This information is intended for US healthcare professionals.

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.

When treating patients like Susan,

have CONFIDENCE IN
CONSISTENT DOSING

Not an actual patient.

When treating patients like Susan,

have CONFIDENCE IN
CONSISTENT DOSING

Not an actual patient.

Convenient single-tablet regimen for TN or TEa patients without cirrhosis or with compensated cirrhosis

One duration, one pill, once a day
pangenotypic (GT 1-6), panfibrotic (FO-F4 (CC)), treatment history (TN/TE)

The same 12-week duration
for all patients1,2

pangenotypic (GT 1-6), panfibrotic (FO-F4 (CC)), treatment history (TN/TE)

a In EPCLUSA clinical trials, TE patients had failed a Peg-IFN + RBV–based regimen with or without an HCV NS3/4A 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

Rx bottle

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CC = compensated cirrhosis (Child-Pugh A); CYP = cytochrome P450; GT = genotype; P-gp = P-glycoprotein; Peg-IFN = peginterferon alfa; RBV = ribavirin; TE = treatment-experienced; TN = treatment-naïve.

CC = compensated cirrhosis (Child-Pugh A); CYP = cytochrome P450; GT = genotype; P-gp = P-glycoprotein; Peg-IFN = peginterferon alfa; RBV = ribavirin; TE = treatment-experienced; TN = treatment-naïve.

REFERENCES:
  1. EPCLUSA Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; 2017.
  2. Lawitz E, Bourlière M, Han L, et al. Poster presented at: International Liver Congress, 19-23 April 2017: Amsterdam, Netherlands.
  3. Mavyret Prescribing Information, North Chicago, IL: AbbVie Inc.; 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.



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.

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