The FDA has approved changes to the Olysio label reflecting that it can be used in combination with Sovaldi to treat patients with chronic hepatitis C virus genotype 1 infection, according to a media alert from the FDA.
Olysio (Simeprevir, Janssen Therapeutics) is a NS3/4A protease inhibitor that functions by blocking the viral protease enzyme HCV uses to replicate. It was approved by the FDA in November of last year as part of an antiviral treatment regimen with pegylated interferon and ribavirin for patients with chronic HCV genotype 1.
Sofosbuvir (Sovaldi, Gilead Sciences), a nucleotide analog NS5B polymerase inhibitor, was approved by the FDA in December of last year as an oral tablet, to serve as a component of a combination antiviral treatment regimen to treat chronic HCV.
According to the FDA alert, Olysio should not be taken as monotherapy, but administered in combination with either pegylated interferon alfa and ribavirin or sofosbuvir.