Gilead Secures FDA Approval For Chronic Hepatitis C Re-Treatment

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Gilead Sciences, Inc. (NASDAQ: GILD) shares remained unchanged after the firm announced an approval from the U.S. Food and Drug Administration (FDA). Essentially, the FDA approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets for the re-treatment of chronic hepatitis C virus (HCV) infection for specific genotypes.

The treatment works to combat the 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.

Keep in mind that Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.

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, commented:

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. 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.

Shares of Gilead were last seen at $71.25, with a consensus analyst price target of $77.29 and a 52-week range of $63.76 to $88.85.