more info or a link regarding lawsuits over Incivek,,,, much appreciated thanks
No cirrhotics were included in the clinical trials. Lots of lawsuits over this drug. One of the major hep c specialists in the country told me the percentage of people that died from complications due to Incivek and my jaw dropped when he told me the numbers.
Vertex - Another thrown together debauchery!
http://www.cafepharma.com/boards/showthread.php?t=451346
Vertex - Another thrown together debauchery!
http://www.cafepharma.com/boards/showthread.php?t=451346
Incivek is still sold in other countries. Vertex is only stopping sales in the
United States. Johnson & Johnson sell Incivek outside U.S.
United States. Johnson & Johnson sell Incivek outside U.S.
As you all know, I did the Telaprevir (Incivek) when it was in clinical trials. I did not have a good result due to the randomization w/o Ribavirin and the horrific rash. I am excited and very hopeful for this Sovaldi + SOC treatment to be my SVR answer. I would LOVE to never have to do this ever again! But, Sovaldi is MUCH easier to tolerate in my opinion than the Telaprevir. When I started my treatment, the pills Sovaldi and Riba were all I was on for the first 5 days and then, the Interferon shot was added. When I was taking the Sovaldi and Riba the side effects were very, very mild. In fact, I blame any side effects I had on those days, on the Riba. The Riba has ALWAYS made me a lunatic, a bitchy, crabby, irritated person. And for that, I don't know that I like the Riba side effects. But, it is an important part of this treatment. The worse side effect I've had for this whole 8 weeks is the grouchy from the Riba and the fatigue. Other than that, this has been one of the easiest treatments I've ever done. I have had some neutropenia and had my 2nd IM given at the doctor's office today - of the Neupogen. Susan400
Hi ya bean,Dee, and others. I agree this is much easier treatment now but at the time the two PI's was all we had. I'll always have a special place in my heart for Victrelis as it more then likely saved my life or at least stopped me from having a TP.
Kwo is nothing short of thrilled by these new meds. Especially the post TP patients. Hope your doing well.
------------------------------------------------
Paul Y. Kwo, MD - 7/10/2014 More from this author
December 2013 marked the first drug approval from a new class of direct-acting antiviral (DAA) agents, the nucleotide polymerase inhibitors. Sofosbuvir was approved for use in combination therapy both with and without interferon. For genotype 1 patients, clinical trials demonstrated overall SVR rates of 90% when sofosbuvir was combined with peginterferon and ribavirin for 12 weeks and 70% SVR rates when sofosbuvir was given with ribavirin for 24 weeks. For genotype 2 and 3 patients, SVR rates were more than 85% with the interferon-free combination of sofosbuvir and ribavirin for 12-24 weeks. In addition, the approval of a once-daily protease inhibitor simeprevir has allowed clinicians to remove interferon and ribavirin from the equation in genotype 1 infection by combining sofosbuvir and simeprevir for 12-24 weeks; a regimen associated with SVR rates > 90% in genotype 1 individuals.
The Arrival of DAA Therapy in the Pretransplantation Setting
The prescribing information for sofosbuvir also included an indication for use in the pretransplantation setting when combined with ribavirin for cirrhotic patients with hepatocellular carcinoma, who meet Milan criteria. The regimen is given and virus suppressed for up to 24-48 weeks in an effort to eradicate virus prior to transplantation and prevent reinfection of the graft after transplantation. In our pretransplantation clinic, we are now able to suppress HCV viremia prior to transplantation with sofosbuvir and ribavirin in those with mild decompensation or with hepatoma. Whether suppression prior to transplantation will be the best strategy remains to be seen as it is not always possible to predict the timing of transplantation, especially without living related transplants. However, most patients we have treated tolerate this approach well, and we are noting that some patients have experienced clinical improvement that has allowed them to come off
the transplantation list. Certainly longer-term follow-up will be required to see if this trend continues. I am interested to see if this approach can be applied to individuals who require orthotopic liver transplantation without hepatocellular carcinoma and who have Child-Turcotte-Pugh scores greater than 7; data evaluating this approach are still needed.
Interferon-Free Options in Posttransplantation Patients
The phase II COSMOS study combining sofosbuvir with simeprevir (without interferon or ribavirin) has demonstrated that SVR may be achieved in traditionally difficult-to-treat patient populations, including those with previous null response to peginterferon and ribavirin as well as those with F3 or F4 fibrosis. Although there are few data currently evaluating this regimen after transplantation, neither sofosbuvir nor simeprevir have meaningful drug–drug interactions with the calcineurin inhibitors tacrolimus and cyclosporine, and therefore, our center and others are now combining these 2 direct-acting antivirals after transplantation. We have found this gives genotype 1 HCV–infected posttransplantation patients a treatment option that removes agents that were difficult to tolerate due to the immunosuppression and poor tolerance of cytopenias.
Sofosbuvir combined with ribavirin is another option after transplantation that has demonstrated SVR rates of more than 70% in one study and, in another study, has shown efficacy as a salvage strategy for those with the dreaded complication of fibrosing cholestatic hepatitis C.
The combination regimen of ABT-450/ritonavir/ombitasvir plus dasabuvir and ribavirin, which is expected to become available for the treatment of HCV infection later this year, has also been evaluated in genotype 1 HCV liver transplantation recipients with recurrent infection. Among evaluable patients at the time of interim analysis, 96% had achieved SVR. Alterations in calcineurin inhibitors were required but were manageable.
These findings make me believe that the future for patients with advanced liver disease and posttransplantation hepatitis C infection is indeed bright. In fact, I think it is likely that with successful eradication of hepatitis C with therapies that are well tolerated, the hepatitis survival for orthotopic liver transplant for hepatitis C will match survival in those who are not HCV infected.
http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Clinical%20Thoughts/CT%201.aspx
Kwo is nothing short of thrilled by these new meds. Especially the post TP patients. Hope your doing well.
------------------------------------------------
Paul Y. Kwo, MD - 7/10/2014 More from this author
December 2013 marked the first drug approval from a new class of direct-acting antiviral (DAA) agents, the nucleotide polymerase inhibitors. Sofosbuvir was approved for use in combination therapy both with and without interferon. For genotype 1 patients, clinical trials demonstrated overall SVR rates of 90% when sofosbuvir was combined with peginterferon and ribavirin for 12 weeks and 70% SVR rates when sofosbuvir was given with ribavirin for 24 weeks. For genotype 2 and 3 patients, SVR rates were more than 85% with the interferon-free combination of sofosbuvir and ribavirin for 12-24 weeks. In addition, the approval of a once-daily protease inhibitor simeprevir has allowed clinicians to remove interferon and ribavirin from the equation in genotype 1 infection by combining sofosbuvir and simeprevir for 12-24 weeks; a regimen associated with SVR rates > 90% in genotype 1 individuals.
The Arrival of DAA Therapy in the Pretransplantation Setting
The prescribing information for sofosbuvir also included an indication for use in the pretransplantation setting when combined with ribavirin for cirrhotic patients with hepatocellular carcinoma, who meet Milan criteria. The regimen is given and virus suppressed for up to 24-48 weeks in an effort to eradicate virus prior to transplantation and prevent reinfection of the graft after transplantation. In our pretransplantation clinic, we are now able to suppress HCV viremia prior to transplantation with sofosbuvir and ribavirin in those with mild decompensation or with hepatoma. Whether suppression prior to transplantation will be the best strategy remains to be seen as it is not always possible to predict the timing of transplantation, especially without living related transplants. However, most patients we have treated tolerate this approach well, and we are noting that some patients have experienced clinical improvement that has allowed them to come off
the transplantation list. Certainly longer-term follow-up will be required to see if this trend continues. I am interested to see if this approach can be applied to individuals who require orthotopic liver transplantation without hepatocellular carcinoma and who have Child-Turcotte-Pugh scores greater than 7; data evaluating this approach are still needed.
Interferon-Free Options in Posttransplantation Patients
The phase II COSMOS study combining sofosbuvir with simeprevir (without interferon or ribavirin) has demonstrated that SVR may be achieved in traditionally difficult-to-treat patient populations, including those with previous null response to peginterferon and ribavirin as well as those with F3 or F4 fibrosis. Although there are few data currently evaluating this regimen after transplantation, neither sofosbuvir nor simeprevir have meaningful drug–drug interactions with the calcineurin inhibitors tacrolimus and cyclosporine, and therefore, our center and others are now combining these 2 direct-acting antivirals after transplantation. We have found this gives genotype 1 HCV–infected posttransplantation patients a treatment option that removes agents that were difficult to tolerate due to the immunosuppression and poor tolerance of cytopenias.
Sofosbuvir combined with ribavirin is another option after transplantation that has demonstrated SVR rates of more than 70% in one study and, in another study, has shown efficacy as a salvage strategy for those with the dreaded complication of fibrosing cholestatic hepatitis C.
The combination regimen of ABT-450/ritonavir/ombitasvir plus dasabuvir and ribavirin, which is expected to become available for the treatment of HCV infection later this year, has also been evaluated in genotype 1 HCV liver transplantation recipients with recurrent infection. Among evaluable patients at the time of interim analysis, 96% had achieved SVR. Alterations in calcineurin inhibitors were required but were manageable.
These findings make me believe that the future for patients with advanced liver disease and posttransplantation hepatitis C infection is indeed bright. In fact, I think it is likely that with successful eradication of hepatitis C with therapies that are well tolerated, the hepatitis survival for orthotopic liver transplant for hepatitis C will match survival in those who are not HCV infected.
http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Clinical%20Thoughts/CT%201.aspx
I do hope that by stopping this drug it will allow those with HCV to take the newer drugs that are not so harsh on the body.
I can only pray this will be the case
Bless you all, Dee
I can only pray this will be the case
Bless you all, Dee
Hurray!! Glad nobody else is going to be but through the hell of the side effects hubby still suffering 16mth EOT should never have been used in the first place!!. Thanx for sharing info. Best wishes Jules
From an article on Express Scripts dropping the drug in two months.
They are keeping the Victrellis, wonder what that means?
Express Scripts has been a vocal critic of rising prescription drug prices. For 2014, it excluded coverage of certain specialty drugs from five therapeutic categories, including multiple sclerosis. It has also criticized the $84,000 cost of Sovaldi, the hepatitis C treatment introduced in December by Gilead Sciences Inc.
For 2015, Express Scripts said, it will no longer cover Incivek, an older hepatitis C drug sold by Vertex Pharmaceuticals Inc, and plans to make a determination on Sovaldi "once clinically equivalent competitors" are approved by regulators in coming months.
http://www.reuters.com/article/2014/08/01/express-scr-amgen-anemia-idUSL2N0Q72VO20140801
They are keeping the Victrellis, wonder what that means?
Express Scripts has been a vocal critic of rising prescription drug prices. For 2014, it excluded coverage of certain specialty drugs from five therapeutic categories, including multiple sclerosis. It has also criticized the $84,000 cost of Sovaldi, the hepatitis C treatment introduced in December by Gilead Sciences Inc.
For 2015, Express Scripts said, it will no longer cover Incivek, an older hepatitis C drug sold by Vertex Pharmaceuticals Inc, and plans to make a determination on Sovaldi "once clinically equivalent competitors" are approved by regulators in coming months.
http://www.reuters.com/article/2014/08/01/express-scr-amgen-anemia-idUSL2N0Q72VO20140801
Personally, I am glad. Since these new treatments have come out it has made the PI's irrelevant. I think they- Incevik and Victrelis - were put on the market prematurely without working out the problematic side effects. I say good riddance to Victrelis too -- even though it cured me and you.
You are right, Cando - it will make - or should make - getting the new drugs easier. Hopefully the Social Security Administration will get the message too so that they will negotiate contracts with the makers of Solvaldi and make it accessible to Medicare recipients.
Hi, by the way. I don't talk with you often enough. Glad to see you are still such a good watchdog. What is Kwo saying about Solvaldi and the newer methods?
bean
You are right, Cando - it will make - or should make - getting the new drugs easier. Hopefully the Social Security Administration will get the message too so that they will negotiate contracts with the makers of Solvaldi and make it accessible to Medicare recipients.
Hi, by the way. I don't talk with you often enough. Glad to see you are still such a good watchdog. What is Kwo saying about Solvaldi and the newer methods?
bean
Oh wait - we all pay for this treatment. It's one factor why the US spends 2x as much as the next industrialized country on health care, our health insurance premiums are so high, and our overall outcomes so low.
I was paying into the Humana risk pool when you and I both treated. We both played our part in rising premiums.
I was paying into the Humana risk pool when you and I both treated. We both played our part in rising premiums.
Can-do. All I can say is good riddance. I know that this drug has helped cure many from this dreaded virus, but at what risk to the patient. Do believe we have not heard the end of continuing debilitating side effects for many whom took this drug.
Fortunately Sovaldi is showing great promise so far, without the unsettling after effects. Must say, the verdict is still out in regards to many of the so called miracle Hep C drugs and their future applications.
Thanks for the article
~Kim
Fortunately Sovaldi is showing great promise so far, without the unsettling after effects. Must say, the verdict is still out in regards to many of the so called miracle Hep C drugs and their future applications.
Thanks for the article
~Kim
Great article, in the comments section someone wrote that Express Scripts has released a list of 66 drugs that it will not cover next year. Incivek is one of them.
Thank you again
D
Thank you again
D
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I am glad those in the future will be spared 48 weeks of Interferon. Having said that I did not have to pay a cent for my treatment. Incivek covered the co-pay and Humana, everything else in addition to the rescue meds. I often ask myself if I would have waited to treat if I knew then what I know now ~ The thing is I wanted the virus GONE. You do make an interesting point though since I know so many Geno 1s (a & b) who are in a fight to treat with the newer treatments or who simply have no idea how to begin planning.