Hep C Discussion Forum

mallani · Guru

Incivik being discontinued

Isiscat2011 · Guru

Tig56 wrote:
I appreciate your position and you have clearly stated your dislike of Incivek and the people responsible for manufacturing and prescribing it.

Btw, Tig. This is a gross oversimplification and distortion of what I have written.

It isn't as simple as one person likes it and another doesn't. It's not that black and white. Too bad the subject can't be discussed a bit more intelligently.

Isiscat2011 · Guru

Tig56 wrote:
Isis,
However, the fact remains that this forum is and always has been a place where people are free to express their own opinions and impressions regarding treatment, without the concern of being challenged for it. I appreciate your position and you have clearly stated your dislike of Incivek and the people responsible for manufacturing and prescribing it. But now that it has been said, don't you think your position has been made and now it's time to let others make theirs without being overly and repeatedly criticized for it? Just sayin... Thank you!
Tig
(Gosh, just when things were going so well!)

I wish they would express their opinions regarding Vertex, Incivek, or informed consent. Instead there are repeated speculations about me, my treatment, and my motivations. That is what you should be objecting to. Those types of expressions are the antithesis of a free forum.

Tig · Admin

Isis,

However, the fact remains that this forum is and always has been a place where people are free to express their own opinions and impressions regarding treatment, without the concern of being challenged for it. I appreciate your position and you have clearly stated your dislike of Incivek and the people responsible for manufacturing and prescribing it. But now that it has been said, don't you think your position has been made and now it's time to let others make theirs without being overly and repeatedly criticized for it? Just sayin... Thank you!

Tig

(Gosh, just when things were going so well!)

Isiscat2011 · Guru

Paul B wrote:
Sounds like the tale of the tape so why the Incivek hate? Many are grateful for the opportunity. I failed treatment twice with Interferon and found out much later that the cure rate from the early treatments were only 10%. Put it down to experience, I wasn't deterred. So many people have been through multiple attempts and stay positive as the journey continues. One failed attempt at treatment hardly seems grounds for condemning what for many was potentially the difference between life and death.

You have completely misunderstood my position. If you wish to argue that patients were fully and honestly informed about SVR rates and safety problems before taking Incivek then I'll be happy to address that. If you wish to argue the merits of Incivek in various treatment populations I'll be happy to address that too.

If it simply makes you feel better to view this as my personal vendetta, rather than legitimate concerns about Vertex and Incivek, then you are welcome to that too. But these personal comments are extremely disrespectful and they fail to address the issues.

Paul B · Senior Member

mallani wrote:

Our own experiences colour our perceptions. In your case, Incivek did get you a 4 and 8 week Undetected. Your anaemia and platelet problems led to a missed dose of Peg. and subsequent dose reduction in Peg. and Riba. To top it off, you had a blood transfusion reaction that eventually led to treatment stoppage. As Peg. and Riba were the culprits, I'm not sure why you're so anti-Incivek.

Sounds like the tale of the tape so why the Incivek hate? Many are grateful for the opportunity. I failed treatment twice with Interferon and found out much later that the cure rate from the early treatments were only 10%. Put it down to experience, I wasn't deterred. So many people have been through multiple attempts and stay positive as the journey continues. One failed attempt at treatment hardly seems grounds for condemning what for many was potentially the difference between life and death.

Isiscat2011 · Guru

Gracie wrote:
I do wish I had been advised about the new treatments coming right up and given the choice to wait. I also wish I was informed of the true SVR rate

Exactly. I know it upsets some people to talk honestly and openly about this, but people come here for information, so why give them only one side of the story? If people want to chalk it up to bitterness then they don't know me. All that does is have a chilling effect on open communications. If that is the kind of forum you want you will probably get it.

Gracie · Guru

It's true. Us incevik failures do have good reason to be bitter. It's a lot to go through, and having it fail is heartbreaking. I do wish I had been advised about the new treatments coming right up and given the choice to wait. I also wish I was informed of the true SVR rate for previous non responders as I think it's around 40%. But, this is my lack of research and I don't blame anybody else. The doctors here where I live are maxed out, with over 50,000 people who cant even find a family physician. Nobody in my province has been approved for the new treatments yet. I honestly don't know if I would have tried the treatment or waited had I known all the facts up front. I really do think that I probably would have done it anyhow as I'm so anxious to get rid of it now that I'm older. I'm happy the new treatments offer fewer side effects and are easier to take. I have swallowed my bitter pill and now look forward to the next (and hopefully easiest) battle against my dragon....

Tig · Admin

Thank you for the debate, your positions are duly noted.

Tig

Isiscat2011 · Guru

marktrux wrote:
Yeah, ignorance is bliss. I got mine, go get yours and quit raining on other peoples parade.

Some people prefer to know the facts such as whether the parade has only a 40% chance of success.

Perhaps you should let others make their own decisions about what they want to consider and stop letting this get to you.

Have a nice day.

marktrux · Senior Member

Isiscat2011 wrote:
marktrux wrote:
It must be something to view others and the world in such simple terms.

Yeah, ignorance is bliss. I got mine, go get yours and quit raining on other peoples parade.

Isiscat2011 · Guru

marktrux wrote:
I believe you are communicating your concerns quite well. Incivek failed for you and now you're filled with spite. It's that simple! Keep your spite and I'll keep my SVR (from Incivek)

The idea that patients should be given the opportunity to make informed choices about all treatments, based on accurate rather than intentionally biased and misleading information, is not novel. For whatever reason applying that concept to HCV tx is threatening to some people.

It must be something to view others and the world in such simple terms.

marktrux · Senior Member

Isiscat2011 wrote:
Hi Malcolm:
I must not be communicating my concerns effectively.

-- Edited by Isiscat2011 on Thursday 14th of August 2014 07:17:53 AM

I believe you are communicating your concerns quite well. Incivek failed for you and now you're filled with spite. It's that simple! Keep your spite and I'll keep my SVR (from Incivek)

Isiscat2011 · Guru

Hi Malcolm:

I must not be communicating my concerns effectively. Again, the issue is not whether Incivek should or should not be used. That is a question best left to the physician and patient.

The issue is how can that decision be knowingly and intelligently made when so much misinformation (much of it intentionally created by the manufacturer and echoed in the media) abounds?

Vertex was sued by its stockholders after it misrepresented clinical trial results prior to FDA approval. Post approval, the FDA issued a warning to Vertex regarding its misleading advertising regarding SVR rates. As you noted, patient selection for its clinical trials was designed to inflate SVR rates. In short, its business practices were dishonest and Vertex was rewarded for it. To say that informed consent could have been done better is an understatement. Informed consent was non-existent for many patients.

I must disagree with the data you cited as well. Cirrhotics do not have a 70% chance of SVR; not even close:

"40 percent of those who took Incivek achieving a sustained virologic response (SVR, considered a cure) 12 weeks after completing therapy. Fifty-four percent of those who took Incivek experienced serious adverse events. Twenty-one percent of those on Incivek discontinued treatment because of adverse events. The study had a 2.4 mortality rate." http://www.hepmag.com/articles/cirrhotic_treatment_2501_23900.shtml

Again, researchers had already discovered that viral replication could be blocked at various sites when Incivek received FDA approval. Sovaldi was well into its clinical trials by then. Protease inhibitors are unnecessary for SVR. The argument that Incivek was required to pave the way for better treatments is, therefore, without merit.

Yes, our own experiences color our perceptions, but regardless of my experiences, I always have and always will believe that patients should be given accurate information and allowed to make informed choices. That idea seems to have been abandoned here.

Finally, I am happy that Victrelis worked for you. Truly, you are a remarkable person and the world is much the richer with you in it. But, the fact is you beat the odds. Sometimes any odds are better than none; I understand that completely. But, that decision should be made by the patient not for the patient based on misinformation. Best regards.

-- Edited by Isiscat2011 on Thursday 14th of August 2014 07:17:53 AM

mallani · Guru

Hi Isiscat,

I can't believe I'm defending Incivek, and it's probably a waste of time. However, many patients are on, or waiting to start 'Incivo' in Europe, UK and Australia. We don't all have the choices you have in the USA.

OK, forget chemotherapy drugs. How about virtually ALL drugs can cause death.

Over 5000 patients took part in the Phase 3 Trials for Incivek (2,250 in ADVANCE and ILLUMINATE alone). The skin rash, anaemia and anorectal problems were well recognised and documented in the FDA approval. Overall, the SVR rates of ~80% were significantly better than the ~45% for Peg/Riba.

I agree that patient selection and full informed consent could have been done better. When you consider the SVR chance for a Rx-naive, CC, young, low VL patient with little fibrosis was >90%, no wonder this was well received. Even for the older cirrhotics, the overall rate was ~70% if you could get through the 48 weeks of treatment.

The early antiproteases were developed from a 'Replicon' to see whether viral replication could be blocked. Surely you accept that if these had not worked, no researcher would go to the trouble of testing other viral sites? As these early antiproteases blocked mutiple protease sites in the body, side effects were to be expected. Work began immediately on more selective antiproteases ( Second Generation). As a result, we have MK-5172 (Grazoprevir), which may even be pan-genotype, and virtually side-effect free.

Our own experiences colour our perceptions. I am naturally grateful to the guys that produced Victrelis. In your case, Incivek did get you a 4 and 8 week Undetected. Your anaemia and platelet problems led to a missed dose of Peg. and subsequent dose reduction in Peg. and Riba. To top it off, you had a blood transfusion reaction that eventually led to treatment stoppage. As Peg. and Riba were the culprits, I'm not sure why you're so anti-Incivek.

We could go round in circles, so let's just say 'goodbye Incivek' in the USA, with 'Thanks' from some, and 'Good riddance' from others. The Defence rests.

Isiscat2011 · Guru

Gracie wrote:
And it is the price we pay to clear the way for new ideas and treatments.
___________________________________________________________________________________________________________
How exactly did Incivek "clear the way" for Sovaldi?
Sovaldi is not even in the same drug class (protease inhibitor) and it was invented long before we "paid the price" of Incivek. Just wondering if anyone can actually answer this. Or maybe this is just another idea we accept without question.

Gracie · Guru

Spoiler alert.... Reading this post may cause random itchy spots... (lol... or maybe just for me). Did the incevik, und, then det. Feeling good again, and would try a treatment which had good odds like this one did again. Was it fun? No. But I was aware of the possible side effects and did it anyway. SVR is so valuable physically and mentally that I was willing to take the chance. And it is the price we pay to clear the way for new ideas and treatments. Didn't work for me, however, having the new treatments within a years grasp sure makes the lost battle more tolerable...:)

Huey · Guru

Better ingredients, Better Drugs, Popa Jaundice

Isiscat2011 · Guru

Hi Guys:

My comments concerned the whitewashing; the story that was never told.

I appreciate that the Incivek triple therapy resulted in more SVRs than Interferon/Riba would have without Incivek but the question that is never asked by the media is: "How many more SVRs and at what cost?" How can the public engage in a meaningful evaluation of the benefits vs the harm when we are never given the full story?

Incivek was heralded in as the "Miracle Cure" for HCV and now it is ushered out, billions richer, with the promise of even better things to come. The overwhelming majority of the public knows nothing of what happened in between the beginning and the end (the unanswered safety and efficacy concerns raised from Incivek's inception to the hasty FDA approval of Sovaldi and Olysio to the selling of Incivek royalties to Janssen a year ago). That works for pharma but how well is it working for everyone else?

As an aside, I reject the comparison to Chemotherapy drugs on the grounds that the only alternative to taking cancer drugs is imminent death (for most people). That is not the case with HCV drugs.

Scruffy · Guru

With all the new treatments options now there really isn't a market for it. Who would want to do 24-48 weeks if they don't have to. I will say even with one foot in the grave for 41 out of the 48 weeks I did, I'm still thankful for Incicvik. Last test I had was eot+7 weeks still undetect. If the hands of time were turned back and that was the best option as it was back then I would still go for it. I'm glad it no longer is the "go to".

mallani · Guru

Hi Isiscat,

Wow! You are being a bit harsh.

Incivek was no picnic, but it was responsible for SVR for many people. The first antiproteases (Incivek and Victrelis) were a giant step forward in HCV treatment. Their success lead researchers to further investigate the possibility of blocking viral replication at different sites. Give the guys some credit.

Without Victrelis, I may be in liver failure by now. There's no way I would get on any Trial, and we won't have the possibility of Sovaldi for years.

Yes, there were a few deaths, probably due to Incivek. This is a killer disease. We also have deaths from chemotherapy drugs. It's easy to criticise in hindsight.

TazKat · Senior Member

wow. I was on that treatment in oct 2011 til dec 2011 then continued the interferon & riba til may 2012.. then relapsed.. I gained some weight for sure.. all that 20 grams of fat every 8 hrs.. that was the pits.. disbelief

Isiscat2011 · Guru

maddie wrote:
Read today that Vertex plans on discontinuing production of Incivik in October. Use has dropped significantly according to a wall street journal article.
http://m.us.wsj.com/articles/BL-270B-455

What a whitewash. They forgot to mention the hospitalizations, long term illnesses, and deaths it caused, or how much lower the actual SVR rates turned out to be. They failed to mention that the FDA approved Incivek knowing how potentially dangerous it was and that within 18 months of its approval, following numerous hospitalizations and deaths, a black box warning was added to finally alert docs and patients.

They also forgot to mention that it is specifically NOT recommended for use in treating HepC patients under existing US medical guidelines. They forgot to mention that despite its record breaking profits the drug actually caused more harm than good for a yet unknown number of the patients who took it. They failed to mention that many of the asymptomatic people who took it did not even have serious liver disease and should never have been prescribed it in the first place. I guess one side of the story is good enough. Hopefully, the lawyers who are now suing Vertex on behalf of some of the patients it harmed will get the rest of the story out.

End of vent.

Tig · Admin

That doesn't surprise me at all. I'm sure if it hasn't already started something similar, Merck's interest in Victrelis will diminish as well. But that doesn't mean production of it will stop, because the use of it will be continued in those countries that can't or won't provide access to the new blockbuster medications like Sovaldi, Ledispavir, Olysio, Daclatasvir and so many others. Stand by for the patent right discussions and/or infringements by countries like India and China. The demand for these medications will remain high as long as the access to medications like Sovaldi are impossible.

Tig

maddie · Senior Member

Read today that Vertex plans on discontinuing production of Incivik in October. Use has dropped significantly according to a wall street journal article.

http://m.us.wsj.com/articles/BL-270B-455

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