Biktarvy (bictegravir sodium/emtricitabine/tenofovir alafenamide)

Biktarvy generic

Biktarvy is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Biktarvy cost and coupons

As with all medications, the cost of Biktarvy can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons: You can visit Optum Perks for price estimates of Biktarvy (see below). These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance: If you need financial support to pay for Biktarvy, or if you need help understanding your insurance coverage, help is available.

A financial support program called the Gilead Advancing Access program is available for Biktarvy. For more information and to find out if you’re eligible for support such as a copay card or the patient assistance program, call 800-226-2056 or visit the program website.

You can refer to this Biktarvy cost article for details. And to learn more about saving money on prescriptions, check out this article.

Biktarvy side effects

Biktarvy can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Biktarvy. These lists do not include all possible side effects.

For more information about the possible side effects of Biktarvy, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Biktarvy, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Biktarvy. To learn about other mild side effects, talk with your doctor or pharmacist, or view Biktarvy’s prescribing information.

Mild side effects of Biktarvy can include:

• nausea and vomiting
• diarrhea
• indigestion
• gas
• abdominal pain or bloating
• headache
• dizziness
• insomnia
• unusual dreams
• fatigue
• rash

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Biktarvy aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening, or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• new or worsening kidney problems, which may include symptoms such as:
  • urinating less than usual
  • swelling of the lower legs or feet
  • itchiness
  • confusion
  • shortness of breath
• severe liver problems, which may include symptoms such as:
  • nausea
  • abdominal pain
  • dark urine or pale stools
  • loss of appetite
  • jaundice (yellowing of your skin or eyes)
• lactic acidosis (buildup of lactic acid in the blood), which may include symptoms such as:
  • weakness or fatigue
  • dizziness
  • shortness of breath
  • fast heart rate or irregular heartbeat
  • cold or blue hands and feet
  • muscle pain
  • nausea, vomiting, and abdominal pain
• immune reconstitution syndrome (a condition in which your immune system gets stronger with HIV treatment and starts reacting to other infections that may still be in your body), which can cause different symptoms depending on the infection but may include:
  • “unmasking” symptoms (symptoms caused by a previously undiagnosed infection)
  • “paradoxical” symptoms (symptoms caused by a previously treated infection)
• depression or suicidal thoughts or actions, which may include symptoms such as:
  • feeling extremely sad, gloomy, or hopeless
  • losing interest in things you used to enjoy
  • changes in your sleep patterns or appetite
  • thoughts about harming yourself or dying
• worsening hepatitis B after stopping Biktarvy*

Note: You can refer to this Biktarvy side effects article for more information.

* Biktarvy has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Biktarvy precautions” section.

ALLERGIC REACTION

For some people, Biktarvy can cause an allergic reaction. This side effect wasn’t reported in the drug’s studies, but is possible.

In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Biktarvy, your doctor may recommend taking a different medication instead.

Biktarvy uses

The Food and Drug Administration (FDA) approves prescription drugs such as Biktarvy to treat certain conditions. Biktarvy may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Biktarvy for HIV

Biktarvy is FDA approved to treat HIV-1 in adults and children weighing at least 14 kilograms (kg), which is about 31 pounds (lb) who:

• have not taken HIV medications before, or
• are switching from a different HIV treatment, and:
  • the amount of virus in their blood is below 50 copies per milliliter (mL), which is also called an undetectable viral load (a virus level too low to be measured with lab tests)
  • the HIV virus in their body doesn’t have mutations (changes) that could make it resistant to treatment with bictegravir or tenofovir (two of the active ingredients in Biktarvy)

HIV is a virus that attacks white blood cells called CD4 cells. There are two main types of the virus, HIV-1 and HIV-2. Most people with HIV have HIV-1.

HIV may not cause symptoms for many years. But if not treated, HIV can severely lower your CD4 count. This reduces your immune system activity (referred to as “weakening” your immune system), making it harder for your body to fight infections and cancers.

HIV is treated with drugs called antiretrovirals. These drugs help lower your viral load to undetectable levels. With an undetectable viral load, you can not transmit the virus to another person through sexual contact. And there’s a lower risk of transmitting the virus to another person through pregnancy, breastfeeding, or sharing needles.

Antiretrovirals also help increase your CD4 count. This strengthens your immune system, making it better equipped to fight infections and cancers. This can help you live a healthier life.

Biktarvy contains three different antiretrovirals. It’s a complete treatment for HIV, which means you don’t need to take other HIV medications with it.

Biktarvy and children

Biktarvy is FDA approved to treat HIV-1 in certain children who weigh at least 14 kilograms (kg), which is about 31 pounds (lb). It’s not known if Biktarvy is safe or effective in children weighing less than 14 kg.

See just above for more details about HIV-1 and which children Biktarvy is approved for.

Biktarvy dosage

The following information describes Biktarvy dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Biktarvy comes as an oral tablet. Each tablet contains three active ingredients. The tablets are available in two different strengths:

• 50 milligrams (mg) of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide
• 30 mg of bictegravir, 120 mg of emtricitabine, and 15 mg of tenofovir alafenamide

Dosage for HIV-1

For adults weighing 25 kilograms (kg) or more, the recommended dosage is one tablet containing 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide, taken once per day. For reference, 25 kg is about 55 pounds (lb).

Children’s dosage

The recommended dosage for children depends on the child’s body weight as follows:

• children weighing 14 kg to less than 25 kg (30 lb to less than 55 lb): one tablet containing 30 mg of bictegravir, 120 mg of emtricitabine, and 15 mg of tenofovir alafenamide taken once per day
• children weighing 25 kg (about 55 lb) or more: one tablet containing 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide taken once per day

About taking Biktarvy

Below you’ll find information about key dosage issues.

• When to take: You should take Biktarvy once per day. Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Biktarvy work effectively.
• If you miss a dose: If you miss a dose, take it as soon as possible. It’s important not to miss doses of Biktarvy. Missing doses can make the level of medication in your blood fall too low to manage the virus. This can allow the virus to develop resistance to the medication, which can make Biktarvy less effective at treating your HIV.
• Taking Biktarvy with food: You can take Biktarvy with or without food.
• Crushing, splitting, or chewing Biktarvy: Biktarvy is not meant to be crushed or chewed. But if you have trouble swallowing Biktarvy, you can split the tablet. Take all parts of the split tablet within 10 minutes.
• Length of use: Biktarvy is meant to be used as a long-term treatment. If you and your doctor determine that Biktarvy is safe and effective for you, you’ll likely take it long term.
• Length of time to work: Biktarvy starts working against HIV within the first hour after taking a dose. If you’re switching to Biktarvy from other HIV drugs, Biktarvy will start working right away to keep your viral load undetectable. (Undetectable means the level of virus in your blood is too low to be measured with lab tests.) If you haven’t taken HIV drugs before, it may take up to 6 months for Biktarvy to lower your viral load to an undetectable level.

Note: You can refer to this Biktarvy dosage article for more information.

Overdose

Do not take more Biktarvy than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Biktarvy

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Biktarvy, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Biktarvy:

• nucleoside reverse transcriptase inhibitors (NRTIs) such as:
  • abacavir (Ziagen)
  • emtricitabine (Emtriva)
  • lamivudine (Epivir)
  • tenofovir disoproxil fumarate (Viread)
  • zidovudine (Retrovir)
• non-nucleoside reverse transcriptase inhibitors such as:
  • doravirine (Pifeltro)
  • efavirenz (Sustiva)
  • etravirine (Intelence)
  • nevirapine (Viramune, Viramune XR)
  • rilpivirine (Edurant)
• protease inhibitors such as:
  • atazanavir (Reyataz)
  • darunavir (Prezista)
  • fosamprenavir (Levixa)
  • ritonavir (Norvir)
  • tipranavir (Aptivus)
• fusion inhibitors such as:
  • enfuvirtide (Fuzeon)
  • maraviroc (Selzentry)
• integrase strand transfer inhibitors such as:
  • cabotegravir (Apretude)
  • cabotegravir sodium (Vocabria)
  • dolutegravir (Tivicay)
  • raltegravir (Isentress)
• attachment inhibitors
  • fostemsavir (Rukobia)
  • ibalizumab-uiyk (Trogarzo)
• combination drugs such as:
  • abacavir/lamivudine (Epzicom)
  • abacavir/lamivudine/dolutegravir (Triumeq)
  • abacavir/lamivudine/zidovudine (Trizivir)
  • atazanavir/cobicistat (Evotaz)
  • cabotegravir/rilpivirine (Cabenuva)
  • darunavir/cobicistat (Prezcobix)
  • darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza)
  • dolutegravir/lamivudine (Dovato)
  • dolutegravir/rilpivirine (Juluca)
  • doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo)
  • efavirenz/lamivudine/tenofovir disoproxil fumarate (Symfi, Symfi Lo)
  • efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
  • elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya)
  • elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild)
  • emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey)
  • emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera)
  • emtricitabine/tenofovir alafenamide (Descovy)
  • emtricitabine/tenofovir disoproxil fumarate (Truvada)
  • lamivudine/tenofovir disoproxil fumarate (Cimduo)
  • lamivudine/zidovudine (Combivir)
  • lopinavir/ritonavir (Kaletra)

Common questions about Biktarvy

Here are answers to some frequently asked questions about Biktarvy.

Can your body become resistant to Biktarvy?

Your body can’t become resistant to Biktarvy, but it is possible for the HIV in your body to become resistant to Biktarvy. With resistance, the virus develops small changes that make it less sensitive to the drug. This can happen if the level of Biktarvy in your body falls too low to manage the virus.

If HIV becomes resistant to Biktarvy, this makes Biktarvy less effective at treating HIV. As a result, your viral load (the amount of virus in your body) can increase.

HIV is more likely to become resistant to Biktarvy if you miss doses of this medication. It’s important that you take Biktarvy every day and don’t miss even a few doses. Be sure to reorder Biktarvy before you run out of the medication.

If your HIV becomes resistant to Biktarvy, your doctor will need to change your HIV treatment.

Does Biktarvy cause pancreatitis?

It’s not likely. Pancreatitis wasn’t reported in people who took Biktarvy in clinical studies. However, pancreatitis has been reported in people taking drugs similar to the active ingredients in Biktarvy.

Specifically, pancreatitis has been reportedTrusted Source in people taking nucleoside reverse transcriptase inhibitors (NRTIs) drugs. It’s also occurredTrusted Source in people taking certain integrase inhibitors. Biktarvy contains drugs from both of these groups.

Symptoms of pancreatitis can include abdominal pain, nausea, vomiting, diarrhea, and loss of appetite. If you have these symptoms while taking Biktarvy, see your doctor.

Besides taking Biktarvy, how else can I prevent HIV from passing to others?

HIV can pass to others in blood, semen, and breast milk, as well as in vaginal and rectal fluids. You can prevent HIV from passing to others by:

• using condoms every time you engage in sexual activity
• choosing sexual activities, such as oral sex, that are less likely to transmit HIV than anal or vaginal sex
• getting regularly tested and treated for other sexually transmitted infections (STIs)
• not sharing needles, syringes, or other drug-injecting equipment with others
• not breastfeeding

For more information about how to prevent HIV transmission, see these recommendationsTrusted Source from the Centers for Disease Control and Prevention (CDC).

Does Biktarvy cure HIV?

No, Biktarvy can’t cure HIV. Currently, there is no cure available for HIV.

But, taking Biktarvy can suppress (reduce) the activity of the virus in your body. It can even reduce your viral load to levels that are undetectable on lab tests. When your viral load is undetectable, it’s not possible to pass the virus to others through sex. And there’s a lower risk of transmitting HIV through pregnancy, breastfeeding, or sharing needles. However, this is not the same as a cure.

Keep taking Biktarvy for as long as your doctor prescribes it, even if your viral load is undetectable. If you stop the treatment, this allows your viral load to increase again.

Can older people take Biktarvy?

Biktarvy is likely safe and effective in people ages 65 years and older. In the drug’s clinical studies, the safety and effectiveness of Biktarvy were similar in older and younger adults. However, these studies didn’t include many older people.

If you’re age 65 years or older, talk with your doctor about whether Biktarvy could be right for you.

Is Biktarvy used for anything other than HIV?

No, Biktarvy is not used for anything other than HIV. The Food and Drug Administration (FDA) has approved Biktarvy for treating HIV in certain adults and children.

Note that Biktarvy is not FDA-approved for preexposure prophylaxis (PrEP) of HIV. PrEP is a treatment prescribed for people who don’t have HIV to reduce their risk of contracting the virus through sex. It’s not known if Biktarvy is effective for this use.

For more information about Biktarvy’s approved use for treating HIV, see the “Biktarvy uses” section above. You can also talk with your doctor.

Biktarvy vs. Truvada

You may wonder how Biktarvy compares with other medications that are prescribed for similar uses. To find out how Biktarvy compares to Truvada, see this article.

Biktarvy vs. Genvoya

You may wonder how Biktarvy compares with other medications that are prescribed for similar uses. To find out how Biktarvy compares to Genvoya, see this article.

How Biktarvy works

Biktarvy works by blocking the action of certain enzymes that HIV uses to make copies of itself. (An enzyme is a type of protein that helps chemical reactions happen.) The way a drug works is called its mechanism of action.

Biktarvy contains three active ingredients from two different groups of drugs:

• emtricitabine, which is a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, which is also an NRTI
• bictegravir sodium, which is an integrase strand transfer inhibitor

Emtricitabine and tenofovir alafenamide block the action of an enzyme called reverse transcriptase. Bictegravir sodium blocks the action of an enzyme called integrase.

By blocking these enzymes from working, Biktarvy stops the virus making more copies of itself. This suppresses the virus and helps reduce your viral load.

If your viral load becomes so low that it’s undetectable on lab tests, the virus can’t transmit to someone else through sex. And, there is a lower risk of the virus transmitting through pregnancy, breastfeeding, or sharing needles.

Taking Biktarvy also allows your CD4 count to increase. CD4 cells are a type of white blood cell. Increased CD4 levels makes your immune system stronger at fighting infections and cancers.

Biktarvy interactions

Biktarvy can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Biktarvy, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

For more information about Biktarvy and interactions, see this in-depth article.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Biktarvy. This list does not contain all drugs that may interact with Biktarvy. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Biktarvy. However, alcohol and Biktarvy can cause some similar side effects. These include headache, nausea, dizziness, and liver problems. So you may be more likely to have these side effects if you drink alcohol while taking Biktarvy.

If you have questions about how much alcohol is safe to drink while taking Biktarvy, talk with your doctor or pharmacist.

Things to consider when taking Biktarvy

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Biktarvy and pregnancy

It’s not known if there are risks to taking Biktarvy during pregnancy. But there is a risk that HIV will transmit to the fetus if HIV is not treated during pregnancy. Because of this, current guidelines recommend that people with HIV who are pregnant take antiretroviral medication, such as Biktarvy. This can help prevent HIV from transmitting to a fetus.

If you’re planning a pregnancy or can become pregnant, talk with your doctor about potential treatments for HIV during pregnancy. Together, you can consider the risks and benefits of your treatment options and decide whether or not you should take Biktarvy during pregnancy.

Biktarvy and birth control

It’s not known if Biktarvy is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Biktarvy.

Biktarvy and breastfeeding

It’s not known if it’s safe to breastfeed while taking Biktarvy. The active ingredients in Biktarvy pass into breast milk, but it’s not known what effects they may have in a child who is breastfed. Also, if you have HIV, there’s a risk of transmitting the virus to the child through breast milk.

Current guidelines note that if you have HIV, taking antiretroviral medications such as Biktarvy can greatly reduce the risk of transmitting HIV to your child through breast milk. But they don’t reduce the risk to zero.

If you have HIV, talk with your doctor about the best way to feed your child.

You can refer to this reproductive health article for more details about Biktarvy and pregnancy, breastfeeding, and birth control.

Biktarvy precautions

This drug comes with several precautions.

FDA warning: Worsening hepatitis B after stopping Biktarvy

This drug has a boxed warning. 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 take Biktarvy to treat HIV, stopping Biktarvy can cause your hepatitis B to get worse. This can lead to liver failure.

Your doctor will typically order a test for hepatitis B virus (HBV) before you start taking Biktarvy. If you have HBV, you should not stop taking Biktarvy without talking with your doctor first. If you stop Biktarvy, your doctor will likely monitor your HBV and your liver function for several months. If needed, they may prescribe medication to treat HBV.

If you have questions about this warning, talk with your doctor.

Other precautions

Before taking Biktarvy, discuss your health history with your doctor. Biktarvy may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

• current use of the arrhythmia drug dofetilide (Tikosyn) or the antibiotic rifampin (Rifadin, Rimactane)
• kidney problems
• liver problems
• history of mental health problems such as depression or suicidal thoughts
• history of infections such as tuberculosis, Pneumocystis jirovecii pneumonia, or cytomegalovirus
• previous allergic reaction to this or a similar drug
• pregnancy
• breastfeeding

Note: For more information about the potential negative effects of Biktarvy, see the “Biktarvy side effects” section.

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.