Vertex Prove2 UK trial, rash strikes in week 2

Hello Everyone.  This is my first post to this forum.  I have been following the experiences of all you Prove1 VX'ers and I am hoping that you will please be able to help me as some of you have been through what I have got to deal with now.  I have broken out in a rash over most of my body.  I just got an antihistamine (chlorphenamine maleate) from my doc which hopefully will control it, and I am now trying to look ahead and see what lies further up this road.  I am on Pegasys and VX950 only, no ribavirin.    

From your posts, I have read that some of you also struggled with a rash and I'd like to ask you how soon into the VX dosing did it start, and what did you use at the beginning to control it?

I also gather that some people had to discontinue dosing because of the rash.  Could you tell me if everybody had to discontinue in the end or were there people who overcame it and completed their study dosing?

I read that the discontinuations were all around day 58 approx. or did some people have to stop sooner?  Was the scenario that people strugged on for the first 8 weeks and then the rash overcame the preventative measures?  

As you will understand, I want to continue with the VX as long as possible.  I was particularly encouraged by the post by mremeet who got clear of the virus and stayed clear despite difficulties and discontinuing the VX early.  I am just in my 2nd week now so any information which you can give me to keep me in this trial and give me a chance at SVR would be much appreciated.

Thank you.

[PSL]

How long are the treatments for

[sunspot]

IIRC, we have maybe 3 people who had the rash although that is a mild word for what they went through. More like dragon scales. Hang on, I'm sure you will get an exact answer soon.

[mremeet]

Hey dointime, welcome aboard. Real sorry to hear about your rash, especially so early on during treatment. I

[FlGuy]

You are always a font of valuable information.  Good show.

[prettydamscared]

Hi, I feel for you.  That rash is a killer.  I'll tell you what I know about it and I am in the Prove 1 study. I just got out my calendar and really looked at this so I'm fairly sure of my timeline.  My rash started as large, red, extremely itchy blotchy bumps around my 36th day, as far as I can figure. Over the next two weeks, it began to cover more of my body, and actually started to itch inside body cavities, nose, ears, rectum, everywhere. Up to this point, I just thought I had the dreaded riba rash.

At Day 50, i told my study nurse who suggested my doctor could prescribe something that would have to be applied topically over each individual bump.  That wasn't going to do it for me so I went to my own dermatologist on Day 53.  At that point, my dermatologist told me this was one of the most extreme allergic reactions she had ever seen.  The rash had converged, if you will, into one large continuous red area that covered, as she said, 90% of my body.  The term she used was confluent.  If you didn't touch it, it looked just as a really bad sunburn would.  There were no longer any indivdual bumps, they had all joined together at this point.  It caused extreme chills and fever and was hot to the touch, as an extremely bad sunburn would be.  I was always cold and taking a shower was excrutiating.  It zapped my strength and the itching was like nothing I've ever experienced before.

Derm told me I had to completely stop all meds, meaning the telaprevir, (vertex), riba and peg.  She prescribed Prednisone with a taper schedule of 21 days, however, my study doctor allowed me to stay on all meds for an additional day or two to see if the prednisone would work.  He was very clear that if the prednisone didn't clear it up quickly, I had to completely come off of the study, including SOC drugs.  

It seems to me that I started to get some relief rather quickly after starting the Prednisone, perhaps 3 days so my doc allowed me to stay on the vertex another 3 weeks.  It did start to come back when my taper schedule went down to one pill and at that point, apprproximately 10 weeks into taking the vertex, my doc had me stop taking the vertex, however, I did continue the peg and riba.  He was convinced from the first time he saw the severity of the rash that it was not from SOC drugs and as it turns out, he was dead right.

That number of 58 days that you're quoting may have come from my doctor.  At one point, he told me all study centers had received notification that the rash was "typically" rearing it's ugly head at Day 58.  That's what study centers across the US were reporting....of course that's not to say tht some will get it earlier or later or of course, some, not at all.

Mremeet's experience was worse than mine and I'm sure he'll post as well.  I hope this helps somewhat and I really do feel for you.

Charlotte

[prettydamscared]

Just to clarify, my taper schedule was different than mremeet's and I think at the time we both thought mine was preferable and perhaps if he'd been prescribed prednisone with the same taper schedule, he may have been able to avoid some addiitional complications.  Mremeet, correct me if I'm wrong about this.  

I was prescribed 40mgs for 5 days, 30mgs for 5 days, 20mgs. for 5 days, and 10 mgs. for the last 5 days.  When I got to day 3 of my last 5 day taper segment, that's when it came back.  I stopped taking it immediately because that rash was scary stuff.

A word of caution, if you are prescribed prednisone or any another steroid, be very careful about weight gain. I was hungry all the time and gained 13 lbs. in a few weeks time, but unevenly.  Even now, one side of my neck and shoulders are larger than the other and it's been a few months now, so I no longer think it's swelling. Neither my doctor or derm can explain it.  The swelling made me look freakish.  My face was round as a moon, my neck, shoulders and back looked kind of like a linebacker.  It was not pretty.  Moral of the story is, if you find you have a freakishly large appetite, try not to give it to it because it does cause distorted and uneven weight gain, especially throughout the trunk of your body.  I found that info on Prednisone's website and I am paraphasing, but that's pretty much what it said.

[FlGuy]

Many, many  people here do a lot for others.  Too bad it is usually wisdom from experience.

[chcnme]

Just wanted to say hello and that it's nice to meet you.  Sorry you have that rash.  There are some folks here who will be an invaluable source of information and support for you!  Best of luck.  

No PegInf ?  Hang in there!

[mremeet]

What PDS said about the taper is correct. My taper was too short, and it's why I ended up with more problems than PDS. One thing that we shared though, was that our rashes both came back after transitioning from 20mg to 10mg of prednisone. 20mg appeared to be the minimal suppressive dose for both of us. And although I didn't really gain weight on the prednisone, it did puff my cheeks up a bit. You can feel this swelling in your jowls and in your cheeks, and it did increase appetite somewhat too. And in case you don't know prednisone is an immunosuppressant, which is what you want to avoid during a time when you're attempting to stimulate your immune system with the IFN. So that's why it's something to be avoided if you can help it.

Flguy thanks for the really kind words. Glad to help out if I can, we're all in this crappy boat together. Hope you're doing well, take care.

[pln]

Hi, I did 12 weeks vx-950, and I had diarreah (diarrhea) the whole time, but nothing an anti-diarreah pill could not handle. I too also got a rash but nothing like MREMEET OR PDS, Good Luck. Pam

[ChrisDDD]

Wow, I really feel for you guys that ended up with this awful rash.  I have sort of a different question.  Maybe I should post on a new thread, but I think this is okay.  I have heard VX-950 is causing a lot of gastrointestinal problems?  Have any of you experienced that?  That's my biggest fear if I get into the trial.  Thanks.

[mremeet]

dointime quote: "There's one thing I don't understand. Mremeet, you say that you and PDS stopped the VX before 12 weeks but stayed in the trial. I thought that the definition of being in the trial was to continue with the full dosing for your group for the duration?"

Not for us, not sure if your trial is structured the same way. Although they may have discontinued us if we had not stayed on the VX for as long as we did. I never probed that issue to determine what they would have done if we had stopped the VX much earlier. On the other hand, in your case since you are only taking interferon in addition to the VX950, if you were to stop the VX, especially well before your full 12 week course, then I can see where they'd remove you from the trial. The reason they would have to do this, is because you'd probably have a very small chance of achieving your SVR remaining on interferon alone (especially for only 12 weeks total). And because that's very likely to be true, the only logical thing for you to do at that point would be to add ribavirin into the mix and extend treatment to 48 weeks. But if you were to do that, then your followup viral load response and subsequent SVR data could not be used for the trial. And the reason it could not be used, is because you would have taken a different mixture/course of drugs and for a much longer period of time; thereby disqualifying that data from being incorporated into the study results (comparing apples to oranges and all that).

But, just because you might be discontinued from the study because of your rash and a cessation of the VX for that reason, that doesn't necessarily mean they won't provide you with interferon and ribavirin therapy for a total of 48 weeks. I don't have my trial contract handy to check on this, but I'm pretty sure they will provide a patient that discontinues VX950+IFN/riba with SOC (i.e. IFN/riba) in lieu of the VX950 if you are not able to continue on with the trial. Although whether they would extend that same courtesy in the UK or not, I'm not sure. You guys have socialized healthcare there, so I would suspect HCV treatment is available for free to everyone. If that's true, then Vertex may not see a moral dilemma in not offering to extend 48 weeks of SOC to a trial participant who must be discontinued (which is a scenario that could arise for an uninsured person in the US). But you'd have to ask about that to be sure, I'm just speculating.

"My trial arm is for 12 weeks dosing with VX and Pegasys only. I was told that if the rash made me stop the VX then I would automatically be out of the trial. This is really important and I am still trying to confirm it but there doesn't seem to be any provision for further HCV treatment for people who are dropped from the trial on medical grounds. Those that make it to the end of their study duration do get offered SOC if the virus has not cleared or if there is a relapse. Anyway, how do you see it that I could drop the VX and still stay in the trial?"

Yeah I don't know, that's a good question. I will say this though - if you find out that they are planning to drop you like a hot potato and NOT offer to continue your treatment with SOC if you do have to stop the VX, then this is exactly what I would do:

1. I would VERY quickly line up healthcare outside of the study with a good hepatologist. Get inducted by the doctor and discuss your situation and that you wish to commence treatment with him/her in the event you are kicked off the Vertex trial.

2. Make sure the point is driven home to your supplemental doctor (mentioned in #1 above), that you wish to be able to start treatment at a moment's notice. The reason this is important, is that if you have to abrubtly stop the VX and IFN, you need to pick up immediately with the ribavirin and without missing any doses of IFN. This way you would be preserving the fantastic benefit you're almost certainly deriving right now by taking the VX950, even for a short course of a few weeks. The VX and the IFN may have already brought you to undetectable status, and may be dramatically improving your odds of achieving an SVR. The longer you take it, the more it will help to squash the virus. So the very last thing you'd want to do is to interrupt your treatment midstream with the virus fully on the run...and have to take time to go looking for a doctor, get all the approvals, get the drugs lined up/delivered etc etc etc. It's very, *very* important to keep the virus down without interruption, especially early on in treatment. It's a critical window of opportunity, and seeing as you are allergic to VX (like I am), then you probably wont be able to take it even if it passes its trials and becomes commercially available in 3-5 years. So SOC is what you'll have for years to come to deal with your virus. Therefore, reaping the full advantage of the VX while you're in a position to do so is *critical*. Ergo -> carpe diem!

Bottomline is that even if this rash does take you down, which I hate to say it, but eventually it might...if you have a properly planned and executed contingency plan worked out ahead of time, you can still derive an *excellent* benefit from being in this trial. You can still very well beat this virus and achieve your SVR, and have terrific odds of doing so. I wouldn't get overly discouraged from your rash, do your best to make it as long as you can. But set things up so that you can still meet with success - you deserve it! Your rash experience is contributing to that study, you're adding value to the research and you're risking your health and body in doing so (even your life, technically!). In return, you deserve more than being dropped like a hot potato - you deserve a shot at your SVR too. Don't settle for less!

Best of luck, keep us posted.

[mremeet]

VX950 did not really cause me gastro problems. I was constipated, and remain so today while only on SOC. I doubt my constipation was being caused by the VX. However, I know it caused persistent diarreah (diarrhea) in others. So if you're prone to that sort of thing (or not), it is one of its possible side effects.

Take care...

[dointime]

Many thanks for all your replies, especially to mremeet and prettydamscared for taking the time to give me such detailed and informative info.  I am sure the rash I got is the same as yours, big red angry splotches with a tendency to join up into one big area of hurt.  The doc said it looked like a drug allergic reaction.  I think it is under control from taking the Piriton (UK brand name) every 4 hrs.  It's a non-prescription allergy drug.  Would make sense to me if everybody on the VX trials were told to take it from day 1 as a preventative measure.  This is one ugly rash to get.  Creeps up under the guise of a normal irritation.  I did all the usual things, changed my shampoo and washed all my sheets & towels with hypoallergenic wash then BAM, after 3-4 days I get up and I'm covered in red blotches!  I was pretty damn scared myself, I can tell you.

There's one thing I don't understand.  Mremeet, you say that you and PDS stopped the VX before 12 weeks but stayed in the trial.  I thought that the definition of being in the trial was to continue with the full dosing for your group for the duration?  My trial arm is for 12 weeks dosing with VX and Pegasys only.  I was told that if the rash made me stop the VX then I would automatically be out of the trial.  This is really important and I am still trying to confirm it but there doesn't seem to be any provision for further HCV treatment for people who are dropped from the trial on medical grounds.  Those that make it to the end of their study duration do get offered SOC if the virus has not cleared or if there is a relapse.  Anyway, how do you see it that I could drop the VX and still stay in the trial?

Thanks
Dointime.

[prettydamscared]

Hi again,

Just want to briefly reiterate to pay close attention to mremeet's comments regarding items 1 & 2 because imo, they're very important. We talked of those things at length during the period of the trial when we both had extremely bad rashes.  The last thing you want is to be left out in the cold especially when, with thoughtful planning, you can alleviate that particular option and maximize the advantage that you already have of taking the telaprevir for however long you are able to take it.  Good luck and please keep us posted.

Char

[dointime]

I am so glad you posted that you got a rash and still made it through your 12 weeks VX dosing.  You are the first person I have heard of directly which has done so.

Was your rash also a systemic drug allergic reaction, just not so severe?  Or was it diagnosed as ribarash or something else?  

How was it treated and did you continue treating it for your whole 12 weeks?

When did it first appear?

Thanks

[pln]

Hi, my rash could have been from the vx-950, I say could, but it probally (sp) was because my study nurse had never seen a rash like mine from riba. I was givin a steroid cream that did help the itch, but really it had to run it's course. I had large red scaley spots, started on chest and then all over leggs and arms. My rash first appeared around week 6 or 7 I think? I will check my diary and get back to you. Try not to quit! and let it run it's course. I will post more later. Pam

[mremeet]

You're certainly welcome for the advice, my pleasure to help. As you can see both me and PDS have been through this whole rigmorole, so we know where you're coming from.

As to your rash, what you've said sounds very encouraging. If your rash is being subdued with just an over the counter (OTC) antihistamine right now, then you might very well make it. Your rash may not be in the same class as mine and PDS's. Our rash could not, and would not be attenuated by a simple antihistamine. It grew in intensity and coverage slowly at first, but then it started picking up steam like a locomotive. Then it got to a stage where it would turn on a dime, and flare up very badly, very rapidly. At no point during having it did it lessen with the exception of taking prednisone the first time around. And prednisone is generally much more effective than an antihistamine for controlling allergic reactions (albeit with much more negative side effects). Anyway, it may be that your rash is not like ours in this regard. If so, you may luck out and not have to go through what we did, and you might be able to take your full course. Keep your fingers crossed.

As to the alternative doctor situation - I was afraid of the "waiting line" phenomenon common with socialized healthcare. It's good to hear your doctor is working with you looking into having Vertex provide the drugs and healthcare in the event you have to quit the trial. Hopefully they'll pull through for you. I was told by our study nurse that they have plenty of extra IFN and ribavirin, since they're a research clinic they get it in bulk. She was telling me that in response to my questions of dropping out and continuing offstudy., and was basically saying they could probably work something out either for free or at a reduced price if need be (or give me enough meds to tide me over until I found another doctor). Here in the states we also have a non-governmental program that will provide you with the meds you need either for free or at a drastic reduction in price directly from the manufacturer. The drugs are available to those who are un/underinsured, and you don

[dointime]

Just a note at this time to say a big thanks to you, mremeet for your last post which really gave me inspiration at a dark and scary time.  You confirmed all of the thoughts that have been going round in my head and it has helped a great deal to get me clear and focused on what I have to do now.

My study doc is querying it with Vertex on whether they will fund up to 48 wks SOC if I am dropped from the study on medical grounds.  Unfortunately, socialized health care means you go on a waiting list aand my number does not come up on that list for another 6 months so it's no good to me in present circumstances.  The doc and I agree that my fallback plan must be to switch at a moments notice to SOC if the rash gets on top of me, but if Vertex don't come through with the funding then how to do that is going to be problematic.

The rash has faded away quite a lot since I started on the antihistamine pills and has not had any recurring flareup or been itchy or sore, so no worries right now.  I am however apprehensive about what might happen after my next pegasys jab on Friday evening.  What a magical mystery tour this is turning out to be - of the not so fun variety.

Will keep you posted on developments,
dointime.

[dointime]

Pam, I really appreciate this information from you, thanks.  Just to know that for some people this rash runs it's course and does not escalate to critical levels is very encouraging.  My rash seems to have run it's course all over in about 1 week with each area of flareup taking about 4 days to dissipate and lose it's angry red appearance.  That was with the aid of OTC antihistamines.

I'll be on rash alert now for the next 10 weeks of VX dosing.  Doc says I can taper off the antihistamines now but I'm not sure.  Anybody know if that's OK or should I just stick with them now for the duration?  I found out that Vertex won't fund SOC if I get knocked out of the trial before my 12 weeks is up, so it is critical that this rash does not get on top of me.

thanks,
dointime.