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An update on Wk.12 Study Results

Well,I received my Trial Labs yesterday and unfortunately I am still DET. @ 284 IU/ml.
For those of you that don"t know,I am a Geno1a,with Stage1(fib).

I had a Base L (vl) of 9.7 Mill.

My trial is 80% chance of taking a P.I  and 20% Placebo(obviously no way to know at this point) The study is unblinded in 15 months.

I have been fortunate to have had basically no s.x .(so far) and my bloods are all in the normal R.R.

Not being UND. at  WK.12 I realize that my % of SVR have been lowered somewhat and chances of relapse have been increased somewhat.

So...my dilemma..Should I put  Tx. on hold for now,wait for the trial to be unblinded (see what I was taking ) watch and research resistance profiles,and revisit  Tx. when the new meds are avail. or do I plunge ahead and try to knock down the rest and take my chances?

My reaction is to not give up on this,especially since I have committed to a  study and it"s not my nature to quite something,however I keep looking at the stats  and it is a tough call on my part.

Any thoughts and advice folks would be greatly appreciated.

  Thx.

WILL
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Avatar universal
Dave  ..sorry that wasn"t clear....if you were on the study drug and did not go UND at  wk.4 then at wk.12 you were put on SOC.
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Avatar universal
Hi Dave...The way the trial worked was this ... if you were on the study drug and did NOT go UND atwk.4  you were taken off of it...that is my case  I am definitely just SOC now ..if I cont.

I agree with you entirely  that these drugs are  very toxic...and that will weigh in my decision next wk.

I did not have a breakthrough..I won"t say too much about how I know that... other than I just know for certain..

And  thanks for your best wishes Dave.. the same to you.

WILL
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Avatar universal
Hi Will-
I am really sorry that your result is not better. It's really difficult to not be disappointed. From what I understand there is a chance that the drugs can be changed in your trial at week 12. If that is correct that it is of course a game changer.

I hate to see anyone take these drugs any longer then they have to. I believe that regardless of the sx they are highly toxic and the less time we take them the better. The good news as you said is that you are stage 1 and you have backup in Boceprevir or Telaprevir in the near future if this doesn't work for you.

I don't believe you've had a breakthrough either, I am sure the trial has strict guidelines about stopping if there is a breakthrough because I believe the FDA is very concerned about dominant variants developing.

Your trial seems more flexible then my boce trial about what is considered a good response and time to stop. In my trial if not und at week 12, the doctor had the discretion to go on only another couple of weeks only if I was in very close range as in 25-50 iu/ml. The difference if I am understanding correctly is that your drugs might be changed so it seems even more difficult to make a decision.


I wish you the best Will. This is tough news but you have lots of options and will beat this beast before long.

good luck,
Dave



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Avatar universal
Babs and Uncledudeness:   Thx  for that!

WILL
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1280753 tn?1367757932
sorry to hear this will. we all had such high hopes for this trial, but it's not over yet. with 80/20 odds, i was big on the trial; i still am. but you roll with it. you will clear. stay positive and keep fighting.
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1420486 tn?1384793153
Went and visited site I was on while I was booootted from here. The fine folks there are seeing some Und. With bms790052. Good for them.. I dont think that sight likes pharma, tx, and clinicaltrials. But there real nice folks. I hope you guys kill it this time around. And Im going to my 12 wk... Satan my kitten tried to eat one of my Riba, bit me 2 X's , scratched my nose and made me bleed (alot) I washed her paw as Im taking no risk of giving a hep to my rotten little evil kitten! I should of dunked her in toilet tank!
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