Last reviewed 2026-04-27 · How we verify

Biktarvy (BICTEGRAVIR)

Biktarvy works by binding to the integrase enzyme, preventing the HIV virus from integrating its genetic material into the host cell's DNA.

Biktarvy (Bictegravir) is a small molecule antiretroviral medication developed by Gilead Sciences Inc. It is used to treat human immunodeficiency virus (HIV) infection. Biktarvy was approved by the FDA in 2018 and remains a patented product. Key safety considerations include the risk of drug resistance and potential interactions with other medications. As a treatment for HIV, Biktarvy works by inhibiting the replication of the virus.

At a glance

Mechanism of action

BIKTARVY is fixed dose combination of antiretroviral drugs bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) [see Microbiology (12.4)].

Approved indications

• Human immunodeficiency virus infection

Boxed warnings

• WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )

Common side effects

• Diarrhea
• Nausea
• Headache
• Fatigue
• Abdominal distention
• Abdominal pain
• Dizziness
• Insomnia
• Rash
• Depression
• Suicidal ideation
• Suicide attempt

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)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Biktarvy CI brief — competitive landscape report
• Biktarvy updates RSS · CI watch RSS
• Gilead Sciences portfolio CI