This post is an adjunct to #msg-47110029 and should be read in conjunction with it. The source of the numbers in the table below is IDIX’s 4Q09 CC held on 2/25/10. Although the number of patients is small and the dosing regimen was suboptimal (see footnote*), I think these results show that 50mg qD is probably too low a dose. Fortunately, IDX184 to date has had a squeaky-clean safety profile and raising the dose as planned ought not to be a problem.
Mean Log Stddev Log # of % of Reduction Reduction Patients Patients # of Viral Load Viral Load Undetctable Undetctable Patients(14 Days)(14 days)(28 days)(28 days) IDX184+SoC* 16 2.7 1.3 3† 19%* SoC alone 4 1.9 1.1 0 0%
*Patients in this arm were given IDX184+SoC for 14 days, followed by 14 days of SoC alone; thus, the 19% figure is not an RVR rate for the triple therapy. The 14-day limit for IDX184 dosing in the phase-2a trial has been imposed because 14 days is the duration of the completed animal-tox studies; optimal IDX184 treatment regimens will include a longer duration of IDX184+SoC (or IDX184 + other DAA’s).
†Two patients went undetectable during the 14 days of IDX184+SoC treatment and one patient went undetectable after 21 days (14 days of IDX184+SoC and 7 days of SoC alone).
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