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

[HectorSF]

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.

[coeric]

the photos of the rash are on my profile page.  the docs asked me to email them weekly photos.
eric

[coeric]

I experienced the telaprevir rash.  i was fortunate to have a caring dermatologist prescribe clobetasol at week 9.  at week 10 the hepatologist discontinued telaprevir and reduced the pegasys and ribavirin..  at week 11 prednisone was started, and i remained on prednisone for 5 weeks. I posted a photographic time-series of the effects of prednisone on the rash. after the rash calmed down i experience stasis dermatitis.  i made it through 48 weeks of treatment albeit on reduced doses. if i experienced SVR, it will all be worth it.  without an experienced hepatologist i would have had to end treatment at week 10.

[pooh55811]

If I was you, I would get an experienced hepatologist as my doctor. I had a GI to begin with and that GI and the treating team, while getting the blood work correct, most of the time, were completely ignorant and useless when it came to side effects. If I had not been a registered nurse with a critical care background, I would have been lost down the pipes. It took me awhile to realize how totally inept they were, but once I did, I put my medical background to work and demanded side effect relief (which they were very reluctant to give). I went along with me basically managing my own care for months. Eventually, when it became clear that they may reduce my Riba by half for anemia instead of giving me Procrit (contrary to what they told me when I started), I switched doctors and got a hepatologist (who does give Procrit). I had to drive 70 miles to the hepatologist but it was worth it to have a doctor who knew what he was doing and who knew how to assess and treat side effects (and was more than willing to do so). Get a good doctor from the outset. If your side effects are mild, great. But if you have side effects that need immediate treatment you need a doctor who can recognize them, assess them, and treat them appropriately and immediately.

Best of luck.

[1swimmer]

Hey there,
Everything about hep c is scary at first.
And then we start to learn, on our own, w/ forums like this, thru our health providers. People like Hector and others post new information so that you can make an informed decision, about your tx.

As pooh pointed out, the doctors need to be informed too. Make sure you have a doc that is on the same page as you. If side effects hit you right away, is your doc going to treat you aggressively or quit on you.  

I learned that the incivek carried the risk of serious rash, so I treated with boceprevir , knowing that anemia was likely to occur. And it did.

Yes, triple tx is serious. Learn everything you can before you start.
I'd like to borrow Poohs phrase "it's doable". Treatment may be very difficult, or for some, not so bad.

I made it thru tx. I worked. It was hard mentally and physically. Now 2 months post, I'm gradually getting my life back.
Good luck,
C

[copyman]

This is very scary news. For a pharm company to admit this is even scarier! I have a feeling it may be a little more serious then 1%

I remember a few MH members during telaprevir trials with the rash from hell ! From what they described it was horrible.
I felt very fortunate only to have severe itching when I treated during a trial.

Even Riba has been known to cause nasty rashes. This was a hot topic on this forum way before telaprevir was in the picture

As for the anemia with telaprevir, my riba dose was reduced at 13 weeks because of anemia. After a few weeks I went back to full dose.

At this point I still think the risk is worth the reward

[dooklebug]

This is all very frightening for someone who hasn't begun treatment yet.  When the time comes, what questions should I ask my doctor related to this?  I have pretty much come to terms with the fact that I'm going to experience side effects such as nausea, fatigue, irritability, depression, etc.  But now this?  I'm beginning to wonder which is worse:  the disease or the treatment.  
#scaredoftheunknown