telaprevir trials and helper meds

[pcds]

For those of you who have taken telaprevir, did you get a serious rash?  If so, what did they prescribe?  I know there are some limits regarding helper medications for side effects when in a trial.  I have concerns about the rash associated with Telaprevir.  I already know there are drugs for low white count, low HGB, but what do they do about the rash?  I had a rash with riba, it was difficult, but I managed.  I hear Telaprevir can be worse, so I expect to face this in the future.  Will Vertex have to have a solution for FDA approval?
Judy

[halc]

My experience was memorable. Day two I developed a mild tolerable rash. Day three it advanced into hives(80% coverage) & began itching. That night I slept only two hours and took cold showers to help ease the pain. I would compare the feeling with severe poison ivy and a serious sunburn X 100! Day four I ceased the telaprevir and had an emergency visit with a dermatologist. The next two days were better, but not much sleep. By day seven 90% of the rash had disappeared. I am continuing with the Ribavirin & Pegasys. I hope everyone who tries this has better luck than I did.
***@****

[earthwarrior54]

I have been "patiently" waiting for something to come down the pike that will finally kick this virus out of my system so maybe I can get on w/ my life. I did try the Rib/Int treatment but for a very short period of time. I had a bad reaction but not sure if it was from the Interferon or the high dose of Lexapro - something got me all freaky and I had to stop. Altho my viral load has been consistently high my Liver function has been great so my Dr felt it has been OK to wait to see if a treatment came about that had a higher cure rate in shorter pd of time. In the interim I have been taking supplements such as Silimarin, Reishi, Sho-Saiko-to, etc etc. I am a little frightened off by the reports of just how bad this "rash" is. Of course prior to reading actual patient reports all I had to go on was what my Dr told me or info online from the company itself which obviously has really downplayed just how bad the rash is. Is there anything that one might be able to take to help prepare their body, naturally, for this? Any holistic supplements that might help offset the severity or duration? did the rash leave scars behind? for those that have cleared the virus I'm curious how their quality of life is now. Do you feel vibrant and more full of energy? Or did the treatment leave you with other side effects that altho cleared the virus now affect your quality of life? I think those of us out here who are waiting and watching really have some serious decision making to do. To treat or not to treat that is the question....any input you guys have is certainly appreciated.

[susan400]

I was in the Telaprevir Prove 3 trial.  I was in the no Riba group C, so I know that it was not the Riba which caused my horrendous Telaprevir rash.  I got it after only 2 weeks on the meds and it was really bad.  Since I was in a trial, this particular one did not allow anything to treat it, other than cortizone cream, over the counter only. And I couldn't have any type of stronger prescription cortisone cream, not could I have any oral steroids.  However, not all people get this rash so, I don't want to discourage you from the Telaprevir as it is a very good combo w/SOC for bringing a number of people to SVR.  I didn't reach it, but I truly believe it was due to not having the Riba in the mix.  I wish you the best of luck.  Susan400

[nygirl7]

My mother had Stevens-Johnson she lost all her skin and mucous membranes (mouth, nose, lungs, intestines etc.) they had her in the burn center of the big hospital out here for six months.  She only lived by a miracle and has never been the same since of course. Nothing I have ever seen (except the children in the burn center) really could matach the horror of that experience.

[Isobella]

~~~ firerehha.....the most horrible burning diharea~~

Thanks for putting a name to it.  I didn't have much diarrhea, but omgosh......about 12 hours after the first dose of Telaprevir, I got a bad case of what I called "the wiggles" , a burning, itching, ouchy sensation in that posterior area.  The prepH didn't quite cut it with me, so I got an rx for Proctofoam HC.....helped more, but the only relief came about 12 hours after stopping the Tela.  It was amazingly like clockwork...came and went....12 weeks exactly of burning, itching, wiggly mess....can't say it was miserable or horrible, but I can say it was worth every minute for of it SVR.  

For the record, the first center I tried wouldn't even consider me for the Tela trial because of my history of excema/contact dermatitis.  I applied at another center and got in no problem. The dreaded rash was never an issue, but I did take Atarax for itching and use Desonide lotion and ointment 0.05% for any itchies that did come up.  I think it was mostly the Riba because it was the typical red pin point rash usually associated with that med.

In my trial, they would give meds for rashes and itching but no helper drugs for the anemia and neutropenia.  I have no proof to back me up, but personally,  I don't think there will have to be a solution to the rash before market approval simply because there are many other drugs on the market that can also cause Stevens-Johnson Syndrome and doctor, nurse and patient education is aimed at stopping the meds before it gets to that point.

Good luck to you, Judy.

Isobella

[lapis]

I was in a trial where I got Telaprevir with SOC for the first 8 wks.  Banarep is right about the burning diarrhea, OMG, it was dreadful and required frequent applications of Preparation H, washing with cool water, etc.  Absolutely miserable.  But SVR is worth it!

The rash started for me in the last week of my tx with study drug (end of week 7).  My skin got super dry, sandpapery, mostly on trunk and arms.  It was tender to touch and very itchy.  I used a cream called CeraVe which I got at hospital pharmacy, it formed a protective barrier and was the only thing I tried that helped at all.  They just told me to keep taking Benadryl and I took it at least once a day.  When my meds were switched from Telaprevir to placebo the rash improved within days.

Also had some serious anemia, Hgb down to 9, with dizziness and chest pressure on exertion, but thankfully it responded to Riba reductions.  For many weeks I was dose-reduced to 600mg (weight based is about 1100mg for me) and that really concerned me, but the Tela did the trick!

[banarep]

atarax was what i was given as well.  also, just read another thread and thought I would bring this one down as well.  another side effect of the telaprevir, after the rash, was what my doctor called firerehha.....the most horrible burning diharea (sp) I have ever had,  it was much worse than the rash.  

the rash just appeared around week 1o 0 and you only take the meds till week 12.  the atarx stopped the itching in less than 24 hours.   none of the creams, etc helped.

by phase 3 of the studies, the doc were allowed to treat for the rashes a bit more aggressively than earlier trials.

[pcds]

I had major anemia issues with SOC, so boceprevir is likely not the right PI for me.  I think the rash issue can be addressed, steroids might be a solution, I was reading about solumedrol.  Thanks for the tip.  Rash vs anemia.  I also think telaprevir will be the tx of choice at least initially per reports.  Only 15% of pharmacy directors believe boceprevir will be drug of choice.  Not sure reasons, maybe just who hits market first.

[GreatBird]

Boceprevir doesn't have a rash.

[copyman]

I was in the Telaprevir trial and had a lot of itching but no rash. I was prescribed atarax and creams. I was in the phase 3 study so not sure if they had changed anything with the drugs formula from the early Phase 1 & 2 studies where the rash sounded horrible. I was also worried about the rash but it never came....Thank god.

[dointime]

Yes I got the serious rash all over my body.  The only thing that controlled it was Elocon cream which is a kind of steroid cream (but don't use it on face).  Steroid lotions can also be got.  I tried antihistamine pills and creams but they didn't work for me.  No amount of moisturising or soaking my body made any difference either.  

I put the Elocon cream on over a light moisturiser so as to thin it out.  Steroid creams should be applied thinly and not on the same patch for longer than necessary.  They are the heavy duty solution but you gotta do what you gotta do to get you through tx.

dointime  

[Cory255]

I haven't taken Telaprevir yet, but I'm still reading about it.  All of the patients in the clinical trial were infected with HCV genotype 1 -- the most common U.S. strain, and the hardest to cure. Without telaprevir, less than half of patients with genotype 1 HCV achieve a cure.
In the world of hepatitis C treatment, "cure" is a relative term. Treatment does not necessarily eradicate the virus from the body. Successful treatment results in "sustained viral response (SVR)" or "viral cure," meaning that treatment has brought the virus to undetectable levels. Usually, the immune system is able to keep any remaining HCV under control after a viral cure.
About 9% of telaprevir-treated patients who achieved SVR relapsed -- that is, their HCV levels once again became detectable during post-treatment follow-up.

The rash side effect appears to be pretty common with VX-950 (34% had the rash).  It can range from mild to moderate.  A lot of the rashes can also be associated with itching.  Once the medication is stopped the side effects gradually diminish.  Cory.