Elvitegravir & Cobicistat & Emtricitabine & Tenofovir

Elvitegravir/cobicistat/emtricitabine/tenofovir is a prescription medication that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults who have never taken HIV-1 medicines before. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if elvitegravir/cobicistat/emtricitabine/tenofovir is safe and effective in children under 18 years of age.

When used to treat HIV-1 infection, elvitegravir/cobicistat/emtricitabine/tenofovir may:

• Reduce the amount of HIV-1 in your blood. This is called "viral load".
• Increase the number of CD4+ (T) cells in your blood that help fight off other infections.
• Reduce the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Elvitegravir/cobicistat/emtricitabine/tenofovir does not cure HIV-1 infections or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Do not take elvitegravir/cobicistat/emtricitabine/tenofovir if you also take a medicine that contains:

• alfuzosin hydrochloride (Uroxatral)
• cisapride (Propulsid, Propulsid Quicksolv)
• ergot-containing medicines, including:
  • dihydroergotamine mesylate (D.H.E. 45, Migranal)
  • ergotamine tartrate (Cafergot, Migergot, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
  • methylergonovine maleate (Ergotrate, Methergine)
• lovastatin (Advicor, Altoprev, Mevacor)
• oral midazolam
• pimozide (ORAP)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• sildenafil (Revatio), when used for treating the lung problem, pulmonary arterial hypertension (PAH)
• simvastatin (Simcor, Vytorin, Zocor)
• triazolam (Halcion)
• St. John's wort (Hypericum perforatum) or a product that contains St. John's wort

You should not take elvitegravir/cobicistat/emtricitabine/tenofovir if you also take:

• any other medicines to treat HIV-1 infection
• other medicines that contain tenofovir (Atripla, Complera, Viread, Truvada)
• other medicines that contain emtricitabine or lamivudine (Combivir, Emtriva, Epivir, or Epivir-HBV, Epzicom, Trizivir)
• adefovir (Hepsera)

Especially tell your healthcare provider if you take:

• hormone-based contraceptives (birth control pills and patches)
• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take elvitegravir/cobicistat/emtricitabine/tenofovir.
• medicines to treat depression
• medicines to prevent organ transplant rejection
• medicines to treat high blood pressure
• any of the following medicines:
  • amiodarone (Cordarone, Pacerone)
  • atorvastatin (Lipitor, Caduet)
  • bepridil hydrochloric (Vascor, Bepadin)
  • bosentan (Tracleer)
  • buspirone
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegreto)
  • clarithromycin (Biaxin, Prevpac)
  • clonazepam (Klonopin)
  • clorazepate (Gen-Xene, Tranxene)
  • colchicine (Colcrys)
  • medicines that contain dexamethasone
  • diazepam (Valium)
  • digoxin (Lanoxin)
  • disopyramide (Norpace)
  • estazolam
  • ethosuximide (Zarontin)
  • flecainide (Tambocor)
  • flurazepam
  • fluticasone (Flovent, Flonase, Flovent Diskus, Flovent HFA, Veramyst)
  • itraconazole (Sporanox)
  • ketoconazole (Nizoral)
  • lidocaine (Xylocaine)
  • mexiletine
  • oxcarbazepine (Trileptal)
  • perphenazine
  • phenobarbital (Luminal)
  • phenytoin (Dilantin, Phenytek)
  • propafenone (Rythmol)
  • quinidine (Neudexta)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
  • risperidone (Risperdal, Risperdal, Consta)
  • salmeterol (Serevent) or salmeterol when taken in combination with fluticasone (Advair Diskus, Advair HFA)
  • sildenafil (Viagra), tadalafil (Cialis) or vardenafil (Levitra, Staxyn), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away.
  • tadalafil (Adcirca), for the treatment of pulmonary arterial hypertension
  • telithromycin (Ketek)
  • thioridazine
  • voriconazole (Vfend)
  • warfarin (Coumadin, Jantoven)
  • zolpidem (Ambien, Edluar, Intermezzo, Zolpimist)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Do not start any new medicines while you are taking elvitegravir/cobicistat/emtricitabine/tenofovir without first talking with your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of elvitegravir/cobicistat/emtricitabine/tenofovir there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed if you take this medication.

• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
• Two of the medicines contained in this tablet can pass to your baby in your breast milk. It is not known if the other 2 medicines can pass into your breast milk.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose is one tablet (equal to 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir) taken once daily with food.

• Store this medication at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep it in its original container.
• Keep the container tightly closed.
• Do not use if the seal over the bottle opening is broken or missing.

Keep elvitegravir/cobicistat/emtricitabine/tenofovir and all medicines out of reach of children.