Sofosbuvir

Brand Names: VOSEVI

Drug Class: Direct-acting antiviral combination (nucleotide analog NS5B polymerase inhibitor + NS5A inhibitor + NS3/4A protease inhibitor)

Overview

VOSEVI is a fixed-dose combination tablet containing sofosbuvir, velpatasvir, and voxilaprevir for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis. It is specifically indicated for patients who have previously failed treatment with certain HCV regimens, including those containing NS5A inhibitors or sofosbuvir-based therapies.

Mechanism of Action

VOSEVI combines three direct-acting antiviral agents with complementary mechanisms: sofosbuvir is a nucleotide analog NS5B polymerase inhibitor that terminates viral RNA chain elongation; velpatasvir is an NS5A inhibitor that disrupts viral replication complex formation; and voxilaprevir is an NS3/4A protease inhibitor that prevents polyprotein processing essential for viral maturation.

Indications

  • Treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor
  • Treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor

Common Doses

  • 400 mg sofosbuvir/100 mg velpatasvir/100 mg voxilaprevir per tablet

Dosage

One tablet (containing 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg voxilaprevir) taken orally once daily with food for 12 weeks.

Contraindications

  • Concomitant use with rifampin

Side Effects

  • Common adverse reactions include headache, fatigue, diarrhea, and nausea
  • Serious adverse reactions include symptomatic bradycardia when coadministered with amiodarone

Interactions

  • Contraindicated with rifampin
  • Serious bradycardia risk with amiodarone coadministration
  • Potential interactions with strong P-gp inducers, moderate to strong CYP inducers, and certain antacids/H2-receptor antagonists/proton pump inhibitors

Counseling Points

  • Take exactly as prescribed, one tablet daily with food
  • Do not miss doses; if a dose is missed, take as soon as remembered unless it's almost time for the next dose
  • Avoid taking with antacids within 4 hours of VOSEVI dose
  • Report any symptoms of slow heart rate, fainting, or dizziness immediately
  • Inform all healthcare providers about all medications being taken