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Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans

Published: 2020-10-21 11:01:00 ET

– BRAAVE 2020 Study Demonstrates Non-Inferiority of Biktarvy for the Treatment of HIV in Black Americans Who Are Virologically Suppressed, Including Patients With a History of Treatment Failure or Pre-Existing Resistance –

–Additional Analysis Shows Potential of Biktarvy to Be an Important Treatment Option for People Living With HIV Who are Virologically Suppressed and Have End Stage Renal DiseaseRequiring Hemodialysis –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial 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. 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.

BRAAVE 2020 is a Phase 3 clinical trial evaluating the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomized 2:1 to switch to open-label Biktarvy or to stay on a standard regimen of two NRTIs plus a third agent for 24 weeks with a delayed switch to Biktarvy until week 48. The study 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. In the analysis of preexisting resistance and virologic outcomes, similar virologic suppression rates were achieved irrespective of the presence of preexisting drug resistance substitutions. Through 48 weeks, 99% of study participants in the Biktarvy group (324/327) and 100% of study participants in the delayed switch group (162/162) maintained HIV-1 RNA

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Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.