Classes
DEA Class; Rx
Common Brand Names; Genvoya
- 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 alafenamide, an acyclic nucleotide reverse transcriptase inhibitor
Used for the treatment of HIV-1 infection in adults and pediatric patients weighing 25 kg or more
Product contains a different tenofovir prodrug, tenofovir alafenamide, developed to help reduce adverse events
Indications
Indicated for ART-naïve or to replace current ART regimen in patients virologically suppressed (HIV-1 RNA <50 copies/mL) on stable ART regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to individual components
Contraindications
Coadministration with drugs highly dependent on CYP3A for clearance
- Alfuzosin
- Carbamazepine, phenobarbital, phenytoin
- Rifampin
- Lurasidone, pimozide
- Dihydroergotamine, ergotamine, methylergonovine
- Cisapride
- St. John’s wort (Hypericum perforatum)
- Lomitapide, lovastatin, simvastatin
- Phosphodiesterase-5 (PDE-5) inhibitor: Sildenafil when administered for treatment of pulmonary arterial hypertension
- Midazolam, triazolam
Adverse Effects
- Nausea (10%)
- Diarrhea (7%)
- Creatine kinase ≥10 x ULN (7%)
- Headache (6%)
- Fatigue (5%)
- LDL-C >190 mg/dL (5%)
- Total cholesterol >300 mg/dL (2%)
- Suicidal ideation, suicidal behavior, and suicide attempt
- Acute renal failure, acute tubular necrosis, proximal renal tubulopathy, and Fanconi syndrome
Warnings
Lactic acidosis and severe hepatomegaly with steatosis reported; treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)
Test patients with HIV-1 infection 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)
Fat redistribution and accumulation observed with ART therapy
Immune reconstitution syndrome reported, including the occurrence of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barre syndrome) with variable time to onset; autoimmune disorder can occur many months after initiation of treatment; during initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment
Pregnancy and Lactation
Not recommended for use during pregnancy; substantially lower exposures of cobicistat and elvitegravir reported during second and third trimesters
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 AF 10 mg/day PO).
1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir AF 10 mg/day PO).
1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir AF 10 mg/day PO).
weight 25 kg or more: 1 tablet/day PO (elvitegravir 150 mg/day PO; cobicistat 150 mg/day PO; emtricitabine 200 mg/day PO; tenofovir AF 10 mg/day PO).
weight less than 25 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 AF (tenofovir alafenamide)
tablet
- 150mg/150mg/200mg/10mg
