FDA approves telaprevir

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=580154

FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment-

-Vertex launches a comprehensive financial assistance and patient support program-

-Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a viral cure (relapsers, partial responders and null responders). INCIVEK is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. INCIVEK will arrive in pharmacies this week.

[EyesofBlue55]

GREAT NEWS !!!!!Even if they did wait till the last minute!!!!

[nygirl7]

Right on time like they said they would.

[spectda]

wonderful news as expected. Thanks for posting!

[somuchmore2]

Amen!

Now Geno-1A previous treatment failure folks like me have two choices to ponder: INCIVEK™ or Victrelis™......it is a good day to prepare for a long year ahead.

Suspect I'll take my doctors lead on which should I do and pray to the Lord for a successful results.

Hope is great.

[frijole]

http://www.incivek.com/

Choices choices.  This is indeed good news.  The above is Vertex's new website for Incivek.  You can downloand the 23 page labeling and it would be advisable.

Everyone does 12 weeks of the three drugs with no lead in.

Yes, relapsers have a chance at 24 weeks of treatment. You must be UND by sensitive test at both 4 and 12 weeks.  If detectable (but under 1000IU/mL ) at 4 and/or 12 weeks, you do 48 weeks total

Prior partial or null responders do 12 weeks of the three drugs and 36 weeks of PEG and INF.  No chance at less time.  

Doses should be taken with a snack containing 20 g of fat. (Interesting that they are that specific)


Anemia -- 36% of trial patients had HGB under 10, and 14% had HGB under 8.5.    There is no mention of EPO in the labeling as there was with Boceprevir (old names come to mind easier than the new ones, sorry)

Serious skin rashes - 1% -- BUT 59% developed a rash!  (that's a lot to me)

Anerectal adverse events (heorrhoids, discomfort, pruritis and rectal burning) -- 29% .  That is compared to 7% without Telaprevir. (Yuk!)

Low ANC (below 500) -- 15% compared to 5% for those without Telaprevir.

Well, the drug companies have given me a lot to think about before my consult in a couple of weeks.  Unlike somuchmore, I will listen to the advice of the heppotologist, but rely on my previous experience before I decide which way to go.  24 weeks may be the deal breaker.  

What do you think now after both guidelines have bee3n revealed????

frijole

[somuchmore2]

Great summary! Thanks.

Yes plenty of information to compare via labels.

Did you see the post on FDA teleconference at 3:30 EST today, 5/23?

number 888.324.7513 password FDA

Briefing to discuss boceprevir and telaprevir treatments.

[FlGuy]

They might call them Incivek and Victrelis but they will always be VX950 and SCH503034 to me.

[R Glass]

This is Great News and a Long Time coming. One Big Step Closer.

[willbb]

  Great news and with currently approx. 40 new drugs in the pipeline the news can only keep getting better and better!!   "GO BIG PHARMA"

[paen53]

A milestone indeed!!  I've been on HCV boards since 2004 and this was always something that was talked about in future-tense. Now it's finally here!

Best wishes to everyone that's been waiting for this moment and thanks to those that participated in these trials that got us to this point.

Pam

[Diamando6]

GREAT GRAT NEWS, THANKS FOR POSTING THIS WONDERFULL INFORMATION. We relapser, and partial responders, now can see something abowe horizon. My Doc, told me today, that for my country, they will process of registration of medication could take 9 months, and additional 3 , for government to approve, the medication . In other words,you are one year ahead of us. Or otherwise I will have to buy directly from USA.

[donnieraye]

This news has made me come out of hiding.  Very excited!  Good Luck to everyone.

[somuchmore2]

VX950 and SCH503034

Yes indeed and I understand that perspective...

Wonder what you opinion is about one vs the other with patient two times failed treatment. First interferon w/rba and then later peginteron w/rba. Since those days long ago...'98 &..'02 I realize GENO 1A with TT is a hard nut to crack even with these new drugs..

I still wonder which path to take VX950 or SCH503034. ;)

[coeric]

let the adventure begin!

well maybe not, just got back from an appointment with a GI. asked for a script.  he tried to look it up.  He said it might take a month or two before he could write a script.

[streamline569]

My liver is still functioning. I've made it.

[nygirl7]

Wow Donnieraye and Streamline in one day!!!!!   Should have made Tela come out ages ago :D

[lapis]

Hmm, I just read in a news release from Vtx that Incivek is to be arriving in pharmacies this week.  Here's the link to the press release.

http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vrtx.com&esheet=6566909&lan=en-US&anchor=www.vrtx.com&index=5&md5=51c09359a48dbe117e1d5ef20f9d62e3

And here's what they're doing to help people get the drug:

    * Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
    * Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of $100,000 or less; and
    * Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.

[streamline569]

The drug will be in the pharmacy next week.

[streamline569]

Long adventure. Yes one day can make a world of difference. I talk to Vertex today and they are doing everything they can to help get this drug to people. It's wonderful:)

[NinjaPinky]

Does vistrelis have its own website up and what is it i wnt to download the 30pages from them too

[frijole]

I tried to copy and paste this from the full prescribing information but of course it did not format correctly.  If  you go to the website I gave above, and go to page 15&16 of the prescribing information - table 9 gives you some info on the IL28b -- if I read the table correctly there is a 61% SVR rate for previously treated TT.  Much better odds than otherwise.

"Among previous treatment failures, subjects of all genotypes appeared to have higher SVR rates with VICTRELIS-containing regimens. The results of this retrospective subgroup analysis should be viewed with caution because of the small sample size and potential differences in demographic or clinical characteristics of the substudy population relative to the overall trial population."

[frijole]

I love what I am reading here -- help with Co-pays regardless of income.

Case managers that will work with the insurance companies.

I am impressed!

Good job, Vertex!

frijole

[lapis]

Yeah, that's what I was thinking, really good news.

Lapis

[somuchmore2]

Got it I see 61%. Thank you

[Jillybean65]

I have to say, I'm very happy that I didn't know I had HCV all these years.  To be diagnosed in March, with the new drugs coming out, etc., feel very fortunate being GT 1a with the options available now versus having to treat, retreat, etc.  

I want to second thanking all of you who have participated in all these trials that made all of this possibly for the rest of us as well.

Now to wait on my liver biopsy...

[willing]

great news - finally!

coeric : thanks for posting. If you want to start the insco coverage cycle now you may have to ask your Dr. to 'hand-write' the rx. Mine mentioned he had to do that when writing the  victrelis rx since the drug  databases were not updated yet.

frijole: nice summary - good luck with your choice!

[somuchmore2]

Thought I knew much about the 2 treatments, but after a day of reading, listening and trying to comprehend this stuff I feel as confused as ever about the successful treatment for hard the treat geno-1 CT and/or TT. Saw 61% for TT success in www.incivek.com label, but heard a much different 24% for prior null responders on the FDA call.

Oh well! I certainly hope my doctor knows more than I do before I go into a long treatment with effects......

[Trish77]

Exciting times for all waiting to treat and particularly those waiting to re-treat.  Good news for folks with HCV today for sure.

[willbb]

Maybe this article will help to clear up some of the treatment sucess rates in trials as it pertains to IL28B and Inciveck.
Best to you..
Will


http://hepatitiscnewdrugs.blogspot.com/2011/05/hepatitis-ctelaprevir-ups-response.html

[coeric]

thanks so much for the great advice about handwriting the rx.   i was hoping to get the rx so that i could see about payment.   the doc said they would give me a call when they figured it out.  i wonder if this is the rationing of service that has been discussed on this site.   i laughed out loud when i read goofy's metaphor about too many turds in the toilet bowl!

[his3707]

3 doses a day with 20 g of fat each, that is 60 grams of fat every day for 12 weeks.   I am on a trail and they never mentioned that I needed 20 g of fat with each dose!  So what does it mean if you havnt done that.  my booklet says "some fat" Some of the suggestions are  
whole milk pudding, icecream, 2 oz potato chips, 1/2 cup trail mix  2 0z cheese, chocolate filled croissant,2 0z guacamole with some chips ....  
I hope the pills that will be marketed are different than the trail meds.  They are BIG, with no coating and hard to get down.  They taste BAD!    I guess I'll up the fat intake.    

[working dog]

thanks!!! thats what i've been waiting for for years...great news......billy

[HectorSF]

We have all been waiting for this day for so long. Hard to believe it is finally here! Yes!!!
These new meds will help so many people and helpfully put a spotlight of Hepatitis C so the public can be more educated about this disease and what we have all gone through.

My wish is for no one to progress to cirrhosis because of chronic hepatitis C. This will free up many livers for others who are in need for their own liver diseases and suffering terribly.

This is a happy day. To have cure rates so high seemed like a miracle a few short years ago.

It's a  day of hope!!!
Hectorsf

[Magnum]

Just received a call from a company who will be sending Victrelis (Bocepravir) to the house. They called to make sure of my address. Keep in mind I have Medicare. I asked her how it looks (as far as Medicare approving it) and she said "good". So, I will post when and if I get the meds. Those of us on Medicare should keep our fingers crossed.

Remember, you can always appeal a decision. It will help if your doctor will also get involved in the appeal if necessary...

Magnum

[screaming48]

Great news, especially for all those who have tried before. Glad about the insurance, help with co-pays and all the rest. Dont know about the anal stuff though, ouch lol.
One question as I am still new to all this, my viral load is 13.9 million is that going to be   harder to get down? I know that VL really is not taken into consideration when treating or does it? Did I make any sense at all on here?

[Isobella]

Magnum's post truly brought tears to my eyes.(again)  After all he's been through---all so many of us have been through---- who ever thought we would finally get to this day. Calls confirming our address so we can finally get these amazing drugs

Thank God for whatever they call themselves these days....like FLGuy, I'm going old school---tela and boce is what I'm always going to remember them by.  

Great day for us all!!!!!!!!!!!!!!!

[Jax_man]

I heard some insurance companies might not pay for these drugs. Is this for real?
I have Aetna PPO. Does anyone know anything about this?

Thanks in advance folks from a 2005 relapser

[nazzareno]

I read somewhere that these new drugs worked better after phlebotomy treatments. Now I can't find the article. Anyone else see this?

[Interfurgen]

Yes ! I am to happy to take it all in, But I am also not under standing the insurance part of it . I have a hmo and it covered mt first tx . HELP!!!

[Interfurgen]

I'm a little slow . at getting it . listen to the press release, GOT IT HEY !!!

[mremeet]

What a long strange trip it's been. Thank god it's finally here, Telaprevir (aka VX-950) is finally available to everyone. Now if I only had the balls to invest heavily in VRTX back in '06? ;-) Oh well, I still got my big payoff and hopefully everyone else will too. I raise my cup of dandelion tea to all the heppers out there! CHEERS

[frijole]

mre -- you got your payday that really counted. (although I admit it would be nice if a profit on the stock would cover my treatment)   So even with what you suffered with the rash -- and I really appreciate your narrative on that - you would jump to take Telaprevir?  I am so torn and want to make my decision and be treating by the end of June.  The deal breaker will be that the doctor will not let me take Procrit on Tel.  I am so swayed by the chance of 24 weeks.  On SOC I had 2580 IU/mL at week 4 and 40 IU/mL at week 12.  Surely the TEL would top me over the edge and I would fall into the 24 week regime!  Did you work?  Could you work?  I work full time and only missed a couple of days with my 56 weeks of SOC.  I worry about that too

frijole

[willing]

mremeet: yes, thanks again from me as well for your frank posts on rash, tx and  post-tx rebuilding Your recent  comments regarding trouble where the sun don't shine helped sway my recent PI decision.

frijole: "the doctor will not let me take Procrit on Tel". how come? You likely won't need it with Tel anyway. Re. vic and anemia one data point that played into my decision was Fig. 11, mean Hgb decline in vic vs control, on page 77 of the Merck submission

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252343.pdf

It looks like at most another unit HgB drop . My Dr. favored tela (as I expect most will, none  want to deal with the epo). However since at w30 I'm still at 11.7 I I argued that I could likely coast to eot without the epo (what I couldn't tell him is that I'm still doing 200mg rbv more than prescribed so can also reduce rbv a bit). Managing to keep working is a big factor for me as well.

That  24w RGT looks very tempting. It's a bit of a gamble because vertex has no phaseIII data on  relapsers to back it up but my hunch is that for someone like you with very good ifn response a small  additional  shove will be  all that's required. If you don't feel like gambling, waiting for tela RGT relapser data to start coming in or going with the vic 36w RGT (for which data is available) would be alternatives.

I'm now on w30 and avoiding the collateral damage of that 2nd 24w of ifn  sure looks  nice...

[coeric]

screaming 48-
on page 74 of the
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
i read that in study 111 the svr rates for people with viral loads greater then 800000 are 79% - not bad.  87% of study participants than achieved sir had viral loads less than 800,000.  i don't know it the difference is significant. i imagine other variables are much more important - diabetes, IL28 degree of fibrosis etc.

willing - thank you for your continuing advice to all.  you are one tough dude to keep doing physical work with hg at 11.7

[willing]

thanks, but it's all computer stuff. I couldn't possibly do physical work on tx and am in awe of those manage to do so. Though I normally  do a fair amount remodeling my tools  are gathering dust exactly where they fell when I started tx - all part of the tx Rip-van-Winkle/Sleeping-Beauty  syndrome.

Good luck with your rx pursuit. The  Dr's handwritten rx for vic seemed to be adequate for my insco and pharmacy.

[evangelin]

"tx Rip-van-Winkle/Sleeping-Beauty  syndrome"
--------------------------------------------------------------------------
I've been witness to that syndrome.  :>)  Everytime Joe thought he would do a little project, he would gather his tools and .... nothing.  "zzzzzzzzzzzzz"
Your energy will return but that hideous virus will not!  You are going to get it done this time.
Ev

[frijole]

I believe I adhered to the Rip Van Winkle syndrome too.  Lucky for me my job is at a desk.  Would not hve made it in physical labor.

I find it interesting that your hgb is still at 11.7 at week 30 even though you have been overdosing.  I wonder if you have some riba- resistance like bill54 and fishdoc had and perhaps your serum levels of riba never reached where they should have been.  Boceprevir will probably do you no harm with regard to hgb.  When I treated I managed to keep the hgb within 10 - 11.5 but only with Procrit.  So that would translate to a 9-10.5 on Boc. I think I could handle that but heck -- I forget what cold weather is until I am in it and I forget what the heat is like until I am in it.  Kind of an out-of-sight, out-of-mind gal.  When I begin to treat again I may up the riba or lead in with some riba I still have on hand.  I don't have much , but .....

What I meant about Telaprevir was that IF a doctor would not rx procrit I probably won't consider it.  Although it may have given them better trial information, not using it, I think not mentioning it on the label may hurt the company.  Perhaps it will not change anything.

frijole

[streamline569]

so I received my three prescriptions yesterday. Vertex had contacted my doctor's office and faxed them over the info to start proceeding if I needed help getting incivek, which I will.

Here's how the day went, doctor ignored it when I told him about Vertex. The office never had told him then received the fax or a telephone call from Vertex..

He said he's been to all the conferences as is up to date on everything, incinuating he didn't need Vertex caller's help.  Wrote the prescriptions and said it should take about two weeks..

I go to the pharmacy and within about an hour I was turned down for all drugs by my insurance company. The pharmacy doesn't know what to do the doctors office is just about clueless. They're going to look into it today. .

Shouldn't the doctor have told me what to do, that I would probably be turned down first time or more.

I spoke to everyone in the office informed them about Vertex but they all seem to be ignoring that someone at Vertex is willing to help and why the doctor would give me prescriptions for drugs without any other instruction about what to do when first turn down is beyond me and why the pharmacist said this is going to cost a lot of money.

Am I the first person with hepatitis that all these people are encountering or am I just being a little over the top now that I've finally decided to treat.

[frijole]

They may not know how to deal with you.  I would suggest printing out the information from Vertex that shows they will guide the doctors through this.  It sounds like he just need to get the prior approval but didn't.  Be persistent and surely you will have all 3 soon.

friojle

[streamline569]

Thanks.I've been so upset with this doctors office.They did contact someone who is going to help me work through it all .

I was told by the person who is going to help (not affiliated with the office) he shouldn't have given the prescription to me.That it should have come to him. I didn't know that. I never would have guessed that a doctor who does this all the time does not know the routine on getting approvals. Now I'm thinking I have to worry about everything. Does he know dosing, can he get me the proper medications I may need along the way. Not a good way to spend a holiday weekend. (worrying.) Hopefully next week will be better.

[mremeet]

frijole - Sorry being a while getting back to you, I don't come here very often anymore. Anyway, to answer your question, yes I would jump to take Telaprevir today if I needed it. When I treated in 2006 I had been infected for 23 years and for me the disease was wearing me down. I wasn't one of the fortunate ones who was asymptomatic. I suffered chronic fatigue of varying degrees from HCV ever since I contracted it. So a quarter century of that was enough for me, and I leapt at the chance when VX950 became available, even with zero data on its long term effectiveness and side effect profile when dosed with SOC. I was motivated. I was willing to take a chance, I was willing to put my hide on the line. And that's exactly what I did.

Just like the saying goes, nothing ventured, nothing gained. Everyone has to make their own decision based on who they are, what they want and where they are in the progression of their disease. There is no easy way out. There are no guarantees. There are risks and potential rewards. Lean as much as you can about the disease, the treatment and where you are with it. Then make the decision for yourself and roll the dice. Although I will say I think at this point there's less dice rolling going on and much more of a "sure thing" going on for geno 1's, thanks to Telaprevir. And with the knowledge base concerning rash and how to handle it if you get it, that yet another feather in your cap going into treatment (remember that the odds are slim you'd even get the bad rash in the first place).

And yes I worked, but my job was not physical. I was on light duty and was fortunate enough to have liberal leave. It ain't easy even if you're sitting around, but everyone's different. Some people are tough as nails and shrug it off. You don't want to be out in the heat, humidity and sunshine though, I can promise you that. Think dark, cool, cave-like. lol

As far as your VL response to SOC earlier: personally I would investigate the possibility of getting primed on SOC for about a month prior to taking Telaprevir. I've been out of the loop, but I recall reading about how the boceprevir researchers had an arm that had predosed with SOC before introducing the PI. In my mind there was a good argument for getting the SOC molecules ramped up in your system and the VL down prior to introducing the PI. I thought it made sense and it might enhance odds of SVR for any given length of treatment. But then I haven't been keeping up on all this, so maybe it wasn't as effective or promising as I had once thought. Do your own homework as always.

Willing I hope my itchy butt comments didn't scare you off from treatment. Having an itchy a$$ is a hardship, but as bad as it was it was still worth it. Being on the other side is worth that and a whole lot more. Everybody's gotta pay their dues, in the grand scheme of things it was just one more hurdle on the way to the finish line. Best if luck when you do take the plunge.  

[coeric]

thank you so much for your words of encouragement.  i am being worked up to start Telaprevir.  the doctor is recommending 48 weeks of riba/inf along with telaprevir for those experiencing cirrhosis.

i believe that the scientists working on boce knew that they did not have as powerful of compound as tela so looked at everything in trials that might make boce work better including lead-in and epo.

my heart goes out to folks like susan that were in the trial that did not include the ribavirin and did not get SVR.  

eric