Da­ta on Gilead­'s an­tivi­ral bring hope for first Covid-19 drug ap­proval

Hours af­ter Gilead an­nounced that an NIH tri­al test­ing their an­tivi­ral drug remde­sivir in Covid-19 pa­tients had suc­ceed­ed, NI­AID di­rec­tor An­tho­ny Fau­ci sat on a couch in the Oval Of­fice and gave the world the top-line read­out.

The drug in­duced a 31% im­prove­ment on the pri­ma­ry end­point of time to re­cov­ery: 11 days in the drug arm com­pared to 15 days in the place­bo arm, he said, adding that pa­tients tak­ing the drug ap­peared less like­ly to die, with an 8% mor­tal­i­ty rate in the drug arm com­pared to 11% in pa­tients giv­en the place­bo.

The mor­tal­i­ty da­ta were not yet sta­tis­ti­cal­ly sig­nif­i­cant, he cau­tioned but were trend­ing in the right di­rec­tion. Fau­ci, sur­round­ed by Pres­i­dent Trump, Vice Pres­i­dent Mike Pence and sev­er­al oth­er ad­vi­sors, said the news was a “very op­ti­mistic” sign in the hunt for treat­ments to fight the virus.

”Al­though a 31% im­prove­ment doesn’t seem like a knock­out 100%, it is a very im­por­tant proof of con­cept,” he said. “Be­cause what it has proven, is that a drug has blocked this virus.”

Fau­ci said more de­tails would come and that the study would be sub­mit­ted to a peer-re­viewed jour­nal. Trump, who de­ferred to Fau­ci in giv­ing the read­out, echoed Fau­ci’s com­men­tary.

“It’s a be­gin­ning, that means you build on it,” Trump said. “But it’s a very pos­i­tive event.”

Short­ly af­ter the brief­ing, the New York Times re­port­ed that the FDA was prepar­ing to is­sue an emer­gency use au­tho­riza­tion for the drug’s use in Covid-19. In an email to End­points News, the FDA did not con­firm or de­ny the Times’ re­port, but a spokesper­son said the agency has “been en­gaged in sus­tained and on­go­ing dis­cus­sions with Gilead Sci­ences re­gard­ing mak­ing remde­sivir avail­able to pa­tients as quick­ly as pos­si­ble, as ap­pro­pri­ate.”

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