II. Precautions

III. Indications

  1. See Hepatitis C Antiviral Regimen
  2. General
    1. Initial therapy for any Genotype
    2. Salvage therapy with addition of Voxilaprevir as Vosevi (Velpatasvir/Voxilaprevir/Sofosbuvir)
    3. May be used in any class of compensated Cirrhosis (Child-Pugh Class A to C Cirrhosis)
      1. Ribavirin is added to regimen in Child-Pugh Class C Cirrhosis
  3. Genotypes
    1. Hepatitis CGenotype 1a
    2. Hepatitis CGenotype 1b
    3. Hepatitis CGenotype 2
    4. Hepatitis CGenotype 3
    5. Hepatitis CGenotype 4
    6. Hepatitis CGenotype 5 or 6

IV. Contraindications

  1. See Hepatitis C Antiviral Regimen
  2. Approved for any eGFR and for those on Hemodialysis
  3. Genotype 3 with Protein 5A resistance associated Y93H substitution
    1. Associated with antiviral resistance

V. Mechanism

  1. Sofosbuvir is a NS5B Polymerase Inhibitor (...buvirs)
  2. Velpatasvir is a NS5A Protein Inhibitor (...asvirs)

VI. Dosing

  1. Take once daily for 12 weeks

VII. Evaluation

  1. See Hepatitis C Antiviral Regimen for Pre and post-treatment protocols

VIII. Adverse Effects

IX. Drug Interactions

  1. See Hepatitis C Antiviral Regimen
  2. Sofosbuvir (Sovaldi) Drug Interactions
    1. See Sofosbuvir
    2. Avoid potent P-Glycoprotein Inducers (reduce Sofosbuvir efficacy)
    3. Avoid Amiodarone (severe Bradycardia risk)
  3. Rosuvastatin (Crestor)
    1. Limit Rosuvastatin to 10 mg orally daily
  4. Topetecan
    1. Avoid with Epclusa
  5. Digoxin
    1. Epclusa may increase Digoxin Levels
  6. Antacids (reduce Epclusa absorption)
    1. Aluminum and Magnesium Salt Antacid or Calcium Carbonate
      1. Avoid Antacids if possible
      2. Do not take Antacids within 4 hours of Harvoni dose
    2. H2 Blockers
      1. May take at the same time as Harvoni, or separated by at least 12 hours
      2. Do not use equivalent greater than Famotidine 40 mg orally twice daily
    3. Proton Pump Inhibitors
      1. Avoid if possible
      2. Take with food 4 hours prior to Epclusa
      3. Do not use equivalent greater than Omeprazole 20 mg orally daily

X. Monitoring

XI. Efficacy

  1. Hepatitis C clearance rate of >95% against all Genotypes

XIII. References

  1. (2023) Presc Lett, Hepatitis C Treatment Overview, Resource #390902
  2. (2016) Presc Lett 23(9)

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Related Studies

Cost: Medications

epclusa (on 7/19/2023 at Medicaid.Gov Survey of pharmacy drug pricing)
EPCLUSA 400 MG-100 MG TABLET Generic $278.34 each