Chronic hepatitis C virus (HCV) patients have a new treatment option with the approval of Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the U.S. Food and Drug Administration.
Gilead Sciences Inc. announced the FDA approval.
Vosevi is a once-daily, single tablet treatment for retreating HCV in adults with the genotype 1, 2, 3, 4, 5 or 6 who previously followed an NS5A inhibitor-containing treatment program. It may also be used to re-treat those with genotype 1a or 3 who received sofosbuvir-containing treatments without an NS5A inhibitor.
“Direct-acting antiviral regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients," principal investigator and Mount Sinai Beth Israel Chairman of the Department of Medicine Dr. Ira Jacobson said. "However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option. Treatment with Vosevi resulted in high cure rates in clinical studies of patients who were not previously cured with several widely-prescribed DAA regimens and will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients.”
The 12-week Phase III POLARIS-1 and POLARIS-4 studies found that 96 percent of the patients treated reached an undetectable viral load 12 weeks after therapy was completed. The participants already had a failed prior treatment.
“The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens." Gilead President and CEO John Milligan said.