vertex Prove 2 update 12 week group vx-950 and Peg

Message from hospital today. could I come in to discuss my last RNA results on thursday with Prof Dusheiko. Rang doctor. Its back "virus reactivated" she said. Viral load 1,000,000. Seems a shame to post this. Feeling bleak at the moment.   Back to the drawing board, it seems. She said to me "Its little comfort but you're not the only one". The journey continues. genotype 1b 55 yr old male. finished treatment 29th march Group D 12 weeks Peg and Vx-950

[mremeet]

Sorry to hear it nick, it seemed like you were going to defy the odds with your initial post trial UND. Must be tough to face up to, but you can always have at it again with ribavirin next time if you're feeling up for another round later. In the meantime enjoy a well earned break and sort your thoughts out in preparation for your eventual next move. I stopped my drugs a week and half ago, and the anxiety's starting to build for me too. I'm trying to be prepared for failure if it comes to that, if it happens, hope to take it as bravely as you have. Take care, and keep us posted.

[nick m]

Thanks. That was right on the money. I needed to hear that.The dispassionate scientist in me sees that it worked to a point and the riba is the next logical step but.... just for this moment, the child holds sway. And saying that, i'm glad i did it. "reconaissance by battle" as they say.

You're right about the break too. Thats definitely the next step!

Well done on reaching end of treatment in your particular odyssey. I wish you well. Thanks again. Nick

[nick m]

Thanks. That was right on the money. I needed to hear that.The dispassionate scientist in me sees that it worked to a point and the riba is the next logical step but.... just for this moment, the child holds sway. And saying that, i'm glad i did it. "reconaissance by battle" as they say.

You're right about the break too. Thats definitely the next step!

Well done on reaching end of treatment in your particular odyssey. I wish you well. Thanks again. Nick

[GrandmaA]

So sorry to hear about the relapse. You will be UND next time.
Thanks for sharing anyway. Take good care.

[web52]

nick, thank you for posting your results. i'm really sorry to hear about the relapse. i know it must be tough. although your present results are disappointing, it is very important information for me and others who read this board.  i'm sure the prof will discuss all the possible "next steps" with you when you meet. please keep us updated on how you're doing. i'm finishing up prove 1, 48 week group, in about 4 weeks. like mremeet, i'm also starting to think about life after tx and hoping my response holds. best of luck to you.

[Cheesegrater]

Reading this sort of thing,... well, I guess reality sucks.

I am always sorry to hear this sort of thing, especialy from someone in a trial with hopes high.

Keep up the fight.

Cheesegrater

[miked]

Nick,

Other that sign-on names, nobody really knows each other here.  I too failed SOC and I took it as quite a shock.  As a felloew human and HCV patient my heart goes out to you.

I've  been reading your posts for sometime now and have been awaiting your outcome; especially with the short tx duration and lack of Ribavirin.  I truely believe that Ribavin is a requirement for SVR  and the optimum timeframe for tx is 6 months....just my gut talking.

I'm week 6 into Prove 3 and know that I am getting Ribavirin.  I also believe that I'm getting the VX-950 and not a placebo because of the taste thing, nausea, etc.  We'll see if I'm right.  For me the big news will be if I'm in the arm of 12 weeks of INF+RBV+VX950 followed by 12 weeks of SOC.  Or in the 48 week arm of VX950, RBV and INF (which I personally think is overkill).

When I failed my first tx after 32 weeks of hell, it took awhile to dust myself off and continue on.  Even though I wasn't cured it did feel good to have my energy back, start running again, listening to music (I love music and loud sounds drove me nuts), going out publically again without the Interferon gaze....etc.  I wish the same for you.

I also wish that your next go around will result in the elusive SVR for us 1b's.

If I'm correct I believe your English, right mate?  Relax and enjoy a non-alcoholic pint over a premire game or two.

Mike

[zazza]

I am so sorry to hear about your relapse. The initial shock is devastating. I feel for you. I guess we can't do without riba in the mix. I have been reading your blog and following your treatment. Thank you for telling us. I wish you the best and SVR in the future!

[orleans]

We all were hoping that the 950 would do the trick w/o the dreaded RIBA. There is only one way to find out and that is to find some brave souls willing to give it a try. thanks, jerry

[LSRL]

So sorry to hear your news.  I understand a bit how you must be feeling, as I relapsed too.  Also geno 1b, 48 weeks SOC, UND from 12 weeks, then relapsed at 6 months post-tx.  It's tough to take, but gradually you adjust to it.  Not fair at all.  I hope someday both of us will be one of the lucky ones who has an SVR, as well as other relapsers and nonresponders, for we're not alone.   For now, enjoy NOT taking meds and getting back to living.

[Happyhungry]

Nick

[pln]

Nick- I am so sad to read this, I too as you know have been following your treatment, and this really sucks!!!. In prove 1 if we relapse vertex will pay for 48 weeks of soc. So we know you can clear and that is the best news, just need some riba and a little more time.
I will keep reading your blog, because I know from now on it will only get better. Good luck.
Pam

[purplecat]

I've been watching your blog waiting for update since 28April.  Thanks for posting.  Sorry to here news.  I'm a Prove 1 who did not get the VX, got placebo so I've been getting regular INF/Riba on week 40/48.  I took the chance of getting the VX and lost.  That info was disappointing.  Because of the conservative protocols followed by Vertex they lowered my INF for 3 weeks shot 8/9/10. My ANC got down to 560.  Under SOC they would not have lowered dose and possibly if dropped below 500 have gotten the neup rescue drug. I have the aching feeling due to being in this trial I've severely compromised my chance of SVR after suffering for 48 weeks. Your positive side is that you only treated for 12 Weeks total.  Looks like 24 weeks with VX/INF/RIBA is the best results for geno 1.  

If I relapse I will work on healing and gear up for retreat once VX approved.  Get ready, get you body in top shape, 2009 is not far away.        

[friole]

I am sorry.  We all want the Teleprivar to be our panacea.  Thank you for posting.  I hope, in time you will be able to retreat, perhaps with the new cocktail which will include Teleprivar and Ribavirin.  The more I hear, the more it would seem than Bertex does not have a stand alone solution.

Do take it easy and heal.

frijole

[APKhaos]

Must be devastating news, all the rationalisation aside. One of the nasty aspects of clinical trials is the arms designed to test the envelope, and your no-Riba arm certainly looks like one of those. Hindsight is 20/20 of course.

Really sorry to hear about this. VX950 is almost definitely strongest in combination with SOC, and maybe the 12 + 12 dosing at that. I guess we won't really know until the 24 week post tx numbers are accumulated from Prove 1 [I was an early starter on 12 + 12 and almost six months post-tx now], Prove 2 and Prove 3.  

Its rough enough for naive treaters like us Prove 1 rats, but to have failed SOC and then get hit again in the trial must be brutal. Feeling for you on that score!

[Forseegood]

really sorry to hear this, but it seems your head's screwed on right, and I'm sure you'll prevail, albeit with a different configuration perhaps?...all the best to you...

[dointime]

Nick, what can I say?  I'm so sorry.  I've been in the same hole and it stinks.  If you're anything like I was you may need to sit and stare at the wall for several days just to digest what has happened.  

The good news - when you're ready for it - is that it is almost certainly the lack of ribavirin and not you that was the problem.  I spent some difficult weeks wondering if I was going to be a hard-to-cure case that would have to fight this virus for the rest of my life.  Actually, when I got the riba I was UND within 8 weeks.  I'm still on tx so the jury is still out on the SVR part.  

All the best for a great drug-free summer and for your next virus-killing spree,

dointime.              

[Happyhungry]

Nick