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Sofosbuvir

Sofosbuvir

Spectrum Of Activity

General Spectrum of Activity
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General Information

Hepatitis C, chronic Genotype 1, 2, 3, and 4 in adults Genotype 2 and 3 in children

Black Box Warning: Test all patients for evidence of current or prior hepatitis B virus infection before initiating treatment with sofosbuvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. 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."

Test for hepatitis B surface antigen and hepatitis B core antibody prior to initiation.

Monitor signs and symptoms of hepatitis flare or HBV reactivation during treatment and post-treatment follow-up in patients with evidence of current or prior HBV infection.

Common

  • Diarrhea
  • Anemia
  • Headache
  • Insomnia
  • Fatigue
  • Pruritus

Severe

  • Bradyarrhythmia
  • Liver failure
  • Increased bilirubin level
  • Reactivation of HBV
  • Psychiatric effects

Contraindications:

  • Rifampin- may reduce plasma concentrations

Major drug-drug interactions:

  • Amiodarone
  • Warfarin
  • Capmatinib
  • Rifapentine
  • P-gp inducers

Antimicrobial class: Antiviral agent, NS5B RNA polymerase inhibitor

Average serum half life: 0.4 hour

Precautions:

  • Monotherapy or sofosbuvir dose reduction is not recommended.
  • Bradycardia and fatal cardiac arrest have been reported during concurrent use of amiodarone, with some cases requiring pacemaker intervention; monitoring recommended and discontinuation may be necessary.