Replies to post #104179 on Biotech Values

[biomaven0]

Here's the actual language from the guidance:

Null Responder [13]: less than 2 log10 reduction in HCV RNA at week 12 of a Peg584 Interferon/RBV

...

[Footnote 13] Other definitions for null response have been proposed, such as less than 1 log10 IU/mL decline in HCV RNA at week 4 of treatment. However, failure to achieve a greater than 2 log10 IU/mL HCV RNA decline at week 12 has typically been used as a treatment futility criterion and use of a null response definition of viral reduction less than 1 log10 IU/mL at week 4 causes a gap in classification for individuals with a viral load reduction greater than 1 log10 at week 4 but less than 2 log10 reduction at week 12.