Skin part 2

[pln]

Kalio, Yes I told my derm I am treating hcv and she cut me off and said interferon and riba. I also told her about the vx, and that I had 6 more days of vx and ? more days of soc. I have not seen my study nurse yet but I have left a message for her to call me. My derm called in my RX I am going to go pick it up at 8, and I will let you know what it is.Pam

[Kalio1]

pln
I am so sorry for the things you are dealing with. I hope the meds. work on your rash right away. Im not sure I would take the word of a derm. alone to stop meds, I'd want to talk to the liver doctor and study doctors and see what the consensus was before I quit therapy completely, obviously I am not you nor have I been going through what you have either. I just hate to see you go through all this and several months of tx and have to stop SOC if it turns out it was the VX causing it. Did they give you your VL numbers yet? Who knows, maybe you have already cleared it with the VX/SOC you have done so far! It could happen!
Thanks so much for doing the trial, and going through all of this for all of us. All of this must be so stressful for you, hang in there.

All VX participants
You and PDS, Lab rat, APK, mremeet ( hope I got all the trial participants) are all my heros! You are all so courageous to blaze the trail for us all.

[pln]

No, my derm did not tell me to quit, in fact when I told her I had 6 more days of vx left and then more soc, she told me to keep up! It's really going to have to be bad to get me to stop!!! svr here we come.......I am going to get my RX now I will let you know what it is.

[FlGuy]

I think 'Travelmom' is another.  But I don't see her post often.

[Kalio1]

Oh thanks! Sorry I missed her.

Travelmom, you are on my hero list too! And anyone out there who is lurking who is participating in the trials, any trials!
My hat's off to you all.

[pln]

triamcinolone acetonide cream usp. this is my rx, It is 1lb, and I have 6 refills, so now going to do my 12th shot and lather up.

[jmjm530]

That's a mid-strength topical steroid similar to what I was prescribed for my seb derm and rosacea. I would not use it on your face for more than 2 weeks at a time, as you can develop steroid-induced rosacea, especially with an immune suppressed system,. Don't ask me how I know :) I'm very glad planning on showing this to your treatment nurse and staying on treatmemt.

When do you find out if you're on VX-950 or the Placebo? Also, do you know when you will be told your viral load results?

All the best.

-- Jim

[Kalio1]

Oh good! When you said she "cut you off" I thought you meant from the IFN an Riba. Sorry I misunderstood but I am so glad I did!
I know you have put a lot into this. I'd be the same way, they'd have to pry it out of my hands. Hope the rash meds work really fast! Thanks for keeping us informed.

[lab-rat]

mremeet - it sounds like you were unblinded...were you?  How many weeks did you take the vx950 before you stopped? Are you still on treatment(SOC) or did they remove you from the study altogether?  Sorry if you've already answered those questions, I searched for the answers in your previous posts but they were not apparent.

Kalio - thanks for your support!

[mremeet]

No I haven't been discontinued from the trial. I came very close this past week because of how bad things got. But after stopping the VX and the riba and then finally getting the rash under control with the solumedrol, I still took my peg shot on time this weekend. My doctor says as long as I was undetectable before this happened, the peg alone should keep me undetectable for a good while until I can reintroduce the riba, which I plan on restarting today. The riba has a long half life and it should still be in my system along with the peg (which was never interrupted), so he's pretty confident I shouldn't have relapsed during the crisis. The VX was interrupted when I had about 30 days left out of the 12 weeks, so I had roughly two months of it before stopping. I have the option of "reintroducing" the VX in the remaining time once my rash is subsided, but would have to take prednisone to be able to tolerate it. But there is no way I'm taking that chance now, I'm through with the VX and now only hope to get back to good ole' peg and riba and hope to move forward from there. My doctor cleared the plan to continue onwards without the VX with the study coordinator, so that part is not a problem.

As far as unblinding, I haven't been unblinded, technically I'm not supposed to know if I'm receiving VX or not. But, I've figured that part out on my own at this point (using a "variety" of methods), and even my doctor pretty openly acknowledges it's obvious I'm getting it as a consequence of my "special" rash. And since I know I'm receiving it, I automatically know I'm not in the 48wk control group. That leaves the 12wk VX group (about a 11% chance of being in that group), and the 24wk or 48wk VX groups (about a 45% chance of being in either one of those). I do not know which one of those groups I'm in, time will tell. Although with the abbreviated VX dosing, interrupted meds and immunosuppressants I really hope I end up in the 48wk group.

How are you doing? Hopefully things will go well for you, keep us up to date with how things are going with you. Best of luck to you.

[FlGuy]

Let's say that you are in the 24 week group and you relapse. (hope not, but for discussion purposes) Did they make any committment to you in the form a gratis SOC for a fresh 48?

[mremeet]

Nope, you're on your own. Maybe a commutation to 48wks of care due to the special circumstances could be negotiated, but there's no guarantee of that to my knowledge.

[FlGuy]

Commutation...you make peg/riba sound like a prison sentence...

[APKhaos]

Not sure my motivations are all that pure, I'm afraid. The VX trial came along at the right time, and offered some hope of a better chance to resolve to SVR.  There are some risks and uncertainties, but the potential benefits of a shorter TX and a better shot at SVR outweighed the risks for me.

If the VX works, then the prognosis for geno 1 people is significantly improved once the drug achieves FDA approval. FWIW, Vertex are moving forward with a Phase 2 trial for non-responders that is said to be enrolling subjects in early 2007. If the results of the current Prove 1 trial are positive, then this non-responder trial may be a good option.

Without wanting to be critical, there is a strong temptation for trial subjects to draw conclusions based on very few solid facts.

None of us lab rats know what arm of the trial we are in, although the Arm D subjects [12 weeks of VX950 + SOC Peg & Riba] are starting to be unblinded now.  

Personally, I could draw all kinds of conclusions based on the fact that my AST and ALT numbers dropped dramatically and have stayed low since.
ALT 124 -> 35, AST 79 -> 18 in less than 8 days. Both have stayed in the low to mid 20s ever since.

However tempting that might be, the fact is that there is no way of attributing this to VX, or SOC, or some combination of the two without knowing the corresponding VL numbers and whether or not I am actually getting VX. The clinic staff believe that I am, but that's only a little better than MRE's assumptions. We have to wait until the trial is beyond week 20 when the VL numbers and the Arm information is unblinded. Its worth the wait in my book!

The real heros here are those hardy souls that step up to 72 weeks of Tx, or multiple rounds of TX. In fact, anyone who makes it through 49 weeks of SOC TX is a hero! Hopefully, these new drugs will make TX a more certain proposition for Geno 1 people in the future.

[Kalio1]

No matter if your improvement and dramatically lowered enzymes are due to one aspect or another of the trial drugs, the important thing is that you have responded incredibly well! I am so glad you are doing so well.
I totally agree with you that conclusions can't be drawn yet. We can speculate all over the place but still have to wait on the final data.

About a year ago I spoke on the phone with the lead researcher/doctor who is working on another avenue of "cure" that is being developed now with Scynexis. He called me yesterday out of the blue to say they are moving forward and it looks very promising. It is not a PI, it is some type of enzyme action and has something to do with cyclophilin B. I'm still sketchy on the details. He talks really fast and the science is WAY over my head! He is forwarding me the info. and I will share it when it arrives. He did say it was taken for ONE WEEK and eliminated the virus. That alone was impressive! It's good to know more options are out there though I do have my hopes on VX at this point. Unfortunately it isn't a solution for ALL sufferers so even VX has limitations, those who cant tolerate IFN are left with no options even if they can eliminate the Riba.
I hope you are feeling pretty good and not having too many side effects.
Hang in there!

[couldn't think of a nickname]

I am a little confused.
Since 950 never had rash problems previously, but IFN and riba do, why would he assume 950 caused it when they removed both 950 and riba from your dosing?

I am surprised he didn't remove you from riba first, that would have been the logical thing to do.

[Kalio1]

Apparently rashes are a problem with other PI's already in use, I searched PI rash and there is a substantial amount of info. It makes sense the same could be true of VX.
Obviously we won't know what is causing it definitively until the data is in, until then it could be any of the agents IFN, RIBA Or VX950 or the combination of drugs, we can't rule VX out as a cause at this point.

[couldn't think of a nickname]

Erythema multiform is a well-known and documented side effect of IFN.
This describes the conditon.

http://www.umm.edu/altmed/ConsConditions/SkinDisordersErythemacc.html

IFN side effects, erythema listed here.
http://www.hepnet.com/nih/dusheiko.html

There was a picture I came across, but it looked kind of bad, so I didn't want to post it.

[jmjm530]

Well said on all accounts.

Could you share with us what week of the trial you're on, and have you experienced a similar rash as mremeet described, or know others who have?

Related -- if you did experience a similar rash, how severe was it? What did your doctor say? Did they treat it? Is it putting your treatment in jeapordy?

Feel free not to answer as anecdotal data like this so early in a trial can be as misleading as enlightening, but as long as we're starting to get it anyway, thought we might get another take.

From my end, I think it important to point out that even if a rash is a sfx of VX-950, the important thing is how the rash impacts treatment outcome, not in one or two but overall in the trial. Certainly don't have to mention how many people now suffer with side effects from Peg and riba alone. If VX-950 turns out to be an agent that can dramatically shorten treatment time, I'm sure many will choose this hypothetical rash over an additional 24-36 weeks or more of conventional treatment.

Good luck with the trial and please keep us posted.

All the best.

-- Jim

[Kalio1]

You have several months of VX950 already, that could be enough right there to do the trick.

Im glad you are still in the study. I hope you are feeling better from the rash.

[couldn't think of a nickname]

I don't recall rashes being an issue with Schering's, and that's the only other PI being tested for HCV.

If you are reading about HIV PI's, it has no bearing on HCV PI's. In fact, HCV PI's could all have different sides. BILN had a cardio tox problem, that VRTX and SGP have not had. It was not a "class" side, but a drug-dependent side.
I still remain skeptical. The only way to know for sure, is if 950 is tested as a monotherapy for 3 months alone, which it should be for side effect profile purposes, as SOC already has these issues.

I would also note VRTX did not want to test it with riba as they said they felt it would hurt the side effect profile, as riba creates many of its own problems, and they are right.

[mremeet]

"I am a little confused. Since 950 never had rash problems previously, but IFN and riba do, why would he assume 950 caused it when they removed both 950 and riba from your dosing?"

The only experience with VX950 prior to this twelve week trial was the very small (12 people) 4 week trial (and earlier, smaller/shorter duration trials). No rashes were reported from those brief, small participant trials. But obviously this current trial is triple the duration with a much larger test population. Therefore, to state "950 never had rash problems previously" and then to suggest/conclude and extrapolate out of those much shorter, smaller population trials that VX just *can't* be the offender would be be ill advised. Remember, myself and PDS did just fine on all of the drugs for two whole months before this thing reared its head. If we were in the earlier trials we too wouldn't have exhibited any rash.

Also, my experienced and competent doctor did not remove me from the riba, I removed myself (temporarily). As I stated in detail in my previous posts, he did not believe it was being caused by riba based on his extensive 10+ years/1000+ HCV patient experience. I just wanted to stop everything because I was so god awful sick, I didn't even want to take the slightest chance of adding (possible) fuel to the raging fire with the riba. So even though he did not advise stopping it, I did myself for a few days until I got this thing under control. Furthermore, as also previously disclosed, a highly experienced derm with experience identifying and treating "PI rashes" concluded that's just what I had. He had seen it before in HIV patients taking experimental PI's and definitely opined it was the same thing.

Lastly, PDS's rash has developed and progressed on a very similar timetable and in a very similar manner as mine has. Even down to the exact amount of prednisone that was/is required to suppress it. I've discussed it in great detail with her, and our radical rash certainly appears to be the same. Also, we both ARE getting VX, we are not in the placebo group.

It's certainly unscientific to look at a very small sample of people like this and attempt to extrapolate what's happened to myself and a few others into the larger test population. And I'm certainly not going to do that. But considering (1) I only know of just a small handful of people in this trial, and (2) out of that small handful I know of three people for sure who are getting the VX. So far two of those "VX people" have developed a very serious, hardcore, systemic, severely debilitating rash which set in around 2 months into treatment. This rash is "special" and very severe. It is unusual and NOT commonly seen in SOC-ers at all. Out of your average, randomly selected 2 or 3 SOC-ers, how likely is something like that to happen? And happen with such close coupled timing and severity/description? *Very* unlikely, especially when the well informed/experienced doctoring opinions (which were formulated after actually *observing* our rashes) are factored in as described above (who again clearly stated and believe the rash is PI related and is not riba related).

The other known VX participant seems to have developed a less severe rash (so far), which may or may not be the same thing a little later into treatment. The few other study participants I know of either started later (and aren't as far along as we are) and/or they describe their VX pills as either being neutral or sweetish in flavor (which means placebo in my fairly well informed opinion). Out of that group, I haven't heard of any rashes except for travelmom who said she was hit with a riba rash immediately after starting treatment on day 4 and stopped the riba right off (rash went away after that). Another curiosity is that pln had her riba cut in half early on, whereas the rest of us have been on a full riba dose all along. Does this possibly imply the riba is a "rash catalyzer" when dosed with VX in some people? Maybe, who knows. Does this small observed sample of circumstantially observed rashes mean that it's happening all over the country in a significant number of study participants and that means it's the end of VX?? Of course not. But it certainly seems that you are VERY hungry to avoid even considering the possibility that the VX might be playing a role in these rashes. I understand why you desperately wouldn't want to believe it's possible, and neither do I or anyone with HCV (and/or holding stock in VRTX). But speaking for myself, I'm pretty well convinced the VX in some way, shape or form caused/contributed to a bad rash in myself and in at least one other person WHEN being dosed in conjunction with peg and riba for a duration exceeding two months. What does that mean in the grand scheme of things at this point based on what little we all really know about the bulk of the study participants?? Who knows? Although I DO think VX will still be shown to be a workable drug in some way for most people. If I could start all over I would simply take the VX along with the other drugs for two months, and then simply drop the VX and continue with SOC drugs and still derive a dandy benefit out of the VX.

"I am surprised he didn't remove you from riba first, that would have been the logical thing to do."

Would it have been? Maybe you should contact my doctors and let them know of your opinion. Sounds like you have a special insight that goes beyond their expertise.

[jmjm530]

I guess I keep missing your point.

For discussion sake, even if the rash was caused by VX-850, the bottom line to me is will it significantlyh affect drop-out rates and SVR. That hasn't been demonstrated at all to me even with your very small sample group.

Again, don't mean to be insensitive, but many of us have had side effects as bad as you describe for *considerably* longer periods of time and we still continued with treatment because we and our doctors concluded the potential benefits  of treatment outweighed the risks and discomforts. Consider yourself lucky with what appears to be only 4 weeks of severe sides, especially with all your not so subtle hints that you achieved a rapid viral response.

-- Jim

[mremeet]

Thanks for the kind thoughts. Unfortunately, as much as I'd like to believe that 2 months of VX+riba+peg might SVR me, I'd say the odds of that are very remote. Although I did hear about a guy with a low starting VL once that was only on SOC for two months and then discontinued because of sides. Assuming he failed he wandered off and then came back to the doc a year later...only to discover he had SVRed! So sometimes even very unlikely things like that can and do happen.

At this point I'm hoping I'm going to make out ok. My doc says he believes since I was undetectable for a good while before the drug interruption, that as long as I didn't stop the peg I would remain undetectable. Also since I didn't stop the riba for very long, he says it has a very long half-life in your body. So I was never completely without a decent dose of anti-viral coverage the whole time. He also said the prednisone shouldn't have harmed the efficacy of the drugs too bad. And now since I've restarted the riba, hopefully I can cobble it back together and just hope I don't get stuck in the 12 or 24 week group. If I'm in the 48wk group, I'll feel optimistic about having a very good chance of SVR. I just hope we all make it, but in the meantime what an eXaSpErAtInG 'sperience! lol

[couldn't think of a nickname]

MrE,

You are being a little too defensive, I think my questions are quite logical, were not antagonistic, but it seems you have taken it that way.
I have been closely monitoring 950 for far longer than you ever knew about it. And, while it is true that prior trials were shorter, it was first tested in healthy volunteers, and the total number dosed is over 100, not 12.

"But it certainly seems that you are VERY hungry to avoid even considering the possibility that the VX might be playing a role in these rashes. I understand why you desperately wouldn't want to believe it's possible, and neither do I or anyone with HCV (and/or holding stock in VRTX)."

Very unfair, and insulting statement to me.
The scientist in me wants definitive proof before I jump to any conclusions. People have had rashes (jim posted as much below) like that before, cause and effect remain open questions in my humble opinion.
I will re-state what I said earlier. 950 should be dosed alone for 3 months as that is the only way one might ever know for sure if the rash is an issue with 950.

And, it is also scientifically incorrect to compare other PI's to each other, especially those that treat other viral illnesses.


Best of luck to you.

[mremeet]

Jim, Who's arguing with you concerning "even if the rash was caused by VX-850, the bottom line to me is will it significantly affect drop-out rates and SVR. That hasn't been demonstrated at all to me even with your very small sample group"???  Certainly not me. All I'm doing is reporting from the field "real-time" what I'm seeing in myself and other study participants. Which, while we're on the subject, DOES provide at least some precursor relevance to the issue of possible drop out rates and SVR. I mean, obviously if VX did turn out to cause bad rashes in a fair number of folks, it would (a) increase drop out rates, (b) cause dose reductions/interruptions/application of immunosuppressants and as a consequence of all that possibly (c) decrease SVR rates (in addition to even precluding FDA approval in a worst case scenario).

And it's me that doesn't want to be insensitive, but I'll tell you right now that you DID NOT have a rash like mine for 50 whatever weeks. You would have EXPIRED long, LONG before that. Again, your two options would have been to (1) DISCONTINUE or (2) DIE a slow horrible death. I won't presume to know what kind of rash nightmare you went through, and I'll take your word for it that is was very bad. But don't presume to understand the nature of my rash, and then assume you (or anyone else) could "handle it" for over a year. You could not handle it, no human being could - FACT!!

[mremeet]

My only point to you is that I've observed your many posts on VX and its performance and now your "analysis" of my (and others) rash. I think I've reported a fairly reasonable assessment that suggests (but certainly does not prove) that VX might, just MIGHT, be contributing to a rash under certain circumstances. That's all. And from my view, you've persistently and systematically foo fooed the possibility at every turn VX just *might* be an offending agent in any way at every single opportunity. I don't recall reading a single post or comment where you even appeared to consider it even possible that the VX may be a rash inducing agent. If I'm wrong, I apologize, but I don't think I am.

Also, I've become aware that my posts (and others) and experiences are being monitored on certain stock trading websites which are hungrily tracking VRTX and any and all potential newsbreaks. Everyone's trying to get the inside scoop on this trial as soon as possible so they can either pump or dump it. Those who own significant alottments now, certainly wouldn't want any bad rumors to get out (be they true or not). I vaguely recall you making some reference to either owning vertex stock or having some type of interest in it?? I could be totally wrong about that, and if I am I apologize profusely. But if you aren't a stockholder, I'm left wondering why you are so intensely pro VX to the point of sounding like an ultra rationalizing cheerleader at times (from my view). And I know there are at least a few here that have a vested interest in the stock price that goes beyond actually being infected with HCV. So yes, I do think of that when it appears from my vantage that you seem a bit overly concerned with dismissing my admittedly anecdotal observations based on my *actual* experiences with the drug in question.

[Kalio1]

Hope that skin situation continues to improve for you. I had systemic poison oak once and was given similar treatment as you and it subsided but while it was happening it was a nightmare and took over my life dealing with it. It was a lot like what you describe. I too was in the hospital and they gave me the IV stuff and it started to improve right away. The doctor told me that these systemic skin situations, whatever the causal agent can become "very dangerous" if they continue so I think you were very wise to cease the meds until you saw improvement. I know that must have been a VERY hard decision for you. I recall how determined of a participant you were so I bet that was a real bit*h of a decision to have to make. SVR doesn't do us any good if we are 6 feet under.( sorry for the black humor!)but you had to make that choice at the time.
I feel this experience is only a blip in your tx and likely will not have an impact on your SVR. Maybe I am overly optimistic but of those 12 previous VXers all but one remained clear of the virus at week 16 after stopping VX and they only had it for half the time you did.
I wish I had 2 months worth! LOL I'd take what I could get, not the rash though!
You are so brave to hang in there on the trial even after this hellish experience. It doesn't sound like any riba rash I have ever heard or read about or have had myself. Im glad to hear PDS is fairing ok with it now too.
I think you are right on saying the duration of the VX you have done has never been tried before so it makes sense the previous 12 didnt have the rash but this group might have a different experience, they didn't take it as long as you guys. Maybe it's like riba and "builds up" and possibly the mixed reaction with the riba as you suggested is contributing?

I would think the IFN is the key at this point in maintaining your UND status and you didn't miss any of that. I think the missed riba isn't consequential as you missed it for such a short duration, it didn't have time to get out of your system.
Thanks so much for taking the time to share your experience with us all on top of having to go through all of this. I hope it is smooth sailing from here on out.

[jmjm530]

Mrmeet: All I'm doing is reporting from the field "real-time" what I'm seeing in myself and other study participants.
-----------------------
That's fine. But stating in so many words you know more about these rashes than your trial doctor; advising another discussion group member to stop taking VX-950 "Right NOW" without consulting with their trial doctor; and coaching folks in a public forum how to "unblind" themselve by tasting how bitter or how sweet the pill tastes, is IMO misleading and irresponsible. As to your hints of "off-campus" viral load testing, maybe you should either share with us your results, or stop posting publically on that matter if not allowed by the trial. I imagine there's a good reason these trials are blinded.

So your rash was worse than my rash. LOL. Well, fortuantely, neither of us will never know. But I will say this, I'll take four weeks of whatever you might have had over the 40-odd weeks of what I had and many others here.

If interested, this is what I'm talking about in my case. Many others have had it worse, not just with their skin but with many other side effects caused by Peg and Riba.

This is pretty much how chest, face and underarms looked for approx 3 months: http://www.dermnetnz.org/dermatitis/seborrhoeic-dermatitis.html

My back looked like the guy in the middle on and off for 8 months while I did UVB narrow band therapy. My front, maybe 40% of the coverage. Arms, legs and buttocks maybe 20%
http://www.dermnetnz.org/scaly/guttate-psoriasis.html

My feet were worse than depicted. Hands about 40% of what is shown. Looked like this for at least six months.  As you can tell, walking itself was difficult at times.
http://www.dermnetnz.org/scaly/palmoplantar-pustulosis.html

I know I'm coming off a bit harsh, and this is not directed at you personally, but I really think the Vertex trial is too important for people to be basing either current tx decisions or possibly future enrollment on what are you suppositions. Remember, everything you write in this forum will be able to be "googled" by anyone researching the Vertex trials for a very long time.

Be well, and good luck in staying undectible as you apparently are.

-- Jim

[couldn't think of a nickname]

I am pro vx because I want a cure and in 6 years of following this area, this has been the best in the clinic right now.

Why don't you criticize me for when I have "cheerleaded" Albuferon, or ITMN? Or when I USED to be favorable to Viramadine?
Don't own any of those stocks, never did. Selective memory.

I guess you don't recall when I said that chemically, ITMN looks superior, but needs trials to prove it.
Or, when I said that the next gen of drugs will be even better, and VRTX is working on one of those also. ITMN is a next gen drug that will be the first one into the clinic. But, I guess by stating that fact I am cheerleading them. Well, it worked, they went up 5 points without me today.

But, seeing how things are taken, I won't be so quick to share my opinions or insights in the future.

[Kalio1]

I just wanted to add that never once, on this forum or anywhere in my reading have I heard of a patient having to have IV administered treatments for a riba rash. That is telling as to the severity of what you experienced.

Did you have other symptoms that went along with the rash issue? Did it cause vomiting or fevers or other symptoms? Was it itchy? Painful at the sites? Did it bleed or change as time went on? I have saved your previous posts on this but Im not sure if you had additional symptoms as a result of the rash.

[mremeet]

Thanks again kalio for the kind words of encouragement, it means alot. And yes this rash thing really has been one of the great trials of my life. Sounds funny saying that, just a rash rising to that level. But jesus crimminy, I just can't truly describe the whole experience with any justice. I used to get bad poison ivy and oak as a kid. Horribly rashed over, puffed up eyes, blisters between my fingers (strangely enough don't get it anymore as an adult). And then I had scarlet fever when I was in 7th grade and I remember most of my skin sluffed off while taking these oatmeal baths. Both situations were bad and very itchy. But by god they were a walk in the park compared to this sh1T! And the scarey thing is, I spoke with the derm today and he said it is definitely possible it could still resurge very badly as I'm tapering down on the pred. I still have to cross that bridge, so we'll see what happens. So in the meantime it still has the fear of god in me until I get past it. If you suddenly stop seeing me post, send flowers to my funeral! lol

Oh, and you ask of other symptoms. Hmm, not sure about that. I never checked if I had a fever, but people in the same room with me said it was hot and I thought it was cold. I probably had a mild fever if I had to guess. Definitely had bad hand tremors and coordination/stumbling problems as it became more advanced. Other than that the main symptom other than severe itching/discomfort was a gradually increasing malaise and mental confusion as the days/weeks went on. By the time I finally went to the ER, I really was very weak, fading in and out, intermittently babbling and then speaking semi-coherently (according to my gf). My eyes were constantly watering alot too, my whole face crusted over with this scaley awful callous like welty rash. And in the ears too, ARGGHH!!!

Alright, enough whining. Thanks again for the kind words, here's to an SVR for all of us.

[APKhaos]

Sorry I missed your questions earlier!

I'm in week 13 of the trial. Completed VX dosing this past weekend. I have what looks more like the more common riba rash - small raised dots across chest, arms and upper back, plus a generalized itch that would make a terrific form of torture. No cause for concern, and not treating it  specifically at present. Nothing like what you and others have described recently.

There are ten subjects in my group. Only one has dropped out so far, and that was due to extreme and unmanageable psych sides. None have serious rash issues.

I have no visibility on the other 190 subjects in the trial, but I share your concern about trial subjects suggesting ill-advised sneak methods to get around the study blinding, out-of-study testing and the like. These studies are hard enough to control without having the subjects deluded by flawed assumptions. At the end of the day, the real worth of VX and other HCV drugs in clinical trial relies on sound study protocol, and subjects that are not determined to break the blinding, delusional or not.

[jmjm530]

Thanks for putting things in as much perspective -- at least as much perspective as can be gotten at this early point in treatment.

Out of your ten study buddies, none had serious rash issues and only one dropped out due to psych issues. Hopefully, mremeet will include your anecdotal experience the next time he posts his. I certainly will. All the best with treatment.

-- Jim

[couldn't think of a nickname]

Thanks for the perspective. I have said many times, and still intend, that when the time comes, I will not take riba. It seems like everyone gets pretty nasty sides from it, and with thalassemia, I won't even risk it.
I don't want IFN either, but am hopeful that Albuferon will be out in a couple of years. It seems to be better tolerated than Peg IFN.

[cuteus]

that certainly sounded like more than a skin issue/condition.  when it becomes systemic as yours seem to have done, the problem is more than skin deep and the fact that it needed a strong oral steroid and IV meds to control it, confirms how systemic it was!  god knows how long it would have continued if you went on with the tx.  As it stands, it does not seem to be completely over yet.  I never heard of anyone reacting   like that with SOC.  Your case might be one of extreme sensitivity to the combination of meds and I wonder what percentage that would make as applied to the general population?
feel better soon

[lab-rat]

I'm glad you're still treating and I hope that you've taken enough of the vx to make a difference and that you'll achieve SVR.  I'm so sorry for the misery you've been going through.

I believe you about the vx950 being a player.  I did find some information that implicates the combination of Peg + VX950 from a 14 day study.  Here's the link: http://www.natap.org/2006/EASL/EASL_12.htm.

Towards the bottom of the page there is a table that lists side effects and the combination of drugs that appeared to cause them - FYI.

I appreciate you posting all of your information concerning the sides you've been enduring.  As you know I've always suspeceted I was getting a placebo, and it's only natural that we would try to unblind ourselves.  I'm not going to be stupid enough to use my vx-pills as dog treats...I'm happy to be treating and will continue to comply with the protocol.  I'm doing well (thanks for asking!).  I haven't had many sides to speak of and so far its been pretty easy.  I'm going on week 7 and my labs look great, (my ALT went down to 30 4 days after it spiked to 91 and it's remained)...I just hope this brain damage isn't permanent!  I've learned to keep a low profile at work, (e.g. don't open my mouth in meetings because I never know what senseless dribble might come out - LOL).  So far I feel very fortunate.  Even if I'm in the control group, I'm getting free drugs and lots of tlc. Frankly, I won't miss the 2 hour drive each way to the study site before work in the morning...in the control group those visits subside to about 3 or 4 after the initial 12 weeks.  Thanks again for keeping us informed, and I wish you the best of luck!

[couldn't think of a nickname]

One must keep in mind, that the rash shown in the table, might not be the one Mre got. If you read the table, it shows a higher rate with those that got IFN. IFN is known to cause rashes too, so it is not known if the rash was caused by the combo, or just the IFN. The logical assumption would be the IFN, since it is known to cause autoimmune issues and skin issues. There were no SAE's there.
This is what I am talking about when it comes to data. You can't just read numbers, there is more to it.

[lab-rat]

You're absolutely right.  This was a short and small study, I just thought I would share it.  It goes on to mention that the rash resolved itself on its own.  Nobody knows for certain what's causing what - especially with 3 drugs in the mix!  There may be an allergic response involved as well.

[couldn't think of a nickname]

In other things I have been reading, I think that bad skin problems were also seen in those that had viruses from the Herpes family (there are a lot of them), and even things like Epstein Barr. I don't know if that would have an affect here either, but each person has their own "microbial issues" (can't think of another term). I also tend to have skin issues (minor), allergies, etc., and they are all examples of autoimmune manifestations. So, I am concerned about taking interferon. But, hopefully Albuferon is out by then, as from what I have seen, it seems better tolerated. Won't take away all of the IFN issues though, for that I have no doubt.

[pln]

There are 7 people in my study only one had to droped out, due to the fact she could not handle the meds no rash. You guys will not see me for awhile because I have come up with this great idea. I have 1 week of vx-950 leftit is the back up box they give us and I am going to put it on ebay, I should make enough to go to balize, of course in the small print I will write (could be placebo). (jk). Pam

[APKhaos]

I can see it now: "The dog ate my backup!" ROTFL!

[jmjm530]

PLN,

Hope this gets to you prior to your Balize trip :) If you know the answer how many of your other seven study participants had a severe rash?

Lab,

Same question if you happen to know.

All the best to both of you in the trial and please keep us updated after things get unblinded, etc.

Be well,

Jim

[pln]

Hi, just doing some lite packing,7 in my study, I do know for a fact one lady had to drop out, no rash involed, thats down to 6, I talk every day to one lady in my study she is doing o.k she has dirrahe (sp) big time she told me no rash. I have 4 more days of vx, I ended my ebay auction at midnight sunday, I will let you know what happens. Pam

[mremeet]

cuteus - Thanks for the kind words. Thankfully it does seem my experience (and PDS') appears to be in the definite minority. I hope, and even suspect, my particular rash problem will be unlikely to affect most others who take VX.

labrat- Thanks for the link, I had read that previously. It's great to hear you're coming along so well. And I know what you mean about keeping your mouth shut at work and in other situations lol. These drugs are a real mind trip, especially when you add prednisone into the mix...what a cocktail. Continued success in your treatment, I'm sure you'll do great.

jim - I respect your opinion here, and greatly value your extensive experience. I have no desire to be on bad terms with you. And you were absolutely correct in calling me out for advising pln to stop the VX. That was a stupid thing for me to do, normally I'd know better than to do something like that, but frankly I'm just not myself lately. Otherwise, I think you've misinterpreted much of what I've said here concerning the rash and have then "reinterpreted" what I've said back to others implying intentions/sentiments I don't have. But that's ok, I have no desire to pursue/debate the issue any further. I think you're a good guy, things just got a little heated I suppose. No hard feelings on my side, hopefully on yours either.

APK - I'd like to apologize to you as well. I shouldn't have told you about the bitter/sweet pill theory. I knew better than to do so, but when the issue of the rash being evident or not was being debated, obviously having knowledge of being on VX or not is important to know. I then felt compelled to reveal my bitter/sweet theory for that reason. But my theory could very well be wrong, as you seem to believe anyway. So hopefully there's no harm done in you hearing my silly theory. I certainly don't want to diminish or undermine your hopes in getting the VX, and I'm really sorry if I may have done that in any way. Also, your LFTs dropping that dramatically and fast IS an outstanding indicator, regardless of what you're on. So congrats on that achievement. And you might even be interested to know that my LFT's actually went ABOVE my pretreatment baseline values and have remained somewhat elevated throughout treatment so far. So that right there should also help cast significant doubt about my "bittersweet" pill theory. Regardless, best of luck in your treatment progress, sounds like you're well on your way.

CTOAN - Once again I'd like to apologize for some rude comments to you. I do think you are overly reluctant to admit the mere possibility that the VX (or any research drug really) could cause or contribute to a rash in some people. But that doesn't really matter, you're entitled to your opinion and owe no explanations to me. I guess I just overpersonalized it a bit because at times in my view you appeared to be outright dismissing my experiences/accounts. Plus I'm physically and emotionally in place right now I've never ever been, which has been clouding my judgment. I know you have HCV just like I do and most everyone else here. You just want this stuff to work, and in all likelihood it will for most people. Who knows, maybe even for me too. Anyway, hopefully there are no hard feelings. Oh yeah one more thing. Part of the reason I snapped at you, is because I actually went to a few of those stock monitoring sites and there was a super advocate "buy now!" guy there that I was somewhat suspicious might have been you based on the nature of his/her posts. I don't think it was you, and I'm certainly not accusing you of being that person. But I should admit that possibility did cross my mind and contributed to my unfounded and unfair insinuation. So I'm sorry for that, hopefully you can cut me some slack there (unless you ARE that guy! lol). In the meantime, good luck with your continued research. And I think you're a pretty wise dude to go out of your way to avoid riba btw!

[FlGuy]

Undoubtedly, one of the best threads I've ever read here - has it all.  Thanks.

[lab-rat]

Thanks for your well-wishes!  I'm only in my 6th week of dosing and I did get that 'sunburned chest' that pln mentioned which began in the beginning (about 4-5 weeks ago - not sure exactly).  I believe that it really was caused by photo-sensitivity due to the meds...I was hanging out by the pool and even though I was using spf 50, it didn't seem to work very well. It's still red and ugly (but it doesn't itch very much) and it didn't show up anywhere else on my body, so who knows?  During my last visit, the PA from my study asked specifically if I had experienced any rash, so I showed her my 'sunburned chest'.  They weren't sure what it was but it did NOT appear to be the rash caused by riba that they typically see.  I asked her if there were others in the study experiencing rash issues and she said no. There are 7 subjects at my study site. I know that during my first week of dosing, the study nurse mentioned that others had shown "skin sensitivity".

So there's my anecdotal evidence to add to the heap!

[couldn't think of a nickname]

thank you so much, that was very nice of you. I also understand you don't feel well at all, and I did think of that.
No, I am not that guy you refer to, and one way to prove it, is that some in here have asked me about owning the stock, and I have shunned advice on that. The posts are probably buried so I couldn't find them, but whoever asked me would likely remember.
I don't think that type of advice should ever be given to a stranger on an interet board, because not everyone has the same style. And that goes not only for in here, but on those finance boards also. Sometimes there is decent info out there, but I am skeptical of most things I read. Just my nature.

Even if a stock is right for me to own, no matter what it is, you will never hear me say others should own it too.

There are no hard feelings, and I do hope you feel better real soon.

[APKhaos]

No harm, no foul. It hard not to get wrapped around the axle with so many unknowns, and ever harder when you are suffering as much as you obviously are [were?].

This whole deal is a little like the mid-term elections. Everyone will know the outcome in November, but with less than a month to go there is no shortage of pundits [both with and without a vested interest] who are fanatically promoting their version of what will happen and why. Just human nature, I guess.

Truly hope you get that rash under control, and maybe even get back onto VX dosing. The sugar pill seems to work too :-)

[cuteus]

you didn't really auction it on ebay, did you?  I thought you have to account for all meds in a trial and any unused or damaged meds are to be returned and accounted for. Is that why you are packing?  you think they will be knocking at your door soon?
they are coming to take you away.... hehe, haha...to the funny farm...
bon voyage!

[jmjm530]

Mre,

These things happen and being on the treatment drugs certainly doesn't help. That I know.

Yes, the coversation was heated, but never personal, always to the topic, and that's good in my book. I also understand that your advice to PLN came from your heart.

Hopefully, based our little subsequent poll, the rash problem is not very widespread but still to early for predictions. That said, common or not, you did have a terrible skin reaction to something, and I hope things clear up when you get off the Prednisone. If not, I'd be happy to share with you some tips for being more comfortable.

As to you concerns re SVR. I doubt very much the Prednisone will hurt your chances as others have taken it on combo tx. And while I certainly have nothing scientific to back this up -- I also doubt very much your little riba vacation will hurt your chances either. First, because it appears you may have achieved RVR anyway, and second., because VX-950 may not even need riba, otherwise they wouldn't be trialing it in Europe without riba in some arms.  

Please keep us updated on the trial, it's a valuable service you, PLN, LabRat and others are providing those of us waiting on the sidelines.

Lab,

Yeah, you really gotta stay out of the sun. I developed what looked like the "Mother Patch" on my chest early-on in tx, but much later my whole chest became inflamed and I think it was due to the UVB-Narrow band light tratments for my psoriais. Treatment skin in most cases just does not like the sun. Glad it finally resloved.