WHAT IS GENVOYA?
The FDA approved Genvoya in 2015 as an ARV for people with HIV infection. Genvoya is manufactured by Gilead Sciences.
One of the drugs in Genvoya, elvitegravir, is a type of drug called an integrase inhibitor. Integrase inhibitors block integrase (an HIV enzyme). HIV uses integrase to insert (integrate) its viral DNA into the DNA of host CD4 cells. Blocking integrase prevents HIV from replicating. Another drug in Genvoya, cobicistat, is a type of drug called a pharmacokinetic enhancer (PK enhancer) or CYP3A inhibitor. PK enhancers are used to boost the effectiveness of other drugs. When the two drugs are given together, the PK enhancer interferes with the liver metabolism and breakdown of the other drug, which allows the other drug to remain in the body longer at a higher concentration. PK enhancers are included in some HIV treatment regimens. Cobicistat itself is not an ARV and does not treat HIV. The final two drugs in Genvoya, emtricitabine and tenofovir AF, are nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs bind to and block reverse transcriptase (an HIV enzyme). HIV uses reverse transcriptase to convert its RNA into DNA (reverse transcription). Blocking reverse transcriptase and reverse transcription prevents HIV from replicating.
When used alone as a complete regimen to treat HIV infection, Genvoya may help:
Reducing the amount of HIV and increasing CD4 cells in your blood may help improve your immune system. This may reduce your risk of death or getting opportunistic infections (OIs) that can happen when your immune system is weak. Read more about viral suppression.
WHO SHOULD TAKE GENVOYA?
Genvoya is a prescription four-drug fixed-dose combination medication to treat HIV infection in adults and children who weigh at least 55 pounds (25 kg):
- who have not received HIV medicines in the past
- to replace their current HIV medicines when their healthcare provider determines that they meet certain requirements
The safety and effectiveness of Genvoya has not been established in children who weigh less than 55 pounds (25 kg).
All people with HIV should be on ART to keep healthy AND not transmit the virus to others. You and your healthcare provider should consider your CD4 cell count, your viral load, any symptoms you are having, and your preferences when deciding which HIV medications are right for you. Read more about U.S. ART guidelines.
Genvoya provides four drugs in one pill. It can be more convenient to use Genvoya than some other combinations of drugs that must be taken separately or at different times of the day. This could mean fewer missed doses and better control of HIV. Genvoya is used as a complete regimen for the treatment of HIV infection.
WHO SHOULD NOT TAKE GENVOYA?
Do not take Genvoya if you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir AF, or any of the ingredients in this drug.
Do not take Genvoya if you are taking any of the following medicines. Taking Genvoya with these medicines may affect how Genvoya works. Genvoya may cause serious or life-threatening side effects or death when used with these medicines:
- Alpha 1-adrenoreceptor antagonist: alfuzosin
- Gout medicine: colchicine (if you have liver or kidney problems)
- Antipsychotic medicines: lurasidone, pimozide
- Seizure medicines: carbamazepine, phenobarbital, phenytoin
- Tuberculosis (TB) medicine: rifampin
- Benzodiazepines: midazolam (when taken by mouth), triazolam
- Cholesterol medicines: lomitapide, lovastatin, simvastatin
- Ergot-containing medicines: dihydroergotamine mesylate, ergotamine tartrate, methylergonovine maleate
- Heart medicine: dronedarone hydrochloride
- Heartburn and reflux medicine: cisapride
- Herbal product: St. John’s Wort (Hypericum perforatum)
- Hormonal birth control: drospirenone, ethinyl estradiol
- PDE-5 inhibitor: sildenafil (when used for the treatment of pulmonary arterial hypertension [PAH])
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of these medicines in the past four weeks, talk to your healthcare provider or pharmacist before starting treatment with Genvoya.
Genvoya is not recommended in people with severe kidney disease, end-stage renal disease (ESRD), or severe liver disease.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING GENVOYA?
Before you take Genvoya, tell your healthcare provider about all of your medical conditions, and in particular if you:
Talk to your healthcare provider if you are pregnant, you plan to become pregnant, you become pregnant, or think you may be pregnant during treatment with Genvoya. It is not known if Genvoya can harm your unborn baby. Genvoya should not be used during pregnancy because you may not have enough Genvoya in your body during pregnancy.
There is a pregnancy registry for people who take ARVs during pregnancy. The purpose of this registry is to collect information about the health of you and your baby and monitor outcomes in people exposed to ARVs during pregnancy. Talk to your healthcare provider about how you can take part in this registry. Read more about pregnancy and HIV.
Talk to your healthcare provider if you are breastfeeding or plan to breastfeed during treatment with Genvoya. At least one of the medicines in Genvoya can pass to your baby in your breastmilk. It is not known if the other medicines in Genvoya can pass into your breastmilk. Do not breastfeed if you have HIV because of the risk of passing HIV to your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with Genvoya.
WHAT ABOUT DRUG RESISTANCE?
Many new copies of HIV are mutations. These new copies are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an ARV. When this happens, the drug will stop working. This is called developing resistance to the drug. Sometimes, if your virus develops resistance to one ARV, it will also have resistance to other ARVs. This is called cross-resistance. Read more about HIV drug resistance.
Resistance can develop quickly. It is very important to take ARVs according
to instructions, on schedule, and not to skip or reduce doses.
HOW IS GENVOYA TAKEN?
Genvoya is taken by mouth as a tablet. Each Genvoya tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir AF. The recommended dosage of Genvoya for adults and children who weigh at least 55 pounds (25 kg) is one tablet once daily.
Take Genvoya at the same time each day with food. If you are on dialysis, take your daily dose of Genvoya following dialysis.
If you need to take a medicine for indigestion (antacid) that contains aluminum hydroxide, magnesium hydroxide, or calcium carbonate during treatment with Genvoya, take it at least 2 hours before or after you take Genvoya.
WHAT ARE THE SIDE EFFECTS?
When you start any ARV, you may have temporary side effects such as headaches, nausea, indigestion, or a general sense of feeling ill. These side effects usually get better or disappear over time.
The most common side effect of Genvoya is nausea.
Genvoya can cause serious side effects including:
Worsening of HBV infection. Your healthcare provider will test you for HBV before or when you start treatment with Genvoya. If you have HBV infection and take Genvoya, your HBV may get worse (flareup) if you stop taking Genvoya. A flare-up is when your HBV infection suddenly returns in a worse way than before. Do not stop taking Genvoya without first talking to your healthcare provider. Do not run out of Genvoya. Refill your prescription or talk to your healthcare provider before your Genvoya is all gone. If you stop taking Genvoya, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medication to treat HBV. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Genvoya.
Immune Reconstitution Inflammatory Syndrome (IRIS). IRIS is a side effect that can happen when you start taking HIV medications. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. This may result in an inflammatory response which may require further evaluation and treatment. Tell your healthcare provider right away if you experience any new symptoms after starting treatment with Genvoya.
New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with Genvoya. Your healthcare provider may tell you to stop taking Genvoya if you develop new or worse kidney problems during treatment with Genvoya.
Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious but rare medical emergency that can cause death. Tell your healthcare provider right away if you develop any of these symptoms:
- Weakness or being more tired than usual
- Being short of breath or fast breathing
- Cold or blue hands and feet
- Fast or abnormal heartbeat
- Unusual muscle pain
- Stomach pain with nausea and vomiting
- Feel dizzy or lightheaded
Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms:
- Skin or the white part of your eyes turns yellow
- Dark or “tea-colored” urine
- Light-colored stools (bowel movements)
- Loss of appetite for several days or longer
- Nausea or vomiting
- Stomach-area pain
You may be more likely to get lactic acidosis or serious liver problems if you are assigned female at birth (AFAB) or are very overweight (obese).
These are not all the possible side effects of Genvoya. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
HOW DOES GENVOYA REACT WITH OTHER DRUGS?
All ARVs can interact with other drugs or supplements you are taking. These interactions can change the amount of each drug in your bloodstream and cause an under- or overdose. New interactions are constantly being identified. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take Genvoya with other medicines.
See above for a list of medications that should not be taken with Genvoya.
Genvoya is a complete regimen for the treatment of HIV infection; therefore, taking Genvoya with other ARVs for the treatment of HIV infection is not recommended.
Visit the Genvoya website.
Visit the Genvoya healthcare professional website.
Download the full Prescribing Information.
Download the Patient Information leaflet.
Apply for the Gilead Advancing Access Program.
Reviewed March 2021Print PDF