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Simeprevir/Sofosbuvir Combo Wins Priority Review for Chronic Hepatitis C Infection
The FDA has assigned a “priority review” designation to a supplemental new drug application (sNDA) for the use of once-daily simeprevir (Olysio, Medivir/Janssen), an NS3/4A protease inhibitor, in combination with sofosbuvir (Sovaldi, Gilead), an NS5B polymerase inhibitor, for 12 weeks of treatment in adult patients with genotype-1 chronic hepatitis C infection.
The regulatory submission for simeprevir and sofosbuvir was supported by data from the phase II COSMOS trial, which included treatment-naïve patients with advanced fibrosis and prior null-responders with all stages of liver fibrosis.
In this study, 93% of the patients achieved a sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates, and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks.
The most common adverse events were fatigue, headache, nausea, anemia, pruritus, dizziness, rash, and photosensitivity. One patient discontinued treatment because of adverse events.
In November 2013, Olysio (simeprevir) was approved by the FDA for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1-infected adults with compensated liver disease.