March 06, 2021: “Gilead Sciences announced new, long-term data from open-label extensions (OLE) of two Phase 3 studies (Study 1489 and Study 1490) of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), demonstrating the sustained efficacy and safety profile and no treatment-emergent resistance with Biktarvy for the treatment of HIV-1 in treatment-naïve adults.
The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).
In both studies, >98% of participants who initiated treatment with Biktarvy and remained in the study achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through four years of follow-up (n=235/237 for study 1489, n=241/243 for study 1490).
The high efficacy and durable viral suppression were also observed in participants who switched to Biktarvy from a dolutegravir-containing triple therapy for the 48-week OLE periods (n=212 for study 1489, n=225 for study 1490).
No treatment-emergent resistance to any components of Biktarvy occurred in participants treated with Biktarvy.
“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.”
Gilead presented additional Biktarvy data at virtual CROI 2021, including findings from a 144-week analysis of the same Phase 3 studies (Study 1489 and Study 1490), which demonstrated that people living with HIV who received initial therapy with Biktarvy reached and maintained an undetectable viral load with no treatment-emergent resistance through 144 weeks (n=634).
In a subgroup analysis of participants with transmitted-drug resistance (TDR, n=248) based on retrospective sequencing of baseline samples, Biktarvy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR (98% vs. 97%; as treated analysis).
“As a clinician, my goal is to initiate treatment immediately after diagnosis with a therapy that achieves and maintains virologic control over the long-term,” said Kimberly Workowski, MD, Professor of Medicine, Emory University.
“The data presented at CROI highlight that Biktarvy can achieve long-term viral suppression at four years among a range of people living with HIV and supports further study for patients with certain transmitted drug-resistant HIV.”
The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. FDA, and the safety and efficacy of Biktarvy for this use has not been established.”
https://www.gilead.com/news-and-press/press-room/press-releases/2021/3/biktarvy-demonstrates-high-efficacy-and-durable-viral-suppression-in-treatment-nave-adults-in-four-year-data-presented-at-croi
