Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.
"Direct-acting antiviral regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients. However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option," said Ira Jacobson, MD, chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Vosevi clinical trials. "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."
Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.
Vosevi is the latest single-tablet regimen in Gilead's portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV, with the convenience associated with once-daily single-tablet regimens. Since 2013, Gilead has brought to market four HCV treatments, including 3 single-table regimens. To date, more than an estimated 1.4 million patients worldwide have been treated with sofosbuvir-based regimens.
"The evolution of Gilead's portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible," said John F. Milligan, PhD, Gilead's president and chief executive officer. "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."
The approval of Vosevi is supported by data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotypes 1a and 3 with or without compensated cirrhosis who had failed prior treatment with a sofosbuvir-containing regimen that did not include an NS5A inhibitor. In these populations across the two studies, 340 of the 353 patients treated with Vosevi (96 percent) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.
The most common adverse events (=10% of patients) among patients who received Vosevi were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received Vosevi for 12 weeks.
To support these patients and their families, Gilead's US Support Path programme provides information regarding access and reimbursement coverage options to patients in the United States who need assistance with coverage for their Gilead HCV medications, including Vosevi. Support Path conducts benefits investigations and provides patients with information regarding their insurance options.
Further, the Vosevi Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.
Gilead's vosevi, us fda, re-treatment of adults, chronic hepatitis c virus
