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Biktarvy 50/200/25 Tab
Biktarvy is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase while blocking protease activity to suppress viral replication.
Biktarvy is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase while blocking protease activity to suppress viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults.
At a glance
| Generic name | Biktarvy 50/200/25 Tab |
|---|---|
| Also known as | biktarvy |
| Sponsor | Radboud University Medical Center |
| Drug class | Antiretroviral combination (integrase inhibitor + nucleotide/nucleoside reverse transcriptase inhibitors) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Biktarvy combines bictegravir (an integrase strand transfer inhibitor), tenofovir alafenamide (a nucleotide reverse transcriptase inhibitor), and emtricitabine (a nucleoside reverse transcriptase inhibitor). Together, these agents target multiple steps of the HIV replication cycle: integrase catalyzes viral DNA integration into the host genome, reverse transcriptase converts viral RNA to DNA, and the combination prevents viral spread and reduces viral load.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Elevated creatinine
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 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated (PHASE2, 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:
- Biktarvy 50/200/25 Tab CI brief — competitive landscape report
- Biktarvy 50/200/25 Tab updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI