Hep C Trials of VX-950

[JER22]

Are there any trials of VX-950 now enrolling volunteers either in the US or abroad?

[doglover28]

Hi,
I think I read in several posts down that one a big one is beginning in Aug.  I will see if I can find it and get back.

[can-do-man]

Hello and welcome, Go to this site put in hcv,your state or others.

WWW.clinicaltrials.gov

It shows what trials our ongoing. Best to you

[Upbeat]

I received the following e-mail this morning from Vertex.

Thank you for your recent email inquiring about the clinical trials for
Vertex's VX-950 compound, being developed for the treatment of
chronic Hepatitis C.


A Phase 1b study is in progress in Europe, and a Phase 2 study will be
initiated in the US by the end of 2006; however, these are small
studies that will recruit subjects from their own clinics.  The larger
Phase 2 multi-center study will start in the United States in early
2006.  The location of clinical sites is being finalized now.  This
study will include patients who are "treatment-naïve", meaning
that they have not had prior treatment for hepatitis C.  We expect to
conduct additional studies in patients who have not responded to prior
therapy, but have not yet initiated these studies.


The Vertex web site (www.vrtx.com) is the best source of current
information on the status of the next study.  As the start of the next
study nears, the web site will include instructions about how to get
contact information for a participating clinical center.  You can also
call us, starting at 617-444-6777; we expect to have the site
information in June of 2006.


We appreciate your interest in Vertex and in VX-950, and the time you
have taken to write to us and to provide your information.  You can
also follow the Vertex website (www.vrtx.com) which will have the most
up-to-date news about the status of all of our investigational
compounds and clinical studies.


We wish you well with your medical care.  Thank you again for your
interest and your continued support of Vertex.


Best regards,


Clinical Development Staff
Vertex Pharmaceuticals Incorporated


                                                          RON

[Pdilly]

Oh sounds good.  I may call tomorrow.

[Pdilly]

Are you two going to check this out?

[can-do-man]

One thing you might want to remember is that to get in these trials requires a bx. And in these early trials they exclude anyone with cirrhosis. Not saying you have it but if i was you i would do the fibrosure test soon. At least for a guideline on where you might stand damage wise. Just my thoughts, best to you.

[doglover28]

Hi All,

I hope everyone had a good weekend.

PDilly,  I guess I will need to wait and see what the specialist says when I go back on the 22nd of June.  At our first visit, he said there was going to be a study coming up at Duke this summer. He went on to say that maybe I could get in the study.  I don't know which one he was talking about. Something about Interferon along with some enzyme.  I had the my ultrasound already, but not my biopsy yet  I spoke with his PA and she said they don't set up the biopsy until after veiwing all the bloodwork results to see if the paitent even qualifys for one.  I definately want one.  

Upbeat,
Thanks for posting the info on the study.

Hi Can-Do-Man,
I hope you are doing well. :)


Pam

[Pdilly]

I have my bx on Thursday.  I won't know the outcome until July 3rd as the doctor will be on vacation.  If I am coherient on thursday I will ask him about it.  Hopefully I don't have cirrosis. I will soon find out.  I wish they would allow cirrosis patients to do the trials too. I mean what would it hurt?  It may help them tons.

Hope everyone had a wonderful weekend.

[can-do-man]

In the early trials of any of these drugs. They want to show the best results. Thats why they don't treat the non-responders, or people who have relapsed, or people with Cirrhosis. But if in the early trials the results are good then they start on the different stage of people. They just need to show these drugs work first. So they go with the best odds to begin with. Hope all is well

[can-do-man]

Thanks, i'm having a much better day. Hope your doing ok

[can-do-man]

If you go to this site and put in hcv, your state it will show you all trials going on. And if in them they use placebos

WWW.clinicaltrials.gov

[doglover28]

Thank you!  I am going to check them out right now.  You all are so great!!  Can-Do-Man pulled me out of a funk yesterday with just a few words of wisdom.  I am grateful for that

[doglover28]

PDilly,
Good luck with the biopsy on Thursday. Please keep us all posted.

Can-Do-Man,
I am glad your day was better. :)
I woke up nervous again, but I got out of bed, weeded the garden, rode the mountain bike 14 miles and swam. The awful nevousness about the unknown just left me. Thank god!! The condition of my liver will be what it is going to be.  I just have to take good care of myself and have faith.

[doglover28]

what is your take on what the specialist doc's PA said to me over the phone about "qualifying for a biopsy."  
My primary care already diagnosed me first as having the antibody to Hep-C, and then the actual virus along with the geno type of 1A.
She said this would be discussed at the next visit.

[Pdilly]

It is hard not to read something into what they say.   If I remember right you said that the scans turned out okay. I remember you are a geno 1 but wasnt everything else low too?  I know what you mean. Some days I am so nervous and others I am so laid back.  Once we find out all the guess work it done and then the road to tx begins. Its the not knowing that is the kicker in all this.  

[can-do-man]

qualifying for a biopsy? I think either the person miss spoke, or just didn't know what they were talking about. The main worry would be your platelet count. (blood cloting time) which they would already know since you've had blood test. Besides your count would have to really really low for that to stop it. And i'm sure thats not a problem. Since your a geno 1 there should be no question about having a bx.

Glad you went out today, keeping busy keeps the mind from wondering.

[doglover28]

you hit the nail on the head...it is the not knowing.  I have always been a big worry wart.  Even as a child.  
My scans did turn out fine.  The tech said if he didn't know from my chart that I had Hep, he wouldn't know by looking at the scan.  He showed me the blood flowing through it. My spleen and kidneys all looked fine, too.  
My ALT was elevated during my routine physical...It was 48. When the doc ran more test, which included the Hep-C antibody, he checked the ALT again, and it was 24.  
Have you had a scan done?

[ohgreat]

Hey Pdilly... I was going in for my Biopsy today, but they called me and told me the radiologist was out eating hot dogs at the lake or something (Memorial Day).  So I am rescheduled for next week too.  I will be sending you my best wishes in my thoughts and prayers and stuff.  I follow up with mine next monday.  You'll be just fine I am sure.

[doglover28]

Thanks!  Yeah, I guess she said that because I wanted them to schedule the biopsy before the next appointment. I must be getting a little anxious to get the show on the road.
Actually, it would probably be good to wait until the end of summer to start treatment if possible.

[cuteus]

If you choose to do tx for hep c, and have  insurance that will cover it, I would do that before any trial. These trials have many restrictions and limitations and if you do not respond as per their expectations, they might drop you and you might  then be labeled as a non responder and unable to get in other trials. Research thoroughly how the trial is going to be held. whether they will drop you at, for example if you don't respond by wk 12 or will they continue you on? Will they use rescue drugs if needed or lower your doses, therefore lowering your shot at SVR? These are just some things to consider, there are more and every person should ask very specific questions before entering the study. You don't want to waste your time on something that will only benefit the researchers.

[doglover28]

I am glad I read your post.  Thanks for that info.  :)

[can-do-man]

Cuteus makes some very good points. Their guide lines are set in stone. Cuteus got me thinking and since i had insurance i talked to my hepo. Glad i did as most trials won't give rescue drugs. But lower the dose, and early on in tx. That might cause you not to have the 2 log drop and out you go. If you have little or no damage and want to go the new drug route i would suggest you wait till their trials our further along.

[doglover28]

Do some of the people get placebos on trials?

[can-do-man]

With some drugs and in early trials yes. I could be wrong but i don't think vertex is one of them.

[cuteus]

Your welcome, I think there was a thread in archives on things to ask before enrolling in a trial.
here are some possible things to read:
http://www.wsaw.com/news/features/1/2744796.html
http://www.healthlit.org/scienceInside/eb_biomedresearch.htm
http://www.annescancer.ca/clinical_trials.html

[jmjm530]

Recent Vertex press release with projected dates and more detailed information on upcoming trials:
http://www.vpharm.com/Pressreleases2006/pr052306.html

Recent thread with some discussion:
http://www.medhelp.org/forums/Hepatitis/messages/40952.html

Vertex Webcast: http://www.vpharm.com/
(takes 30-60 minutes to listen to)
-------------------------------------------

Regarding some concerns and points made, but please double-check with Vertex release and webcast above --

1)Initial trials for treatment naive.

2)Trials for non-responders projected for second half of 2007. (Phase IIb study)

3) No one will receive just a placebo. However, intially, one arm will substitute a placebo for Vertex, meaning treatment would be  peg and ribavirin.  

4)Depending on results of Phase II studies, the Vertex placebo arm could be dropped for Phase III projected for mid-2007.

5) There will be a Peg and Vertex arm only (no ribavirin) but for now that is only planned for the European study.

6) It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:

..." As in the PROVE 1 study, patients in the 12 and 24-week treatment arms who achieve a rapid viral response (RVR) defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who maintain this status through to either week 10 or 20 respectively, will stop all treatment at the 12 or 24-week time point and will be followed post-treatment to evaluate whether they achieve SVR. Patients in these treatment arms who do not meet the RVR criterion will continue on peg-IFN and RBV for a total duration of 48 weeks. The 24-week treatment arm will evaluate whether 12 weeks of additional treatment with peg-IFN and RBV adds substantially to the SVR rate compared to 12 weeks of VX-950 in combination with peg-IFN and RBV."

###

[FlGuy]

Just because your primary or treatment doc goes on vacation it shouldn't mean you can't get the bx results if they are ready.  Chances are if the doc is on vacation so is his office.  Before he leaves try to get the name of the pathologist who will read the biopsy. It does not make a patient any less anxious knowing the doc is recharging his batteries in the south of France.  Tell him you want to know when the results are ready.

[can-do-man]

Don't quite understand your point... In my post i has said i did not think vertex was one using a placebo. As for tx naive. Of course all new trials are. Are you saying someone with little or no damage that has time to wait jump right in the early trials, shouldn't they wait for vertex to prove them selfs more?
Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?

you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right? and when they add the  ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?

Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive. While this drug looks good now as you know lots can happen.

[52TELE]

Man , I'm sorry to here about the delay. I know it's driving you up the wall. Hang in there , it will be here before you know it.

On another note , I would love to go to the ACL Festival in September , but it looks like they only have 3 day passes for sale , I doubt I could hang that long. I saw that Cliff Antone died , Shame , the guy really did alot for the Austin music scene.
Take care ,
52tele

[merlino]

I am also looking into this trial. I have never treated and have very little damage. Genotype 1- I had no idea when you do a trial you are not allowed any rescue drugs. I have an appt with my Gastro in 2 weeks and I want to discuss this with him and now I am having doubts. Is it safer to do Pegasus/Copegasus with all the help. I am aware of all the sides and can't imagine not being able to have help with them. Can anyone give me some advice.

[FlGuy]

There are some risks with trials, as Kalio points out. Exclusion of 'rescue' drugs for white blood cells (wbc) and hemoglobin (hgb) and the possibility of placebos in some trials can put more risk on the patient.

[merlino]

I gave myself such a letdown. Here I was thinking it might soon be over. So if your getting sick while on a trial the only option is to stop. Then you would have to start traditional treatment from the beginning. Right now a trial does not sound like a wise choice. Sorry for sounding so negative. I lost a family member to cancer this weekend and am at a loss in the hope department.

[FlGuy]

Sorry to hear about your loss.  As you've already noticed that there are highs and lows asscoiated with hcv.  However, and especially in your case, there is always room for hope. It's the anxiety of waiting for the highs and lows that make you kinda nuts.

[ohgreat]

My doctor told me to stop caring about one particular pharm company and their drug.  He compared pharm companies to any other corporation like Exxon, McDonalds, Phillip Morris even..  They will do everything possible to not let the shareholders get concerned about their product up to the point of practically lying.

He knows from experience.  He pointed to a piece of paper on his wall that had a Phase 3 HIV drug he had about 20 or so of his patients on that just collapsed when it got to the FDA.  Whole thing scrapped, millions down the drain.

He did say that in 5 years better drugs will come down the pipe...It is almost a certainty.  but for me and my situation I needed to focus on what is at hand insterad of worrying so much about making it to VX-950. (I had bought 40 shares of VRTX stock hopping it does cure all and my stock will pay for the medication..lol...Im still kind of hoping that will happen, even though I've lost 25 cents a share just today)

52tele:  Yea, this looks like the best year for ACL fest in a long time.   Antone did die young thats for sure.  Definately a bummer.  A lot of austin's greatness was originally from Dallas!(Vaughn Brothers)  Hopefully everything will be fine next week with bx.

[JER22]

Thanks. I am desperate for what looks like the best new drug on the horizon. Age and cirrhosis probably will keep me out of the trials but I keep hoping.

[jmjm530]

CDM: Don't quite understand your point.

Wasn't trying to make a point per se or contradict anything you said. Simply wanted to add more information/references regarding the Vertex trials.

CDM... In my post i has said i did not think vertex was one using a placebo.

Again, not contradicting anything you said, just wanted to expand/clarify that they are using a placebo in the sense that early trials will placebo the Vertex component, while still using peg and riba. Later they might drop the placebo component if things pan out. This is different from using a 100% placebo arm where someone gets only placebo and no drugs.

CDM: Are you saying someone with little or no damage that has time to wait jump right in the early trials, shouldn't they wait for vertex to prove them selfs more?

I did not make that point in my post. But personally, if I had little or no liver damage, yes, I'd wait until Vertex proves itself in the trials. That way, I'd have both more data to consider as well as be able to have my treatment personalized regarding dosing, length, real-time blood test results, rescue drugs, etc.

CDM: Vertex says....Trials for non-responders projected for second half of 2007... 'Projected is the key word there.' What happens when they add the ribavirin? Will they use rescue drugs?

Yes, "projected" but so far they seem to be moving along on schedule. I believe they are using ribavirin in all the intial American trials. Only one European arm will be without ribavirin. I have no idea what their policy will be regarding rescue drugs such as ribavirin, nuprogen, etc. That's another advantage of waiting until a drug comes to market.

CDM: you said... It does not appear that slow responders will be dropped, at least as defined here (in terms of RVR) from above referenced release:...... But could happen right?

According to what I read, those that do not RVR will not be dropped. Instead their treatment will be extended longer. I don't know what their policy is regarding conventional benchmarks such as two-log drop, etc. However, based on data from the initial small trials, most people should get at least a two-log drop -- actually be non-detectible by 12 weeks. In any event, it's a good question, and anyone who's thinking about a trial should try and get hold of the exact trial protocol, or at least call/email Vertex for clarification.

CDM: ...and when they add the ribavirin what happen if you have a quick drop in your hgb? They either lower the dose, boot you out, or use rescue drugs. Which most don't. And has vertex said they will?

Don't think that was covered in release. Again, a good question for Vertex.

CDM:

Just think someone one with little or no damage should NOT jump right in the early trials and make their self tx naive.

Again, I agree. And personally I don't think a person with little or no liver damage should treat with any drug. But others have a different view.

CDM: While this drug looks good now as you know lots can happen.

Yup. And I guess that's why they are called "trials". Still, looks promising so far. Certainly hope so for everyone's sake.
-------

What you didn't ask, but possibly alluded to, is who should do the Vertex trials?

We both agree that those with little or no liver damage should wait. That said, some folks might not agree with you and I :) --
and therefore want to treat with little or no liver damage. I think entering the Vertex trial might be reasonable for this category, since treatment/exposure could end up being less, plus it it doesn't work out, they have time to watch and wait. Also, those with more liver damage might also want to take a chance with the trials after considering the risks versus awards of the Vertex trials against conventional treatment. And, then of course, there are the projected trials for relapsers in early 2007. Should I relsapse, depending on my biopsy result and how the preliminary data flows in, I might be interested in entering one of those trials. Frankly, don't think I have another year of treating with peg and riba in me.

Hope this finds you relatively well.

-- Jim







-- Ji

[jmjm530]

Projected timeline for Vertex trials for non-responders is second half of 2007, not "early 2007" as stated in previous post.

[Upbeat]

Vertex has structured these trials with one goal in mind. FDA approval. This is the fastest and easiest way, even with fast track drugs to get FDA approval. Its very possible that VX-950 could work as a stand alone or even with only Peg. The bundle approach ( As with most HIV drugs ) is what Vertex as well as other companys strive for. Share prices is the main goal.

                                                           Ron

[can-do-man]

Sounds like we agree more then disagree:) Just some people are so eager to jump in. And as you know if you don't ask or check on the what if's alot of Doctors won't sit and explain it to you. You know my stage so i hope all these new drugs work out. And in my case the sooner the better. Doing ok here and hope you are to.

If i was able to join one of these trials and wanted to i would at least wait till the end of this year. I feel by then alot more will be known on how this drug will pan out.

Should add i hope these drugs work out for everyone that has hep-c.

[FlGuy]

Although I've been aware for several weeks, it's helpful in planning a strategy whenever you get information that has a  confirming aspect, even though it eliminates a possibility.  In my case, I know that vrtx is quite a way from relapsing cirrhotics.  As a result, it makes my decision to re-tx with peg/riba less cloudy.  Although I care very much about the progress for the 'next generation' of drugs I must live in the current generation.

[can-do-man]

says..... I know that vrtx is quite a way from relapsing cirrhotics........ So true, And yes your  decision to retreat is the best way to go. I look at my odds and know their not to great as for SVR. I figure if i don't get SVR then i need to do everything possible to at least slow the damage being done. And hope it does till maybe these new drugs hit the market. And i know we'll make it. I came in to this world kicking and screaming and hep-c will have to take me out the same way. Plus theres so many people left that i haven't drove crazy. So i have alot of work ahead of me. And i plan on being around long enough to finish the job.:)

[amirtracy]

amen brother.

[NYgirl]

These new Vertex trials are going to be EXTREMELY limited in the number of participants that they allow in - considering how many people are just absolutely dying to get in to them...and the specific qualifications (most promising patients for response etc) that they are looking for. It's not going to be something simple like "just signing up".

There are a LOT of different trials going on right now not JUST the Vertex.  If you are dead set against doing the Interferon/Riba waiting for the Vertex makes no sense to me since right now as I understand it is Interferon/Riba and Vertex that is being tested with the best response right?

While the drug does seem promising...

As Ohgreat said:
Phase 3 HIV drug he had about 20 or so of his patients on that just collapsed when it got to the FDA. Whole thing scrapped, millions down the drain.


Remember the press releases are written BY the company (even if they are picked up and REWRITTEN to an article) to drive the stock.

I mean it would be worth trying the Int/Riba combo and see if that killed it first wouldn't it?  Until I knew I wouldn't be dying to add yet MORE meds in...enough is enough and by the time you are actually ON treatment you'll find...it's way more than just the "treatment" that you will be on.

Yowza...pill after pill after shot upon shot. Enuff!

[merlino]

Hi my friend, I am discouraged. Wasn't aware of everything that involves a clinical trial (read above comments). Will talk to Dr. P when I see him in 2 weeks. I will not do a trial that doesn't allow any rescue drugs. I am not that brave. I see Dr. C tonight. If next blood work same I don't think I will keep going. Rough weekend. Trying to find my silver lining.

[merlino]

PS - I miss my carbs!!!!!!!!!!!!!!!!!!!!!

[FlGuy]

Don't foget to tell the doc about that gluto stuff when you speak to him. And, who is Funkasaurus?

[cuteus]

don't get in a funk! the current tx is a pain in the butt, but it does work. You have to be in the right frame of mind, know the possible side effects, and hope you won't feel them, but remaining alert enought to catch any dangerous situation. It can be done. You have to be sure and research everything, whether you are going to treat or wait.
Mild Liver damage should not be the main consideration for waiting, because hep c is not just a liver disease. It is a blood disease. Every organ fed by blood flow might get affected by the substances released by the presence of the virus. Already there is connection bt cognitive function, diabetes, renal dysfunction, neuropathy, to name a few and hep c. You do not have to experience severe liver damage to be a victim of extra hepatic symptoms. Your quality of life with hep c, your insurance, your age, support, type of job, all those things should have a prominent place in the decission making, not just the liver bx results. People with mild damage should have the same opportunity(as stage 3 amd 4) to rid themselves of HCV, should they choose that path after learning all they can about tx.
I opted for tx, at stage one, after considering many factors, with the advantage that I could stop and wait should the tx prove to be too much for me, or I did not respond to it. I had to try, and glad I did. No regrets.

[can-do-man]

First i'm sorry about your loss of a family member. And try not to be discouraged. You stated you had little damage. And for the most part this is a slow moving virus. So you have time to decide on whats best for you. You had a very Rough weekend and then trying to deal with this sure don't help. You have many options open to you and time to make what you think is the best choice. If all goes well with vertex they think it will be on the open market sometime in 2009. Stress and worry is no good for anyone. Your gonna be just fine. Heres wishing you only the best.