Drugs / Bictegravir/emtricitabine/tenofovir alafenamide
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07532304 | May → Jul 2026 overdue | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| 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. |
| 2026-02-25 | Merck Sharp & Dohme LLC | Results Merck Announces Late-Breaking Data from Three Phase 3 Trials Evaluating Doravirine/Islatravir (DOR/ISL), an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living with HIV-1 at CROI 2026 merck.com ↗
DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority and a similar safety profile at Week 48 to BIC/FTC/TAF in adults living with HIV-1 who had not previously received antiretroviral treatment |
| 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 |
| 2025-10-15 | Merck Sharp & Dohme LLC | Results Merck Announces New Data from Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) in Adults with Virologically Suppressed HIV-1 Infection merck.com ↗
These changes were comparable to trial participants who continued BIC/FTC/TAF. |
| 2025-03-12 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48 merck.com ↗
In the double-blind trial MK-8591A-052 (Abstract #204A), results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF (treatment difference 0.9%, 95% CI -1.9, 2.9). |
| 2024-12-19 | Merck Sharp & Dohme LLC | Results Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection merck.com ↗
DOR/ISL was demonstrated to be non-inferior to bART in open-label trial MK-8591A-051 and non-inferior to BIC/FTC/TAF in double-blind trial MK-8591A-052. |
| 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 |
| 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. |
| 2021-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection merck.com ↗
At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels ≥50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). |
All press releases naming this drug 14 releases
Evidence & citations 3 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 NCT07532304 ↗ |
| Known as | BIC/FTC/TAF | “Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).” NCT07532304 ↗ |
| Route | Oral | “Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).” NCT07532304 ↗ |