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VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets

aSustained virologic response (SVR12) was the primary endpoint and was defined as HCV RNA <15 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

INDICATION

VOSEVI is indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis who have:

  • genotype 1, 2, 3, 4, 5 or 6 and were previously treated with an NS5A inhibitor.
  • genotype 1a or 3 and were previously treated with sofosbuvir without an NS5A inhibitor; additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5 or 6 infection in this population.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VOSEVI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. 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.

Contraindications

  • VOSEVI is contraindicated with rifampin.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of VOSEVI with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: St. John's wort and carbamazepine are not recommended for use with VOSEVI as they may significantly decrease sofosbuvir, velpatasvir, and/or voxilaprevir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (≥10%, all grades) with VOSEVI were headache, fatigue, diarrhea, and nausea.

Drug Interactions

  • Coadministration of VOSEVI is not recommended with phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir, voxilaprevir, and/or the other agent.

Consult the full Prescribing Information for VOSEVI for more information on potentially significant drug interactions, including clinical comments.

 

Please click here to see full Prescribing Information for VOSEVI, including BOXED WARNING.