Is it possible that Bavi/RIB beating Rib/Interferon is not the necessary outcome for the Bavi/Rib trial? Absolutely, that would be the desired outcome, however, does Bavi/Rib not producing more EVRs at 12 weeks kill Bavi? Here is what I think will be the next step from just a simple logical (non-scientific gut feeling). I think the FDA and a lot of folks want to get rid of Interferon, however, they don't currently have a solution yet for all the various patient types in HCV. Even most of the new drugs are still being used in combination with Rib/Interferon. So while it would have been nice for Bavi/Rib to beat Rib/Interferon because that would have made replacing Interferon easy, the real need was at least to show Bavi and Ribravin together showed EVRs at 12 weeks. Although we may not see up front money, I still think we will see somebody come in and pay to see if Bavi/Rib is equal to Ribravin/Interferon when combined with all the other new therapies that still require Rib/Interferon. The question for the future may now be can these new therapies do just as well in combination with Bavi/Rib as with Rib/Interferon without all the side effects.
With the new drug therapies, the days of using Rib/Interferon alone are most likely finished so the comparison to them alone may not have been the absolute bar to meet. Maybe it was about how much activity was there with Bavi/Rib and side effects and does it warrant testing bavi/Rib in combination with other drug therapies and how to structure the trials. SK already said we would license Bavi for HCV regardless and we will see if anyone steps in to do some trials.
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