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 Carl,

HAVE CONFIDENCE IN
CONSISTENT OUTCOMES1

a In EPCLUSA clinical trials, treatment-experienced patients had failed a Peg-IFN + RBV–based regimen with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).

Not an actual patient.

When treating patients like Carl,

HAVE CONFIDENCE IN
CONSISTENT OUTCOMES1

a In EPCLUSA clinical trials, treatment-experienced patients had failed a Peg-IFN + RBV–based regimen with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).

Not an actual patient.

A pangenotypic treatment with consistent outcomes in clinical trials1

98 percent overall cure rate in clinical trials for GT 1-6 patients

bSustained virologic response (SVR12) was the primary endpoint and was defined as HCV RNA <15 IU/mL at 12 weeks after the end of treatment. Achieving SVR12 is considered a virologic cure.

Treat all genotypes, from the most common (GT 1) to the most difficult (GT 3)1
Genotype chart in clinical trials for GT 1-6 patients

Cure rates (SVR12) for: GT 1, 4, 5, and 6 from ASTRAL-1; GT 2 from ASTRAL-1 and ASTRAL-2; GT 3 from ASTRAL-3.

A panfibrotic treatment with consistent outcomes in clinical trials2

Fibrosis chart with overall cure rate in GT 1-6 patients and overall cure in GT 1 patients

Cure rates (SVR12) derived from completer efficacy analysis of ASTRAL-1, -2, and -3 and POLARIS-2 and -3 studies, which included all patients who were randomized, completed assigned study treatment, and had HCV RNA data observed at post-treatment Week 12 or thereafter.

Consistent outcomes also
seen in the real world4,5

97 percent overall cure rate in HCV-TARGET real-world study for GT 1-6 patients
99 percent overall cure rate in Puglia real-world study for GT 1-4 and GT 6 patients in Italy

Cure (SVR12) = HCV RNA <LLOQ at 12 weeks post-treatment.
Real-world data are observational in nature and are not based on controlled clinical studies. Results from the HCV-TARGET and Puglia studies may differ from those observed in clinical practice and are not presented in the EPCLUSA Prescribing Information. The HCV-TARGET study was supported by Gilead Sciences, Inc.

▲ Back to top

CC = compensated cirrhosis; CYP = cytochrome P450; GT = genotype; HIV = human immunodeficiency virus; ITT = intent-to-treat; LLOQ = lower limit of quantification; NC = non-cirrhotic; Peg-IFN = peginterferon alfa; P-gp = P-glycoprotein; PP = per-protocol analysis is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated; RBV = ribavirin; SVR = sustained virologic response.

CC = compensated cirrhosis; CYP = cytochrome P450; GT = genotype; HIV = human immunodeficiency virus; ITT = intent-to-treat; LLOQ = lower limit of quantification; NC = non-cirrhotic; Peg-IFN = peginterferon alfa; P-gp = P-glycoprotein; PP = per-protocol analysis is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated; RBV = ribavirin; SVR = sustained virologic response.

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; April 19-23, 2017; Amsterdam, Netherlands.
  3. Moorman AC, Rupp LB, Gordon SC, et al. Long-term liver disease, treatment, and mortality outcomes among 17,000 persons diagnosed with chronic hepatitis C virus infection: current chronic hepatitis cohort study status and review of findings. Infect Dis Clin North Am. 2018;32(2):253-268.
  4. Landis CS, Sulkowski MS, Reau N, et al. Safety and efficacy of velpatasvir and sofosbuvir-based regimens for the treatment of HCV genotype 1-6: results of the HCV-TARGET study. Poster presented at: AASLD The Liver Meeting®, October 20-24, 2017: Washington, DC.
  5. Mangia A, Piazzolla V, Giannelli A, et al. SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: a real world experience. PLoS ONE. 2019;14(5):1-14.

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.

©2019 Gilead Sciences, Inc. All rights reserved. EPCP0419 08/19