Integrase Inhibitors
Bictegravir
Last Updated: April 16, 2019; Last Reviewed: April 16, 2019
Bictegravir (BIC)
Bictegravir (BIC)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/ |
| Formulations |
Note: Bictegravir is only available in a fixed-dose combination tablet.
Fixed-Dose Combination Tablet:
- [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 25 mg
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| Dosing Recommendations |
Selected Adverse Events |
[Biktarvy] Bictegravir plus Emtricitabine plus TAF
Child and Adolescent (Aged <18 Years) Dose:
- Biktarvy has not been approved by the Food and Drug Administration for use in patients aged <18 years.
Children Aged <6 Years and Weighing <25 kg:
- There are currently no data available on the appropriate dose of Biktarvy in children aged <6 years or weighing <25 kg.
Children Aged 6 Years to <12 Years and Weighing ≥25 kg:
- One tablet once daily. This is an investigational dose that has only been studied in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable antiretroviral (ARV) regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Children and Adolescents (Aged 12 to <18 Years and Weighing ≥35 kg):
- One tablet once daily. This is an investigational dose that has only been studied in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Adult (Aged ≥18 Years) Dose:
- One tablet once daily in ARV therapy-naive patients. This dose of Biktarvy can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
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- Diarrhea, nausea, headache
- See the emtricitabine and TAF sections of the Drug Appendix for information about the adverse events that are associated with the use of these drugs.
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Special Instructions
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- Administer Biktarvy with or without food. See product label for guidance if administering with antacids or iron or calcium supplements.
- Screen patients for hepatitis B virus (HBV) infection before using emtricitabine or TAF. Severe acute exacerbation of HBV can occur when discontinuing emtricitabine or TAF; therefore, monitor hepatic function for several months after halting therapy with emtricitabine or TAF.
- Biktarvy is not recommended for use with other ARV drugs.
- See the emtricitabine and TAF sections of the Drug Appendix for special instructions and additional information about the individual drug components of Biktarvy.
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| Metabolism/Elimination |
- Bictegravir is metabolized by cytochrome P450 3A4 and uridine diphosphate glucuronosyltransferase 1A1.
- Refer to the emtricitabine and TAF sections of the Drug Appendix for more information about the metabolism and elimination of these components of Biktarvy.
Biktarvy Dosing in Patients with Hepatic Impairment:
- Biktarvy is not recommended for use in patients with severe hepatic impairment.
Biktarvy Dosing in Patients with Renal Impairment:
- Biktarvy is not recommended for use in patients with estimated creatinine clearance <30 mL/min.
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U.S. Department of Health and Human Services
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