EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

Please see below for Important Safety Information for EPCLUSA.

EPCLUSA and its Authorized Generic provide 95% of all patients access to treatment (vs 62% for Mavyret®) nationally.1

Placement on the formulary is not intended to imply any claims regarding safety, efficacy, or comparability of products.

Based on national covered (Exclusive or Preferred) lives as of June 2021. Local coverage may differ.
Exclusive = is on formulary while other DAAs are not, has a lower tier status than other DAAs, or is required in a step therapy process vs other DAAs.
Preferred = shares the lowest tier status with at least one DAA.

Illustration with stick figures showing coverage for EPCLUSA and its Authorized Generic and Mavyret

Based on national covered (Exclusive or Preferred) lives as of June 2021. Local coverage may differ.
Exclusive = is on formulary while other DAAs are not, has a lower tier status than other DAAs, or is required in a step therapy process vs other DAAs.
Preferred = shares the lowest tier status with at least one DAA.

FINANCIAL RESOURCES

Commercial

Cost should not be a barrier to treatment. Commercial patients may pay as little as $15 for a full course of treatment of EPCLUSA or its Authorized Generic.2

$5 Co-Pay Coupon

Help patients register for a co-pay coupon. Commercial patients may pay as little as $15 for a full course of EPCLUSA or its Authorized Generic

EPCLUSA $5 Co-pay Coupon

Visit the EPCLUSA patient website to learn more

Check Your Patients' Eligibility

Commercial patients may pay as little as $5 per co-pay for their medicine. Patients are not eligible if they are enrolled in a government healthcare prescription drug program such as Medicare Part D or Medicaid (including patients who are in the Medicare coverage gap known as the “donut hole”).

The EPCLUSA Co-pay Coupon Program will cover the out-of-pocket costs for EPCLUSA prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of EPCLUSA.

EPCLUSA $5 Co-pay Coupon

Commercial patients may pay as little as $5 per co-pay for their medicine. Patients are not eligible if they are enrolled in a government healthcare prescription drug program such as Medicare Part D or Medicaid (including patients who are in the Medicare coverage gap known as the “donut hole”).

The EPCLUSA Co-pay Coupon Program will cover the out-of-pocket costs for EPCLUSA prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of EPCLUSA.

Medicaid

99% of Medicaid patients taking EPCLUSA or its Authorized Generic pay $5 or less per co-pay.3,a

Patients who are dual-eligible may be covered through their Medicare benefit and pay $9.20 or less per co-pay.4

Medicare

8 out of 10 Medicare patients taking EPCLUSA or its Authorized Generic pay $15 or less for the full course of treatment.2,b

For your patients with insurance or who are uninsured, our team of Support Path Program Navigators can provide coverage information and financial support options that can help get patients started with treatment.

Talk with Support Path:

aGilead Analysis of patient data provided by Symphony Health (Patient Transaction Data for HCV market) May '20-Apr '21, accessed July '21. Out-of-pocket costs are based on average cost sharing on claims for new and continuing patients who take EPCLUSA, or the Authorized Generic of EPCLUSA, after any secondary benefit is applied.

bGilead Analysis of patient data provided by Symphony Health (Patient Transaction Data for HCV market) May '20-Apr '21, accessed July '21. Out-of-pocket costs are based on average cost sharing on claims for new and continuing patients who take EPCLUSA, or the Authorized Generic of EPCLUSA, after any secondary benefit is applied.2

With EPCLUSA and its Authorized Generic, you have access for the majority of your insured HCV patients.

When you write a prescription for EPCLUSA, the pharmacy may fill for either EPCLUSA or its Authorized Generic, depending on the patient's coverage.

The Authorized Generic of EPCLUSA has the same clinical profile as branded EPCLUSA.

If the Authorized Generic of EPCLUSA is covered by your patient's formulary, it will be automatically substituted if you have written the prescription for EPCLUSA in states with mandatory generic substitution laws. In states with permissive substitution laws, pharmacies will substitute the Authorized Generic per instruction from payers.

You can also write the Authorized Generic name (ie, sofosbuvir/velpatasvir) directly.

PATIENT SUPPORT

Support for your patients through their treatment journey

Nurse icon

NURSES & EPCLUSA EDUCATORS

  • Nurses and EPCLUSA Educators are available through phone, text, or email, 7 days a week, to answer questions your patients might have about hepatitis C or EPCLUSA
  • Nurses and EPCLUSA Educators can provide ongoing contact with your patients to better understand their concerns and provide specific resources they need every step of the way

Nurse support does not take the place of talking with a physician.

Thumbnail of EPCLUSA Patient Brochure

EPCLUSA in-office brochure

A resource you can share with your patients highlighting HCV education, financial support options, and patient support

Download download
Thumbnail of EPCLUSA Patient Brochure Spanish

EPCLUSA brochure
(en Español)

A resource in Spanish to share with your patients highlighting HCV education, financial support options, and patient support

Download download
Thumbnail of Patient Hep C Story Brochure

Chris’ Hep C story brochure

A resource you can share with your patients about Chris' struggle given his history of addiction, and how EPCLUSA worked for his Hep C

Download download
SUPPORT PATH®

Have a patient starting treatment?
Support Path is here to help

Our team of Support Path Program Navigators can provide coverage information and financial support options that can help get patients started on treatment.

Support Path is a program that can help patients get started on Gilead treatments

Talk with Support Path:

Visit MySupportPath.com
Support Path is a program that can help patients get started on Gilead treatments
See Efficacy Data
See Dosing

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.

INDICATION

EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

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 Strong 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 in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug.

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, 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.

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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.

INDICATION

EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

References:

  1. Data on file. Gilead Hepatitis C virus coverage status report. June 2021.
  2. Data on file. Gilead Sciences, Inc.
  3. Data on file. Medicaid cost per treatment. Gilead Sciences, Inc.
  4. Center for Medicare and Medicaid Services. Announcement of calendar year (CY) 2021 Medicare Advantage (MA) capitation rates and Part C and Part D payment policies. Published April 6, 2020. Accessed March 12, 2021. https://www.cms.gov/files/document/2021-annoucement.pdf