European regulators have approved a label extension for Bristol-Myers Squibb’s hepatitis C drug Daklinza, allowing a shorter 12-week course of treatment for patients with genotype 3 forms of the disease.
A 24-week regimen of Daklinza (daclatasvir) in combination with Gilead’s Sovalid (sofosbuvir) and ribavirin was cleared for this subset of patients back in August; the updated label now offers access to a once-daily, all-oral treatment regimen of shorter duration for the first time.
The approval came on the back of trial data showing a sustained virology response at 12 weeks with the Daklinza/sofosbuvir regimen in 90% of treatment-naïve and 86% of treatment-experienced chronic HCV genotype 3 patients.
SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history and, in the more difficult-to-treat patients with cirrhosis, rates were reduced (63%) following the 12 weeks of treatment with the Daklinza plus sofosbuvir regimen, the firm said.
