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Renal Safety In The Spotlight At FDA Panel Review Of Gilead’s Quad

This article was originally published in The Pink Sheet Daily

Executive Summary

The four-drug, single-tablet HIV treatment regimen was associated with higher rates of serious adverse events and study drug discontinuations due to renal events in the pivotal trials. FDA is seeking the Antiviral Drugs Advisory Committee’s views on renal safety and whether monitoring recommendations should be stricter than those proposed by Gilead.

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