Key takeaways

Biktarvy is a prescription medication used to treat HIV. Each pill contains bictegravir, emtricitabine, and tenofovir. Common side effects include GI symptoms, headaches, fatigue, and insomnia.
Serious side effects of Biktarvy include lactic acidosis, liver toxicity, kidney problems, and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, though these are rare.
To minimize the risk of side effects, patients are advised to disclose all medical conditions and medications to their healthcare provider, follow dosing instructions carefully, and monitor for adverse reactions.
Biktarvy may interact with certain medications and conditions, and patients should avoid taking it concurrently with antacids that contain aluminum or magnesium without proper timing.

Biktarvy is a brand-name prescription antiviral medication used to treat human immunodeficiency virus (HIV). It combines three different medicines into a single pill, including bictegravir, emtricitabine, and tenofovir. These medications work together to reduce the HIV viral load over time. It’s not a cure for HIV but may help manage the infection and slow the disease progress. It comes in tablet form and is prescribed as a once-daily three-in-one medication.

Biktarvy is a newer drug and has been FDA-approved to treat HIV-1 since 2018. There is limited data on its long-term safety and effectiveness. However, so far, it appears to be safe and well-tolerated. The most common side effects are diarrhea, nausea, and headache. More severe side effects are rare and include lactic acidosis and liver toxicity.

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Common side effects of Biktarvy

The manufacturer lists the following as common side effects:

Diarrhea
Nausea
Headache
Fatigue
Abnormal dreams
Dizziness
Insomnia

The manufacturer also lists the following side effects as occurring in less than 2% of clinical trial subjects:

Vomiting
Gas
Indigestion
Abdominal pain
Rash
Depression

Other possible side effects of Biktarvy are listed on Epocrates. They include:

Elevated bilirubin levels in the blood
Elevated creatine kinase (CK) levels in the blood
Elevated cholesterol levels
Elevated amylase levels
Abnormally low neutrophil levels
Elevated liver enzyme levels
Creatine increase
Loss of bone density
Joint stiffness
Muscle aches
Cough or stuffy nose
Burning or prickling sensations
Peripheral neuropathy
Hyperpigmentation of hands and feet
High triglycerides
Blood in urine
Elevated blood glucose levels
Sugars in urine
Weight gain

Serious side effects of Biktarvy

Serious side effects of Biktarvy are less common but may require immediate medical advice. The manufacturer warns about the following serious reactions:

Worsening of hepatitis symptoms in those with both HIV and hepatitis B (HBV)
Changes in your immune system including a severe condition called
Immune reconstitution syndrome
Autoimmune disorders
Kidney problems including kidney failure and kidney toxicity
Increased levels of lactic acid in the blood (lactic acidosis)
Enlarged liver or liver toxicity
Suicidal thoughts
Severe skin reactions like angioedema (swelling underneath the skin), Stevens-Johnson syndrome (painful blister-like rash accompanied by flu-like symptoms), or toxic epidermal necrolysis (blistering/peeling skin rash).

Other serious side effects listed on Epocrates include:

Pancreatitis
Low white blood cell count

Rash and other skin side effects

Biktarvy may cause a rash in some people. The rash may be mild or severe, and it may go away on its own or require immediate treatment. According to a clinical trial by GILEAD Sciences, the manufacturing company of Biktarvy, less than 2% of participants had experienced a skin rash by week 48 of treatment.

Two rash-like adverse effects of Biktarvy are Steven-Johnson Syndrome and toxic epidermal necrolysis. Both conditions are rare but require immediate medical attention.

Steven-Johnson Syndrome is when the top layer of skin dies and separates from the lower layers, causing painful sores or lesions on the body. It’s often accompanied by flu-like symptoms such as fever, chills, fatigue, and muscle aches.

Toxic epidermal necrolysis is another serious condition in which the top layer of the skin dies and separates from the lower layers, causing large blisters and widespread peeling. It can also lead to extensive scarring, vision loss, and even death.

If you experience a rash while taking Biktarvy, seek medical attention right away.

Biktarvy and weight gain

Although not noted in the FDA-approved labeling, Biktarvy may cause weight gain and changes in body fat. Studies have linked the use of antiretroviral therapy with weight gain. While it’s not clear why this occurs, it may be due to changes in the body’s metabolism or the medications themselves.

Although Biktarvy has been linked to weight gain, it’s important to understand that every person’s experience is different. The side effects listed here are based on clinical studies, but they’re not set in stone. Talk to your doctor if you are concerned about your risk of Biktarvy side effects.

How long do Biktarvy side effects last?

Mild Biktarvy side effects usually go away on their own over time, often within a few months as the body adjusts. However, some side effects may linger longer. These include headache, fatigue, diarrhea, and stomach discomfort.

More severe Biktarvy side effects may require immediate medical attention, including rash, liver toxicity, kidney toxicity, pancreatitis, lactic acidosis, enlarged liver, inflammation of the pancreas (pancreatitis), and new or worsening hepatitis B symptoms in those who are infected with both hepatitis B virus and HIV.

Biktarvy contraindications and warnings

Abuse and dependence

Biktarvy is not known to be addictive. There is no evidence of physical dependence or withdrawal symptoms when the medication is stopped. However, stopping treatment could lead to an increase in HIV levels in your blood. Never stop taking Biktarvy unless recommended to do so by your medical team.

Overdose

The standard adult dosage of Biktarvy is one daily tablet containing 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide. The standard pediatric dosage in children, weighing at least 55 pounds, is one tablet daily containing 30 mg of bictegravir, 120 mg of emtricitabine, and 15 mg of tenofovir alafenamide.

It’s possible to take too much of this medication resulting in an overdose. Symptoms of overdose include:

Weakness or lethargy
Abdominal pain and/or vomiting
Shortness of breath
Rapid heartbeat
Dizziness
Muscle pain

If you think you or someone else has overdosed on Biktarvy, call the poison control center at 1 (800) 222-1222 or get medical attention right away.

Restrictions

As with most medications, Biktarvy may not be safe for everyone. Some medical conditions and medications may prevent you from taking Biktarvy. To avoid serious complications, always check with your doctor before starting or stopping any medication.

Do not take Biktarvy if you’ve had an allergic reaction to any of its ingredients in the past.
Those with renal impairment who have a creatinine clearance of less than 30 should avoid taking Biktarvy.
Biktarvy is not recommended for those with severe liver impairment. If you have a history of liver problems, your doctor may recommend liver function tests before beginning treatment. Tell your doctor if you have any loss of appetite, yellowing of the skin or eyes, or darkening of the urine.
Use caution in patients with hepatitis B. An increase in hepatitis B symptoms has been reported in patients who are coinfected with HIV and hepatitis B. Patients should be closely monitored during treatment, as well as after stopping this medication.
Use caution in those who are obese.
Those with existing psychiatric disorders should seek a doctor’s advice before taking Biktarvy. This medication may increase symptoms of depression and/or thoughts of suicide. Careful monitoring by a healthcare professional is recommended.
Pregnant women should talk to their doctor before taking Biktarvy, as it is unknown if the drug is safe for use during pregnancy. There is limited human data to determine whether Biktarvy affects the developing fetus.
Avoid breastfeeding. Women who have HIV should not breastfeed because of the risk that an HIV-positive woman can pass HIV infection to her baby through breast milk. There is no data to determine whether the medication affects lactation or milk production.

Biktarvy interactions

Drug interactions are possible when taking Biktarvy, according to the prescribing information. Avoid taking:

Antivirals, including cidofovir, may increase the serum levels of both drugs, causing adverse effects.
Antiarrhythmics Biktarvymay increase levels of dofetilide in the body resulting in cardiac complications.
Barbiturates, including phenobarbital, may decrease tenofovir alafenamide levels in the body.
Anticonvulsants including carbamazepine and phenytoin may decrease tenofovir alafenamide levels in the body.
Antimycobacterials including rifampin and rifapentine may decrease tenofovir alafenamide levels in the body.
St. John’s wort may decrease bictegravir and tenofovir alafenamide levels in the body.

How to avoid Biktarvy side effects

As with any medication, there is always a chance for side effects. However, there are some ways you can minimize your risk of adverse reactions.

1. Tell your doctor about all pre-existing medical conditions.

Some medical conditions may prevent you from taking Biktarvy. Make sure to tell your doctor about all pre-existing medical conditions before starting HIV treatment. Those with a history of kidney disease, liver disease, hepatitis B, obesity, and psychiatric disorders should be monitored closely.

2. Tell your doctor about all medications you are taking.

Some medications are contraindicated when taking Biktarvy. Make sure to tell your doctor about all medications you are currently taking, including any prescription drugs, over-the-counter products, and herbal supplements.

3. Take Biktarvy as directed by your healthcare provider.

Your doctor will give you instructions on how to take Biktarvy. It’s usually prescribed once daily and is taken by mouth, with or without food.

To get the most out of treatment, it’s important to take your medication exactly as directed. Read the entire label and follow the drug information given to you by your pharmacist. You should never discontinue the medication without being told to do so by your doctor.

4. Watch for adverse reactions.

Biktarvy may cause adverse reactions in some people. Watch for nausea, vomiting, diarrhea, dizziness, headache, fatigue, rash, and muscle pain. Report any adverse reactions to your doctor immediately.

5. Don’t stop taking Biktarvy without being instructed to do so.

Make sure to take Biktarvy exactly as your healthcare provider tells you. If you are experiencing any adverse reactions, be sure to tell your doctor immediately.

6. Take Biktarvy at the same time each day.

While Biktarvy can be taken at any time of day, you should aim to take it at the same time every day. This will help you avoid missed doses. Missing doses can lead to the HIV virus developing resistance to Biktarvy. Don’t change your dosing schedule without consulting with your healthcare provider first.

7. Get your medication refills on time.

It’s important to take your medication on a set once-daily schedule. Failing to follow your treatment plan may result in an increase in virus levels in your blood. Be sure to set a reminder for prescription refills to avoid running out.

8. Store Biktarvy at room temperature.

Biktarvy should be stored at room temperature in its original container. Keep it away from excessive heat or moisture. Make sure it’s out of reach of children and pets at all times.

9. Tell your doctor if you’re pregnant or plan to become pregnant in the future.

There is limited data to show how safe Biktarvy is when used during pregnancy. It’s important to consult with your doctor before conceiving. They may recommend alternative medications.

10. Report any skin rashes or blisters to your doctor immediately.

Biktarvy may cause skin rashes or blisters in some people. The rash may be mild or severe. Because Biktarvy has been associated with Stevens-Johnson syndrome and toxic epidermal necrolysis, you should inform your doctor immediately if you develop a rash.

11. Avoid taking antacids with Biktarvy unless instructed otherwise.

Some antacids may interact with the way Biktarvy works and make it less effective. You should never take this medication at the same time as antacids. Biktarvy should be taken at least two hours before or six hours after taking antacids that contain aluminum or magnesium. Calcium-containing antacids or supplements containing iron can be taken at the same time as Biktarvy, as long as they are taken with food.