title: Daclatasvir + asunaprevir: first global approval.
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.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand, dru@adis.com.
authors.forename: Raewyn M
authors.initials: RM
authors.lastname: Poole
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D002219:Carbamates; D017277:Drug Approval; D004338:Drug Combinations; D015195:Drug Design; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D007546:Isoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D007564:Japan; D011759:Pyrrolidines; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D004338:Drug Combinations; D007093:Imidazoles; D007546:Isoquinolines; D011759:Pyrrolidines; D013449:Sulfonamides; D014633:Valine; C549273:daclatasvir; C571889:asunaprevir