Interesting Vertex Shareholders Article

[jmjm530]

Mike Simon posted this below with some other HCV links, but thought I'd post again for those following VX-950.

http://tinyurl.com/2uqu93

Interesting investor article in that it seems to cover a lot of the bases we've talked about. I take issue with the author, however, that things will rise and fall on Group "D" -- the 12-week group. While a success with Group "D" might be termed a home run, I think a success with the 24-week group would be certainly termed a game winner. And while I don't know any more about the Barcelona meeting than anyone else, I remain optimistic. I figure that if they had bad news they'd try and slip it in -- like the goverment LOL -- on a Friday afternoon after the markets closed and not at a major hepatitis conference. Not a very scientific analysis but trying to be optimisitc. The one thing the article does seem to emphaisze is investor jitteriness because so much is at stake. This could account for the current price with investors taking profits and all waiting on the sidelines until the Barcelona data is analyzed.

-- Jim

[willows]

I read the article and just wrote the gentleman a letter.  Mostly asking him to be clearer in his numbers.  And to help him understand better the side effects and the bigf freakin need for Telapravir.

The SVR rate is 40%, not 50%.

Rash as a side effect is not a deal killer, not if "suicidal ideation" can make it past the FDA when they approved IFN.  There is also a rash from riba, quite severe for some folks and riba made it past the FDA.

with numbers like 500,000 of us trying to clear or non-responding, Telapravir is on the lips of my doctor as being approved in 2 years.  The stock price can go to hell and come back between now and then, but ole Doc Scott is involved in the HALT-C trial, a Gilead trial and consults for a Vertex trial starting in Washington, so I believe the man.  

I was nice to the writer of the article, but I had many disagreements with what he was writing.  How much value is there in being able to bring an UND in four weeks, by itself? Even to a slow moving organization like the FDA?   And then let the SOC take over for 24 weeks?  Very much value, I think, just on that one aspect of Telapravir.  And to shorten time from 48 to 24 weeks of SOC?  More value, I believe.  Even if SVR rates didn't change one whit, to rewrite protocols to include Telapravir and only 24 weeks has much value, saves money and shortens our exposure to IFN and the damage it does.  Telapravir and it's rash....for me, the rash is would be welcome over what I still experience from IFN.  

It's all so interesting, stock price is irrelevant now tho in my mind.  The bigger picture, for those of us non-responders, Telapravir may add a great twist to the story.

Have a good one.

Ranting, wondering WIllow  

[Kalio1]

Even the mother of all riba rashes doesn't come close to the rash the trial participants endured.
They really suffered and it required stopping meds for some. In addition the rash affects three times as many people taking VX as rashes affect those on SOC. Some had to be administered heavy doses of steroids just to try to control it. Rashes of this type that are confluent can be extremely dangerous. Our skin is our largest organ and the situation is a big concern. I was hospitalized once for a confluent rash and told it could kill me, so I know how serious they can be. As I recall from participants reports it took quite some time for it to resolve completely. That will trouble the FDA Im afraid. Im still optimistic that they can resolve the issue.
The fact that they approved SOC with "suicidal ideation" affecting a tiny percentage is no different than many many other drugs that have that listed in their warnings where everything and the kitchen sink is listed to avoid liability. Most all psychotropic drugs have this warning as well as sleep aids and Im sure many other types of drugs too. This is due I would think more to the fact that a large portion of the population suffers from depression and a fraction of those will have suicidal ideation  regardless of what meds they are taking.

In my view there is no way the drugs will be available in "two years" to everyone. The trials coming up don't even start until summer and then it will be weill into next year before they are even done.

[friole]

Thanks for the link to both Jim and Mike.

I too have watched the market closely lately and think it might be time to buy more Vertex, not sell off.  I don't think shareholders know any more than the rest of us, hungering for a better treatment.

The author did make some good points in watching the numbers they use to analyze their data.

frijole

[willows]

I was hospitalized once for Hep C and was told it would kill me, so I know how serious it can be.  Give me the chance to be hospitalized from a Telapravir rash, I already know the consequences of my Hep C.

As for the "suicidal ideation", part of the protocol for Hep C and it's diagnosis and tx has listed for docs is to check for depression and start anti-dees if they deem necessary.  Or deny the patient treatment if they are too depressed.  I don't mean to sound flippant, but to write off the depression aspects of IFN as "a large percentage of the population is depressed" does not answer the issue of the FDA approving many drugs, in spite of terrible side effects.

We are not doctors, Kalio, I have never claimed to be.  All I can relay is what Doc Scott from the University of Washingtons liver and hep clinic wrote me in our last weekly correspondence.   And he wrote, chided me actually and said that "the drug will be approved in the next two years."  He was telling me to chill and wanting me to back down from pressing him to treat me again with SOC.  But with my daughter being in med school there and in contact with Doc Scott, he knows that I get good info, so if he fibs to me, I know it.

Actually, this will be amazing, but I trust him and his expertise.  Trust is almost as wonderful as hope.

Willow

[GrandOak]

From what I've heard Kalio makes a very good point on the rash issue.  It's a bit disconcerning to see some many jumping on the bandwagon as though VX950 is the Holy Grail for HCV.  Makes me wonder if Pegylated Interferon received the same pandimonium when it was being tested?

If it makes tx more tolorable and increases the odds of slaying the dragon for many more than current tx regimen does, then it's great!  But it still seems to fall far short of being a silver bullet.  Is it really the blessing many seem to think it is if newer drugs like VX950 bring yet another round of sx's which makes tx impossible or more burdensome?

[mremeet]

willow's quote: "Rash as a side effect is not a deal killer...Telapravir and it's rash....for me, the rash is would be welcome over what I still experience from IFN. Give me the chance to be hospitalized from a Telapravir rash, I already know the consequences of my Hep C."

Be "wery wery" careful what you wish for! ;-)

[Kalio1]

I think people have the idea it's like a "normal" rash or like something they have had that was similar. I don't think they can imagine just what you guys experienced. Words can't describe it!!

But thankfully you survived it and you are probably right now clear of this creepy virus! Even though the rash is discoraging for everyone waiting on it's approval, I am so encouraged by the fact that it looks like most reporting back are SVR. Even if it doesn't make it to market, at least you guys were cured!!

I hope you are hanging in there and things are going ok.

[willows]

I understand what you are saying, as much as someone can who has never experienced the rash, when and if I suffer from the rash, I will work hard to remember I "wished" for it.  I promise.  It just seems like "suffering" from the rash is just one more bit of "suffering" and Hep C has taught me how to be quiet and "take it like a girl."

Let's just pray there is a bit of hope on the horizon, wrapped in a rash or not.  Telapravir is not a silver bullet, but then, we ain't huntin werewolves.  Personally, as a non-responder, I am learning to embrace the word "combo".  Then all my suffering can be at one time.  I get tired of it all now.

Willow speaking rashly?

[jmjm530]

I'm with you on most of your points. How people can compare one rash to another is beyond me unless they've seen or experienced both. I could post pictures of what my body looked like on SOC that would make even Mre wince :) And I'm not kidding and it wasn't for 12 weeks it was for the lion's share of FIFTY-FOUR WEEKS. Feet so bad at times with pustular psoriasis sores that I had to limp around.  Let's all wait for the Barcelona data in another 4 weeks. It will all come out in the wash, and for me, I'm optimistic based on prelimiary news plus my nature to be.

-- Jim

[mremeet]

kalio, thanks for the kind words. My gfriend is a nurse and she told me the same thing you said about a bad rash, that it can absolutely be life threatening. She said in her ten years of nursing she'd never seen a rash as bad as mine and pleaded for me to stop all the drugs immediately (she also forced me to go to the ER too).  Looking back it was quite scary, moreso than I fully appreciated at the time. But so far at least I'm glad I hung on and made it this far. Really hoping to salvage an SVR outta this whole mess. If I do, the rash would have been worth it. (just barely ;-) How much time do you have left anyway? You've got to be getting close by now - here's to an SVR all around!

willows - I know where you're coming from and I don't blame you. I'd want access to it too, even if it did come with a significant chance of a rash. I'd take my chances with it, just like I did rather blindly when signing up for this trial in the first place. Bottomline is that the closer our livers move towards cirrhosis, the more the luxury of time slips away. When that situation arises, our hands are forced into making tough decisions based on limited/imperfect information and living with their associated risks and lack of guarantees. Bottomline is that I'm guessing telaprevir will make it to the market - with significant side effects, but with a significant improvement in odds of treatment success too. Lets keep our fingers crossed.

jim - Your rashes do sound awful, and I know you're still struggling with it. Hoping you're coming along aok.

[Tallahassee]

I'm just holding my breath...

Over the years, I observed so many promising drugs... but for one reason or another they did not reach of the FDA approval.  

I hope this one will be approved and be suitable for some patients.

[willows]

Woohoo!!   We all discussed some pretty funky stuff and some darn important stuff and we played together nicely!  Woohoo!!  Honest, to discuss such differing views and experiences and to do it in such "good manners" ways is very cool.  We are very cool.  Another better day under my belt.

Willow

[ladybug52]

That was very nicely done. It was like listening to an intelligent discussion among adults. And really, you all sounded so informed and educated you should be proud of your knowledge that you can even discuss the issues. Very interesting thread!

[GoofyDad]

"Our skin is our largest organ "

Speak for yourself, Sister!!

[GoofyDad]

It's been a while since I looked at this issue at all, let alone closely. Do you have a feel for the projections investors are making with regards to earnings, and how that compares to the current market cap?

My guess is that there's a lot of pent up demand that may or may not be factored in to current share price. I get the sense that a lot of GI's are advising patients with moderate damage to wait for a better mousetrap. And VX could be that trap.  

[Sincebirth]

This drug scares me.  It is totally manufactured atom by atom.  Interferon is at least made naturally by our bodies.  This thing may end up causing major long term sides.  You just don’t know.  At least with the rash you will see and feel it and could go off the meds if need be.  Although I may not want to go off VX early due to setting up a VX resistant strain in your body as evidenced by the mutations it caused during monotherapy

Hoping that all works out.  

I have watched all of the conferences and at one they said that they think the rash may be due to the combination of the ribaviron with the VX.  Maybe if the arms that have no riba work out and the sides will not be that bad for just VX & interferon.

I really respect all of you that are willing to be the guinea pigs for this drug.  

[Forseegood]

I just think that riba is a far scarrier drug then then the vertex, but necessary in the soc...from all the research done on these drugs, a monotherapy with vertex ain't as bad in terms of side effects, etc...this is just what I read...

[ChrisDDD]

Willows,

Thank you for writing the author of this article, though I haven't read it.

Mremeet, I hear the same ticking clock that you do.

Hopefully people will see this part of my post.  Does anyone here get scared or nervous about posting their concerns, problems or fears re treatment due to the fact that Vertex or doctors may be reading our posts?  I hope I'm not becoming paranoid.  I have things I'd like to say/share that now I'm worried about saying/sharing since I read recent posts about Vertex reading our comments and have seen some of our threads showing up on internet news sites.  I wish there was a more secure way for us to talk about these things.

[Happyhungry]

Just one point on the Telaprevir rash.  I'm in Prove2 now in week 12/12 on triple therapy.  We unblind in just a few days. Unfortunately one of  my group also recently went down from this horrible rash in week 10 and had to stop all meds. The term "Rash" is an understatement for what happens.   mre and others are absolutely right in pointing out the seriousness of this condition.  Those who talk about being prepared to put up with it in exchange for its benefits are missing the point. This is a frightening and explosive effect, nor some kind of "temporary side" that can be "toughed out" by strong mental attitude or somesuch.  It is a particularly  insidious condition affecting the entire body and bringing various other complications and possibly long term (i.e. post tx) problems with it. You dont muck around with it - you have to stop the Telaprevir at the very least and do it quick.  However,  I note that both mremeet and the person in our group, broke out with the rash toward the end of their trial periods.  I also noticed some kind of pre-rash symptoms myself  around this period, fortunately countered with antihistemeins and some great advice I got here from Jim and MRE.  Anyway my speculation, based on totally unscientific principles, is that for some, the rash tends to show up more toward the end of the Telaprevir trial period - some kind of build-up threshold effect in the last few weeks.  Maybe  the risk could be substantially mitigated by shorteneing the dosing period to 8 or 9 weeks. The power of Telaprevir may just prove strong enough to do its thing anyway in such time.  I  get a feeling that there will be lots ahead in terms of optimizing Telaprevir dosages and drug combinations to avoid the rash. At the least using this drug may become much more manageable in days ahead than it has been for trial participants.

[mremeet]

Happy - Good to hear from you, was starting to wonder if your rash blossomed into the dreaded "full monte". Really glad to hear it's been manageable using an antihistamine and that you've succeeded in making it to the end of 12 weeks on full dosage of everything. That should give you every chance of performing as well as anyone could hope in 12 weeks. With any luck you had a relatively treatment sensitive virus and a low starting VL. That would help seal the deal in only 12 weeks. And for what it's worth, I had to discontinue VX at roughly 8 weeks. At the same time I was taking gobs of prednisone and temporarily stopping and/or cutting back on my riba. This went on for over a month (and I'm still on reduced riba dose to this day) after stopping the VX, finally capped off with a big jolt of solumedrol (a powerful IV steroid). I would later find out I was UND by day 15, and remained so during the entire rash fiasco (and up until this day). When you really think about it, for me to have stopped the VX at merely 8 weeks while at the same time cutting back on riba and loading up on powerful immunosuppressants for over a month afterwards (which are clearly known to depress the immune system and stimulate increases in HCV VL) - well, that's pretty incredible for the virus NOT to have rebounded during that timeframe. To this day I wonder what the SOC+VX must have done to my virus for it to have been so mightily subdued by a mere 8 weeks of treatment. The VX clears from your body very quickly (within just a day or two), so when you think about the ongoing effects of the immunosuppressants and reduced riba all working in unison for over a month in the complete absence of VX, and even then the virus STILL didn't rebound??? At least just a little above 10 IU/ml?? (and my starting VL was 1.6 mil, certainly not low) I almost dare not admit this out loud, but I've secretly pondered to myself at times; is it possible I might have SVR-ed even at that very early point in time with a mere 8 weeks under my belt? Seems too fantastical to be true, but when you factor everything in, it's almost a case of how else can it be reasonably explained? Of course  there's no way for me to know now, but my point in telling you all this is to demonstrate what it clearly did for me in a mere 8 weeks. Imagine what it might have done for you with a full 12 weeks with no reductions or interruptions of IFN/riba/VX and no immunosuppressants? Hang in there, wishing you the best during your unblinding.

Chris - Vertex is watching this site, make no mistake about it. I don't know what it is you wish to discuss, but I'd be willing to speak with you in private if it would help. If you're interested leave your email address and I'll drop you a line.

[Kalio1]

I agree with your assement, I too noticed that they seemed to get the rash towards the end of taking the VX. I so hope they can resolve it by simply lessening the time on the drug. The problem will be that that might mean they have to run more trials and it will be a lot longer before it will be available and other protease inhibitors right on their heels will be moving towards approval.

Im so glad you were able to avoid the rash, I was astonished that some of the participants who visit here managed to keep going, what an incredible sign of their tenacity that is! You guys are all such trail blazers for everyone of us. I hope even if it does get bogged down with issues that require them to go back to the drawing board all of the participants will succeed in clearing the virus and acheive SVR. You all deserve it, that's for sure.

[jmjm530]

Happy: Those who talk about being prepared to put up with it in exchange for its benefits are missing the point.
------------------------------------
I don't want you to think I was trying to minimize the effect the rash had on some in the Vertex group. The point was that, yes, many of us would take our chances with the rash in return for a shortened 12-24 week treatment verus what some of us went though in 48 weeks or more of treatment. While I may not be able to walk in your rash, you also aren't able to walk in my 54 weeks of one problem after another after another. Some people think being eaten by ants is better than eaten by a bear but I'm not so sure.  Glad btw that some of those tips worked out!

-- Jim

[raheem]

Hello to all, I used to post here all the time about 4 years ago when I had Hep C, genotype 1b for about 25 years.  I was very fortunate to have responded to interferon and ribavirin...48 weeks of a rough time.  My heart goes out to all of you still battling Hep C. Four years later, I am still healthy.  I try to stay abreast of Hep C info and I do some investing as well.  Living in Massachusetts, Vertex caught my attention and I am aware of the nasty rash side effect of telaprevir.  Rashes were also an issue with INF/ribavirin as well as low blood counts, weight loss, hair loss, depression and so on.  I had only low WBC so the dosage of INF was reduced and I also took Epogen to jack up my low RBC.  No other side fx for me.   On the whole, do you folks think the side fx of telaprevir are unmanageable or worse than INF and ribavirin alone?  I really have no idea except from what I read on some HepC boards but it is hard to quantify.  "Iron" Mike Simon and Rev......the only names I recognize from my time on this board...... keep fighting!