What is Biktarvy?

 

Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) is a once-daily antiretroviral treatment that is FDA-approved to treat human immunodeficiency virus-1 (HIV-1 infection). Biktarvy can be used to treat adults and adolescents where the virus has not developed a resistance to HIV medications. Biktarvy is manufactured by Gilead Sciences Inc.

How does Biktarvy work?

Biktarvy combines three different antiviral medications into one pill. Emtricitabine and tenofovir alafenamide, which are also known as NRTIs or nucleoside reverse transcriptase inhibitors, insert themselves into the HIV’s DNA and block an enzyme that helps stop the DNA-making process. Bictegravir sodium, which is an integrase strand transfer inhibitor or INSTI, prevents the virus from inserting itself in your DNA.

Biktarvy does not cure HIV, but reduces the level of “viral load” in the body to protect against further damage to your immune system and stops HIV from being passed on to a partner.

What doses of Biktarvy are available?

Biktarvy comes in a dosage containing 25mg of TAF (tenofovir alafenamide fumarate), 50mg of BIC (bictegravir), and 200mg of FTC (emtricitabine). It is a brown tablet with “GSI 9883” printed on one side. Be sure you consult your healthcare provider, as the prescribed dosage may change depending on your weight.

How do you use Biktarvy?

Biktarvy is an oral tablet and should be taken once daily, with or without food. Like other HIV treatments, take Biktarvy at the same time each day. Avoid missing doses but do not take a double dose if you have missed a day. Biktarvy is a complete regimen in the treatment of HIV and should not be taken with other HIV medications.

What are the side effects of Biktarvy?

The most common possible side effects of Biktarvy in clinical trials include:

• Headache

• Nausea

• Diarrhea

• Fatigue

• Dizziness

• Insomnia

• Mild stomach pain

• Bloating

• Abnormal dreams

• Mild allergic reaction

Rarely, Biktarvy may cause some serious side effects, including:

• Symptoms of liver damage, including

  • Mild to severe abdominal pain

  • Loss of appetite

  • Dark urine

  • Jaundice (yellowing skin or whites of eyes)

• Symptoms of lactic acidosis (increased lactic acid), including:

  • Muscle pain

  • Fatigue

  • Increased heart rate

• Symptoms of kidney problems or kidney failure, including:

  • Nausea or vomiting

  • Problems with urination

  • Swelling in ankles or feet

  • Confusion

• Worsening symptoms of hepatitis B virus (HBV infection) after stopping Biktarvy treatment

• Severe allergic reactions

• Depression

• Immune reconstitution syndrome (IRIS)

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Biktarvy. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Biktarvy drug interactions

The use of Biktarvy with other prescription drugs, over-the-counter medications, vitamins, and supplements, may change how they work or increase the frequency or severity of side effects. Some drug interactions with Biktarvy include:

• Carbamazepine

• Oxcarbazepine

• Phenobarbital

• Phenytoin

• Dofetilide

• Rifampin

• Rifabutin

• Rifapentine

• St. John’s wort

• Supplements, vitamins, or antacids containing calcium or magnesium

Boxed warnings

WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

See full prescribing information for the complete boxed warning. Severe acute worsening hepatitis B has been reported in patients who have both HIV-1 and HBV that have stopped taking products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF). This may occur with the discontinuation of Biktarvy. Your liver function should be closely monitored and if appropriate, anti-hepatitis B therapy may be needed.

Biktarvy precautions

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Allergies to bictegravir, emtricitabine, or tenofovir alafenamide

• Previous liver problems, including:

  • Hepatitis B

  • Hepatitis C

  • Cirrhosis

• Previous or current alcohol use

• Kidney disease

• Are pregnant or trying to become pregnant

• Are breastfeeding or plan to breastfeed (Based on some clinical studies, Biktarvy may affect breastmilk)

• Have had HIV RNA testing completed before starting Biktarvy

• Are taking vitamins or supplements that could reduce the concentration of Biktarvy

• Are already taking medication for the treatment of HIV (Biktarvy substitution)

Is there a generic available for Biktarvy?

Currently, there is no generic available for Biktarvy in the United States.

How do you store Biktarvy?

Be sure to store Biktarvy in its original blister pack at room temperature (around 25° C (77° F)). The brown tablet has “GSI 9883” printed on one side. Keep medication out of reach of pets and children.

Related medications

• Ziagen (abacavir)

• Truvada (emtricitabine/tenofovir disoproxil fumarate)

• Reyataz (atazanavir)

• Descovy (emtricitabine/tenofovir alafenamide fumarate)

• Epzicom (abacavir/lamivudine)

• Triumeq (abacavir/lamivudine/dolutegravir)

• Trizivir (abacavir/lamivudine/zidovudine)

• Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide)

Sources

Medical News Today https://www.medicalnewstoday.com/articles/drugs-biktarvy#side-effects

Aids Map https://www.aidsmap.com/about-hiv/arv-factsheet/biktarvy

Manufacturer https://www.biktarvy.com/

Healthline https://www.healthline.com/health/drugs/biktarvy-side-effects#more-common-side-effects