PS 7977 and BMS 790052 trial

[linda880]

Does anyone know if you have to go to the study site every day for the first 9 days after one is accepted and begins
dosing?  I was told by the Study nurse here in Florida.  I know this was the protocol of the initial study, but these
arms are add-ons to the original trial.  If this is the case, what is the reason?

[UKgirl55]

You mean with the nulls? If so I don't know, but I imagine it was the 400mgs. Can't imagine they would have used 200....but then again, I wouldn't have imagined they would have treated the hardest to treat population first!

[Jimeeboy]

Great article. Do you know what the dosage was in the Electron GT1 relapses with just 7977 and riba for 12 weeks?  I can't find it anywhere.

[UKgirl55]

Hi Jimee,

Did you see this that Will posted earlier. In this particular article it talks about the S282 mutation. I believe this was the mutation that they were concerned about, as far as resistence. I hope it is anyway because as you can see in this trial it says, NO PATIENT DEVELOPED S282 mutation.

When you talk to your doctor this week, maybe you can ask him about the resistance factor (I'm sure you already plan on it).

http://www.gastroendonews.com/ViewArticle.aspx?d=Hepatology+in+Focus&d_id=481&i=February+2012&i_id=809&a_id=20229

[Jimeeboy]

Yes, you do.   Days -1,1,2,3,4,5,6,7,9,11,14,21,28.....is what I have.  I'm waiting to hear if I was accepted.  

[UKgirl55]

Yes Linda, you do. I can't remember exactly. Think it's the first seven days then the next week three days. You are going to be monitored very closely on this trial. They will be checking your blood work closely for the first two weeks. I screened for the trial on the 16th. Have you screened yet? Although these are add on arms. The first trial was for 24 weeks and now this one is for 12 weeks. A lot is riding on the 12 weeks working for the pharma's these days.