Drugs / Bictegravir / Emtricitabine / Tenofovir Alafenamide
Bictegravir / Emtricitabine / Tenofovir Alafenamide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | — | “As announced in August 2021, the MAA has been fully validated and is now under evaluation with the EMA.” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT04712058 | Jan 2021 → Dec 2022 | HIV infectious disease | National Taiwan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. |
| 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 |
| 2024-10-19 | 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three studies evaluating the efficacy and safety profile of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for a broad range of people with HIV, including those with HIV/hepatitis B (HBV) coinfection and HIV/tuberculosis (TB) coinfection. |
| 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. |
| 2022-07-28 | 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 Sciences, Inc. (Nasdaq: GILD) today announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American. |
| 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. |
All press releases naming this drug 23 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bictegravir / Emtricitabine / Tenofovir Alafenamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04712058 ↗ |
| Known as | B/F/TAF | “Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF), a novel, INSTI-based regimen” PMID 29956087 ↗ Oct 2018 |
| Known as | Bic/F/TAF | “Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests” NCT04712058 ↗ |
| Known as | Biktarvy | “Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]” NCT04712058 ↗ |
| Modality | Other / unclassified | “Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF), a novel, INSTI-based regimen” PMID 29956087 ↗ Oct 2018 |
| Route | Oral | “Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet” NCT04712058 ↗ |