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.

TREATING HCV
IN YOUR PRACTICE

TREATING HCV
IN YOUR
PRACTICE

TREATING HCV IN YOUR PRACTICE CAN HELP ENSURE PATIENTS RECEIVE PROMPT CARE

TALK2

  • Educate patients on general information about HCV
  • Discuss preventing transmission and behaviors to reduce progression of liver disease

EVALUATE2

  • Test for HCV genotype
  • Conduct liver screening to determine level of fibrosis
  • Test for conditions that may accelerate liver fibrosis (hepatitis B and HIV)

PREVENT2

  • Vaccinate against other infections as appropriate
  • Assess potential drug interactions with concomitant medications

LAB TESTS2

(within 12 weeks before starting treatment)

  • Complete blood count (CBC)
  • International normalized ratio (INR)
  • Hepatic function panel
  • Calculated glomerular filtration rate (eGFR)

Monitor patients for adverse reactions

LAB TESTS2

(4 weeks after start of therapy or as clinically indicated)

  • Complete blood count (CBC)
  • Hepatic function panel
  • Serum creatinine level and calculated eGFR

Conduct quantitative HCV RNA (viral load) test2

  • At end of treatment (optional)
  • 12 weeks after end of treatment to assess for sustained virologic response at 12 weeks (SVR12), or curea

aCure is defined as undetectable HCV RNA at 12 or more weeks after the end of treatment.2

For patients with cirrhosis2

  • Continue to monitor and consider referring to a hepatologist for additional consultation

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GT = genotype, HIV = human immunodeficiency virus

GT = genotype, HIV = human immunodeficiency virus

REFERENCES:
  1. McGowan CE, Fried MW. Barriers to hepatitis C treatment. Liver Int. 2012;32(1):151-156.
  2. AASLD-IDSA. HCV guidance: recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed October 15, 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.

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