Bictegravir / Emtricitabine / Tenofovir AlafenamideBrand Name: Biktarvy Other Names: BIC / FTC / TAF, bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate Drug Class: Combination Drugs
What are the most important things to know about Biktarvy?
Biktarvy can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ) and severe problems.
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
- Feeling very weak or tired
- Unusual (not normal) muscle pain
- Trouble breathing
- Stomach pain with nausea and vomiting
- Feeling cold, especially in your arms and legs
- Feeling dizzy or lightheaded
- Fast or irregular heartbeat
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Feeling sick to your stomach (nausea)
- Pain, aching, or tenderness in your stomach area
If you have both HIV and(HBV) and take Biktarvy, your HBV infectionmay get worse (flare up) if you stop taking Biktarvy. To help avoid this, take Biktarvy exactly as prescribed. Do not run out of Biktarvy or stop taking Biktarvy without talking to your health care provider.
If you take Biktarvy, you should not take other HIV medicines.
While taking Biktarvy, it is important to keep all of your appointments with your health care provider.
What is Biktarvy?
Biktarvy is a prescription medicine approved by the U.S.(FDA) to treat HIV in adults:
- who have never taken HIV medicines before, or
- to replace the current HIV medicines in the HIV regimen of people who:
- have a (the amount of HIV in a sample of blood) that is less than 50 copies/mL, and
- have been on the same HIV regimen for at least 3 months, and
- have never had (treatment failure is when an HIV regimen is unable to control HIV infection), and
- have no mutations associated with any of the HIV medicines in Biktarvy (drug resistance mutations are changes in the genetic material of HIV that cause the to become insensitive to certain HIV medicines).
Biktarvy contains the following three different medicines combined in one pill:
- Bictegravir – an HIV medicine called an inhibitor
- Emtricitabine – an HIV medicine called a (NRTI)
- Tenofovir alafenamide – another HIV medicine (also an NRTI)
Integrase inhibitors block an HIV
HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV . If you are taking HIV medicines, including Biktarvy, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.
What should I tell my health care provider before taking Biktarvy?
Before taking Biktarvy, tell your health care provider:
- If you are allergic to any of the HIV medicines in Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) or any other medicines.
- If you have or have ever had liver problems, including B virus infection (HBV).
- If you have or have ever had kidney problems.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether Biktarvy can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking Biktarvy when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Biktarvy.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Biktarvy may affect the way other medicines or products work, and other medicines or products may affect how Biktarvy works. Taking Biktarvy together with certain medicines or products may cause serious side effects. Do not take Biktarvy if you take dofetilide or rifampin. Taking Biktarvy with dofetilide or rifampin can cause side effects that may be serious or life threatening or could result in reduced effectiveness of Biktarvy.
How should I take Biktarvy?
Biktarvy comes in tablet form. Each tablet contains:
Take Biktarvy with or without food. If you are taking any other medicines, carefully follow instructions on how to take them with Biktarvy.
If you take too much Biktarvy, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take Biktarvy, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?
If you miss aof Biktarvy, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What side effects can Biktarvy cause?
Biktarvy may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.
Some side effects of Biktarvy can be serious. Serious side effects of Biktarvy include a buildup of lactic acid in the blood (lactic acidosis) and severe liver problems. (See the WARNING box above.)
Other possible side effects of Biktarvy include:
- Changes in your (called or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- New or worsening kidney problems.
These are not all the possible side effects of Biktarvy. To learn more about possible side effects of Biktarvy, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.
How should Biktarvy be stored?
- Store Biktarvy below 86°F (30°C).
- Keep Biktarvy in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
- Do not use Biktarvy if the original seal over the container opening is broken or missing.
- Throw away Biktarvy that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Biktarvy and all medicines out of reach of children.
Where can I find more information about Biktarvy?
More information about Biktarvy is available:
- The Biktarvy drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking Biktarvy.
- Biktarvy-related research studies, from the AIDSinfo database of study summaries.
- A list of FDA-approved HIV medicines, from AIDSinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
The above Patient Version drug summary is based on the following FDA label(s): Tablet.
Last Reviewed: February 8, 2018