Vertex Trial Detroit Area -Looking for Participants

[Tippyclubb]

They called this morning about the Vertex Trial which will start in one month.  This is the one I have been waiting for--no excuses anymore I have to treat now.  I am excited,  also scared at the same time.  

She said they are looking for more people so if anyone is interested I can provide the contact information.  Its Phase 3 and the best thing is NO PLACEBO--will get Telepavir for 12 weeks along with Riba and Interferon for 6 months.  She said if I clear early treatment will only be 6 months.  Success rate of 70%, but thats lower for clearing within 6 months.  I will not know the virus count during trial, and no rescue drugs are provided.  Thats all I know for now and shes sending all the information today, so I will know more in a few days. I think she said this trial is for people who have not treated, but not positive of that. I got so excited and couldn't remember everything. Just wanted to let people within my area know they can get into this trial.

I'm a nervous wreck now!  Not sure what to expect and how my life will change, but I have spent countless hours reading this forum so its a comforting thought to know I can come here for support.

[MIBunny55]

Mmmmm. . . didn't know of Dr Stuart Gordon. I used to see Dilip Moonka, now trying to get in to see Kim Brown. Thanx so much for letting me know you're out there and have the same site for Hepatology. I am going thru much mental & physical distress that this appt. can't come soon enough! If you don't mind maybe we can share experiences?
SuzyQ

[Tippyclubb]

Are you with Dr. Stuart Gordon?  Its a great team of doctors there, and Dr Gordon is head of the Hep C research department.  I really trust their opinions.  Good luck to you !

[MIBunny55]

You've got me rooting for your success!! I am in the greater Detroit area and have had all my past tx at Henry Ford, waiting for an appt. to see the Doc/hepatologist there. Don't think they will try any treatment right away -- from my past experiences, it's doubtful that I can handle the sides from these drugs.  But then, who knows?? I'll keep my faith handy ;)

[foofighter]

mkp13 made an excellent point about rescue drugs. By the time you might need them you may almost be done and certainly would have gotten enough of the PI.

I think trial docs always have a little discretion on prescribing some things, I think it may just be the blood products they are talking about.

Sounds like a perfect trial for so many. With my platelets going up and down, it IS too much of a gamble for me to walk away from SPRINT2 so I am going to stay where I am 100% in. I will start trial Monday.

Good luck to both of you! It is a wonderful opportunity and you are helping get a drug to market from a great company that will help so many others in the future.

[Tippyclubb]

Now thats a rough decision.  Like you said --A bird in the hand !  Sounds like too much of a gamble.

I was pretty sure they told me rescue drugs are allowed, but I could be mistaken--so much information to remember.  I will double check.  Either way I am going forth with it.  Maybe I get lucky and won't need them.  Worse thing could happen is I have to quit.  I just love the fact I know that you know the meds you are given.  Plus, treatment could only be for 6 months.  How nice would that be?  I can't pass it up.

[foofighter]

No rescue drugs allowed.

Just got the consent forms and visited with trial nurse at a location near me, who is in a site visit with the Vertex rep all day today (she has been kind enough to email while in the meeting).

She sent the consent forms with this note:

"competitive enrollment, so even if you have signed the consent - that doesn't hold a spot for you. Also, rescue drugs are not allowed."

Tough one for me. I am ready to go in the Sprint2, I may not pass screening for the Vertex trial and then I have lost both.

A bird in the hand????

[foofighter]

Whoo Hoo! So they are "allowed" just not covered! If you are lucky enough to have insurance that will help, it is a slam dunk.

Wow.

[Tippyclubb]

I asked about rescue drugs--she said " No".  Meaning they will not provide, or cover the cost.  However, I could take them if needed, but I am responsible for cost.  I'm not sure of the names of these rescue drugs so I can't call blue Cross to inquire if they cover them.  I'll do some reading around here and try to find out more about these drugs in case they are needed.

Yes, its a dream come true ---  I've been waiting to get into the Vertex trial but had no ideal it would be one with no placebo!  Lucky, huh ?  

[foofighter]

Maybe we are assuming there are no rescue drugs. Could happen...I hadn't heard about any trial with PIs that have no placebo and now this!

Maybe this is the dream trial. Tippy, did you ask or did they tell you if they are allowing rescue drugs?

[Tippyclubb]

I don't know much about the rescue drugs.  I am taking the attitude that I won't need them, maybe thats a little foolish and I should take this into consideration.  What is the name of these rescue drugs and the cost?  Thanks

T

[mkp13]

Regarding no rescue drugs:  Keep in mind that in all these trials you are free to drop out at any time.  Yes, it can result in unpleasant tradeoffs if your need for rescue drugs comes before the end of the experimental drug regimen.  But it's not like there are no options.  If you drop out and your doctor is reasonable, they can make arrangements for you to continue SOC treatment without interruption.  Note that even if you're not in a trial, there's still the question of whether your health insurance will cover the rescue drugs.  Some do, some don't.

(FYI, I'm not advocating dropping out of trials, but if your counts go so low that your treatment is seriously compromised, it's sometimes warranted.  Of course the prohibition on rescue drugs will muck with the stats they're collecting in weird ways.  I have no idea how the companies plan to deal with this in their results analysis.)

[Tippyclubb]

I am definitely going to treat--I can start screening next week.  They called me about the Boceprevir Trial a few months ago. It was a hard decision to refuse it , but I was waiting on this trial, and I can't believe they finally called.  It sure was a gamble to refuse the other one and I worried so much weather I was doing the right thing.   Wheeeeeew.  You must be treating out of Henry Ford ?

[GreatBird]

That's where I am: Cedars LA. They must be recruiting hard. I had sent them an email sometime way back last spring? winter? and suddenly heard from them out of the blue. It's all happening at the right time for me, though, and there are elements of it dovetailing into my life like a jigsaw puzzle piece, so I'm feeling like I'm good to go with it.

[foofighter]

Boceprevir is showing about equal promise I believe or close to it. The difference between the trials is that even though you will get the real drug if you didn't SVR on the placebo arm, they don't know if the boceprevir will work added that late in treatment. There's no track record for that protocol.

And I guess we don't know how many weeks that would end up being. This is frustrating news for me. I am set to go, but if there is a chance that I can 100% get teleprevir even without rescue drugs...

Again, arrrrrggghh. I got all the contact info at the Mayo (they aren't in right now) and I came home to find a message from Cedars (LA) talking up this trial, telling me they are recruiting immediately.

[GreatBird]

I'm going to be starting the boceprevir trial in about two weeks (different city). I'm under the impression that it also has really good results. Am I wrong? Is Teleprevir doing better?   (Should I wait?)

I'm a treatment naive 1b and there is a placebo arm, but they said that anyone on the placebo arm who doesn't clear is given the opportunity to re-tx with the boceprevir.

[foofighter]

You have got to be kidding me!!!!! I waited and waited and tried to find a Vertex trial that I could get to. After almost a year of back and forth I gave up. It just wasn't worth the hassle of relocating/traveling to far off places, with no rescue drugs or guarantee that you will get the real drug. Now this pops up. And in my neighborhood! ARRRRGGGGH!!!!!!

I start the boceprevir trial in about 16 hours, which DOES have a placebo arm (but it was the best option I had). What are you gonna do? Jim what do you think?

Justme...take a look! A bit of a drive but and no rescue drugs, but so what! Guaranteed teleprevir!

[Tippyclubb]

Yes, I am sure there is no placebo. That is why I will treat now!  I received the paper work today.  There will be two groups which will be randomized.  Both groups receive teleprevir for 12 weeks along with peg and RBV.  One group will will stop treatment at week 24, the other group will treat for 48 weeks.  We will not know what group we are in, nor will we know our viral level.

My papers state there will be 470 - 500 people in the trial  The project title is VX08-950-111 in case you want to research it.

Tippy

[kespr]

Are you sure there is no Placebo in this study? Or are you in a leg that is not getting the placebo. I,ve been watching all the trials from the Vertex web site and know of no study from them that doesn't have at least one control arm

[toughluck]

I did it with no rescue drugs except over the counter stuff, personally I think it is cruel to give this tx to people with no line of defense. I had 2 different rashes been off tx 5 weeks and still fighting one. My tongue got so swollen I could not talk, magic mouth wash took care of that, just be aware of what can happen.  

[Fl_Gator]

RVR would have been within the first 4 weeks and since this is a double blind study they don't give viral load info....I just have to hope.

No rashes....I was itchy at first...I was told that only 9% of participants get the rash.  

I had to take a riba reduction when my HBG went down.  I am still tired and a bit short of breath if I do too much.

I also started taking an AD close to week 10.

I am fortunate to have great family support with my dear Husbad and Children. I didn't have to work during tx either. I am anxious to see how I feel after this is over. I hope to feel young again.

Gator

[Tippyclubb]

Lets hope your RVR on your 24th shot.  How was treatment for you?  What about rashes-get any of those?  

Tippy

[Fl_Gator]

I am in a Vertex trial...placebo controled....week 23. I will take shot # 24 on Friday. I am hoping for the best as I haven't been told yet what I am getting but there is a 2 in 3 chance that I rec'd Telaprevir and if I had RVR I will be told to stop tx after shot # 24.

I wish you the best of luck...please keep us posted on your success!

Gator