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Re: mcbio post# 84244

Monday, 09/28/2009 9:37:58 PM

Monday, September 28, 2009 9:37:58 PM

Post# of 257253
ACHN re: ACH-1625 phase-1a results

Dew (or others): the PR noted that there were no SAEs in the Phase 1a trial and that adverse events were "mild and transient." I am just curious if it's normal to see adverse events of any kind in a Phase 1a trial for an HCV PI in healthy patients.

Inasmuch as the phase-1a portion of the study tested subjects for only 5 days, I think it’s too early to say that ACH-1625 will have a clean safety profile.

The dose tested in the Phase 1a went up to 2000 mg/day, which I assume is well above what will be tested in HCV patients in the Phase 1b given the potency of ACH-1625.

That’s unclear, IMO. ACHN appears to be playing its cards close to the vest; however, it’s worth noting that the cumulative daily doses of Telaprevir and Boceprevir being tested in phase-3 are 2250mg and 2400mg, respectively.


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