Drugs / B/F/TAF
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03110380 | Jun 2017 → Dec 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 26
| 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 ↗
BIC/LEN efficacy was found to be statistically non-inferior 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 ↗
New Data Show Higher Treatment Satisfaction After Switching from IM CAB+RPV to Biktarvy ® |
| 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. |
| 2024-11-07 | Gilead Sciences | Results Late-Breaking Clinical Data and Real-World Evidence Presented at HIV Glasgow as Gilead Extends Leadership Efforts Toward Ending the Epidemic gilead.com ↗
Four-Year Outcomes From Real-World BICSTaR Study Further Demonstrate the Consistent Efficacy and Safety Profile of Biktarvy, Providing Insights for HIV Clinical Care |
| 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. |
| 2024-04-26 | Gilead Sciences | Regulatory FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV gilead.com ↗
This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant. |
| 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 ). |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. |
| 2023-10-19 | Gilead Sciences | Results Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities gilead.com ↗
Three-Year Outcomes from the BICSTaR Study Further Demonstrate the Consistent Efficacy and Safety Profile of Biktarvy, Providing Insights for HIV Clinical Care |
| 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. |
| 2022-10-24 | 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of real-world results from the BICSTaR study, highlighting Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a generally well tolerated and efficacious regimen regardless of prior treatment and comorbidity status in people with 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. |
| 2022-07-21 | Gilead Sciences | Results Scientific Innovation and Collaboration Highlighted at AIDS 2022 as Gilead Extends Leadership Efforts Toward Ending the Global HIV Epidemic gilead.com ↗
Five-year cumulative outcomes from two Phase 3 trials (Study 1489 and Study 1490), evaluating Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve people living with HIV, reinforcing Biktarvy’s high barrier to resistance, durability, efficacy, and safety in people with HIV who initiated treatment with the single-tablet regimen. |
| 2022-02-11 | Gilead Sciences | Results Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults gilead.com ↗ |
| 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. |
| 2021-10-29 | 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. |
| 2021-10-18 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy ® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. |
| 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 ↗
At 72 weeks, 99% of participants (n=246/248, missing=excluded) who switched to Biktarvy at the start of the study maintained an undetectable viral load regardless of age or sex at birth. |
| 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). |
| 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. |
| 2020-10-21 | 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 |
| 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 support the continued evaluation of Biktarvy as an effective and durable option for virologically-suppressed people living with HIV with known 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 ↗ |
| 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 ↗
The study showed noninferior antiviral efficacy for people switching to Biktarvy from a variety of regimens, including in patients with pre-existing NRTI resistance. |
| 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 26 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 NCT03110380 ↗ |
| Route | Oral | “50/200/25 mg FDC tablet(s) administered orally once daily” NCT03110380 ↗ |