Biktarvy

Generic name: Bictegravir, Emtricitabine, Tenofovir
Dosage form: tablet (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg), (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg)
Drug class: Antiviral combinations

Usage of Biktarvy

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).

Biktarvy side effects

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.

    Before taking Biktarvy

    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.

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    How to use 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.

    Warnings

    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.

    What other drugs will affect Biktarvy

    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.

    Popular FAQ

    Yes, the Gilead Advancing Access Biktary copay card can help eligible patients who need financial assistance with their copays. The copay card is for commercially insured patients only. If you’re eligible, you may be able to pay as little as $0 to $5 for your co-pay. Contact Gilead Sciences at ‍‍1-800-226-2056 M–F, 9am–8pm ET for more information. If you are enrolled in a government prescription drug program (Medicare Part D, Medicaid, or in the "donut hole”) you are not eligible for the Biktary copay card. Gilead may be able to offer additional financial support in these cases.

    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 Biktarvy. 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

    Yes, Dovato (dolutegravir and lamivudine) has been associated with significant weight gain in people living with HIV, although the exact mechanism is not fully understood. Studies have shown that weight gain with dolutegravir can range from 2.4 to 6 kg (5.3 to 13.2 lb) after one year of treatment. 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

    Biktarvy is not an immunosuppressant, it can actually help your immune system because it increases the number of CD4 T-cells in your blood. T-cells are an important part of your immune system because they help your body fight off infections. Biktarvy reduces the amount of HIV in your body which improves your immune system and reduces your risk of developing illnesses linked to HIV infection. 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

    Most commercial and government health insurance plans in the U.S. cover some portion of the cost for Biktary. Typically a person taking Biktarvy pays between $0 and $9 per month. Continue reading

    Yes, the Gilead Advancing Access Biktary copay card can help eligible patients who need financial assistance with their copays. The copay card is for commercially insured patients only. If you’re eligible, you may be able to pay as little as $0 to $5 for your co-pay. Contact Gilead Sciences at ‍‍1-800-226-2056 M–F, 9am–8pm ET for more information. If you are enrolled in a government prescription drug program (Medicare Part D, Medicaid, or in the "donut hole”) you are not eligible for the Biktary copay card. Gilead may be able to offer additional financial support in these cases.

    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 Biktarvy. 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

    Yes, Dovato (dolutegravir and lamivudine) has been associated with significant weight gain in people living with HIV, although the exact mechanism is not fully understood. Studies have shown that weight gain with dolutegravir can range from 2.4 to 6 kg (5.3 to 13.2 lb) after one year of treatment. 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

    Biktarvy is not an immunosuppressant, it can actually help your immune system because it increases the number of CD4 T-cells in your blood. T-cells are an important part of your immune system because they help your body fight off infections. Biktarvy reduces the amount of HIV in your body which improves your immune system and reduces your risk of developing illnesses linked to HIV infection. 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

    Most commercial and government health insurance plans in the U.S. cover some portion of the cost for Biktary. Typically a person taking Biktarvy pays between $0 and $9 per month. Continue reading

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