I'm not naive so I can't get into this trial, but I'm very interested in these drugs and think that there will be a trial for non-responders sooner or later.
Pharmasset's drug R7128 has demonstrated a high barrier to resistance in trials so I think it is likely that PSI-7977 will be the same or better. However that is just speculation on my part. Both of these drugs have only been tried with small numbers of people. So I cannot see how this study doc can be so sure that there will be no mutations.
In a different study it was reported that "Resistance to both BMS-790052 and BMS-650032 was seen in the 6 people (out of 11) who had HCV breakthrough."
http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0412_2010_a.html
So it is possible to have BMS-790052 mutations. But whether they would occur in combination with PSI-7977 who knows? Is there any data on that out there?
dointime
The mutation question was one of my questions and they said there were none. If your naive and don't have any serious liver issues I believe it would be worth your time to at least talk to these people.
I'm not as enthusiastic about this trial now as in my previous posts because I had a good think about the danger of resistant mutations. So maybe it's good after all that you didn't get into the trial Upbeat. I think I got carried away with the great results and the non-interferon idea but in cold hard facts I don't think we have enough information about resistance to these 2 DAAs.
I should know better by now .... sigh.
dointime
What do you think is best for naive 1st time treater genotype 1b, ct? to treat with boc and soc, or to go for this trial of PSI-7977 + BMS-790052?
I would love to avoid interferon and riba, but am afraid of failure and/or mutations. Also, would love to try boc and soc, since like 75% chance of success it seems, but afraid of sides and then that would make me a non naive, and I would therefore not qualify for most trials.'
Any suggestions?
I have set up an appt. for Joe to just meet the trial coordinator in hopes of her remembering us, if by some miracle, Joe could eventually qualify for something good. I have bugged the poor lady frequently by phone and she said it was highly irregular for her to talk to me instead of the person wanting to be in the trial. I told her to think of me as his manager.
:>)
We will just go meet her and who knows. One of the times I called her, she told me about a trial she had for testing an antifibrotic. I can't remember what it was called now but we turned it down. It was halted because of some negative SX that popped up. I was glad we'd not gone down that road. We said no because Joe had just finished TX and was too worn out to endure all the traveling it involved.
Ev
Sounds like you don't have much hope of getting in to that trial, although they did not actually turn you down so you can't be sure yet. Oh well bu**er. I only wish they could get the damn drugs on to the shelves in 3 years. Well as you say, you gave it a shot, and well done for that. Maybe the practice will come in handy for some other trial. Jeez, this trial business is getting to be like going for a job interview.
I would like the contact info please, although I am not naive so would not be eligible for this particular trial, but no harm in watching out for what comes along.
dointime
This is a phase 2 Naive trial. They were really high on these drugs as a non interferon treatment. If your interested let me know and I will send the contact info.
Where in San Diego did you go? I live in SD and am looking to possibly get into a 3rd phase trial. Thank you
Thx
Thats the one. I might try that trial but theres a 50 50 shot you get the placebo and my luck says I would. Yes Naive but bad liver so the trials don't want me. They like people who stand the best odds of making their drugs look good.
They thought that the new pi from johnson and johnson going into phase 3 now was the best of the upcoming drugs with interferon, Its called Tioc or something like that. Oh well I have given it a shot.
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Tibotec; TMC435
Naive?
http://clinicaltrials.gov/ct2/show/NCT01289782?term=TMC+435&rank=18
Hey
I went to san diego today and pre screened to do the trial. I gota tell ya there is no way in hell that they will accept me. They took the blood and did all the required tests but it sounded like they were going to be real picky as to who they let in. They even told me I would have to stop taking the metformin I take for diabeties if they let me in. They were real upbeat on these new drugs and figured the new pi's would be outdated in about three years. They thought that the new pi from johnson and johnson going into phase 3 now was the best of the upcoming drugs with interferon, Its called Tioc or something like that. Oh well I have given it a shot.
I don't have any more info than what you already saw from EASL but this is THE combo that I am watching.
My understanding is that Pharmasset is pushing PSI-7977 as a replacement to interferon and as the backbone of future combos. They also have R7128 and I have been wondering why they have not progressed that one faster despite it's very good results. I am speculating that they learned from it, have incorporated that knowledge into PSI-7977, and are now concentrating their resources on a major push with PSI-7977 to corner the market on non-interferon combos.
Not only is it great news that we might not have to suffer with interferon again, this combo seems to be just as effective for ifn non-responders. It doesn't get better than that unless the mythical vaccine comes along.
If I wanted to do any trial currently on offer, this is the one I would choose. Please keep us posted on what you decide and good luck.
dointime