Biktarvy is a complete HIV-1 treatment in a once-a-day single tablet containing three antiviral medicines bictegravir, emtricitabine, and tenofovir.  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. Biktarvy is not a cure for HIV.

Human immunodeficiency virus type 1 (HIV-1) is the virus that causes acquired immune deficiency syndrome (AIDS).

Who can take Biktarvy?

Biktarvy is an FDA-approved medicine used as a complete regimen for treatment of HIV-1 infection in adults and pediatric patients who weigh at least 14 kg. Bikarvy 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 
• no known substitutions associated with resistance to the individual components of BIiktarvy (bictegravir, emtricitabine, and tenofovir)

Worsening of hepatitis B virus (HBV) infection. 

Your healthcare provider will test you for HBV infection before or when you start treatment with this medicine. If you have HBV infection and take Biktarvy, your HBV may get worse (called a flare-up) if you stop taking Biktarvy. A "flare-up" is when your HBV infection suddenly returns worse than before.

Do not run out of Biktarvy. You should refill your prescription or talk to your healthcare provider before your Biktarvy is all gone.

Do not stop taking this medicine without first talking to your healthcare provider.

If you stop taking this medicine, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver and may need to 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 this medicine.

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 HIV-1 treatment regimen. You should not take it with other HIV-1 medicines.

• Take one Biktarvy tablet once a day, with or without food.
• If you are unable to 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.
• You should 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 that contain 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 Biktarvy at least 2 hours before or 6 hours after you take these antacids.
• If you are on dialysis, take your daily dose of Biktarvy 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 Biktarvy and become harder to treat.
• You will need frequent medical tests.
• Do not miss a dose of Biktarvy.

Usual dose for HIV infection in adults and pediatric patients weighing at least 25 kg:

• Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.

Usual dose for HIV infection in pediatric patients weighing at least 14 kg to less than 25 kg:

• Biktarvy (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg) one tablet once a day, with or without food.

Comments:

For children who are at least 14 to less than 25 kg, and 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.

You should not use Biktarvy if you are allergic to antiviral medicines bictegravir, emtricitabine, or tenofovir contained in medicines such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada.

Some medicines can cause unwanted or dangerous effects when used with Biktarvy, and your doctor may need to change your treatment plan. Do not take Biktarvy if you also take a medicine that contains: 

• dofetilide; or
• rifampin.

Tell your doctor if you have or ever had:

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

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with Biktarvy. It is not known if Biktarvy can harm your unborn baby. There is a pregnancy registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

You should NOT breastfeed if you take Biktarvy.

• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
• At least one of the medicines in Bikatrvy can pass to your baby in your breast milk. It is not known if the other medicines in Biktarvy can pass into your breast milk.

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

Take 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.

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

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

Serious Biktarvy side effects include:

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 to fight infections that have been 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.

The most common Biktarvy side effects include:

• diarrhea
• nausea
• headache.

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 FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time as taking Biktarvy. 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 Biktarvy with

• dofetilide; or
• Rifampin.

It is not recommended to take Biktarvy with:

• Rifabutin
• Rifapentine
• St. John's wort

When taking Biktarvy, alternative anticonvulsants should be considered instead of:

• carbamazepine
• oxcarbazepine
• phenobarbital
• phenytoin

Many drugs can interact with Biktarvy. 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 Biktarvy click the link below.