Global biopharmaceutical company Bristol-Myers Squibb announced that the U.S. FDA has approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. The HCV is a bloodborne virus transmitted most commonly through unsafe injection practices, inadequate sterilization of medical equipment and the transfusion of unscreened blood and blood products.  It is estimated that 130-150 million people globally have chronic hepatitis C, according to the World Health Organization.  Hepatitis C genotype 3 is one of the most difficult to treat genotypes.  Daklinza is an inhibitor of NS5A (Nonstructural protein 5A), a protein encoded in the HCV genome important for viral RNA replication.  Daklinza has shown dual modes of anti-viral activity that inhibits both RNA replication and virion assembly.  According to Bristol-Myers Squibb press release, this approval marks the first time patients with chronic HCV genotype 3 have a 12-week, once-daily, all-oral treatment option.  In addition, it is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need of co-administration of interferon or ribavirin, two drugs approved by the FDA to treat HCV infection previously.


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