I believe that SOC failures still are considered *essentially* wild type, in terms of the remaining sub-variant types which exist following treatment by SOC.
Strictly speaking, I do not believe they are, but that the changes in the sub-variant populations do not change as much as those left changed by treating with a PI. The resistance imposed by PI's changes the population's make up far more than does those affected by RBV or IFN.
So they are lumping the naives in with the Nulls since those sub-variant populations remain pretty similar.
They want to keep the groups tested discrete.
Think of this as a control or baseline.
The upcoming PI resistant trials/cohorts ones will be compared with these.
Why not just add one more cohort with past PI resistance?
Perhaps they need the data from this to ensure successful dosing/duration on subsequent cohorts, besides, they might need two more considering the high/low ABT-530 dosing is still being evaluated.
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What might one do with the resultant list of resistant subspecies that this combo will be pitted against?
1) Well, if the drug combo knocks them out, then it ain't an issue
2) but presumably, the toughest to treat may not be cured 100%. If so..... what does the population look like of survivor resistant subspecies?
If you know that, then you also may know what drug you may add to the mix to cover that TX resistant group. For instance; what if you determined you did need a nuke? Or needed a nuke to treat in 4-6 weeks? You will want to see what the surviving populations look like, that this 493/530 combo spins off.
Testing discrete groups helps answer such questions, IMHO
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Why test nulls?
If the drug combo will not cure nulls, ya might as well find out sooner than later.
I think the bar is just that high. There is little point going forward testing naive 1b groups.
One may also infer that Abbvie/Enta are confident this combo will work on past null responders. Also.... null responders are null responders for a reason; it may be that they were poor responders with interferon, or it may be a different reason; that they started out with a group of sub-variants which were more resistant to that form of TX. One has to define the enemy before one can fight it.
Sorry for the length. Theory, opinion, conjecture, all of which may be wrong or miss the point. : )
~W
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