Not Good News

Just got off the phone with Karen Walsh at the Phoenix Mayo Clinic, where clinical trials have been going on for both Telaprevir and Boceprevir. According to what they've head from the FDA, the release date for either drug is now anticipated to be the end of 2011 or the beginning of 2012.

This, because the FDA wants more data yet. As for the side effects, she said both drugs are equal. There are no studies coming up this year for non-responders. Although I went from 3.2 million to 1600 in my count after four months with one of the treatments (Infergen), she said I am still considered a non-responder as opposed to a partial-responder.

At this point, I’m very disappointed obviously and pray I don’t progress rapidly. There may be a study for non-responders next year at Mayo, and I do have my name on their list (as I do at L.A.’s Cedar-Sinai), but as I mentioned before, in my opinion the pharmaceutical companies do NOT want to show failures to the FDA. Therefore, very very few non-responder clinical trials.

I’m convinced again that this is an important factor for the stockholders of pharmaceutical companies. I watched a recent American Greed program where a doctor was watering down chemo therapy drugs to make more money, and the commentator mentioned that in 2009, the combined income of the major pharmaceutical companies was $315,000,000,000. I somehow have no sympathy for the stockholders...

Magnum

[spectda]

Hi Magnum, I am sorry that people like yourself who really need the drugs are having to wait even longer. we should be able to take our own risks when we are dealing with something serious.
My guess is the mutation possibility is what is holding them back. I don't think it's the side effects since they are no worse then soc for most people.

[RCM829]

Hang in there Magnum! One month they say it is coming out in 2011, the next month it is 2012. I really don't think anyone knows for sure at this point.

I know how disappointed and frustrated you must feel but please try to stay positive. I really believe this makes a huge difference. Keep informed (which you clearly are) and keep pestering your
clinical trial contacts.
My thoughts are with you.

P.S. Cedars is usually very good about follow-up. Try to maintain contact with one person there who knows of you and seems informed and on top of stuff.

[Willy50]

I just listened to a Vertex presentation and they predicted 2011.  They have held back any earlier predictions so far as I know.  They pushed back the expectation of approval of DAA  (twin PI's; TVR and VX-222) for 2015 or 16.  This wasn't just some talking head; it was the CEO of Vertex.

Obviously, no one knows; it's up to the FDA.  Take whatever you were told with a grain of salt.

The FDA is also very aware that many people need to be treated.  So far Telaprevir has the better results for treating past treatment failures and I believe that their NDA will be filed before Boceprevir.  Many people are waiting for the new drugs.  Time will tell, but I wouldn't put too much stock in anyone's predictions.

By the way, Vertex has only recently rolled out the first Phase 3 trial results for TVR w/ geno 1 naives, the next two of the phase 3 TVR trials will be a past TX failure, followed by a naive, and there is yet one more completed trial for past TX failures which they may not have the complete results by the time that Telaprevir is approved.  This final trial was not expected to be used in approval, but rather for purposes of developing a protocol for response guided therapy for past TX failures.

If I recall the very best that a past TX failure might hope for in retreating would be a 10% chance w/ SOC; the most current results were that telaprevir was able to provide about a 50% SVR rate.  That is about a 5 fold increase and I think that for past null responders the increase was probably closer to 10 fold improvement.

Magnum, I know you are concerned about delays, but I think it will get approved without undue delay.

best,
Willy

[HectorSF]

Thanks for the information. I always appreciate the information you provide.

I am in the same boat you are. Up the creek without a paddle so to speak. Hoping to be stable enough to try a treatment with the new STAT-C drugs before the only option is transplant. I would like to give treatment one more try. If it doesn't work than I'll know I did all I could and will better be able to wait for a transplant. So close, yet so far!

Did you hear that Greg Allman had a liver transplant this morning after trying HCV treatment. He apparently ran out of time to treat.

"Rocker Gregg Allman undergone a liver transplant in Florida.
It is hoped the surgery, which took place on Wednesday morning, will aid the Rock & Roll Hall of Fame member in his battle with Hepatitis C.A spokesman for the Allman Brothers star says, "He had a successful liver transplant operation at the Mayo Clinic in Jacksonville. He had been on a waiting list for the transplant and is looking forward to a speedy recovery."Allman, 62, says, "I feel pretty good, considering everything that's happened. Everybody involved here - my doctors and nurses in the hospital and all the Allman Brothers fans, they've just all been great. All I can really say is 'thanks.'"The rocker began a series of treatments for Hepatitis C, but chronic damage of his liver led to doctors to recommend a transplant.He says, "I changed my ways years ago, but we can't turn back time. Every day is a gift."

I do have a few questions...
1. When you say "There are no studies coming up this year for non-responders" do I understand you correctly that you are talking about a study at Mayo?
2. So your source is saying that there will need to be at least an additional Telaprevir trial added to the ILLUMINATE study (treatment naive) and the REALIZE trial (failed to achieve SVR with SOC)?

http://www.eurekalert.org/pub_releases/2008-10/zg-tbe101408.php

The REALIZE trial (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes) is a phase III, randomized, placebo-controlled double-blind study conducted over 72 weeks to examine two regimens of 750 mg telaprevir every eight hours (with and without a delayed start) combined with Peg-IFN and RBV versus Peg-IFN and RBV alone. To be eligible for the study, patients must belong to one of the following three groups:

    * Null responders (defined as patients who achieved <2 log reduction in HCV RNA at week 12 of prior therapy);
    * Partial responders (defined as patients who achieved at least a 2 log reduction at week 12, but never achieved undetectable HCV RNA during prior therapy); and
    * Relapsers (defined as patients who had undetectable HCV RNA at the completion of at least 42 weeks of prior treatment, but relapsed during follow-up).

The trial will enroll approximately 650 HCV patients at more than 30 centers in the U.S., 50 centers in Europe and 20 centers in the rest of the world. The study will include 300 null- and partial-responder patients and 350 patients with viral relapse. REALIZE is the first phase III study to evaluate a direct antiviral (or STAT-C) treatment for HCV in null responder patients.

Best of luck to us all!

Regards-
Hectorsf

[Magnum]

I was told they had only one non-responder trial this year and no more at Mayo. I'm awaiting the 2011 clinical trials for non-responders. I'm also trying to get in at Cedar-Sinai's trials. You should get in line for non-responder trials close to where you live. It wouldn't hurt to ask them to put you in line. It's a battle to be sure, but there is still a good chance for victory. I will keep on top of all this and report in a timely fashion. Best of luck to you...

Mag

[copyman]

Hang in there Mag. I was told by the study center where I treated with Telaprevir that the "inside word"  was approval coming in 2011. Not sure if that means 1st or 4th qtr of 2011. Keep in mind that this drug is still under the "fast track" status.

[EricAgain]

There could be additional clinical trials for telaprevir and boceprevir beyond those currently underway. These studies could be done after the drugs are approved based on "Postmarketing Commitments". A PMC enables FDA to fast track a drug, while asking for more data from special patient populations. Examples might include patients with early signs of decompensated disease or post-transplant patients. Postmarketing commitments are spelled out in FDA regulations. There is nothing stopping Vertex or Schering from designing these clinical trials now and beginning to line up clinical trial sites. Interferon alfa-2b (INTRON A) was approved based on a PMC to conduct longer studies. These studies showed that a 12-month course of therapy produced higher SVR rates than a 6-month regimen.

http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

[susan400]

There may be a few other non-responder trials coming up (not for Telaprevir or Boceprevir), but for other drugs, before 2011/2012.  I wouldn't write that off just yet.  I was told that BMS-790052 was going to be coming up with a non-responder trial sometime before the end of 2010.  There's always hope.  I too, am sick and tired of waiting.  I want to be done with this and it gets old waiting and waiting and waiting.  We both just need to try and keep our hope, no matter how hard that is at times.

Susan400

[EricAgain]

Actually, there are a number of things that impede pharmaceutical companies from doing additional studies with sicker patients. These include cost, approval risk, and time to market. That is where FDA comes into it. They have the authority to insist on specific postmarketing commitments.

For future multi-DAA therapies, FDA could request that specific preclinical tests and controlled studies in sicker patients be done earlier in the process. That could pave the way for compassionate use in sicker patients. That is because compassionate use (or expanded access) is not possible under FDA regulations until clinical trials have been done with sicker patients to determine safety and efficacy. That is why we have been posting our concerns on the FDA website. We cannot wait until 2016.

I think Vertex, Schering, and others have done a lot of things right. Companies who deliver drugs to cure chronic HCV deserve to profit from their investments, ingenuity, and hard work. However, pharmaceutical companies working on HCV can make their revenue goals from patients who are asymptomatic. We - with help from FDA - need to nudge them to do more for our sicker patients. Waiting and watching will not do it. This year alone, many of us will move out of the HCV warehouse and onto the transplant list. Donor livers will not keep up with the demand.

[nygirl7]

I'm sorry Magnum we've been playing this 'next year, no next year' game way way too long now. I guess they aren't so concerned - with 3million Americans infected I guess they figure the more infected the merrier.  Actually that's not true I am sure they want their money but it's very disappointing news - usually when one starts the 'an extra year' thing it eventually comes true and I think enough is enough already. It just pisses me off for you guys.

[EricAgain]

I posted before reading your reply. I know how you feel. I have been waiting since 1990. I noticed in the non-responder pool that you were diagnosed with non-A/non-B back in 1985. I hope that a non-responder trial opens up for you. BMS-790052 would be a very good option.

[Rockerforlife]

Something dont sound right,i do not understand how they approved  other drugs so fast and not the PI`s...ambent,the sleeping walking drug was approved faster and this drug is way more dangerous if ya ask me...BTW..im on the afternoon work shift,if ya wondering why im posting in the middle of the day...LOL..LIFE IS GOOD

[susan400]

Eric,

I used to be classified as non-A/non-B in 1985, prior to them developing a test for Hep C, which I tested pos for in 1994.  I was geno 1A/1B and now I'm just 1A.  Susan400

[dointime]

Well, as soon as these drugs are available there's going to be a gigantic demand - and who is going to be looking at the bill?  Whoever that is, my guess is that they're not in any hurry for the drugs to be approved.

dointime