Member Comments are provided by individuals and reflect their personal opinions only. Under NO circumstances should you act on any advice or opinion posted in this forum. ALWAYS check with your personal physician before taking any action regarding your health! MedHelp International and our partners, sponsors and affiliates have no obligation to monitor any comments posted on this site, or the content and/or accuracy of such exchanges. MedHelp International does not endorse the views of any user.
Hi everyone, just wanted to give you all an update
by prettydamscared, Oct 19, 2006 12:00AM
Hello, I hope everyone is doing well. FLguy you started, huh - the 13th? You got all your ducks in a row before starting treatment but the big questions is, did you get your painting done?
My hubby does his last shot Sat. night. I can barely believe it - it seems to have flown by....course not from his perspective. All in all, he's lost some weight, some hair, definitely some time from work but, overall, he did well with the treatment. Got some "riba-rash" of course, I think the standard old dry skin kind. Never developed "riba rage", mood swings, depression and his reaction from shots were like clockwork. He did them Sat pm and was exhausted and sick on Sunday, a little better on Monday and by Tuesday, he was feeling better. He was undedected at week 4 and hasn't had any viral breakthrough since last test in Sept. He is a 2b with stage 1 liver damage. He's been on Procrit since approx. the third month of tx.
Now, for me. As of yesterday, my study doctor officially took me off of the vertex-950/placebo. I made it to day 68 out of 85. I gave it my very best shot but the rash made it impossible for me to continue.
Just a brief update, you guys may remember, I came down with the "CONFLUENT" rash over 90% of my body, yada, yada... about 2 months ago. I hobbled along with it, trying Gold Bond, oatmeal baths, etc. for a few weeks. By the time, I actually went to my derm, she called my study nurse and said I had to completely stop all meds....that I was having an extreme allergic reaction, that the rash had spread (was confluent) over 90% of my body.
My hubby does his last shot Sat. night. I can barely believe it - it seems to have flown by....course not from his perspective. All in all, he's lost some weight, some hair, definitely some time from work but, overall, he did well with the treatment. Got some "riba-rash" of course, I think the standard old dry skin kind. Never developed "riba rage", mood swings, depression and his reaction from shots were like clockwork. He did them Sat pm and was exhausted and sick on Sunday, a little better on Monday and by Tuesday, he was feeling better. He was undedected at week 4 and hasn't had any viral breakthrough since last test in Sept. He is a 2b with stage 1 liver damage. He's been on Procrit since approx. the third month of tx.
Now, for me. As of yesterday, my study doctor officially took me off of the vertex-950/placebo. I made it to day 68 out of 85. I gave it my very best shot but the rash made it impossible for me to continue.
Just a brief update, you guys may remember, I came down with the "CONFLUENT" rash over 90% of my body, yada, yada... about 2 months ago. I hobbled along with it, trying Gold Bond, oatmeal baths, etc. for a few weeks. By the time, I actually went to my derm, she called my study nurse and said I had to completely stop all meds....that I was having an extreme allergic reaction, that the rash had spread (was confluent) over 90% of my body.
Related discussions
-
skin question (53 replies):Hello,I am going to the dermatologist today, I have a ra...[more]
-
Lab report (17 replies):Male, age 42 Ht. 5'11" - Wt. 175 Professional occupation...[more]
-
VX Rash Victims - speak up please (12 replies):There have been posts here by people with the VX950 rash...[more]
-
Vertex Prove2 UK trial, rash strikes in week 2 (20 replies):Hello Everyone. This is my first post to this forum. I...[more]
-
Echoing mremeet's post of 10/3 regarding rash (18 replies):Hi mremeet and all, Just wanted to throw my $.2 in alth...[more]
-
Vertex study (23 replies):I was told to stop after week 12 probably had the placeb...[more]
-
Interesting Vertex Shareholders Article (23 replies):Mike Simon posted this below with some other HCV links, ...[more]
-
Nasty rash after day 5 (16 replies):My body is red arms, torso, back and legs, feels like a ...[more]
-
Prove 3..Taking myself off the treatment (12 replies):I had to change my name due to Forum changes. I have bee...[more]
-
Vertex VX950 good news (50 replies):Why can I never find the button to make my links live? ...[more]
Post Comment
Related Communities
Recent Videos
Related Expert Forums
Recent Activity
Most Popular Trackers
RSS
Expert Activity
Community Members
Popular Groups
Can you treat again later with regular Interferon/Riba or Infergen/Riba instead?
See the 10/16 thread 'Skin Part 2' - a great thread about the rash of rashes the vx crash test dummies have experienced.
I was thinking the other day, during rash topics, about how fortunate you were and how it was that Mr. PDS who was slogging through combo tx. What a difference a couple of months make! Glad to hear he's almost done and still standing, if wobbly. The two of you together must have been a sad sight
So, all meds discontinued - even soc? What's next? Since you're communicating you must be feeling better. Hope it continues.
I wish you and your hubby the very best. And SVR to you both.
Take care
Nicki
Did they determine which caused your allergic reaction?
I read it as the other 2 as well. If you are taking 3, and having an allergic reaction, you wouldn't know which one necessarily, especially if you never treated before. I guess I just answered my own question above as well.
Again, I wish they had put in a 3 month monotherapy control arm in these. Otherwise, it is too easy to speculate. I guess fairly speaking, there is a 33% chance it is any of those 3.
Being in the control group means you did receive the Peg/Riba right? So in other words, you simply under went standard treatment, but received a placebo instead of the actual VX950, correct?
Hopefully your reaction was to the placebo so that you can try Std tx in the event you can't wait for new meds to hit market.
Here's the rub. When I got to the taper portion that calls for 10 mg of prednisone (that's the very end of the prescription) the "dreaded rash" came back. That was on Saturday evening around 8:00 pm. It came back suddenly and with a vengeance.
Briefly, here's how it works. I took 40 mg for 5 days, 30 mgs for 5 days, 20 mgs for 5 days and lastly 10 mgs. for 5 days. The prednisone seemed to be able to keep rash under control until I got down to 10 mgs. Please understand I'm calling this a rash for lack of a better word. It's not really a rash. It's bumps that eventually run together on your body so that you have basically one huge, red, burning, itching, bleeding lump on your body from head to toe. Ohhhhh, and then it goes inside those cavities. I wouldn't wish it on my worse enemy but it's gone now.
Anyway, back to my story. I immediately came off of the riba and vertex. By Monday, after discontuining those 2 drugs, rash was gone again. Tuesday, I started back taking 1000 mgs of riba and, so far, have had no problems. As I said in the beginning, my study doctor does not think this is related to peg or riba. He has unblinded me so he knows that I am receiving vertex as opposed to placebo. In this situation, it did become necessary to get special permission from the monitor even before the completion of the study to have me unblinded, but I still don't know which group I'm in, just that I'm receiving vertex.
pln told me yesterday that there's a whole lot of discussion below about rash, vertex, etc. I haven't read any of that recently, will try to do so today. I am simply relaying my personal experience. No conclusions being drawn about the efficacy, safety, or how prominent this rash is in folks taking vertex. What is a fact is that it does exist. Both mremeet and myself have experienced the same rash. We are in the same study and obviously have the same doctor. I think there are 8 people in our study. We have both relayed to him that it's ok to discuss with the other our medical conditions so we basically talk rather freely about the "rash". I think it may have been helpful to our study doc to have two people in his study with the same experience, i.e., for all of you out there who may say "how do you know you have the same rash". Bascially, symptoms identical, and doc took us both off the vertex and told us in his opinion, it was unrelated to the other drugs that we're taking. Additionally, mremeet met with a derm in our study center who told him it was a pro-tease inhibitor rash.
They'll definitely figure it out, either we're taking massive dosages, taking vertex for too long, or some such problem. Perhaps it's somehow a combination of the vertex with the other drugs but I have no doubt that they'll come up with something to countermand the effect of this "rash". So, for anyone anxiously awaiting the release of a P.I. my money is betting on the fact that they'll get this figured out. Too much at stake not to, right?
I'm gonna go lie down and come back later. I have some questions to ask you guys.
Char
Great to hear that your husband made it to the finish line with such positive labs. Must give you both a terrific sense of it all having been worthwhile. Won't be long before the residual drugs are oout of his system, by which time his new-found bright eyed and bushy tailed energy might be chasing you around the table like old times :-)
You have certainly had a rough ride with that mega rash. I know your were trying to make the last week of VX-950 dosing, but your dermo made a gutsy call. Hopefully, the rash will begin to resolve quickly. Please keep up posted on that.
Like others, I'm not clear on whether you stopped all TX meds, or only the VX950. If it was just the 950, then you probably have the benefit of the full dosing schedule. The study design allows a +/- two day window on completing the VX dosing, so given it was your last week, you only lost a couple of days. Hopefully, you got 99% of the benefit. Please let us know if you are staying in the trial and continuing SOC.
There are a bunch of people here rooting for you, grrl!
If it doesn't come back, it could be the 950. If it does, then it could be riba. That could still be possible since the riba was only reintroduced a couple of days ago. Just trying to look at all possibilities.
My initial thought was, that if an immunosuppressant was helping the rash, the IFN is what really ramps up the immune system, but maybe not.
My second post is sort of a continuation of my saga so it helps clear up some of those questions.
I think you have me mixed up with pln. I did NOT make it through to the last week. I made it through day 68 and part of 69 and then study doc took me off of vertex ONLY. I'm still on soc.
Char
For example, yesterday my stomach felt like ****. I told my wife that if I were on treatment, the way it felt, I would have blamed it on treatment. But I am not treating.
Those results aren't that easy to find, but I imagine they must be published somewhere. It is assumed they are successful when the start the next part based on them.
I have read in the past, that when tested at higher doses, (healthy volunteers I think) it was still well-tolerated. I don't know how long that was done, but it had to be no less than 14 days I would imagine.
Bottom line, study doc took me off VERTEX 950 ONLY because after careful observation and determining that I am receiving the vertex, he determined that was the offending agent.
I am still on treatment and only had to be off of riba for a few days. After vertex got out of my system, (24 hours), my symptoms abated. Other than feeling like the normal dog pooh, rash is GONE.
It took about a month and a half for rash to show up. Later, I'll check that to tell you exactly. I can tell by when I wrote a check to derm's office and I know it was about 3 weeks prior to that.
Back to 950, that's why dosing is so high (excreted quickly), and that's why the next gen of drugs will be better. That's also why they have experimented with boosting it with Ritonavir, as it could cut down dosing to once or twice per day.
It has been said that protease inhibitors for HCV do re-enable the immune system that the virus suppressed, but that would happen quickly.
On another note, the skin is the largest organ in the body. It is said that when you detox, the skin is one of the first places you'll see it (besides feeling crummy). I have experienced that when I have used apple cider vinegar at first, or other herbs. In THOSE cases though, they say it is a good thing as your body is getting rid of toxins. I would not draw that parallel to your situation though. It is just a comment on skin and detoxing.
So very sorry things turned out so badly. Like the others, I'm a little unclear how much Peg and Riba you missed and if you're continuing with them and for how long. I do hope you are able to get back on at least Peg and Riba and finish the course of treatment.
Yes, we had quite a discussion in the thread "Skin 2" below on the VX trial and skin issues. I'll try and summarize as best I can but the thread and comments contained speak for themself.
In summary, it appears from what has been reported anecdotally so far, that other than your situation, we had one member (MreMeet) who stopped VX-950 4 weeks early due to rash/reaction, and 26 other participants who either had no rash, or nothing considered severe, and therefore no stoppages. I'm only guessing, but I would imagine that the same reaction/drop out rate might be found in a similar population of those taking only Peg and Riba.
Of course, this doesn't minimimize what happened to you or MreMeet, but does suggest that no one should jump to any conclusions regarding serious skin problems and VX-950 at this point, in fact if any conclusion would be drawn it would be the opposite. Soon enough, all the data will be made available and we will have all the facts, including SVR data which should start streaming in as soon as six months from now.
-- Jim
The reason they worry about the rash returning, regardless of the offending agent, is that the prednisone suppresses it and sends it to the nerve endings, as you taper off the prednisone, you can have what is known as a "rebound reaction" as the steroids are reduced and the rash comes roaring back because it isn't really "gone" the prednisone is just suppressing it. They then restart the prednisone and try to re taper again and hopefully it will have resolved or burntout by then. That is why mremmeet was strongly warning others to watch out for it getting worse or returning.
I had a "confluent" allergic reaction rash from a different offending agent that sounds a lot like the horror they are experiencing ( which can be very dangerous health wise, this is no "rash" situation these guys are dealing with, it is a systemic issue with 90% of their bodies involved!)when I tapered off the prednisone as instructed it came roaring back with a vengence, they restarted prednisone, ran it for a longer course, tapered it again and that time it worked. I realize the offending agents are different but the treatment sounds exactly the same.
You are so completely unwilling to look at the reality of this situation and admit that Vertex is likely the offending agent, verified by their study doctors and study dermatologists no less that it makes you look like you can't accept the obvious and you will convolute any scenario to try to defend your position that it is riba. There is nothing I hve ever seen showing riba causing this tpe of reaction.
Like PDS said so well, It doesn't spell the end for VX at all, it is a problem that has to be worked out.
I challenge you to show ONE case of riba rash or SOC related skin situation that even approaches this type of situation and post it here. You are so convinced it must be the riba because you personally are afraid of Riba that you are blind to what seems obvious to many of us.
These kind folks come here to give us info on VX that we all are dying to hear, your constant fingers in your ears position isn't very helpful. They are giving us the FACTS, not debating points. They are going thru hell and still find the time to share with us so let's try not to keep telling them they are wrong, they don't have to justify anything they are just reporting the facts as they are happening to them.
It is becoming more and more obvious that VX is the culprit in both of these cases. I think it is also pretty clear that the DURATION or DOSAGE of VX is at issue particularly since the 28 day group did not see this problem. We will see if in time this reash develops in other participants that started their trial later on.
Denying the problem does not help towards a solution.
Accepting it, analysing it and making a plan to try to solve the problem is more productive.
But if it does come back, and there is no 950, why would it be 950?
She is off prednisone. There is no rash since she stopped both riba and 950. She just recently restarted riba.
I ACKNOWLEDGED IN AN ABOVE POST IT COULD BE 950! CAN YOU READ, OR ARE YOU INTENT ON JUST ATTACKING ME?
I am sick and tired of your attacks, your criticism, and your attitude towards me.
As to your statement that we've never seen such severe reactions before with ribavirin, I disagree. I've read of people dropping out over at J&F's both because of riba (and I believe Peg as well) because of a severe drug reaction.
This is not to say that VX-950 wasn't the culprit in either Mre's or Pretty's case. It appears it may, but certainly nothing conclusive. But even it it was, why hold VX-950 up to a more severe standard than Peg and Riba? It seems that our little anecdotal study group is doing pretty good statistically in that regard. Let's wait unitl we HAVE ALL THE FACTS before jumping to conclusions and suggesting what has or has not to be done.
-- Jim
I would appreciate it if you would not put words in my mouth, as you are so good at.
Stop speaking for me.
--------------------------------------------
This is by no means the only instance of people being pulled off treatment from riba, but you asked for one and I have other stuff to do today to look for more:
From J&F:
"2nd week in TX-I developed" Hot Burning Needle " sinsations on my Chest,Thighs,Back and Inner Arms. It would intensify to being unbearable,when i came in contact with WATER. I never actually itched,no red marks etc. Just a very Hot pin pricks that would move around my Body. After a shower it was so bad. I had to put ice packs 5 and 6 at a time all over my body.If I sweat they appeared again. Nothing topical worked: Aveeno soaps and Cremes,Cetahil soap and cremes, Benedryl,Atarax, Doxepin. I've been showering only twice aweek and it is Horrible, Waterless soaps don't work either.The Allergist says I'm Allergic to the Ribavirin,My Doc says the same thing. I took my first Blood work after Tx 5. The Doc says stop Ribavirin Immediately for 5 or 6 days so he can look at the Blood work...What happens from there I don't know..."
http://forums.delphiforums.com/friendship7/messages/?msg=22134.1
I think the start order was APK (mid July), PLN (late July), PDS (early Aug), Mr E (early-mid Aug), You (early Sept) - not sure about Travel Mom. I think you said you already had that 'sunburn' thing and that when you started the nurse has mentioned 'skin sesnitivity' which was before PDS and Mr E 'erupted'. So, it sounds like 'skin stuff' may not be real rare in the participants. Reading how devastating the situations became for Mr. E and PDS - be aware to changing conditions and responsive early.
If you find one, please post it.
neck to ankles rash above from riba.
http://ndt.oxfordjournals.org/cgi/reprint/14/6/1558
read page 2.
http://www.personalmd.com/drgdb/1279.htm
severe rash occurs due to allergic reaction in the above.
Ooops, you CHALLENGED me to find 1. It took me 3 minutes to find those.
You asked NiceGuy not to be "the boy who cried wolf" in another thread. I think you're doing the same thing with a lot more potential harm. Why don't we wait until we have ALL THE FACTS AND DATA before jumping to conclusions about a promising drug in early trial.
I did not attack YOU, I spoke to your constant avoidance of admitting that VX950 could be the offending agent causing this situation for them both. Now if their rash comes back I suppose you will then claim that it isn't VX950 without considering that the prednisone can cause rebound reactions when it is tapered and the original offending agent would in FACT still be the cause.
Are you going to threaten to leave the forum yet AGAIN?
------------------------
LOL. Thanks for the gift. You're basing your statments on two anecdotal accounts from members here, yet you want a "documented" case????? Actually, there are documented cases of allergic reactions to riba. Where is your "documented" case of a similar reaction to VX-950. J&F's posters have the same credibility as those here do IMO.
Anyway, DOCUMENTED case:
http://tinyurl.com/ynd9zx
-- Jim
"and 26 other participants who either had no rash, or nothing considered severe, and therefore no stoppages"
how in the world could you possibly know this?
Be well,
-- Jim
We have four members in here on Vertex that I know of who post in here and THREE now have had the sunburn rash problem on the vertex. It certainly ISNT the Riba, as PDS even had to stop temporarily to make sure.
One other didn't but may be on placebo (face it somebody has to be).
This rash is NOT the riba rash that we complain of at all - it sounds like a brand new rash that I'm VERY glad I did not get (and as you know I had BAD BAD riba rash in the beginning)
Jim, Why do you simply refuse to believe that it might be the Vertex? Quite honestly you seem lately to want to just refute what other people are saying for the sake of it or something. Nobody knows anything for SURE which is the reason for trials but...it certainly SEEMS as it is the vertex so why not just say so?
You've NOT been on vertex and have NO IDEA what this MIGHT be but the people who have it and the doctors who are treating it SAY that it is the VERTEX causing it.
What is the big giant mystery that is here?
And PS Telling niceguy (if he is a real and legit person) that hs it he boy who cried wolf is the NICE and RIGHT thing to do. If he continues to believe every single thing that happens is a bad bad reaction to the meds.....than when something REAL happens NOBODY WILL LISTEN TO HIM. As an adult of whatever nationality or language - people DO understand basic basic things like that and not to over react and be so damn dramatic all the time.
She did him a FAVOR putting it out like that.
Boy I wish I didn't read this thread but - please OTHER people have opinions and it does NOT make them incorrect just because you always disagree.
I've wanted to ask you that question there for MONTHS and only just realized I still hadn't! :)
You are quick to blame SOC for your problems, even sleeping 10 hours a night ( which doesn't seem to even count as a problem to me)but when presented with what seems an obvious, documented connection to VX verified by the study doctors no less, you can't see that their trial doctors taking them off of VX and leaving them on SOC indicates it is the VX?
okie dokie
how in the world could you possibly know this?
--------------
Please read my first post in this thread and then the "Skin 2" thread below. As stated, I am basing my statment on anecdotal accounts given by member here, as you are basing your statments on anecdotal accounts given by members here. There is anecdotal evidence that two member had a severe skin reaction to the trial drugs, and anecdotal evidence that 26 other people didn't have a severe reaction. Again, please read my first post, ane d then PLNs, APK's, and Lab Rat's posts in the "Skin 2 thread".
NY: Jim, Why do you simply refuse to believe that it might be the Vertex? Quite honestly you seem lately to want to just refute what other people are saying for the sake of it or something.
------------
Obviously, you haven't read my posts either in this thread or in the "Skin 2 thread". I AM giving the benefit of the doubt that VX may indeed be the offender. That was not my argument and that was not my point. Please read the entire threads before mischaracterizing my position. The fact that I don't agree with Kalio's take on this, or your take on a number of issues, doesn't mean I'm refuting things "for the sake of it". Please give me one example and I'll be glad to give you the reason why I beleive or don't believe in a position I've taken.
Nothing mystical or magical about it.
It's a reasonable conclusion by people who have HAD ribarash and realize it's NOT the same thing WHATSOVER - it's WAY more debilitating and obviously not the same thing.
I don't think there is any problem connecting the dots here if you use common sense and LOGIC to solve the equation.
if the dr is sure, why aren't we?
-------------------------------
I can't defend what I never said (never said VX did not cause the mentioned problems in 2 out of 29 reports) so I'll leave it up to those interested to make up their own mind. Hopefully, they will wait until more complete trial data is in before jumping to any conclusions. BTW "low blow" on the sleep thing but that seems your modus lately.