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For Gilead’s Sofosbuvir, Questions Remain About Breadth Of Indication

Executive Summary

The company seeks a broad label in hepatitis C that would allow for easy integration with other direct-acting antivirals making their way toward FDA approval, but the agency seems to favor an indication limiting use of the first-in-class “nuc” to the ribavirin- and pegylated interferon-containing regimens studied.

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