why don't we hear from more trial people

[streamline569]

I would like to hear the experience from people without cirrhosis and diffenent degrees of liver damage and how they did in trials with 24 and 48 weeks. We never hear from this group of people. It would be nice to know who reach SVR and who didn't without just reading trial information that is so limited as to the individual personal situation and end result. They are out there, how do you find them?

[lynda607]

I suspect many of them attained SVR and have moved on.  Even those who posted back in the day were experiencing the same side effects we see from those who are undergoing triple therapy right now but they didn't talk about it as much.  They were warriors, no doubt about it.  

[willbb]

Hi stream..
I was in a trial for BMS790052 last year..and fwiw..didn"t have such a stellar result, have fairley minimal damage..however from what I have gathered from  any info.I heard about my particular trial the results were quite good (some I know had quite significant damage)
Best
Will

[rockymoe]

When I was in the telaprevir study part of the agrrement you signed was that you wouldn't discuss it in chat rooms or forums.

[nowhine]

I will chime in. I have been following this site for about a year now and I start a Gilead 4 drug tx next week. Have not heard much about the Gilead trials except from mary4now. I am a previous null responder to SOC. 1a, stage 2, male, 54. I appreciate all the information and treatment tips. I know it will be rough but I'm ready, again. I will keep everyone posted. Maybe it will help others.  Thanks.

[curiouslady1]

I also think it is critical for people to post or journal their experiences in trials.  I see that oftentimes on this forum there is an fair amount of dogmatic preachiness.  When viewed in terms of what that person has experienced themselves, it would be far more palatable than if it seems to be handed down from Sinai.  

Nowhine, this I can tell you.  Adamben is in a Gilead study and did not receive ifn at first.  He is a 1a and had a low VL.  He had UND in a week.  He had a breakthrough at 6-7 weeks.  He is now on ifn.  You may want to troll the net a bit.  There are other forums after all.  

Willbb, are you saying that people incurred "damage" from BMS 7900052?  Your post is unclear.  What were the results of the study and the AE?  

Rockymoe,  I have not been asked to refrain from discussing my experiences in my trial.  If anything the people from the University research center are curious about what the scuttlebutt on the forums is.  I wonder what it means that you were sworn to secrecy so to speak?  Were you given an explanation?

[willbb]

Willbb, are you saying that people incurred "damage" from BMS 7900052?  Your post is unclear.  What were the results of the study and the AE?  
-------------------------------------------------------------------------------------------------------
No...the baseline damage going in..from those I spoketo   at my site and a handful here in the same trial
AE"s were fairly minimal from what I gather...as they were for myself..
Will

[curiouslady1]

So what were the results of the study in general?  How many people SVR'd?  What was the finding on BMS?  

[willbb]

It is still ongoing and blinded   it was a 2b    the 2a had 83% SVR

[curiouslady1]

Dear Stream,  Perhaps people have posted the information you seek but they do it at the time they are going through the trial and it may become tedious to continue to post about it and perhaps difficult to figure out how to find it again once the info becomes a few months past.  When I go back on people's posts it is hard to wade through all to find their postings when they went through trials.  I have often thought it would be a good idea to have another community for people who are going through trials for HepC or interested in finding out about them.  

[curiouslady1]

And you were part of the 17%?  How awful!  I think this is a major fear that we all have, that we will be in that small percentage that does not SVR though the drug itself may be very good.  

[Willy50]

The Vertex trials had non-disclosure passages in them; part of the blinding process, I believe.  I can't explain why the trials all seem to vary so much, but they have the right to design them as they see fit.  Vertex did not want to in any way possibly undermine their trials, such as through unblinding, and in virtually all cases, no use of rescue drugs.  It may have been overkill because Boceprevir seemed to be approved as easily as Telaprevir.

Years ago the first Prove 1 telaprevir trial participants found that the trial coordinators were reading their posts and almost threatened them with being dropped from the trial for revealing information, such as viral load results or information about the rash. That was probably 5 years ago.....

All trials are different.  : )

willy

[curiouslady1]

Yes.  And people are different.  I find that a lot of people PM me about the trial I am in but after some little we discover that they are not eligible.  My study doc told me that 50% of the people they screen for trials at this particular site turn out to be ineligible.  In fact, I was more worried about getting into this particular trial than I was worried about efficacy or side effects.  By the time I had done my research I was convinced that this was the trial that matched my needs and no other would do.  

[streamline569]

I find that horrifying to read but not unexpected to hear . I wonder how much goes on that we will never know about. Good movie on last night about the man who pushed to get the drug heptersen (spelling) It was drug approved for breast cancer and his battle to get it into trials. True story.....and again scary what goes on behind the scenes

[willbb]

And you were part of the 17%?  

  well not quite   As I said the  83% was results of the 2a trial..My trial is still on going and blinded..there  are no results yet.

[willbb]

By  just the nature of a trial ..it is a fact that some will fail. In the vertex results obvoiusly they came up  with the approx. 75% on data..in other words 1 of every 4 failed in their trials  and I believe even slightly more  in Vic trials.
I have  always maintained ..trials are not set up to cure people(however that is the hoped for result by both patient and  pharma...they are experiments to gather data(ie.how many succeed ,how many fail,how many and what AE"s  ,resistance testing on failures..etc.etc.)

So just by the nature of the beast many  fail...and we hope less and less in the future.
It would seem that these new all oral trials ..less and less seems to be the norm...however the finally tally is just not known yet.
Will

[Willy50]

Well.... it was discussed on the forum and it was scary but to put in a word for the pharms..... many trials are double blinded, it's part of the process in ensuring the validity of the results of the trial.  

...If that process is compromised by revealing results in can have the effect of unblinding, and thereby potentially compromising the trial results.

Think what would happen if after a trial which lasted 1.5 years and when the results were turned over to the FDA they were to say; "not valid because it was not double blinded. Do it over."  It didn't happen but it's a scary thought.

Vertex was trying to protect the trial design.  It is a very tough call anymore with the internet.  It's damned hard to keep the info secret.  We are also seeing that news embargoes at technical conferences often get leaked.  
I don't know how they deal with it now, but it was a hot topic 5 years ago when many Prove 1 participants were in this forum and sharing some info.

willy

[curiouslady1]

I agree with all that has been said.  Double blinds are necessary.  Researchers know more than they are telling.  You make educated guesses about what is going on behind the scenes in order to make determinations about what you will do.  The data reigns over all for researchers.  I myself get obsessed with reading about what is happening to my drug in other studies and arms being added and subtracted.  I do a bit of generalizing . . . well they must be pretty confident in (?) otherwise why add an arm that is monotherapy on a notoriously difficult to treat GT for only 3 months in an SVR study? . . . not scientific perhaps.  But then I am not a scientist when it comes to my own treatment.  I am a beggar pleading at the halls of ivy for my own welfare.  But since I am a curious lady I kinda, sorta knew that double blind would not work for me esp with drugs that have few or no side effects.  I would be going for a year without knowing anything.  Uh, no.  I don't think so.  So I went with open trial.  And now I know a lot about the study and the drugs which is, of course, why I would pick willbb's brain about his study because one of my drugs is BMS 7900052 and BMS is our sponsor.  Entirely selfish here.

[willbb]

But since I am a curious lady I kinda, sorta knew that double blind would not work for me esp with drugs that have few or no side effects.  I would be going for a year without knowing anything.  Uh, no.  I don't think so.  
---------------------------------------------------------------------------------------
Well..I for one am very grateful to those that went before us under those conditions to give some idea of safety and approx. efficacy.

[rockymoe]

The contract or whatever it is that you sign said.If you participatein this clinical study you should feel free to discuss with family and your other healthcare providers. however, to help make surethat data from the studyis as accurate andreliable as possible, please do not discuss info. about the study in public places while in study process . Public places include suppot groups , or may be places likeinternate message boards.

[UKgirl55]

Yes, yes, and yes! We need some sort of  discussion board (place), where those that are trialing (all orals and a separate one for INF) can post updates on their treatment. Especially when they hit those landmarks of RVR, SVR etc.  Surely this can be done on this site??

[curiouslady1]

So who do we ask?  There should be enough interested people to keep it at least as busy as the Hepatitis C Social community.  Of course, all this probably costs money so we should be prepared for a veto from the mods.

[curiouslady1]

I did write a missive to the mods. in the "contact us" section under "suggestions".  I was thinking that all trial information and discussions should be included in the same forum.  I am requesting a new forum to be operative for the next few years because of the swiftness of change in this particular area right now . . . particularly involving the identification of new cases, the increased public health awareness, the paradigmatic shifts in treatment types and the explosion of research information available.  I am not of a mind to think that everyone should treat with all orals or all SOC included.  We are all at different stages of infection and disease and our bodies respond differently.  But the options need to be close at hand and side by side.  Wading through the range of choices in the world of experimental research can be a daunting task.  Also, if they split it up there would not be near enough activity to justify keeping it going.  So I am asking for a forum and not a message board.  I see that we already have journals but most people don't use them and it is hard to find them if a person has stopped posting.  

[Mary4now]

I would be happy to share my experience with the trial i participated in that ended 3 months ago.  How can we put this information in a specific place within this forum?

[lynda607]

You have the option of starting a user group that could contain exactly the the type of information and discussions you seek.