VX-950: Prove 1

Vertex just announced that they are beginning their Prove 1 and Prove 2 studies both in the US and Europe.  

http://www.vpharm.com/Pressreleases2006/pr052306.html

The first phase is still for tx naive people.  The IIb phase which starts in the 2nd half of the year is for non-responders.

The objectives for the studies are to judge effectiveness for short-term tx (12 weeks) and also for SVR.

They expect to have 1,000 people enrolled.

I've been reading all the comments about not getting your hopes up....but as a geno 1b non-reponder I have say I'm really encouraged by what's going on.  My hope is to some day close this chapter of my life and move on without the worry.

God Bless us.

[merlino]

I also have that info. I have never treated. Have appt w/Dr. on th 15th. Will talk with him about it.From what I read they will be finalizing the locations of trials this month. I have a number to call if you want.

[FlGuy]

Miked: Two weeks ago I checked with the Univ of Miami who does the vx trails. As a 3a relapser I was interested in vx trial as the next possible tx. They said they won't get to non-resp/relapsers til late 2006 or early 2007. They also thought they'd go after the 1's before 3's so I'm going to double date Peg and Riba again, sooner.
Merlino: Making progress, good. Did you find a doc in your area that's hooked into trials?  When you see the new doc make sure you tell him about the supplements, amounts, frequency.  As you go along this stuff gets a little less intimidating and makes you a little less nuts.

[merlino]

Hi,my appt. is with my Gastro. I am hoping the trials are either in Phila, or somewhere close to me. I have read the sx's for this treatment is tolerable, however if its the VX-950 plus Pegasus/Co-pegasus wouldn't the sx be the same.Since talking to you and others on site have done a lot of soul searching. I NEED to do something. If I cannot get into this trial I will treat with Pegasus/Co-pegasus as my Gastro wants. I simply cannot go on each knowing I have this alien in my body. At least now I have a place to go for help.

[RichCM]

Hello, when I first started to seek treatment, I contacted some leading hospitals in N.Y.C. (Columbia I think) They said they were having trials with the VX 950 drug. Since I am so far away from the city and you have to be monitored daily, this was not feasable. Just passing on some info. if you want to check it out.

[FlGuy]

With a gastro who has a lot of hvc experience you'll be able to get an idea of how the alien invasion is going. Will probably involve a biopsy though. Your liver may be in a condition where you can wait a while and watch for the new drugs to become available and maintain a healthy life in the meantime.  You're probably surprised about what you know about hcv already, not that you ever wanted or intended to be this knowledgeable.

[merlino]

The dreaded biopsy! I have been reading where many doctors are finding the results of the Fibrosure are extremely accurate. The results were from patients who had  biopsies and did the Fibrosure. So, what do you think? I won't have a choice if it is part of the requirements for the trials.

[FlGuy]

Until something else comes along (like Fibroscan) biopsy is the definitive test for liver condition. Although one of the scarier concepts of hcv, it's not so bad.  An outpatient thing they basically relax you, numb an area, find target area with an ultrasound, take a core sample(s) with a syringe and then let you rest on your side a while. With the waiting and laying around after it'll take around 6 hours - try to get the first appt. of the day. Not much residual pain or discomfort (my experience). This is one of those can't do it alone things (need a driver). But, with all the lab stuff it gives you a pretty complete picture and important in mapping out a plan with the doc.  The gastro will probably bring it up when you see her. You'll miss a day of work. There are some risks with a bx that the doc should inform you of.  Almost all the people here have had a bx and some of the ones that did't wish they had.

[Pdilly]

Is this only for those that are no responders?  When does the trial start does anyone know?

[Mister beagle bailey]

Bobby you'll be fine, I believe you'll clear this virus for good. Every thing will work out, you'll see.
See you in 2 weeks at the reunion, I'm looking forward to it.

Bob

[NYgirl]

What they "said" is that the sides are no MORE than regular Peg/Riba - since they add the Vertex in ADDITION to the first two what they mean is that it doesnt add any to standard treatment sides.

They kind of sneak it in there if you aren't looking you would think indeed that is says no sides - but it's not what it says at all.

As long as it WORKS that is ALL that really matters - I can deal with the sides I just want to kill the virus.

Treatment is DOABLE even if it's not FUN. I'm on week 36 out of 48 (or perhaps 72) and have only taken three sick days from work...it's not been easy but I need my job (and insurance)

[miked]

Sure, what's the number to call?  

I live in Indiana and there's no way I can do a trial in Miami because of the requirement of frequent checkups.  I'm hoping IU Med. Center is included in the trial.

There's one arm that will include low-dose ritonavir which is very interesting because it is being used successfully with HIV protease inhibitors to boost effectiveness.

Thanks everyone for replying.

[merlino]

Hi, Site information is supposed to be out by June #617-444-6777
the website is www.vrtx.com. I am praying one is in my area.

[bobbyullc]

i too have noticed the pesimistic comments but i have a real hope for sucess. if tx is shortened to 12 weeks and the svr rates go up dramatically i think it will be a real blessing. i am stage 3.3 so cannot wait ( week 38 of 48 now) but if i do not clear there is hope on the horizon.

the glass is half FULL.

hope you all have a good week.

[merlino]

It will start out with people who have never treated and then move on to non-responders. You call look at the web or call the number I forwarded to miked. Good Luck

[merlino]

Hi, hope you can answer this question. If I am accepted into this trial, which if for 24 weeks. If at the end of these 24 weeks and I don't respond will I just continue  with the Int/Riba for an additional 24 weeks or will I have to start over.