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Russian health department approves simeprevir to treat HCV

The Russian Ministry of Health approved simeprevir as treatment for chronic hepatitis C genotype 1 infection, Medivir AB reported today in a press release.

According to the release, simeprevir, an NS3/4A protease inhibitor, was indicated for use in combination with pegylated interferon-alfa and ribavirin in adult patients with compensated liver disease who have failed previous interferon therapy with or without ribavirin, or are treatment naive.

“The Russian approval is another important event for simeprevir and provides the hepatitis C patients in Russia with a new HCV treatment,” Maris Hartmanis, chief executive officer of Medivir AB, said in the release.

Russia is the first country within Europe, the Middle East and Africa to be granted access to the drug; it had the third-greatest HCV prevalence based on 2011 WHO data, according to the release.

Simeprevir (Olysio, Medivir AB, Janssen R&D Ireland) was approved by the FDA in November 2013.