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

[RobertBeWell]

Hey Will,

I don't have any new thoughts other than what we discussed already except to remember that in our study, we don't get to see other important info like our VL drops and when they ocurred. With a starting load like yours, and that huge log drop, you're probably doing a lot better than you think. Talk to study doc, he has whole picture.


RBW

[James10500]

I'm sorry you did not get the result you wanted.  That's a huge drop 4 log approximately.  What if you are getting PI's and you stop, but what if your not.  A very tough call.  By seeing you guys talk about your studies I see the added stress they bring b/c you don't know.  I feel for you.  Good luck with your next lab should you continue.

[Trinity4]

Sorry will, I really am.  It is a tough call.  Do you what your gut says. that usually works for me.  Maybe privately get PCR's during the next couple of weeks and if UND doesn't happen then stop?  The longer is takes to get to UND, the less chance of SVR and I get skiddish when I see no UND by 12 wks because that's what happened to me.  I guess since you're considered a slow responsder extending treatment would be a consideration under normal circumstances but they wouldn't do that in a trial.  If it's a Protease Inhibitor the resistance issue comes in to play with Boce & Tela for at least a couple of years.  You could consider a polymerase inhibitor ut who knows when those will be on the market.  Yikes will, good luck with whatever you choose.

Trin

[R Glass]

Sorry to read this. I can't imagine all that is running through your head.

[nygirl7]

I didn't get to UND at week 12 but I extended to 72 and that worked. I guess that is not an option for you. I'm sorry I too know the terrible emotional feelings that happen and how much you just want to post your I'm UND thread.

You are so close - I would see if i a week or two I could get a private PCR and find out. That would change the dyanamic completely if you could get there like this week.

[copyman]

Personally I would stop, regroup and tx with the new drugs when available. I think if you were getting the real PI you would have been UND by now.

I started with a VL close to yours and was UND at 3 weeks or less. The PI's usually kill the virus in the beginning and come back when the PI is removed. This is why my thinking is you did not get the real drug.

As for leaving the study early I felt the same way you do. Like I was letting down the people at the clinic, etc. They even laid a guilt trip on me that all my data could not be used and how it would hurt the study. But you know what I decided that this was my health & body and I stopped. The difference with my study was it was unblinded and everyone got the real drug. They only blinded the PCR's so I did my own.  I went in only wanting to do 24 weeks. Of course I got randomized to the 48 week group. They told me this at the 24 week mark, but I already knew I was und at 3,8,12,16,& 24 weeks from my own tests. I hung in until 30 weeks then quit. I never regretted it for one min.

Best of luck whatever you decide

[blondie717]

I am so sorry, bunch of cuss words...... It would seem to me that BMS790052 is a big flop. I actually have heard of no good responces with that product. How did it get this far? I tried to get in it! Im glad I missed the window by a day. 80% odds of getting trial drug? Surely you and my other friend were not both unlucky! Im really scared no about my own trial. its worse than yours as far as trial record. only 36 folks in the trial and 66.6??? odd's of getting a study drug,  which is or is not a polymerase. googled it some say protease some say polymerase, confused! Maybe we with no bad sx can look forward to failure? Im sorry, I dont even feel like going to my 12wk now. Im sorry your vl load is low. Your lucky you can go on!  I sorda hope you choose to. Lets hope the polymerase works > and you can get into that... God Will really sorry for us all. I wonder what the odds are of failure w clinical trials. I guess we should of thought of that first! Maybe this is just a way to boost stocks for a drug company!

[blondie717]

In my trial I can break the blinde @ wk 12 and learn if I have been given study drug, you and Robert need to see if that option.

[willbb]

Hey  folks...I just read your comments and all much appreciated. I am meeting with the hepa next week and we will discuss my situation further.  My shot day is THUR. so I had taken my shot before the call and for at least until I meet with them next week I will cont. to bang down the RIBA.

I appreciate  the suggestions about testing and  just let me say...ah...well  ,I have looked after some things.

BLONDIE: PLease stay positive, BMS is not necessarily  "a flop" as you call it   there is great results from early testing... yes Robert and I  seem to be stalled a little right now, but you  just continue and DON"T  even think about not going to your wk.12.  Trials are just that a bit of aroll of the dice...and hey three times lucky..if Robert and I are struggling a little you are the third and you will do fine  :)

THX...WILL

[fretboard]

Sorry amigo that ***** but it's definitely not the end of the world by no means.  I would quit plain and simple.  At least now you know that you were responding, just not good enough this time around.  The way I see it you've already done your part for the clinical trial by going thru the 12wks.  Best in my opinion to stop and fight another day!  good luck!!

[RobertBeWell]

Blondie, actually, this study drug had incredible results in Phase 1 trials - significantly better than Telaprevir or any of the next crop of DAAs.

So, check it out Will. You had a very strong response. Not perfect, but very strong.

So, you can:

1. Continue, and have no guarantee of success now; or,
2. Stop, and have no guarantee of success later.

That's what clinched it for me. I am rolling on.

In our lifetimes, it will probably not be possible to take some pills and get rid of Hep C with 100% certainty. So, you have decent odds now, or decent odds later. At this point in the space time continuum - you have 13 weeks of your life invested in the endeavor.

Toss 13 weeks for work out? I could never do it, not with that good of a response.

Robert

[RobertBeWell]

Forgot to put this example in my prior post:

There is another person in here who is on the Boceprevir trial - which didn't have blinded results. They stalled at 250ish for 4 weeks before dropping to UND - then bounced back to < 25 DET at week 12 - and then has UND since. Think he regrets continuing on?

You might be one week away from clearing. Course, you may never clear either. No guarantees. Not now, not in 6 months.

All I'm saying is things aren't always cut and dried, and they don't always work out just the way the statistics say they should. Talk to your research doc. He can sit down with your lab results and couple that with his years of experience, and give you a feeling for what HE THINKS is gonna happen based on his experience.

RBW

[dointime]

Without your viral load history you can't tell if the virus is just dragging it's heels to get cleared or if you were undetected at some point and are now having a breakthrough.  For a breakthrough you would almost certainly want to quit.  For a slow drop in vl you'd have to consider it carefully.

It is not in the interests of the drug company for it's subjects to quit, so convenient for them that you don't get told your vl, but not so much for your decision making.  It happened to me that I had a breakthrough at day 15 but Vertex kept me on the pills for 12 weeks.  If I had known about the breakthrough I would have quit then and to he!! with the trial.  Maybe some folks might think that's not very ethical but it was my body that got left with resistant mutations, so you need to be in that difficult position yourself before you can really say.  I wish that I had got off-study pcr's all the way through my trial, but hindsight is a wonderful thing.

Good luck to you,
dointime                

[RobertBeWell]

"Without your viral load history you can't tell if the virus is just dragging it's heels to get cleared or if you were undetected at some point and are now having a breakthrough."

Just to clarify, a breakthrough in our study will result in the old "patient is not meeting study protocol" and you'll be removed.

I agree with getting off-study counts. If I ever have to do this again, I will get off-study load counts very frequently. The other thing is I will never consider another trial where I don't have a 100% chance to receive the study drug.

RBW

[willbb]

I appreciate your comments...I would just say that I know for a fact that this remaining vl  is not a breakthrough.

WILL

[babs824]

this is such a tough one and i am so sorry u have to face such complicated decisions. you sure have a good team here with good advice so all i can offer is a sincere and consoling hug. babs

[blondie717]

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!

[uncledudeness]

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.

[willbb]

Babs and Uncledudeness:   Thx  for that!

WILL

[spectda]

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

[willbb]

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

[willbb]

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.

[eureka254]

It's hard not getting that undetected at week 12, and I'm sorry to hear about this disappointment, but on the face of things, your response has nonetheless been a strong response.  9.7 mil to 286 in 12 weeks is nothing to sneeze at for a geno 1.  Certainly if the 286 didn't continue to drop it might be cause for pause, but if you're having minimal side effects, maybe not too much skin off your back to continue.  When would the next VL quant be drawn if you continued?  Might make the decision making easier to see if you continue to knock down VL, trial drug or not. Either way, wishing you the best. ~eureka

[blondie717]

I just wondering if you could eat extra Riba?

[burned74]

If I was in your situation, I would definitely continue for a while. Although you are not UND, you have had over a 4 log drop.I thought that current recomendations are to continue if more than a 2 log drop at 12 weeks.

I dont see where you have a lot to lose ( but a lot to gain) by continuing for another month or two and seeing where you are then.

[willbb]

Blondie:  Pretty much eating them like crazy now!  :)   Got any extra??

[willing]

to paraphrase RBW - walk into a casino and pretty much everyone in there is looking at less than even odds. You don't need a 80% odds to walk away a winner. All the best!

[willbb]

Willing:    " You don't need a 80% odds to walk away a winner. "

I certainly agree with that...  however if statitically they start to get in around the high 20"s  percent range then I am just not sure this Casino is the one to be in.  :)

Thx for your  good wishes.

WILL