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AVAC Comments to Antimicrobial Drugs Advisory Committee and FDA re: TAF/FTC (Descovy) as PrEP

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AVAC
August 2019

AVAC comments submitted to the Antimicrobial Drugs Advisory Committee and FDA re: TAF/FTC (Descovy) as PrEP, which encourage the Advisory Committee to recommend, and the FDA to approve, the supplemental indication for daily oral PrEP with F/TAF for adult men and women at risk of sexually acquired HIV-1 infection – with the appropriate requirements for labeling, post-marketing surveillance and REMS as described in the letter, and as per the FDA’s own updated guidance on REMS and access posted earlier this year.