Clinical trial GS-7977 and BMS-790052

[katla]

I started this clinical trial yesterday, 12 weeks, all oral. (NCT01359644)

There were two arms -  one with and one without Ribavirin. My arm is (unfortunatley) without.

I know some people here are contemplating and/or screening for this trial. I'd love to keep in touch and exchange feedback.

Good health to all...

Kat

[HCV-B-GONE]

What I was referring to is this (and I'm referring to contract law versus drug company protocols).  When a corporation buys another, the purchased company has outstanding contracts and the buying company actually buys those contracts along with the company they bought.  Granted, they could violate the contracts and be sued and maybe gain something, but in this case, Gilead would gain knowledge.  So, the trial agreement I signed specifically states it was an agreement between BMS and Pharmasset.  I'm assuming (maybe wrongly), that this agreement began just before the purchase took place by Gilead so it was an honored contract.  At the time I began the trial Pharmasset was already owned by Gilead, so that is the reason I'm making this comment.

[FaithforHealing]

The good thing is that the Gil/Pharm/BMS collaboration of trial (Phase II) has opened up with many new arms all over the country, and anyone who gets into it should do well. I guess it's been successful even on the arms with no riba.

"... when a company buys another they have to honor any outstanding contracts, and there was no contract apparantly for a phase 3 with BMS and Pharmasset (Gilead)." (Do you have a link to info on this?)

From what I know I don't think a Phase III (in a any study) can be written or started until it is approved by "the powers that be" which would be outside independent groups (the government, AASLD, EASL.).  Until Phase II is deemed conclusive it can't move to Phase III. The protocols of a Phase III are written on the results of Phase II. Gilead claims there is no Phase III because Phase II (while promising) still has issues to be researched. That's why there was no Phase III contract to "buy"?

A drug company can't just write/contract/start their own Phase III (or any study)  w/o outside scrutiny and approval. It will allow thousands of people into the study as opposed to the smaller number that go into a Phase II and it darn well better be as safe as it can be.

If they are not going ahead and asking for a Phase III and the Phase II is really conclusive enough (i.e., been reviewed by all the doctors/scientist/researchers at groups like AASLD, EASL) to move ahead to a Phase III, then we would have to conclude there is a conspiracy for the almighty $$$. All of these reviewers and groups would also be in on it as they should be screaming if it is really safe to go on to Phase III.

Big business and medical care.....who knows what's really going on? I find it hard to believe that AASLD, EASL, etc and trial doctors would participate in a conspiracy, but they are all paid by big pharm.  AASLD and EASL (lots of jobs) would not exist w/o big pharm.

I wonder how long it took from the first studies/trials for SOC on genotype 2 to move through the phases. I wonder how long the "experimenters" knew if was a done deal before they could move onto Phase III and finally get FDA approval for marketing? Just wondering if it dragged out as long as this one is.

[HCV-B-GONE]

The important issue this month is who is post 12 weeks on 7977/790052 and is getting blood results for SVR 2 and SVR 4.  That will tell BMS and Gilead a lot.  If they do get SVR after only 12 weeks, then they may actually have to get more results because they essentially halved the treatment time (reduce the following:  cost to us, cost to insurance companies, cost to Medicare, cost for other countries).  They are also waiting for the nulls that are still treating.  Tomorrow is my 12 week point and I still go another 12 weeks.  So, there is still data that needs to be gathered (in my opinion).  The crime is that Gilead is not willing to go forward with BMS 790052.  I read my trial agreement and it is with Pharmasset (not Gilead), so when a company buys another they have to honor any outstanding contracts, and there was no contract apparantly for a phase 3 with BMS and Pharmasset (Gilead).  I'm hoping they are discussing this and that they too are mostly in a waiting phase as we are.  Time will tell.

[FaithforHealing]

NCT01359644 is still the Phase II, correct? And the petition urges them to go onto Phase III?

There are independent outside monitors that watch over trials, I would like to think they would speak up if Gilead/Pharmasset is lying about still needing further Phase II info/results before moving onto Phase III.

If it is a definitive "known" that they already know which drug combos/doses work and which ones don't, it is criminal to keep putting people through an experimental Phase II arm that is already proven not to work.

Who knows?

[tiredofhepc]

http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c

[FaithforHealing]

Did you check out the other study/trial at
http://clinicaltrials.gov/show/NCT01359644 ?

I don't know your details, but this one may apply to you. It's the one I (above) posted to BBB.

The biopsy I had was a piece of cake, no meds except a local as I recall. Did not hurt, was fast, and no bleeding and I already had low platelets (possible enhanced bleeding issue). I could not believe they were going to take out a chunk of my liver while awake!  
I went alone (I had flown out of state to a med facility), I walked out a few hours later, caught a shuttle back to my hotel.

Ask for a xanax or something like that to take before the bx.

Maybe bx's are different today or there are different kinds, but this was easy. Mayo Clinic, MN 2003