the more I read on here, concerning some of these trials, the crueler they seem to me.
Best of luck
As far as I know there is no real remedy for the rash - but if your numbers were dropping so significantly perhaps you did not get the placebo (the vertex rash is much worse than the riba rash).
The lack of rescue drugs is one reason I would not participate by taking this drug until it was approved by the FDA and rescue meds were allowed.
I would not have made it through regular SOC without procrit. It is barbaric at this stage in the game to refuse the meds and then give the telepravir and allowing someone to build up an immunity to the meds or to create mutant strains knowing then later they cannot do this treatment again.
Agrees with Deb CRUEL to the 9th degree.
If you had the rash, then you probably werent on the Placebo.
As NYGirl said Rabi Rash is a lot different than the VX rash.
I guess you will find out when its unblinded.
All the Best
I had both rashes the hot on fire rash week 2 then the itchy rash week 12
Sorry to hear you had to stop but...did you reach und? If so, it might have been worth it.
Thing that has me so upset is the day I was told to stop the TX, the nurse coordinator of the study and the the doctor both looked at my rash and said take Benadryl and since you stopped TX it will go away. It took of like a fire covered my whole body, 2 weeks later still fighting it, they were kind enough to send me to a Dermatologist to get a steroid cream to fight it. It is still popping up everywhere this *****. I lived up to my end of the deal do not feel like they did.
You sure are living up to your name...I'm sorry that this is happening to you.
Did they say that you had to stop because of the rash or did they say that it wasn't working?
I was told that there was a VX 950 study that ran for 12 weeks and 2/3 of patients did achieve SVR...so...maybe...if you got the trial drug...you will be SVR to...did they tell you if you had any VL? What was your baseline VL?
I'm starting week 20 in a vertex trial and had some itching but no rash...
Just went there to complain about the rash because it just started, and was shown a fax sent there from Vertex study patient # so and so has to stop TX now, I asked why and was told we don't know. Blind study have to wait till unblinded for any info. You are lucky first rash was like my body was on fire, second one feels like I was used as a dart board.
Thats BS. But it is what it is. I am assuming you never did tx before? If I were you I'd give my body a little time to recover then do the standard tx. With rescue drugs as needed.
I will wait for one of the new drugs to get the fda ok.
I am writing because what is happening STILL with Vertex is breaking my heart.
I was in the Vertex Prove2 trial. Here's what I think everybody should know who is thinking of going into a Vertex trial.
Line up your planB in advance in case you are ejected from the trial, which Vertex will do without mercy if you don't make it through all their hoops. This usually means another doc who is willing to continue you on SOC and rescue drugs provided your health allows.
IF you develop a rash DO NOT MESS ABOUT. GET STEROID CREAM ASAP. Advice on this forum for other remedies may be good advice for the regular rash but the Vertex rash is a different animal altogether. ACCEPT NO OTHER SOLUTION AND DO NOT BE PUT OFF.
Get your own PCR's privately offsite from day 1. I say this because I suffered through 12 weeks of rash only to find out at the unblinding that I had breakthrough on day 15! By being informed of your VL you will be able to take immediate decisions regarding your further treatment if you are kicked off the trial.
Toughluck, I'm really sorry you had this experience. I had a brutal experience wih Vertex too. But you know, a lot of people got cured in these trials, so I don't want to put anybody off. All the best to you,
Toughluck..., I know the empty feeling that you are feeling right now. I've been through that many times. I was in the Prove 3 VX-950 trial, but I got Group C..., the no Riba group. However, I did get the Telaprevir but, because I didn't go undetected by the week 4 magic cut-off..., I was 'cruelly' booted out of the trial, too. I too, had the horrible rash and I can attest to the fact that it was indeed the Telaprevir because I had NO RIBA. My skin itched so d*rn bad and I was strawberry colored! My viral load dropped hugely in the 1st 1-2 weeks but, then, rebounded-though, still lower than the screening viral load. But, I was still booted out. I don't feel that it's fair of Vertex to not offer those of us who didn't get the 3 drug combo, to be allowed to retreat; but that's my issue. I have gotten over my heartbreak from it though. At first I was very angry, very hurt, feeling very much like..., NO FAIR, NO FAIR, NO FAIR!!! But, I've gotten past that now and I'm knowing that it was the risk that I took by doing a trial. It will be the risk that I take in any trial that I do in the future..., as I am still not undetected. This whole disease is a big up and down emotional hurdle for me at times. I try to go for awhile and just forget about it and pretend that it's no big deal and then, I get reminded and it starts all over again. I'm not giving up though.
Wow I am one of many it seems, I think there should be a rollover for us lab rats using Telaprevir with rescue drugs and rash care, I know you can't stop the rash but the ointment I have is clearing it up thanks to the dermatologist.
So sorry about your experience, I thought i really wanted in on that trial until now. I am in Boston too and we probably see the same doc.
I would do what dointime suggests and have a backup, I did not and regret it. Lisa take care and be careful it may work for you, I am going to wait for the drugs to available with rescue meds.
The problem with a rollover or a retreat with telaprevir is that when we've had it once and failed tx we are probably left with resistant mutations which telaprevir can't kill 2nd time around. Therefore retreat with the telaprevir triple has a high likelyhood of failure.
For those who have already had telaprevir once, with or without riba, I'd forget about using the telaprevir triple in the future. There's other drugs in the pipeline. Use of 2 active agents with a favorable cross-resistance profile to telaprevir, plus SOC, should give us a better chance of killing our telaprevir resistant mutations and getting to SVR.
Does just the Telaprevir cause mutations, does it happen with soc
Interesting spin on the telaprevir that I just read. Is this old news?
I saved a comment made by a previous poster that differentiated telaprevir from the placebo. See if any of this makes sense to you:
telaprevir - thin layers of the drug melt away on your tongue as the saliva adds moisture to the tablet. The layers are dissolved as a subtle chemical reaction occurs similar to the carbonation of an alka seltzer tablet. The after taste in the mouth is slightly metallic in nature. The telaprevir is extremely hygroscopic in that it readily absorbs moisture from its surrounding environment, this is the reason that the pills must be protected in the blister packs.
Placebo - bland, no taste, no chemical reaction when contact is made with tongue and saliva.
It is the telaprevir that causes the mutations, not SOC. It is also possible for a person to already have the mutation in their pool of quasispecies and the telaprevir selects it out.
Any direct antiviral such as telaprevir has the potential to cause HCV to mutate to get round it, which is how these mutations come about.
As the action of the SOC drugs is indirect, it is harder for HCV to mutate round it, so SOC can be used more than once.
I should add that it is not out of the question to use telaprevir more than once, only that it will not kill off those pesky resistant mutations. Theoretically you could use it to cut down your wild-type virus fast as long as it is in combo with another active agent that CAN KILL the resistant mutations that you have. Unless you are sure of this it is a waste of time to do another tx with telaprevir. To this end it is may be useful if you can get the information from Vertex on which particular mutations you have been left with. They have this data on you, however they are not handing it out as a matter of course.
I left the study on not so good terms, I was upset with them for telling me to take care of a dangerous rash with benadryl, after this I opted out of the study, do they still have to give me all info when unblinded or do I deal with Vertex.
If you are asking about your resistance data then you will not get that at the unblinding. There's nothing which says that you are entitled to get it at all.
But you can ask nicely, and ask anybody you think would be willing to advocate for you. For instance your local doc, your study doc, direct request to Vertex, your local politician, etc etc. It is up to you how far you want to go to pursue it.
After donating your self for there and sometimes your good I would hope they would release that info.