VBX-950, heart problems???

[copyman]

i called a hepatologist that was the first doc i saw after finding out i had HCV. i now see a differnt doc closer to home. although the doc i see now is involved with several trials he does not have the VX trial. So i called my old doc to ask if he would be having the VX trial and of course was not able to speak to him directly but talked to one of the fellows which told me they will have the VX trial there. He said he will put me on the list. he said there was some concern with the sx and i said about the rash? he said no there was more concern about heart problems! said they would know more after the boston meeting. has anyone heard of heart problems with vx-950? this was the first i had heard of it and was very susprised. thanks for any info on this.

[copyman]

LOL, early morning posts before coffee, of course i meant VX-950 in the title.

[mremeet]

Wow, I hope the guy you spoke to was simply confused and there aren't any real "heart problems." There was another protease inhibitor a few years back called BILN2061 that was looking real promising, but it was discontinued because of heart toxicity observed in primate studies. And then someone was on here recently asking about BILN2061 again, saying something to the extent that it may be tested again and possibly it's been slightly reformulated?? Not sure I have that right at all, and not sure the person sugggesting that had it right either...but maybe the guy you spoke to was thinking of BILN2061 instead of VX950??? I hope so anyway, keep us updated if you hear anything more.

[Myown]

first i had heard of it and was very susprised. thanks for any info on this.
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Hi Copy,
Actually it wasn't the first you heard. You were in a thread last year where I posted this. I didn't have any site I could point people to read about this -and I still don't have any studies to show as proof, but I did say the person who told me is a friend who is a retired liver researcher.

[jmjm530]

From what I remembered of that thread -- even though your friend may have mentioned Telaprevir,  it appeared that he was talking about an earlier PI called BILN2061 which was pulled from trials due to adverse heart events. If indeed there is anything significant re Telaprevir and the heart, it is indeed new.

-- Jim

[Myown]

He was talking about VX. I mentioned to him that you said BILN and he said he was talking about VX.

[jmjm530]

LOL. I knew you would going to post that.

Now I could say, "show me a study" or any mention in the literature, for that matter, of Telaprevir and heart issues back then -- but I know you too well to ask, because you're not going to waste your Saturday looking it up (I wouldn't) not that you'd find it anyway.

I will grant you that there may be some heart issues with the PIs, including Telaprevir -- as they are with riba for example -- but the important thing is if they are signficant or not. With BILN2061 they were -- like people died I think -- but never heard any major red flags re Telaprevir until now.

Be well,

-- Jim

[Willy50]

It would seem odd that we would finally hear about this and in this way.  

On one hand it seems unlikely that a doctor who was interested in the study and was looking towards findings at the AASLD would confuse a drug that never made it out of Phase 1 trials with the Telaprevir.  Biln 6021 was discontinued over 3-4 years ago I think.  Most folks don't even remember it.

Assuming that there were a heart issue would we have heard about it yet?  There have been over 1000 patients dosing on TVR.  We've not heard about any heart issues; not with those who have completed nor on those who are currently undergoing treatment.  All other issues we have gotten wind of and saw evidence of attempting to deal with the possible issue.

IF it were a possiblity wouldn't Vertex be gathering information that would support whether it were an issue or not?  How would one do that?  I'd think it would be with baseline type tests and with continued monitoring.  If that has been occurring those on the trials haven't been reporting it.

I hope this is just an unfounded rumor, a miscommunication or misunderstanding.

Willy

[PSP-n-Me]

I heard the same thing about heart prob's with that new drug - not sure if it is true or not but fummy two different places said the same thing - I hope it is not true

[mremeet]

No one died with BILN2061, at least no one human. And at the time I seem to remember the monkies were given pretty high doses of the stuff too. BILN2061 may have actually been viable for people if the dose amount and duration was right. They might have kiboshed it just to be on the safe side (i.e. for liability reasons of course). And I haven't heard a single thing about heart issues with telaprevrir. I've received every revision of the consent form and nada. We also were monitored with ECG's both before starting, during, and after treatment concluded. All of my ECG's were normal and I haven't heard anyone else saying they had any problems either. And I know they've been checking for heart enzyme levels (which are similar to liver enzymes in the sense they indicate heart cell death rate) too because of the known cardiac toxicity stuff seen in BILN2061 and perhaps other PI's. And the trials have been chugging along, with new trials being aggressively scheduled and planned, with no mentiomn of heart toxicity. Anyway, I'm calling this rumor just that...a rumor probably started by some half informed "ohhh I dunno, that's what I heard" guy. Hope I'm right about this, I was afraid we'd be hearing about the long term wang fall-offage stuff after I took it. Looks like me and joachim are going to have to be drinking buddies for now on.

[jmjm530]

Mre:   No one died with BILN2061, at least no one human.
---------------------------------
Wasn't that Michael Vick's defense? Anyhow, no one will touch that drug now. It's finished.

And yes, I agree, the responsible thing is to view this as "rumor" until we know something concrete. Given the studies being presented at the Boston Meeting, I assume we will know very soon if there's anything to it.

-- Jim


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[Myown]

I was not saying that my friend was correct cause he never pointed me to any studies either if thats how I want to look at it,,BUT he did liver research for many years - retired and last year when I mentioned VX to him he said he was VERY surprised cause they squashed the trials in Europe due to heart problems and at one time that his place and Duke (I think he said Duke but I can't remember) was supposed to do a study or trial - what ever you call it. At that time the only reason I mentioned it (inside of a thread) was becasue you had told me to wait for VX, if I remember correctly, and thats when I thought I could mention it without really throwing it out there without any data to point people to. I knew it might upset some people(and I WAS knocked by someone) and that is why I didn't want to just say it in the open without real proof AND to tell you the truth, after you mentioned BILN, I DID think my friend was mistaken - but on the other hand it was hard to think he was mistaken.

As far as people thinking that they would have heard or whatever....Is it impossible to keep things behind closed doors when trials are conducted in other countries? I have no idea and I don't know anything about that. But a thought just came to my mind and I wondered if sometimes drug companies would rather test something outside of the USA to "test the test" so to speak. I know we have the FDA as the watchdog (the sometimes sleeping watchdog) but I don't know what happens outside of USA. And  again I am just guessing and don't know what I am talking about as far as that goes.

But as far as I am concerned my friend had accurate info cause Copys doc said the same thing and now that they are going to discuss it in Boston, this too would lead me to think it is true. I hope I'm wrong.

[Willy50]

Thanks for the info on the ECG tests.  My guess is that a new concern might spawn increased testing, of which I've not heard of any.  You are right that heart attacks can cause raises in AST/ALT scores; that's an old method of testing for heart attacks.  I'm not sure if those scores would be affected if unless there was damage.  Most of the Vertex participants experienced rapid AST/ALT improvements like in a week or two of starting the trial. If there were a new problem would there be increased heart testing or more bloodwork done?  Possibly.  Could any old participants be recalled to check for some odd heart related issue?  Perhaps, but that too has not occurred that we've heard.

There may be information in the conference about Prove 1 or 2 but there are no papers being presented that deal with it heart issues directly.  It's possible that in a presentation on the sides that some mention could have been made on any toxicity issues and that a rumor started.  ANY new information is going to be scrutinized and probably "hyped" to the max.  And why not?  It would be a "sensational" news story and a possible deal breaker for FDA approval.  As it sits however......there don't seem to be any news articles/stories on line at the moment.....except possibly here at Medhelp.  

In that there are no articles yet I'd suggest that for the time being to leave it as rumor.  I'm not certain that it will be addressed at the AASLD although if it were strictly a rumor they might address it.  

Willy

[mremeet]

As to the theory that Vertex may be using foreign trials and test subjects (foreign to the US that is) in a more laissez faire manner when compared to what they could get away with in the US: I've thought about that myself, especially since they seemed to conduct the testing for the more likely to fail treatment groups in Europe (i.e. no riba and/or 12 weeks of treatment). As far as I know, the liability laws are more constrained in Europe than they are in the US due to their socialized healthcare systems. It's probably also harder to sue a foreign company than it is a domestic one just because of the differing laws and logistics of it all. However, on the other hand I've seen some Prove 3 people in the states who were exceptionally ill suited for the no-riba group basically get screwed by being put into that group. However, the concept that Vertex may be conducting riskier testing in the sense of cardiac toxicity in Europe as opposed to here? I definitely don't think that's true at all. Prove 1 and 3 were and are conducted here, hundreds of participants have received the drug, some for 12 weeks some for much longer. If Teleprevir has cardiac toxicity issues, American participants are going to be affected by them just as much (if not more) than our European counterparts.

I think the Telaprevir --> cardiac thing is probably bogus. But I guess we'll see soon enough at the Boston conference.

[jmjm530]

Yes, now I remember the original post clearer. There were never any Telaprevir trials in Europe "squashed" so he defintely is confusing one PI with another. In this case he's confusing Telaprevir with BILN which was literally squashed.  There really is no reason to believe otherwise.

-- Jim

[jmjm530]

The unfortunate thing with a thread like this -- and especially with a title like this -- is that I have a feeling we're now going to have references about Telaprevir heart toxicity here for a long, long time -- whether or not, any evidence really comes forth. Not a criticism of anyone, just a fact and one of the Internet's downsides.

-- Jim

[Myown]

I certainly hope that Telapreivr proves to be safe for the sake of all you guys and also for the fact that others may tx sometime down the road, including myself. It bothers me though Copy was also told this and PSP also. Maybe PSP can tell us if her info was from her doctor or medical person. I would guess her source was reliable otherwise she wouldn't have mentioned it. My friend would of course never make something like this up and he said he wished he still had the info for me so that he could send it. I know its hard for all you guys to take this as gospel, you don't really know me, but I would never say something like this unless I was told and told only by someone who was in the medical field. But even with saying that, I still wonder if he could have made a mistake and is still just getting confused with BILN, but now with Copy saying this, I just don't know what to believe.

But ya know what too...if you guys that were/are in the studies asked if they had a trial in Europe that was halted, would they be obligated to tell you? Cause I guess that would be one way of finding out. You might have to be good at reading body language though if they are not obligated to tell you.

Ps.Jim- as far as 'no reason to believe otherwise,',,,,these drug companies are all out for money - bottom line and we all know that. They do what they have to do to get these drugs approved as far as I am concerned and I'm not just talking about this particular drug company. IF this turns out to be true and not a mistake that 3 people made (my doc friend, the doc that copy knows and whoever told PSP) well then that is pretty bad news,,,,but why would any of us be surprised what drug companies would do in order to make money? Ask any parent of an autistic child that question.

[jmjm530]

Not being critical of your friend, but doc's -- like the rest of us -- get confused all the time with studies/trials unless they are actively and intimatly involved. If you read Copy's post carefully you'll note that he said "they will know more after the Boston meeting". Boston is a public conference and not a hush-hush meeting, so I think it fair to assume that if Copy's doctor (through Copy) doesn't report any adverse heart effects after the meeting, then we can cross that "source" off the list.

-- Jim

[Andiamo1]

When I signed he consent form for the prove 3 trial, it had a list of all negative side effects. HEART problems were definitely not on the list.  My research coordinator gets a fax every Monday with negative reactions regardless of links to Telaprevir, and heart problems are not on that list either.  Telaprevir does exacerbate anemia when used with Riba and that can definitely trigger existing heart problems.

I don't think there is any credibility to the heart problem story.

[copyman]

sorry, i did not mean to open a can of worms here. i was just passing on what a "fellow" NOT the doctor told me. PLEASE take it with a grain of salt and lets wait for the boston results. i just asked here because i wanted to know for myself.  i'm hoping that this guy has it wrong because i'm counting on this drug to help me !!!!

[jmjm530]

After a quick read of all six Telaprevir asbracts at AASLD 2007, there is no mention of any heart issues other than anemia.  

[PSP-n-Me]

Yes I heard talk at my clinic, they have the trial co ordinators sit right next to my Hep Nurse and if I am waiting to see her I hear their talk...I was almost afraid to post it in here for fear that I would be "jacked" by a certain someone - but when Copyman posted it I said what the hey...I feel it is important for people to know this, the ones that are in the watch and wair mode and putting all their eggs in one basket...It is so important for newbies to be advised that these PI trials are just that - A trial, you will be a lab rat if you participate.....

[dmhrdh]

The following is on my Prove 3 consent toward the end under the heading "Side effects of Telaprevir".

"Uncommon but serious side effects occurring in people taking telaprevir in combination with pegylated interferon and ribavirin included:

-Anxiety
-Mood disorder (bipolar disorder) 1 subject experienced this
-Itching skin
-Eye problems (scotoma such as a blind spot)
-Heart Attack
-Lump (non-cancerous) in a gland in the stomach found on a CT scan.

[PSP-n-Me]

good post thanks :)

[Myown]

thanks for your input PSP-n-Me.

dmhrdh- thanks for the info.

Jim, "heart attack" is just that,,,A heart attack. That to me is different and a little bit more serious than 'heart problems,"heart issues,"and anemia.

My question is where did Vertex get this info from - which trial? Didn't the results JUST come out? How would they be able to state all this IF in fact all these folks are the first to use this stuff?
I noticed that they have "1" subject experienced Mood disorder, yet they didn't mention how many experienced "heart attack." Maybe I am missing something? Did they have several other trials before the one that the forum members got into?. I really haven't been following the Vertex threads to tell you the truth so I really don't know.

Take care.