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.

TEST AND CONNECT TO CARE.

HEPATITIS C IS A CURABLE
LIFE-THREATENING
DISEASE1,2

HEPATITIS C
IS A CURABLE
LIFE-THREATENING
DISEASE1,2

Learn how cure starts with you

Steps can be taken in your practice to identify patients who need treatment and help connect them to a cure1

MANY PATIENTS
AREN'T AWARE THEY
NEED TREATMENT3

Risk of cirrhosis with hepatitis C

UNTREATED HCV CAN LEAD
TO LIFE-THREATENING
COMPLICATIONS4

and can cause serious
complications beyond
the liver5

Baby Boomers born 1945-1965
Baby boomers represent
~75% of current infections6
People who inject drugs
People who have injected
drugs account for
~70% of new infections1
AASLD/IDSA and CDC recommend

screening every at-risk patient, regardless
of symptoms1,4

Screen with an HCV antibody test.1

SCREENING AND
DIAGNOSIS ARE
THE KEY TO CURE1,4

CONFIRM DIAGNOSIS
WITH AN HCV RNA TEST1,4

Select “reflex testing” at laboratory screening to automatically test for HCV RNA with a positive HCV antibody result.1

Diagnosis and screening for hepatitis C

CURE IS POSSIBLE FOR
MOST PATIENTS WITH HCV1,2

REFER FOR TREATMENT

  • Educate patients on the importance of prompt treatment
  • Find a healthcare provider who has experience treating HCV infection and is located near your patient

AMA doctor finder

Follow up to ensure patients receive treatment for hepatitis C
Follow up to ensure your patient has received treatment
OR

TREAT IN YOUR PRACTICE

Treating in your practice can help ensure that your patients receive prompt care.

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aAASLD/IDSA does not recommend treatment in patients with a short life expectancy that cannot be remediated by HCV therapy, liver transplantation, or another directed therapy. Patients with a short life expectancy owing to liver disease should be managed in consultation with an expert.

AASLD/IDSA = American Association for the Study of Liver Diseases/Infectious Diseases Society of America, CDC = Centers for Disease Control and Prevention, GT = genotype, USPSTF = United States Preventive Services Task Force, WHO = World Health Organization

AASLD/IDSA = American Association for the Study of Liver Diseases/Infectious Diseases Society of America, CDC = Centers for Disease Control and Prevention, GT = genotype, USPSTF = United States Preventive Services Task Force, WHO = World Health Organization

REFERENCES:
  1. AASLD-IDSA. HCV guidance: recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed October 15, 2018.
  2. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.
  3. Chhatwal J, Chen Q, Bethea ED, et al. Changing cascade of care for hepatitis C in the era of direct-acting antivirals. Presented at: AASLD: The Liver Meeting®; November 9-13, 2018; San Francisco, CA.
  4. Hepatitis C questions and answers for health professionals. Centers for Disease Control and Prevention website. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed October 15, 2018.
  5. Cacoub P, Comarmond C, Domont F, Savey L, Desbois AC, Saadoun D. Extrahepatic manifestations of chronic hepatitis C virus infection. Ther Adv Infect Dis. 2016;3(1):3-14.
  6. Final recommendation statement. Hepatitis C: screening. US Preventive Services Task Force website. https://www.uspreventiveservicestaskforce.org/‌Page/Document/RecommendationStatementFinal/hepatitis-c-screening#consider. Accessed August 31, 2018.
  7. McGowan CE, Fried MW. Barriers to hepatitis C treatment. Liver Int. 2012;32(1):151-156.

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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