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