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Information

An Overview of Genvoya (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate)

October 10, 2017

Brand Name: Genvoya
Other Name(s): EVG/COBI/FTC/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Drug Class: Combination Drugs
Approved Use: Treatment of HIV Infection


Genvoya pill

WARNING:

Genvoya can cause serious, life-threatening side effects. These include buildup of lactic acid in the blood (lactic acidosis) and liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual (not normal) muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feel cold, especially in your arms and legs
  • Feel dizzy or light-headed
  • Fast or irregular heartbeat

Some people taking Genvoya have had liver problems. People with a history of hepatitis B virus (HBV) infection or people who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Genvoya. Liver problems have also occurred in people taking Genvoya who have no history of liver disease. Liver function tests may be done before and during treatment with Genvoya.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite
  • Nausea
  • Pain, aching, or tenderness in the right side of your stomach

Genvoya is not approved for the treatment of HBV infection. If you have both HIV and HBV infection and take Genvoya, your HBV infection may get worse (flare up) if you stop taking Genvoya.

If you take Genvoya, you should not take other HIV medicines.


While taking Genvoya, it is important to keep all of your appointments with your health care provider.


What Is Genvoya?

Genvoya is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection in adults and children who weigh at least 55 pounds (25 kilograms):

  • who have not taken HIV medicines before, or
  • To replace the current HIV medicines (called an HIV medicine regimen) in individuals who:
    • have a viral load (the amount of HIV in a sample of blood) that is less than 50 copies/mL, and
    • have been on the same HIV regimen for at least 6 months, and
    • have never had treatment failure (treatment failure is when an HIV regimen is unable to control HIV infection), and
    • have no drug resistance mutations associated with any of the HIV medicines in Genvoya (drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines).
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Genvoya is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

Genvoya contains the following four different medicines combined in one pill:

  • Elvitegravir -- an HIV medicine called an integrase inhibitor.
  • Cobicistat -- a medicine called a pharmacokinetic enhancer, which is used to increase the effectiveness of elvitegravir.
  • Emtricitabine -- an HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI).
  • Tenofovir alafenamide fumarate -- another HIV medicine (also an NRTI).

Integrase inhibitors (such as elvitegravir) block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) NRTIs (such as emtricitabine and tenofovir alafenamide fumarate) block an HIV enzyme called reverse transcriptase. By blocking integrase and reverse transcriptase, the drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including Genvoya, don't cut down on, skip, or stop taking them unless your health care provider tells you to.


What Should I Tell My Health Care Provider Before Taking Genvoya?

Before taking Genvoya, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Genvoya (elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide fumarate) or any other medicines.
  • If you have liver problems, including hepatitis B virus (HBV) infection.
  • If you have kidney problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether Genvoya can harm an unborn baby is unknown. Genvoya should be used during pregnancy only if the potential benefits outweigh the risks. Talk to your health care provider about possible risks with taking Genvoya when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Genvoya.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Genvoya may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking Genvoya. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Genvoya may affect the way other medicines or products work, and other medicines or products may affect how Genvoya works. Taking Genvoya together with certain medicines or products may cause serious, life-threatening side effects.


How Should I Take Genvoya?

Genvoya comes in tablet form. Each tablet contains:

Take Genvoya according to your health care provider's instructions.

Take Genvoya with food. Do not take Genvoya with other HIV medicines.

If you need to take a medicine for indigestion (an antacid) that contains aluminum and magnesium hydroxide or calcium carbonate during treatment with Genvoya, take it at least 2 hours before or after you take Genvoya.

If you take too much Genvoya, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Genvoya, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)


What Should I Do if I Forget a Dose?

If you miss a dose of Genvoya, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose. It is important to avoid missing doses.


What Side Effects Can Genvoya Cause?

Genvoya may cause side effects. Most side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Genvoya can be serious. Serious side effects of Genvoya include buildup of lactic acid in the blood (lactic acidosis) and liver problems. (See the WARNING box above.) 

Other possible side effects of Genvoya include:

  • Changes in your immune system (called immune reconstitution syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • New or worsening kidney problems, including kidney failure.
  • Nausea.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Genvoya. To learn more about possible side effects of Genvoya, read the drug label or package insert or talk to your health care provider or pharmacist.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.


How Should Genvoya Be Stored?

  • Store Genvoya below 86°F (30°C).
  • Keep Genvoya in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Genvoya if the original seal over the bottle opening is broken or missing.
  • Throw away Genvoya that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Genvoya and all medicines out of reach of children.


Where Can I Find More Information About Genvoya?

More information about Genvoya is available:


Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).

[Note from TheBody.com: This article was created by AIDSinfo, who last updated it on Oct. 10, 2017. We have cross-posted it with their permission.]


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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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