FDA Approves Breakthrough Therapy for Hepatitis C

The U.S. Food and Drug Administration approved Gilead Sciences’ oral pill Sovaldi to treat chronic hepatitis C infection, or HCV. Sovaldi is the first drug for hepatitis C that can be taken without weekly injections of interferon.

The FDA based its approval on results in mid- and late-stage trials where 50 to 90 percent of patients treated with Sovaldi achieved sustained response with no detectable virus 12 weeks after completing therapy. These patients were considered cured of the disease and treatment duration was half the time or less compared to current standard of care. Many doctors kept their patients from treatment with other drugs in anticipation of Sovaldi’s approval.

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