VX-950 Phase 3 question

I was diagnosed 10-6 and won't get in to see a Hepatologist until end of December. I am going to write the doctor and ask him if he would order a biopsy to be done prior to the appt and if I could possibly get on the list for the phase 3 testing of VX-950. I've heard it works best if used with peg and rib. Does anyone know if it's possible to get in the testing group? Also, how long does it take to get a biopsy arranged?

[sfbaygirl]

Ususally hepatologists like to have these tests done before the appt. Where are you? The biopsy appt. depends on your ins. plan and doctor. I would call the Hep dr and ask what they want from you...

I just got an appt. to a good hep dr. (thanks Goof!) YEAH! Never thought they would call. They want me to get all dr. notes for the past two years, all labs, and any scans, biopsies etc. before I go in. NYgirl, it sounds like this appt. could cost me $600. like yours. I know it will be worth it. Hopefully my ins. will cover it.

[ladhill]

I live in portland oregon. I can't believe how slow everything is moving!! Do you live in San Francisco? I lived in SF and peninsula for about 13 years. It's a great place to live!

[sfbaygirl]

It all seems to take forever to get to tx. Let's see...I had my new PCP (Primary Care doc) refer me to a GI in Dec. and it took until March or April until I had my meds and was ready to go. I got no biopsy, because my doc believes they are unnecessary if you are going to treat anyway. NOT TRUE! I think everyone needs either a biopsy or a fibroscan to make tx decisions.

Hey welcome to our forum! Could someone post the acronyms for Ladhil? Thanks

[GrandOak]

Good luck and please pass along any information you find on this topic.  It would appear the Phase III trials of VX950 must be a matter of National Security that Homeland Security has under tight wraps as it seems to be the hardest thing to get information on that I've ever seen.

Everyone points to the clinical trials site, which that last time I looked was still posting the status of accepting candidates for the Phase II trials, that has nothing to say.  Even contacting Vertex directly results in a response, that you receive one month after you're inquiry, which simply points you to the trials site.

chcnme: The only information I've seen on Phase III trials suggest that it is for non-responders, which obviously are not naive patients, and may also included relapsers as the major thrust as I understand it on these newer drugs is to obtain a kinder more effective treatment.  As I understand it, Phase II was for naive patients only.

[chcnme]

Hi lad.  Hi sfbaygirl (sf, i've concluded - the missing link??? It's a conspiracy -lol!)  

Lad, It sounds like you've never treated?  The PROVE1  (VX-950 trial) from my understanding has done all the recruiting they're going to do in the US (in other words - that trial is full, at least in the U.S. from my understanding.)  It was for treatment naive patients  (those who have never treated.)  I couldn't get in because I'd had two prior weeks of treatment in 2003.

I think their next trial will be for nonresponders (from my understanding it will be reserved for those who have had a minimum of 12 weeks or prior treatment and did not respond.)

If you can find a site in Oregon where VX-950 will be recruiting for their upcoming trials, you can probably get more information about the trial  (but not necessarily.)  But if can find a site and show an interest in participating in their trials, you indeed might get more information from the doc or research coordinator, but again - not necessarily  (not unless you are chosen to participate.)  

This might help you some (link below).  You can write them (and you can call, them, too.)  I think they respond with generic letters (in other words, they don't answer very specifically or answer all your questions, necessarily.)  But write them anyhow!


http://www.vrtx.com/clinicaltrials.html

They have a home page, too, with info on Hep C, their drug VX-950, press releases, webcasts, etc.  


There is a clinical trials site, too
www.clinicaltrials.org  

(I think that's the link.)  You can type in VX-950, hepatitis c, in the search box on that site, and it will give you information on the VX trial that has already recruited  (and I think it is totally full in the U.S. and has stopped recruiting in that trial).   It also shows the trial sites (where they are conducting their research.)   Clinical trials dot org (or any other trial information site)  will not give you any information on any upcoming trials until the trial has been ironed out and all criteria decided upon and formally announced (at least that's how I've always found it to be.)  

Best of luck!

[NYgirl]

Yay for you!!!!!!!!!  YAY YAY YAY!  I know jUST how you feel it's almost like getting permission to get an appt with a rock star isn't it? hahahah.

Make SURE you have all of your questions WRITTEN DOWN in a notebook (so you can take notes. I put each question on a different page so I could scribble away while he was talking knowing that I would never remember all of the info!)

I have to fight my insurance company - they are really junk (not the word I want to use). There is NO reason they shouldn't pay the 80% or whatever it is for out of network. I don't know why I am such a lazy chicken....but man $600 is a LOT of money!

Even if I don't get any back though - it was WORTH IT.  Just knowing that a real EXPERT wasnt going to jerk me around with psuedo answers ... knowing he KNEW the RIGHT answers ... knowing everything I wanted to ask I could...worth it worth it worth it.

I can't WAIT until you post!  YAY!

I am SO Happy for YOU!  :)

[FlGuy]

I also paid out of pocket for a similar consult. Best money I ever spent (will let you know for sure in 40 weeks).  Prioritze the discussion, the time goes fast - start with the real important stuff.

[sfbaygirl]

There is a website that gives all the Vx trials. Try googling Vertex or VX950 trials. Someone here has the site..I don't.

Phase 3 was written about a few days ago. Damn, I think it was deleted. Anyway, remember there are some strict restrictions when you get into trials, like no rescue drugs, blinding etc. You might try the archives on some of this, but we have about 7 people here in the VX trial now, about to be unblinded.

Did your PCP give you a VL (Viral Load) test? And GT (genotype) test yet? Those are good to have. Also a CBC to get a baseline. Get copies of all your labs and tests, it is really important. I have all my labs sent by fax to me. I usually get them before the dr's. If I don't understand them, I come here and ask. What are your LFT's (Liver Function test) The ALT and AST on the CBC is how you know your LFT's. Using those acronyms, you will get the hang of them. It doesn't take long.

[Forseegood]

hey, wasn't referring to you, this place is just getting stranger and stranger...

[willows]

My doc gave me a little info, he's getting his hospital accredited for the Phase III trials and wants me to try VX, I am a viral breathru, well, I never really cleared in the first place.  Had 100,000 at 12 weeks, which in 2003 was okay, it was a two log drop.  But at 24, I had 800,000 so he made me quit.  I started at 2,000,000 so there was some good going on, but with new protocols today, I probably would have been bumped at 12 weeks.  He called me a viral mutator and said my profile was not perfect for Phase III, but he would put me on it anyway.

So you are correct and Phase III is going to begin, he hopes, in about March of 2007.  So I wait and pray.  Non-responders, relapsers and viral breathru, we may get our chance very soon to try the magic pill.  Good days to us all til then.

Willow

[GrandOak]

Sounds like you may have an inside track, so I hope you'll keep us posted.

Like yourself, I was classified as a VB nonresponder one month ago after 10 months of tx.  Baseline VL 72 million, 6 wk 2.4 mill, 12 wk 1.8 mill, 24 wk 2.9 mill, and finally 40 wk 4.4 million.  Fortunately, last weeks AFP was 6.9 ng/mL so apparently no HCC yet, but Hgb was still only 11.6 after 3 weeks of no Riba which is a bit disappointing despite me feeling better.

Being stage 4 already, I've interested in considering more options that sitting around for a couple of years waiting for new meds to be added to tx.  VX has been looking most promising, despite 10% rash incidents I've been hearing about, but it's appearing to be a very closely guarded secret as to where it's at and where the next Phase is going to be tested.

[sfbaygirl]

Yep, I am excited to be going to the "rock star" office. It will sure be a difference from what I am used to. "Ah, are you on tx?" I hope the ins. will pay, of course I havent' heard from the GI with a referral. My PCP will give me one, but thought it would be better coming from the GI. The doc is in my network, not my group though. GI said it was really hard to get them to let you out of the "group." So we shall see...NY, you have Dr. J monitor and consult with your dr? I do see a battle with ins. on extending, but I may qualify for the free drugs. The percentages on these studies seem to make extending a no brainer when they go from about 33% at 48 to 67% at 72 weeks with my VL at 10 weeks. At least it was low, but I think I want to cover my bases. Going 48, stopping and feeling like **** for 6 months, relapse?, Re-treat for another 72 weeks, feel like crud for another year. Treating once seems to be better odds and less toxic all the way around. I still haven't decided of course. Perhaps Goof's dr. will tell me not to extend...then maybe I won't.

I think I will need a tape recorder to remember everything. I tend to take "little breaks" when people are talking or I am watching TV. Thank goodness for Tivo, if only we had a Tivo for conversations...LOL

[APKhaos]

GO said,"The only information I've seen on Phase III trials suggest that it is for non-responders, which obviously are not naive patients, and may also included relapsers...."

THis is another perfect example of why you should be careful about what you read on the 'net. What GO said is a complete confusion of terms. Not intentional, but very misleading.

Phase 1, Phase 2, Phase 3 are the stages of FDA testing and approval. These Phase numbers have nothing whatever to do with the name or number of the clinical trials that take place in each Phase of FDA testing.

The VX950 Prove 1 trial was for treatment naive Geno 1 subjects in the US. The VX950 Prove 2 trial was for treatment naive Geno 1 subjects in Europe. The VX950 Prove 3 trial is for non-responder Geno 1 subjects in the US.

ALL OF THESE ARE FDA PHASE 2 TRIALS. You have not seen any information on Phase III trials, because none has been released.

So, Prove # trials are the name Vertex has given to its various clinical trials. Phase # is the stage of FDA testing. The two sets of numbers are completely unrelated.

[honey11]

Hey,,just saw you are still at stage one! High Five! lol  I also remember your pic from OOB and that you had long,,really pretty hair and sorry if I said that here, the other night! I apologize!

[Forseegood]

no worries Honey, always good to see you post! this place can get so silly sometimes, can't it? maybe the too few shopping days till xmas? ha ha ha! Be well Honey Girl, and have the best holidays ever, same thing to everyone who reads this!

[APKhaos]

Shot night for me last night, so maybe a slight overreaction was possible. Still, facts is facts, right?

[chcnme]

Hey, I'm thinkin' maybe it's the Vertex Cops on-line :)   Da** it's weird to me that thread just wound up gone. You're right - it's like a matter of Homeland Security!  Hope you're doing well.

[APKhaos]

We're good. It has been getting a bit weird here lately, so I'll try to cool it down early rather than have it get silly.

Sounds like you are doing well, which is just as it should be!