Biotech Values

[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).