If you don't treat the rash by quitting tx, what will happen

Has anyone been hospitalized on here or had severe complications from a rash from this triple therapy/ Incivek?  
I can't find any info out on this in the guidelines. Just wondered what the worst case sinareo would be or the best case?
Thanks again and again!

[Bill1954]

This is from Clinical Care Options. You might be required to sign up to view the page, but it’s an excellent site and well worth the effort for free registration. You should go ahead and read through the article; there are tables, charts and other info that doesn't copy/paste well. Sorry to hear you’re struggling with this;


http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%206.aspx

“The rash associated with telaprevir therapy is a primarily eczematous rash that resolves with discontinuation of therapy (Table 11). Typically, rash is seen within the first 4 weeks of therapy but can occur at any time during treatment. There are rare reports (< 1% of individuals treated with telaprevir-based therapy) of serious cutaneous adverse reactions, including drug rash with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome. However, because these complications may be life-threatening, they must be recognized early and all therapy must be stopped immediately.

To promptly identify rash, clinicians should encourage patients to report the following symptoms as they occur: rash, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes (“pink eye”), facial swelling, or fever. The help of a trained dermatologist is strongly recommended as deemed necessary by the clinician, particularly in more severe cases or those with mucous-membrane involvement. Although efficacy has not been fully established, rash can be managed with topical steroids or oral antihistamines when the rash is mild to moderate. Systemic corticosteroids should be avoided.

If discontinuation of telaprevir is necessary for progressive or severe rash, it is recommended that only telaprevir be discontinued first. If no rash improvement is observed within 7 days of stopping telaprevir (or earlier for worsening rash), clinicians should consider interrupting RBV or possibly pegIFN as deemed necessary. Patients should be monitored until the rash has resolved. Telaprevir must not be reduced or restarted if discontinued due to rash. For grade 3 rash, telaprevir must be stopped immediately. If there is no improvement in rash within 7 days of stopping telaprevir (or earlier if rash worsens), interrupt RBV. All treatments should be stopped if drug rash with eosinophilia and systemic symptoms, erythema multiforme, or acute generalized exanthematous pustulosis is suspected. For severe rash, all treatment should be permanently discontinued.”

Good luck with everything,

Bill

[willbb]

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

Serious skin reactions,including drug rash with Eosinophilia and Systemic Symptoms(Dress) and Stevens-Johnson Syndrome(SJS) were reported in less than 1% of patients who  received Incivek compared to INF/RIBA alone.
The symptoms of (DRESS) may include rash ,fever,facial edema. Signs of SJS may include fever,target lesions,and mucosa erosion's or ulcerations(possibly on eyes and /or lips)


According to this presentation ,if you are having a serious adverse event and were UND the protocol is sometimes to stop the Incivek a little early
It would seem serious is the key(as your rash may or may not be(and only a doctor would be able to determine that.and if you are UND.).

Go to the 5th  segment  slide #3  if you have not registered for this site you will need to ,however it is free and has very credible info.
Good luck ...
Will

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

[willbb]

sorry ..the second link was supposed to be this:

http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/Battling%20HCV/Interactive%20Virtual%20Presentations/Adverse%20Events.aspx

[Willy50]

To simplify it..... if you ignore, try to tough it out, it it can be life threatening.

If you ignore it the effects can be so bad that you can end up in the hospital and AND with possibly life changing circumstances, large hospital bill, and possible have all forms of HCV treatment stopped.  Be careful..

For many people with the help of a physician one can manage the rash,  and succeed.  For many people the rash shows up late enough that if need be the rash can be managed, or riba reduced and if it gets bad enough the telaprevir/incivek discontinued with (often) no effect in treatment success.

But..... you need to monitor and treat rash before it gets to a certain point, after which....PROMPT actions/interventions must take place.

best,
Willy

[MsDragonSlayer]

I was hoping to hear from someone that went through my situation. I have done a lot of research. My doctor told me...quote" if you can't tuff this out we are going to have to pull you off incivek." so...I am willing to endure if I have to, I just feel like such a failure. Doc gets in around 9:30 this morning, I WILL call him for sure.

My question was:  Has anyone on this forum been hospitalized for this?

Just wanted to hear from a poster child  ( -_- )
thanks for the feedback, I am having trouble navigating that med site you recommended because my iPad is having trouble scrolling on there.
I need to make it into the office...................upstairs.

[MsDragonSlayer]

Okay, spoke with the doc, I am through with incivek. So...let's hope for the best now! Thanks for your help!

[nygirl7]

I have never heard of anyone ever being hospitalized for the rash - niether the Inc rash or the riba (interferon induced) rash or autoimmune eczema.  

I developed the worst autoimmune eczema towards the end of treatment big oozy welts everywhere (mostly on my face unfortunately).  The derm got it under control in one moment, I should have gone weeks before rather than trying to do it on my own. One cream and it was all cleared up and stopped itching immediately.

[nygirl7]

What week are you on?

[MsDragonSlayer]

I was starting my 11th week... in the last 5 minutes it's spread to the palms of my hands, everything except my face and insides of my ears is not covered in a rash. I'm hoping it will subside, took that shot last night too. Nobody can know which drug is doing it if not all f them! How crazy! I just have to let go of this stress. Everything's gonna be ok, I will repeat this mantra and breath deeply.

[spectda]

As willbb posted sometimes you have to stop the incivik early, and 11 weeks is barely early. It's already done it's job at this point since you have been und since week 4. I think your doctor is being irresponsible to tell you that you need to tough it out.

You need some attention ASAP. Even if they are giving you attitude call your doctor and tell them what's happening before it gets even more serious.
-Dave

[nygirl7]

I really think you should find out from  your doctor what dermatologist knows about hcv and treatment.........perhaps they can consult with each other or something.  It was the only thing that helped me.

[Aaron57]

So sorry to hear about your situation .. the following is not from this forum , but another I frequent that has a nurse practitioner working as a member and works at a large clinic .. I know this isn't helping your situation .. other than to know you aren't alone having a severe reaction ...

" We are part of a major academic hospital and we have really seen the gamut with the telaprevir rash and honestly one patient in the icu is enough to give you pause. it's also sobering because these patients seem to have come in rapid succession, i think two were admitted at the same time. we are up to 5 admissions for telap rash"

[Karl62]

I'm going thru the same. It started at week 9 and tomorrow i start week 11. I saw my Doctor on Monday and i will be seeing him on Friday and he stated we might have to stop the Incivek. The rash is getting worse, it started on my forehead and now all over my neck, throat,upper body , arm and now my legs are breaking out, i'm so bad i dont want anyone to see me this way.

Karl62

[researchmonkey326]

nygirl7 is correct -if you find a dermatologist that is knowledgeable about the effects of these drugs, you can be treated.  I did not take Incivek but was in a trial with possibly two DAA's.  I had a horrible rash which threatened to cause end of participation.  My wonderful doctor referred me to a derma who had already met with the drug companies about these rashes and he was expecting it.  He gave me a few prescription creams and a shot of long-acting steroid - I forget the name of it but you can look over my old posts to find out.   It had everything under control within 12 hours.

[MsDragonSlayer]

Hey everyone,
I was told and I read in my medication guide that steroids were not good mixes with tx also. I am on a steroid cream for the last 14 hours, and the rash has only gotten worse, but itching has been relieved somewhat. I have another post going asking questions also regarding this situation. I will wait till this first drug is out of my body before I seek more drugs. Hugs,
Carolyn

[MsDragonSlayer]

Let me know what your doctor says, I would like to compare notes,
thanks dear,
Carolyn

[chuckles333]

I had quite a lot of rash on my shins at about week 10 of TX with Riba & interferon. I was prescribed a steroidal ointment an this helped only slightly in controlling it. Good news was it got a little better rather than a lot worse. My TX was 26 weeks and I made it through without having to adjust any dosages. Good luck.

[MsDragonSlayer]

That's great that's all your rash has spread. I will be sending healing thoughts out to you! You are all blessing!
Carolyn

[Willy50]

The answer is yes, there are people who have been hospitalized.  I know of one, whom I personally know.  It was very serious, required hospitalization and took some time to recover from and to some extent they are still recovering.

Mremeet (Prove 1trial,  2006) also had to go to the ER w/ his rash and he reported people saw him and hit the deck; either running to help him or running from him like he had *ebola-leprosy*.  

Vertex says that less that 1% experienced stevens johnson grade rash and if possibly 2500+ people were treated w/ telaprevir I think you might be able to infer that possibly 10-20 people *during trials* may have had this even to this extreme, AND while being looked after at the trial clinics w/ free medical care and from doctors experienced with the drugs.

Vertex touches on steroidal use, just saying it is unproven.  I believe is a double edged sword, since while it may improve the response to the rash,  it does this through diminishing immune response.

willy

[MsDragonSlayer]

I know that people have been hospitalized, I just wondered what the protocol for them was once they were admitted? I was hoping someone on the forum had been through this and could share their experience with me and what was the SOC there? I am always trying to be prepared, I like having plan a, b & c...it comforts me. I know no one on here is ready for any unnecessary hospital bills.
I thank you again for the wonderful advice.

Carolyn

[Dee1956]

I know that there is something called Steven Johnson Syndrome which I believe 1% of people can get from the incivek and they do have to hospitalized.  In the dose instruction it states that doctors should be on the look out for this.  I would look up the symptoms.  I think it has to do with mucus membranes drying up and/or burning from the inside out
I found a small amt of information on burning mouth syndrome
I hope that you have found something by now or at least gone to Hospital so that they could make you comfortable.  HepCExperiment is having similar symptoms, it sounds just awful
Dee