Drugs / Bictegravir/emtricitabine/tenofovir alafenamide
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03998176 | Oct 2019 → Oct 2021 | HIV infectious disease | University of Nebraska | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Merck Sharp & Dohme LLC | Results Investigational Once-Weekly Oral HIV Treatment Regimen Of Islatravir And Lenacapavir Maintained Virological Suppression In Adults With HIV Who Switched Antiretroviral Therapy msd.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. |
| 2026-07-21 | Merck Sharp & Dohme LLC | Results Investigational Once-weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy merck.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 | Merck Sharp & Dohme LLC | Results Gilead and Merck Announce Positive Topline Results from two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment merck.com ↗ |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data at CROI 2026 showing a treatment switch to an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was effective in people living with HIV with virological suppression, including those switching from complex multi-tablet regimens or a global guideline-recommended single-tablet regimen. |
| 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. |
| 2025-11-13 | Gilead Sciences | Results Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-1 Trial gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. |
| 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. |
| 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. |
| 2022-02-16 | Gilead Sciences | Results New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor gilead.com ↗ |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. |
| 2019-07-18 | Gilead Sciences | Results Gilead to Present New Data on HIV Prevention, Treatment and Cure Research at IAS 2019 gilead.com ↗
The first late-breaker presentation will share additional results from the DISCOVER trial, evaluating Descovy ® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for HIV pre-exposure prophylaxis (PrEP). |
All press releases naming this drug 11 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 | Bictegravir/emtricitabine/tenofovir alafenamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03998176 ↗ |
| Known as | B/F/TAF | “This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances.” NCT03998176 ↗ |