update on drug trials and my decision on contnuing treatment

[cruelworld]

all of vertex 950 is full nationwide, wyeth 796 still has some naive positions but no room  for non responders. it looks like non responders are usually only a small group in these trials. the other issue is truly thousands of applicants for only 10 or 20 spots per arm. one guy said he thought he got in because he offered a kidney and they still turned him down! i guess ill have to learn some new tricks to run through that brick wall! now i understand why chrisDDD and susan 400 and others are having so much trouble. all of you who made it in,consider yourself very lucky. in the meantime, im in late responder limbo (19 week vl 89 iu/ml) and my conservative small town gastro doc would not approve of temporarily increased doses. i think shering  plough (pegintron) discourages this, i think this is the only reason he stands stiff on this issue. i can still do it surreptitiously if i want to (up the doses)but i havent decided. i would gladly owe someone a favor if they could give me a good argument against temporarily higher doses. what is the down side? that is the question of the day. help!

[wyntre9]

I feel bad for you.  I have no idea of how to advise you.  Honestly, I haven't even thought about talking to my Dr. yet about upping riba and or peg. (90 VL at 16 weeks - 18 week today - waiting for results).  i guess I'm willing to do the 24 and see where I'm at, then.  But, my damage is Stage 1, grade 1 and i know you're a 2/3.

you know, you (we) COULD reach SVR, even as a late responder.  you (we) have a one in three chance.  And even if you (we) don't, you will probably have improved your liver and in the meantime slots in the trials will have probably opened up.

Hang in there.  

wyn

[Electra56]

If I could give you any advice it would be NEVER go to the community doc to treat a significant disease.  I went to the local doc the first time around and was under-dosed and ended up relapsing after 52 weeks of therapy.  Can you get to major city with an academic hospital?  I don't think s-p is against increasing the dose- though they can't advocate it because that would be promoting "off-label".  I was offered double-dosing of PEG-Intron for a second round- but that was at an academic site.  Are you getting 1.5ug/kg?  That is the dose that you should be getting.

[orphanedhawk]

I would think higher dosages would increase the amount of low wbc and rbc problems. How much procrit and neupogen can one take?
  I see a heptologist/researcher at a liver clinic. They sometimes have trials which aren't advertised. The best thing to do, other than checking the usual sites, is to try calling Universities and health centers in your area, specializing in liver disease. Ask about upcoming trials.   Good luck

[cruelworld]

yea im on full dosage. im doing vl count monday so ill see what to do.
as for as blood counts, mine have been fairly normal the whole time (no rescue)

[Electra56]

At least you are responding, which is a good thing,  I switched doctors after I failed my first therpy, and went to an acdemic hospital to see an expert- fortunately I have good insurance and a flexible job because it takes 3 hrs to get there.  Before I got into a trial, my doctor suggested double dosing (3.0ug/kg) for 4 weeks to knock the virus down to 0, then continuing on regular dose.  You might suggest that strategy if you are still detectable next week.  (This is the dose ofetn used to treat African Americans because they don't respond as well to IFN.) As long as you feeling OK otherwise and your blood counts are good- he should give you a shot at that. Good luck- you can get there it will just take longer.

[susan400]

Cruel,

I'm just curious, who gave you the info on the Prove 3 and HCV-796 and their "full" status?  

Susan

[cruelworld]

im not exactly sure
katy?
713-791-1414  x5619

this is the number, it is for houston area and they said were full for non responders
but still had other spots.

[susan400]

I wonder if that is true for the WHOLE country, or just for Texas area.  I just talked to the study nurse for Prove 3 on Fri. and at that point, they were still turning in their screening(s) to Vertex.  She had told me that she was going to get the doctor to talk to the trial manager.  This was Study nurse #2.  It looks like if she already knew that it was closed, that she would have said it then, instead of what she did say.  I'm still thinking that I'll get the call on Mon. about my being rejected again on Vertex.  But, as far as HCV-796  it's still showing recruiting at the Gainesville site in Fla.

Susan

[ChrisDDD]

I'd be curious, too, how valid this info is about whether they're really full, etc.  That's what I get so upset about, is being told they wouldn't be screening for PROVE 3 until June, when it turns out it was really March, and first I was in and then I was out.  I have a couple of questions:

1)  Does it look to anyone besides me like they're picking Stage 1/Grade 1's for PROVE 3?  I don't think it's fair, but I'd be interested to know, and I think it's reasonable on Vertex's part to do that.

2)  Do you think it does any good to keep arguing your case with a study site once they've rejected you or do you just **** them off?

I think everyone who got into PROVE 3 is VERY fortunate, and good luck!