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Hepatitis C Drug Simeprevir (Olysio) Gets FDA Nod
The FDA has approved simeprevir (Olysio, Janssen Pharmaceuticals), a new therapy to treat chronic hepatitis C virus (HCV) infection.
Simeprevir is a protease inhibitor that blocks a specific protein needed by HCV to replicate. It is to be used as a component of a combination antiviral treatment regimen. In clinical studies, simeprevir was evaluated in combination with peginterferon-alfa (peg-IFN-alpha) and ribavirin, two drugs also used to treat HCV infection. Simeprevir is intended for adults with compensated liver disease, including cirrhosis, who are treatment naïve or for whom previous treatment has not been effective.
The safety and effectiveness of simeprevir were evaluated in five clinical studies involving a total of 2,026 treatment-naïve and treatment-experienced participants who were randomly assigned to receive simeprevir plus peg-IFN-alpha and ribavirin or placebo plus peg-IFN-alpha and ribavirin. The studies were designed to measure whether a participant’s HCV was no longer detected in the blood at least 12 weeks after completing treatment (sustained virologic response), suggesting that a participant’s infection had been cured.
Eighty percent of treatment-naïve subjects treated with simeprevir plus peg-IFN-alpha and ribavirin achieved a sustained virologic response compared with 50% of subjects treated with placebo plus peg-IFN-alpha and ribavirin. In one of the studies with treatment-experienced participants whose infection had returned (prior relapsers), 79% of those treated with simeprevir plus peg-IFN-alpha and ribavirin achieved a sustained virologic response compared with 37% of those treated with peg-IFN-alpha and ribavirin alone.
Source: FDA; November 22, 2013.