>ITMN – Is comparing the median log reduction in viral load to the mean log maximum reduction, which measure 2 different parameters really reflects viral rebounds?<
I think the comparison is accurate enough for discerning whether there was a serious problem with viral breakthrough. For most antivirals, the distribution of the log viral reduction at EoT and the distribution of log maximum viral reduction during the treatment period during a short study typically do not have the kind of tail that leads to a wide discrepancy between the median and the mean.
ITMN’s PR of 1-April-08 (#msg-28091523) gave the range of log maximum reduction for each cohort. In cohorts 3 and 4 (the ones of greatest consequence for taking the drug into combination studies), the mean was almost exactly the midpoint of the range: in cohort 3, the mean was 3.4 and the range was [2.4,4.4]; in cohort 4, the mean was 3.9 and the range was [3.0,5.0].
Based on the above, I think it’s reasonable to infer that the discrepancy between the mean and the median in these distributions is small enough to ignore, which allows us to focus on the discrepancy between the max-drop and EoT figures.
If the data reported in #msg-28126092 had been from a combination study, viral rebound would have been a serious concern. But a small amount of viral rebound from the maximum drop to the end of treatment (3.1->3.4 in cohort 3; 3.8->3.9 in cohort 4) ought not to be a major concern in a monotherapy study, IMO.
All told, I think the ITMN-191 are very impressive as far as they go, but we’ll have to wait for the unblinding of the safety data to get a complete picture.
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