Drugs / B/F/TAF
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04296695 | Jul 2021 → Dec 2022 | HIV infectious disease | Peking Union Medical College Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-10-19 | Gilead Sciences | Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
In a 12-week interim analysis of the Phase 4 EMPOWER study ( NCT06104306 ), individuals who switched from IM CAB+RPV to once-daily Biktarvy maintained viral suppression with no treatment-related serious adverse events and reported an increase in treatment satisfaction scores, citing higher satisfaction with side effects of their treatment. |
| 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. |
| 2023-10-03 | Gilead Sciences | Results Gilead to Present Latest Innovative Virology Data on Current and Potentially Transformative Therapies Across HIV and COVID-19 at IDWeek 2023 gilead.com ↗
Latest HIV Treatment Research Reinforces Biktarvy Efficacy Data in a Broad Range of People with HIV |
| 2022-10-18 | Gilead Sciences | Results Gilead Presents Real-World and Long-Term Data From HIV Research Programs at HIV Glasgow 2022 gilead.com ↗
Clinical Data Reinforces the Sustained Efficacy of Twice-Yearly Lenacapavir in People with Multi-Drug Resistant HIV |
| 2022-07-28 | Gilead Sciences | Results Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection gilead.com ↗
The Week 48 results show Biktarvy demonstrated superior HBV DNA suppression. |
| 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. |
| 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 ↗
Analysis of Separate Studies Shows Biktarvy is Effective and Well-Tolerated in Treatment-Naïve Adults 50 and Older, with No Significant Differences in Bone Density, Kidney Safety or Weight Over Three Years |
All press releases naming this drug 9 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | B/F/TAF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04296695 ↗ |