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bictegravir/emtricitabine/tenofovir alafenamide
bictegravir/emtricitabine/tenofovir alafenamide is a Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) Small molecule drug developed by Midland Research Group, Inc.. It is currently FDA-approved for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection as a complete regimen for antiretroviral therapy. Also known as: BIKTARVY® (BIC/FTC/TAF), Biktarvy, Biktarvy ®, Biktarvy®.
This combination drug inhibits HIV reverse transcriptase and integrase to block viral replication and reduce viral load in HIV-infected patients.
This combination drug inhibits HIV reverse transcriptase and integrase to block viral replication and reduce viral load in HIV-infected patients. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection as a complete regimen for antiretroviral therapy.
At a glance
| Generic name | bictegravir/emtricitabine/tenofovir alafenamide |
|---|---|
| Also known as | BIKTARVY® (BIC/FTC/TAF), Biktarvy, Biktarvy ®, Biktarvy® |
| Sponsor | Midland Research Group, Inc. |
| Drug class | Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Bictegravir is an integrase strand transfer inhibitor (INSTI) that prevents HIV from integrating into host cell DNA. Emtricitabine and tenofovir alafenamide are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that block reverse transcriptase, preventing conversion of viral RNA to DNA. Together, these three agents target multiple steps of the HIV replication cycle.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection as a complete regimen for antiretroviral therapy
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Abnormal liver function tests
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE: A Multi-Center, Single-Arm, Open-Label, Phase 4 Study Assessing the Safety and Efficacy of B/F/TAF in HIV-Positive Adults Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks (PHASE4)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV (PHASE1)
- Study of GS-3242 in Participants With HIV-1; Substudy-05 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- bictegravir/emtricitabine/tenofovir alafenamide CI brief — competitive landscape report
- bictegravir/emtricitabine/tenofovir alafenamide updates RSS · CI watch RSS
- Midland Research Group, Inc. portfolio CI
Frequently asked questions about bictegravir/emtricitabine/tenofovir alafenamide
What is bictegravir/emtricitabine/tenofovir alafenamide?
How does bictegravir/emtricitabine/tenofovir alafenamide work?
What is bictegravir/emtricitabine/tenofovir alafenamide used for?
Who makes bictegravir/emtricitabine/tenofovir alafenamide?
Is bictegravir/emtricitabine/tenofovir alafenamide also known as anything else?
What drug class is bictegravir/emtricitabine/tenofovir alafenamide in?
What development phase is bictegravir/emtricitabine/tenofovir alafenamide in?
What are the side effects of bictegravir/emtricitabine/tenofovir alafenamide?
What does bictegravir/emtricitabine/tenofovir alafenamide target?
Related
- Drug class: All Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) drugs
- Target: All drugs targeting HIV integrase, HIV reverse transcriptase
- Manufacturer: Midland Research Group, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced adults
- Indication: Drugs for HIV-1 infection as a complete regimen for antiretroviral therapy
- Also known as: BIKTARVY® (BIC/FTC/TAF), Biktarvy, Biktarvy ®, Biktarvy®
- Compare: bictegravir/emtricitabine/tenofovir alafenamide vs similar drugs
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