Generic Name: elvitegravir + tenofovir alafenamide + emtricitabine + cobicistat

Pronunciation: jen-VOY-uh

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Single-Tablet Regimens

Company: Gilead Sciences

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A


Drug Recommendation

A recommended treatment regimen for antiretroviral-naive people living with HIV, as indicated by the U.S. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.


General Info

Genvoya is a single-tablet regimen for HIV. It contains three different types of HIV drugs: two nucleotide/nucleoside reverse transcriptase inhibitors and one integrase inhibitor. It also contains a pharmacokinetic enhancer, a drug that has no activity against HIV, but boosts the blood levels and effectiveness of other drugs. Genvoya was approved by the U.S. Food and Drug Administration in November 2015, for use by people living with HIV who are 12 years of age or older and who are either starting HIV treatment for the first time or those wishing to switch their current regimens (provided that they have been on a stable regimen for at least six months, have an undetectable viral load and no history of HIV treatment failure or resistance to any of the drugs in Genvoya).

Genvoya is a combination of four drugs: Vitekta (elvitegravir), tenofovir alafenamide, Emtriva (emtricitabine) and Tybost (cobicistat). Vitekta, Emtriva and Tybost can be purchased individually for use in combination with other HIV drugs. Tenofovir alafenamide is currently unavailable as a standalone drug.


Dosage

Adult Dose: One tablet once a day. Each tablet contains 150 mg elvitegravir, 150 mg cobicistat, 10 mg tenofovir alafenamide fumarate and 200 mg emtricitabine.

Pediatric Dose: N/A

Dosing Info: This is a complete one-pill, once-daily drug regimen. Take with food.


Side Effects

Common side effects include gastrointestinal symptoms, notably diarrhea and nausea, fatigue, and headache.

Genvoya may lead to new or worsening kidney problems, though this risk is lower compared with those using Stribild. Your healthcare provider may do blood tests to check your kidneys before and during treatment with Genvoya.

Genvoya may lead to bone problems, though this risk is lower compared with those using Stribild. Problems include bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.

If you also have hepatitis B virus (HBV) and take Genvoya, your hepatitis may become worse if you stop taking Genvoya. Do not stop taking Genvoya without first talking to your healthcare provider.


Drug Interactions

The following medications should not be taken while you are being treated with Genvoya:
Acid reflux/heartburn medications: Propulsid (cisapride)
Antibiotics: Mycobutin (rifabutin), Rifamate (rifampin), Priftin (rifapentine)
Antimigraine medications: Ergostat, Cafergot, Ercaf, Wigraine (ergotamine) or D.H.E. 45 (dihydroergotamine)
Pulmonary hypertension medications: sildenafil (Revatio; used to treat pulmonary hypertension)
Cholesterol-lowering drugs (statins): Zocor (simvastatin) and Mevacor (lovastatin)
Antipsychotics: Orap (pimozide)
Sedatives: Versed (midazolam) and Halcion (triazolam)
Enlarged prostate: Uroxatral (alfuzosin)
Antivirals: Hepsera (adefovir)

Genvoya should not be combined with any HIV medications that contain any of the active ingredients in Genvoya. These include: Atripla, Complera, Descovy, Emtriva, Evotaz, Odefsey, Prezcobix, Stribild, Tybost, Viread, or Vitekta. Combining Genvoya with HIV medications containing active ingredients similar to those in Genvoya should also be avoided. These include: Combivir, Epivir, Epzicom, Isentress, Norvir, Tivicay, Triumeq, and Trizivir.

Genvoya should not be taken at the same time as common antacids, particularly those containing aluminum, magenesium hydroxide, or calcium carbonate; they should be taken at least two hours before or after Genvoya. Genvoya can, however, be taken at the same time as acid-reducing H2-receptor antagonists and proton pump inhibitors.

Blood levels of fluticasone, one of the drugs in inhalable medications like Advair, Flonase, and Flovent, can become increased if used with Genvoya. Careful monitoring for Cushing’s syndrome, a side effect of corticosteroids like fluticasone, is advised.

Important hepatitis C treatment drug-drug interactions: Genvoya can be combined with Sovaldi (sofosbuvir), ribavirin, and pegylated interferon alfa. Do not use Genvoya with Harvoni (ledipasvir/sofosbuvir), Olysio/Sovriad (simeprevir) or Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir).

Caution is also necessary when combining commonly used anti-seizure medications, erectile dysfunction drugs, heart rhythm medications, anti-depressants, immune suppressants, hormonal contraceptives, and some other drugs. Consult the Genvoya package insert for details: http://www.gilead.com/~/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi.pdf?la=en


Other Info

Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.


For More Info: http://www.gilead.com/~/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi.pdf?la=en

Co-Pay Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs

Patient Assistance Program Info: https://www.poz.com/basics/hiv-basics/drug-assistance-programs

Last Revised: July 15, 2016