GENVOYA is a four-drug combination of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs) and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA. (1)
DOSAGE AND ADMINISTRATION

• Testing: Prior to initiation of GENVOYA, patients should be tested for hepatitis B infection. (2.1)
• Recommended dosage: One tablet taken orally once daily with food. (2.2)
• Renal impairment: GENVOYA is not recommended in patients with estimated creatinine clearance below 30 mL per minute. (2.3)
• Hepatic impairment: GENVOYA is not recommended in patients with severe hepatic impairment. (2.4)

Tablets: 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide. (3)
CONTRAINDICATIONS

• Avoid coadministration with other antiretroviral products: Do not use with drugs containing elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, lamivudine, ritonavir, or adefovir dipivoxil. (5.3)
• Risk of adverse reactions or loss of virologic response due to drug interactions: The concomitant use of GENVOYA and other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of GENVOYA and possible development of resistance; and possible clinically significant adverse reactions from greater exposures of concomitant drugs. (5.4)
• Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. (5.5)
• Immune reconstitution syndrome: May necessitate further eva luation and treatment. (5.6)
• New onset or worsening renal impairment: Assess creatinine clearance, urine glucose, and urine protein in all patients before initiating GENVOYA therapy and monitor during therapy. Monitor serum phosphorus in patients with chronic kidney disease. (5.7)
• Bone loss and mineralization defects: Consider monitoring BMD in patients with a history of pathologic fracture or other risk factors of osteoporosis or bone loss. (5.8)

Most common adverse reaction (incidence greater than or equal to 10%, all grades) is nausea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• GENVOYA should not be administered with other antiretroviral medications for treatment of HIV-1 infection. (5.3, 7.1)
• GENVOYA can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Drugs that induce CYP3A can alter the concentrations of one or more components of GENVOYA. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions. (4, 7.2, 7.3, 12.3)

• Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk. (8.1)
• Nursing mothers: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.3)