WASHINGTON -- An oral tablet that combines as second-line therapy for hepatitis C virus (HCV) infection, the FDA announced Tuesday.
Containing sofosbuvir, velpatasvir, and voxilaprevir, the product will be sold under the name Vosevi by Gilead Sciences. The first two drugs were already approved; this is the first approval for voxilaprevir in any form.
Vosevi's specific indication is for patients infected with HCV genotypes 1-6 previously treated with a direct-acting agent targeting the HCV NS5A protein such as sofosbuvir (Sovaldi).
"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," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a statement.
Gilead had originally hoped the three-drug combination could be approved as first-line treatment, but it failed a non-inferiority trial comparing it to the currently approved combination of sofosbuvir and velpatasvir (Epclusa). It did, however, succeed in two other trials testing the three-drug product in patients not fully responding to NS5A inhibitors. In that setting, Vosevi achieved 12-week sustained viral response rates of 96% and 98% in the two studies.
The FDA noted that treatment recommendations for Vosevi will differ depending on the HCV genotype and prior treatment history.
As with other direct-acting antivirals for HCV, patients should be screened for hepatitis B infection prior to starting Vosevi because of the risk of HBV reactivation.
Gilead did not say what it would charge for Vosevi. Its pricing strategy for other HCV drugs beginning with Sovaldi, approaching $100,000 for a course of therapy, has generated considerable controversy. The firm did indicate that its .