FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced Friday the
U.S. Food and Drug Administration (FDA) approved an updated label with
additional data reinforcing the safety and efficacy profile of Biktarvy
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets,
B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads.

These additional data stem from Study 5310, which evaluated the
pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have
suppressed viral loads and no known resistance to any components of Biktarvy in
their second and third trimesters and through a median of 16 weeks postpartum.

This update makes Biktarvy the only second-generation integrase strand transfer
inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial
data and FDA approval in virologically suppressed adults who are pregnant.

The U.S. Department of Health and Human Services (DHHS) perinatal guidelines
recognize Biktarvy as having sufficient data to support being recommended as an
alternative complete regimen for use in pregnancy and for people who are trying
to conceive. Additionally, guidelines recommend continuing Biktarvy for PWH
already on treatment who are virologically suppressed and tolerating treatment
well who may become pregnant.

The updated label now includes additional data from Study 5310, a Phase 1b,
open-label, single-arm, multicenter clinical trial evaluating the
pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who were
virologically suppressed) and had no known resistance to the components of
Biktarvy.



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