I sometimes question my own objectivity, or wonder if I'm missing something.
To me, a G-1B past TX failure with cirrhosis looks as though 12 weeks only (treated with 3D and RBV) looks like it should indeed be on the table for discussion, but I think that they will end up factoring in results from other Abbvie trials to broaden the data set, but all that I have seen indicates exceptional response rates for 1B's on the Abbvie 3D program.
(Frankly, only the past null responder genotype 1A's clearly look like 24 weeks would provide a meaningful increase in cure rate, but once again, I don't have ALL the data in spread sheet form comparing all cirrhotic 1a's from all Abbvie trials)
Were this to be the case the choice between Abbvie 12 weeks versus Gilead 24 weeks would be a no-brainer. I'm thinking roughly 25% of those in the intent to treat pool are cirrhotics/past failures, half of these are 1b's in the USA.
I am also assuming that a higher percentage of those who treat in the upcoming 1-2 years will be cirrhotics. It will not be the representative damage aggregate of the HCV population.
This could be a very sizable group in the upcoming year.
So yes, I totally agree the FDA decision could have great consequence.
~W
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