Daklinza (daclatasvir) plus Sovaldi (sofosbuvir) filed with FDA for hepatitis C patients with HIV co-infection- BMS/Gilead Sciences

Bristol-Myers Squibb announced that the FDA has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir) with Sovaldi (sofosbuvir), from Gilead, with or without ribavirin. The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.

Daklinza was initially approved in the US in July 2015 and is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials. ALLY-2 evaluated the once-daily 12-week combination of daclatasvir and sofosbuvir for the treatment of patients with HCV coinfected with HIV-1, a patient population that historically has been challenging to treat, in large part due to the complexities of the overlapping therapeutic regimens used to treat each infection. ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.