Biktarvy® (BIC/FTC/TAF)
Coadministration with Levetiracetam

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Biktarvy® (BIC/FTC/TAF)

Coadministration with Levetiracetam

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

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 levetiracetam. Based on the PK profile of each active ingredient within BIC/FTC/TAF and levetiracetam, a PK interaction would not be predicted.1,2 For more information about levetiracetam, please refer to its product labeling.1

BIC/FTC/TAF PK2,3

DDI Mechanism

BIC

FTC

TAF

Drug Transporters

OCT2

Inhibitor

N/A

N/A

MATE1

Inhibitor

N/A

N/A

P-gp/BCRP

N/A

N/A

Substrate

OATP1B1

N/A

N/A

Substrate

OATP1B3

N/A

N/A

Substrate

Drug Metabolizing Enzymes

CYP3A

Substratea

N/A

Minor Substrate

UGT1A1

Substratea

N/A

N/A

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 levetiracetam.


Available Data

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

Additionally, a literature search was conducted in Ovid MEDLINE and Embase databases for studies published between 1946 and January 23, 2025 using search terms that included Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, levetiracetam, and related search terms. No relevant citations were found.

References

  1. UCB, Inc. KEPPRA® (levetiracetam) tablets, for oral use, KEPPRA® (levetiracetam) oral solution. U.S. Prescribing Information. Smyrna, GA.
  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

Page 1 of 3


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

Data Privacy

The Medical Information service at Gilead Sciences may collect, store and use your personal information to provide a response to your medical request.  We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately.  If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.

It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers and regulatory authorities located in countries besides your own.  Gilead Sciences has implemented measures to protect the personal information you provide.  Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights.  If you have any further questions about the use of your personal information, please contact privacy@gilead.com.

BIKTARVY, DESCOVY, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.

Page 1 of 3