Classes
DEA Class; Rx
Common Brand Names; Delstrigo
- HIV, ART Combos
Description
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
Indications
Indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral-naive and certain treatment-experienced patients.
Contraindications
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)
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).
1 tablet/day PO (doravirine 100 mg/day; lamivudine 300 mg/day; tenofovir disoproxil fumarate 300 mg/day).
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Doravirine/lamivudine/tenofovir DF
Doravirine/lamivudine/tenofovir disoproxil fumarate
tablet
- 100mg/300mg/300mg
