Drug: Vosevi (voh-SEV-ee)
Vosevi is a combination of three drugs—sofosbuvir (polymerase inhibitor), velpatasvir (NS5A inhibitor), and voxilaprevir (protease inhibitor) combined into one pill taken, once-a-day for 12 weeks. It is approved by the Food and Drug Administration (FDA) to treat adults with chronic hepatitis C with and without compensated cirrhosis. Vosevi is manufactured by Gilead Sciences Inc.
It is approved to treat patients with the following characteristics:
- HCV genotype(s) 1, 2, 3, 4, 5 or 6 who have been previously treated with a HCV therapy containing an NS5A inhibitor,
- HCV genotype(s) 1a, or 3 infection and have been treated with an HCV therapy containing sofosbuvir without an NS5A inhibitor
- Additional benefit of treatment with Vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5 or 6 infection previously treated with sofosbuvir without a NS5A inhibitor.
The overall cure rates of Vosevi are 91% to 100% in patients who had been previously treated with sofosbuvir-containing therapies. The wholesale acquisition cost (WAC) for Vosevi is $24,920.00 for a 28-day supply.
Patient Assistance Program: Support Path – 1-855-769-7284 – www.mysupportpath.com
Common Drug Interactions: The herb St. John’s wort should be avoided. Antacids and other products to relieve heartburn (stomach problems) can affect how well Vosevi works. Talk to your medical provider about any medications, supplements, herbs or over-the-counter medications you are taking to prevent any possible problems that may interfere how well Vosevi will work.
See the Highlights of Prescribing Information for a complete listing of drug interactions.
Note: The Food and Drug Administration (FDA) is requiring that hepatitis C (HCV) medication guides (package inserts) list a warning about a possible risk of hepatitis B (HBV) reactivation while on HCV antiviral therapy. Reactivation of HBV can cause possible liver damage. However, the risk is extremely rare. The reactivation has been reported with interferon and direct-acting antiviral medications.
Patients should talk to their medical providers about the hepatitis B tests and vaccination prior to starting HCV treatment.
Side Effects: The most common side effects of Vosevi that occurred in more than 10% of patients in the clinical trials were headache, fatigue, diarrhea, and nausea.
Pregnancy: There is no adequate human data available to establish whether or not Vosevi poses a risk to pregnancy outcomes. Please refer to the Highlights of Prescribing information and talk to a medical provider for more information.
Pediatric Patients: The safety and effectiveness of Vosevi has not been studied in pediatric patients.
Recommended Treatment Durations – Cure Rates
Treatment Period: 12 weeks – all of the patients were prior treatment experienced who did not have cirrhosis or who had compensated cirrhosis. The cure rates listed below are from two clinical trials—Polaris-1 and Polaris-4. A breakdown of the study results can be found in the Highlights of Prescribing Information.
|Total – genotype 1
||97% (198 of 204 patients) *
*Four patients had HCV genotype 1 but a different subytpe other than 1a or 1b
|Genotype 2 through 6
||100% (36 of 36 patients)
||95% ( 126 of 132 patients)
||91% (20 of 22 patients)
||100% (1 of 1 patients)
||100% (6 of 6 patients)
Highlights of Prescribing Information
Patient assistance information