Epclusa® (sofosbuvir/velpatasvir)

Coadministration with Apixaban

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

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 apixaban. Based on the PK profile of each active ingredient within SOF/VEL and apixaban, a PK interaction would not be predicted.1,2 While a potential increase in apixaban concentration from P-gp inhibition by VEL is not expected to be clinically significant, monitoring may be advised. For more information about apixaban, please refer to its product labeling.2

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 apixaban.

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).

Clinical Data on Coadministration of SOF/VEL and Apixaban Retrospective International Multicenter Cohort Study3

A retrospective, multicenter, international cohort study evaluated the safety of DOACs with concomitant use of DAAs in adult HCV patients with or without cirrhosis. The primary endpoint was the incidence of clinically relevant bleeding, including major bleeding and clinically relevant nonmajor bleeding.

Of the 204 patients who met the inclusion criteria, 29.2% of patients (49/168) without cirrhosis and 47.2% of patients (17/36) with cirrhosis received concomitant SOF/VEL. Of the overall population, the DOAC apixaban was prescribed in 37.5% of adults (63/168) without cirrhosis and 50% of adults (18/36) with cirrhosis. Three patients (1.5%) experienced major bleeding, including 1 patient who was receiving apixaban with concomitant SOF/VEL, and none experienced clinically relevant nonmajor bleeding. All 3 patients who had major bleeding were receiving apixaban with concomitant antiplatelet therapy (aspirin with or without clopidogrel). Additionally, of the 3 who had major bleeding, 2 (including the patient receiving SOF/VEL) had stage 5 CKD and were on hemodialysis. Six (3%) patients discontinued use of DOACs; none of these discontinuations were linked to a specific DAA.

Available Data

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

Additionally, a literature search was conducted in Ovid MEDLINE and Embase databases for studies published between 1946 and May 14, 2025 using search terms that included Epclusa, velpatasvir, sofosbuvir, apixaban, and related search terms. An additional citation was identified.

• Rosato V, Nevola R, Dallio M, et al. Safety of Sofosbuvir-Based Direct-Acting Antivirals for Hepatitis C Virus Infection and Direct Oral Anticoagulant Co-Administration. J. Clin. Med. 2024;13(19). doi:10.3390/jcm13195807

References

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

2. Bristol-Myers Squibb Company, ELIQUIS® (apixaban) tablets, for oral use. US Prescribing Information. Princeton, NJ.

3. McDaniel K, Utz AE, Akbashev M, et al. Safe co-administration of direct-acting antivirals and direct oral anticoagulants among patients with hepatitis C virus infection: An international multicenter retrospective cohort study. J Viral Hepat. 2022;29(12):1073-1078.

Abbreviations

BCRP=breast cancer resistance protein
DDI=drug-drug interaction

DOAC= direct oral anticoagulants
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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