Key Points

• Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) is an oral prescription medicine used to treat human immunodeficiency virus (HIV) in adults and children who are at least 12 years old and who weigh at least 55 pounds (25 kilograms). HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
• Genvoya is approved by the FDA for two groups of patients:
  • for use in patients who have never received antiretroviral treatment (known as treatment-naïve).
  • for use in patients who have been on a stable regimen for at least six months, have an undetectable viral load, and no history of HIV treatment failure or known resistance to any of the components of Genvoya.
• Genvoya is made by Gilead Sciences and comes in a tablet form. It contains a combination of four agents: 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF).
• It is considered a complete treatment regimen in one pill for HIV treatment. It is taken once-a-day with food and you do not need to use other HIV medicines with Genvoya.

What types of medicines are in Genvoya?

Genvoya is a fixed-dose, four-drug combination treatment for HIV-1 disease.

Genvoya contains:

• Elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI).
  • INSTIs block the action of the enzyme integrase that facilitates insertion of the HIV virus into the cell.
• Emtricitabine (Emtriva) and tenofovir alafenamide (Vemlidy) are both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs).
  • NRTIs block the action of reverse transcriptase and inhibit viral replication.
• Cobicistat (Tybost), a CYP3A inhibitor.
  • Cobicistat is known as a pharmacokinetic enhancer and is given only to help increase your blood levels of other HIV medications, such as elvitegravir. It is not an antiviral medication and will not treat HIV infection.
  • Cobicistat works by reducing the action of CYP3A enzymes in your liver that break down (metabolize) certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

How do I take Genvoya?

• Genvoya is an oral tablet taken once a day with food. It’s a complete treatment regimen and is not taken with other HIV medications.
• Don’t change your dose, stop your medication, or skip any doses without checking with your doctor first. The amount of virus in your blood may increase and develop resistance to treatment if the medicine is stopped, even for a short time. Be sure to get your refills on time and keep your scheduled doctor appointments.
• You should take medicines for indigestion (antacids) that contain aluminum hydroxide, magnesium hydroxide or calcium carbonate at least 2 hours before or 2 hours after you take Genvoya. Taking them together may decrease absorption and blood levels of elvitegravir, a medicine in Genvoya.

What does the HIV virus do?

When a foreign organism enters your body, it is attacked by white blood cells and antibodies in a response coordinated by a type of white blood cell called CD4 lymphocytes (these are a type of white blood cell, also called T-cells). These white blood cells help you to recover from disease and infections.

If you are infected with HIV, the virus attaches to the CD4 lymphocyte and enters your cells. Once inside, the virus inserts its own genetic material into the CD4 lymphocytes and then makes copies of itself (replicates).

When the new copies of the virus break out of your host cell and enter the bloodstream, they look for other cells to attack. The cycle repeats itself leading to more than 10 billion new HIV particles every day. To fight off the HIV virus, your immune system turns out as many as two billion new CD4 lymphocytes daily.

Eventually, the virus wins. The number of CD4 white blood cells decrease over time and your body develops severe immune deficiency, You are no longer able to effectively fight off viruses and bacteria that cause infections and other diseases. AIDS is the final and most severe stage of HIV disease, in which the signs and symptoms of severe immune deficiency have developed.

How can HIV medications help me?

Treatment with HIV medicines -- called antiretroviral therapy (ART) -- is recommended for everyone with an HIV diagnosis. Starting treatment early can delay the progression of HIV to AIDS, lower the risk of infectious complications, improve your quality of life, and prolong life expectancy to near normal. You should start antiretroviral therapy as soon as possible after your diagnosis, and continue your medications lifelong.

However, you cannot start treatment until you know your status. HIV screening is recommended by the CDC for patients between 13 and 64 years of age at least once in their lifetime. If you have not been tested, you should make this a priority.

Antiretroviral drugs slow down the growth, replication and amount of HIV in your blood (your viral load). By lowering your viral load, you can increase your CD4 count, which helps to fight off infections and keep you healthy. Your immune system is boosted, and this drastically lowers your risk of progressing to AIDS and its complications.

Antiretroviral therapy is not a cure for HIV or AIDS, and you need to take your medication daily to help prevent HIV resistance.

Research shows that diagnosis combined with advanced treatments and regular medical follow-up can significantly improve the health outcomes of a patient living with HIV. The viral loads can become undetectable, meaning there are fewer than 50 copies of HIV per milliliter of blood (<50 copies/mL). This is now an achievable goal in treatment for many patients. In fact, many people with HIV who are treated appropriately, take their medications as directed, and are monitored closely can live close to a normal life-span.

Bottom Line

• Genvoya is an oral prescription medicine used to treat human immunodeficiency virus (HIV) in adults and children. It is a complete, one pill treatment regimen. You do not need to take other HIV medications.
• Genvoya comes in a tablet form and contains four medicines: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF). Cobicistat is not an antiviral agent but is included in Genvoya to boost blood levels of elvitegravir.
• Advanced HIV treatments such as Genvoya allow many people living with HIV to achieve undetectable viral loads and live close to a normal life-span.

This is not all the information you need to know about Genvoya for safe and effective use. Review the full Genvoya information here, and speak to your health care provider if you have questions or concerns.