Biktarvy: Uses, Side Effects, Warnings, Precautions, and Patient Information

What Is Biktarvy?

Biktarvy is a prescription antiviral medication used for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection in adults and certain pediatric patients. It is a complete once-daily HIV treatment regimen that combines three antiretroviral medicines in a single tablet to help control HIV infection.

Biktarvy contains bictegravir, emtricitabine, and tenofovir alafenamide (TAF). These medicines work together to reduce the amount of HIV in the body (viral load), improve immune function, and lower the risk of HIV-related complications. While Biktarvy effectively controls HIV infection, it does not cure HIV or AIDS. Patients should continue regular medical care and take the medication exactly as prescribed.

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Drug Information

• Generic Name: Bictegravir / Emtricitabine / Tenofovir Alafenamide
• Brand Name (USA): Biktarvy
• Common Brand Names (International): Biktarvy
• Drug Class: Combination Antiretroviral (Integrase Strand Transfer Inhibitor + Nucleoside Reverse Transcriptase Inhibitors)
• Prescription Required: Yes
• Controlled Substance: No
• Dosage Form: Film-coated Tablet
• Route of Administration: Oral
• Manufacturer: Gilead Sciences
• FDA Approval: 2018

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Active Ingredients

Each tablet contains:

• Bictegravir – 50 mg
• Emtricitabine – 200 mg
• Tenofovir Alafenamide (TAF) – 25 mg

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Available Strengths

Film-Coated Tablets (Adults and Older Pediatric Patients)

• Bictegravir 50 mg / Emtricitabine 200 mg / Tenofovir Alafenamide 25 mg

Low-Strength Tablets (Certain Pediatric Patients)

• Bictegravir 30 mg / Emtricitabine 120 mg / Tenofovir Alafenamide 15 mg

Availability of pediatric formulations may vary by country.

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Brand Names

United States

• Biktarvy

International

• Biktarvy

Biktarvy is marketed globally under the same brand name in most countries.

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Uses of Biktarvy

Biktarvy is prescribed for:

HIV-1 Infection

• Treatment of HIV-1 infection in adults.
• Treatment of HIV-1 infection in eligible pediatric patients who meet approved age and weight requirements.
• Replacement therapy for certain patients who are already virologically suppressed on another stable HIV treatment regimen, as determined by a healthcare provider.

Biktarvy is intended for long-term management of HIV infection and should be taken every day as prescribed.

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How Biktarvy Works

Biktarvy combines three antiretroviral medicines with different mechanisms of action:

• Bictegravir blocks the HIV integrase enzyme, preventing the virus from integrating its genetic material into human cells.
• Emtricitabine inhibits HIV reverse transcriptase, reducing viral replication.
• Tenofovir Alafenamide (TAF) also inhibits reverse transcriptase and helps prevent the virus from multiplying.

Together, these medications significantly reduce viral replication, allowing the immune system to recover and function more effectively.

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General Dosage

The appropriate dose depends on:

• Age
• Body weight
• Kidney function
• Liver function
• Previous HIV treatment history
• Other medications being taken

Biktarvy should be taken exactly as prescribed. Missing doses may increase the risk of treatment failure and the development of drug-resistant HIV.

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How to Take Biktarvy

• Take exactly as prescribed by your healthcare provider.
• Usually taken once daily.
• May be taken with or without food.
• Swallow the tablet whole with water.
• Take the medication at approximately the same time each day.
• If taking antacids or supplements containing aluminum, magnesium, calcium, or iron, follow your healthcare provider's instructions regarding timing because these products can affect absorption.
• Do not stop taking Biktarvy without consulting your healthcare provider.

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Common Side Effects

Common side effects may include:

• Diarrhea
• Nausea
• Headache
• Fatigue
• Dizziness
• Insomnia
• Abnormal dreams
• Stomach discomfort

Most side effects are mild and improve as treatment continues.

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Serious Side Effects

Seek immediate medical attention if you experience:

• Severe allergic reaction
• Difficulty breathing
• Swelling of the face, lips, tongue, or throat
• Signs of liver problems (yellow skin or eyes, dark urine, severe abdominal pain)
• Kidney problems
• Lactic acidosis (persistent weakness, muscle pain, trouble breathing, stomach pain)
• New or worsening hepatitis B symptoms after stopping treatment
• Severe skin reactions

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Boxed Warning

Severe Acute Exacerbation of Hepatitis B

Biktarvy contains emtricitabine and tenofovir alafenamide, which are also active against hepatitis B virus (HBV). Patients with HIV and HBV coinfection who discontinue Biktarvy may experience severe acute worsening of hepatitis B. Liver function should be monitored closely if treatment is stopped.

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Warnings and Precautions

Tell your healthcare provider before taking Biktarvy if you have:

• Hepatitis B infection
• Hepatitis C infection
• Kidney disease
• Liver disease
• Bone disorders
• Osteoporosis
• Pregnancy or plans to become pregnant
• Any history of allergic reactions to HIV medications

Regular blood tests may be required to monitor kidney function, liver function, and viral response during treatment.

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Contraindications

Do not take Biktarvy if you:

• Are allergic to bictegravir, emtricitabine, tenofovir alafenamide, or any ingredient in the medication.
• Are taking dofetilide.
• Are taking rifampin, as it can significantly reduce the effectiveness of Biktarvy.

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Drug Interactions

Biktarvy may interact with:

• Rifampin
• Rifabutin
• Rifapentine
• Dofetilide
• Carbamazepine
• Oxcarbazepine
• Phenytoin
• Phenobarbital
• St. John's Wort
• Metformin
• Certain anticonvulsants
• Calcium supplements
• Iron supplements
• Magnesium-containing antacids
• Aluminum-containing antacids

Always inform your healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you are taking.

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Food and Alcohol

Biktarvy may be taken with or without food.

There is no known direct interaction with alcohol, but excessive alcohol consumption may increase the risk of liver damage and reduce adherence to HIV treatment.

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Pregnancy

Biktarvy should be used during pregnancy only under the guidance of a healthcare provider. HIV treatment during pregnancy is important to reduce the risk of transmitting HIV to the baby. Your healthcare provider will determine the most appropriate treatment plan.

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Breastfeeding

In the United States, individuals with HIV are generally advised not to breastfeed, as HIV can be transmitted through breast milk, even when viral levels are well controlled. Follow your healthcare provider's recommendations.

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Missed Dose

If you miss a dose:

• Take it as soon as you remember.
• If it is almost time for your next scheduled dose, skip the missed dose.
• Do not take two doses at the same time.
• Try to avoid missed doses, as consistent daily treatment is important for maintaining viral suppression.

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Overdose

Symptoms of overdose may include:

• Nausea
• Vomiting
• Dizziness
• Fatigue
• Headache
• Stomach discomfort

Seek emergency medical attention or contact a poison center immediately if an overdose is suspected.

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Storage

Store Biktarvy:

• At room temperature between 20°C and 25°C (68°F to 77°F).
• Keep the tablets in the original bottle with the lid tightly closed.
• Protect from excessive moisture and heat.
• Do not remove the moisture-protecting desiccant from the bottle.
• Keep out of reach of children and pets.

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Disclaimer

This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. HIV treatment should be taken exactly as prescribed to maintain viral suppression and reduce the risk of drug resistance.