Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns
Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.
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Gilead has priced its new 4-in-1 HIV treatment, more commonly referred to as Quad, slightly above the only other integrase inhibitor-based regimen on the market, Merck’s Isentress, but at a 35% premium to its own three-drug combo product, Atripla.
With cost concerns already arising, the sponsor says it is working to ensure the drug is covered by state AIDS Drug Assistance Programs.
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.