Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat HIV-1 in certain adults as well as certain children who weigh at least 25 kilograms (55 pounds). Biktarvy is typically prescribed as a long-term treatment.

Here are some fast facts on Biktarvy:

  • Active ingredients: bictegravir/emtricitabine/tenofovir alafenamide
  • Drug class: antiretroviral
  • Drug form: oral tablets
  • FDA approval year: 2018

Like other drugs, Biktarvy can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Biktarvy, including details about its uses, see this article.

Biktarvy 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 Biktarvy in clinical trials:

  • diarrhea
  • fatigue (lack of energy)
  • headache
  • nausea
  • sleep disturbances, such as unusual dreams or insomnia (trouble sleeping)
  • dizziness

Mild side effects can occur with Biktarvy use. This list doesn’t include all possible mild side effects reported with the drug. For more information, you can refer to these important facts on Biktarvy.

Mild side effects of Biktarvy can include:

  • abdominal (belly) pain
  • diarrhea
  • dizziness
  • fatigue (lack of energy)
  • flatulence (gas)
  • headache
  • nausea and vomiting
  • dyspepsia (stomach discomfort or indigestion)
  • sleep disturbances, such as unusual dreams or insomnia (trouble sleeping)
  • rash (see “Side effect specifics” below)

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 and reviews side effects of the medication. If you develop a side effect while taking Biktarvy and want to tell the FDA about it, visit MedWatch.

Biktarvy may cause serious side effects. The list below may not include all possible reported serious side effects of the drug. For more information, you can refer to the Biktarvy prescribing information.

If you develop serious side effects while taking Biktarvy, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects and their symptoms can include:

  • Lactic acidosis (too much lactic acid in your body). Symptoms can include:
    • abdominal (belly) pain
    • cold hands or feet, which may turn blue in color
    • increased heart rate
    • muscle pain
  • Liver damage. Symptoms can include:
    • abdominal pain
    • decreased appetite or loss of appetite
    • jaundice (yellowing of your skin or the whites of your eyes)
    • pale stool
    • urine that’s darker than usual
  • New or worsening kidney problems, such as kidney failure. Symptoms can include:
    • confusion
    • nausea and vomiting
    • producing less urine than normal or needing to urinate less often than usual
    • swelling in your ankles and feet
  • Immune reconstitution syndrome.*
  • Depression and suicidal thoughts or actions.*
  • Worsening of existing hepatitis B after stopping Biktarvy treatment.*†
  • Allergic reaction.*‡

* See “Side effect specifics” below for more information about this side effect.
Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See “Side effect specifics” below for more information.
‡ An allergic reaction is possible after using Biktarvy. But this side effect wasn’t reported in clinical trials.

Biktarvy may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Biktarvy cause weight gain?

No, this hasn’t been reported in clinical trials of Biktarvy.

However, Biktarvy contains active drugs from a class of medications* called nucleoside reverse transcriptase inhibitors. It also contains an active drug from a class of medications called integrase inhibitors. And drugs in these classes have been reported to cause weight gain.

If you notice unintended weight gain while taking Biktarvy, contact your doctor. They can recommend ways to handle this side effect.

* A class of medications is a group of drugs that work in a similar way. Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are nucleoside reverse transcriptase inhibitors. It also contains the active drug bictegravir sodium, which is an integrase inhibitor.

How long does Biktarvy stay in your system and cause side effects?

It isn’t known how long it may take for side effects to go away after stopping Biktarvy treatment. None of the active drugs in Biktarvy typically stay in the body longer than a couple of days after the last dose. But this can vary by individual.

Do not stop taking Biktarvy unless your doctor gives you permission to do so. Stopping Biktarvy can sometimes cause serious side effects in people who have certain conditions.* Your doctor may want to monitor you for these side effects if you’re going to stop taking the drug. If you have side effects that bother you or last a long time, be sure to talk with your doctor.

* If you have hepatitis B, stopping Biktarvy could worsen your infection. Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See “Side effect specifics” below for more details.

What are the long-term side effects of Biktarvy?

Biktarvy may cause some long-term side effects. These aren’t common, but can occur.

Potential long-term side effects of Biktarvy can include:

If you notice symptoms of long-term side effects while taking Biktarvy, call your doctor. (See the “Serious side effects” section above for examples of symptoms.) Your doctor can help determine how to handle any side effects you have. This may include trying an HIV medication other than Biktarvy.

Does Biktarvy cause hair loss?

No, hair loss wasn’t a side effect of Biktarvy in clinical trials.

However, Biktarvy contains active drugs from a class of medications* called nucleoside reverse transcriptase inhibitors, and an active drug from a class of medications called integrase inhibitors. And drugs in these classes have been reported to cause hair loss.

If you notice hair loss while taking Biktarvy, contact your doctor. They’ll be able to help you decide how to manage this side effect.

* A class of medications is a group of drugs that work in a similar way. Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are nucleoside reverse transcriptase inhibitors. It also contains the active drug bictegravir sodium, which is an integrase inhibitor.

Is joint pain a side effect of Biktarvy?

No, it’s not. Joint pain wasn’t reported as a side effect by people who took Biktarvy in clinical trials. And it hasn’t been reported with the active drugs in Biktarvy. These drugs are bictegravir, emtricitabine, and tenofovir alafenamide.

If you experience joint pain while taking Biktarvy, call your doctor. They can recommend treatments for this side effect.

Learn more about some of the side effects Biktarvy may cause.

Worsening of hepatitis B

Biktarvy has a boxed warning for worsening of existing hepatitis B. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

If you have hepatitis B and HIV and you stop taking Biktarvy, your hepatitis B may get worse. There have been reports of worsening hepatitis B in people who stop taking the medications emtricitabine, tenofovir disoproxil fumarate, or both. Biktarvy contains emtricitabine and a form of tenofovir called tenofovir alafenamide.

Specifically, severe side effects such as liver failure have occurred in people with hepatitis B who stop taking drugs such as Biktarvy.

For more information, see Biktarvy’s drug label information. You can also talk with your doctor.

What you can do

Before you start treatment with Biktarvy, your doctor will order a test to check if you have hepatitis B. If you have hepatitis B, make sure to talk with your doctor before you start Biktarvy.

It’s important that you don’t run out of Biktarvy tablets. You also shouldn’t stop taking Biktarvy unless your doctor gives you permission to do so. Stopping Biktarvy could cause serious side effects in people with hepatitis B.

If you have hepatitis B and your doctor decides to have you stop taking Biktarvy, they’ll monitor your liver function for several months. This is to make sure your hepatitis B doesn’t get worse. If your hepatitis B does get worse, your doctor may have you take medications to treat it.

Depression

Although rare, it’s possible to experience depression as a side effect of Biktarvy.

Most people in clinical trials didn’t report depression as a side effect of the drug. Of those who did, most experienced depression that was mild. A few people experienced serious depression, including suicidal thoughts. Serious depression was only reported in people taking Biktarvy who also had an existing mental health condition.

What you can do

While taking Biktarvy, be aware of any changes in your mood, emotions, or thinking. Specific symptoms can include:

  • anger or irritability
  • fatigue (lack of energy)
  • feelings of helplessness or hopelessness
  • feeling sad or “empty”
  • not getting pleasure from activities you usually enjoy

If you have these symptoms, call your doctor right away. If you have thoughts of harming yourself, call 911 or your local emergency number.

Immune reconstitution syndrome

Immune reconstitution syndrome can be a side effect of Biktarvy. This may also be called immune reconstitution inflammatory syndrome.

With this condition, your immune system starts to get stronger after you start HIV treatment, and may react to infections that may already be present in your body. This may cause symptoms that develop unexpectedly. They could be from an infection that hasn’t been diagnosed, or an infection that was previously treated.

Immune reconstitution syndrome may also cause certain autoimmune diseases. Graves’ disease is one example. An autoimmune disorder means your immune system mistakenly attacks your own tissues.

Immune reconstitution syndrome is most likely to occur when you first start treatment with Biktarvy. Symptoms vary depending on the condition that develops, which can include:

What you can do

Watch for possible symptoms of immune reconstitution syndrome while you’re taking Biktarvy. Make sure to call your doctor right away if you notice new symptoms after you start Biktarvy treatment.

Allergic reaction

As with most drugs, Biktarvy can cause an allergic reaction. However, this side effect wasn’t reported in clinical studies of the drug.

Symptoms can be mild or serious and can include:

  • rash
  • itching
  • flushing (warmth, swelling, redness, or discoloration in your skin)
  • 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 Biktarvy. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Suicide prevention

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 National Suicide Prevention Lifeline is available 24 hours per day at 800-273-8255. During a crisis, people who are hard of hearing can call 800-799-4889.

Click here for more links and local resources.

Biktarvy has several precautions.

Boxed warning: Worsening of hepatitis B

This drug has a boxed warning for worsening of existing hepatitis B. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

If you have hepatitis B and HIV and you stop taking Biktarvy, your hepatitis B may get worse. For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Biktarvy. 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:

Liver problems, including hepatitis B. If you have liver damage, you may have a higher risk for side effects from Biktarvy. For this reason, Biktarvy isn’t recommended for use in people with severe liver problems. Talk with your doctor about any liver problems you may have before beginning treatment with Biktarvy.

Kidney problems. One of the active drugs in Biktarvy, tenofovir alafenamide, can cause or worsen kidney problems in some people. Be sure your doctor is aware of any kidney problems you have before you take Biktarvy.

Mental health conditions, such as depression. Rarely, people with existing mental health conditions had severe depression while taking Biktarvy in clinical trials. This may have included suicidal thoughts and actions. If you have a history of depression or mental health conditions, talk with your doctor before taking Biktarvy.

Past infections. If you have a history of certain infections, your doctor may monitor you more closely than usual during your Biktarvy treatment. These infections include cytomegalovirus and tuberculosis. Biktarvy may cause your immune system to get stronger and react to infections that may already be present in your body. This side effect is called immune reconstitution syndrome.

Make sure to talk with your doctor about your history of infections before you start Biktarvy. And if you develop any new symptoms of an infection while taking Biktarvy, call your doctor.

Allergic reaction. You shouldn’t take Biktarvy if you’ve ever had an allergic reaction to Biktarvy or any of its ingredients. Talk with your doctor about treatments that may be better choices for you.

Note: See the “Side effect specifics” section above for details about possible side effects of Biktarvy.

Alcohol use with Biktarvy

There isn’t a known interaction between drinking alcohol and taking Biktarvy. But, both Biktarvy and alcohol can cause liver problems, including liver damage. And alcohol could make certain side effects of Biktarvy worse. These include nausea, vomiting, and diarrhea.

If you drink alcohol, talk with your doctor about how much, if any, is safe for you to have while taking Biktarvy.

Pregnancy and breastfeeding while taking Biktarvy

Below are details on pregnancy and breastfeeding while taking Biktarvy.

Pregnancy

It isn’t known if Biktarvy is safe to use during pregnancy, because the drug’s use during pregnancy hasn’t been studied. If you have HIV and you’re pregnant or planning to become pregnant, talk with your doctor about the best HIV treatment choice for you.

No harmful effects were seen when Biktarvy was given to pregnant females in animal studies. But animal studies don’t always predict how the drug will affect humans.

If you’re pregnant and taking Biktarvy or other HIV drugs, you might consider signing up for the Antiretroviral Pregnancy Registry. This program tracks the health of children born to people who took HIV drugs during pregnancy. This can help others with making decisions about their own treatments. See the registry’s website or call 800-258-4263 to learn more or enroll. Your doctor may also be able to provide more information.

Breastfeeding

You should not breastfeed while taking Biktarvy. Emtricitabine, one of the active drugs in Biktarvy, passes into breast milk. And this could lead to side effects in a breastfed child. It’s also important to note that the Centers for Disease Control and Prevention (CDC) recommends against breastfeeding your child if you have HIV.

Talk with your doctor about the best ways to feed your child if you have HIV.

Side effects can occur while taking Biktarvy, but they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention.

You should call your doctor right away if you experience symptoms of

These side effects could be serious and may require medical attention.

You should also call your doctor right away if you become pregnant while taking Biktarvy.

If you’d like to learn more about Biktarvy, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Note: For more information on HIV, see our HIV and AIDS content hub.

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 other 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.