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     153  0 Kommentare Real-World Evidence Reinforces Biktarvy as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities

    Gilead Sciences, Inc. (Nasdaq: GILD) announced today new long-term real-world data from the BICSTaR study highlighting the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment regimen for a broad range of people with HIV, including those with a prior treatment history or comorbidities. These findings were presented at the 19th European AIDS Conference (EACS 2023), taking place October 18-21 in Warsaw, Poland.

    “HIV affects a wide range of people so understanding a treatment’s efficacy and safety profile through real-world studies can help further inform HIV clinical care. The goal of the BICSTaR study is to provide us with a more comprehensive understanding of Biktarvy and its role in clinical practice,” said Michael Sabranski, MD, presenting author and physician at the ICH Study Center, Hamburg, Germany. “The three-year outcomes from the BICSTaR study further support the real-world profile of Biktarvy in a diverse range of people with HIV, and these findings align with evidence from randomized clinical trials of Biktarvy treatment.”

    New real-world data from the ongoing, multinational, observational, real-world BICSTaR study were collected from individuals with HIV who were enrolled in Canada, France, and Germany. Overall, Biktarvy was found to be highly effective for trial participants after three years of follow-up, with 97% (58/60) of treatment-naïve and 97% (356/367) of treatment-experienced participants virologically suppressed (HIV-1 RNA <50 copies/mL; missing=excluded analysis). Additionally, there were no reports of treatment-emergent resistance.

    Overall, 10%, 2% and <1% of participants had any drug-related adverse events (DRAEs) across years one, two, and three respectively, with the most commonly reported DRAEs being weight change (2%) and depression (1%). Numerically small median changes in estimated glomerular filtration rate (eGFR) and stable total cholesterol to high-density lipoprotein (TC:HDL) ratios were observed in both treatment-naive and treatment-experienced participants over the three-year period. Among study participants, the median change in weight from baseline to three years was +4.3kg for treatment-naïve participants and +1.7kg for treatment-experienced participants. These findings are consistent with previously presented data. Initiation of therapy generally leads to weight change in people with HIV who have no prior treatment history, which is partially attributable to a return-to-health effect. Few participants (7%) discontinued Biktarvy due to DRAEs, with most discontinuations occurring in the first year.

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    Real-World Evidence Reinforces Biktarvy as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities Gilead Sciences, Inc. (Nasdaq: GILD) announced today new long-term real-world data from the BICSTaR study highlighting the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) …

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