Dosing | EPCLUSA® (sofosbuvir/velpatasvir)

This information is intended for US healthcare professionals.

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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.

Convenient single-tablet regimen for TN or TE^a patients without cirrhosis or with compensated cirrhosis

The same 12-week duration
for all patients^1,2

^aIn 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 treatments^1,3

Manageable drug interaction profile¹

No food restrictions¹

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:

EPCLUSA Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; 2017.
Lawitz E, Bourlière M, Han L, et al. Poster presented at: International Liver Congress, 19-23 April 2017: Amsterdam, Netherlands.
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.

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

EPCLUSA HELPED PATIENTS WITH HCV/HIV COINFECTION ACHIEVE A CURE FOR HCV^1,a

% SVR in subjects treated with EPCLUSA for 12 weeks^1,a

Coadministration of EPCLUSA with efavirenz-containing regimens and tipranavir/ritonavir is not recommended
Monitor for tenofovir-associated adverse reactions in patients receiving EPCLUSA concomitantly with a regimen containing tenofovir disoproxil fumarate. Refer to the prescribing information of the tenofovir DF–containing product for recommendations on renal monitoring

ASTRAL-5 Study Design: Open-label trial in TN and TE GT 1-4 subjects with HCV/HIV-1 coinfection without cirrhosis or with compensated cirrhosis (N=106). Subjects received EPCLUSA for 12 weeks.

^aSVR12 is defined as undetectable HCV RNA at 12 weeks after the end of treatment.¹ Achieving SVR is considered a virologic cure.²

See study designs ▸

GT = genotype, HCV = hepatitis C virus, HIV = human immunodeficiency virus, SVR = sustained virologic response, TE = treatment-experienced (patients who have failed a peginterferon alfa + RBV–based regimen with or without an HCV protease inhibitor [boceprevir, simeprevir, or telaprevir], TN = treatment-naïve

REFERENCES:

EPCLUSA US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2017.
US Department of Health and Human Services, Center for Drug Evaluation and Research. Guidance for Industry. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment. November 2017.

ASTRAL-1

Double-blind, placebo-controlled trial in GT 1, 2, 4, 5, or 6 subjects (N=740). GT 1, 2, 4, or 6 subjects were randomized 5:1 to receive EPCLUSA or placebo for 12 weeks; GT 5 subjects received EPCLUSA for 12 weeks.¹

ASTRAL-2

Open-label trial in GT 2 subjects (N=266). Subjects received EPCLUSA or SOF + RBV for 12 weeks.¹

ASTRAL-3

Open-label trial in GT 3 subjects (N=552). Subjects received EPCLUSA for 12 weeks or SOF + RBV for 24 weeks.¹

ASTRAL-5

Open-label trial in GT 1, 2, 3, 4, 5, or 6 subjects who were coinfected with HIV-1 (N=106). The proportion of subjects with GT 1, 2, 3, or 4 HCV infection were 74%, 10%, 11%, and 5%, respectively; no subjects with GT 5 or 6 HCV were treated with EPCLUSA. Subjects received EPCLUSA for 12 weeks. Subjects were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, raltegravir, or elvitegravir/cobicistat.¹

POLARIS-2

Open-label comparator trial in GT 1-6 DAA-naïve subjects (N=941) who were randomized to receive EPCLUSA for 12 weeks or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.²

POLARIS-3

Open-label comparator trial in DAA-naïve GT 3 cirrhosis subjects (N=219) who were randomized to receive EPCLUSA for 12 weeks or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.²

CC = compensated cirrhosis; DAA = direct-acting antiviral; GT = genotype; HIV = human immunodeficiency virus; NC = non-cirrhotic; RBV = ribavirin; SOF = sofosbuvir; TE = treatment-experienced (patients who have failed a peginterferon alfa + RBV–based regimen with or without an HCV protease inhibitor [boceprevir, simeprevir, or telaprevir]); TN = treatment-naïve.

REFERENCES:

EPCLUSA Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; 2017.
Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. July 2017; 153(1):113-122.

HCV-TARGET

HCV-TARGET was a prospective, longitudinal, observational study evaluating the safety and efficacy of EPCLUSA, with or without RBV, in GT 1-6 adults treated for 12 weeks in academic or community settings. HCV-TARGET included TN and TE patients with or without cirrhosis (N=520). SVR12 rates in HCV-TARGET were reported for 239 patients who received EPCLUSA without RBV and excluded patients who had not yet completed 12 weeks of treatment or were lost to follow-up. This included 15 patients with a history of decompensated cirrhosis treated with EPCLUSA alone for 12 weeks at the providers’ discretion. The recommended treatment regimen for patients with decompensated cirrhosis is EPCLUSA + RBV for 12 weeks. The majority of sites were in North America; 6% were in Europe. Overall discontinuation rate due to AEs was 1%. Per protocol analysis is a comparison of treatment groups that included those patients who completed the treatment originally allocated.¹

Puglia, Italy Study

The Puglia study was conducted to conﬁrm real-world efficacy and safety of EPCLUSA for 12 weeks, regardless of baseline features, in patients treated in Puglia, Italy. From the registry, 1319 patients initiated treatment from June 2017 through May 2018. 3.1% of patients were treated with RBV at their physician's discretion. This study included patients with decompensated cirrhosis. Patients who had failed SOF + RBV or SOF + NS3 inhibitor were included; patients with prior NS5A inhibitor therapy were excluded.²

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.

AE = adverse event; GT = genotype; SOF = sofosbuvir; RBV = ribavirin; TE = treatment-experienced; TN = treatment-naïve.

REFERENCES:

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.
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.

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have CONFIDENCE IN
CONSISTENT DOSING

have CONFIDENCE IN
CONSISTENT DOSING

Convenient single-tablet regimen for TN or TE^a patients without cirrhosis or with compensated cirrhosis

The same 12-week duration
for all patients^1,2

A PROTEASE INHIBITOR–FREE
CHOICE FOR YOUR PATIENTS¹

Find out about broad coverage ▸

▲ Back to top

have CONFIDENCE IN CONSISTENT DOSING

have CONFIDENCE IN CONSISTENT DOSING

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

The same 12﻿-﻿week duration for all patients1,2

A PROTEASE INHIBITOR–FREE CHOICE FOR YOUR PATIENTS1

Find out about broad coverage ▸

▲ Back to top

EPCLUSA HELPED PATIENTS WITH HCV/HIV COINFECTION ACHIEVE A CURE FOR HCV1,a

% SVR in subjects treated with EPCLUSA for 12 weeks1,a

CLINICAL TRIAL STUDY DESIGNS

Clinical trials in TN and TE subjects with chronic HCV without cirrhosis or with compensated cirrhosis1,2

ASTRAL-1

ASTRAL-2

ASTRAL-3

ASTRAL-5

POLARIS-2

POLARIS-3

REAL-WORLD STUDY DESIGNS

HCV-TARGET

Puglia, Italy Study

have CONFIDENCE IN
CONSISTENT DOSING

have CONFIDENCE IN
CONSISTENT DOSING

Convenient single-tablet regimen for TN or TE^a patients without cirrhosis or with compensated cirrhosis

The same 12-week duration
for all patients^1,2

A PROTEASE INHIBITOR–FREE
CHOICE FOR YOUR PATIENTS¹

EPCLUSA HELPED PATIENTS WITH HCV/HIV COINFECTION ACHIEVE A CURE FOR HCV^1,a

% SVR in subjects treated with EPCLUSA for 12 weeks^1,a

Clinical trials in TN and TE subjects with chronic HCV without cirrhosis or with compensated cirrhosis^1,2