Drugs / B/F/TAF
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02600819 | Dec 2015 → Sep 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-07-21 | Gilead Sciences | Results Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy gilead.com ↗
The data provide strong evidence for the potential of ISL/LEN to be the first and only once-weekly oral HIV treatment option for adults with virologic suppression on a stable antiretroviral regimen. |
| 2026-06-08 | Gilead Sciences | Results Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment gilead.com ↗ |
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
Data from an ongoing, randomized, open-label Phase 2 study ( NCT05052996 ) demonstrate that switching to an investigational once-weekly combination regimen of islatravir and lenacapavir enabled people living with HIV to maintain viral suppression to two years. |
| 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. |
| 2024-07-25 | Gilead Sciences | Results Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
Three participants experienced virologic rebound, with emergent lenacapavir resistance detected for one participant, who had no resistance to bNAbs and resuppressed with resumption of oral ART. |
| 2024-03-06 | Gilead Sciences | Results Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24 gilead.com ↗
At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study. |
| 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. |
| 2023-07-23 | 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. |
| 2022-07-28 | Gilead Sciences | Results Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection gilead.com ↗
Safety findings were similar between the Biktarvy and DTF+F/TDF groups. |
| 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 ↗
First data from the ALLIANCE trial, a first-of-its-kind study evaluating the efficacy of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) versus dolutegravir (50 mg, DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection who are initiating treatment. |
| 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. |
| 2021-07-17 | Gilead Sciences | Results New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor gilead.com ↗
Phase 2 data from CALIBRATE, an ongoing, open-label, active-controlled trial in treatment-naïve people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide (F/TAF) led to high rates of viral suppression by Week 28 (94%; n=147/157). |
| 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 ↗
Viral blips were infrequent and similar among study participants switching to Biktarvy or DTG+F/TAF, and baseline NRTI resistance did not result in a higher rate of blips. |
| 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. |
All press releases naming this drug 14 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 NCT02600819 ↗ |
| Route | Oral | “50/200/25 mg FDC tablets administered orally once daily” NCT02600819 ↗ |