Daclatasvir: Additional Phase IIa data

Additional data from 16 treatment-naïve, non-cirrhotic patients with HCV genotype 1 infection in Part 1 of an open-label, international Phase IIa trial showed that an oral regimen of asunaprevir, daclatasvir and BMS-791325 for 12 weeks produced an SVR defined as undetectable HCV RNA levels (<25 IU/mL) 12 weeks after end of treatment in 94% of patients. Bristol-Myers said the 1 patient was lost to follow-up after completing treatment but did return about 24 weeks post-treatment and preliminary data show that the patient achieved an SVR24. All 16 patients had achieved undetectable HCV RNA levels at the end of treatment week 12. Additionally, 94% of patients who received asunaprevir, daclatasvir and BMS-791325 for 24 weeks achieved an SVR 4 weeks after end of treatment. There were no virologic breakthroughs or relapses. There was 1 grade 3/4 adverse event of headache and 1 grade 3/4 laboratory abnormality concomitant with influenza infection. Data were presented at the American Association for the Study of Liver Diseases meeting in Boston. ...