Biktarvy (Bictegravir, Emtricitabine, and Tenofovir alafenamide ...

What Is Biktarvy?

Biktarvy is an oral prescription medication used to treat human immunodeficiency virus (HIV) in adults and children weighing at least 31 pounds. Biktarvy contains three HIV-fighting medicines: bictegravir, emtricitabine, and tenofovir alafenamide.

Bictegravir belongs to a group of drugs called integrase inhibitors. Emtricitabine and tenofovir alafenamide are nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). Working together, these drugs prevent the virus that causes HIV from replicating (growing).

The FDA has issued boxed warnings for Biktarvy. Talk with your healthcare provider about these risks before starting treatment.

Drug Facts

Generic Name: Bictegravir, emtricitabine, and tenofovir alafenamide

Brand Name(s): Biktarvy

Drug Availability: Prescription

Therapeutic Classification: Integrase inhibitor; nucleoside and nucleotide reverse transcriptase inhibitor

Available Generically: No

Controlled Substance: No

Administration Route: Oral

Active Ingredient: Bictegravir, emtricitabine, and tenofovir alafenamide

Dosage Form(s): Oral tablet

What Is Biktarvy Used For?

Biktarvy treats HIV in adults and children weighing at least 31 pounds.

HIV affects approximately 1.2 million people in the United States. HIV is caused by a virus attacking the body's immune system, targeting the cells that help fight disease and infection. Most people get HIV through sex (anal but also vaginal) or sharing needles. If left untreated, HIV can progress to AIDS (acquired immunodeficiency syndrome), leading to severe and potentially deadly infections.

The only way to know if you have HIV is to get tested. Some people develop flu-like symptoms two to four weeks after becoming infected, while others may not have any symptoms, so testing is essential. While there is no cure for HIV, effective treatment has allowed people with HIV to live long, healthy lives and protect their sexual partners.

How to Take Biktarvy

Biktarvy should be taken once daily, with or without food. Do not stop taking Biktarvy without talking to your healthcare provider first.

Take your daily dose of Biktarvy after dialysis if you are on dialysis.

Certain supplements and antacids can affect how your body absorbs Biktarvy:

If you take supplements or antacids containing aluminum or magnesium, take Biktarvy at least two to six hours before.
If you take supplements or antacids containing iron or calcium, take Biktarvy with food simultaneously as your supplement or antacid.

Storage

Your Biktarvy prescription may come in a bottle or a blister pack. Store the bottle below 86 degrees F and keep the cap tightly closed. Store the blister pack at room temperature. Keep Biktarvy and all your medicines in a safe location, out of the reach of children and pets.

How Long Does Biktarvy Take to Work?

Biktarvy lowers the amount of virus in your blood (viral load) over time. Most people can achieve an undetectable viral load (no measurable amount of virus in their blood) within six months. Your healthcare provider will likely monitor your viral load with a blood test two to four weeks after starting Biktarvy and regularly thereafter to ensure your treatment is working.

What are the Side Effects of Biktarvy?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects while taking Biktarvy. Let your healthcare provider know if you develop any side effects that bother you or don't go away.

Common side effects include:

Diarrhea
Nausea
Headache

Severe Side Effects

Biktarvy may cause severe and sometimes life-threatening side effects. Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

Worsening of hepatitis B virus (HBV) infection: If you have HBV, Biktarvy may cause your infection to get worse if you stop taking it. Your healthcare provider will test you for HBV before or during treatment with Biktarvy. Do not stop taking Biktarvy without talking to your healthcare provider first.
Immune reconstitution syndrome (a condition involving changes to your immune system that can occur after you start taking HIV medicines): After starting Biktarvy, your immune system may get stronger and begin fighting infections hidden in your body. Let your healthcare provider know if you develop any new symptoms, including inflammation or signs of an infection, after starting Biktarvy.
New or worsening kidney problems, including kidney failure: Your healthcare provider will monitor your kidney function with urine and blood tests before starting and during treatment with Biktarvy.
Lactic acidosis (a severe and sometimes deadly condition that causes lactic acid to build up in your blood): Let your healthcare provider know if you have weakness, unusual muscle pain, shortness of breath, fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, dizziness, light-headedness, fast or abnormal heartbeat, or you are more tired than usual.

Severe liver problems, which can rarely be deadly. Signs of liver problems include yellowing of your skin or the white parts of your eyes, dark "tea-colored" urine, light-colored stools, loss of appetite, nausea, or stomach-area pain.

Report Side Effects

Biktarvy may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Biktarvy Should I Take?

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For treatment of HIV infection:
  - Adults and children weighing 25 kilograms (kg) or more—One tablet once a day. Each tablet contains 50 milligrams (mg) bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
  - Children 14 kg to less than 25 kg—One tablet once a day. Each tablet contains 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide.
  - Children weighing less than 14 kg—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Biktarvy:

Severe allergic reaction: Avoid using Biktarvy if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In animal studies, Biktarvy was not found to have harmful effects on the fetus. Not enough is known about the safety and effectiveness of Biktarvy in pregnant humans and their fetuses. Still, all pregnant people who are HIV-positive should receive treatment with HIV medicines to prevent transmitting the virus to their babies.

Treatment guidelines state that there is not enough evidence to recommend using Biktarvy and that other medication regimens may be preferred. Let your healthcare provider know if you're pregnant or plan to become pregnant, and discuss the benefits and risks of taking Biktarvy during your pregnancy.

Breastfeeding: The Centers for Disease Control and Prevention (CDC) recommends that people who are HIV-positive not breastfeed their babies since HIV can be transmitted through breast milk. Talk with your healthcare provider and pediatrician about the best way to feed your baby.

Adults over 65: Clinical trials did not show any difference in the safety or effectiveness of using Biktarvy in adults over 65 compared to younger adults. Some older adults may be more sensitive to Biktarvy's side effects.

Children: The FDA has not approved Biktarvy to treat children with HIV who weigh less than 31 pounds.

Kidney and liver problems: Individuals with kidney or liver problems may not be able to clear medication from their bodies as easily. This means the medicine stays in the body longer and can have increased side effects. For this reason, if you have severe liver impairment, severe kidney impairment, or kidney failure and are not receiving dialysis, your healthcare provider will likely not prescribe Biktarvy.

Administration modifications: The Biktarvy tablet may be split into smaller parts if you have trouble swallowing the tablet whole. Each part may be taken separately, but you must swallow all parts within 10 minutes.

Missed Dose

If you accidentally forget your Biktarvy dose, take it as soon as you remember. If it's already close to your next scheduled dose, skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

When your Biktarvy prescription runs low, obtain a refill from your pharmacy. Don't wait until you're completely out. Going without your Biktarvy, even briefly, can increase the HIV in your blood and make your infection harder to treat.

Try to find ways to help yourself remember to keep your appointments and take your medication routinely.

Overdose: What Happens If I Take Too Much Biktarvy?

There is limited information available about the effects of a Biktarvy overdose.

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Biktarvy?

If you think you or someone else may have overdosed on Biktarvy, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Biktarvy, call 911 immediately.

Precautions

It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine together with dofetilide (Tikosyn®) or rifampin (Rifadin®, Rimactane®). Using these medicines together may cause serious or life-threatening side effects.

This medicine may cause a hepatitis B infection to worsen if you stop using it. Your doctor may check for the presence of hepatitis B before and during treatment with this medicine and for at least several months after your last dose.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, including pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn't Take Biktarvy?

Do not take Biktarvy if you take any of the following medications:

Tikosyn (dofetilide): Biktarvy can cause dofetilide levels to become dangerously high and may result in severe and life-threatening reactions.
Rifadin or Rimactane (rifampin): Rifampin can cause levels of Biktarvy to become too low and be less effective at treating your HIV infection. It can also cause your HIV infection to become resistant to Biktarvy, making it harder to treat.

What Other Medications Interact With Biktarvy?

Do not take Biktarvy with the following medications:

Rifadin or Rimactane (rifampin)
Tikosyn (dofetilide)

Use caution when taking Biktarvy with the following medications:

Other medicines for HIV
Aptivus (tipranavir)
Carafate (sucralfate)
Dilantin (phenytoin)
Erleada (apalutamide)
Glumetza (metformin)
Hepsera (adefovir)
Lorbrena (lorlatinib)
Mavenclad (cladribine)
Mycobutin (rifabutin)
Mysoline (primidone)
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil (ibuprofen) or Aleve (naproxen)
Phenobarbital
Priftin (rifapentine)
Saint-John's-wort
Supplements or antacids containing calcium, iron, aluminum, or magnesium
Tegretol (carbamazepine)
Trileptal (oxcarbazepine)
Valcyte (valganciclovir)
Valtrex (valacyclovir)
Zovirax (acyclovir)

Other medications may interact with Biktarvy. Be sure to inform your healthcare provider and pharmacist about all your medicines, including over-the-counter, nonprescription products, vitamins, and herbal supplements.

What Medications Are Similar?

Biktarvy contains three HIV medicines in one tablet. Another HIV combination pill that contains three similarly acting medications is Triumeq (dolutegravir, abacavir, and lamivudine).

Deciding on treatment will depend on several factors, including potential side effects, whether you are pregnant or plan to become pregnant, dosing frequency, drug interactions, other medical conditions, and cost. You and your healthcare provider will work together to determine your best treatment.

Frequently Asked Questions

Biktarvy treats HIV in adults and children weighing at least 31 pounds.
Biktarvy contains three HIV medicines in one pill that work together to prevent the HIV virus from replicating. Unlike other HIV medicines, Biktarvy is a complete HIV treatment regimen and does not need to be taken with other HIV medications.
Biktarvy works by lowering the amount of HIV in your blood (viral load). Most people will achieve undetectable viral levels within six months.
The most common side effects include diarrhea, nausea, and headache.

How Can I Stay Healthy While Taking Biktarvy?

Living with HIV can have challenges, but proper medical care can help keep the virus at bay. By receiving effective treatment, many people with HIV can live long, healthy lives and protect their sexual partners. Refer below for some general tips to support your health:

Take HIV-related medications as recommended by your healthcare provider.
Follow-up with all appointments and tests. Blood and urine tests will help your healthcare provider monitor for side effects and confirm that Biktarvy is working to treat your HIV.
Be sure to refill Biktarvy when your supply begins to run low. Do not wait until you're completely out. Going without HIV treatments—even briefly—can increase your viral load and make your infection harder to treat.
When you first start treatment for HIV, it's essential to protect your sexual partners. You can do this by using condoms, encouraging your HIV-negative partner to take PrEP (pre-exposure prophylaxis), or abstaining from sex for at least the first six months until your healthcare provider confirms your viral load is low enough to prevent transmission.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

Adblock test (Why?)

Signs of STD