Drugs / Biktarvy
Biktarvy
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 | 2017-06-12 | “Gilead filed a New Drug Application for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017” gilead.com ↗ “Gilead submitted a New Drug Application (NDA) for BIC/FTC/TAF in the United States on June 12, 2017” gilead.com ↗ “Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017” gilead.com ↗ “Gilead filed the NDA for BIC/FTC/TAF with a priority review voucher on June 12, 2017” gilead.com ↗ |
| Filed | EU (EMA) | Biktarvy | HIV infectious disease | — | “Additionally, Gilead submitted a marketing authorization application for BIC/FTC/TAF in the European Union during the second quarter of 2017.” gilead.com ↗ “As announced in August 2021, the MAA has been fully validated and is now under evaluation with the EMA.” 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 15
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV. |
| 2026-07-27 | GlaxoSmithKline | Results ViiV Healthcare’s 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy in first-of-its-kind head-to-head study in treatment-naïve adults living with HIV gsk.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count1. |
| 2026-07-27 | ViiV Healthcare | Results ViiV HEALTHCARE’S 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY IN FIRST-OF-ITS-KIND HEAD-TO-HEAD STUDY IN TREATMENT-NAÏVE ADULTS LIVING WITH HIV viivhealthcare.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count. |
| 2026-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DATA SHOWING SWITCHING TO DOVATO WAS ASSOCIATED WITH A LOWER PROPORTION OF STEATOTIC LIVER DISEASE VERSUS BIKTARVY FOR HIV-1 TREATMENT viivhealthcare.com ↗
Steatotic liver disease, an increasingly recognised comorbidity in people living with HIV, was reported in 49% (n=26/53) of participants switching to BIC/FTC/TAF versus 29% (n=17/58) switching to DTG/3TC |
| 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 ↗
In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to BIKTARVY. |
| 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 novel treatment combination is now progressing to Phase 3 clinical development. |
| 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. |
| 2024-11-07 | 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 |
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF |
| 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. |
| 2024-07-23 | 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. |
| 2024-07-23 | ViiV Healthcare | 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 viivhealthcare.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. |
| 2024-04-26 | Gilead Sciences | Regulatory FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. |
| 2024-03-06 | Gilead Sciences | Results Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities gilead.com ↗ |
| 2023-10-19 | Gilead Sciences | Results Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities gilead.com ↗
The three-year outcomes from the BICSTaR study further support the real-world profile of Biktarvy in a diverse range of people with HIV, and these findings align with evidence from randomized clinical trials of Biktarvy treatment. |
| 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. |
| 2022-11-29 | 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. |
| 2022-10-24 | 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 ↗
Trial participants who initiated treatment with Biktarvy experienced high viral suppression (HIV-1 RNA <50 copies/mL). |
| 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). |
| 2022-02-08 | Gilead Sciences | Results Gilead to Present Latest Antiviral Research and Development Data at CROI 2022 Addressing Urgent Global Needs gilead.com ↗
These results demonstrate Biktarvy’s long-term safety and tolerability profile, and sustained efficacy with a high barrier to resistance in participants who initiated treatment with the guidelines-recommended, once-daily, single-tablet regimen. |
| 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 presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. |
| 2021-10-18 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations gilead.com ↗
In October 2021, the FDA approved a new low-dose tablet formulation of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg. |
| 2021-07-17 | Gilead Sciences | Results Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults gilead.com ↗
In the 48-week open-label extension, there were zero cases of treatment-emergent resistance to any components of Biktarvy in participants treated with 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 ↗
No treatment-emergent resistance to any components of Biktarvy occurred in participants treated with Biktarvy. |
| 2021-03-02 | Gilead Sciences | Results Gilead to Present New Data at CROI 2021 Demonstrating the Company's Commitment to Addressing Urgent Global Health Needs gilead.com ↗
At CROI 2021, Gilead will share new findings on daily and long-acting HIV prevention and treatment strategies, as well as updates from the company’s continued pursuit of a cure for HIV. |
| 2020-10-21 | Gilead Sciences | Results Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans gilead.com ↗
BRAAVE 2020 Study Demonstrates Non-Inferiority of Biktarvy for the Treatment of HIV in Black Americans Who Are Virologically Suppressed, Including Patients With a History of Treatment Failure or Pre-Existing Resistance |
| 2020-10-05 | Gilead Sciences | Results Gilead Presents Biktarvy® Findings From Switch Studies & Analysis of Real-World BICSTaR Study At HIV Glasgow 2020 gilead.com ↗
People Living With HIV Switching to Biktarvy from Boosted PI-Based Regimens Achieved Sustained Viral Suppression up to 156 Weeks |
| 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. |
| 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. |
| 2019-03-26 | 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. |
| 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 ↗ |
All press releases naming this drug 58 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Biktarvy | “Subjects will receive once-daily Biktarvy for 4 weeks to ensure all moieties of interest reach steady-state prior to the baseline PK assessment.” NCT04551573 ↗15“a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®)” NCT04051970 ↗ |
| Known as | B/F/TAF | “Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF).” NCT03696160 ↗ |
| Known as | BIC/FTC/TAF | “containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®)” NCT04734652 ↗ |
| Known as | Bictegravir/Emtricitabine/Tenofovir Alafenamide | “Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects” NCT06356194 ↗ |
| Known as | BIK | “A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)” NCT06356194 ↗ |
| Action | Inhibit | “Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor” NCT04222283 ↗ |
| Modality | Other / unclassified | “Biktarvy® is a fixed dose combination” NCT04734652 ↗ |
| Route | Oral | “Oral Biktarvy 50/200/25 mg.” NCT03549312 ↗ |