Yeztugo® (lenacapavir)

Clinical Practice Guidelines

This document is in response to your request for information regarding Yeztugo® (lenacapavir [LEN]) and clinical practice guidelines.

This document includes content from, or references to, clinical practice guidelines, and inclusion should not be interpreted as a treatment recommendation or an endorsement of the guidelines by Gilead Sciences, Inc.

The full indication, important safety information, and boxed warning are available at: www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.

Clinical Guidelines that Recommend LEN for HIV-1 Pre-Exposure Prophylaxis (PrEP)

The Centers for Disease Control and Prevention published Clinical Recommendation for the Use of Injectable LEN as HIV PrEP in the US (2025), which can be accessed at: http://dx.doi.org/10.15585/mmwr.mm7435a1.

Following the US Food and Drug Administration approval of LEN for HIV-1 PrEP, the International Antiviral Society–USA (IAS-USA) panel published a brief update of its 2024 recommendations for the prevention of HIV, which can be accessed at: jamanetwork.com/journals/jama/fullarticle/2835835.

The World Health Organization also published guidelines on LEN and testing strategies for long-acting injectable PrEP which can be accessed at:
www.who.int/publications/i/item/9789240111608.

PrEP Clinical Practice Guidelines

Guidelines from the IAS-USA panel on antiretroviral drugs for the prevention and treatment of HIV in adults can be accessed at: jamanetwork.com/journals/jama/fullarticle/2827545.

The Centers for Disease Control and Prevention clinical practice guidelines of PrEP for the prevention of HIV in the US can be accessed at: stacks.cdc.gov/view/cdc/159891.

Guidelines from the World Health Organization for HIV PrEP and treatment can be accessed at: www.who.int/publications/i/item/9789240031593.

The European AIDS Clinical Society produces guidelines for the management of prevention and treatment of HIV in Europe, which can be accessed at: www.eacsociety.org/guidelines/eacs-guidelines.

Product Label

For the full indication, important safety information, and boxed warning, please refer to the Yeztugo US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_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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