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Doravirine/Lamivudine/Tenofovir DF

    Brands

    DEA Class; Rx

    Common Brand Names; Delstrigo

    • HIV, ART Combos

    Fixed-dose combination tablet containing doravirine, an NNRTI, lamivudine, an NRTI, and tenofovir DF, an acyclic nucleotide reverse transcriptase inhibitor
    Used as a complete regimen to treat HIV-1 infection in treatment-naive adults and pediatric patients weighing at least 35 kg who are virologically stable on an antiretroviral regimen without history of treatment failure and no known resistance-associated substitutions to the individual drug components
    Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir DF

    Indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral-naive and certain treatment-experienced patients.

    Hypersensitivity to lamivudine

    Strong CYP3A inducers

    • Doravirine is contraindicated with strong CYP3A inducers, which may decrease effectiveness
    • Strong CYP3A inducer examples
      • Anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
      • Antimycobacterials (eg, rifampin, rifapentine)
      • Enzalutamide
      • Mitotane
      • St. John’s wort (Hypericum perforatum)
    • Sleep disorders and disturbances (12%)
    • Dizziness (9%)
    • Nausea (7%)
    • Headache (6%)
    • Fatigue (6%)
    • Diarrhea (5%)
    • Abdominal pain (5%)
    • Total bilirubin 1.1 to <1.6x ULN (5%)
    • Altered sensorium (4%)
    • AST 2.5 to <5x ULN (4%)
    • Lipase 1.5 to <3x ULN (4%)
    • Creatinine >1.3 to 1.8x ULN (3%)
    • ALT 2.5 to <5x ULN (3%)
    • Lipase ≥3x ULN (3%)
    • Creatine kinase ≥10x ULN (3%)
    • Rash (2%)
    • Total bilirubin 1.6 to <2.6x ULN (2%)
    • Creatinine >1.8x ULN (2%)
    • Creatine kinase 6 to <10x ULN (2%)
    • Abnormal dreams (1%)
    • Insomnia (1%)
    • ALT ≥5x ULN (1%)

    Severe acute exacerbations of hepatitis B (eg, liver decompensated, liver failure) reported in patients coinfected with HIV-1 and HBV and who have discontinued products containing lamivudine and/or tenofovir DF

    Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with tenofovir DF; avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs)

    Discontinue if CrCl declines below 50 mL/min

    Tenofovir DF associated with decreased bone mineral density (BMD) and increased biochemical markers of bone metabolism; consider assessing BMD in patients at risk

    Immune reconstitution syndrome reported with combination ART

    Autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) reported to occur in the setting of immune reconstitution; however, time to onset varies and can occur many months after initiation of treatment

    Data are not available to establish drug-associated risks to pregnancy outcomes

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

    Adults

    1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).

    Geriatric

    1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).

    Adolescents

    weight 35 kg or more: 1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).
    weight less than 35 kg: Safety and efficacy have not been established.

    Children

    weight 35 kg or more: 1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).
    weight less than 35 kg: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Doravirine/lamivudine/tenofovir DF

    Doravirine/lamivudine/tenofovir disoproxil fumarate

    tablet

    • 100mg/300mg/300mg