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Biktarvy

Generic Name: bictegravir, emtricitabine, and tenofovir (bik TEG ra vir, EM trye SYE ta been, and ten OF oh vir)
Brand Name: Biktarvy
Drug class: Antiviral combinations

Medically reviewed by Judith Stewart, BPharm. Last updated on Dec 16, 2021.

What is Biktarvy?

Biktarvy contains a combination of bictegravir, emtricitabine, and tenofovir. Bictegravir, emtricitabine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Biktarvy is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Biktarvy is for use in adults and children who weigh at least 31 pounds (14 kilograms).

Biktarvy is not a cure for HIV or AIDS.

Warnings

Biktarvy may cause a serious condition called lactic acidosis. Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.

If you've ever had hepatitis B, it may become active or get worse after you stop using Biktarvy. You may need frequent liver function tests for several months.

Before taking this medicine

You should not use Biktarvy if you are allergic to antiviral medicines that contain emtricitabine or tenofovir (such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada).

Some medicines can cause unwanted or dangerous effects when used with Biktarvy. Your doctor may need to change your treatment plan if you also use:

Tell your doctor if you have ever had:

Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry to track the effects of Biktarvy on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Biktarvy?

Take Biktarvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Biktarvy is a complete regimen and is not for use with other antiviral medications.

You may take Biktarvy with or without food. If you take a multivitamin or mineral supplement that contains iron or calcium, take it with food at the same time you take Biktarvy.

For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are swallowed within about 10 minutes.

If you are on dialysis, take your daily dose following dialysis.

You will need frequent medical tests.

Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Biktarvy. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Dosing information

Usual Adult Dose for HIV Infection:

Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Usual Pediatric Dose for HIV Infection:

At least 14 to less than 25 kg: Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg orally once a day
At least 25 kg: Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg orally once a day

Comments:
-For children at least 14 to less than 25 kg who are unable to swallow a whole tablet, the tablet can be split and each part can be taken separately as long as all parts are ingested within about 10 minutes.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Biktarvy side effects

Get emergency medical help if you have signs of an allergic reaction to Biktarvy: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

  • lactic acidosis - muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or

  • liver problems - swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Biktarvy side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Biktarvy?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Certain antacids, laxatives, or buffered medicines can make Biktarvy much less effective when taken at the same time. Take your dose on an empty stomach, 2 hours before you take any of these other medicines.

Many drugs can interact with bictegravir, emtricitabine, and tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Popular FAQ

  • Biktarvy is a complete regimen and use with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • Biktarvy is associated with many drug interactions as it contains three different medicines, increasing your risk for interactions. Have your health care provider check for possible interactions with other prescription medicines, OTCs or herbal you take.
  • You should not take Biktarvy with dofetilide (Tikosyn), a drug used for heart rhythm disorders or rifampin (Rifadin), a medicine for tuberculosis (TB). These drugs are contraindicated with the use of Biktary.
Continue reading

Biktarvy (bictegravir, tenofovir, and emtricitabine) is not FDA approved for use as an HIV-1 preventive for pre-exposure prophylaxis (PrEP) or as a post-exposure prophylaxis (PEP) treatment. Biktarvy is used for HIV treatment (not for prevention) as a once-daily, oral complete regimen in adults and children.

Medications approved by the FDA for use in PrEP are emtricitabine plus tenofovir alafenamide (oral Descovy), emtricitabine plus tenofovir disoproxil (oral Truvada) and the long-acting injection cabotegravir (Apretude).  Continue reading

Biktary is not listed as being associated with weight gain in the package insert. However, recent research suggests all integrase strand inhibitors such as bictegravir found in Biktary may be linked with some weight gain. Studies have demonstrated a median weight gain of between 1 kg (2.2 lbs) and 4 (8.8 lbs) kg over one to two years of follow-up. However, some patients have seen a  greater than 10% weight gain. Continue reading

If you miss one dose of Biktarvy (bictegravir, tenofovir, and emtricitabine), take the missed dose as soon as you remember it. If it is almost time for your next dose, just skip the missed dose and take your next dose at the regular time. Try not to miss doses. Taking your medicine as prescribed will help you to keep your HIV under control and help prevent drug resistance. Continue reading

There is not a specific warning in the product label against alcohol (ethanol) consumption with Biktarvy, a medication used for HIV treatment. But drinking too much alcohol can damage your liver. Ask your doctor if it is safe and how much alcohol you can drink while taking Biktarvy. Continue reading

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Biktarvy only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.