Biktarvy Label Update Adds Data on Safety, Efficacy in Pregnant HIV Patients
The approval was based on data from an open-label clinical trial that included 33 virologically-suppressed pregnant adults.
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The approval was based on data from an open-label clinical trial that included 33 virologically-suppressed pregnant adults.
The updated label with additional data reinforces the safety and efficacy profile of Biktarvy to treat pregnant people with HIV-1 with suppressed viral loads, the company said.
The approval was based on data from an open-label clinical trial that included 33 virologically-suppressed pregnant adults.
26.04.2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced 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 ... Seite 1
Patients with HIV who have suppressed viral loads and pre-existing resistance will be able to use bictegravir with this FDA approval.