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FDA AdComm Prep For Gilead’s Sofosbuvir Shows Agency Thinking On HCV Dosing

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA staff cites a favorable benefit-risk assessment for sofosbuvir, though evidence is insufficient to support dosing recommendation in patients with HCV genotypes 5 and 6. Dosing duration and use in prior nonresponders and pre-transplant patients will be discussed by Antiviral Drugs Advisory Committee Oct. 25.

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