Beware lab rats

[wescoastgy]

Week 13 was told by my doctor you are no longer in the Vertex study per there request, must have been Riba and Interferon reduction because of low red white blood counts. After the rashes, headaches, brain fog, and the rash I have now I feel real disappointed, not even a we will take care of the rash you have now just stop taking the drugs and it will go away, gee thanks.

[GoofyDad]

1. West says he had the rash, I expect he means the vertex rash & not the riba rash... and also that someone can tell him the difference.

2, Some people have tried to determine placebos by tasting pills

3. If one was going to continue time would be of the essence.

4. Assuming one has insurance, a PCR is a normal test for a C patient.

5. I would continue on meds (asking for some donations on an internet forum if I could fine one frequented by hep c patients.

6. I would also get a pcr ASAP.

7. Based on results of PCR I'd consider whether to continue. If I was on vertex, I wouldn't  want to loose out on  the advantage it gave me.

8. All above depending on dose reduction amts and duration off the meds

9, I would not advise others to do what I would do. They can find their own path. But I'd wish them good luck on their way.  

[Renee543]

Can anyone tell me if the phase 3 Vertex trial is one that is worth being in? They called me from the institute and told me I qualify for this trial and that there is no plecebo. I told them I would not do a trial if there was a plecebo. They said this phase there was none. I know nothing about this drug or the effects.  I also have a chance to just do the regular interferon/rib. from a hospital at little cost to me. I don't have health ins. Any suggestions?

[wescoastgy]

If study is unblinded at week 24 do they to reveal why I was terminated.

[dmhrdh]

I'm sorry to hear this.  I was in the Telaprevir Prove 3 trial and my Riaba was dose reduced at week two and discontinued soon after for a few weeks.   I was rarely on full dose Riba throughout the trial...but, luckily, I was on full dose the first 2 weeks.  I was terrified.  Luckily, I cleared and am now SVR. My assumption is that there's a good chance you may have been in a placebo arm.  Do they offer a roll over for this trial?
Denise

[sandbash]

"must have been Riba and Interferon reduction because of low red white blood counts. After the rashes, headaches, brain fog, and the rash "

I'm at week 13 and have also had all the above!  I just got a call from the study coordinator....my neutrophils are down to 350 and I have to skip my injection this week...hgb is up to 9.9 after 4 weeks of ribo reduction.  I haven't been dropped from the study yet....but go in next week to see if counts are up.  

I review this site daily, but hesitate to post because I am in the same study.
I signed up with the hopes of getting in on one of the telaprevir arms with the possibility of treating for 24 wks...or the very least SOC.

Actually, it is less than SOC without the availability of procrit and neupogen!!!

I know what you have been through, and will pray that things will work out for you to continue to fight this disease.

[Isobella]

That trial will be unblinded at 24 weeks, so shouldn't you find out then what happened??

They will drop you if you do not have a 2 log drop at 4 weeks and then if you are not UND at 12 weeks.  This is to (try to) prevent mutations as I understand it.

If I get that same boot at week 12, that should mean that I was not UND at that time and I could then resume SOC -for 72 weeks- outside the trial.  They did, after all kick you out-not the other way around??? Or will they not allow that?  

[frijole]

If it were me I would go to my general practitioner and request an order for a PCR.  My recommendation would be a LabCorp QuantaSure or a Quest Heptimax.  Even if you need to pay for it yourself
frijole

[wescoastgy]

worst thing is they will not tell the reason for dropout for at least 1 year, best bet is wait for one of new drugs to pass the FDA and be assured rescue drugs.

[nygirl7]

Seriously - get an emergency appt with someone right away.  Unless you have had a breakthrough or are not responding you should continue with regular SOC and a doctor who can and will give you rescue meds to help manage the rest of the course.  You've already had 12 weeks plus of the telepravir.......you should be UND by now and could continue onwards.  If you were not UND and that is why they dropped you that's a different story.  You need to find that out if that is why you were dropped as that would be a whole different set of reasons and would make sense not to continue.

Riba rash unless it was extreme wouldn't be a reason and the other problem could be managed with Neupogen from another non-trial doc.

I agree - at this point it's barbaric not to offer patients the rescue drugs...they have years of data stocked up and too many drop outs.  If they want to be a viable solution they are going to have to get with it - I wouldn't have made it through treatment without procrit, couldn't even imagine it.

[frijole]

Goof is right - see if you can get in with another doctor ASAP.  Are they going to at least release your records?  This is terrible.  Until Vertex allows rescue drugs in their studies, I don't think studies are a viable solution -- especially for relapsers.  Why should we provide data for them when they are not willing to help us SVR.  

Do you have any meds left?
frijole

[GoofyDad]

Dude,

Can you roll over into SOC? I don't know your details, but I think I'd jump on that as quick as I could.