Bictegravir Emtricitabine Tenofovir Alafenamide

Pronunciation: bik-TEG-ra-vir, em-try-SITE-a-been, and ten-NO-foe-vir al-a-FEN-a-mide
Generic name: bictegravir/emtricitabine/tenofovir alafenamide
Brand name: Biktarvy
Dosage form: oral tablet
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on May 24, 2024.

What is bictegravir emtricitabine and tenofovir alafenamide?

Bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy) is a complete HIV-1 antiviral treatment in a once-a-day single tablet containing three antivirals.

Biktarvy works by preventing HIV from multiplying in your body and lowers HIV blood levels, which decreases your chance of developing AIDS and HIV-related illnesses such as cancer or serious infections. It does not cure HIV. Human immunodeficiency virus type 1 (HIV-1) is the virus that causes acquired immune deficiency syndrome (AIDS).

Bictegravir is an integrase strand transfer inhibitor (INSTI) that works by blocking an enzyme called integrase that HIV uses to replicate. Emtricitabine and tenofovir alafenamide both belong to the class of medicines known as nucleoside reverse transcriptase inhibitors (NRTIs). These work by blocking the HIV enzyme called reverse transcriptase that converts HIV RNA into HIV DNA. This also prevents HIV from replicating or making copies of itself, reducing levels of HIV in the body and slowing its spread.

Although Biktarvy will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer.

Bictegravir, emtricitabine, and tenofovir alafenamide were FDA-approved on February 7, 2018, under the brand Biktarvy. There is no Biktarvy generic available.

Bictegravir, emtricitabine, and tenofovir alafenamide uses

Bictegravir/emtricitabine/tenofovir alafenamide is an FDA-approved medicine used as a complete regimen for the treatment of HIV-1 infection in adults and children who weigh at least 14 kg. Biktarvy can be used by patients who:

• have not taken HIV-1 medicine in the past OR
• to replace their current HIV-1 medicine if they are virologically suppressed (HIV-1 RNA less than 50 copies per mL), on a stable antiretroviral regimen with no history of treatment failure and with no known substitutions associated with resistance to bictegravir or tenofovir.

Related/similar drugs

Descovy, Cabenuva, Truvada, Atripla, Stribild, Epzicom, Complera

Bictegravir, emtricitabine, tenofovir alafenamide side effects

Bictegravir, emtricitabine, and tenofovir alafenamide may cause serious side effects, including a worsening of hepatitis B infection (HBV), risk of drug resistance in undiagnosed HIV-1 infection, immune reconstitution syndrome kidney damage, lactic acidosis or liver disease. See warnings below.

The most common Biktarvy side effects affecting 5% or more people who take it are:

• diarrhea
• nausea
• headache.

These are not all the possible side effects of bictegravir, emtricitabine, and tenofovir alafenamide. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Allergic reactions: Get emergency medical help if you have signs of an allergic reaction to bictegravir/emtricitabine/tenofovir alafenamide, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Worsening of hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before or when you start treatment with bictegravir/emtricitabine/tenofovir alafenamide. If you have an HBV infection and take bictegravir/emtricitabine/tenofovir alafenamide, your HBV may get worse (flare-up) when you discontinue treatment.

• Do not run out of bictegravir/emtricitabine/tenofovir alafenamide or stop taking it without your healthcare provider's advice. Refill your prescription or talk to your healthcare provider before it is all gone.
• If you stop taking bictegravir/emtricitabine/tenofovir alafenamide your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B.
• Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking it.

Kidney problems: New or worse kidney problems, including kidney failure. Your healthcare provider should organize blood and urine tests to check your kidneys when starting and during treatment with this medicine. If you develop new or worse kidney problems, your healthcare provider may tell you to stop taking this medicine. Symptoms of kidney problems include:

• little or no urination
• swelling in your feet or ankles
• feeling tired
• shortness of breath.

Changes in your immune system (Immune Reconstitution Syndrome): This can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin fighting infections hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.

Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms:

• skin or the white part of your eyes turns yellow,
• dark "tea-colored" urine,
• light-colored stools,
• loss of appetite for several days or longer,
• nausea,
• stomach-area pain.

Too much lactic acid in your blood (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
• a fast or abnormal heartbeat.

Bictegravir/emtricitabine/tenofovir alafenamide is not recommended in severe liver disease or in patients with an estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history.

This is not a complete list of side effects and others may occur. Talk to your doctor, pharmacist, or healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use bictegravir/emtricitabine/tenofovir alafenamide if you are allergic to bictegravir, emtricitabine, tenofovir, Biktarvy or other antivirals such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada.

Bictegravir/emtricitabine/tenofovir alafenamide may interact with several other medications. Talk to your healthcare provider about these interactions. Do NOT take bictegravir/emtricitabine/tenofovir alafenamide with:

• dofetilide; or
• rifampin.

Tell your doctor if you have or ever had:

• liver disease (especially cirrhosis)
• hepatitis B virus (HBV)
• kidney disease.

Before starting bictegravir/emtricitabine/tenofovir alafenamide treatment:

• you will be tested for hepatitis B virus infection
• your serum creatinine, estimated creatinine clearance, urine glucose, and urine protein will be monitored as clinically appropriate. In patients with chronic kidney disease, serum phosphorus will also be assessed. These tests will be repeated regularly during treatment.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with bictegravir/emtricitabine/tenofovir alafenamide. There is a pregnancy registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about you and your baby's health. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. bictegravir/emtricitabine/tenofovir alafenamide passes to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with bictegravir/emtricitabine/tenofovir alafenamide:

• the HIV-1 virus may pass to your baby if your baby does not have an HIV-1 infection.
• the HIV-1 virus may become harder to treat if your baby has HIV-1 infection.
• your baby may get side effects from Bictegravir/emtricitabine/tenofovir alafenamide.

Talk with your healthcare provider about the best way to feed your baby.

How should I take bictegravir, emtricitabine, and tenofovir alafenamide?

Take bictegravir, emtricitabine, and tenofovir alafenamide 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 HIV-1 treatment regimen. Do not take it with other HIV-1 medicines.

• Take one Biktarvy tablet once a day, with or without food.
• If you cannot swallow a whole tablet, you can split the tablet in half and swallow each part separately, as long as all parts are swallowed within about 10 minutes.
• Do not change your dose, or stop taking this medicine without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with this medicine.
• If you take antacids or supplements containing iron or calcium, take Biktarvy with food at the same time that you take these antacids or supplements.
• If you take antacids that contain aluminum or magnesium, take bictegravir/emtricitabine/tenofovir alafenamide at least 2 hours before or 6 hours after you take these antacids.
• If you are on dialysis, take your daily dose of bictegravir, emtricitabine, and tenofovir alafenamide following dialysis.
• When your medicine supply starts to run low, get more from your healthcare provider or pharmacy, so you do NOT run out. This is very important because if the medicine is stopped for even a short time, the amount of virus in your blood may increase and the virus may develop resistance to bictegravir/emtricitabine/tenofovir alafenamide and become harder to treat.
• You will need frequent medical tests.
• Do not miss a dose of Biktarvy.

Bictegravir, emtricitabine, tenofovir alafenamide (Biktarvy) dosing information

Adults and children weighing at least 25kg, or virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis

• 1 Biktarvy 50/200/25 tablet once daily.
• May be taken with or without food.

Children weighing at least 14 kg to less than 25 kg

• 1 Biktarvy 30/120/15 tablet once daily.
• May be taken with or without food.

Pregnant individuals who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance

• 1 Biktarvy 50/200/25 tablet once daily.
• May be taken with or without food.

Comments:

For children 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.

What happens if I miss a dose?

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

What happens if I overdose?

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

What other drugs will affect bictegravir/emtricitabine/tenofovir alafenamide?

Sometimes it is not safe to use certain medications at the same time as taking bictegravir/emtricitabine/tenofovir alafenamide. Drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

You should not take bictegravir/emtricitabine/tenofovir alafenamide with

• dofetilide; or
• Rifampin.

It is not recommended to take bictegravir/emtricitabine/tenofovir alafenamide with:

• Rifabutin
• Rifapentine
• St. John's wort.

When taking bictegravir/emtricitabine/tenofovir alafenamide, alternative anticonvulsants should be considered instead of:

• carbamazepine
• oxcarbazepine
• phenobarbital
• phenytoin

If you take antacids or supplements that contain:

• iron or calcium, take bictegravir/emtricitabine/tenofovir alafenamide with food at the same time that you take these antacids or supplements
• aluminum or magnesium, take bictegravir/emtricitabine/tenofovir alafenamide at least 2 hours before or 6 hours after you take these antacids.

Many drugs can interact with bictegravir/emtricitabine/tenofovir alafenamide. This includes prescription, 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. To check for drug interactions with Bictegravir/emtricitabine/tenofovir alafenamide click the link below.

Storage

Store bictegravir/emtricitabine/tenofovir alafenamide tablets in their original bottle below 86 °F (30 °C).

Keep the bottle tightly closed.

This medicine contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.

Biktarvy ingredients

Active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide.

Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Biktarvy is available in 2 strengths:

• Biktarvy 50/200/25 tablets: bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg
• Biktarvy 30/200/25 tablets: bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg.

Manufacturer

Gilead Sciences, Inc.

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