announced that the Food and Drug Administration (FDA) has accepted for
review the resubmitted New Drug Application (NDA) of daclatasvir in
combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.
The initial NDA now includes data from the ALLY-3 trial (n=152), a
Phase 3 open-label study in which patients received daclatasvir 60mg +
sofosbuvir 400mg once daily for 12 weeks with 24 weeks of follow-up. The
study demonstrated high cure rates for the combination therapy with
sustained virologic response 12 weeks after treatment (SVR12) seen in
90% of treatment-naive genotype 3 HCV patients, and in 86% of
treatment-experienced patients. SVR12 rates were seen in 96% of
non-cirrhotic genotype 3 patients, regardless of treatment history.
Labels: ALLY-3 trial, daclatasvir plus sofosbuvir, GT 3