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mcbio

07/31/10 10:03 AM

#100315 RE: DewDiligence #100312

Re: ANA598 SVR12 data

Then along came VRTX’s PROVE-3 study, which changed the prevailing view on this subject to some degree. In the ‘12+12’ arm of PROVE-3, only one patient out of 60 who achieved SV12 failed to achieve SVR (see note 4 in #msg-36464842).

So this data would appear to support that SVR12 is predictive of SVR24 data where one DAA is involved with SoC if I'm reading it right.

p.s. The original point of this thread was not the degree to which SVR12 was predictive of SVR, but rather that ANDS chose to issue a PR to report SVR12 data on only six patients. My contention is that ANDS’ PR was a pump because ANDS could simply have waited to report the SVR data (#msg-52795076).

Before anyone gets excited about ANDS' data showing 100% of the six patients achieving SVR12 with ANA598, I would add not just the point that we're only talking about six patients, but more importantly that these six patients are a subset of a larger group of patients (I believe a subset of 30 per #msg-50635544 ). Per #msg-52795076, "The six patients who stopped all treatment at Week 24 were part of an investigation of response-guided treatment duration for ANA598 in which patients who had achieved undetectable levels of virus (<15 IU/mL) at Weeks 4 and 12 were randomized 1:1 to stop all treatment at Week 24 or Week 48."

We should also keep in mind that this trial of ANA598 involves SoC. With the ultimate goal of HCV DAAs being to replace at least ifn, if not both ifn+rib, it's going to take a lot more than one non-nuke to accomplish this feat. (I know you know that, but just posting this for others that don't follow this as closely.)