Classes
DEA Class; Rx
Common Brand Names; Stribild
- HIV, ART Combos
Description
Fixed-dose combination tablet containing elvitegravir, an HIV integrase strand transfer inhibitor; cobicistat, a pharmacokinetic enhancer; emtricitabine, a nucleoside reverse transcriptase inhibitor or NRTI; and tenofovir DF, an acyclic nucleotide reverse transcriptase inhibitor
Used for the treatment of HIV-1 infection in patients who are least 12 years of age and weigh at least 35 kg
Carries a Black Box Warning for acute exacerbations of hepatitis
Indications
Indicated as a complete regimen for treatment of HIV infection in treatment-naive adults and as replacement of current antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable ART regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Stribild
Contraindications
Coadministration of with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events
- Alfuzosin
- Carbamazepine, phenobarbital, phenytoin
- Rifampin
- Lurasidone, pimozide
- Dihydroergotamine, ergotamine, methylergonovine
- Cisapride
- St. John’s wort (Hypericum perforatum)
- Lomitapide, lovastatin, simvastatin
- Sildenafil when administered for pulmonary arterial hypertension
- Triazolam, orally administered midazolam
Adverse Effects
- Proteinuria (39%)
- Nausea (16%)
- Diarrhea (12%)
- Abnormal dreams (9%)
- Headache (7%)
- Serum creatinine increased (7%)
- Fatigue (5%)
- Creatine kinase increased ≥10 x ULN (5%)
- Serum lipids increased (4%); ie, additional patients started on lipid lowering agents while on Stribild
- Rash (3%)
- Dizziness (3%)
- Insomnia (3%)
- Hematuria (3%)
- Flatulence (2%)
- AST increased >5 x ULN (2%)
- Amylase increased >2 x ULN (2%)
- Somnolence (1%)
Warnings
Lactic acidosis and severe hepatomegaly with steatosis reported
Test patients with HIV-1 for the presence of chronic hepatitis B virus (HBV) before initiating antiretroviral therapy (see Black Box Warnings)
Fat redistribution and accumulation observed with antiretroviral therapy
Immune reconstitution syndrome reported, including the occurrence of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barre syndrome) with variable time to onset
Pregnancy and Lactation
Not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during second and third trimesters
Avoid use in pregnant individuals; an alternative regimen is recommended for individuals who become pregnant during therapy
The Centers for Disease Control and Prevention do not recommend HIV-infected mothers breastfeed their infants due to potential risk for postnatal transmission of HIV
Maximum Dosage
1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir disoproxil fumarate 300 mg/day PO).
1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir disoproxil fumarate 300 mg/day PO).
weighing 35 kg or more: 1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir disoproxil fumarate 300 mg/day PO).
weighing less than 35 kg: Safety and efficacy have not been established.
12 years weighing 35 kg or more: 1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir disoproxil fumarate 300 mg/day PO).
1 to 11 years or weighing 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
Elvitegravir/cobicistat/emtricitabine/tenofovir DF (ie, tenofovir disoproxil fumarate)
tablet
- 150mg/150mg/200mg/300mg
