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Prescribing information, details of adverse event reporting and indications can be found at the bottom of this page.

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Supporting the ambition to leave no patient behind on the path to HCV elimination with EPCLUSA®

 

 

EPC Overview

aEASL defines cure as SVR, i.e. undetectable HCV RNA after treatment completion4

bCo-administration with proton pump inhibitors is not recommended. If it is considered necessary to co-administer, then EPCLUSA® should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg8 

cBased on a study that assessed patient preferences based on blinded product profiles of EPCLUSA® vs glecaprevir/pibrentasvir (n=29).2

Mode of Action

EPCLUSA® is a combination of two direct-acting antiviral agents with different mechanisms of action.8 

 

•    Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication8 

•    Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication and virion assembly8 

 

EPCLUSA® is the only PI-free, pan-genotypic and pan-fibrotic DAA regimen for eligible HCV patients.8

Dosing

One pill, once a day, with no automatic food requirement.8,*

Indication

EPCLUSA® is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older.8

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Real World Data

Footnotes:

*Except when EPCLUSA® is coadministered with PPIs or in combination with ribavirin. Refer to EPCLUSA® SmPC for further information.1

Abbreviations:

AE = adverse event; DDI = drug-drug interaction; EASL = European Association for Study of the Liver; HCV = hepatitis C virus; NS5A = non-structural protein 5A; NS5B = non-structural protein 5B; PPI = proton-pump inhibitor; PI = protease inhibitor; RNA = ribonucleic acid; SVR = sustained virologic response.

References:

  1. University of Liverpool. HEP Drug Interactions Checker. Available from: https://www.hep-druginteractions.org/checker. Accessed July 2024.
  2. Gilead. Data on file. 2019.
  3. Mangia A, et al. Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts. Liver Int. 2020;40:1841–1852.
  4. European Association for the Study of the Liver (EASL). J Hepatol. 2020;73:1170–1218.
  5. Younossi Z, et al. Sofosbuvir and velpatasvir with or without voxilaprevir in direct-acting antiviral-naïve chronic hepatitis C: patient-reported outcomes from POLARIS 2 and 3. Aliment Pharmacol Ther. 2018;47:259–267.
  6. Solomon S, et al. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022;7:307–317.
  7. Grebely J, et al. Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial. Lancet Gastroenterol Hepatol. 2018;3:153–161.
  8. EPCLUSA Summary of Product Characteristics.
  9. Rosati S, et al. Real-world Effectiveness of sofosbuvir/velpatasvir for the Treatment of Hepatitis C Virus in Prison Settings. Future Virol. 2022;17:419–428.

UK-EPC-0468

Date of preparation July 2024