any info on VX950 protease inhibitor

[orphanedhawk]

I heard that the FDA just okayed the use of vx950. Does anyone know anything about this ?

[APKhaos]

Early Phase 1 trials last year were encouraging, but not definitive. First small Phase 2 trial early this year [VX950 + SOC Peg and Riba] produced strong efficacy results, although only 12 subjects.

200+ treatment naive subjects are enrolled in the current Phase 2 trial - Prove 1. Early starters are around week 13 of what will be 12, 24, or 48 weeks for each arm of the trial respectively. VL information may start to become available one all subjects are unblinded around week 20.

A similar large study for non responders is in the works for early 2007, although I suspect this will be somewhat dependent on early results from the Prove 1 trial.  

VX950 was recently granted FDA Fast Track status, which should speed up the approval process IF the trials confirm good efficacy and no safety issues.

[NYgirl]

Trials only - several members in here are in them (three I think).

Most of us remain with regular old combo.

[Upbeat]

Not likely.  No news on their web site and stock price is down today. If it had been approved I would think the stock price would be soaring.

                                                 Ron

[APKhaos]

Full disclosure: I'm in week 13 of the VX trial. There are at least four other regular posters here who are in the trial also:

PLN, PrettyDamnScared, mremeet, LabRat and TravelMom are all in the trial, although mremeet stopped VX dosing early due to a nasty rash issue. PLN has rash problems as well, but said today that she will finish her final week of VX dosing.

There may be others here who are in the trial , but they are the names I know for sure.

[jmjm530]

In case you missed it, I posted to you about a dozen threads down in "Skin Part 2"

[APKhaos]

Sorry if I missed it! Just scrolled down Skin Part 1 and Part 2, and didn't see your post to me.

FWIW, your skin condition is definitely the toughest side I've read about. You are a man of steel to hang in through all that!

[jmjm530]

Thanks. It was no amusement park ride :) I guess that's why I flew off a little at Mre who was telling folks to stop treating after a few weeks of a rash he never saw on them. I went 54.

Post was thread "Skin Part 2", post C18, about 13 threads down from here.

http://www.medhelp.org/forums/Hepatitis/messages/43220.html

[copyman]

have you had any side effects especially with the rashes a few of the other vx people had? do you think you are getting vx or placebo? good luck to you and hope you will post with any vx info when you get it.

[APKhaos]

jmjm,
got you covered on the other thread. Sorry I missed your post earlier!

copyman,
I've got a mild case of what look very much like the usual soc sx, including intense itching, a simple small dot rash on chest, arms and upper back, mild insomnia, and borderline anemia. Ambien deals with the sleep when required, a gallon a water a day seems to calm the itch a little. No dose reduction so long as the HGB bounces along above 10.0 [its 10.5 at last test].

I flat out don't know if I'm on VX or placebo, but my ALT and AST levels dropped from 124 & 79 respectively to normal range in less than 8 days, and have remained in the 20's since then. I see that as a good sign, but nothing will be certain until we are unblinded and get to see the VL numbers for the entire trial period. That will be a great day, I suspect!

[jmjm530]

Thanks for getting back and responding below. To summarize up here, out of your ten study "buddies" in the Vertex trial none... well, why don't I just use your words...

"...There are ten subjects in my group. Only one has dropped out so far, and that was due to extreme and unmanageable psych sides. None have serious rash issues..."

Hopefully this will put in perspective some recent posts on a rash problem reported by another member. I'd hate to see people discouraged, scared away, or given irresponsible advice based on a single treatment experience.

All the best moving forward, and that swift drop in LFT's certainly is encouraging.

Be well,

Jim

[APKhaos]

Jim,
This is a cross-post from Skin 2. Adding it here as another data point:

PLN said "There are 7 people in my [VX950] study only one had to droped out, due to the fact she could not handle the meds no rash."

The evidence is mounting. While we all must feel empathy for what is obviously an acute rash that MRE is suffering, there seems to be little clear evidence to suggest that his rash is due to VX950 specifically. At very least, we would expect to see similar rash issues in other groups in the study. We now know of two groups that have experienced no such issues.

[FlGuy]

But, are the groups sprinkled with both VX and placebo pts?

[APKhaos]

The distribution of subjects to the four arms of the study is randomised, with equal numbers in each of the four groups. On this basis, 75% of subects are receiving VX950. It is entirely possible [but improbable] that any small study group could contain all placebo subjects. Its more likely that the majority [or all] of a given small group are VX-950 subjects.

[mremeet]

Actually the odds are not quite 25% for getting placebo. They shrunk the size of the 12 week group down to 20 people (from 80 if memory serves), which elevates the odds of being in the control group to roughly 30%. This may come as a surprise because they did not ammend the contract to reflect that important fact prior to the initiation of the trial. But if you go to the vertex website you'll see the revised group sizes and the subsequent odds of random enrollment into each group.

[jmjm530]

APK says: The evidence is mounting. While we all must feel empathy for what is obviously an acute rash that MRE is suffering, there seems to be little clear evidence to suggest that his rash is due to VX950 specifically. At very least, we would expect to see similar rash issues in other groups in the study. We now know of two groups that have experienced no such issues.
-----------------------------------------------------------

This is really the important point. I'd just ammend that to say that even if MRE's rash was caused by VX-950, such a severe reaction is uncommon with the rest of the study participants that you, PLN and LabRat have reported on. Maybe there was something in the placebo pill that MRE was allegic too :) Just kidding, MRE and no hard feelings at all. I posted to you more in the skin 2 thread below.

-- Jim