Drugs / B/F/TAF
last change Oct 2025 re-read 3 minutes ago

B/F/TAF

Developed for
HIV infectious disease
Investigated by
Gilead Sciences

Trials 1

202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07055451 Aug 2025 → Mar 2028 expected HIV infectious disease Gilead Sciences Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
2025-10-19 Gilead Sciences Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
New Research Reaffirms Veklury ® in High-Risk COVID-19 Populations and Obeldesivir in Emerging Pathogens
2025-10-15 Gilead Sciences Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance.
2024-07-25 Gilead Sciences Results Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
Specifically, results of the subgroup analysis showed that at five years, Biktarvy treatment was generally well tolerated and maintained high virologic suppression.
2024-02-26 Gilead Sciences Regulatory U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance gilead.com ↗
Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.
2023-07-23 Gilead Sciences Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from multiple studies reinforcing Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment option for a broad range of people with HIV.
2022-02-08 Gilead Sciences Results Gilead to Present Latest Antiviral Research and Development Data at CROI 2022 Addressing Urgent Global Needs gilead.com ↗
These results demonstrate Biktarvy’s long-term safety and tolerability profile, and sustained efficacy with a high barrier to resistance in participants who initiated treatment with the guidelines-recommended, once-daily, single-tablet regimen.
2021-07-17 Gilead Sciences Results Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults gilead.com ↗
In the 48-week open-label extension, there were zero cases of treatment-emergent resistance to any components of Biktarvy in participants treated with Biktarvy.
2021-03-02 Gilead Sciences Results Gilead to Present New Data at CROI 2021 Demonstrating the Company's Commitment to Addressing Urgent Global Health Needs gilead.com ↗
The data include a sub-analysis in participants with certain transmitted drug resistance and cumulative outcomes from an open-label extension (OLE) phase of two Phase 3 studies evaluating treatment outcomes in participants who initiated therapy with Biktarvy and those who switched to Biktarvy from a DTG-containing regimen.
2020-10-05 Gilead Sciences Results Gilead Presents Biktarvy® Findings From Switch Studies & Analysis of Real-World BICSTaR Study At HIV Glasgow 2020 gilead.com ↗
The results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV.
2020-03-09 Gilead Sciences Results New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults gilead.com ↗
2019-07-22 Gilead Sciences Results Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance gilead.com ↗
“These data presented at IAS provide new information about the treatment of HIV among women and patients with known drug resistance,” said Diana Brainard , MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences .

All press releases naming this drug 11 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as B/F/TAF ClinicalTrials.gov intervention name — accepted as the source's own label NCT07055451 ↗
Known as Bictegravir/Emtricitabine/Tenofovir Alafenamide “Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)” NCT07055451 ↗
Route Oral “tablet for oral suspension” NCT07055451 ↗