Epclusa® (sofosbuvir/velpatasvir)

Coadministration with Cannabinoids

This document is in response to your request for information regarding Epclusa® (sofosbuvir/velpatasvir [SOF/VEL]) and coadministration with cannabinoids.

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/liver-disease/epclusa/epclusa_pi.

PK DDI Evaluation

Drug interaction studies have not been conducted between the single-tablet regimen SOF/VEL and cannabinoids. Based on the PK profile of each active ingredient within SOF/VEL and cannabinoids, a PK interaction would not be predicted.1 Please note, however, that the DDI liability of cannabis has not been completed to a similar standard as that for prescription medications, and thus a DDI cannot be confidently ruled out.

SOF/VEL PK1

Relevant SOF/VEL Label Information1

There is no information in the SOF/VEL product labeling about the coadministration of SOF/VEL and cannabinoids.

Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. For more information, please refer to Section 7.3 of the SOF/VEL US Prescribing Information (Established and Potentially Significant Drug Interactions).

Available Data

There are no Gilead studies evaluating the coadministration of SOF/VEL and cannabinoids.

Additionally, a literature search was conducted in Ovid MEDLINE and Embase databases for studies published between 1946 and May 8, 2025 using search terms that included Epclusa, sofosbuvir, velpatasvir, cannabis, cannabinoids, marijuana, and related search terms. No relevant citations were found.

References

1. Enclosed. Gilead Sciences Inc, EPCLUSA® (sofosbuvir and velpatasvir) tablets, for oral use. US Prescribing Information. Foster City, CA.

Abbreviations

BCRP=breast cancer resistance protein
DDI=drug-drug interaction
OATP=organic anion transporting polypeptide
P-gp=P-glycoprotein
PK=pharmacokinetic(s)
SOF=sofosbuvir
VEL=velpatasvir
 

Product Label

For the full indication, important safety information, and Boxed Warning(s), please refer to the Epclusa US Prescribing Information available at:
http://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/epclusa/epclusa_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 Pharmacovigilance and Epidemiology ☎ 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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