Biktarvy® (BIC/FTC/TAF)

Coadministration with Topiramate

This document is in response to your request for information regarding Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) and coadministration with topiramate.

Some data may be outside of the US FDA-approved Prescribing Information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA approved prescribing information.

The full indication, important safety information, and boxed warnings are available at: www.gilead.com/-/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi,
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.

PK DDI Evaluation

This interaction has not been studied between the single-tablet regimen BIC/FTC/TAF and topiramate. Based on the PK profile of each active ingredient within BIC/FTC/TAF and topiramate, a PK interaction would not be predicted.1,2 For more information about topiramate, please refer to its product labeling.1

BIC/FTC/TAF PK2,3

aA drug that is a strong inducer of CYP3A and also an inducer of UGT1A1 can substantially decrease the plasma concentrations of BIC. Similarly, the use of BIC/FTC/TAF with a drug that is a strong inhibitor of CYP3A and also an inhibitor of UGT1A1 may significantly increase the plasma concentrations of BIC.2

Relevant BIC/FTC/TAF Label Information2

There is no information in the BIC/FTC/TAF product labeling about the coadministration of BIC/FTC/TAF and topiramate.

Available Data

There are no Gilead studies evaluating the coadministration of BIC/FTC/TAF and topiramate.

Additionally, a literature search was conducted in Ovid MEDLINE, BIOSIS Previews, and Embase databases for studies published between 1946 and December 30, 2024 using search terms that included Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, topiramate, and related search terms. No relevant citations were found.

References

1. Janssen Pharmaceuticals, Inc, TOPAMAX®  (topiramate) TABLETS, for oral use. TOPAMAX®  (topiramate capsules) SPRINKLE CAPSULES, for oral use. U.S. Prescribing Information. Titusville, NJ.
2. Enclosed, Gilead Sciences Inc. BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use. U.S. Prescribing Information. Foster City, CA.
3. Enclosed. Gilead Sciences Inc, DESCOVY® (emtricitabine and tenofovir alafenamide) tablets, for oral use. U.S. Prescribing Information. Foster City, CA.

Abbreviations

BCRP=breast cancer resistance protein
BIC=bictegravir
DDI=drug-drug interaction
FTC=emtricitabine
MATE=multidrug and toxin extrusion protein
OATP=organic anion transporting polypeptide
OCT=organic cation transporter
P-gp=P-glycoprotein
PK=pharmacokinetic(s)
TAF=tenofovir alafenamide
UGT=uridine 5'-diphospho-glucourosyltransferase

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Biktarvy and Descovy US Prescribing Information available at:
www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi,
www.gilead.com/-/media/files/pdfs/medicines/hiv/descovy/descovy_pi.

Follow-Up

For any additional questions, please contact Gilead Medical Information at:

☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

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