Telaprevir

[Electra56]

I stumbled upon this site while looking for information on the VX-950 associated "rash".  I have just been screened for Vertex's Phase II in non-responders/relapsers.  

I am a PegIntron/Ribavirin relapser- non-dectable by 16 weeks, relapsed after 52 weeks of therapy.

I read a post by "mremeet" who seems quite knowledgeable about the drug- I was wondering if you'd like to share more of your story?

I'd be interested in hearing from anyone else with experience with this drug.  Thanks!

[friole]

Do you know when the screening is over?  I am interested too but think I may be too late

[Electra56]

This is for PROVE3- I understand that the screening period is short-  I was screened last week in NYC. They plan to enroll 440 pts- mostly in EU.  You should go to the Vertex website for info on participating sites.

[mremeet]

Hi, welcome aboard, great to hear you might be getting into the prove 3 trial. Although I'd advise looking very closely into all of the details in the consent form before committing to it. If there's anything in particular you'd like to know, just ask and we'll do our best to clue you in.

[web52]

hi. im in week 33 of 48. took vx for the first 3 months prove-1). und at 22 weeks. had a rash (not severe) but it went away pretty much about a month after discontinuing the vx. sx were toughest for first 4 months of tx. been feeling much better since about week 29. have only missed work due to doc appts. on much looked forward to vacation now till april 11. staying home and will hopefully clean up the yard and do some planting. it's spring here and i feel up to some not-too-strenuous outside activity. good luck to you! sounds to me like prove-3 is a great opportunity for relapsers.

[orleans]

Hey, You were not und until week 22? jm

[mremeet]

Web52 just misspoke is all, he was UND by day 22, not week 22.

[Electra56]

Are you folks on VX naive, or have you been previously treated?  I consented to the vertex study with a good amount of trepidation- having already experienced 52 weeks of IFN/Rib....and 3y later still wondering if my cognitive abilities will ever return to normal.  I have 0-1 fibrosis and am otherwise asymtomatic...I was concerned about the rash and does it resolve completely after stopping treatment and what does a second round of treatment (IFN/Rib)do to your frontal cortex?  Any comments?  Thanks- it's just that I like my liver , but I like my brain too-

[mremeet]

Everyone in prove 1 and 2 were treatment naive, prove 3 is for relapsers. PDS and myself got a very bad rash from telaprevir forcing us to stop taking the drug early (i.e. prior to the full 12 week dosing interval). It took both of us a long time to fully clear the VX rash. However the rash plagued me a bit moreso than pds because mine was not managed as effectively with steroids as hers was (she was on a longer course of prednisone with a much more gradual taper than me). And so the rash just exploded on me so that even when I stopped taking the VX the rash persisted in full force for more than a month more (even while taking large amounts of prednisone). Even after the rash was finally mostly subdued with a jolt of solumedrol, its "residue" remained for months afterwards. I'd say it took 3-4 months for my skin to settle down to a mere riba rash stage, although I still have sores on my legs and a really itchy scalp. But I mostly attribute that to ribavirin now, although it did seem as if the VX rash left a lasting resonating effect which seemed to exacerbate the "normal" riba rash. Although I do feel reasonably confident that once I stop all drugs, my skin eventually will normalize. So to answer your question, I don't feel the effects of the VX rash are permanent (although the full long term effects of it are yet to be seen).

Anyway, that's just me and pds, most people did not get a super nasty rash like that, so the odds are in your favor that won't happen to you. Plus, at this point in time, presumably Vertex has collected enough empirical and possibly analytical data (from rash sufferer bloodwork) from the hundreds of participants in both prove 1 and 2 to have some sense of how and when the rash comes on. And hopefully the doctors that will be managing prove 3 will be properly endoctrinated with this information, thereby giving them the "cliff notes" they'll need to properly diagnose the rash early on, and to take appropriate steps to effectively manage it before it gets out of hand. Also, if there are blood markers in those who get the rash (which was indicated as a point of study/inquiry in our consent form), then the head Vertex study doctor might also play a role by analyzing your bloodwork and providing helpful info to your study doctor in his diagnosis and management of any potential rash. So I wouldn't get too worked up over the rash, true it can definitely happen, but overall the odds are in your favor you either won't get it at all or if you do it'll be both manageable and transient.

As far as these drugs damaging our brains thereby resulting in cognitive damage...dunno about that, although I do notice lately that it takes me longer to come up with names and factoids that usually come very quickly. Of course I'm knee deep in treatment right now (week 34), so I'm not going to get too upset about it. Plus speaking for myself, I've had HCV for almost 25 years. It had to go before it really started working on me. I simply had to take the risk, and if it ends up deteriorating my memory or cognitive abilities in some way - well, I won't like it of course, but it beats steadily marching towards ESLD and/or HCC and/or death. I think of it as a situation where I simply have no choice, and what comes will come. Like the old saying, I just do my best to not worry about things that are outside of my control. And I'm not suggesting your concerns are illegitimate, especially considering you've already done 52 weeks and also have a near perfect liver. Sounds like waiting is definitely still an option for you. Plus I'd read over that consent form REAL closely, do your independent research and ask lots of questions before agreeing to it. If you're worried about IFN/riba overexposure, enrolling in that trial could result in that very thing (if you were to end up in the control group). If telaprevir is really going to work out and go to market, there will be later phase 3 trials you could have access to in just another year or two. Those phase 3 trials would in all likelihood have no placebo group, plus you might also have access to rescue drugs, plus the average treatment duration will likely be considerably less than 48 weeks. Obviously all of those factors would maximize your odds of success and thereby minimize the risk of any further unnecessary IFN/riba exposure.

My $0.02 anyway, best of luck whichever road you take.

[Electra56]

Thanks for your very thoughtful response.  Yes, I've had HCV for about 30 years, so I understand your thinking.  You make some really good points about waiting for another year or so, but I am also concerned about getting rid of it because I wonder how long my good luck will last.  I've been struggling with this decision for 3 years now. I guess I am kind of afraid to jump in again.

You are in week 34- that's great- just keep going.  I don't know how you are coping or what your situation is, but when I went through treatment I was single and lived by myself. That was good and bad. Anyway, I'd be more than happy to share my experience.  I kept a journal that I wrote in everyday- this really helped with depression- because I could look back and show myself that in a day or 2 I would feel fine again. It was also a good place to vent. You are on Pegasys, I did PegIntron and the two have different pharmacokinetics.  The symptoms with PEG-Intron were definitely cyclical. Anyway...to battle forgetfullness, I kept a "to do" list and wrote everything down so that I wouldn't forget.  I never found a solution for the itchy scalp (except to scratch it!) - but hot baths became a ritual to soothe achy joints. I lost about half of my hair- but no one ever noticed and it all grew back just fine. I lost 20 pounds- but being a woman this was a good thing- and I did it while eating all the candy and ice cream I wanted!  Staying active (ie. exercising)  actually helped with the fatigue, I rode my bike and lifted weights.  I also decided to learn a language so as to exercise my mind in a way that was different from my usual routine.  Maybe that's weird, but I really think it worked.  Mind you- I have yet to master it. I also had insomnia, but became immune to Ambien.  But by 8 months that sort of went away.  Anyway- I started to feel better almost immediately after I completed treatment- and just kept feeling better everyday- everything has resolved, just the lingering question. I say this because I used to ask myself...Am I ever going to be the same again?  And the answer is yes.  You sound as though you are in pretty good shape.  So good luck to you! and Thanks again.