Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat HIV. The drug can be used in adults, as well as children who weigh at least 25 kilograms (about 55 pounds).
If you and your doctor determine that Genvoya is safe and effective for you, it’s likely that you’ll take the drug long term.
Here are some fast facts on Genvoya:
- Active ingredients: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
- Drug class: antiretroviral
- Drug form: oral tablet
Like other drugs, Genvoya can cause side effects, although they aren’t common. Read on to learn about potential common, mild, and serious side effects. For a general overview of Genvoya, see this article.
Genvoya can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Genvoya in clinical trials:
Mild side effects can occur with Genvoya use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Genvoya’s medication guide.
Mild side effects that have been reported with Genvoya include:
These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Genvoya and want to tell the FDA about it, visit MedWatch.
Genvoya may cause serious side effects, including some long-term side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Genvoya’s medication guide.
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.
Serious side effects that have been reported and their symptoms can include:
- New or worsening kidney disease, including acute (sudden) kidney failure. Symptoms can include:
- dark urine
- muscle weakness or pain
- swelling in your ankles, feet, or legs
- urinating less than usual
- Immune reconstitution syndrome (a sudden overactive response by your immune system).*
- Liver problems, including lactic acidosis and enlarged liver.*
- High cholesterol.*
- Worsening of hepatitis B.*†
- Allergic reaction.*‡
* For more information about this side effect, see “Side effect specifics” below.
† Genvoya has a
‡ An allergic reaction is possible after using Genvoya. But this side effect wasn’t reported in clinical studies.
Genvoya may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
How do the side effects of Genvoya compare with those of Biktarvy?
|Mild side effects may include
|Serious side effects may include
|In people taking Genvoya or Biktarvy
• fatigue (lack of energy)
|•worsening of existing hepatitis B*
• lactic acidosis (a buildup of lactic acid in your body)
• allergic reaction
• new or worsening kidney problems, including acute (sudden) kidney failure
• immune reconstitution syndrome (a sudden overactive response by your immune system)
|In people taking Biktarvy
|• insomnia (trouble falling or staying asleep)
• abnormal dreams
|• no unique serious side effects
|In people taking Genvoya
|• no unique mild side effects
|• high cholesterol
* Genvoya and Biktarvy both have a
For more information on how these drugs compare, check out this article. To learn more about Biktarvy’s side effects, see this article. And if you have other questions about side effects of HIV medications, talk with your doctor or pharmacist.
Is depression a side effect of Genvoya?
It’s unlikely. Rarely, people with a history of mental health conditions (such as depression) reported suicidal thoughts or behaviors as a side effect of Genvoya in clinical trials. But the drug is not known to cause depression.
If you have a history of mental health conditions, be sure to talk with your doctor about this before you begin treatment with Genvoya. And if you have thoughts about harming yourself, call 911 or your local emergency number.
Can Genvoya cause me to gain weight?
No, weight gain hasn’t been reported as a side effect of Genvoya.
If you’re concerned about your weight while taking Genvoya, talk with your doctor. They can help suggest ways for you to maintain a moderate weight.
Is hair loss one of Genvoya’s side effects?
No, hair loss hasn’t been reported as a side effect of Genvoya in clinical trials. People with HIV may experience hair loss due to factors such as other medical conditions. But hair loss isn’t a symptom of HIV itself.
If you’re concerned about hair loss while taking Genvoya, talk with your doctor.
How will Genvoya affect my skin?
Taking Genvoya is very unlikely to affect your skin.
The drug wasn’t reported to cause any side effects that directly affect the skin in clinical trials. But some rare, serious side effects* of Genvoya may affect the skin. These include:
- allergic reaction, which may cause a rash and other symptoms
- liver problems, which may cause jaundice (yellowing of your skin or the whites of your eyes)
* For more information about these side effects, see the “Side effect specifics” section just below.
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
Learn more about some of the side effects that Genvoya may cause.
Liver problems, including lactic acidosis or enlarged liver
With lactic acidosis, there’s a buildup of lactic acid in your body. Lactic acidosis can cause severe liver problems if it’s not treated. Symptoms of this condition may include:
- abdominal (belly) pain
- cold hands or feet, which may cause your skin or fingernails to look blue
- fatigue (lack of energy)
- increased heart rate
- muscle pain
- nausea and vomiting
Symptoms of other liver problems, including hepatomegaly, can include:
- dark urine
- loss of appetite
- pale stools
- upper right abdominal pain
- jaundice (yellowing of your skin or the whites of your eyes)
What you can do
If you experience symptoms of liver problems, call your doctor right away. They’ll likely order a blood test to check your liver function and to check for lactic acidosis or other liver issues.
It’s possible for Genvoya to cause high cholesterol. Some people taking the drug in clinical trials had increases in low-density lipoprotein (LDL) cholesterol (also known as “bad” cholesterol) and total cholesterol, although this wasn’t common.
High cholesterol doesn’t usually cause any symptoms.
What you can do
While being treated with Genvoya, you’ll have tests to monitor how the drug is working for you. This may include tests to check your cholesterol levels. For more information, talk with your doctor about lab tests you may need while taking Genvoya.
Immune reconstitution syndrome
Immune reconstitution syndrome can occur with Genvoya treatment. This is a sudden overactive response from your immune system that can occur when you begin HIV treatment. It’s most likely to occur when you first start taking Genvoya.
With immune reconstitution syndrome, your immune system reacts to infections that may already be present in your body. These symptoms may develop due to an infection that was treated in the past or that was undiagnosed. Immune reconstitution syndrome can also lead to certain autoimmune disorders, such as Graves’ disease. With autoimmune disorders, your body’s immune system mistakenly attacks your own tissues.
What you can do
Watch for symptoms of immune reconstitution syndrome while you’re taking Genvoya. Some general symptoms may include a fever, swollen lymph nodes, and fatigue (lack of energy). Other symptoms can vary depending on the condition that develops, such as:
- infections, for example:
- autoimmune diseases, for example:
- Graves’ disease
Talk with your doctor right away if you develop new symptoms when you start taking Genvoya.
Worsening of hepatitis B
Genvoya has a
Two of Genvoya’s active drugs are emtricitabine and tenofovir alafenamide. Worsening of hepatitis B has been reported in people with hepatitis B infection and HIV who stop taking drugs that contain emtricitabine. This has also been reported after people with these conditions stopped taking drugs that contained a different form of tenofovir, which is called tenofovir disoproxil fumarate.
- loss of appetite
- dark urine
- jaundice (yellowing of your skin or whites of your eyes)
- pale stool
- upper right belly pain
You’ll be tested for hepatitis B virus (HBV) before you begin taking Genvoya.
What you can do
It’s important that you don’t stop taking Genvoya unless your doctor approves first. If you have hepatitis B and your doctor recommends that you stop Genvoya treatment, you’ll likely have liver function tests for a few months after your last dose.
If you have symptoms of this side effect, talk with your doctor. If your hepatitis B infection gets worse after stopping Genvoya, your doctor will likely prescribe treatment for it.
Symptoms can be mild or serious and can include:
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your lips, eyelids, feet, or hands
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Genvoya. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Below is information about Genvoya’s boxed warning and other precautions.
Boxed warning: Worsening of hepatitis B
This drug has a
Be sure to talk with your doctor about your health history before you take Genvoya. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Mental health conditions, including depression. If you have a history of mental health conditions, you may be at higher risk for suicidal thoughts or behaviors while taking Genvoya. Talk with your doctor about your history of mental health conditions, such as depression, before you start Genvoya. They may have you try a different HIV treatment. If you experience suicidal thoughts while taking Genvoya, call 911 or your local emergency number right away.
Liver problems. You shouldn’t take Genvoya if you have liver problems or poor liver function. Doing so could increase your risk for other liver problems, including fatty liver disease. Make sure your doctor is aware of any liver problems you have before you take Genvoya. They’ll likely recommend a different medication for you.
Kidney problems. You shouldn’t take Genvoya if you have kidney problems or poor kidney function. Taking Genvoya could increase your risk for other kidney issues, including acute (sudden) kidney failure. Be sure your doctor is aware of any kidney conditions you have before you take Genvoya. They’ll likely recommend a different treatment for you.
Allergic reaction. You shouldn’t take Genvoya if you’ve ever had an allergic reaction to Genvoya or any of its ingredients. Talk with your doctor about which other treatments are better choices for you.
Alcohol use with Genvoya
There aren’t any known interactions between alcohol and Genvoya. But drinking excessive amounts of alcohol can lead to liver disease. And Genvoya may also rarely cause severe liver problems.
If you drink alcohol, you should talk with your doctor about how much is safe for you to drink while you’re taking Genvoya.
Pregnancy and breastfeeding while taking Genvoya
Using Genvoya during pregnancy is not recommended. Pregnancy can affect how much of the drug is in your body, which can make the drug less effective. And, there isn’t enough information to determine if the drug could affect a fetus. Talk with your doctor if you’re pregnant or planning to become pregnant before you take Genvoya.
Genvoya should not be taken while breastfeeding. One of the active drugs in Genvoya, emtricitabine, passes into breast milk, which may put a child who is breastfed at risk for side effects. The
While Genvoya can cause side effects, they aren’t common. And when they do occur, they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention.
Although rare, Genvoya can also cause serious side effects. You should talk with your doctor if you experience symptoms of:
- worsening of hepatitis B
- liver problems, including lactic acidosis or an enlarged liver
- immune reconstitution syndrome (a sudden overactive response by your immune system)
- new or worsening kidney disease, including acute (sudden) kidney failure
- high cholesterol
- allergic reaction
You should also talk with your doctor if you become pregnant while taking Genvoya.
If you’d like to learn more about Genvoya, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Disclaimer: Medical News Today 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.