FDA Committee Unanimously Recommends Telaprevir (Incivek)

[willy]

http://www.hivandhepatitis.com/hep_c/news/2011/0503_2011_a.html

FDA Committee Unanimously Recommends Telaprevir (Incivek)

SUMMARY
The FDA Antiviral Drugs Advisory Committee last week voted 18-0 to recommend approval of the HCV protease inhibitor telaprevir (Incivek) for people with genotype 1 chronic hepatitis C.


By Liz Highleyman

The advent of direct-acting antiviral agents that target different steps of the hepatitis C virus (HCV) lifecycle is expected to revolutionize hepatitis C treatment. While these drugs will initially be used in combination with the current standard of care -- pegylated interferon plus ribavirin -- all-oral combinations are currently under study.

The first drugs out of the pipeline are 2 HCV protease inhibitors, Vertex's telaprevir (now given the brand name Incivek) and Merck's boceprevir (Victrelis). On April 28 the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of telaprevir. The committee also gave a unanimous nod to boceprevir the previous day.

The committee reviewed clinical trial data (including findings from the Phase 3 ADVANCE, ILLUMINATE, and REALIZE studies) showing that combining telaprevir with pegylated interferon/ribavirin produced a higher cure rate -- and in less time -- than standard therapy alone. This improvement is most notable for hard-to-treat patients including those with HCV genotype 1, people with liver cirrhosis, and those who did not respond to a prior course of interferon-based therapy.

The most extensively studied regimen added 750 mg 3-times-daily telaprevir to pegylated interferon/ribavirin for 12 weeks, followed by pegylated interferon/ribavirin alone through 24 or 48 weeks, using a response-guided strategy based on early response. Telaprevir boosted sustained virological response rates to around 70% overall (and 80% for treatment-naive individuals), compared with less than 50% for standard therapy alone.

Telaprevir is generally well-tolerated, but it increases the risk of skin rash and anemia; a small number of people in trials to date have developed severe skin reactions including Stevens-Johnson syndrome. In most cases, however, rash is mild-to-moderate and resolves after telaprevir is discontinued.

The committee recommended further studies looking at people of African descent -- a population that responds more poorly to interferon -- but commended Vertex for already conducting a study of telaprevir in people with HIV/HCV coinfection (reported at this year's Retrovirus conference in February).

The pending approval of telaprevir and boceprevir bring up a host of issues, including how best to use these drugs to avoid development of resistance, the importance of adherence, and whether HCV protease inhibitors should now be considered the comparison standard of care when conducting clinical trials of new agents.

The full FDA is not required to accept committee recommendations, but it usually does so. Agency approval of telaprevir and boceprevir is expected by the end of May, and if that occurs, the drugs will likely be commercially available by the end of the summer.
"Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee's unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C," Peter Mueller, PhD, Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex, said in a company press release. "We look forward to working with the FDA as it prepares to make its decision next month."
Briefing materials on telaprevir provided by the FDA and Vertex are available online at [http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
AntiviralDrugsAdvisoryCommittee/ucm252559.htm].

[DougV]

Supposed to meet Monday for final review.  No reason to think it won't pass and pass easily.

Cost, man who knows.  Just heard Merek has wholesale pricing of 50 grand for 24 weeks worth and Vertex us expected to be even higher.

Availability is also a big question.  Talked to my Dr office today who in turn called Merek rep, she has no news whatsoever on availability and suggested I call back middle of June.

Doug

[Helen]

Well, I'll surely be waiting to see how this all plays out and will be interested to hear what you find out in June Doug.

 Im still really tx. shy, but of course the door is open and time will tell. 

[willy]

Man, it has been a loooooong time coming.

I have great hopes for both boceprevir and telaprevir. 
Oh damn..... now i am going to have to learn to call them by their new names.

This is really going to shrink our numbers.

This is going to cure many people.  These drugs are going to dramatically reduce the number of livers needed for transplant.
That means that there will be greater availability, better matches for those who will need them.  It won't happen over night of course, but it will change in the years to come.

For those who have had liver transplants and face the infection this could provide a cure, so that the liver will last longer due to no HCV.

It is going to mean shorter treatment times for many people.

The new drugs may also provide a shorter recuperation period following TX.  It may mean fewer long term post TX issues.

The great news is that while these treatments will greatly provide better shorter treatments there are even more potent new drugs and drug combination on the way.

It has been a long wait and i can't wait to see people treating getting cured and forgetting they ever had HCV. 

I know that cannot happen for 100% of us but I think that many many many of us are going to get some relief soon.

best,
Willy

[willy]

It just was approved today.
there is also a program for low income and for those without insurance.

 Info is below;

http://www.vrtx.com/patients.html
http://www.incivek.com/

It's been a long time coming....

Willy

[DougV]

Merck is going to have a hard time with their product I think.  Much more expensive, 50 grand versus 28 grand for Incivek (what a name), less efficacy, and longer treatment times.

Here are some things to keep in mind...

Anemia with both drugs is huge issue.  Really large number of common drugs may cause drug interactions.  Drop out rates much higher than standard SOC, with Merck's 3% vs 1%, not sure of Vertex.

Due to higher incidence of anemia < 10 and < 8.5 you are going to have much higher incidence of people unable to work or go to school.  This of course is also going to impact costs as rescue drugs aren't cheap and of course have risk of their own.

Not that it is going to stop me from making an appointment mind you.  Vertex allegedly will be available within the next three or four business days.  If true I'll make my appointment for next week.  I should be able to get through EMT school before anemia gets too bad and be a good part done before starting this fall so it's as good a time as any.

Doug

[RiverRandy]

Doug

I just found out today that my doctor is recommend that I start this new treatment with incivek with the other two meds ribavirin and Interferon.  Is the support group that Mouse had still iexist.

Randy

[willy]

Hi Randy, yup many of us are still around.  Doug, in the post above you has also just started.

There is a lot of action going on in treatments right now.  Lots of people are starting.

willy

[MissyMouse]

Hi Randy!!!  Great to see you posting!!!!  Unfortunately we didn't think it financially sensible to keep the chat room growing as traffic had died down so much.  But now that people are starting to go back on treatment we may re-open it after I get through my breast cancer surgery.   In the mean time... we are all still right here on the bulliten board.

Hugs,

Mouse

[RiverRandy]

That is great , it has  been a long time since I've posted on the bulleting board, and sometime not sure what catagory do I send my message too to make sure you and the other can respond to my messages.  I went through 48 weeks of treatment back in 2008- 2009 and never got to SRV. My viral load dropped from 2.5 million all the way down to 120 but in the 48 week of treatment my viral load started rising back up to 10,000 and then they said my treatment was done for now and just f/u with labs and have my Abdomen CT Scans every 6 months to make sure there is no cancer or tumors which I have been cancer free.  Now in July I went back and my doctor recommended round 2 with Pefasus /Ribia/Incivik.  I am going to start back on Oct 10th.  First I need to go back to the hospital for a stress EKG and a echo cardiogram, which is routine my heart is strong.  My concerns right now is the Riba, that made me cuckoo , Riba rage whatever you want to call it, thta dammm drug is nasty.  I only was on the Riba for 3 -4 weels out of the 48 wks due to a severe blistering rash all over my body.  I also had to spend time in the hospital.  I finsihed the 48 weeks with the interferon shots once a week which also had be dried heaving on every monday moring like clock work...5:30 am puke..puke....dried heaves...sorry don't want to gross anyone out.  If I start any reactions to the Riva or Incivik due to rash they will stop the treatment.  I do miss Willy Missy , Robin, and the others in the room for their great support and other's sharing their thoughts while they are going thru treatment or have been thru treatment. When I first had my liver Biopsy 6/08 I went 20 - 25 years without being diagnosed which casue my stage 4 without any symptoms until 5/08.

Diagnosed 8/08 1a Stage /4
Round 1 2008 48 wks Riba/DC/Interferon relapse
Round 2 Peg/Riba/incivik 10/11

[MissyMouse]

LOL, you can't gross anyone out here Randy, we have all written about everything from our vomitting, to our bowels to our monthly girly things, everything is on the table here.

By the way I think I had just started my third round of treatment when you were last around ... I had my 6 month post PCR and I finally beat this dam dragon ... I have my 1 year post next month ... now all I have to do is beat breast cancer.   

Mouse

[RiverRandy]

Merck is going to have a hard time with their product I think.  Much more expensive, 50 grand versus 28 grand for Incivek (what a name), less efficacy, and longer treatment times.

Here are some things to keep in mind...

Anemia with both drugs is huge issue.  Really large number of common drugs may cause drug interactions.  Drop out rates much higher than standard SOC, with Merck's 3% vs 1%, not sure of Vertex.

Due to higher incidence of anemia < 10 and < 8.5 you are going to have much higher incidence of people unable to work or go to school.  This of course is also going to impact costs as rescue drugs aren't cheap and of course have risk of their own.

Not that it is going to stop me from making an appointment mind you.  Vertex allegedly will be available within the next three or four business days.  If true I'll make my appointment for next week.  I should be able to get through EMT school before anemia gets too bad and be a good part done before starting this fall so it's as good a time as any.

Doug

[RiverRandy]

Doug

Good luck on your new treatment, it sounds like you have already started. How are you doing ?...Are you having any side effects from the new drug Incivek.  I am also going for round 2 in Oct 10th .  I am so glad that I have great insurance Tri Care Prime which is one of the better insurances.  I only paid $12.00 co-pay when I go see the doctor.  All the medication is paid for with my insurance. That medication call be very costly , I don't know how others can afford it without insurance.  I guess they don't get the treatment that they deserve.  I believe everyone in America should have free medical care.  Many people died everyday because they don't have the means to pay for medical insurance.

River Randy

[DougV]

He Randy,

Did 4th shot yesterday and am on the Incivek trinity.

Ony three issues to date.

First on day 3 ii was nauseated pretty badly in the am.  I do however occassionally get nauseated, as probably you do as well, so impossible to blame drugs for sure.  Only the one time.

Next a systemic rash.  Very minute, worse in evening, hardly visible and no itch, but was everywhere.  Only lasted maybe 5 days and Benedryl tablets worked fine.  It was so fine that no one ever noticed it but my wife.

Finally the super secret side effect, and one that appears far more common than reported on their website, I believe they list as anorectal discomfort (11%) and hemorrhoids (12%).  If they choose to call nuclear butt burning with lava hot fecal matter as discomfort I guess they can but it's not the choice of words I'd choose.  Started day 5 and has continued to this day.  It's kinda like tossing two cups of scotch bonnets along with couple cups habanero in a nice solution of lye, drink it all down and wat for morning constitutional.  Very nice, I tkink you'll enjoy...

However those things aside, I feel pretty good so far.  I am taking head in sand approach to labs and while I get blood drawn weekly I have yet to check and no one has called in a panic, but that is all I know.  I suspect they are circling around on the descending path to the depths like normal but being as I'm running a couple weeks late for the start of the Tour de France no matter.

Doug

[Hank's mom]

Dear Doug -
Aside from the gripes, this sounds better than last time so far. I met a bunch of people starting or having started the new treatments. Glad to hear that you do rebound from the odd, bad sides fairly quickly though the butt issues sound like five days were more like five months. LOL. Stay well and let this be the one,
Susie