Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a prescription drug used to treat HIV. Genvoya can cause side effects that range from mild to serious. Examples include nausea and headache.
Specifically, Genvoya is used in adults and certain children as a first treatment for HIV or to replace your current HIV treatment in some situations.
Genvoya has four active ingredients. These include:
- elvitegravir, which is an integrase inhibitor
- cobicistat, that helps boost elvitegravir levels in your body
- emtricitabine, which is a reverse transcriptase inhibitor
- tenofovir alafenamide, which is also a reverse transcriptase inhibitor
Keep reading to learn about common, mild, and serious side effects that Genvoya can cause. For a general overview of the drug, including details about its uses, see this article.
Genvoya has a boxed warning for the risk of worsening hepatitis B infection after stopping Genvoya. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects explained” section.
Some people may experience mild to serious side effects during Genvoya treatment. Examples of the drug’s commonly reported side effects include:
These are just a few side effects of Genvoya reported in the drug’s studies.
Mild side effects have been reported with Genvoya. These include:
- nausea
- diarrhea
- headache
- fatigue
In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop Genvoya treatment unless your doctor recommends it.
Genvoya may cause mild side effects other than those listed above. See the drug’s prescribing information for details.
Serious side effects have been reported in studies of people taking Genvoya. These include:
- lactic acidosis*
- serious liver damage, including an enlarged liver*
- immune reconstitution syndrome (a sudden overactive response by your immune system)
- new or worsening kidney problems, including kidney failure
- high cholesterol
- bone density problems
- boxed warning: risk of worsening hepatitis B infection†
If you develop serious side effects while taking Genvoya, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
* To learn more about this side effect, see the “Side effects explained” section.
† Genvoya has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Side effects explained” section.
Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Genvoya, visit MedWatch.
ALLERGIC REACTIONFor some people, Genvoya may cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Genvoya treatment.
If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
If your doctor confirms you’ve had a serious allergic reaction to Genvoya, they may have you switch to a different treatment.
Get answers to some frequently asked questions about Genvoya’s side effects.
How do the side effects of Genvoya and Biktarvy compare?
Genvoya and Biktarvy are both brand-name prescription drugs used to treat HIV. They have some similar and some different side effects. See the table below for details.
| Medication | Mild side effects | Serious side effects |
|---|---|---|
| Genvoya and Biktarvy | • nausea • fatigue • diarrhea • headache | • immune reconstitution syndrome • lactic acidosis* • liver damage* • boxed warning: risk of worsening hepatitis B† • new or worsening kidney problems, including kidney failure • allergic reaction |
| Genvoya | no unique side effects | • high cholesterol • bone density problems |
| Biktarvy | • dizziness • insomnia • unusual dreams • indigestion (upset stomach) | • depression |
* To learn more about this side effect, see the “Side effects explained” section.
† Genvoya has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Side effects explained” section.
Check out this article to learn more about how these two drugs compare.
Does Genvoya cause long-term side effects?
It’s possible. In rare cases, Genvoya may cause certain long-term side effects. These are side effects that may begin during treatment and may even continue after treatment ends. They include:
- liver damage*
- new or worsening kidney problems, including possible kidney failure
- worsening of hepatitis B infection after stopping Genvoya†
If you have ongoing or bothersome side effects with Genvoya, talk with your doctor. They’ll decide whether you should stop taking it and switch to a different HIV treatment.
Do not stop taking Genvoya without first talking with your doctor. Suddenly stopping this medication can cause serious side effects if you have certain conditions. (See the “Side effects explained” section for more information.)
If you stop taking Genvoya, your doctor will monitor you for worsening of certain conditions.
* To learn more about this side effect, see the “Side effects explained” section.
† Genvoya has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Side effects explained” section.
Does Genvoya cause weight gain or skin-related side effects?
It’s not likely. Weight gain and skin-related side effects weren’t reported in Genvoya’s studies.
However, having HIV can cause weight loss, so you may gain weight once you start treatment for your condition. It’s not known whether this is due to the medication or an improvement in your condition.
In rare cases, Genvoya may cause serious side effects which can affect the skin. They include:
- allergic reaction, which may cause skin rash
- liver damage, which may cause jaundice (yellowing of your skin or the whites of your eyes)
If you’re concerned about weight gain or skin-related side effects from Genvoya, talk with your doctor.
Learn more about some of the side effects Genvoya may cause.
Lactic acidosis
Lactic acidosis was a rare but serious side effect reported in studies of Genvoya. This condition may cause symptoms such as:
- nausea and vomiting
- stomach pain
- fast heart rate
- dizziness
- muscle pain or cramping
- fatigue
- disorientation and confusion
- jaundice
- rapid, shallow breathing
Factors that can increase the risk of lactic acidosis when taking Genvoya include problems with your liver or kidneys.
What might help
Talk with your doctor if you have kidney or liver problems. Kidney and liver conditions can cause lactic acid to build up in your body, which can increase your risk of lactic acidosis.
Your doctor will monitor your liver and kidney function before and during treatment with Genvoya. Call 911 or your local emergency number immediately if you have symptoms of lactic acidosis. This is a serious, potentially fatal condition that requires immediate medical attention.
Risk of worsening hepatitis B
Genvoya has a boxed warning for the risk of worsening hepatitis B infection after stopping Genvoya. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.
Genvoya may cause hepatitis B to worsen in some people. This can cause severe liver problems, including liver failure. Your risk of worsening hepatitis B infection is higher if you also have HIV and stop taking Genvoya.
To learn more about this serious side effect, see Genvoya’s prescribing information or talk with your doctor or pharmacist.
What might help
Your doctor will check if you have hepatitis B infection before you start treatment with Genvoya.
If you have both HIV and hepatitis B infection, do not suddenly stop taking Genvoya. Doing so could increase your risk of serious liver damage from worsening hepatitis B. If you have both infections and need to stop taking Genvoya, your doctor will order tests to monitor your liver function for several months after you stop treatment. This is to make sure the hepatitis B infection isn’t worsening. If it does get worse, you may need hepatitis B treatment.
Liver damage
Genvoya may cause serious liver damage. This was reported as a rare but serious side effect in the drug’s studies. Problems include a buildup of lactic acid (lactic acidosis) and an enlarged liver.
Symptoms of liver damage may include:
- nausea and vomiting
- abdominal pain
- jaundice
- dark brown urine
- pale stools
- loss of appetite
What might help
If you have symptoms of liver damage while taking Genvoya, call your doctor right away. They’ll likely order blood tests to check your liver function. If you have liver damage, they may stop your Genvoya treatment and suggest a different HIV treatment.
Keeping track of side effectsDuring your Genvoya treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.
Your side effect notes can include things such as:
- what dose of the drug you were taking when you had the side effect
- how soon you had the side effect after starting that dose
- what your symptoms were
- how your symptoms affected your daily activities
- what other medications you were taking
- any other information you feel is important
Sharing notes with your doctor will help them learn more about how Genvoya affects you. They can then use this information to adjust your treatment plan if needed.
Below is important information you should consider before starting Genvoya.
Boxed warning: Risk of worsening hepatitis B infection
Genvoya has a boxed warning about the risk of worsening hepatitis B infection after stopping this medication. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects explained” section.
Other warnings
Genvoya can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you. Talk with your doctor about your health history before starting Genvoya. Be sure to tell them if any of the following factors apply to you:
- kidney problems
- liver problems
- mental health conditions
- previous allergic reaction to Genvoya
- decreased bone density
- pregnancy
- breastfeeding
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.