Biktarvy
Biktarvy is a combination antiretroviral that contains bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF). It's a complete antiretroviral therapy (ART) to treat human immunodeficiency virus (HIV) infections in adults and children who weigh at least 30 pounds. Biktarvy isn't used for HIV pre-exposure prophylaxis (PrEP), but it is a first-choice option for people starting HIV treatment. Typically, this medication is taken by mouth once daily. Biktarvy doesn't commonly cause weight gain, but it can cause other side effects, such as nausea, diarrhea, and headache.
What is Biktarvy?
What is Biktarvy used for?
Treatment of HIV infection in adults and children weighing at least 30 lbs, and:
Starting HIV treatment for the first time, or
Have a HIV viral load of less than 50 copies/mL from a previous ART
How Biktarvy works
Biktarvy is a combination of three medications:
Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs). They insert themselves into the genetic material of the virus. As a result, emtricitabine and tenofovir alafenamide prevents HIV from making copies of itself and spreading.
Bictegravir is an integrase strand transfer inhibitor (INSTI). Integrase is an enzyme (protein) that HIV uses to insert its genetic information into your cells. Once inserted, HIV uses your cells to make more copies of itself. Bictegravir works by blocking integrase, which then helps prevent HIV from spreading.
Drug Facts
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What are the side effects of Biktarvy?
Common Side Effects
- Diarrhea (6%)
- Nausea (6%)
- Headache (5%)
Other Side Effects
- Feeling tired
- Abnormal dreams
- Dizziness
- Trouble sleeping
- Swollen belly
- Vomiting
- Passing gas
- Heartburn
- Belly pain
- Rash
- Feeling depressed
Serious Side Effects
- Buildup of lactic acid in the blood (lactic acidosis): feeling more tired and weak, belly pain, muscle pain, breathing problems
- Overactive immune system (immune reconstitution syndrome): headache, pain, fever, tiredness, swollen lymph nodes, night sweats
- Kidney problems: tiredness, confusion, nausea, urinating less than usual, swelling in your legs, joint or bone pain
- Liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
- Infection—fever, chills, cough, or sore throat
- Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Biktarvy
Pros
Only taken once a day
First-choice option for people who've never taken ART
Possible option during pregnancy
Cons
Might not be safe for people with kidney or liver problems
Must take at least 2 hours before or 6 hours after antacids containing magnesium or aluminum
Must store in original bottle
Pharmacist tips for Biktarvy
Take Biktarvy every day to help the medication treat or prevent HIV the best it can. You can use an app on your phone to help you remember.
You can take Biktarvy with or without food. If you have trouble swallowing, split the table in half and take each part separately. Make sure to take the entire dose within 10 minutes.
Make sure to get your routine blood tests done on time before and while you’re taking Biktarvy. This helps your healthcare team make sure the medication is working for you and not causing side effects.
Taking Biktarvy can sometimes put you at risk for kidney problems. It's best to avoid other medications that can raise your risk of kidney damage, such as ibuprofen (Advil) and naproxen (Aleve), while you're taking Biktarvy. Let your healthcare team know what medications you're taking or planning to take, including over-the-counter products and supplements.
If you take iron supplements or calcium carbonate (Tums), make sure to take these medications at the same time as Biktarvy and with food.
Don't take medications that contain aluminum and magnesium, such as aluminum/magnesium/simethicone (Mylanta) at the same time as Biktarvy. Take Biktarvy at least 2 hours before or 6 hours after these antacids.
Speak with your healthcare team before stopping Biktarvy or any of your HIV medications. Stopping your HIV medications too soon can cause the virus to spread and become harder to treat. And if you also have hepatitis B, stopping Biktarvy suddenly can cause your hepatitis B infection to come back or worsen.
If your child is taking Biktarvy and you notice major weight changes in your child, make sure to tell the healthcare team. Your child's Biktarvy dose might need to be changed with changes in weight (for those weighing less than 55 pounds).
Not every pharmacy will have Biktarvy in stock. Make sure to get your refill early to avoid missing a dose. If you're starting this medication for the first time, you might need to fill your prescription at a specialty pharmacy.
Frequently asked questions about Biktarvy
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What are the risks and warnings for Biktarvy?
Biktarvy can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Worsening of hepatitis B infection
Risk factors: Have hepatitis B and HIV | Stopping Biktarvy | Severe liver problems
Before you start Biktarvy, your healthcare team will test you for hepatitis B virus (HBV). If you have HBV, suddenly stopping Biktarvy might make your liver condition worse (also called an HBV flare-up). Don't stop taking Biktarvy without talking with your care team first. Make sure to get your refills on time so that your treatment isn't interrupted. If you need to stop taking Biktarvy, your healthcare team might follow up with you for several months after you stop treatment. Your care team will order blood work to check your liver for an HBV flare-up.
Overactive immune system
Taking Biktarvy can cause changes to your immune system called immune reconstitution syndrome. This medical condition happens when your immune system becomes more active after you start Biktarvy. Your immune system begins to fight off different infections that it was too weak to fight off before you started treatment. In rare cases, your immune system might improve so much with treatment that it starts to attack normal cells in your body (autoimmune). You can develop immune reconstitution syndrome as early as during the first few weeks of taking Biktarvy or many months later. Tell your healthcare team right away if you start having any new symptoms, such as fever, pain, swollen lymph nodes, or night sweats, after you start Biktarvy.
Kidney problems
Risk factors: History of kidney problems | Taking other medications known to harm kidneys
There have been reports of kidney problems in people who took medications containing tenofovir. It's unclear whether those problems were caused by the medication or other factors. To prevent kidney injury, you're recommended to avoid taking Biktarvy with other medications that can also harm the kidneys, like high doses of nonsteroidal anti-inflammatory drugs (NSAIDs). Before starting and during treatment with Biktarvy, your healthcare team will order blood work or urine tests to check on your kidneys. If you already have kidney problems, your healthcare team might ask you to consider another medication for treating HIV. Let your care team know right away if you experience bone or muscle pain, pain in your arms or legs, and general weakness that don't go away. These might be signs of kidney problems.
Liver problems and lactic acidosis
In some rare cases, people who took medications containing NRTIs, such as emtricitabine or tenofovir, have reported liver problems, like fatty liver disease. Some have also experienced buildup of lactic acid in the blood (lactic acidosis). Both conditions can be life-threatening.
Your healthcare team will order blood tests while you take Biktarvy to check for liver problems or lactic acidosis. If you develop these problems, they'll ask you to stop taking Biktarvy. Talk with your healthcare team right away if you experience signs and symptoms of liver damage, such as upper right stomach pain, yellowing of the skin or whites of the eyes, or dark urine. Also, let your care team know if you have symptoms of lactic acidosis, such as feeling weak, muscle pain, and trouble breathing.
Interaction with other medications
Taking certain medications for seizures (e.g., carbamazepine (Tegretol)), bacterial infections (e.g., rifampin (Rifadin)), or herbal supplements (e.g., St. John's wort) can lower the amount of Biktarvy in your body. This can can cause the HIV virus to spread and become harder to treat. Because of the potential for drug interactions with Biktarvy, tell your healthcare team about all the medications you take or plan to take. They can make sure your medications are safe to take together.
Biktarvy dosage forms
Typical dosing for Biktarvy
Adults and children who weigh at least 55 pounds: The typical dose is 1 tablet (50 mg bictegravir / 200 mg emtricitabine / 25 mg tenofovir alafenamide) by mouth once daily.
Children who weigh 30 to 54 pounds: The typical dose is 1 tablet (30 mg bictegravir / 120 mg emtricitabine / 15 mg tenofovir alafenamide) by mouth once daily.
Pregnant people: The typical dose is 1 tablet (50 mg bictegravir / 200 mg emtricitabine / 25 mg tenofovir alafenamide) by mouth once daily.
How much does Biktarvy cost?
Biktarvy contraindications
Taking dofetilide (Tikosyn) or rifampin (Rifadin) at the same time
What are alternatives to Biktarvy?
Treatment of HIV infection in adults and children weighing at least 30 lbs, and:
Starting HIV treatment for the first time, or
Have a HIV viral load of less than 50 copies/mL from a previous ART
People who have never taken HIV ARVs
People who are well controlled on an HIV ARV regimen, have a viral load of less than 50, and want to switch regimens
What is the latest news about Biktarvy?
Biktarvy images
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). Effective interventions.
Centers for Disease Control and Prevention. (2024). PrEP.
ClinicalInfoHIV.gov. (n.d.). Immune reconstitution inflammatory syndrome (IRIS).
ClinicalInfoHIV.gov. (n.d.). Integrase strand transfer inhibitor (INSTI).
ClinicalInfoHIV.gov. (n.d.). Nucleoside reverse transcriptase inhibitor (NRTI).
ClinicalInfoHIV.gov. (2024). Recommendations for use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States.
ClinicalInfoHIV.gov. (2024). What to start: Initial combination antiretroviral regimens for people with HIV.
Eckard, A. R., et al. (2020). Weight gain and integrase inhibitors. Current Opinion in Infectious Diseases.
El Zein, S., et al. (2019). Alopecia after switch to tenofovir alafenamide in 6 African American women. Open Forum Infectious Diseases.
Gilead Sciences, Inc. (2024). Biktarvy- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate tablet [package insert]. DailyMed.
Holt, L. M., et al. (2024). Bictegravir use during pregnancy: A multicenter retrospective analysis evaluating HIV viral suppression and perinatal outcomes. Clinical Infectious Diseases.
International Association of Providers of AIDS Care. (2024). Immune reconstitution inflammatory syndrome (IRIS).
MedlinePlus. (2017). Fatty liver disease.
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