FDA greenlights label update to Gilead’s Biktarvy to include more data in pregnant people

The FDA on Fri­day ap­proved a la­bel up­date on Bik­tarvy, Gilead’s block­buster HIV drug, to in­clude more da­ta on the drug’s safe­ty and ef­fi­ca­cy for preg­nant peo­ple with HIV.

The ad­di­tion­al da­ta re­flect­ed on the la­bel are sup­port­ed by pos­i­tive re­sults from Gilead’s Study 5310, which eval­u­at­ed Bik­tarvy in preg­nant peo­ple with HIV-1 who have sup­pressed vi­ral loads, mean­ing that they have a low lev­el of virus in their bod­ies. The study eval­u­at­ed peo­ple in their sec­ond and third trimesters through a me­di­an of 16 weeks post­par­tum.

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