FDA announced the approval of Vosevi for the treatment of adults with chronic hepatitis C genotypes 1 through 6, according to an agency press release.
“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,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation Research.
Researchers evaluated Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences) during two phase 3 clinical trials. The first compared Vosevi to placebo for 12 weeks in patients with genotype 1 who had previously failed NS5A inhibitor treatment, and patients with genotypes 2 through 6 who all received Vosevi. The second trial compared Vosevi to Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) in adults with genotypes 1, 2 and 3 who failed previous treatment. Both trials resulted in sustained virologic response in 96% to 97% of patients.
The FDA advises that the common adverse reactions in patients taking Vosevi include headache, fatigue, diarrhea and nausea. The agency also advises that Vosevi is contraindicated in patients taking Rifadin (rifampin, Sanofi) and that reports showed hepatitis B reactivation in patients with HCV/HBV coinfection.
Vosevi’s application received priority review designation.