Sofosbuvir Ledipasvir

Aka: Sofosbuvir Ledipasvir, Ledipasvir/Sofosbuvir, Harvoni

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II. Precautions

  1. See Hepatitis C Antiviral Regimen

III. Indications

  1. See Hepatitis C Antiviral Regimen
  2. Genotypes
    1. Hepatitis CGenotype 1a
    2. Hepatitis CGenotype 1b
    3. Hepatitis CGenotype 4
    4. Hepatitis CGenotype 5 or 6

IV. Contraindications

  1. See Hepatitis C Antiviral Regimen

V. Mechanism

  1. Sofosbuvir is a NS5B Polymerase Inhibitor (...buvirs)
    1. Blocks RNA Polymerase, resulting in inhibition of viral replication
  2. Leipasvir is a NS5A Protein Inhibitor (...asvirs)

VI. Dosing

  1. Take once daily for 12 weeks
  2. Shorter, 8 week protocols may be used for specific Genotypes, depending on comorbid infections
  3. Longer, 24 week courses are used in Cirrhosis and prior treatment failure

VII. Evaluation

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

VIII. Adverse Effects

  1. See Hepatitis C Antiviral Regimen

IX. Drug Interactions

  1. See Hepatitis C Antiviral Regimen
  2. No significant CYP450 interactions
  3. Sofosbuvir (Sovaldi) Drug Interactions
    1. See Sofosbuvir
    2. Avoid potent P-Glycoprotein Inducers (reduce Sofosbuvir efficacy)
    3. Avoid Amiodarone (severe Bradycardia risk)
  4. Antacids (reduce Harvoni 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. May take at the same time as Harvoni on an empty Stomach
      2. Do not use equivalent greater than Omeprazole 20 mg orally daily
  5. Rosuvastatin
    1. Avoid with Sofosbuvir
  6. Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir)
    1. Avoid with Sofosbuvir
  7. Digoxin
    1. Sofosbuvir may increase Digoxin Levels

X. Monitoring

  1. See Hepatitis C Antiviral Regimen

XI. Efficacy

  1. As effective as combinations that include Ribavirin and Interferon in Genotype I Hepatitis C infections

XII. Resources

  1. Harvoni (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4ec77e4-bae8-4db0-b3d5-bde09c5fa075

XIII. References

  1. (2023) Presc Lett, Hepatitis C Treatment Overview, Resource #390902

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