Descovy for PrEP® (FTC/TAF)

HIV-2 Pre-Exposure Prophylaxis

This document is in response to your request for information regarding Descovy for PrEP® (emtricitabine/tenofovir alafenamide [FTC/TAF] for HIV-1 pre-exposure prophylaxis) and HIV-2 pre-exposure prophylaxis.

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.

FTC/TAF is not indicated to reduce the risk of HIV-2 infection.

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

Product Labeling1

FTC/TAF is indicated in at-risk adults and adolescents weighing ≥35 kg for PrEP to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating FTC/TAF for HIV-1 PrEP.

Limitations of Use: The indication does not include use of FTC/TAF in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Literature Search

A literature search was conducted in Ovid MEDLINE, BIOSIS Previews, and Embase databases for studies published between 1946 and November 26, 2024 using the search terms of Descovy, emtricitabine, tenofovir alafenamide, PrEP, pre-exposure prophylaxis, HIV-2, and related search terms. No citations relevant to your inquiry were identified.

References

1. Enclosed. Gilead Sciences Inc. DESCOVY® (emtricitabine and tenofovir alafenamide) tablets, for oral use. U.S. Prescribing Information. Foster City, CA.

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Descovy US Prescribing Information available at:
https://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

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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.

DESCOVY, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2024 Gilead Sciences, Inc.