FDA approves Daklinza (daclatasvir) + sofosbuvir for cirrhosis patients, HIV patients and post liver transplant patients co-infected with Hepatitis C.- BMS

Bristol-Myers Squibb Company (BMS) has announced that the European Commission has approved Daklinza (daclatasvir) for the treatment of chronic hepatitis C (HCV) in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 (human immunodeficiency virus) co-infection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis.

Comment:The new indications are based on data from the ALLY-1 clinical trial (in post-transplant patients and patients with advanced cirrhosis) and ALLY-2 clinical trial (in HIV-coinfected patients). In ALLY-2, the Daklinza/sofosbuvir regimen demonstrated overall SVR 12 in 97% of patients co-infected with HIV, including 100% in genotype 3, and SVR 12 rates were found to be greater than 94% across all combination antiretroviral therapy regimens.In ALLY-1 trial, 94% of post liver-transplant patients and 83% of patients in the cirrhosis cohort achieved SVR 12.