...back from the clinical trial abyss...

[uncledudeness]

i went for the Vertex VX11-950-114 trial screening today. all that worrying about the trial for nothing. ya see, when i  said to DR. "gee, I'm surprised i am even screening for this trial when it appears that i have cirrhosis, and that is an exclusionary factor for the trial". his jaw just about hit the floor. "ah, ah, my assistants carefully evaluate each case to see if the patient meets the criteria" (he said with a confident tone. "let me check the trial information, ah, ah, they seem to have left that page out, I'll be right back". he comes back in looking like someone just told him that there is no Easter bunny. "I guess my assistants missed that".  he then proceeded to tell me that i would not be eligible for the trial. he said that with cirrhosis, i would not be eligible for the trial.....(wow, imagine my surprise...shocked).

it's funny, just last month when i asked him if i had cirrhosis, he was somewhat on the fence about it...he gave me a scenario that the biopsy was too small and it's hard to determine it precisely without another biopsy, which he wouldn't advise.  BUT, this time he came right out and said "with you being cirrhotic, getting in the trial would not be possible". ya gotta wonder. ok moving on. one would think that discussing another trial for me would be rather, let's see what's a good word...mmmmm....STUPID...ya that's it. so NOW, he thinks i would be a better candidate for the BMS Daclatasvir (BMS790052) vs: Telaprevir trial. yes in this corner 790052 and in this corner The Big T.  HOOOOOLY SHEEP SHEEEIT....yes he did, he said i would be a good candidate for the trial....i asked him if he really went to Doctor school or was he just playin at it....so guess what, i said "sure count me in, let's do it, no problem....do i still get free parking?????" wooohooo......ya think he would have told me about the BMS trial earlier? i was turned down for the BMS790052 trial in 2010...my how time flies...

i think this is the trial: http://www.clinicaltrials.gov/ct2/show/NCT01492426?term=Daclatasvir&rank=3
Study Comparing BMS-790052 (Daclatasvir) to Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients (COMMAND-3)

a randomized trial, with and without Daclatasvir. one arm (leg/foot) would get triple w/Telap, and the other one would get triple w/Daclatasvir. he told me that the FDA requires that phase 3 trials include a small portion of cirrhotic patients. i didn't know that. how lucky am i, really.....sweet.....if accepted into the trial (haha what a joke) i would start in august...fear not, cuz i am gonna start with TripleTelap treatment in august anyhow.  

he told me that he had 5 patients reach SVR on the 790052 drug. so, here i go again. sorry for the novel.
i do see an advantage to this trial tho; either i get the NS5A inhibitor, or i get Telaprevir. either way i win. as far as rescue drugs are concerned, they are not offered by the sponsor, however my DR can prescribe them after dose reduction should i need them. so, back on the trial merry-go-round i go...weeeeeee, isn't this funnnnnn..

[nygirl7]

It certainly appears to say treatment experienced black/african americans in the subject line.........

I'm and Iwap Irish/Italian ;)

[uncledudeness]

you got that right Deb, here's the latest response:

It is also enrolling “Non-Black or African American” subjects.
******

notice how she left out the "cirrhotic" part.

I hope i meet the new criteria, cuz I'm a "SWAP"...half Sweedish and half Italian.

I am seriously considering skipping the trial thing with them and going right to my original plan....i can't take the abuse anymore.

[nygirl7]

What a dolt.  I would really get him to pucker this time that is absurd. I wouldnt have thought that of a doc at yale but I've only visited people there never been treated there.

Now I'm glad there are hospitals closer to me :(

Get on the phone right now and straighten them out. These assistants might be a part of the problem.....just a thought because I can't believe a doctor can make that many mistakes.

I'm sorry Dude.

[BoceprevirGal]

Oh, you must have posted this while I was blathering on...
    They are conducting that same Study at the Clinic I am Txing at, as well.
How could they have over-looked such a major detail...hulllooo?
   I'm glad you still have your sense of humor....

[BoceprevirGal]

Geez, and this is at Yale?
    I have to say, the Research Doctor I dealt with kept giving me msinformation, as well. He kept reassuring me that I would be eligible for The Study, and then, my enzymes ended up being two high, for both his Study last March, and then again in October.
  I wasted almost a year, trying to get into the Quest Study (Dr. Lalezari, in S.F.), he kept stringing me along, and promising me he would get me into his next study. He even told me that last October, after administering me a FibroSure test that had me .77 (cirrhosis).
   Doctor Lalezari never even pointed out to me, the huge warning sign, in my labs: my platelets had slipped from 150,000, last march, to 120,000 last October.
   He never ONCE suggested that I go to another Doctor, to have my Hep C
treated by another Doctor, who didn't just conduct Trials. He told me to contact him in the spring, and he would "get me in, for sure", and he promised me.  
   When I questioned him about wether a person with Hep C and cirrhosis could be treated, he said, "do you even have Medical Insurance?"
   He seemed to care more about his Research, than my well being, but dont Doctors take a hypocratic oath, swearing to put patients health before anything?
    I am sorry that your Doctor has made so many errors, concerning something as important as your Treatment plan. In the end, we are all in the "save our own a@% club".
   One thing I am noticing, is that you are getting very well-educated, concerning your health. Now...will this "sister study" also be accepting a few cirrhotics?
   I am glad you also have a regular TX plan lined up for August. Have you tried getting your vitamin levels tested, like willbb did? That way, if you are low on something, you can correct that, within the next few months~
   I have heard that Procrit needs some iron to stick to, so I have been eating food high in iron, I just went out and bought raw beets...guess I have to boil them. I am eating roast-beef, and olives.
   Make sure you are giving yourself the healthiest diet you can muster...I know it's hard~
  

[uncledudeness]

i just checked the Vertex 116 trial out....here it is:

Telaprevir in Combination With Peginterferon and Ribavirin in Treatment-experienced Black/African American Subjects.

i know i got soul and i can get down and move, but i'm white and i really can't dance....do ya think my DOCTOR is color blind? ... or just a dolt.

at they got half of the trial right...i am treatment experienced...

[uncledudeness]

what did i do to diserve this???? wtf is going on with these clowns at Yale? so the assistant sends me the trial info at my request. here is her response:

Yes, I apologize. Yesterday, Dr. Lim said you would qualify for this study but he was mistaken, I think confusing it with a different study. You do have other trial options though. I’ll send you the consent form for the ‘sister’ study to the Vertex 114, this is the VERTEX 116.

other options...hmmmmm...let's see i already bent over and puckered up...options? i'll give them an option. whit a medical team like this i shoot just go out and find the tallest bridge and jump off...

i wonder what the "sister" study is? i bet is run by a bunch of high school kids lookin for extra credit...wait....i bet they'll do a better job.....

pardon me while i SCREAMMMMMMMMMMMMMMMMMMMMM

[HectorSF]

" i might have to break in his house and viciously rearrange his furniture." LOL

"ya don't think he could make the same mistake twice in one day do ya?"
Only if he has been shimming off a little too much of that "surplus" opiate stock.  ;-)

Cheers!
Hector

[uncledudeness]

i could have the link wrong. i did a search on clinicaltrials.gov and i came across that one..i should have read it more closely..(boy, did i pull the wool over my doctor's eyes with my hep knowledge...hehe)...i'll call the assistant tomorrow and get the right trial number....if he screwed up again i might have to break in his house and viciously rearrange his furniture....i'll do it...

he did say that cirrhotics are included it the trial. ya don't think he could make the same mistake twice in one day do ya?

[Idyllic]

Are you sure that is the right link for the trial Uncle? It does indicate treatment naive folks.

[willbb]

uncledudeness  & Hector

Unc.  Hector brings up a good point. The Command 3  (if that is the one your doctor was referring to is for Naive's.

Chirrotics are excluded ,however you did mention he said that there "would be a small portion of chirrotics allowed?

A bit confusing what he is suggesting here...

When you were speaking about this trial offered to you it was automatically assumed because your doctor is familiar with your case it was for experienced??

Will

[BoceprevirGal]

I dont know...the Trial Doctor I went to in San Francisco, only does the Trials, and after he discluded me, didn't offer any referrals, to Doctors that DID specialize in Hep C.  
   The Doctor I have now, does Trials and regular Tx. I tried to get into one of her trials as well, but was excluded for three different reasons this time, so I was glad to find out she accepted my Medical Insurance, and that my meds would be covered, and went ahead to get Tx~
  

[HectorSF]

" so NOW, he thinks i would be a better candidate for the BMS Daclatasvir (BMS790052) vs: Telaprevir trial."

Help me out here folks. My H.E. has still got my head in a cloud. Can others including Will double check my facts here.

I may be way off base... but the only Daclatasvir and Telaprevir study I see that is phase III is at the link in your post UncleD. http://www.clinicaltrials.gov/ct2/show/NCT01492426?term=Daclatasvir&rank=3

I see no other Daclatasvir studies for prior relaspers at all.

"A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C" NCT01492426

This study is for TREATMENT-NAIVE patients. UncleD you are a previous SOC relasper correct? Not sure what your doctor is thinking???

Criteria

Inclusion Criteria:

* "No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals"

Also no cirrhotics will be allowed to participate in the study.
* "if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year."

Again, I need another pair of eyes to look this over. Maybe I missed the obvious?

Thanks.
Hector

[uncledudeness]

thanks for you encouraging words and support.

my treatment doctor and the trial doctor are one in the same.

i would like to get in the trial and get the NS5A BMS drug. but if i don't it's Telaprevir for me. my concern with the PI was that if i didn't SVR, would i build up a tolerance to future treatment. he said that the new drug pipeline would not present a re-treatment resistance problem. if you fail with a protease inhibitor, you can still clear with a nucleotide.??? i think he started speaking in a different language at one point  there....not 100% sure on that, but he said it wouldn't be a problem retreating in a few years when they are released.

again i don't have high hopes of getting in the trial. we'll see what happens. one thing i am sure of, i have all of you on my side so i can't lose....yahtzee...


sidenote: it felt great telling my doctor that i wouldn't qualify for the trial and that there was exclusionary criteria that his assistant missed. later in the talk he complimented me on my knowledge of HCV and he said that he enjoys when patients who take an active role in their treatment. i quickly switched into my Rodney Dangerfield impersonation and I said " so DOC, whadda ya think, I'm gonna rely on you BOZO's to fix me? what's the medical profession comin to...."

sidenote 2: i think i have "treatment envy"....bwahahaha..i'll get that checked out.

[can-do-man]

My trial Doctor was my regular treatment Doctor, most of the time wouldn't that be the case?

[BoceprevirGal]

I just feel more comfortable with my regular Treatment Doctor, knowing my cure is her top priority, rather than the Trial Doctor, who's top priority seemed to be his Trial.
  Like Keith up above pointed out, there isn't as much lee-way, concerning your Doctor individualizing the Tx to meet the individual patients needs.
   This might not be as important, to a person who is at Stage 1 or even Stage 2.  But if you are now going towards Stage 4, more Sx occur, the vl is more stubborn, and you will need all the help you can get.
  One question:  If you did participate in this Trial, and didn't achieve SVR, would you still be a canidate for treating again, with Triple Tx  Teleprivir?

[hrsepwrguy]

Hey unc this is just my expirience, you may want to get specific asking questions about stopping criteria, I was told that I would be allowed rescue drugs and all the good stuff but one thing they left out (I'm sure I signed off on it but didn't remember) was that if my HGB dropped below 8 I would be removed from the trial because it was a safety issue, as you all ready know all trials are different and this may not be the case but I would ask.

[pooh55811]

I don't have much to add to all of the comments above, but I do want to wish you the very best going forward.

[FaithforHealing]

Not fun to be jerked around at a time like this, but what a blessing that you have options. It used to be if you were "out" there wasn't anything else available.
Hope springs eternal in this battle, good luck to you.

[can-do-man]

Good luck Unc, Looks like you just crossed over into the land of cirrhotics. The main thing is the sooner you get rid of Hep-C the better, so be very careful going in and out of trials unless you have no other options

[Idyllic]

Well, at least the guy came out and confirmed your cirrhotic which is what you and Hector managed to piece together in your last thread anyway. But hey, it wasn't a total waste since other options were presented :)

The once daily dose, no fat requirement and no side effects that Will pointed out sounds enticing only I am not sure about the (interim) 75-78 % UND @ week12 . . . . . .

Hang in there.

[nygirl7]

Gee Unk they are making you go through hoops huh? Great assistants over there ;)  I'm sorry you are having to go through all of this.....but whatever it takes to get you to SVR is what it takes and it will have been worth it in the long run.

AND you get your parking validated!

[willbb]

) once a day dose and 2) no fat required and # there were no serious sides.
----------------------------------------------------
  should say  "   and 3) no serious sides "

[willbb]

Hi Unc.. as you know I was in the BMS 790052  W/Peg Riba..Did I get 790052?? Don't know yet  (july) ,however here are some "interim results from that trial and the latest on how it performs with Peg/Riba.

If you read through all the minutia ,basically what it says is 75-78 % were UND @ week12  (remember these are just interim results and the % of SVR's  are not published yet,however one might confer that the mid 70's would be  about what they will end up being

Seems to me this drug with Peg/Riba is very comparable to INCI in results ,however the three huge benefits to it over INCI,, in my opinion are 1) once a day dose and 2) no fat required and # there were no serious sides.
This trial would be a good option IMO..

Best with your desicion Unc..

http://hepatitiscnewdrugs.blogspot.ca/2011/11/aasld-interim-results-on-daclatasvir.html
Will


the 365 patients with HCV genotype 1, 54% in each of the daclatasvir dose groups (20 mg:79/147)(60 mg:79/146) and 14% (10/72) in the control group achieved undetectable viral load (HCV RNA <10 IU/mL) at Weeks 4 and 12 (eRVR). The proportion of HCV genotype 1 patients with undetectable viral load at Week 12 (cEVR) was 78% (115/147) and 75% (110/146) in the daclatasvir 20 mg and 60 mg groups, respectively, compared with 43% (31/72) in the control group. At Week 12, the proportion of patients with viral load below the lower limit of quantification (HCV RNA <25 IU/mL) was 84% in each of the daclatasvir dose groups (20 mg:123/147)(60 mg:123/146), compared with 53% (38/72) in the control group.