Drugs / B/F/TAF
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02607930 | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-02-25 | Gilead Sciences | Results Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy gilead.com ↗
The results demonstrate the potential of BIC/LEN to broaden HIV treatment options for adults with virological suppression, offering comparable efficacy to BIKTARVY ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), as well as to tre |
| 2025-12-15 | Gilead Sciences | Results Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial gilead.com ↗
In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to BIKTARVY. |
| 2025-10-19 | Gilead Sciences | Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
These include new findings that further reinforce the strong clinical profile of Biktarvy ® (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) as a leading standard of care for people with HIV, with data showing greater patient preference for Biktarvy over intramuscular cabotegravir + rilpivirine (IM CAB+RPV). |
| 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. |
| 2024-10-19 | Gilead Sciences | Results Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48 gilead.com ↗
At 48 weeks, the novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study. |
| 2024-03-06 | Gilead Sciences | Results Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities gilead.com ↗
These data and other studies supporting the important role of Biktarvy in the HIV treatment landscape were presented at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ). |
| 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 ↗
In an open-label study evaluating the pharmacokinetics, safety, and efficacy of switching to once-daily Biktarvy in virologically suppressed pregnant women with HIV, Biktarvy was generally well tolerated and all participants maintained virologic suppression at delivery (HIV-1 RNA <50 copies/mL; n=32). |
| 2022-10-24 | Gilead Sciences | Results Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy® for the Treatment of People Living With HIV With a Range of Comorbidities gilead.com ↗
New real-world data was presented from the 24-month BICSTaR follow-up analysis, evaluating the effectiveness and safety of Biktarvy in clinical practice across nine countries. |
| 2022-10-18 | Gilead Sciences | Results Gilead Presents Real-World and Long-Term Data From HIV Research Programs at HIV Glasgow 2022 gilead.com ↗
New Clinical and Patient-Reported Outcomes in People with HIV on Biktarvy ® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting |
| 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 ↗
Interim data from the ALLIANCE trial evaluating Biktarvy in adults with HIV/HBV coinfection who were initiating therapy show potential suppression of HBV and HIV suppression comparable to an alternative HIV regimen. |
| 2022-02-11 | Gilead Sciences | Results Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of cumulative 5-year results from 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). |
| 2021-10-29 | Gilead Sciences | Results Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting gilead.com ↗
Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. |
| 2021-03-06 | Gilead Sciences | Results Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI gilead.com ↗
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). |
| 2020-10-21 | Gilead Sciences | Results Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans gilead.com ↗
BRAAVE 2020 Study Demonstrates Non-Inferiority of Biktarvy for the Treatment of HIV in Black Americans Who Are Virologically Suppressed, Including Patients With a History of Treatment Failure or Pre-Existing Resistance |
| 2020-07-04 | Gilead Sciences | Results New Findings on Gilead’s Biktarvy® Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults gilead.com ↗
At 48 weeks, 92 percent of those who switched to Biktarvy maintained virologic suppression, achieving HIV RNA<50 copies/mL. |
| 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 ↗
The primary endpoint for this study conducted exclusively in women, was previously presented, and demonstrated noninferior maintained virologic suppression, with a low frequency of serious adverse events and no emergent resistance at Week 48. |
All press releases naming this drug 16 releases
Evidence & citations 2 cited values
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 NCT02607930 ↗ |
| Route | Oral | “50/200/25 mg tablets administered orally” NCT02607930 ↗ |