Replies to post #140487 on Biotech Values

[DewDiligence]

ABT—SVR36 [i.e. % of patients with undetectable virus 36 weeks post-treatment] in the PILOT study is down to 82% from SVR24 that was 91%.

On first glance, this looks ominous; however, SVR36 data have rarely been reported, so it’s not yet clear how this revelation should be benchmarked.

[iwfal]

ATB

SVR36 in the PILOT study is down to 82% from SVR24 that was 91%

Anyone seen the SVR4/12 data for PILOT? (A quick search of the web didn't find it) It would be interesting to see the curve of relapse - even a crude one with 4, 12, 24 and 36.

[DewDiligence]

How is SVR defined? In what might be a consequential change, the FDA label for Incivek was recently modified to include the following language on page 16:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf

SVR was defined as HCV RNA less than 25 IU per mL at last observation within the SVR visit window, i.e., weeks 32-78 for patients assigned to 24 weeks of treatment and weeks 56-78 for patients assigned to 48 weeks of treatment [emphasis added].

Clearly, this is a more stringent definition than merely having undetectable virus 24 weeks after the end of treatment.

I wonder if this change has anything to do with the late relapse seen in ABT’s PILOT study (#msg-74608528).