Telaprevir - 18 yes 0 no

[frijole]

Whew - that was dicey.  One of the FDA advisory committee panelists was agressive in his pursuit of issues with the rash, but in the long run, he and everyone else on the panel voted to approve.

Now it goes to the FDA.  Approval date (or not) is May 23. Some people are betting that the FDA will announce both BOC and TEL on May 7 - the date for Boceprevir approval (or not)

[frijole]

The biggest issue on the table was the rash.  DRESS (drug rash with eosinophilia and systemic symptoms) and SJS (Stevens Johnsons sydrome) were the biggest issues.   Although both of these can be very bad - the SJS can be life threatening - in the long run the panel decided the benefits outweigh the risks. They didn't recommend additional trials.  Vertex did an excellent job of presenting and were very well prepared.  

[HectorSF]

Good news!


Hectorsf

[frijole]

Question 3 ---Please comment on the strength of evidence to support response-guided therapy with telaprevir in combination with pegylated interferon and ribavirin for the following patient groups?
a)Treatment-naïve
b)Prior relapsers


seems like panel is leaning towards RGT for relapsers

chair summarizing - -ringing endorsement for RGT in treatment naives. less clear for strong endorsement for relapsers but majority say evdience supports RGT in these patients. some concerns for underlying conditions...

[frijole]

4. Please comment on the strength of evidence to support a recommendation for use in specific populations, including but not limited to Blacks/African Americans and patients with cirrhosis. What, if any, additional efficacy or safety data are needed for specific populations

clay - patients with gout and tuberculosis
clay - i know, i'm driving people crazy with this tuberculosis issue...
chair summarizing question 4 -- need more data on patients with gout, TB... (clay!) more data on AAs and cirrhotics, some concerns about null responding cirrhotics, patients over 65

[nygirl7]

My mother had SJS - you dont ever want to see anybody who gets that.  She was in the burn unit of our major hospital out here for months......

Sounds like they had more trouble getting through then boce I would have thought it would have been the other way around.

Exciting times ahead - very exciting indeed.

Thank you for the excellent recaps Frijole I wouldn't have known where to look to watch.

[frijole]

Good news for sure.

It looks like Telaprevir may be on label for null responders.  Probably not so for Boceprevir because they avoided them in their trials and did not have the data.  They had a little data from the placebo group who did not respond and were then given BOC - I think about 30% were SVR - but the FDA advisory panel would not accept that data since it wasn't part of the trial.

The other really good news is that relapsers will be treated like treatment naive as far as response guided therapy.  That is even relapsers have a chance of 24 week therapy if they are EVR.

[frijole]

You are right, Deb.  I googled picutres of SJS.  All we ever heard it called was "the rash" and severe, yes, but I really never concerned myself that it might be life threatening.  We will have to be on guard with that one.
frijole

[Magnum]

Why isn't anyone talking about Boceprevir except for frijole? My Gastro wants me on it because I didn't have an issue with Anemia. Now I'm getting a feeling that Teleprevir is outgunning the efficacy of Boceprevir? Can anyone unconfuse me?

Mag

[susan400]

ALL, I have been talking about it wanting to get on the Bocep.  I have not even had Telap. on my radar screen since I won't even consider ever doing it again.  However, each person has to make their own decision.  I had my experience with the Telap., had the horrendous rash 2 wks into it and I will not go through that again, have no desire to.  If given the opportunity, I'll take my chances with the anemia.  I went through all of my treatments anemic and only used the Procrit on 1 of the 10 TX's, I did.  

Susan400

[Magnum]

Unless my gastro changes plans, that's what I'm going to do as well. Luckily, throughout four tries, no Anemia. Still felt shi**y though...

Magnum

[miked]

About week 4 of my participation in the Prove 3 trial I got the rash from hell.

My family was camping at the lake and we had a great day at the beach.  At dinner that night my daughter exclaimed, "Dad, is that poison ivy all over your arms!".  

Well the poison ivy was actually the Vertex rash.  Over the next few days it moved around my body with the exception of my face (odd).

My doc prescribed a steroid cream and within a couple of days the rash was under control.

I went on to complete the 24 week Prove 3 trial and learned that I was UND between week 1-2 and remain that way to today.

Poor Susan400 above was also in the trial but didn't get inn the arm with RBV which I believe was necessary for RBV.

I'm so happy that these options are becoming available to everyone!!

miked

[frijole]

I think it is important for both drugs to be approved.  You and I and Susan and others here have had months - no, years - to weigh the odds for ourselves. I think if any one has auto immune problems (of any kind)  they ought to really look hard at this issue of rash.  It is some kind of immuno suppression issue and needs to be a primary consideration in determining which to treat with.  I have never had any skin issues or auto immune problems and think TEL is the right one for me.  Another thing --, I was following the investor blog.  I tried once to get on the FDA sight but it was jammed -- the message said too many viewers (imagine that!) -- so I missed a lot of details on a lot of stuff.  But there is some real issue with anyone who has gout or TB.  I think it is some kind of acid, but I can't tell you what.  I think there may be some label warnings about that.  I am sure we will hear more.

One other thing I didn't like about the TEL.  If anemia arises (and the anemia with TEL is greater than SOC, just not as bad as BOC) that the recommended solution is riba reduction.  Now I believe this can still be remedied with epogen, but that too will be off label.  I think it will be easier to get epogen with BOC.

I have seen such wonderful successes with BOC that that my mind is not set in stone.  I had anemia on SOC but it was not so bad that I would not consider BOC.  After cando man was cleared on BOC after 96 unsuccessful months on SOC, I was sold on BOC.  And Ejoili - and others i consder friends.

I am rambling.  Sorry
frijole

Magnum - you weren't a null responder were you?  YOu were a responder/relapser like me, right?  If you were a null responder you may have to find a good heppo - not a GI - to treat with.  BOC may be off label for null responders.

[Magnum]

I responded down from 3.2 million to 6500 with Infergen, but nearly died because it made me jaundiced. The other three treatments didn't work and I was stopped after several months on each, with the longest one going for 6 months.

As for Hepatologist, Dr. Robert Gish is soon opening a clinic in Las Vegas. I will run all this by him and post his response. He only does livers... Gastros do all abdominal cavity organs. Big difference if logic prevails. Stay tuned...

Mag

[susan400]

Who knows, maybe, just maybe, Merck will do a late stage trial, 'wide-spread' like throughout regular physicians offices, for the non-responders?  Stranger things have happened.   Merck, are you listening??????       The very first time I ever treated back in 1997 was in a Dr.'s office, a clinical trial, widespread, for the Ribavirin...back then, it was the 'new combo' and it was 3 x a week using the Intron-A and the trial drug "Riba".  But, that was a trial - widespread - late stage - in a regular doctor's office.  

Susan400

[JRenquist]

If boceprevir is off-label for non-responders, does that mean that insurance companies won't pay for it?  

My gastro really wants me to use that instead of telaprevir. I'd been looking forward to the telaprevir for a long time. Says that it's easier to treat the anemia than the rash and I had bad riba rash and autoimmune thyroid problems .

Said that Vertex had covered up the number of people who had dropped out of the original trial because of the rash, so he didn't trust them.  

Talked about mutation problems, but reading this forum, it seems like that's an issue with both of the new drugs.

Guess I'll just have to go  with whatever my insurance will pay for.  Does anyone have any idea how long it might take for insurance companies to put either PI on their formularies after FDA approval?

Thanks.  You guys are such a help.  Just reading this every day and knowing that I'm not alone in this is so helpful.  Wish I had more to contribute.  S.

[desrt]

If your doctor is thoughtful enough to take autoimmune, thyroid, and rash into consideration when Rxing, I'd listen to him.
Don't worry about 'contributing'. Learning there's at least one MD who feels Vertex wasn't honest in reporting their trial results just made my day more interesting.
Wish I could help you with your insurance questions, but I think we'll all just have to wait and see.

[Andiamo1]

"Says that it's easier to treat the anemia than the rash and I had bad riba rash and autoimmune thyroid problems ."

Does that mean he thinks that epo is safer than steroidal creams?  I would find another doctor.  Epo has many dangerous side effects.

"Said that Vertex had covered up the number of people who had dropped out of the original trial because of the rash, so he didn't trust them."

Does anyone think they could have gotten through all the people at the FDA looking at the trials if they were dishonest?  People talk about big pharma -- well Vertex is small pharma and Merck is big pharma.

Of course, I might be an ambassador and therefor must be dishonest myself.

I find these discussions, Telaprevir vs Boceprevir, about as rational as Republicans vs Democrats

why not poll all the people on this forum that took Telaprevir and find out who had a bad rash that wasn't' easily treated;  ask how many dropped out because of the rash.

[willing]

>If boceprevir is off-label for non-responders, does that mean that insurance companies won't pay for it?  
good question, I've been  trying to understand this as well. As far as I can tell under federal ERISA law that governs employer contribution health plans inscos can refuse to cover off-label rx use but individual state statutes can broaden coverage. For example California Health and Safety Code Section 1367.21 seems to limit off-label denials under conditions relevant to hcv use:
http://law.onecle.com/california/health/1367.21.html

>easier to treat the anemia than the rash
another great question and one many here seem to be wondering about.  The choice of sx is likely the biggest factor in the PI decision and It's hard to know who to trust. On one hand there's a lot of money to be made on the choice so the drugco marketing is suspect. Also there are very few Drs with significant experience at this point so their judgment is  mostly opinion.

My tendency has been to trust my fellow lab rats . Collectively there's' a lot of experience with epo on this forum. Nobody likes it, it's expensive, comes with risks and sx, but by and large it seems to work. This is what he may mean by 'easier'. The tela rash is more of an unknown. For some it was well-managed with creams for others (susan400/dointime/mremeet?) it seems to have been a show stopper. My current choice is to start with tela and switch to boce if the rash is too much. Direct feedback from other patients is probably  your best guide. However, if you really are a null-responder treating now may not be the best choice, regardless of sx.

As to "trusting" the drug cos that seems a non issue: they're in this to make money. One should expect them to promote their strengths and hide their weaknesses - it's part of the landscape. Vertex is smaller and more motivated and seems to have done more aggressive 'data fishing' than Merck, but any results that survived the recent intense FDA screening should be reliable.

[Andiamo1]

Susan400 dropped out because she was in the arm with no Riba and didn't respond.

mremeet was the only one that had the severe rash and had to stop but still ended up SVR

Dointime also ended up the the no riba arm.

I know about 10 people that participated in the vertex trials.  Only mremeet had the severe rash and all are SVR.  The rest had rashes that were slightly worse than a Riba rash, but all treatable with steroidal cream.

Personally, I would rather not take EPO unless I had  no choice.  Many doctors think it is linked to increase probability of cancer and until that is proven one way or another, I am  not taking a chance.

[susan400]

While the trial dropped me, at week 5 after my week 4 blood work showed that I had not cleared..., the rash appeared on me as a horrendous thing at week 2.  I never had rash issues anywhere close to being like the Telaprevir rash.  I was barely even noticing any rashes from Riba.  However, Telaprevir rash was like I was hit with scalding hot water.  I had horrible hive-like, blistery like things on my body.  The steroidal cream was little to no help with this rash.  In fact, the steroidal cream was OTC and it made me sweat, which in turn made the rash itch more and made the breakout repeat.  It's not something I will EVER consider going through again.  I'd rather keep the Hep C, not be SVR than to have to go through that horrible thing again.  But, that's my choice.  Susan400

[Magnum]

In the context of our discussions of rash vs. anemia, anemia can be controlled. Rash? When both drugs are approved, it would not be regulated as to when and if to change horses (drugs) mid stream. It's not a dictatorial mandate by the clinical trial directors at that point.

So, my summation on all this is that if one doesn't work, try the other, but why suffer to start with the proven rash horror stories. Some would rather dive off the empire state building or climb to the top of Mt. Everest naked than to go through the rash. Torture should never be part of a treatment...

Magnum

[pilgrim1951]

Just a quick response to all of this rash and anemia dialogue.  I was in the phase III Vertex trial and had a terrible rash that convinced my doc ( great guy at UPenn) that I "probably" was on teleaprivir.  My blood counts were so bad I almost reached the point of needing a transfusion (the trial didn't allow Procrit).  Turns out I was in the placebo arm of the trial and did not get these side effects from telaprivir.  So, I guess that some people suffer these sides from the existing protocal for treatment.  Food for thought.  SVR is gret regardless of how you get there.  

[Isobella]

First of all..big hello to Pilgrim, one of my fav lab rats!!

I remember you thought you were on tela because of the rash and then I got a wake up call at 24 weeks when they extended me to 48 and I then thought I got the placebo. What a trip we had, my friend!  Hope you are doing well and enjoying your SVR.

To everyone else, I treated in a Vertex trial for a total of 48 weeks.  The first 12 were triple therapy.  I have a lifelong history of contact and atopic (eczema) dermatitis.

I didn't experience a rash from tela at all. I did, for a few weeks, experience what we here on the forum called the riba rash....random small red dots on my body.  Throughout the 48 weeks, I did experience the photosensitivity that riba can cause.  I spent most of my tx oceanfront, so I stayed inside or in the shade during the day. If I didn't my skin felt like liquid fire. That lasted 48 weeks, not just the 12 weeks on tela.

I don't understand why any treating center would not offer anything other than an OTC solution after seeing what sounds like a pretty severe rash.  Susan400 , my heart goes out to you.  If memory serves, when Mrmeet was in rash trouble, he was given steriods and perhaps other rx help.  And I believe there was another forum member that was a school teacher that experienced a severe rash as well.  Hopefully he is around and will give his insight.

The center that initially diagnosed me no longer gives Procrit when patients become anemic.  They prefer to dose reduce and tranfuse at Hgb < 8.  They believe the risk/benefit ratio is not worth the risk of aplastic anema.  The center that I treated at believes in Procrit...thinking hit the virus hard and keeping patients on full doses is best.  

The anemia we all experience is not like the aplastic anemia Procrit may cause in some patients.  The rash some of us may experience on tela will not come close to SJS.  Maybe we should look at the number of adverse reactions from Procrit vs the number of adverse reactions to the tela rash-SJS when deciding.  

I can only give my opinion based on my 12 week experience with tela.  But please understand, I don't take this lightly.  I passed this virus to my only child.  Every single day I toss this these factors in my head and keep coming up with what is for us the best answer--telaprevir. I would also want to be aggressive and add Procrit to the mix if need be.

Please don't demonize tela based on the rash issue.  Please look at the numbers for cure rates, adverse reactions, risk ratios for both the treatment and the rescue drugs that lead us to SVR.

[Andiamo1]

Finally a voice of reason in this discussion.   Thanks for adding some information to the discussion.

All you have to do is look at the total dropout numbers due to sx and you can see that both drugs have about the same number.  SJC is very rare and I think mremeet was the only one to have it.  A rash that is very treatable is the more common SX.

Procrit (epo) is a very powerful drug with major side effects and should not be taken lightly.  Anyone choosing between these drugs needs to understand that both have side effects that are manageable for most people and both have risks that can be serious.