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FDA approves simeprevir-sofosbuvir combo for hepatitis C


 

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The Food and Drug Administration has approved the use of sofosbuvir in combination with simeprevir for treatment of patients with chronic hepatitis C virus. It is a ribavirin- and interferon-free regimen.

The approval is reflected in changes to the label of simeprevir (Olysio), an HCV NS3/4A protease inhibitor, which was approved in 2013 for chronic hepatitis C genotype 1 infection “as a component of a combination antiviral treatment regimen.”

The new label summarizes the results of COSMOS, an open label, randomized phase II trial of HCV genotype 1–infected prior null responders with a METAVIR fibrosis score of F0 F2 or treatment naive subjects and prior null responders with a METAVIR fibrosis score of F3 F4 and compensated liver disease. The sustained virologic response rates 12 weeks after planned end of treatment was 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The study was published online (Lancet 2014 July [doi:10.1016/S0140-6736(14)61036-9]).

In COSMOS, the most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), pruritus (11%), rash (11%), and photosensitivity (7%). Among those treated for 24 weeks, dizziness (16%) and diarrhea (16%) were reported, according to the revised label.

When combined with sofosbuvir, treatment of treatment-naive and treatment-experienced patients is recommended for 12 weeks (for patients without cirrhosis) or 24 weeks (for patients with cirrhosis).

Simeprevir is marketed by Janssen Therapeutics. Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor approved in December 2013 for treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen, is marketed as Sovaldi by Gilead Sciences. The combination was approved Nov. 5.

emechcatie@frontlinemedcom.com

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