IDStewardship

Ledipasvir/sofosbuvir (Harvoni)

[ledipasvir/sofosbuvir photo]

Here is a helpful tip for these new hepatitis C virus drugs:

KEY POINTS

  • Ledipasvir/sofosbuvir (Harvoni) is a medication utilized to treat infection caused by certain genotypes of the hepatitis C virus (HCV)
    • Ledipasvir inhibits the NS5A protein needed for viral replication
    • Sofosbuvir is a prodrug that converts to its active form, which then inhibits NS5B RNA-dependant RNA polymerase needed for viral replication
  • Refer to HCV treatment guidelines for treatment duration and when it is indicated
    • FDA indication is for chronic HCV genotype 1, 4, 5 or 6 with or without ribavirin
    • Duration and regimen consideration typically include: genotype, cirrhosis status, and treatment history
      • 12 weeks is a common duration
    • Patients should receive proper screening prior to initiating therapy
  • Dose is 1 pill once daily by mouth
    • Should be used with caution in patients with creatinine clearance <30 mL/min
    • No dosage adjustment in package insert for Child-Pugh class A, B or C
    • Can be administered with or without food
    • Patients should be advised not to miss doses to increase chances of treatment success
  • Beware drug-drug interactions with acid-suppressing drugs (e.g., proton pump inhibitors, H-2 antagonists, calcium carbonate)
    • There are many other drug-drug and drug-herbal interactions to beware, but this one with acid-suppressing drugs is frequently relevant clinically
  • Common side effects are headache, fatigue and weakness
  • An FDA warning exists regarding the use of amiodarone with ledipasvir/sofosbuvir, which can lead to bradycardia
  • Only available brand-name in the United States and is extremely expensive, meaning a treatment course without insurance can be many tens of thousands of dollars

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