Gilead's Biktarvy shows sustained long-term benefit in range of studies

• Gilead Sciences (NASDAQ:GILD) announces long-term results from switch studies and an analysis of real-world data that support the safety and efficacy of once-daily single-tablet Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), approved in the U.S. in February 2018 for the treatment of adults with HIV-1 infection. The results were presented at HIV Glasgow.
• Patients who switched to Biktarvy from a boosted protease inhibitor-based regimen consisting of atazanavir or darunavir plus either emtricitabine/tenofovir disoproxil fumarate or abacavir /lamivudine maintained virologic suppression (defined as HIV-1 RNA <50 copies/mL) with no emergent resistance, through a maximum of 156 weeks.
• On the safety front, the most common drug-related adverse event was headache (2%).
• An analysis of pooled data from six studies assessing the efficacy of switching to Biktarvy among virologically suppressed people living with HIV who have the most common treatment-emergent resistance mutations (M184V/I) showed that 98% (n=179/182) maintained virologic suppression at the last study visit (weeks 24-156) with no emergence of treatment resistance.
• New findings from an open-label Phase 3b study showed that HIV-positive patients at least 65 years old who switched to Biktarvy from Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a TDF-based complete treatment regimen maintained high rates of virologic suppression, with no virologic failures or emergent resistance through week 72.
• Results from the real-world BICSTaR study showed that 100% (n=74/74) of treatment-naïve and 96 percent (n=357/372) of treatment-experienced participants who completed 12 months of treatment with Biktarvy maintained virologic suppression.
• https://seekingalpha.com/news/3619711-gileads-biktarvy-shows-sustained-long-term-benefit-in-range-of-studies