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Biktarvy Approved to Treat Pediatric Patients With HIV-1

[From Monthly Prescribing Reference, June 19, 2019]

“The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide; Gilead) to include treatment of both adult and pediatric patients weighing at least 25kg with HIV-1 who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Previously, the combination therapy had only been approved for adults.”

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