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Biktarvy Tab
Biktarvy is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase while blocking the CCR5 co-receptor to prevent viral replication and CD4+ T-cell infection.
Biktarvy is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase while blocking the CCR5 co-receptor to prevent viral replication and CD4+ T-cell infection. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection as a complete regimen or in combination with other antiretrovirals.
At a glance
| Generic name | Biktarvy Tab |
|---|---|
| Sponsor | Southampton Healthcare, Inc. |
| Drug class | Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors) |
| Target | HIV integrase, HIV reverse transcriptase, CCR5 co-receptor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Biktarvy combines bictegravir (an integrase strand transfer inhibitor), emtricitabine (a nucleoside reverse transcriptase inhibitor), and tenofovir alafenamide (a nucleotide reverse transcriptase inhibitor). These three agents work synergistically to block multiple steps of HIV replication: reverse transcriptase inhibitors prevent conversion of viral RNA to DNA, while the integrase inhibitor prevents integration of viral DNA into the host genome. This multi-target approach reduces the likelihood of resistance development.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection as a complete regimen or in combination with other antiretrovirals
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Abnormal liver function tests
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)
- 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 B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) (PHASE4)
- Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV (PHASE2)
- 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 Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed (PHASE2, PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |