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Bictegravir/Emtricitabine/Tenofovir AF

    Brands

    DEA Class; Rx

    Common Brand Names; Biktarvy

    • HIV, ART Combos

    Oral 3-drug combination of an integrase strand inhibitor (bictegravir) and 2 nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide)
    Used as complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing 14 kg or more
    Black Box Warning for acute exacerbations of hepatitis B

    Indicated as complete regimen for antiretroviral therapy (ART)-naïve patients

    Indicated to replace current ART regimen

    • In virologically suppressed patients (HIV-1 RNA <50 copies/mL) for ≥3 months
    • No history of treatment failure
    • No known substitutions associated with resistance to individual components

    Coadministration with dofetilide and/or rifampin

    Adults

    • Diarrhea (3-6%)

    • Nausea (3-5%)

    • Headache (4-5%)

    • Creatine kinase ≥10x ULN (4%)

    • Abnormal dreams (<3%)

    • Fasting LDL-C >190 mg/dL (2-3%)

    • Fatigue (2-3%)

    • Dizziness (2%)

    • Insomnia (2%)

    • Neutrophil <750 mm³ (2%)

    • Amylase >2x ULN (2%)

    • ALT >5x ULN (1-2%)

    • AST >5x ULN (1-2%)

    Children

    • Insomnia, grade 2

    • Anxiety, grade 2

    Patients with HIV-1 infection should be tested for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy (ART); not approved for the treatment of chronic HBV infection (see Black Box Warnings)

    Immune reconstitution syndrome reported in patients treated with combination ART therapy; autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) may occur in the setting of immune reconstitution; time to onset varies and can occur many months after initiation of treatment

    Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use; suspend treatment if patient develops signs or symptoms of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis, even in absence of marked transaminase elevations)

    There is insufficient human data on use of bictegravir/emtricitabine/tenofovir AF during pregnancy to inform a drug-associated risk of birth defects and miscarriage

    The Centers for Disease Control and Prevention do not recommend HIV-infected mothers breastfeed their infants owing to potential risk for postnatal transmission of HIV

    Adults

    1 tablet/day PO (bictegravir 50 mg/day; emtricitabine 200 mg/day; tenofovir alafenamide 25 mg/day).

    Geriatric

    1 tablet/day PO (bictegravir 50 mg/day; emtricitabine 200 mg/day; tenofovir alafenamide 25 mg/day).

    Adolescents

    1 tablet/day PO (bictegravir 50 mg/day; emtricitabine 200 mg/day; tenofovir alafenamide 25 mg/day).

    Children

    weighing 25 kg or more: 1 tablet/day PO (bictegravir 50 mg/day; emtricitabine 200 mg/day; tenofovir alafenamide 25 mg/day).
    weighing 14 to 24 kg: 1 tablet/day PO (bictegravir 30 mg/day; emtricitabine 120 mg/day; tenofovir alafenamide 15 mg/day).
    weighing less than 14 kg: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Bictegravir/emtricitabine/tenofovir AF (tenofovir alafenamide)

    tablet

    • 50mg/200mg/25mg