VX-222 trial coming up

Hi all!  I've been keeping arm's length from this forum, but have been hugely thankful for all the info I'm learning.  Me- 39, 220 lbs, diagnosed geno 1a in Sep2009.  Viral load 868.  Doc and I decided to wait a few months and retest.  Retest in March2010 showed viral load 50,000.  So now I'm wondering how to finally take on this dragon most efficiently.  Of course I'd love to treat for 6 mos in one of those Telaprevir studies and get the heck outr of here but that doesn't look like it's gonna happen.  My Dr wants me to treat with SOC, even though I have some trials available to me.  He says it will have less sides and if it doesn't work there's always somewhere else to go with treatment.  If I do the trial and it doesn't work it's kind of the end of the road.  A trial coordinator seems to think differently.  She thinks treating with one of these new trials with 80%+ chance of SVR is the way to go.  Seems like they treat a lot more people than my Dr too.  In June they are starting a 48-week trial with VX-222, Peg, and Rbn.  I'm thinking of biting the bullet after hearing such great things about this drug.  To boot, I just started a new job and would hate to just quit after only a few months, if it comes to that.  So I have two questions for the rest of you...1) What's your thoughts / comments on working while treating?  My job is software based sales but involves travel here and there.  and 2) What's your thoughts about getting into this trial?

Thank you for everything you've done.  Huge applause goes to those who have beaten the dragon and still hang around to help us who have not (yet)!!!

Adam

[nygirl7]

It's a tough decision Adam one that really only you can make.  I do see both sides of the coin though. Have you had a biopsy yet do you know if you even really NEED to treat right now or is it more that you can't decide which treatment to do since they are both available to you (like are you just going to treat regardless)?

I'd go for the tele or boce (probably boce) if I had an option today (back when I treated there were no options).  What is Vx-222 about?  I think the PIs are a miracle but in your case just starting a new job the 'trial' part of it might be the hard part.  You have to mjake sure you get the PI and also that they will let you use rescue drugs if you need them - that can make the difference between functioning and not functioning, especially with a  new job.  That to me would be the difference between a make or break deal - doing SOC if you could get the rescue drugs and not doing the trial if you  couldn't. (I couldn't have made it without Procrit)  You have a very very low VL which can be a great indicator that you will succeed (i hope I had a regular old 568k low VL and it took me longer to get to UND as happens sometimes, don't know why).

I have to admit working....I missed 3 days in 72 weeks.  Thought I was a major player because I came in faithfully every single day. I didn't realize until later though what a crappy job I was doing. I thought just making it here was enough some days - now looking back I remember taking naps at lunchtime and wearing slippers sometimes boy I was a bit out of it!  Still many of us have done it and made it through and kept our jobs intact (although my boss wanted to fire me I got promoted instead go figure!).

There is SO much to consider with it all but to me the bad part about the trial is if you don't succeed you are out of luck right now.  I don't know the drop out rates due to rash and sides but if you do go for it and get that PI you have to also make sure you are definitely getting the riba too - you NEED all three of them and you'll have  to follow through till the end.

Gosh so much to think about most people don't have the options you have.....it makes it harder honestly!!!!!!!!

Nice to see you again I remember talking a while back!

Deb

[WriteItDown]

Can you please tell us the specific trial number so that we can look at the trial design?

The only trial I saw on the clinical trials web site with this compound, it is being tested both with and without standard of care drugs -- some of the trial arms have both VX -- 222 and Telaprevir WITHOUT peg or riba. is this it?

By the way, I think that VX -- 222 is a polymerase inhibitor.

Also, some trials have a requirement that your viral load not be too low.  Is this not an issue on this trial?

[adamben101]

Thanks for the comments so far.  The trial I mentioned is listed as NCT00911963.  It uses VX-222 (a Polymerase Inhibitor, oral), Peg and Riba.  VX-222 is fairly new on the block.  However it's use in previous trials has been nothing short of amazing.  One trial last year used it for only 3 days before starting regular Peg/Riba treatment and average drop was >3.1.  That's in only 3 days and without SOC.  My trial coordinator says the stuff absolutely decimated the virus.  This trial would be typical SOC (48 weeks for geno 1a) with the addition of VX-222 for the first 12 weeks.  More on VX-222 available at http://www.medicalnewstoday.com/articles/185729.php.

[adamben101]

Deb, to answer your q's, I have not had a biopsy yet, but I realize the importance and am working on scheduling one for the next 30 days.  The trial recommended a good one to use.  Also, this trial center uses rescue drugs if needed - I made sure.

One other trial coming up is pretty interesting...It uses 4 arms with VX-222 in all of them in conjunction with Telaprevir.  All patients get both and for those that are UND at 2 and 8 weeks, ALL treatment stops at 12 weeks before any Peg/Riba.  Now that's pretty cool!  For others who don't meet those reqs, treatment continues for 24 or 36 weeks with Peg/Riba.  None stay in the typical 48 weeks.

[WriteItDown]

Okay, I think it's entirely possible that this is a great drug; however, the trial you're considering is a phase 1b/2a trial, i.e. this is a pretty new drug in the protocol for treatment has not been ironed out yet.  In my opinion, you should have a biopsy, as NYgirl advised, and see what stage you are.  If you are still at a low stage, and since you are treatment-naïve, I would hold out for a better, later stage trial.  As a treatment-naïve patient, you are in demand, and should wait for the best possible trial if you can afford to.

I disagree with your doctor that you ought to treat now with standard of care, or at least, and absence of a biopsy, I think he's being premature in advising such. There are many excellent new treatments on the horizon, and both Telaprevir and Boceprevir are likely scheduled to come out in the next year.

Again, this VX-222 could be the best thing since sliced bread, but I would rather eat that bread after more other people had eaten at first, so I knew I was getting the right amount.

[nygirl7]

I agree with WID wait and see what your biopsy says - if you have time you get into the BEST most studied of all the trials and take complete advantage of all of the new drugs possible...rather than an 80% chance what if you could grab 90% odd?  Of course I know nothing about these trials and just want to see you CURED - that is most important thing of all.  I don't think you are in any rush unless your bx comes back very late stage......here's hoping this is the best thing since sliced bread!!!!!!

[adamben101]

Hmm...are there any 90% studies?

[Marcia2202]

Safety and Tolerability Results

Safety and tolerability information collected for Part A of this trial remains blinded and thus the safety information provided today includes pooled data for patients after administration of placebo or VX-222. Placebo or VX-222 were well-tolerated across all four dose groups, no severe or serious adverse events were reported and no treatment discontinuations occurred. All adverse events reported after administration of placebo or VX-222 were mild or moderate in severity. The most frequently reported adverse events occurring in at least two patients per dose group were diarrhea, headache, nausea, asthenia and fever.

[adamben101]

So that's good, right?  Do you have an opinion on what you posted, Marcia?

[willing]

as writeitdown wrote,  tx-naives have a number of trial options to choose from at this point ( with many more coming).  Choosing one is a bit like placing an investment bet - how risk averse are you?

At the low end of the risk range is the boce trial (NCT01023035) - having pretty-much completed phase III, the likelihood of surprises is very small. Next is probably the r7128 phase IIb ( NCT00869661). Their RVR stats are better than boce/tela and the drug has successfully been through a number of  trials   (several here have participated). The BMS-790052 Phase IIb is probably next in line. The phase IIb doesn't seem to have a trial id, but the phaseIIa results just  presented at EASL10 were very good (see the thread started by uncledudeness). The VX-222 trial seems at the high end of the risk/return range. On one hand it includes a polymerase-inhibitor still in early testing, however  it also offers the combination of 2 independent DAAs plus SOC - which is likely a golden ticket to SVR. There's also the issue of the tela-rash to weigh into the equation.

A key problem in making your decision is lack of data on home much liver time you have. If a fibroscan or bx show you are still in f0/f1 territory you can easily afford to wait for both protease (2011) and polymerase (2014) approval. Good luck!

[winner727]

willing and writeitdown  have great points . everyone really .    i would want to know my liver damage before making that decision . i will add , i treated SOC , genome 1a ending in jan 09 , & got a big fat UND .  grade 2 / stage 2 .   good luck, whatever you choose .