Drugs / B/F/TAF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Biktarvy | HIV infectious disease | — | “As announced in August 2021, the MAA has been fully validated and is now under evaluation with the EMA.” gilead.com ↗ “A marketing authorization application for Biktarvy is under review in the European Union .” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07645287 | Jun 2026 → Aug 2027 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. |
| 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 pivotal PURPOSE 1 ( NCT04994509 ) and PURPOSE 2 ( NCT04925752 ) data provided further insight into the safety of twice-yearly Yeztugo ® (lenacapavir – or LEN) for pre-exposure prophylaxis (PrEP). |
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors with appropriate monitoring and dose adjustment. |
| 2025-03-12 | Gilead Sciences | Results Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option gilead.com ↗
These data demonstrate the high rates of viral suppression by Biktarvy in adults with both HIV-1 and HBV switching their treatment to Biktarvy. |
| 2024-11-12 | Gilead Sciences | Results Scientific Leadership Spotlighted as Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
These data demonstrate the clinical benefits of Biktarvy for adults with both HIV-1 and HBV initiating antiviral therapy. |
| 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. |
| 2024-02-26 | 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. |
| 2022-11-29 | Gilead Sciences | Regulatory European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has authorized a new low-dose tablet dosage form of Biktarvy ® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. |
| 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 ↗
The Week 48 results show Biktarvy demonstrated superior HBV DNA suppression. |
| 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). |
| 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. |
| 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 |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
In both studies, Biktarvy was well-tolerated and demonstrated high rates of virologic suppression through Week 144. |
| 2019-08-09 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy ® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 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 were presented at the 10 th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City . |
| 2019-03-26 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy ® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women gilead.com ↗
Through Week 48, Biktarvy maintained high rates of virologic suppression with a low incidence of study drug-related adverse events and no treatment-emergent resistance. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance gilead.com ↗
The studies found high rates of virologic suppression with Biktarvy in treatment-experienced adults, regardless of pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs). |
| 2018-10-30 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy. |
| 2018-10-03 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. |
| 2018-06-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy ® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 2018-04-27 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Biktarvy ® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Data From Phase 3 Study Evaluating Women Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) From a Boosted Protease Inhibitor-Based Regimen or Boosted Elvitegravir-Containing Regimen gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2018-02-07 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Biktarvy ® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
All press releases naming this drug 40 releases
Evidence & citations 3 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 NCT07645287 ↗ |
| Known as | Biktarvy | “A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy...” NCT07645287 ↗ |
| Route | Oral | “Administered orally” NCT07645287 ↗ |