Avatar universal

a question for the treatment-experienced out there

I have a shot at getting into the telaprevir Phase 3 trial in the very near future.  I've been waiting for this for a while, but now that I got the call from the study nurse I'm having second thoughts.  Those of you that have treated with or without telaprevir---would you do it if you were me?

Here's my profile: male, age 50, genotype 1b, stage 1 grade 2 (from last year's biopsy), score of 18 on Fibrosure (which means "F0-F1"), viral load somewhere between 200 and 800 thousand (it goes up and down), probably have had hep C for over 30 years.

The results from the Phase 2 trials are encouraging, and I've already decided that if I treat, it's got to be with something more than SOC.  My GP says that with my mild damage I shouldn't be in a hurry to treat at all and advises me to wait until telaprevir comes on the market, probably in 2011.  My hepatologist is more aggressively pro-treatment but says I could go either way.

Anyone with any opinion about this, I'd love to hear from you.  Thanks in advance!  
10 Responses
Avatar universal
i would wait. trials have far to many drawbacks. bad arms, too many treatment
restrictions, no rescue drugs etc.  if you can jump over all of that, do it.
86075 tn?1238115091
do you know the parameters of the trial youre getting into...first and foremost, are they allowing rescue drugs? At what point? Find out as much as you can....I'd find out all of this beforehand from the trial coordinator to bring a little more info to your ultimate decision, you do have little liver damage at this stage, that is true...
Avatar universal
I asked about drugs for treating anemia, like procrit, and they said they won't be allowed.  

One reservation I have concerns viral resistance.  If I understand correctly, with telaprevir if you don't get SVR, you get a viral mutation which is resistant to telaprevir and means that telaprevir is useless to you forever after that.  So then it would be an advantage to have the rescue drugs, to be able to keep on the therapy as long as possible, no?
362971 tn?1201987034
    In my opinion as long as you feel ok right now I would wait. Most people don't feel anything but some people have extreme tiredness as a side effect of HCV. If this is not you than you can wait to see if Telaprevir is approved. If it is approved the treatment should be shorter, 24 weeks instead of 48.  
    If you get into a trial you don't now which arm you will be in. They are usually double blinded. An f0-f1 is pretty good. Just take care of yourself until 2011 and then check things out again.

80575 tn?1207132364
Your stats look almost like mine.  50 years, geno 1b, 30 years infection, mild damage and inflammation.

I started the Prove 3 trial in May of 2007.  Unlike many here, I lucked out by getting in the trial Arm with the real deal (VX950) and Ribavirin.  I also lucked out by getting an RVR by going UND somewhere between Week 1 and Week 2.  At 12 weeks post tx I was still UND and hope I'm still that way in March for 24 week post tx which means cured.

I just got lucky.  Period.

Others here like Susan400 got into a trial Arm without Ribavirin and relapsed.  WCMissy got the placebo and I think is about to roll over to the real deal.

Going into Prove 3 I knew that I had a 50% chance of receiving VX950 + Ribavirin.  Only one Arm was for 24 weeks (mine) and one for 48 weeks (a guy here named Andiamo1 is just about finished with this Arm).  Day one I knew that if there were no pink pills (Ribavirin) given, I would drop out.  Resistance to VX950 happens like someone said above.

I knew that I wasn't getting the placebo because about Week 5 into the trial I got the rash from hell that moved around my body.  It itched like crazy but ensured me I was in the right Arm.

I'd find out all of the parameters of the new trial, look at your percentages of getting VX950+RBV, evaluate how you are feeling right now, and decide.

In trials luck is a huge factor.

Avatar universal
this phase 3 trial odds are much better at getting telaprevir. most will have a very good chance at getting the "real deal", all three drugs. good luck with what ever you decide.
189269 tn?1189755825
Are you In MA I am also starting the VX950 trial sometime in May
412873 tn?1329174455
I'm geno1, vl 2,000,000 and will have a biopsy next Friday (14th).  
I also have a "shot" (no pun intended!) at getting into this trial and will be watching to see what everyone has to say.
I have atopic dermatitis, which I hear can contribute to the rash that is considered a pretty major side affect, so I don't know if I will get in or not.  
I was under the impression that everyone would be getting all 3 drugs in this trial-no rescue drugs-but they say they have other drugs-in place of procrit and some of the other rescue drugs, so that makes me want more info....
I am healthy otherwise, so there is lots to think about before May

Avatar universal
i had similar stats, got into prove 1, august 2006, did 48 weeks (12 weeks vx950, riba & int, plus 36 additional weeks of soc). und by day 21 & und 6 months post tx.
at 54 i was in pretty decent health & didn't want to wait to treat till i got older & sicker. tx was tough & i'm glad i got it done. the dragon is no longer breathing down my neck, and that is a big relief. good luck to you.
Avatar universal
I like your thinking of wanting to treat with more guns than SOC. But given you minimal liver damage, I'd be patient and wait to see how the trials play out. Some protocols doubt (ARMs) no doubt are going to do better than others. If you wait, you can be in those ARMs. Also, as mentioned, you will also have more flexibility plus in terms of individualized treatment plus a full arsenal of meds standing by, such as the helper drug Procrit (epo) assuming it's not allowed in the trial.

-- Jim
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