FDA Approves New Hepatitis C Treatment

The US Food and Drug Administration has approved Vosevi for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6 in adult patients without cirrhosis or with mild cirrhosis.

Vosevi is a fixed-dose combination tablet that contains sofosbuvir, velpatasvir, and voxilaprevir. Treatment recommendations are based on the different viral genotypes and prior treatment history of the patient. It is the first therapy approved for patients who have been previously treated with sofosbuvir or other direct acting antiviral HCV drugs that inhibit NS5A.
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Approval was based on the results of 2 clinical trials that included approximately 750 adult patients without cirrhosis or with mild cirrhosis and HCV. Overall, 96% to 97% of patients in both trials who received Vosevi had no virus detected in the blood 12 weeks after treatment ended.

Common adverse reactions associated with Vosevi included headache, fatigue, diarrhea, and nausea. Patients taking rifampin should not receive Vosevi.

In addition, hepatitis B reaction (HBV) has been reported among patients with HCV/HBV coinfection who are not taking antiviral therapy for HBV. Physicians should screen all patients for HBV infection prior to initiating treatment with Vosevi.

—Melissa Weiss

Reference:

FDA approves Vosevi for hepatitis C [press release]. FDA. July 18, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567467.htm. Accessed July 18, 2017.