New, long-term data from open-label extensions of a pair of phase 3 studies of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets showed the sustained efficacy and safety profile of the treatment.
New, long-term data from open-label extensions of a pair of phase 3 studies of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF; Biktarvy, Gilead Sciences) showed the sustained efficacy and safety profile of the treatment. The results also demonstrated there was no treatment-emergent resistance to any components of B/F/TAF in the treatment of HIV-1 among treatment-naïve adults. The new data were presented by researchers at the 28th Conference on Retroviruses and Opportunistic Infections (CROI).
In both phase 3 studies, which included study 1489 and study 1490, more than 98% of participants who started treatment with B/F/TAF and continued treatment throughout the study achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) during the study’s 4 years of follow-up (n=235/237 for study 1489, 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 of virology therapeutic area at Gilead Sciences, in a press release. “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.”
In an additional analysis of the same phase 3 studies, which include both study 1489 and study 1490, the researchers also found that people with HIV who initiated therapy with B/F/TAF were able to reach and maintain an undetectable viral load with no treatment-emergent resistance through 144 weeks (n=634).
Among participants with transmitted-drug resistance (TDR), B/F/TAF demonstrated comparably high levels of durable viral suppression through 144 weeks based on retrospective sequencing of baseline samples. Specifically, participants with TDF had a viral suppression of 98% and participants without had a viral suppression of 97%.
“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, in the press release. “The data presented at CROI highlight that Biktarvy can achieve long-term viral suppression at 4 years among a range of people living with HIV and supports further study for patients with certain transmitted drug-resistant HIV.”
However, the researchers explained that the use of B/F/TAF in individuals who have known resistance to some of the treatment’s components remains investigational. The treatment among this population has not yet been approved by the FDA, and the safety and efficacy of B/F/TAF for this use has not been established. Additionally, the researchers noted that B/F/TAF is not a cure for HIV or AIDS.
Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI. Foster City, CA: Gilead Sciences; March 6, 2021. https://www.businesswire.com/news/home/20210306005010/en. Accessed March 9, 2021.