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genisi

04/20/12 3:54 PM

#140559 RE: oc631 #140557

I agree. The case seems rare and less likely to occur with a potent drug like 7977 in the combo.
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iwfal

04/20/12 4:36 PM

#140562 RE: oc631 #140557

No such event has been documented using GS-7977.



Does such SCR36 data exist for GS-7977 without Ifn? So far as I can tell from clinical trials the earliest trial of G1 treated with 7977 (wo inf) started in June 2011, so no 36 week data would exist. (There might be some 36 week data for G2/G3 since there was a trial that started in Dec 2010. - but it might still be immature given it is still enrolling?)

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mcbio

04/20/12 7:24 PM

#140566 RE: oc631 #140557

Keep in mind this late relapse, in the ABT study, was seen in a oral combination which didn't have a nucleotide analog backbone. No such event has been documented using GS-7977.

But also keep in mind that the late relapse in the ABT study was seen in an oral combo that included ribavirin. In following Medivir of late as a long and as I understand from following the ACHN CCs much closely when I was long ACHN before, it's my understanding that the ultimate goal is to remove ribavirin out of the equation completely due to side effect issues (along with IFN obviously). If that is indeed the ultimate goal, I would think this might increase the odds that a three-drug HCV DAA combo (nuke+NS5A+PI?), and not simply a two-drug HCV DAA combo (nuke+NS5A?), may be needed. I.e., how certain can we be that just a two-drug combo of GS-7977+an internal GILD NS5A will be sufficient in light of what we saw in the ABT combo trial with ribavirin, notwithstanding that the trial didn't include a nuke?

It is for this reason that I believe those that are writing ACHN and Medivir, and any others, in the PI class off are perhaps being a bit premature.