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Abstract Details
Daclatasvir + Asunaprevir: first global approval
Poole RM. Drugs. 2014 Sep;74(13):1559-71. doi: 10.1007/s40265-014-0279-4.
Author information
Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand, dru@adis.com.
Abstract
The combination of daclatasvir + asunaprevir [Daklinza(®) + Sunvepra(®) (Japan)], two direct-acting antiviral agents, has been developed by Bristol-Myers Squibb for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infections, including those with compensated cirrhosis. Daclatasvir + asunaprevir has received its first global approval in this indication in Japan. Daclatasvir + asunaprevir is the first all-oral, interferon- and ribavirin-free regimen for this indication. This article summarizes the milestones in the development of daclatasvir + asunaprevir leading to this first approval for the treatment of chronic HCV genotype 1 infections.