Gilead’s Biktarvy provides high-efficacy and durable viral suppression in Phase III trials

Gilead Sciences have announced new long-term data from two Phase III trials (Study 1489 and Study 1490) of their all-in-one pill Biktarvy – comprising of bictegravir 50 mg, emtricitabine 200 m and tenofovir alafenamide 25 mg. The data demonstrated “sustained efficacy” and no treatment-emergent resistance was seen.

Across both studies >98% of participants achieved and maintained an undetectable viral load (<50 copies/mL) through four years of follow-up (n=235/237 for study 1489 and n=241/243 for study 1490).

“Gilead is committed to developing innovative HIV treatments, like Biktarvy, that help to address the unmet needs of people living with HIV today, including achieving and maintaining an undetectable viral load over the long-term,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. “These data reinforce that Biktarvy provides durable viral suppression, strong efficacy and a high barrier to resistance in both adults that are new to HIV therapy and those replacing their existing treatment.”

Data presented by Gilead at Virtual CROI 2021 including a sub-group analysis the 144-week analysis of the two aforementioned studies which showed that participants with transmitted-drug resistance (TDR) achieved “comparably high levels of durable viral suppression” (98% vs 97%) compared to those without TDR across the 1344 weeks.