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446474 tn?1446347682

Hep C Drug Linked to Fatal Skin Reactions - less than 1% of patients

Hep C Drug Linked to Fatal Skin Reactions
By John Gever, Senior Editor, MedPage Today
Published: December 19, 2012
The oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning about potentially fatal skin reactions in the wake of multiple deaths, its manufacturer said Wednesday.

According to a statement from Vertex Pharmaceuticals, "Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified."

The new warning stresses that combination treatment with telaprevir should be stopped immediately in patients with serious skin reactions, such as rashes with systemic symptoms or progressive severe rashes. Discontinuation of other drugs with the potential for skin reactions also should be considered.

Serious skin reactions were seen during the drug's clinical trials prior to approval, including some requiring hospitalization and considered life-threatening. The risk was noted on telaprevir's original label.

But these events were rare -- affecting less than 1% of patients -- and all patients eventually recovered, Vertex said.

The reports of deaths associated with skin reactions emerged during postmarketing surveillance. The company did not indicate how many fatalities were reported.

"Given the severity of the events reported in the postmarketing setting, and the importance of discontinuing Incivek combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning," Vertex said.

It also said the telaprevir label had been modified with new information on the time to onset of anemia and on its management.

The drug, a hepatitis C virus protease inhibitor, was approved in May 2011.
44 Responses
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163305 tn?1333668571
No worries.

Please remember that we live on the other side of the planet and surprisingly or not, what may seem like common knowledge to people in one country, is not in another.

Although I know that tylenol can cause severe liver damage and people have had emergency transplants due to taking too much, I'd never heard a thing about antibiotics.

In fact, I'm supposed to take them whenever I have dental work, since I'm post transplant. Logic made me assume they were safe though of course most things are filtered through either the liver or the kidneys.
It's always best to avoid foreign substances when possible.

Best of luck,
OH
Helpful - 0
4309115 tn?1357606283
Sorry about that last comment,I really do believe we should support each other this is serious buisness,but we all get a bit emotional sometimes,mabye I am afraid as in less than two weeks thy want me to go on Downunder it's called incivo,Telapravir and I'm trying to stay positive sorry.
Helpful - 0
4309115 tn?1357606283
I,m so glad a Person like you thinks That it makes me feel much better.I am Happy that you are clear of the virus,and are well,I will be starting telapravir on the 18th of this month I pray I have the same result,HAPPY New Year.
Helpful - 0
163305 tn?1333668571
Well, I guess that says it all, Mr Quayle, I don't know anything, except I am finally hep C free after losing my damn liver to this virus and am ready to say to one and all, HAPPY NEW YEAR.


( ps did you see my reply to Diana ???)
Helpful - 0
4309115 tn?1357606283
Just about every diclaimer that comes with the antibiotics. It,s been known for years that there is a risk,in fact if you knew anything you would know that every drug you take goes through the liver,and you would also know that every Drug Co. protects themselves at the end of every drugs possible side effects you will also see,(and some effects not yet seen).
Helpful - 0
317787 tn?1473358451
Keith, thank you for your information, as always it was very informative, helpful and appreciated
Dee
Helpful - 0
Avatar universal
I think it has been 6 years since Prove 1.  Time flies.
=========================================
http://www.aidsmeds.com/articles/Incivek_Deaths_1667_23316.shtml

One of two FDA-approved protease inhibitors available for use in triple combination therapy with interferon and ribavirin to cure hepatitis C virus (HCV), Incivek caused skin reactions in less than 1 percent of those taking the antiviral in Phase III clinical trials. Some of those study participants were subsequently hospitalized, but there were no fatalities. This is the first report of deaths from the drug. Vertex urges anyone who has a skin reaction to stop treatment immediately, as the two who have died continued therapy after identifying the reaction.
=======================================

http://investors.vrtx.com/releases.cfm?hdr02=press

"INCIVEK® (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK has been prescribed to more than 50,000 patients in the United States. Approximately three out of four U.S. patients who are prescribed a direct-acting antiviral for the treatment of genotype 1 chronic hepatitis C (HCV) receive INCIVEK combination therapy. "
======================================
http://en.wikipedia.org/wiki/Telaprevir

On December 19, 2012, Vertex announced it would add a “Black Box” warning of possible side effects on the US labels of Telaprevir, following "reports of a small number of fatal skin reactions in patients who continued to receive Incivek combination therapy after a serious skin reaction was identified.”. The FDA reported that two people had died from serious skin reactions caused by the Incivek combination treatment and that a total of 112 patients had developed serious skin reactions of two different types.[8]
==========================

willy
Helpful - 0
Avatar universal
I was in a phase 2 trial of incivek 5 years ago and got the dreaded rash bad.  So how come I am only finding out NOW that the rash can be FATAL.  I wonder how information as important as this could have been suppressed for 5 years?  

Would it have made any difference to my determination to tough it out with incivek?  He!! yes!  So just as well that I, and now several thousand other people didn't know, isn't it.

dointime          
Helpful - 0
Avatar universal
during my end of treatment visit in August the doc volunteered that i had one of worst rashes seen in the clinic.  at the time the clinic was treating about 120 with incivek and had also conducted stage 2 and 3 clinical trials.  i hope the images posted on my profile don't freak anyone to the point of not using this drug.  my experience like mremeet's represents less than 1 percent of all those that have used the drug. i feel very fortunate to have had the opportunity to use this drug.  and to have been treated by a hepatologist that knows enough to discontinue the drug before the patient is in danger.
blessing and happy holidays to all
eric
Helpful - 0
Avatar universal
A lot of new faces around here. I was in the first cohort to take Telaprevir (called VX-950 at the time) way back in 2006. I got a horrible rash (coming on strong at about week 6) and experienced all sorts of troubles dealing with it as it progressed. Nothing was known at the time of Telaprevir's propensity to trigger severe rash in some people or how best to handle it. So my situation devolved into a comedy of errors trying to deal with it while still pushing forward with my treatment. It got REALLY bad before it was under control. Even then it was just managed in a crippled, hobbled way for the remaining 2/3rd year until EOT and final RELIEF from it all.

I'm not surprised that a few people have died - probably out of many thousands who have taken the drug by now - as a result of the rash. It's too bad, because I'm confident if doctors were educated and attentive to the potential side effects of this drug, the death toll could approach zero. I'm sure there are some HCV+ people that are in pretty bad shape before treatment and they aren't robust enough to tolerate a serious stressor like THE RASH without an astute and quick acting doctor on their side.

Bottom line is that Telaprevir is a very effective drug, I probably owe my life to it. Even with all the hardships I went through with it, I'm glad I took it. It was an imperfect vehicle that brought me to the promised land: SVR! At a time when there was only a ~40% chance of being cured with the only other two FDA approved drugs complete with their own horrible side effects.

I hope Telaprevir isn't yanked and I hope anyone pondering treatment isn't scared off from treatment because of these stories. People with HCV in slowly declining health (as I was) need all the arrows they can get in their quiver. Telaprevir is a golden arrow and it drives at the very heart of the beast. Sometimes it can fly back at you, but only rarely. And even if it does, it can still strike a fatal blow against the dragon (as it did for me). You just have to be educated and wary. You have to know when to turn it off and walk away. And you need to know the side effect treatment strategies to give you the best chance for dealing with whatever level of side  effects you're experiencing. EDUCATION is the key along with working with and even prompting and guiding your doctor based on your education. Especially if he/she is not a highly experienced hepatologist.

That's how it should be done. Hopefully Teleprevir won't get shut down. HCV+ people need this imperfect drug until better drugs come along.
Helpful - 0
Avatar universal
A few things....  

---------------------------------
"Could Hector please inform us as to the exact source of his information so that we may read it ourselves"
=============================
First you complain that a link is not provided.  
I copied the first 2 lines into the browser and had the result in less than a second.  It was more work to complain than to just do the work.  

You also wrote;
"there has been no official statement made by the manufacturer that I've seen"

That is because you haven't looked.  Vertex has it right in their site and it has been provided in this thread;

http://investors.vrtx.com/releases.cfm?hdr02=press

I got my notification by e-mail from vertex.     : )

You seem to be diminishing the importance of this 1%.  First off to be clear.....it's less than 1%.  Second, if 1% of the people died during trials the drug would not have been approved.  It is a big deal.

The reason that this is being "hyped"..... publicly announced and discussed is that often, the lesser experienced doctors may monitor people as well as the more experienced trial doctors.  The intention of this thread is probably not to scare people away from treatment, but to better educate the patients so that they will get a higher level of care.

I know a patient who got very very sick from the rash.  People in weakened conditions can get very sick, very fast.  

willy
Helpful - 0
163305 tn?1333668571
Thanks for the link.
I had no idea.
Personally I avoid antibiotics and have had allergic reactions to some, including immediately after my transplant while in the hospital.
My hepatologist has all his post transplant patients use them whenever they have dental work. The reason, is to avoid a very rare though horrible, possible infection.

I copied this from the link you provided:

"Patients at risk are mainly those with previous experience of hepatotoxic reaction to antibiotics, the aged or those with impaired hepatic function in the absence of close monitoring, making it important to carefully balance potential risks with expected benefits in primary care."
Helpful - 0
1747881 tn?1546175878
"You just simply can't feel it, cause you haven't been there."

But I have treated and I didn't try to minimize or maximize the %'s, only point out where the maker had changed their packaging and share my personal experience with someone who hasn't started treatment yet, not everyone has every side effect, so what is your point.
Helpful - 0
3093770 tn?1389739126
yes, some antibiotics can cause liver failure and some are very hepatotoxic

http://jac.oxfordjournals.org/content/early/2011/05/17/jac.dkr159.full
Helpful - 0
Avatar universal
"I treated with incivek/peg/riba for 48 wks and never got a rash, it's clear you just want to argue, so I will step out of the conversation."

that's wonderful!

It might be really hard for you to understand or empathize with those many who did not have the smooth sailing you did.  You just simply can't feel it, cause you haven't been there.
Helpful - 0
Avatar universal
The warnings utterly lack any % likelihood, and simply naming a syndrome does little to impart the nature of its afflictions upon the layman's brain.  This is especially true when everything starts off with "you're likely to feel flu like symptoms and fatigue"

The warnings on all the INF drugs fail to state that if you suffer one bad side effect, you are likely to suffer a number of them.  

The seller almost always knows the product better than the buyer.  

Caveat emptor, for sure.
Helpful - 0
163305 tn?1333668571
Who told you antibiotics could cause hepatic failure ?
I've never heard of such a thing.
After my liver transplant I was put onto antibiotics for several weeks.
Perhaps you're thinking of analgesic meds such as tylenol ?

Helpful - 0
Avatar universal
Whats your response to me have to do with what I said???
Helpful - 0
4309115 tn?1357606283
You see Good one Lets be positive and as you say take note,I'm so glad it was ok for you,I'm going on it in four weeks and if something happens,I will be Johnny on the spot for sure thanks for the hope.
Helpful - 0
1747881 tn?1546175878
You stated

"there has been no official statement made by the manufacturer that I've seen"

I pointed out the makers packaging had been changed, no drama on my part, just valid info, I treated with incivek/peg/riba for 48 wks and never got a rash, it's clear you just want to argue, so I will step out of the conversation.

Have a great day
Helpful - 0
4309115 tn?1357606283
Antibiotics can cause hepatic failure!
Helpful - 0
4309115 tn?1357606283
In less than 1%! that's hardly earth shattering and incase you have not read the side of thousands of Drugs they cover everything from discomfort to death,and most all drug disclaimers say and other effects not listed hear your being very melodramatic my friend,I'm willing to bet there will be more to come.
Helpful - 0
Avatar universal
"Could Hector please inform us as to the exact source of his information so that we may read it ourselves to make our own determination,please inform us of links articles research and such."

I have always been told from Medhelp that a link must be provided when you copy from another site. not sure why it's not enforced...
Helpful - 0
1747881 tn?1546175878
"there has been no official statement made by the manufacturer that I've seen"

They changed the package warning is that not enough, I don't think it was meant to scare people but to warn them that the drug has the potential to cause death in some cases

WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment [see Warnings and Precautions (5.1)]. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.

5 WARNINGS AND PRECAUTIONS
5.1 Serious Skin Reactions/Rash  Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified.  
For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.  
In clinical trials, serious skin reactions, including DRESS and SJS were reported in less than 1% of subjects who received INCIVEK combination treatment compared to none who received peginterferon alfa and ribavirin alone. These serious skin reactions required hospitalization, and all subjects recovered. The presenting signs of DRESS may include rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis). Eosinophilia may or may not be present. The presenting signs of SJS may include fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).     TEN and Erythema Multiforme (EM) have been observed in post-marketing experience [see also Boxed Warning and Adverse Reactions (6.2)].

6.2   Post-marketing Experience The following adverse reactions have been identified during post-approval use of INCIVEK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.  
Skin and Subcutaneous Tissue Disorders: Toxic Epidermal Necrolysis (TEN) and Erythema Multiforme (EM) [see also Boxed Warning and Warnings and Precautions (5.1)]

http://pi.vrtx.com/files/uspi_telaprevir.pdf
Helpful - 0
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