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Bictegravir (BIC)
Bictegravir (BIC) is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently FDA-approved for HIV-1 infection in treatment-naïve and treatment-experienced adults (as part of combination antiretroviral therapy).
Bictegravir inhibits HIV integrase, preventing the virus from inserting its genetic material into human host cell DNA.
Bictegravir (BIC) is a small molecule inhibitor that targets the human immunodeficiency virus type 1 integrase. It is used to treat HIV/AIDS, specifically HIV-1 infection, as part of the combination therapy bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), also known as Biktarvy.
At a glance
| Generic name | Bictegravir (BIC) |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Bictegravir is an integrase strand transfer inhibitor (INSTI) that binds to the HIV integrase enzyme and blocks its catalytic activity. By preventing integration of viral DNA into the host genome, it stops HIV replication at a critical step in the viral lifecycle. This mechanism allows for potent suppression of HIV viral load when used as part of combination antiretroviral therapy.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults (as part of combination antiretroviral therapy)
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
Key clinical trials
- 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)
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (PHASE3)
- Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (PHASE2)
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 (PHASE2, PHASE3)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
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 (BIC) CI brief — competitive landscape report
- Bictegravir (BIC) updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about Bictegravir (BIC)
What is Bictegravir (BIC)?
How does Bictegravir (BIC) work?
What is Bictegravir (BIC) used for?
Who makes Bictegravir (BIC)?
What drug class is Bictegravir (BIC) in?
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What does Bictegravir (BIC) target?
Related
- Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
- Target: All drugs targeting HIV integrase
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced adults (as part of combination antiretroviral therapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing