Vijayaganesh Kasinathan
Written & Compiled by Pharmacist Vijayaganesh Kasinathan, B.Pharm, M.Pharm
Suchitra Chari
Medically Reviewed by Suchitra Chari, M.S. M.Sc.
Last Updated on Mar 30, 2018
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General Information on Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Generic Name : Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Latest prescription information about Bictegravir, Emtricitabine, and Tenofovir Alafenamide. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Antiretroviral Agents

Trade Names/Brand Names of Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Biktarvy

Overview of Bictegravir, Emtricitabine, and Tenofovir Alafenamide

• Bictegravir, emtricitabine and tenofovir alafenamide combination tablet of three antiviral drugs was approved by FDA in 2018 for treating HIV infection in adults.

Why is Bictegravir, Emtricitabine, and Tenofovir Alafenamide Prescribed? (Indications)

Bictegravir, emtricitabine, and tenofovir alafenamide is a three-drug combination where bictegrair is an HIV-1 integrase strand transfer inhibitor, and emtricitabine and tenofovir alafenamide are HIV -1 nucleoside analog reverse transcriptase inhibitors prescribed to treat HIV infections in adults.

The drug combination can be used in patients-

• Who has not been previously treated with antiretroviral therapy
• To replace current antiretroviral therapy for those who are virologically suppressed after taking antiretroviral regimen for at least three months; these patients must not have had any failed treatment nor any known substitutions associated with resistance to the individual components 

When should Bictegravir, Emtricitabine, and Tenofovir Alafenamide not to be taken? (Contraindications)

Bictegravir, emtricitabine and tenofovir alafenamide should not be used in patients-

• Allergic to any of the ingredients present in the drug combination
• History of hepatitis B
• Severe liver disorder
• Serious kidney disease (whose creatinine clearance is below 30 ml per min)
• Children under 18 years of age
• Breastfeeding mothers

What is the dosage of Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• The three-drug combination consists of 50 mg of bictegravir, 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide.
• The recommended adult dose in treating HIV type-1 infection is one tablet taken once a day.

How should Bictegravir, Emtricitabine, and Tenofovir Alafenamide be taken?

• Bictegravir, Emtricitabine, and tenofovir alafenamide drug combination is available in the form of tablets that have to be taken by mouth either with or without food.
• It is recommended not to miss a dose of bictegravir, emtricitabine and tenofovir alafenamide.

What are the warnings and precautions for Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Before starting treatment with bictegravir, emtricitabine and tenofovir alafenamide, it is recommended to test for the presence of hepatitis B infection and treat the condition.
• There is also a chance of worsening of hepatitis after treatment with bictegravir, emtricitabine and tenofovir alafenamide particularly in liver disorder patients who should be treated accordingly.
• Immune reconstitution syndrome may occur during the antiretroviral treatment and patient may require further evaluation and treatment. In some cases, autoimmune disorders such as Graves’ disease or polymyositis can occur even several months after the start of treatment that requires constant monitoring.
• Patients should be assessed for serum creatinine, creatinine clearance, glucose and protein level in urine before starting and during the treatment with bictegravir, emtricitabine and tenofovir alafenamide. Treatment should be discontinued if any significant decrease in the kidney function or Fanconi syndrome occurs.
• Treatment with bictegravir, emtricitabine and tenofovir alafenamide must be discontinued if symptoms of lactic acidosis (abdominal discomfort, diarrhea, reduced appetite) or severe liver toxicity are reported and followed by appropriate medical care.

What are the side effects of Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

•  Common: Diarrhea, nausea, headache
•  Gastrointestinal: Loss of appetite, stomach discomfort
•  Respiratory: Difficulty in breathing
•  Nervous system: Inability to sleep, fatigue, abnormal dreams, dizziness
•  Others: Kidney impairment, decreased phosphorous levels in the blood, abnormal level of liver enzymes and alteration in neutrophil counts.

What are the other precautions for Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Do not alter the dose or stop treatment without consulting the physician.
• Take exactly as directed and at the same time every day.
• Refill the medications before running short, as discontinuation even for short periods results in viral resistance which becomes difficult to treat.
• Medications should not be shared with other patients without physician approval even if they have a similar infection.

What are the Drug Interactions of Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Antacids such as magnesium, aluminum or calcium should be taken two hours after taking bictegravir, emtricitabine and tenofovir alafenamide to avoid the reduced therapeutic effect.

• Bictegravir, emtricitabine and tenofovir alafenamide should not be taken with the antiarrhythmic drug dofetilide as co-administration could lead to increased plasma concentration of dofetilide resulting in life-threatening complications.

• Rifampin when taken along with bictegravir, emtricitabine and tenofovir alafenamide results in a decreased effect of antiretroviral drugs causing resistance to antiretroviral therapy or treatment failure.

What are the storage conditions for Bictegravir, Emtricitabine, and Tenofovir Alafenamide?

• Store the tablets in the original container at room temperature below 25°C.
• Keep the container tightly closed and protect from excess heat and moisture.
• Keep the tablets away from children.

Last Updated : 3/30/2018

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