Bristol-Myers Study

[evalbca]

Hi Everybody! Never wrote before...there is always the 1st time! Have Genotype 1b, for 30+ years from transfusion. Did 27 weeks of Riba and Peg had great results at 12 weeks but later had to be discontinued for non-responding! Now I am looking into a study for BMS-790052 w/ riba and peg. included by Bristol-Myers for non-responders. Anybody out there who knows anything about this drug or anybody who is already involved in the study and can share. Thank You so much!

[uncledudeness]

here is a thread that i started on the topic:

http://www.medhelp.org/posts/Hepatitis-C/BMS-790052-NEW-DRUG-trial-decision-/show/1230362

[uncledudeness]

I am enrolled in the BMS-790052 Phase 2b trial, to start in July. the trial will consist of 400 participants, and will include SOC. I don't know the trial # yet, but i will email my patient advocate to see if i can get it. i can't find any info on the trial sites. my Hep DR was involved in the Phase 2a trial; J. Lim from Yale.

since i am at stage 3, i don't think i have much to lose in this trial. i'm gonna do it.

as i get more info, i would be happy to share it.

[willing]

interesting - hopefully not unexpected news on either 790052 or 650032; keep in touch!

[evalbca]

Hi everybody,
Today I was scheduled to go for my lab tests and consultation for the Bristol-Myers Study and they cancelled! They said the study is on HOLD...maybe paperwork or they run out of meds?! So there you go, all the anticipation for nothing! E

[WriteItDown]

Wow, I looked at this trial and I'm really not sure what to say. If I were considering it, I'd want to do a lot more research, because two of the three arms don't involve any SOC drugs, but rather combine a protease inhibitor with an NS5A inhibitor, which personally I know nothing about. But, I do know enough to say that this is pretty new, which, depending upon your personality, and your feelings about the SOC drugs, could be a plus or a minus.

I think if it were me, I think I would rather be in a trial that combined one of the new inhibitors with SOC. That sort of approach is currently more tried-and-true -- it's what they've done with Telaprevir and Boceprevir, and it's the approach that has thus far yielded the best results.  I'm not saying that I have any real knowledge of whether combining these two novel inhibitors could work or not; I'm just saying it's very ne potentially more risky.

You'll note that they are only recruiting 50 people.  The bigger trials recruit many more that this, and that usually indicates that they have a better idea about ideal dosage and duration.  A small trial like this usually indicates that they're really still working out the kinks. Again, that doesn't mean it might not be a fabulous therapy -- it might very well be -- it's just at an earlier stage, from what I can tell.

Hopefully others will chime in as well.

[Diamando6]

Hello,

I was also the same luck with my treatment. I am desperately waiting for a new drug, and I am reading every article, I come across, about telaprevir, boceprevir, .......so and so, brystol and myers, etc.
A lot of us here, seems to be relapsers, non responders, breakthroughe-rs. I jus hope, that all those from Pharmaceutical Companies, Government people, and other responsible for health of people, are watching from time to time at least, those Forums, and hear the voice of thousands people, around the World, that wait to be cured.
Blessings,  

[willing]

note that trial NCT01012895  is not only testing BMS-790052 but a BMS-790052 + BMS-650032 combo ( and those two + soc in one of the 3 arms).  

650032 is BMS' entry into the (crowded) NS3/NS4A field
790052 goes after NS5A a relatively new viral target

going after 2 viral proteins concurrently is always a good thing; definitely looks like a good trail to get into (and the 60mg 790052 dosing has given the best results).

[evalbca]

Hi Guys,
Thank You so much for responding...means a lot to me! The study by Bristol is in Phase II and the number on Clinical Trials site is NCT01012895
:-)

[WriteItDown]

Can you tell us the phase of the study and the study number?  I am guessing this is a phase IIb?  It's important before participating in any study to read as much as you can about the study drug, and also to read all the fine print on the study design and agreement.

My husband recently finished a phase IIb study for another protease inhibitor, which worked out well for him, so I am generally pro-clinical trials. However, it's always very important to select the study carefully. We were lucky in that there was a lot of information available about the drug in his study; sometimes there really isn't that much out there.

This is the best info I've found, but it's only from a 12 week study.  It seems from this that 83% of the study participants who received either of the higher dosage amounts were still virus free at 12 weeks.That's pretty good! Check this out, if you haven't seen it already, and please let us know what the study number is if you can.

http://www.bms.com/research/investigational/hepatitis/Pages/BMS790052_easl.aspx

[tashka]

I would also travel anywhere, sell everything we have, and go in debt if my husband could get cured without the threat of severe side effects. This sounds amazing. I am sure, there are a lot of advances ahead for hepatitis C. Almost every day now brings some exciting news. This is the only viral disease that actually can be cured by drugs.

[nygirl7]

Love you too James x  ♥

[inteluck]

this drug seems amazing, log 3 reduction in viral load FROM SINGLE DOSE in 7 out of eight patients in last trial, with NO adverse events. I am in Canada am willing to travel to anywhere to get into a trial with this drug.

[jusjames]

good luck with the trials


Nygirl
you crack me up ;-)
x

[nygirl7]

Hello this is a new one to me (but Im not the most current on trials by far as I finished treatment 3 years ago) - I might not know about it but just wanted to say hi. I remember my first post a long time ago and I was so anxious to see if anybody would answer me! Of course I haven't shut up since then so I am betting odds that they wish they hadn't!

Best of luck with the trial - pretty exciting times for us guys!