Drugs / Bictegravir
Bictegravir
also known as
BIC · BICTEGRAVIR SODIUM · Bictegravir sodium component of biktarvy · Bictegravir/FTC/TAF · GS-9883 · GS-9883 SODIUM · GS-9883-01 · GS-9883-01 SODIUM
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 2 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2026-04-29 | “FDA accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN)” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2017-06-12 | “it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for an investigational, once-daily single tablet regimen containing bictegravir” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Biktarvy | — | 2018-06-21 | europa.eu ↗ |
| Approved | US (FDA) | BIKTARVY | — | 2018-02-07 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| 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| Phase 1 | NCT04853524 | May → Jun 2021 | — | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| 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 | Met primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2/3 | NCT02881320 | Sep 2016 → Mar 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 38 trials · 5 met primary | ||||||
| Phase 3 | NCT06630286 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT06333808 | Mar 2024 → Oct 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02603107 | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 422 trials · 1 met primary · 2 missed | ||||||
| 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 Stop: Business |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 4 | NCT04054089 | Jan 2020 | HIV infectious disease | Cristina Mussini | Completed | Missed primary |
| 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 | 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 Stop: Enrollment |
| Comparator or background therapy22 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 2/3 | NCT06613685 Comparator | Oct 2024 → Mar 2026 | HIV infectious disease | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT06544733 Comparator | Aug 2024 → Jan 2028 expected | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| 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 | Met primary |
| Phase 3 | NCT05979311 Comparator | Feb 2024 → Apr 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | Met primary |
| Phase 3 | NCT05705349 Comparator | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| 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 Stop: Enrollment |
| Phase 3 | NCT04542070 Comparator | Nov 2020 → Jul 2022 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT04223791 Comparator | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Met primary |
| Phase 4 | NCT04249037 Comparator | Dec 2020 → Jul 2023 | HIV infectious disease | University of Colorado, Denver | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 4 | NCT04553081 Comparator | May 2020 → Mar 2026 | HIV infectious disease | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT03986697 Comparator | Feb 2020 → Mar 2021 | HIV infectious disease, coronary atherosclerosis | University of Liverpool | Withdrawn | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2026-08-27 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens gilead.com ↗ |
| 2026-04-29 | Gilead Sciences | Regulatory U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir gilead.com ↗
The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026. |
| 2025-11-19 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 Infection merck.com ↗
The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamide i [BIC/FTC/TAF (50 mg/200 mg/25 mg)]. |
| 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 Data Show Higher Treatment Satisfaction After Switching from IM CAB+RPV 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 ↗
New outcomes from two datasets derived from the Bictegravir Single Tablet Regimen (BICSTaR) study are consistent with the results observed from multiple Phase 3 clinical trials, which demonstrated the sustained efficacy, safety profile, and high barrier to resistance of Biktarvy. |
| 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 |
| 2024-07-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1 gsk.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2024-03-05 | Gilead Sciences | Results Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health gilead.com ↗
The findings help support the efficacy and safety profile of switching individuals with HIV on complex regimens to a potentially less complex combination of bictegravir and lenacapavir. |
| 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. |
| 2023-02-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1 gsk.com ↗
12-month findings from the SOLAR study showed that the every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy compared to continuation of daily oral BIC/FTC/TAF |
| 2023-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING LONG-ACTING INJECTABLE CABENUVA (CABOTEGRAVIR, RILPIVIRINE) IS AS EFFECTIVE AS DAILY ORAL BIKTARVY (BIC/FTC/TAF) FOR THE TREATMENT OF HIV-1 viivhealthcare.com ↗
Study findings showed that CAB+RPV LA dosed every two months achieved the primary endpoint of non-inferior virologic efficacy versus daily oral BIC/FTC/TAF, while 90% of participants who switched to CAB+RPV LA from BIC/FTC/TAF, and who completed a survey (n=425), preferred the long-acting regimen. |
| 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 ↗
In the oral lenacapavir + F/TAF arm, 85% achieved an undetectable viral load. |
| 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). |
| 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. |
| 2019-07-22 | 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 ↗
The studies further demonstrate the potential for Biktarvy to be an important treatment option for appropriate patients. |
| 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. |
| 2018-03-05 | 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. |
| 2017-10-04 | Gilead Sciences | Results 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 ↗
In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-08-10 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination |
| 2017-07-24 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. |
| 2017-07-13 | Gilead Sciences | Regulatory 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 | Regulatory 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 | Results 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 | Results Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗
Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at Week 24 and Week 48. |
| 2016-06-20 | Gilead Sciences | Results Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗
Bictegravir was well tolerated at all dosing levels and provided rapid dose-dependent decreases in viral load that were sustained throughout the treatment period. |
All press releases naming this drug 38 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 69 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“Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to...” PMID 39226296 ↗ Feb 2025 “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 ↗ |
| Known as | BIC | “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 ↗15“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)” NCT07031063 ↗ |
| 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 | 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 ↗ |