Drug Update: July 2017

New Specialty Drug Approvals

FDA Approves New Hepatitis C Medication: Vosevi®

In July 2017, the U.S. Food & Drug Administration (FDA) approved a new fixed-dose combination medication for the treatment of chronic hepatitis C virus (HCV): Vosevi®. Vosevi is a combination of three anti-viral medications: sofosbuvir, velpatasvir, voxilaprevir. Vosevi is approved for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). It is specifically indicated for patients who have genotype 1, 2, 3, 4, 5 or 6 infection and have been previously treated with an HCV regimen containing an NS5A inhibitor (such as, daclatasvir [Daklinza®], elbasvir [found in Zepatier®], ledipasvir [found in Harvoni®], ombitasvir [found in Technivie®], or velpatasvir [found in Epclusa®]). It is also indicated for patients with genotype 1a or 3 infection who have previously received treatment with an HCV regimen containing sofosbuvir without an NS5A inhibitor. These prior regimens include sofosbuvir with or without: peginterferon alfa/ribavirin, ribavirin, boceprevir, simeprevir, or teleprevir. Read more