Bristol-Myers daclatasvir combo achieves 94% response in hep C patients

US drug major Bristol-Myers Squibb (NYSE: BMY) has, for the first time, released Phase II data demonstrating that the 12-week Triple DAA treatment regimen of three compounds in its R&D pipeline - daclatasvir (DCV), asunaprevir (ASV) and BMS-791325 - achieved sustained virologic response 12 weeks post-treatment (SVR12) in 94% (15/16) of treatment-naive, genotype 1 chronic hepatitis C patients.

This is welcome news for B-MS, which earlier this year discontinued development of BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor that was in Phase II development for the treatment of hepatitis C, a market sector projected as being worth some $20 billion with the anticipated arrival of oral treatments (The Pharma Letter August 24).

The remaining one patient in the Triple DAA regimen had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR24. The Phase II results from this interferon-, ribavirin- and ritonavir-free investigational regimen combining three different classes of direct-acting antivirals (DAAs) – an NS5A replication complex inhibitor (DCV), an NS3 protease inhibitor (ASV) and an NS5B non-nucleoside polymerase inhibitor (BMS-791325) – were presented at the American Association for the Study of Liver Diseases congress in Boston.