European Commission approves extended use of Daklinza (daclatasvir) in 3 new patient categories, in Gen 1, 3 and 4
Shadowfax said
Jan 30, 2016
It's great to keep reading these changes and advances and they seem to be coming faster now. Options and hope is what we all need. Thank you for sharing this.
Cinnamon Girl said
Jan 29, 2016
European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV
Bristol-Myers Squibb has announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C 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) coinfection, 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. 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).
The recommended treatment regimens and durations are as follows:
It's great to keep reading these changes and advances and they seem to be coming faster now. Options and hope is what we all need. Thank you for sharing this.
European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV
Bristol-Myers Squibb has announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C 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) coinfection, 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. 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).
The recommended treatment regimens and durations are as follows:
European Commission approves daklinza