bictegravir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Biktarvy | — | 2018-06-21 | europa.eu ↗ |
| Approved | US (FDA) | BIKTARVY | — | 2018-02-07 | fda.gov ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04950530 | Dec 2022 → Feb 2024 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT04853524 | May → Jun 2021 | — | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT03960645 | Jun 2019 → Jul 2022 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02400307 | Apr → Jul 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02275065 | Oct 2014 → Jan 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05052996 | Oct 2021 → Dec 2023 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04483674 | Dec 2020 → Nov 2022 | primary viral infectious disease | Anna Cruceta | Unknown | No outcome recorded |
| Phase 2 | NCT02397694 | Mar → Nov 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06532656 | Nov 2024 → Jul 2030 expected | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05502341 | Aug 2022 → Sep 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02881320 | Sep 2016 → Mar 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06630286 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06333808 | Mar 2024 → Oct 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04416906 | Oct 2020 → May 2023 | HIV infectious disease | Judit Pich Martínez | Completed | No outcome recorded |
| Phase 3 | NCT04653194 | Sep 2020 → Jul 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04155554 | Jan → Aug 2020 | HIV infectious disease | University Hospital of Siena | Unknown | No outcome recorded |
| Phase 3 | NCT03631732 | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02603107 | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 423 trials | ||||||
| Phase 4 | NCT07476339 | Jun 2026 → Jun 2027 expected | HIV infectious disease | CAN Community Health | Recruiting | No outcome recorded |
| Phase 4 | NCT06602622 | Aug 2024 → Nov 2025 overdue | HIV wasting syndrome | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06375304 | May 2024 → Jun 2026 overdue | HIV infectious disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06374758 | Apr 2024 → May 2026 overdue | HIV infectious disease | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 4 | NCT06104306 | Dec 2023 → Jan 2025 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 4 | NCT04944654 | Jan → May 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Terminated | No outcome recorded |
| Phase 4 | NCT05663892 | Nov 2022 → Nov 2024 overdue | HIV infectious disease | Maple Leaf Research | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05602506 | Nov 2022 → Mar 2024 | HIV infectious disease | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 4 | NCT05243602 | Feb 2022 → Apr 2023 | HIV infectious disease | University of Nairobi | Completed | No outcome recorded |
| Phase 4 | NCT04636437 | Jul 2021 → Oct 2024 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 4 | NCT05147740 | Jul 2021 → Dec 2022 | HIV infectious disease | Tulika Singh, MD | Unknown | No outcome recorded |
| Phase 4 | NCT04530630 | Nov 2020 → Aug 2024 | HIV infectious disease, transplant rejection | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT06177574 | Oct 2020 → Oct 2023 | HIV infectious disease | Carmen Hidalgo Tenorio | Completed | No outcome recorded |
| Phase 4 | NCT04311957 | Sep 2020 → May 2022 | HIV infectious disease | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Unknown | No outcome recorded |
| Phase 4 | NCT04054089 | Jan 2020 | HIV infectious disease | Cristina Mussini | Completed | No outcome recorded |
| Phase 4 | NCT04538040 | Dec 2019 → Nov 2021 | HIV infectious disease | Quest Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT03858478 | Nov 2019 → Mar 2021 | — | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Unknown | No outcome recorded |
| Phase 4 | NCT04616963 | Oct 2019 → Jan 2024 overdue | HIV infectious disease | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03711253 | Oct 2019 → Jun 2023 | — | University of Southern California | Unknown | No outcome recorded |
| Phase 4 | NCT04039217 | Sep 2019 → Aug 2020 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT03797014 | Apr 2019 → Nov 2022 | HIV infectious disease, hepatitis B virus infection | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT03499483 | Jan 2019 → Mar 2020 | — | Fenway Community Health | Completed | No outcome recorded |
| Phase 4 | NCT03348163 | Jun 2018 → Dec 2020 | HIV infectious disease | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT06338826 Background | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05719441 Background | Aug 2024 → Apr 2028 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT05729568 Background | May 2023 → Jul 2024 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06613685 Comparator | Oct 2024 → Mar 2026 | HIV infectious disease | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2/3 | NCT06544733 Comparator | Aug 2024 → Jan 2028 expected | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07683000 Background | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07075146 Comparator | May 2025 → Jun 2026 overdue | HIV infectious disease, obesity disorder | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05979311 Comparator | Feb 2024 → Apr 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05705349 Comparator | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05457530 Comparator | Aug 2022 → May 2023 | HIV infectious disease, abdominal obesity-metabolic syndrome, obesity disorder | Prism Health North Texas | Withdrawn | No outcome recorded |
| Phase 3 | NCT04542070 Comparator | Nov 2020 → Jul 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04223791 Comparator | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07138144 Comparator | Jul 2025 → Feb 2026 overdue | HIV infectious disease | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 4 | NCT07031063 Comparator | Apr 2025 → Dec 2026 expected | HIV infectious disease, metabolic syndrome X | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04884139 Comparator | Jul 2021 → Feb 2024 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT04249037 Comparator | Dec 2020 → Jul 2023 | HIV infectious disease | University of Colorado, Denver | Terminated | No outcome recorded |
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04553081 Comparator | May 2020 → Jun 2026 overdue | HIV infectious disease | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT03986697 Comparator | Feb 2020 → Mar 2021 | HIV infectious disease, coronary atherosclerosis | University of Liverpool | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06629480 Comparator | Jun 2021 → Feb 2024 | HIV infectious disease, metabolic syndrome X | Mexican Social Security Institute | Completed | No outcome recorded |
| — | NCT03825523 Background | Jan 2018 → Aug 2025 | HIV infectious disease | Gustavo Reyes-Teran | Completed | No outcome recorded |
Press releases naming this drug 24 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-29 | Gilead Sciences | U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir gilead.com ↗ |
| 2026-02-25 | Gilead Sciences | Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy gilead.com ↗ |
| 2025-12-15 | Gilead Sciences | Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial gilead.com ↗ |
| 2025-11-13 | Gilead Sciences | 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 ↗ |
| 2019-08-09 | Gilead Sciences | China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗ |
| 2019-03-26 | Gilead Sciences | 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 ↗ |
| 2019-03-06 | Gilead Sciences | 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 ↗ |
| 2019-03-06 | Gilead Sciences | Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance gilead.com ↗ |
| 2018-10-30 | Gilead Sciences | 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 ↗ |
| 2018-10-03 | Gilead Sciences | 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 ↗ |
| 2018-06-25 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗ |
| 2018-04-27 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) gilead.com ↗ |
| 2018-03-05 | Gilead Sciences | 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 ↗ |
| 2018-03-05 | Gilead Sciences | 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 ↗ |
| 2018-02-07 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗ |
| 2017-10-04 | Gilead Sciences | Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗ |
| 2017-10-04 | Gilead Sciences | Gilead Announces New License Agreement With the Medicines Patent Pool for Access to Bictegravir gilead.com ↗ |
| 2017-08-10 | Gilead Sciences | Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ |
| 2017-07-24 | Gilead Sciences | Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ |
| 2017-07-13 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ |
| 2017-06-12 | Gilead Sciences | Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment gilead.com ↗ |
| 2017-05-30 | Gilead Sciences | Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies gilead.com ↗ |
| 2017-02-13 | Gilead Sciences | Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗ |
| 2016-06-20 | Gilead Sciences | Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bictegravir | “The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing...” NCT06630286 ↗62“The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in...” NCT06532656 ↗ “The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a...” NCT05147740 ↗ “Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine...” NCT06602622 ↗ “Data support the use of single-tablet coformulated bictegravir (30 mg), emtricitabine (120 mg), and tenofovir alafenamide (15 mg) for treatment of HIV in children aged at least...” PMID 38621393 ↗ Apr 2024 “Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will...” NCT07138144 ↗ “The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate.” NCT04442737 ↗ “B/F/TAF is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements.” NCT06375304 ↗ “Adults with HIV-1 RNA viral load of less than 50 copies/mL receiving daily bictegravir, emtricitabine, and tenofovir alafenamide combination (B/F/TAF) for 24 weeks or more.” PMID 41429026 ↗ Dec 2025 “received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily.” PMID 41763226 ↗ Feb 2026 “Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide” PMID 29794828 ↗ Jul 2018 “SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC).” NCT07683000 ↗ “Single-tablet, fixed dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily.” NCT04311957 ↗ “Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France” NCT03858478 ↗ “co-formulated once-daily bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), herein known as the bictegravir group” PMID 29925490 ↗ Jun 2018 “Drug-drug Interaction Study Between Bictegravir/Emtricitabine/Tenofovir Alafenamide and Feminizing Hormones in Trans Women Living With HIV” NCT05663892 ↗ “A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.” NCT04530630 ↗ “This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.” NCT04416906 ↗ “BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).” NCT04542070 ↗ “Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg” NCT04944654 ↗ “Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg” NCT04653194 ↗ “This is a combined pill containing 50mg of bictegravir, 200mg of emtricitabine and 25mg of tenofovir alafenamide” NCT05243602 ↗ “Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet orally once daily with or without food” NCT05719441 ↗ “B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)” NCT03348163 ↗ “once-daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; B/F/TAF) during pregnancy.” PMID 37939141 ↗ Nov 2023 “Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine” NCT03986697 ↗ “fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)” NCT03631732 ↗ “switch or stay on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, n = 45)” PMID 39226296 ↗ Feb 2025 “Bictegravir sodium 50 mg, emtricitabine 200mg, tenofovir alefenamide fumerate 25mg” NCT05457530 ↗ “bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®)” NCT06630299 ↗ “bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg)” PMID 38734016 ↗ May 2024 “Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity” PMID 28219610 ↗ Feb 2017 “INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir” NCT06338826 ↗ “including bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL)” NCT04636437 ↗ “bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]” NCT03825523 ↗ “bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)” PMID 40982450 ↗ Sep 2025 “Bictegravir/emtricitabine/tenofovir alafenamide” NCT03797014 ↗ “Bictegravir/Emtricitabine/Tenofovir Alafenamide” NCT05630755 ↗ “Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)” NCT06104306 ↗ “Bictegravir” NCT04950530 ↗ |
| Known as | BIC | “The goal of this clinical study is to learn about the safety and tolerability of bictegravir/lenacapavir (BIC/LEN) and to learn how the study drug interacts with the body in...” NCT06532656 ↗15“The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or dolutegravir/lamivudine/abacavir (DTG/3TC/ABC), are associated with metabolic, renal, and cardiovascular adverse effects” NCT07138144 ↗ “Because coformulated bictegravir, emtricitabine, and tenofovir alafenamide [BIC/FTC/tenofovir alafenamide (TAF)] is effective for HIV treatment, it was evaluated for use for PEP.” PMID 34991141 ↗ May 2022 “Studies 1878 and 1844 demonstrated non-inferior efficacy of switching suppressed HIV-1-infected adults to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)” PMID 31430369 ↗ Dec 2019 “The second generation integrase strand transfer inhibitors (INSTIs) dolutegravir (DTG) and bictegravir (BIC) are widely prescribed for the treatment of HIV” NCT04311957 ↗ “BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).” NCT04542070 ↗ “once-daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; B/F/TAF) during pregnancy.” PMID 37939141 ↗ Nov 2023 “bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC)” NCT02397694 ↗ “Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC)” NCT06602622 ↗ “Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)” NCT04853524 ↗ “Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)” NCT07031063 ↗ “including bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL)” NCT04636437 ↗ “bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]” NCT03825523 ↗ “Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg” NCT05502341 ↗ |
| Known as | BICTEGRAVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Known as | Bictegravir sodium component of biktarvy | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Known as | Bictegravir/FTC/TAF | “This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF.” NCT05602506 ↗ |
| Known as | Emtricitabine Tenofovir Alafenamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04616963 ↗ |
| Known as | GS-9883 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Known as | GS-9883 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Known as | GS-9883-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Known as | GS-9883-01 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989866 ↗ |
| Action | Inhibit | “Bictegravir is a potent integrase strand-transfer inhibitor (INSTI)” PMID 34302760 ↗ Jul 2021 |
| Modality | Small molecule | — CHEMBL3989866 ↗ |
| Route | Oral | “Bictegravir tablet(s) administered orally once daily” NCT02275065 ↗ |