Update on Quantum

[joy5116]

The name of the roll-over trial for those whose PSI-938 trial was halted will be Reactor (not Refractor as previously told). It will be open label for 12 &/or 24 weeks, response guided, with PSI-7977and riba, said to begin in April.  Since the PSI-938 is a polymerase and not a protease inhibitor resistance is basically thought to be a non-issue.

[curiouslady1]

The BMS/PSI trial is NCT01359644

Try to go to one of the sites listed and ask about the EXTENSION which is supposed to start in March/April.  

[linda880]

which trial is BMS/PSI.  I screened for quantum but did not get in.  Arms
closed before they got my results back.

[rivll]

"The trial was stopped due to toxicity where initially the numbers dropped and then after a few weeks began to rise..."
The numbers you refer to are the liver enzyme levels or the VL?
The results from the last 2 weeks of the study are still pending. I was told I would have it in a week or two.

[joy5116]

I was told the trial was stopped due to toxicity where intially the numbers dropped and then after a few weeks began to rise. No one became jaundice which would have represented damage, this info per Dr Schiff.  I was further told that no one at my site had any issues, still waiting on VL. have you gotten yours?

[rivll]

My Dr. replied to my email about resistance. His answer:"not a single person has developed resistance to this class of drugs so far." Not really much of an answer but since he is on vacation, I won't bother him again until next week.

[joy5116]

That was my intial understanding of it also. Once I had the meds in my hot little hands however it was explained a bit differntly in that they said I could still be receiving a placebo.  My response was like yours (not that it matters now) especially when I was told I was in the 12 week arm.  Somehow that feels like the distant past.  It's not at the forefront for me because there are so many other things.  But again I think you for your well wishes.
Are you in a trial?

[candyce1953]

Yes that's what I heard and read also on gov trial website
Was -
9 arms(One placebo arm)
A few arms done  with ribivarin
And either 7977 with 938
Or  the PSI alone

[joy5116]

Thanks so much...

Did someone say 938 was a replacement?  I didn't think it was.  The bottles I had read 938 OR placebo, 7977 OR placebo.  

[candyce1953]

That's great Joy I wish you much success in your new tx

Quantum had 9 arms ( only one was placebo)
Some with 938+7977 and ribivarin

I believe 938 was not not a replacement of RIBA

But hopefully 7977 and RIBA will be great for you

[joy5116]

That was the trial I intially had wanted and shared the info with Curiouslady.  It however did not come to a theater near me so I gambled on Quantum. I'am gald I have the opportunity to treat coming up and wish it could have been as smooth going as that trial.
I cannot say I understand the resistance issue either, though my fears have been quieted. I spoke with my GI guy several weeks ago and he said resistance is always present with any medication. I spoke with Dr Schiff from U of Miami on Monday prior to speaking with my PI and he basically said the same thing and added the PS-7977 would wipe out the virus and implide it would overide such concerns.  Were these liesurely conversations I might have explored it further and since you bring it up I will ask for further explanation when given an opportunity. .

[UKgirl55]

This is how I read it also and would love to have an answer to that question. I myself could possibly go on the next PSI/BMS trial and since it's only for 12 weeks, we yet again take a big risk. So having some sort of knowledge that a polymerase may in fact be a non-issue would be of great comfort. However, like you said, "It sounds rather too good to be true."

[dointime]

" Since the PSI-938 is a polymerase and not a protease inhibitor resistance is basically thought to be a non-issue."

Joy, many thanks for the update on this new trial.

I am finding the above statement very interesting.  It would be great if you could manage to get more info from your doc about it.  The question I am asking is : "so do we not have to worry about resistance when we treat with a polymerase only?"

It sounds rather too good to be true so I'd like to learn more.  Any specifics you can get, or links to data which demonstrates this would be very helpful.

dointime  

    

[curiouslady1]

Well, the two drugs are different (pyrimidine/purine) though the chemistry is a question.  Evidently, the researchers don't see their both being polymerase inhibitors as being a dealbreaker.  I keep thinking of what I was told (and somewhat experienced myself) that the PSI 7977 is quite powerful at 400mg per and, in addition, has a high barrier to resistance.  This means to me that it does not operate in the same way as so many drugs which have gone before it.  I have complete faith that Joy is going to be quite joyful come about the second or third week of April . . . you can call me a cockeyed optimist :)

[joy5116]

Thanks being supportive, it helps.
That was pretty much my understanding from the few minutes we had together.  I was in the arm that potentially had both drugs, which as of yet has not been unblinded.  Doc did not differnetiate between the two PI's. If I had to guess what I was getting I'd guess the 7977 was a placebo by the consitency of the pill, but who knows. I'll find out next visit unless they call me sooner with the info, which I'm thinking they will.  I started to feel headachy, under the weather with intense heartburn while in the trial so I do think I was taking at least one drug instead of 2 placebo's.

[UKgirl55]

This is good news Joy....You continue to be in my prayers and it seems that God is listening :-)

[UKgirl55]

But what about the people that were on the 7977 and 938? This was one arm of the Quantum trial.

Both of them are a polymerase. Are they saying there is going to be no problem with resistance with polymerase drugs? I'm not understanding. If you only took the 938, then I understand that the 7977 is a different class of polymerase and therefore possibly no fear of resistance to the 7977.

[curiouslady1]

Yes! Neither of the drugs are protease inhibitors so those who have taken the triple and failed, can enroll in another trial which is an extension of the BMS/PSI trial now underway.

While both  PSI 7977 and PSI 938 are both polymerase inhibitors apparently, one is a pyrimidine and the other is a purine.  Here is a further discussion.  I assume that one was supposed to potentiate the other so that is why I believe it was hoped that the PSI 938 would take the place of ribaviron as a second drug (according to a reading that was linked here on the forum) but I guess that is not to be unless they lower the dosage of PSI 938 substantially.  

http://www.hivandhepatitis.com/2010_conference/easl/docs/0511_2010_a.html

[rivll]

That is good news!