The U.S. Food and Drug Administration (FDA) on Tuesday approved Gildad’s Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir, explains the FDA.
“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,” Jacobson added.
Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients. See below for important safety information.
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.
Edward Cox, who is the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said: “Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.
According to Gilead’s President and Chief Executive Officer, John F. Milligan, the evolution of Gilead’s portfolio of HCV single-tablet regimens is a part of the company’s commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible. “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,” said Miligan.