EPCLUSA is indicated for the treatment of adults with chronic hepatitis C virus (HCV) GT 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

TREAT WITH SIMPLICITY.

EPCLUSA OFFERS
SIMPLE DOSING1

EPCLUSA OFFERS
SIMPLE DOSING1

Simple 12-week dosing for patients without cirrhosis or with compensated cirrhosis1

Simple 12-week dosing for patients without cirrhosis
or with compensated cirrhosis1

Simple dosing treatment for hep C patients




One duration one pill once a day


With or without food1

ONE 12-WEEK DOSING REGIMEN FOR ALL PATIENTS1,2

12-week HCV treatment duration for all patients

CC = compensated cirrhosis (Child-Pugh A), TN = treatment-naïve, TE = treatment-experienced (subjects who have failed a peginterferon alfa + ribavirin–based regimen with or without an HCV protease inhibitor [boceprevir, simeprevir, or telaprevir])

A PROTEASE INHIBITOR–FREE CHOICE FOR YOUR PATIENTS1

  • Convenience of one-pill, once-a-day dosing1
  • Fewer pills than other approved treatments1,3
  • Manageable drug interaction profile1
  • No food restrictions1
EPCLUSA® (sofosbuvir/velpatasvir) tablets packaging

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GT = genotype

GT = genotype

REFERENCES:
  1. EPCLUSA US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2017.
  2. Lawitz E, Bourlière M, Han L, et al. Treatment with SOF/VEL or SOF/VEL/VOX is well tolerated and results in high SVR12 in genotype 1–6 HCV–infected patients with minimal fibrosis: a retrospective analysis of the ASTRAL and POLARIS clinical studies. Poster presented at: International Liver Congress™, 19-23 April 2017: Amsterdam, the Netherlands.
  3. MAVYRET US Prescribing Information. AbbVie Inc. North Chicago, IL. August 2018.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

  • If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (10%, all grades) with EPCLUSA were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

Drug Interactions

  • Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
  • Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

Please see full Prescribing Information for EPCLUSA, including BOXED WARNING.

The information contained on this site is intended for audiences in the United States only. The content on this site may not apply to non-US audiences, as regulatory control, legal requirements, and/or medical practices may vary in other countries.

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Photos not of actual patients.

EPCLUSA, the EPCLUSA logo, SUPPORT PATH, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

©2019 Gilead Sciences, Inc. All rights reserved. EPCP0311 03/19