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Gilead: New Data Shows Biktarvy As Effective Treatment Regimen In Black Americans With HIV

Gilead Sciences, Inc. (GILD) announced Wednesday that new 48-week data from the BRAAVE 2020 study shows Biktarvy as an effective treatment regimen in Black Americans with HIV.

BRAAVE 2020, a Phase 3 clinical trial, is evaluating the safety and efficacy of switching to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American.

The study of 495 study participants demonstrated that at 48 weeks, treatment with Biktarvy maintained high rates of virologic suppression in study participants and did not result in treatment-emergent resistance to any component of Biktarvy.

These data presented at IDWeek 2020 show that switching from a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent to Biktarvy is an effective treatment regimen in Black Americans with HIV who are virologically suppressed, including individuals with a history of treatment failure or pre-existing resistance.

Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral treatment history. The company noted that Biktarvy does not cure HIV or AIDS.

Gilead presented additional Biktarvy clinical development program data at IDWeek 2020, including 48-week findings from a Phase 3, open-label, 48-week
extension study, which found that a once-daily regimen of Biktarvy maintained virologic suppression in people living with HIV on chronic hemodialysis.

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