…the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin[i.e. no ifn] and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
This trial is plainly intended to give BMY and JNJ an avenue for testing an all-oral HCV combination that does not include PSI-7977 and thereby does not rely on GILD. If the results of the trial are positive, BMY and JNJ could then ink a full-fledged collaboration to bring such a combination to market.
BMS-790052 (a/k/a daclatasvir) from BMY is the leading NS5A inhibitor; TMC435 from JNJ/Medivir is the leading second-generation PI. In previously announced phase-2 trials, each of these dugs is being tested in combination with PSI-7977.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”