Name Sofosbuvir
Classes Antiinfective Agent
Antiviral Agent
Diseases Hepatitis C
Infectious Disease

Sofosbuvir

Sofosbuvir is an inhibitor of the Hepatitis C Virus RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate, which can be incorporated into HCV RNA by the polymerase and acts as a chain terminator.

Sofosbuvir is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.

  • One 400 mg tablet taken once daily with or without food.
  • Should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. Recommended combination therapy:
Patient Population Treatment  Duration
Genotype 1 or 4  Sofosbuvir + peginterferon alfa + ribavirin  12 weeks
Genotype 2  Sofosbuvir + ribavirin  12 weeks 
Genotype 3  Sofosbuvir + ribavirin 24 weeks 

The most common adverse events observed with Sofosbuvir in combination with peginterferon alfa and ribavirin were-

  • fatigue
  • headache
  • nausea
  • insomnia
  • anemia
  • Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients receiving amiodarone and Sofosbuvir in combination with another direct acting antiviral (DAA), especially in those receiving beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease. It is not recommended to take amiodarone with Sofosbuvir in conjunction with another DAA. Cardiovascular monitoring is advised in patients who do not have other viable treatment options.
  • P-gp inducers in the intestine (e.g., rifampin, St. John's wort) may significantly reduce sofosbuvir plasma concentrations and thus reduce Sofosbuvir's therapeutic effect.
  • Because Sofosbuvir is used in combination with other antiviral drugs for treatment of HCV infection, consult the prescribing information for these drugs used in combination with Sofosbuvir. Warnings and Precautions related to these drugs also apply to their use in Sofosbuvir combination treatment. 
  • The use of Sofosbuvir with other products containing sofosbuvir is not recommended. 

Contraindication

When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to Sofosbuvir combination therapy.