Biktarvy dosage, forms, and strengths

Biktarvy is a brand-name prescription drug approved as a complete drug regimen to treat HIV-1 infections in adults and children. Human immunodeficiency virus (HIV) is the virus that causes HIV/AIDS. It attacks the body’s immune system, making people vulnerable to serious infections and cancers. HIV/AIDS treatment always consists of three drugs from two drug classes. Biktarvy is a complete three-drug regimen with emtricitabine (also called FTC), tenofovir alafenamide (TAF), and bictegravir sodium (BIC). This drug combination is considered by the International Antiretroviral Society to be one of two three-drug combinations that should be used as a first-line HIV treatment.

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Biktarvy forms and strengths

Biktarvy is taken only in tablet form, but Biktarvy tablets come in two dosage strengths. The stronger tablet is for adults and children weighing 25 kg (55 lbs) or more. The lower dose tablet is given to children weighing between 14 kg and 25 kg (30 to 55 lbs). 

• Tablets: 50 mg of bictegravir, 200 mg of emtricitabine, 25 mg of tenofovir alafenamide; 30/120/15 mg bictegravir/emtricitabine/tenofovir alafenamide

Biktarvy dosage for adults

Biktarvy is FDA approved as a complete, first-line antiretroviral therapy (ART) for HIV-1 infections. Biktarvy can also be used to replace any current HIV-1 three-drug regimen if the virus is suppressed on another drug regimen and there is no history of treatment failure or drug resistance. People prescribed Biktarvy will take one tablet a day. It’s not necessary to take other HIV antiviral drugs with Biktarvy.

Source: Epocrates

Biktarvy dosage for HIV-1 infection

Biktarvy is FDA approved as a first-line complete drug regimen to treat HIV-1 infections, the virus that causes AIDS. 

Emtricitabine and tenofovir prevent HIV from making a DNA copy of itself. Emtricitabine and tenofovir are called nucleoside reverse transcriptase inhibitors, or NRTIs. 

All HIV infections are treated by a drug protocol called antiretroviral therapy, or ART. This protocol recommends that at least two NRTIs daily are combined with at least one other antiretroviral drug that targets some other part of the virus’s life cycle. Bictegravir is an integrase strand transfer inhibitor, which is the third drug in the daily antiretroviral protocol. 

These three drugs work together to stop HIV from reproducing, reducing the amount of virus in the body (the “viral load”) and allowing the immune system to either recover or stay healthy.

• Standard dosage for HIV-1 infection: One 50/200/25 mg tablet taken once per day

• Maximum dosage for HIV-1 infection: One 50/200/25 mg tablet daily

Biktarvy dosage for children

The U.S. Food and Drug Administration has approved Biktarvy as a first-line drug regimen to treat HIV-1 infections in children weighing 14 kg (30 lbs) or more. It can also be prescribed as a replacement antiretroviral treatment if the virus is suppressed on other HIV medications and there is no history of treatment failure or drug resistance to emtricitabine, tenofovir, or bictegravir. 

• Standard dosage for HIV-1 infection in children weighing 25 kg or more: One 50/200/25 mg tablet taken once per day

• Maximum dosage for HIV-1 infection in children weighing 25 kg or more: One 50/200/25 mg tablet daily

• Standard dosage for HIV-1 infection in children weighing 14–24 kg: One 30/120/15 mg tablet taken per day

• Maximum dosage for HIV-1 infection in children weighing 14–24 kg: One 30/120/15 mg tablet daily

 Source: Epocrates

Biktarvy dosage restrictions

Because Biktarvy is a fixed-dose, three-drug tablet, dosage adjustments are not possible for people with liver problems or kidney problems. 

Biktarvy should not be taken by people who are allergic to any part of the medication. Healthcare providers are advised to avoid using Biktarvy in people with severe hepatic impairment (Child-Pugh class C). Biktarvy should not be used in people with severe renal impairment who are not on hemodialysis, or by those who are on hemodialysis but are just starting antiretroviral treatment. 

For people who also have hepatitis B infection, the condition may worsen if Biktarvy is stopped. Healthcare providers may also monitor people more closely if they have kidney disease, liver disease, excess weight, or are taking other medications that may affect the kidneys. People with a history of depression or other psychiatric conditions should also be monitored for any changes in symptoms or thoughts of suicide.

How to take Biktarvy

For Biktarvy to successfully fight an HIV infection, make sure to take each tablet daily without skipping or missing doses. Missing doses may make the HIV infection harder to treat. Biktarvy can be taken with a meal or on an empty stomach.

• The prescribing healthcare professional will tell you how much medicine to use. Do not use more than directed.

• Biktarvy is taken by itself without other HIV medications.

• If a child is unable to swallow the tablet, it may be split into two or more parts. Each part must be swallowed within 10 minutes of dividing the tablet.

• Antacids will affect Biktarvy’s effectiveness. For antacids containing aluminum or magnesium, Biktarvy must be taken two hours before or six hours after taking the antacid. For antacids containing calcium or iron, only take Biktarvy with a meal at the same time the antacids are taken.

• People on dialysis should take Biktarvy tablets after dialysis treatment.

• Contact a doctor or pharmacist when Biktarvy is running low to avoid running out.

• Store Biktarvy tablets in the original bottle at room temperature (below 86°F).

• Store Biktarvy tablets in the original blister pack at room temperature (68°F to 77°F).

Biktarvy dosage FAQs

How long does it take Biktarvy to work?

Based on clinical trials, over 70% of people taking Biktarvy as an initial treatment for HIV infection will achieve the optimal reduction of HIV in the body after four weeks of treatment. Maximum viral load reduction should be experienced three months after treatment starts, after which a small number of patients will see the virus start to recover its numbers. Still, clinical trials have shown that over 80% of people taking Biktarvy still maintain optimal viral levels after almost three years of daily treatment. 

What happens if I miss a dose of Biktarvy?

A missed dose should be taken as soon as it’s remembered. However, if it’s almost time for the next dose, take the next dose as scheduled. Do not take two doses to make up for a missed dose.

For HIV treatment to be successful, 95% of the doses must be taken on time. Missed doses allow the virus to grow back. This increases the risk that the virus will develop resistance to the drugs being taken. Try using an alarm, smartphone app, or enlisting the help of a friend to keep from missing doses. A pharmacist or healthcare provider will also have solutions if missing doses is a problem.

How long can you take Biktarvy?

Biktarvy is intended as a long-term treatment. In clinical trials lasting almost as long as two years (192 weeks), viral suppression was successful in over 99% of patients. If the virus develops drug resistance or side effects become too severe, people will be switched to another three-drug regimen.

How do I stop taking Biktarvy?

Do not stop taking Biktarvy except as directed by a healthcare professional. Stopping antiretroviral therapy will allow the virus to recover and the infection to worsen. There are no withdrawal symptoms when stopping Biktarvy, but people who also have hepatitis B may experience a worsening of the condition. 

For anyone who needs to stop taking Biktarvy, there are alternatives. The recommended HIV/AIDS drug regimen includes two NRTIs like emtricitabine or tenofovir alafenamide. If one or both of these drugs is a problem, a healthcare provider can turn to other NRTI alternatives such as zidovudine, lamivudine, abacavir, and tenofovir disoproxil fumarate. There are also other integrase inhibitors if bictegravir causes problems. Some other types of drugs can also be combined with NRTIs. 

What interacts with Biktarvy?

Although all three drugs in Biktarvy target unique processes in the HIV life cycle, drug interactions can still reduce its effectiveness or increase the risk of side effects. 

First, because both tenofovir and emtricitabine are eliminated through the kidneys, it’s not a good idea to take drugs that are toxic to the kidneys such as non-steroidal anti-inflammatory drugs (NSAIDs), aminoglycoside antibiotics, platinum-based anticancer drugs, and some antiviral medications.

Healthcare providers will be careful about drugs that either block or speed up the liver enzymes (CYP3A, P-gp, and UGT1A1) that break down either bictegravir or tenofovir. If Biktarvy is taken with drugs that block these enzymes, the body won’t clear the drug and more side effects will be experienced. 

More concerning though, are drugs that speed up these enzymes. If this happens, the body rapidly eliminates either bictegravir or tenofovir from the body, reducing the drug’s effectiveness in stopping HIV. Many of these drugs are contraindicated such as phenobarbital, carbamazepine, phenytoin, rifampin, and St. John’s wort, an over-the-counter dietary supplement. Though not prohibited, healthcare providers may modify some drug treatments that only moderately speed up the metabolism of Biktarvy such as rifabutin and oxcarbazepine.

Finally, bictegravir blocks the metabolism of some other drugs, increasing the problems caused by those drugs. Some of these are common prescription drugs, like metformin. Dofetilide, a drug used to treat abnormal heartbeats, can never be taken with Biktarvy for this reason.

Is it safe to take Biktarvy during pregnancy?

Pregnant women or women planning to become pregnant must be immediately started on antiretroviral treatment to prevent transmission of the virus to the unborn baby. As a first-line treatment, Biktarvy is used to treat pregnant women. The risks and benefits of Biktarvy during pregnancy should be discussed with a healthcare professional.

The Centers for Disease Control (CDC) recommend that women who are infected with HIV never breastfeed an infant regardless of treatment or viral load. It is not known if any of the active ingredients in Biktarvy are present in human breast milk or if they harm the infant, but HIV is present in breast milk and will harm the baby if it’s transmitted.

Related resources for Biktarvy dosages:

• Biktarvy, Epocrates

• Biktarvy HCP, Gilead Sciences, Inc.

• Biktaryy prescribing information, U.S. National Library of Medicine

• Human immunodeficiency virus; Breastfeeding, Centers for Disease Control (CDC)

• HIV antiretroviral therapy, StatPearls

• Reverse transcriptase inhibitors, StatPearls