Anyone completed VX-950 trial who didn't clear?

[ChrisDDD]

I know this data is probably on here somewhere, but sometimes I can't tell when people say they've cleared if it was SOC or VX-950.  I know there's UND, EVR and SVR.  I'm interested in knowing the answer to this question.  Thanks!

[jmjm530]

Currently, we only have a handful of people here on VX-950. There's PLN, Mremeet, APK, Pretty Damn Scared and I'm probably forgetting one or two others. Beyond those, most everyone else is on some variation of intereron and Ribavirin, with the vast majority either on Peg Intron or Pegasys plus ribavirin.

UND (undetectible) means no virus to the limit of whatever test is being used. UND is most meaningful when a very sensitive test is being used. Some tests now go down to 5 and even 2 IU/ml.

EVR (early viral response) means a two-log or better drop by week 12. Some might definie it as UND by week 12.

RVR (rapid viral response) is like EVR but by week 4.

SVR is when you are UND six months after stopping all treatment drugs. This is what we all shoot for. Studies show SVR to be durable out to 5 and ten years and longer at close to 100 per cent, especially after UND for one year after treatment ends, and there  is no reason to believe that SVR is not durable for life.

-- Jim

[jmjm530]

LOL. I answered your comment but forgot to answer the quesion in your subject line. I think the answer is "no" among those who belong here. We may have heard of a drop out or two but not a relapse and I'm sure others more knowlegeable will chime in. But keep in mind that we currently only have week 4 data for the 24-week ARM of the trial and week 8 and week 12 data will be more informative -- as well more complete data yet to be published by Vertex. That said, the two here who reported their four week post treatment results were both non-detectible at week 4.

-- Jim

[dointime]

There was one very brave person who got VX950 who reported viral breakthrough at day 21 and never cleared.

[mremeet]

Chuck (crsph?) had a rebound during treatment with the VX. He's the only one I know of this has happened to, although we're not a huge number of people here.

[crsrph]

yes i was the only one on this board with the vx950 who didnt clear that i know of vl start was 10 million was down to 18,000 by day 8 after that it was back up to to over 7 million in dec feb 1 million was on tripple for almost 12 weeks and soc through feb 1 person on my site also didnt clear ( a group of 10 ) a couple of people were in trial never reported back at least 3 from this site. still looks to get about a 80-85% clearemce rate on tripple quite an improvement in my opinion

[ChrisDDD]

Thanks to everyone who answered.  I'm eager to see as much info as possible ...

[GrandOak]

Let us expand the question a bit further and see how many were afflicted with the horrible rash which is reported to hit 10% or more of those who received the drug.

Some of the dropouts I heard reported where due more to the inability to handle the rash sx which appears to be abnormally high, at least according to my doctor and some of the reports I've read.

[dointime]

I got the rash in my 2nd week of tx.  I looked like spiderman for about a week.  It scared the heck out of me but it went away and hasn't come back so far (I am in week 9 now).  I took OTC antihistamines and they seemed to help, but I think overall that the rash just ran it's course.
dointime.

[mremeet]

Yeah the rash was awful, at least in mine and pds' case. It's interesting to hear about variations on it though, like what happened to dointime. When he first mentioned his rash, I thought almost for sure he'd be in for an awful situation and would have to discontinue. But as demonstrated in dointime's experience, obviously the rash can come and go in some, while in others it can become a full blown drug allergy, forcing one to discontinue. And the rash incidence was reported by Vertex as being 34% in a recent update on our consent form. The dropout rate within the first 12 weeks was 9%, or triple that of SOC alone. Although this stat is a little misleading, both myself and pds had a godawful rash, but we managed not to drop out - so we're not included in that 9%. There are probably a few more percentage points above 9% who were like us in that they had an awful rash, but managed not to quit.

But we have to remember that the reported incidence of rash was when VX was being dosed with IFN and riba together. I think it's quite possible the severity of the rash will likely be reduced somewhat if ribavirin can be left out of the equation (something they're investigating now in Prove 2). There's no doubt in my mind that ribavirin was contributing to my VX rash at least a little (as it still does today long after stopping the VX). Removing riba from the treatment protocol might also delay the onset of a rash caused by the telaprevir. And if the rash onset can be delayed, this would allow a prospective patient to take it longer, and therefore derive a more substantive benefit before having to stop.

[ChrisDDD]

Thank you again.  You guys are the best!  I check ClinicalTrials.org every day for sites recruiting for PROVE 3, and only Birmingham and Puerto Rico are currently recruiting, according to their web site.  My research assistant's prediction that my early June appointment with my guru doc will coincide nicely with the anticipated pre-screening for PROVE 3 is consistent with Vertex's web site announcing the commencement of PROVE 3 enrollment toward the end of the second quarter of '07.

I know the rash must be awful, but I'll deal with it if I'm lucky enough to get in if my eyes will just hold up, which I think they will because my blood pressure is now under control, and I never had any retinal bleeding on Peg.  I'll do anything to get rid of this #!*$^%g virus.  I don't want to get too old and too sick to treat, and also want to treat before, god forbid, anything else happens, like I get diabetes or something!

[ChrisDDD]

P.S.  Yeah, viral breakthrough would definitely be a problem.  I never got far enough on treatment to have viral breakthrough because I've only cleared once, at week 4 of monotherapy back in '98.

[GrandOak]

Thanks for sharing your observations.  I will be equally interested in seeing if VX950 w/o ribavirin is as effective as it is when used in conjuction with SOC.

Most study data I've seen or heard about has been either as a mono-therapy (which I understand was quickly abandoned due to ineffectiveness) or in conjunction with SOC.

I hope that they would also consider combining with SOC but perhaps a lower ribavirin dosage in addition to w/o ribavirin.  Particularily if they are shooting for their original intended goal of providing an improved therapy which increases the rates of SVR by 1) being more effective and 2) making tx more tolerable for patients.

[najeen]

I believe the issue with monotherapy in the case of VX-950 would be mutation and viral resistance. None of the new drugs can be used without the peg and riba at this point due to the above.

[TravelMom]

Just wanted to let u all know, was group C, cleared by day 10, stayed clear but showed a viral load at 24 weeks.. I was not able to take the riba due to an intense rash starting at day 4...so this I believe is the reason I did not stay clear.

Very upset, to go through this and not have cleared...luckily my biopsy shows stage 1, grade 0/1

Happy to hear the rest of the VXers are doing well...stay strong and knock em dead!!!

Best Wishes.
Jodi

[najeen]

I'm sorry to hear of this. You will win against this disease. I know the feeling of relapse. It is a blow. You fought hard. My prayers are with you.

[prettydamscared]

I'm so surprised and disappointed.  I thought sure you'd clear.  I am so incredibly sorry to hear this news and on so many different levels.  So, you got "the rash" on Day 4.  What a really tough break. THere's no way at Day 4, I could of toughed through that rash.  A couple months in to the rash and suicide was looking like a viable option.  I'm just kidding about that, but just barely.

Did you have to dose reduce on your regular SOC drugs during the first 12 weeks at all due to lack of being able to take rescue drugs while on the study?  I'm guessing you're not going to be waiting with bated breath for the telaprevir to come to market.  I'm pretty sure that when we're this allergic to it, that allergy may be here for good, which pretty much precludes our shot at taking Vertex again.

But, as you know, you definitely have options.  Perhaps after you've regrouped, are you going to consider the full course of SOC for Geno 1?  You're probably just adjusting to the news now. Please let us hear from you.  PLN and I have been anxiously awaiting hearing from you again and I'm so very sorry the news had to be bad.  Please keep us posted as to your progress.  We all really do care.

Charlotte

[jmjm530]

Very sorry you didn't clear. I'm sure you'll do better with another drug or protocol when the time is right for you.

A couple of things were unclear from your post and if you would be so kind to clarify it might help others understand a few more things about the trial and how the drugs are working.

You say you "cleared by day 10". Was your day 10 viral load test "29" or was it "<30"?  There had been some confusion in the past here regarding results.

Also, did you ever have a positive viral load test (such as "29") between day 10 and week 24, or were all your viral load tests between day 10 and week 24 "<30"?

You say you weren't able to take the riba starting at day 4 because of the rash. You do mean "riba" and not "VX-950"? I ask this because some others had to stop VX-950 early because of the rash, but I believe you're the only one that reported stopping the riba and continuing on with VX-950.

But assuming you did stop the riba, then you were on triple therapy for 4 day; then peg and VX-950 for the balance of the 12 weeks; then peg and VX-950 for another 12 weeks?

Lastly, how quickly did your rash go away after you stopped the ribavirin?

Be well,

-- Jim

[pln]

So very sorry to read this. could you please clarify this for me, are you saying you had to stop the riba at day 4? then being in group c you did 12 weeks of vx + soc, then 12 more weeks of vx? Thank you Pam

[pln]

one more thing were you still treating when you showed vl at week 24. Thanks

[jmjm530]

Assuming the riba was stopped at day 4 as stated, I think you meant to ask if she then did 12 weeks (minus 4 days) of Vertex plus peg and then 12 more weeks of Peg only. I believe that would fit the protocol minus the riba.

-- Jim

[pln]

Hi, Thanks that is what I meant. Yes that would be the protocol for group c, no one has done more then 12 weeks vx. so if she had vl in week 24 still doing peg would that be called a breakthrough and if done tx relapse. Thanks

[jmjm530]

Hopefully TravelMom will be able to clarify what drugs she took and how long, as well as her exact viral load results, etc. Hard to draw conclusions when we are somewhat guessing at things.

-- Jim

[ChrisDDD]

I as well am sorry you didn't clear and would be interested in the information others were asking about.  It's very disheartening and can also be infuriating.  I've been through it (non-response) three times.  I'm so sorry.

[JackABCD]

How can I know where Vertex open sites for Prove  ?